COATED DENTAL DEVICES WITH

DRY-TO-THE-TOUCH, FLAVOR-ABSORBING, SALIVA SOLUBLE COATINGS AND METHODS FOR MANUFACTURING

PRIORITY CLAIM

This application claims priority from U.S. Patent Application Serial No. 11/549,670, filed October 16, 2006, the disclosure of which is hereby incorporated herein by reference.

FIELD OF INVENTION

The field of the present invention relates to methods for coated, interproximal, disposable, one-handed dental devices with dry-to-the-touch, saliva soluble coatings, that are capable of absorbing flavors from a flavor reservoir contained in a flavor- sealed package that is purged with inert gas, prior to sealing and methods of manufacture of these devices. These disposable, one-handed, flavor-enhanced, dental devices include a variety of medical devices suitable for cleaning spaces between teeth and below the gumline, including dental flossers, dental picks, dental massagers, proxy brushes, and the like. All of these biofilm therapy, disposable, one-handed dental devices are treated with saliva soluble emulsions, film-formers, sialagogues and combinations of these substances that are dry-to-the-touch when the coating is completed. These coatings absorb volatile flavors when the coated devices are

subsequently stored under flavor-sealed conditions, provided with a flavor reservoir.

These coatings contain: (a) saliva-soluble film forming agent mixtures, (b) saliva soluble chemotherapeutic ingredient/film-forming agent mixtures, and/or (c) complex, saliva-soluble mixtures containing any or all of the above plus surfactants and/or emulsions, all of which are dry-to-the-touch according to the teachings of this invention and capable of absorbing volatile flavors, when contained in flavor-sealed packaging fitted with a flavor reservoir containing volatile flavors. These coated devices are suitable for physically controlling, disrupting and removing biofilms, while delivering high levels of adsorbed flavors, along with efficacious levels of chemotherapeutic ingredients.

Specifically, the present invention relates to coated dental devices with adsorbed flavors and methods for improving disposable, one-handed dental devices with dry-to-the-touch, saliva soluble coatings, that are suitable for absorbing volatile flavors from a flavor reservoir when contained in a flavor-sealed package that has been purged with an inert gas, including:

(1) dental flossers as described in U.S. Pat. Nos.:

147,987; 175,795; 413,001; 2,217,917; 2,059,287;

2,784,722; 1,815,408; 2,187,899; 3,974,842; 3,926,201;

2,187,899; 2,443,415; 4,615,349; 3,974,842; 4,006,750;

4,016,892; 5,086,792; 5,538,023; 5,692,531; 3,858,594;

2,180,522; 2,187,899; 2,443,415; 3,926,201; 4,615,349;

1,415,762; 2,702,555; 2,811,162; 3,693,594; 4,192,330;

4,522,216; 4,807,651; 5,113,885; 5,123,432; 5,538,023;

5,503,168; 5,483,982; 5,388,600; 5,287,865; 5,246,021;

5,738,125; 5,704,379; 5,904,155; 5,829,458; 6,065,479; 6,227,210; and U.S. Pat. Publication No. 2005-0205107 Al.

Additional examples of such devices are described in

copending application Ser. No. 11/349,042, filed February 7, 2006, now U.S. Pat. Publication No. 2006-0177384 Al.

(2) dental picks and dental stimulators as described in U.S. Pat. Nos.: 4,651,760; 4,805,646; 5,234,009; 1,527,028; 2,008,206; 3,101,172; 3,910,293; 4,135,528; 4,271,854; 4,314,574; 4,403,625; 4,570,653; 4,577,649; 4,942,034; 2,667,443; 2,748,781; 2,772,205; 2,896,639; 3,838,702; 3,897,795; 4,029,113; 4,175,326; 4,462,136; 4,510,127; 4,627,975; 4,616,667; 5,234,009; 1,527,028; 2,008,206; 3,101,172; 3,910,293; 4,135,528; 4,271,854; 4,314,574; 4,403,625; 4,570,653; 4,577,649; 4,942,034; 2,667,443; 2,748,781; 2,772,205; 2,896,639; 3,838,702; 3,897,795; 4,029,113; 4,175,326; 4,462,136; 4,510,127; and 4,627,975.

Additional examples of suitable other one-handed devices are described in co-pending Patent Application, Serial No. 11/349,042, filed February 7, 2006, now U.S. Pat. Publication No. 2006-0177384 Al.

(3) Proxy brushes as described in U.S. Pat. Nos.:

D333,002; D360,077; D421.841; 5,027,467; 5,201,091; 5,309,596; 5,377,377; 5,633,083; 5,934,295; and 6,446,640, which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

Disposable, one-handed dental devices, including dental flossers, proxy brushes and dental picks/dental stimulators, are often preferred over traditional dental floss, because they require only one hand to insert into interproximal areas. Additionally, these convenient, portable, one-handed, disposable dental devices can be carried in pocket or purse, and/or stored in desk drawers, glove compartments, etc.,

- A - and therefore are accessible for use throughout the day, after meals, snacks, coffee breaks, etc., when you can't brush, but should.

Because of the injection molding process used to manufacture dental flossers, the dental floss or dental tape used in the device cannot be coated with substantial quantities of saliva soluble substances that can be released during flossing into the mouth. See U.S. Pat. Nos. on compression coating dental flosses and tapes, including:

4,911,927; 5,057,308; 5,057,309; 5,057,310; 5,098,711;

5,165,913; 5,538,667; 5,665,374; 5,711,935; 6,545,077;

6,575,176; 6,591,844; 6,604,534; 6,609,527; 6,907,889;

6,916,880; 7,017,591; and 7,025,986

Specifically, the dental floss or dental tape substrate in dental flossers cannot be similarly coated prior to injection molding due to the high temperatures encountered in the injection molding process used to capture the floss or tape in flossers. These high temperatures will not accommodate coated dental floss or dental tape substrates, such as described in the above referenced U.S. Patents. Accordingly, disposable dental flossers generally are unflavored or ineffectively flavored, and therefore deliver very little, if any, coating substances or flavor into interproximal areas during flossing.

Heretofore, most disposable flossers have had limited opportunity to introduce flavors, mouth feel agents, tingling substances, etc., into the oral cavity during use. Certain flossers have been provided with post-added zones of flavor, etc., such as described in U.S. Pat. Publication No. 2006-0042650. To date, no disposable, one- handed, dental devices have been able to deliver volatile flavors, tingling sensation, and/or mouthfeel to the oral cavity during use, such as described in U.S. Patent Publication No. 2006-0177384. Attempts to post-coat dental flossers and dental picks via dipping, spraying, etc., have generally been unsuccessful. Most post-coated

devices have been unsightly and consumer unfriendly, indicating substantial flaking of the coating prior to use.

It is generally agreed that dental flossers, dental picks, dental stimulators and other one-handed, disposable dental devices, including proxy brushes, could be improved substantially if they were coated with dry-to-the-touch, saliva soluble coatings that are suitable for subsequently absorbing volatile flavors when contained under flavor-sealed conditions that are provided with a volatile flavor reservoir and purged with an inert gas.

OBJECTS OF THE INVENTION

An object of the present invention is to coat disposable, one-handed dental devices with dry-to-the-touch, saliva soluble coatings that are capable of subsequently absorbing volatile flavors.

A further object of the invention is to coat disposable, one-handed dental flossers, dental picks and dental stimulators with multiple coatings of dry-to-the- touch, saliva soluble coatings, wherein the coated devices subsequently adsorb volatile flavors from a flavor reservoir provided under flavor-sealed conditions with an inert gas purge.

Still another object of the invention is to adapt commercial confectionery equipment and processes to coating disposable, one-handed dental devices, including dental flossers, dental stimulators and dental picks with multiple coatings of dry-to- the-touch, saliva soluble, flavor-absorbable coatings.

Yet another object of the invention is to coat disposable, one-handed dental devices, including dental stimulators, dental picks and dental flossers with multiple coatings of dry-to-the-touch, saliva soluble, flavor-absorbing coatings containing MICRODENT® emulsions.

Still another object of the invention is to coat disposable, one-handed dental devices, including dental stimulators, dental picks and dental flossers, with multiple coatings of saliva soluble, flavor-absorbing coatings containing film- forming ingredients.

A further object of the invention is to coat disposable, one-handed dental devices, including dental flossers, dental stimulators and dental picks, with multiple coatings of saliva soluble coatings containing chemotherapeutic ingredients and film- forming mixtures.

A still further object of the invention is to coat proxy brushes with saliva soluble coatings that are capable of subsequently absorbing volatile flavors from a flavor reservoir provided under flavor-sealed conditions with an inert gas purge.

These and other objects of the invention are achievable and understandable by one skilled in the art after reviewing the specification and examples and claims set out below.

SUMMARY OF THE INVENTION

The present invention is directed to coated, disposable, one-handed, dental devices with saliva soluble coatings capable of absorbing volatile flavors and methods for their manufacture. The present invention also includes a method for imparting a high mouth feel impact to disposable, one-handed, dental devices, such as dental flossers, dental stimulators and dental picks, comprising: imparting tumbling motion to said devices by means of a rotating drum-type means and simultaneously periodically introducing into the drum a saliva soluble, flavor absorbing coating, such as a: wax, a film former, or a MICRODENT® emulsion, and/or combinations thereof, accompanied by controlled heat and air flow; thereby coating the devices in their entirety with a series of dry-to-the-touch, saliva soluble coatings, followed by drying each coating with heat and air prior to applying a subsequent coating and drying with

heat and air said subsequent coatings. Said multiple flavor-absorbing coatings comprise from between about 0.25% and about 6% by weight of said multi-coated, disposable, one-handed dental device. The present invention further includes methods for coating proxy brushes with a saliva soluble, flavor-absorbing coating during proxy brush assembly or after assembly.

Thus, one aspect of the present invention is a method for coating disposable, one-handed dental devices with dry-to-the-touch, flavor-absorbing, saliva soluble coatings suitable for subsequently absorbing volatile flavors, comprising: a. introducing said devices into a moving coating drum that imparts tumbling motion to said dental devices, b. introducing, periodically into said drum, a dry-to-the-touch, saliva soluble, coating mixtures, c. coating said moving dental devices with coatings of said dry-to-the-touch, flavor-absorbing, saliva soluble, coating mixtures, d. removing substantially all the moisture between coatings, and e. discharging said coated dental devices from said coating drum, at such time as said dry-to-the-touch, flavor-absorbing coating comprises from between about 0.25and about 6% by weight of said coated devices.

Preferably, the dry-to-the-touch, saliva soluble, flavor-absorbing, coating mixture contains a surfactant selected from the group consisting of solid and liquid surfactants and mixtures thereof. Preferably, the saliva soluble, flavor-absorbing coating contains a polydimethylsiloxane. Preferably, the dry-to-the-touch, saliva soluble, flavor-absorbing coating contains a film former. Preferably, the film former is selected from the group consisting of hydroxypropyl cellulose, methylcellulose, ethylcelluose, hydroxypropyl methylcellulose, hydroxymethylcellulose, carboxymethylcellulose, gelatin and mixtures thereof.

Another aspect of the present invention is an apparatus useful for coating disposable, one-handed dental devices with multiple dry-to-the-touch, flavor-

absorbing, saliva soluble coatings that includes:

(a) a coating drum arrangement, which preferably rotates around an axis, keeping dental devices introduced into said drum in motion,

(b) a means for periodically introducing a dry-to-the-touch, flavor- absorbing, saliva soluble, coating mixture containing high levels of active ingredients into said drum at a controllable rate, and

(c) controllable heat and air flow means for removing moisture from said dry-to-the-touch, flavor-adsorbing, coated dental devices between coatings as they are tumbled in said coating drum.

Yet another aspect of the present invention is a method for coating disposable, one-handed dental devices with dry-to-the-touch, flavor-absorbing, saliva soluble, coating mixtures containing chemotherapeutic ingredients and suitable for absorbing volatile flavors, comprising: introducing said devices into a coating vessel that imparts motion to said devices, periodically introducing said dry-to-the-touch, saliva soluble, coating mixtures containing chemotherapeutic ingredients into said coating vessel, and removing moisture from said vessel between coating applications with the introduction of controllable heat and air flow.

The method for coating said one-handed dental devices is selected from the group consisting of pan coating, fluidized bed coating, dragee kettle coating, perforated pan coating, vibrating screen coating and combinations thereof. Preferably, in some embodiments, the coating of such devices uses a modified confectionery pan coating. Preferably, in some embodiments, the coating of said devices uses a modified confectionery fluidized bed coating. Preferably, in some embodiments, the coating of such devices uses a modified confectionery dragee kettle coating. Preferably, in some embodiments, the coating of such devices uses a modified confectionery perforated pan coating. Preferably, in some embodiments, the coating of such devices uses a vibrating screen coating. In some embodiments, multiple coating methods are employed.

Another aspect of the present invention comprises disposable, one-handed, flavor-absorbing, coated dental devices produced by adapting confectionery coating processes, including: a. introducing said devices into a moving coating drum that imparts tumbling motion to said dental devices, b. introducing, periodically into said drum, a dry-to-the-touch, flavor- absorbing, saliva soluble, coating mixture, c. coating said moving dental devices with said coating mixtures, d. removing substantially all the moisture between coatings, and e. discharging said dry-to-the-touch, flavor-adsorbing, coated dental devices from said coating drum, at such time as said coating comprises from between about 0.25 and about 6% by weight of said coated devices.

Preferably, the coated, disposable, one-handed, dental device comprises a flavor-absorbing, saliva soluble coating contained in a flavor-sealed package fitted with a flavor reservoir containing a volatile flavor. Preferably, the coated, disposable, one-handed, dental device comprises a flavor-absorbing, saliva soluble coating, and having adsorbed a volatile flavor from a flavor reservoir, while contained in a flavor- sealed package. Preferably, the dental device further comprises a flavor-sealed package, purged with an inert gas, prior to sealing. Preferably, the dental device is selected from the group consisting of dental flossers, dental stimulators, dental picks, dental massagers, proxy brushes and combinations thereof. Preferably, the saliva soluble, flavor-absorbing coating is selected from the group consisting of waxes, emulsions, film-formers and combinations thereof. Preferably, the flavor reservoir is selected from the group consisting of blotter paper, absorbent paper, absorbent resins, cotton, ethylene vinyl acetate, absorbent polymers, and combinations thereof. Preferably, the flavor-sealed package is purged with nitrogen, prior to sealing. Preferably, the dental device is a proxy brush and said flavor-absorbing, saliva soluble coating contains a chemotherapeutic ingredient. Preferably, the chemotherapeutic ingredient is selected from the group consisting of antimicrobials, anti-tartar substances, anti-plaque substances, remineralizing agents, desensitizing agents,

NSAIDs, antibiotics, nutraceuticals and combinations thereof. Preferably, the antimicrobial is selected from the group consisting of cetylpyridinium chloride, triclosan, chlorhexidine, metronidazole and combinations thereof.

A further aspect of the present invention is an improvement in confectionery coating technology; the improvement comprising introducing disposable, one-handed dental devices into a rotating confectionery coating drum and periodically introducing dry- to-the-touch, flavor-absorbing, saliva soluble, coating mixtures to coat said devices with multiple coatings of a dry-to-the-touch, saliva soluble, coating that is capable of subsequently absorbing volatile flavors. Preferably, the saliva soluble coating is substantially flavor-free.

DEFINITIONS

For purposes of describing the present invention, the following terms, as used throughout this specification, are defined as set out below:

"Disposable one-handed dental devices of the invention" are defined as medical devices treated with dry-to-the-touch, flavor-absorbing, saliva soluble coatings that are subsequently treated with an absorbable flavor under conditions that promote flavor adsorption. These saliva soluble coatings can also contain dry-to-the- touch, saliva soluble chemotherapeutic ingredients. These devices are suitable for physically controlling, disrupting and removing biofilms, while delivering: chemotherapeutic ingredients, high flavor impact and exceptional mouth feel. Disposable, one-handed dental devices of the invention include saliva soluble coated: dental flossers, proxy brushes, dental stimulators, dental massagers, dental picks, etc., including:

1. Disposable, one-handed dental flossers such as described below:

For more than one hundred years there have been attempts to

improve and modernize the dental flossing technique by development of holders onto which floss is detachably or permanently secured, and a few hundred patents have already been granted on various flossing devices. These go back to the Shurtleft U.S. Pat. No. 147,987 of 1874, and Wallace U.S. Pat. No. 175,795 of 1876. In general, the dental flossers of the prior art have fallen into two basic categories, namely the reusable or permanent dental flossers wherein the customer threads the device with floss and then throws away the floss after use, but retains the flosser; and the disposable dental flossers having a structure to which the floss is permanently attached, the entire device being thrown away after one or more uses and replaced by another similar device.

In general, the dental flossers of the permanent type are, as would naturally be expected, of considerably more complex construction and made of more expensive materials. Examples of such devices are those shown in the patents to Munroe U.S. Pat. No. 2,217,917; Storm U.S. Pat. No. 2,059,287; Chamberlin et al. U.S. Pat. No. 2,784,722; and Jordan U.S. Pat. No. 1,815,408.

Disposable, one-handed flossers, such as contemplated by the present invention, have to be made inexpensively and the floss has to be permanently attached to the flosser in some way. Examples of patents disclosing disposable flossers are the Chodorow U.S. Pat. No. 3,974,842; Katz U.S. Pat. No. 3,926,201; and Henne U.S. Pat. No. 2,187,899. Buscarino U.S. Pat. No. 2,443,415 shows both disposable and permanent flossers. A major problem with disposable flossers of the prior art is the inadequate means of attachment of the floss, because in all cases the prior art requires either complex and expensive, or insufficient means of attachment. Thus, the Chodorow and Katz patents require that the flosser be molded about the floss, which is

extremely expensive. Knotting has also been suggested, but this also is expensive and in some cases inadequate. Henne U.S. Pat. No. 2,187,899 suggests various types of mechanical attachment, but none of these provide adequate anchoring; often when floss is forced between two adjacent teeth and the spacing is small, tremendous tensile force is applied and mechanical attachments of this type are not adequate, the floss ends merely pulling from their mechanical anchoring means.

With regard to the molding of the flosser about the ends of the floss, such as shown in the Chodorow and Katz patents, this produces not only a very expensive product, but also limits the types of floss which can be used. For example, medicated and flavored flosses, wherein the medicaments and flavorings are heat sensitive or volatile, cannot be used in the hot molding process because the heat of the operation and the molten plastic will degrade and/or drive off the medicament and/or flavoring material. Further, the medicaments and flavorings negatively impact the strength of the hot molded plastic as well as the polymer's ability to firmly affix the floss into the flosser device. See U.S. Pat. Publication No. 2005-0205107 Al and also the following U.S. Pat. Nos.:

4,615,349, 3,974,842; 4,006,750; 4,016,892; 5,086,792;

5,538,023; 5,692,531; 3,858,594; 2,180,522; 2,187,899;

2,443,415; 3,926,201; 4,615,349; 413,001; 1,415,762;

2,702,555; 2,811,162; 3,693,594; 4,192,330; 4,522,216;

4,807,651; 5,113,885; 5,123,432; 147,987; 175,795;

413,001; 2,217,917; 2,059,287; 2,784,722; 1,815,408;

2,187,899; 3,926,201; 2,187,899; 2,443,415; 3,974,842;

5,538,023; 5,503,168; 5,483,982; 5,388,600; 5,287,865;

5,246,021; 5,738,125; 5,704,379; 5,904,155; 5,829,458;

6,065,479; and 6,227,210.

Additional examples of such devices are described in U.S. Pat. Publication No. 2006-0177384 Al.

All of the foregoing dental flosser references are incorporated herein by reference.

2. Dental picks and dental stimulators of the invention such as described below, are coated with saliva soluble, flavor-absorbing coating:

In U.S. Pat. No. 4,651,760, a toothpick made from plastic is disclosed which has a pointed end supported by a mid portion having longitudinal notches which allows the toothpick to be compressed in a transverse direction and also has transverse flaps which may strike the tooth surfaces. A projecting plate is used as a handle. The flaps also insure that the toothpick attains considerable rigidity to keep its shape even though it may be subject to twisting.

In U.S. Pat. No. 4,805,646, a toothpick is disclosed which has a tapered triangular point which extends from a flexing joint which allows the point to assume various different angles. However, the tip itself if fairly rigid.

U.S. Pat. No. 4,616,667 discloses another toothpick design which has two ends which are pointed, having a shaft, a preferably substantially rectangular transverse cross-section and a longitudinally grooved cleaning tip which permits deformation of the tip in such a manner and direction to reach in between the narrow gaps of teeth while not sacrificing the longitudinal rigidity of the cleaning tip. Consequently, the area adjacent the tip may be bent but the tip itself

remains rigid.

See also U.S. Pat. Nos.:

5,234,009; 1,527,028; 2,008,206; 3,101,172; 3,910,293;

4,135,528; 4,271,854; 4,314,574; 4,403,625; 4,570,653;

4,577,649; 4,942,034; 2,667,443; 2,748,781; 2,772,205;

2,896,639; 3,838,702; 3,897,795; 4,029,113; 4,175,326;

4,462,136; 4,510,127; 4,627,975; 4,651,760; 4,805,646;

5,234,009; 1,527,028; 2,008,206; 3,101,172; 3,910,293;

4,135,528; 4,271,854; 4,314,574; 4,403,625; 4,570,653;

4,577,649; 4,942,034; 2,667,443; 2,748,781; 2,772,205;

2,896,639; 3,838,702; 3,897,795; 4,029,113; 4,175,326;

4,462,136; 4,510,127; 4,627,975; 4,616,667; 4,135,528;

4,271,854; 4,314,574; 4,403,625; and 4,570,653.

See also the discussion of wooden toothpicks by Diamond Brands at their website, www.diamondbrands.com.

All of the foregoing dental pick and dental stimulator references are incorporated herein by reference.

3. Proxy brushes of the invention have their bristles coated with dry-to- the-touch saliva soluble, flavor-absorbing coatings.

Proxy brushes of the invention are preferably not coated with the tumbling- type action, but rather are preferably coated with a saliva soluble, flavor-absorbing coating:

(a) during the assembly of the proxy brush by spray coating the bristles with saliva soluble, flavor-absorbing coatings from several spraying

stations, either prior to assembly of the coated bristles into the proxy brush handle, or after attachment of the handle; or

(b) by spray coating the bristles of assembled proxy brushes with a saliva soluble, flavor-absorbing coating.

See proxy brushes described in U.S.: D333,002; D360,077; D421.841; 5,027,467; 5,201,091; 5,309,596; 5,377,377; 5,633,083; 5,934,295; and 6,446,640, which are hereby incorporated by reference, which are hereby incorporated by reference.

Additional examples of suitable other one-handed devices are described in U.S. Pat. Publication No. 2006-0177384 Al which is incorporated herein by reference.

"Flavor-absorbing" dental device coatings are defined as saliva soluble coatings capable of absorbing volatile flavors when the coated dental devices are contained under flavor-sealed packaging, fitted with a flavor reservoir containing volatile flavors where the flavor-sealed package has been purged with an inert gas, prior to sealing.

"Flavor-sealed packaging" for one-handed devices of the invention includes various sealed packagings that are resistant to flavors and provided with a hermetic- type seal that: (a) retains the volatile flavor components released from a flavor reservoir contained inside the package, (b) resists the admission of air into the package that has been previously purged with an inert gas, and (c) maintains the stability of the volatile flavors and various ingredients contained in the coatings on said dental devices.

"Flavor reservoir" is defined as a source of volatile flavors, contained in the flavor-sealed dispenser. These volatile flavors are absorbed by the flavor reservoir and released into the head space of the flavor-sealed dispenser, to be absorbed by the

coatings on the unit-doses of dental devices. To insure stability of the volatile flavor in the head space of the flavor-sealed dispenser, the flavor-sealed dispenser is purged with an inert gas, prior to sealing. Suitable flavor reservoir materials include various absorbent substances such as blotter paper, tissue paper, natural resins, polymers, EVA resins, cotton, cellulose and other inert absorptive substances that can contain a wide range of volatile flavors which are held in the flavor reservoir to be released into the head space of the flavor-sealed dispenser for subsequent adsorption by the dental device coatings. Suitable volatile flavors for use with the flavor reservoir include various: lemon, lime, mint, cinnamon, vanilla, peppermint, spearmint, tangerine, orange oil volatile notes and combinations thereof, as detailed in the Examples below. Fortunately, these volatile flavors have flash points from between about 116° and 119 ⁰ F.

"Dry-to-the-touch" coatings, suitable for coating the disposable dental flossers, dental stimulators, dental picks and proxy brushes of the invention are defined as those compositions which, in spite of high levels of surfactants, waxy emulsions and/or film formers and chemotherapeutic ingredients are, by reason of their formulation with dry-film forming agents surprisingly rendered dry-to-the-touch and remain dry-to-the-touch subsequently after absorbing volatile flavors, without reducing their saliva-soluble properties or limiting their ability to deliver biofilm- removing, controlling and disrupting properties when used in the oral cavity.

The surfactant component of the saliva soluble, flavor-absorbing coating includes liquid and solid surfactants, such as:

Liquid surfactants including: polyoxyethylene glycol sorbitan mono- and di- aliphatic esters represented by the general formula:

R ₃ OiOi ₃ CHp:.,

wherein R ₁ , R ₂ , R3, R ₄ and H or aliphatic acyl groups having from between about 10 and 30 carbon atoms, and the sum of w, x, y, and z is from between about 20 and about 80. These liquid surfactants are available under the trade name Emsorb®, Span®, Tween® from Cognis, N.A. and ICI. Specific examples of these include: PEG 20 sorbitan monooleate (Tween® 80, ICI); PEG 40 sorbitan monostearate (SPAN 60 ICI) and PEG 40 sorbitan diisostearate (Eumulgin® SDI 40, Cognis N.A.).

Solid surfactants including: sodium lauryl sulfate, sodium lauryl sarcosinate, polyethylene glycol stearate, polyethylene glycol monostearate, coconut monoglyceride sulfonates, sodium alkyl sulfate, sodium alkyl sulfoacetates, block copolymers of polyoxyethylene and polyoxybutylene, allylpolyglycol ether carboxylates, polyethylene derivatives of sorbitan esters, propoxylated cetyl alcohol, block copolymers comprising a cogeneric mixtures of conjugated polyoxypropylene, and polyoxyethylene compound having as a hydrophobe a polyoxypropylene polymer of at least 1200 molecular weight (these surfactants are generally described as poloxamers; specific examples are described in the Examples below) as Poloxamer 407 and Poloxamer 388, soap powder, and mixtures thereof.

Preferably, the surfactant is included with a film forming polydimethyl- siloxane, i.e., MICRODENT® or ULTRAMULSION®. As used herein, the terms "MICRODENT®" and "ULTRAMULSION®" refer to emulsion mixtures containing polydimethylsiloxane at various molecular weights in various poloxamer surfactants

as described and claimed in U.S. Pat. Nos. 4,911,927; 4,950,479; 5,032,387; 5,098,711; 5,165,913; 5,538,667; 5,645,841; 5,651,959 and 5,665,374. These mouth conditioners are preferably included in crystal-free, saliva soluble, flavor-absorbing coatings of various disposable one-handed dental devices of the invention.

"Waxes and wax emulsions" suitable for coating the disposable, one-handed dental devices of the invention are defined to include: (a) various water-soluble waxes such as PEG, alone or with a flavor solubilizing surfactant, (b) Lipowax (mixtures of fatty acid PEG surfactant, a long chain alcohol), and (c) emulsifying waxes.

"Saliva soluble coatings" suitable for the various disposable, one-handed, dental devices of the invention are defined as those saliva soluble substances used to coat disposable dental devices for purposes of: absorbing flavors from flavor reservoirs, lubricating, ease of device insertion interproximally, and for delivering interproximally: cleaners, biofilm-responsive substances, chemotherapeutic ingredients, absorbed flavors, and other additives. These saliva soluble coatings generally comprise from between about 0.25% to about 6% by weight of the disposable, one-handed dental device.

Preferred saliva soluble, flavor-absorbing coatings for devices of the invention are dry-to-the-touch and suitable for subsequently absorbing volatile flavors. These include:

(a) those emulsion coatings described in the following U.S. Pat. Nos., 4,950,479; 5,032,387; 5,538,667; 5,561,959; and 5,665,374, which are hereby incorporated by reference,

(b) various dental device coatings, such as described in U.S. Pat. Nos.: 5,908,039; 6,080,495; 4,029;113; 2,667,443; 3,943,949; 6,026,829; 5,967,155 and 5,967,153, which are hereby incorporated by reference,

(c) those substantive saliva soluble coatings described and claimed in U.S. Pat. Nos. 6,907,889; 6,609,527; 6,916,880 and 6,545,077, which are

hereby incorporated by reference,

(d) those coatings described in U.S. Pat. Publication No. 2005-0199334 Al, entitled "Coated Monofilament Tape Bobbins and Methods for Winding"; U.S. Pat. Publication No. US 2005-0226820 Al, entitled "Non-Crystalline Saliva-Soluble Coatings for Elastomeric Monofilament Dental Tapes"; and U.S. Pat. Publication No. 2006- 0034782 Al, entitled "Biofilm Therapy Interproximal Devices," and

(e) film-forming substances such as described in copending Patent Application, Serial No. l l/xxx,xxx, filed 16 October 2006, (Attorney Docket No. 004526-00071), entitled "Clean Perception Oral Products," which are all hereby incorporated by reference.

All of the foregoing saliva soluble coatings are suitable for coating the one- handed dental devices of the invention, including dental flossers, dental stimulators, dental picks and proxy brushes. These coatings will absorb volatile flavors when retained under flavor-sealed conditions provided with a flavor reservoir and can contain biofilm-responsive levels of one or more substances suitable for controlling and disrupting biofilms.

As used herein, "coating" is generally defined as the process of introducing dry-to-the-touch, saliva soluble coatings, as well as other oral care substances onto the surfaces of various disposable, one-handed dental devices; and is accomplished by tumbling means as described above for coating dental flossers, dental stimulators and dental picks, or by spraying means as described above for proxy brushes.

"Dry-to-the-touch film forming agents" include hydroxypropyl cellulose, methyl cellulose (i.e., methyl ether of cellulose), ethyl cellulose, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, carboxymethyl cellulose, gelatin, mixtures thereof, and the like. Preferably, a branched chained film- forming agent such as hydroxypropyl cellulose, is utilized. Preferably, the hydroxypropyl cellulose has a Brookfield viscosity of not less than 145 cps for a 10% aqueous solution at 25 ⁰ C. The

coating emulsion can contain more than one film-forming agent and as such, for example, hydroxypropyl cellulose and methyl cellulose may be utilized. In such a combination the branched chained film- forming agent (e.g., hydroxypropyl cellulose) can be used in amounts of about 0.05 to about 1.5 wt. % with about 0.01 to about 0.5 wt. % being preferred, and the straight chained film-forming agent (e.g., methyl cellulose) can be used in amounts of about 0.5 about 1.0 wt. % with about 0.1 to about 0.5 wt. % being preferred.

Dry-to-the-touch film-forming agents, surfactants and/or emulsions in the coatings of the one-handed devices of the invention function as attractants for volatile flavor molecules, to such an extent that they will absorb and hold a high percentage of flavor molecules even from volatile flavor reservoirs after the film formers, surfactants and/or emulsions have been coated onto the devices of the invention. This property of absorbing and holding flavor molecules, while retaining dry-to-the-touch properties, contributes to the consumer satisfaction associated with the dental devices present invention. The absorbed flavor molecules are released from the coatings as these coatings are dissolving in the saliva, thereby releasing the absorbed flavors which become accessible to olfactory organs in the oral cavity.

As used herein, the phrase "saliva-soluble, flavor-absorbing, crystal-free coatings" refers to those saliva soluble emulsions that indicate substantial flake resistance and flavor-absorbing properties, yet release from various disposable, one- handed dental devices of the present invention during use when exposed to saliva in the oral cavity. These coatings can include SOFT ABRASIVES® that are dispersed and not solubilized in said coatings. These SOFT ABRASIVES® remain insoluble when delivered between teeth and below the gum line during use. Additionally, saliva-soluble, flavor-absorbing, crystal-free coatings preferably contain surfactants, mouth conditioners, chemotherapeutic ingredients, along with the subsequently absorbed flavors that are released from the devices into the oral cavity, along with dry-to-the-touch, saliva soluble coatings. For example, see U.S. Pat. Nos. 6,609,527 and 6,575,176. The absorbed flavors generally do not influence flaking of crystal-free

coatings.

As used herein, the term "crystal-free" refers to a smooth surface on the device as distinguished from rough surfaces typical of crystalline coatings when observed through a 3Ox stereo zoom microscope. See U.S. Pat. No. 6,609,527. Generally, crystal-free coatings containing dry-to-the-touch, saliva soluble coatings and absorbed flavors indicate minimum flaking. Examples of suitable crystal-free, flavor-absorbing coating formulations for various disposable, one-handed dental devices of the invention are detailed in the Tables and Examples below.

As used herein, the term "biofilm therapy disposable, one-handed dental devices" are defined as dental devices coated with dry-to-the-touch, saliva soluble coatings and emulsions such as MICRODENT®/ULTRAMULSION® with a subsequently absorbed flavor that control, disrupt and physically remove biofilms, while imparting high flavor and mouth feel impact to the oral cavity. In a preferred embodiment of the invention, the coated biofilm therapy disposable, one-handed dental devices of the invention with absorbed flavor include a SOFT ABRASIVES® overcoating that is also released, along with the dry-to-the-touch, saliva soluble coatings, during use to work with the substrate to help physically remove biofilms. Working the disposable, one-handed dental picks and dental stimulators with adsorbed flavor, interproximally, massages interproximal soft tissues thereby increasing blood flow. The simultaneous release of dry-to-the-touch, saliva soluble coatings or various saliva soluble coatings containing dry-to-the-touch, active ingredients, while working these picks and/or stimulators interproximally imparts high flavor and mouth feel impact to the oral cavity.

As used herein, the term "additional adjuvants" refers to additional ingredients that can be added to the dry-to-the-touch, saliva soluble coatings with flavor- absorbing capability to provide color, or sweetening effects, as desired. Examples of suitable sweetening agents include sorbitol, sodium cyclamate, saccharine, commercial materials such as Nutrasweet® brand of aspartame and xylitol. Citric

acid or acetic acid is often utilized as a flavor modifier and is generally used in amounts of about 1.0 to about 20 percent by weight, preferably about 2.0 percent to about 15 percent by weight.

As used herein, the term "buffering ingredient" refers to substances that may also be added to the dry-to-the-touch, flavor-absorbing, saliva soluble coatings of the invention in order to prevent natural degradation of the subsequently absorbed flavoring components or chemotherapeutic ingredients. Generally, the pH of these compositions is adjusted from about 3.5 to about 8, depending on the chemistry of the chemotherapeutic ingredient most requiring protection. Buffering ingredients such as an alkali metal salt of a weak organic acid, for instance, sodium benzoate, sodium citrate, sodium phosphate, sodium bicarbonate or potassium tartrate is generally added in an amount of about 0.1 to about 1.0 percent by weight. Other buffering agents such as weak organic acids or salts of weak bases and strong acids such as boric acid, citric acid, ammonium chloride, etc., can also be used in similar concentrations.

As used herein, the term "stabilizers" refers to substances that are often added to the dry-to-the-touch, saliva soluble, flavor-absorbing coating for additional control, such as:

(a) sodium benzoate, sodium or potassium sorbate, methyl paraben, propyl paraben and others approved for ingestion, and

(b) chemical oxidative control substances, such as ethylene- diaminetetraacetic acid, BHA, BHT, propyl gallate and similar substances approved for ingestion. Concentration levels of these stabilizers comply with industry and regulatory standards.

As used herein, the term "SOFT ABRASIVES®" defines saliva-soluble and saliva-insoluble abrasive substances added to the flavor-adsorbing, coated devices of the invention that are suitable for cooperating with the various disposable, one-handed dental devices of the present invention to remove, control and disrupt biofilm, tartar and stained pellicle from tooth surfaces. SOFT ABRASIVES® include: tetrasodium

pyrophosphate, calcium carbonate, dicalcium phosphate, silica, glass beads, polyethylene and polypropylene particles, pumice, titanium oxide, alumina, quartz, aluminum silicate, etc., at various particle sizes suitable for use in oral care. See U.S. Pat. No. 6,575,176.

As used herein, the term "cleaners" refers to essentially all surfactants suitable for use in the oral cavity and suitable for coating various disposable, flavor-adsorbing, one-handed dental devices of the present invention.

As used herein, the phrase "chemotherapeutic ingredients" refers to those substances other than dry-to-the-touch, saliva soluble, flavor-absorbing coatings suitable for addition to the coatings of the present invention that impart therapeutic effects to the oral cavity including: antimicrobials; anti-tartar and anti-plaque substances; remineralizing, desensitizing, NSAID; antibiotic ingredients; nutraceuticals and the like. Specific chemotherapeutic ingredients suitable for the present invention include: stannous fluoride, potassium nitrate, cetylpyridinium chloride (CPC), triclosan, metronidazole, chlorhexidine, aspirin and doxycycline.

As used herein, the phrase "crystal formation eliminating additives" is defined as those coating additives that reduce, control and/or eliminate crystal formation and enhance the substantivity of the dry-to-the-touch, flavor-absorbing, saliva soluble coating to disposable, one-handed dental devices of the invention when added to these coatings at modest levels. These include certain aliphatic, long chain, fatty alcohols having from between about 10 and 30 carbon atoms and/or various liquid surfactants such as polyethylene glycol sorbitan dialiphatic esters.

Aliphatic, long chain, fatty alcohols are suitable for the crystal-free, dry-to- the-touch, flavor-absorbing, saliva soluble coatings of the present invention. These can be represented by the structural formula ROH, wherein R represents a long chain alkyl group having from 20 to 30 carbon atoms. Specific examples include:

1-decanol 1-heptadecanol 1-pentacosanol

1 undecanol 1-octadecanol 1 -hexacosanol

1-dodecanol 1-nonadecanol 1 -heptacosanol

1-tetradecanol 1-decosanol 1 -octacosanol

1 -pentadecanol 1-henticosanol 1 -nonacosanol

1-hexadecanol 1-tricosanol 1-triacosanol

1 -tetracosanol, and mixtures thereof.

Naturally occurring mixtures with substantial quantities of these fatty alcohols, or isomers thereof; including those chemically derived from natural sources also constitute suitable sources of aliphatic, long chain fatty alcohols for the purpose of this invention.

The long chain fatty alcohols can be purchased commercially from Stepan, Procter & Gamble and Aldrich Chemical Co. and a variety of companies processing vegetable and animal derived fatty alcohols.

METHODS FOR COATING DISPOSABLE, ONE-HANDED DENTAL DEVICES WITH DRY-TO-THE-TOUCH COATINGS SUITABLE FOR ABSORBING FLAVORS

Various post-coating operations such as dipping, soaking and spraying have been used to coat dental flossers and dental picks. Unfortunately, the resultant coating levels are difficult to control as indicated by the substantial coating build up that is generally encountered during drying. This results in unpleasant-appearing, consumer unfriendly, coated devices that "turn-off most consumers who try them.

Surprisingly, it has been found that various confectionery coating processes can be modified and controlled for use with dry-to-the-touch, saliva soluble coatings for coating disposable, one-handed dental devices including dental picks, dental stimulators and dental flossers of the invention. The resultant multi-coatings of

various dry-to-the-touch, saliva soluble coating mixtures are suitable for subsequently absorbing volatile flavors when contained in a flavor-sealed package fitted with a flavor reservoir. These multi-coated dry-to-the-touch, saliva soluble coated dental devices are: not sticky to handle; they are pleasant to look at; they are easy to use; and most importantly, after absorbing volatile flavors, deliver high impact flavor and mouth feel sensation to the oral cavity, along with a prolonged, smooth mouthfeel that lasts for an extended period. Depending on the volatile flavors absorbed, these high- impact coatings with absorbed flavors can be held stable for prolonged periods when contained under flavor-sealed conditions and provided with a flavor reservoir and inert gas purge. Accordingly, these devices are commercially feasible as consumer- preferred replacements for current, commercial, disposable, one-handed dental devices.

The primary mechanical requirement of any selected coating process and apparatus is the ability to suspend the dental flosser and dental pick/stimulator dental devices in the air, or otherwise provide movement of these devices during the coating/drying operations which prevent the accumulation of the coating agents at the points of contact between the dental device and the apparatus can result in the "pooling" of the coating agents while they are still liquid and then drying in the "pooled" state. It will be obvious to one skilled in the art that allowing a manufacturing opportunity for droplets or areas of high concentration to occur at various places on the dental device during drying would be counterproductive to the intent of the invention. As noted previously, the proxy brush dental devices are preferably coated with the flavor-absorbing coatings of the present invention during manufacture of the proxy brushes. This coating is preferably carried out via several spraying stations positioned around the brush element, prior to staking the coated proxy brush into the proxy brush handle. Alternatively, the brush coating process can also be carried out after the brush is assembled on the handle using comparable spraying stations.

There are several established confectionery coating processes and apparatus,

which can be adapted by one skilled in the art to coat disposable, one-handed flosser, pick and stimulator dental devices with dry-to-the-touch, saliva soluble coatings; which are then suitable for subsequent flavor adsorption. These include:

(a) pan coating, both batch and continuous, as described in U.S. Pat. Nos. 5,010,838; 4,334,493; 3,911,860; 4,245,380; 3,448,718; 3,063,843; and 2,726,959.

Additional pan coating references include:

For example, U.S. Pat. No. 4,334,493, to Okawara shows a rotary drum type apparatus for applying a coating to devices which includes a rotary drum supported by a frame for receiving a body of devices to be coated by spraying with a solvent. The drum which can be inclined through about 10-20" in such a manner that its front surface is turned upwardly, includes a device which supplies a coating material into the interior of the drum and an inlet tube and an outlet tube to provide a supply of drying gas such as air to the interior. The support frame cooperates with an outer periphery of the drum to define an air suction duct disposed on the front side of the support frame and an air exhaust duct disposed on the rear side of the support frame so that a smooth flow of hot blast through the drum can be obtained.

Similarly, in U.S. Pat. No. 4,245,580 to Okawara, a device for coating granular solids is disclosed which has a double-cone rotary drum perforated so as to permit flow of air or gas into and out of the rotary drum, and which is tiltable about the axis at right angles to the axis of rotation of the rotary drum so that in the case of the discharge of product solids, the opening of the rotary drum may be directed downwardly. Axial annular insulating covers are providing which insure the effective thermal insulation of the rotary drum when the hot air or gas is blown thereinto. However, each of the Okawara disclosures discussed above relate to coating drums for batch operation since each body of cores to be coated must be fed into and discharged from a single opening. Similar operation and apparatus are shown in U.S. Pat. Nos. 3,448,718; 3,063,843; and 2,726,959.

U.S. Pat. No. 3,911,860 to Nohynek discloses a coating drum for continuous coating of dragees with a coating material and for subsequent application and glossing of a protective skin over the coating by use of a co-axially connected after-treatment drum. In particular, both drums are fixed in a scaling to each other and may be driven at different speeds by means of a variable speed transmission rotationally interconnected. The dragee drum shown by Nohynek is a double frustum, while the after-treatment drum is cylindrical. Both drums are equipped with a conveying baffles in order to push the product through from the entrance to the exit.

(b) fluidized bed/wurster machine coating: as described in U.S. Pat. Nos. 6,911,087; 3,196,827; 3,110,626; 4,330,502; 4,535,006; 5,236,503; 6,579,365.

In most of these fluidized bed techniques, the container acts as a processing zone in which the devices are processed, dried and/or treated. In order to optimize the processing of the devices, a certain spatial extent of the processing zones and/or of the extension of the fluidized bed is required, particularly with regard to the "flight altitude" of the devices. An analogous rule applies to fluidized bed granulation. One means of controlling the fluidized bed is by varying the gas flow into the processing zone. As is well known, this can be accomplished by manually changing the air volume, e.g., by means of an air slide, until the desired height of the fluidized bed has been achieved. The modification of the setting, as well as the monitoring of the fluidized bed zone, usually takes place visually by an operator. However, in order to maintain a constant altitude o the fluid bed zone, a continuous control is necessary, since, under certain circumstances during the treatment process, modifications of the material to be processed may occur that necessitate corresponding modifications of the "flight altitude" of the devices. It is also necessary to make different adjustments in situations where the material to be processed is different. Consequently, for good results during processing, expensive and cumbersome monitoring and manual setting by an operator are necessary. However, even careful monitoring by an operator cannot insure that an optimal setting is maintained continuously throughout the processing period. Optical illusions may affect the operator during visual control

which can result in processing the devices in an undesirable manner.

Additional fluidized bed references include:

U.S. Pat. No. 3,110,626 to G.L. Larson et al. discloses an apparatus whereby coating discrete solids suspended in a moving air stream is carried out within the interior region of a velocity concentration control element mounted in the base region of a funnel-shaped coating chamber. However such apparatus does not include any means for shielding the base of the spray pattern with an upwardly flowing column of air in order that the spray pattern may substantially develop before entrance thereinto of discrete solids to be coated.

U.S. Pat. No. 4,335,676 to Christian Debayeax et al. discloses a spouted bed granulating and/or coating apparatus wherein flow directing structure is provided to direct the gaseous flow stream in the upward direction for preventing contact and agglomeration of particles in the vicinity of the walls of the device. This patent fails to disclose structure by which the lower portion of the spray pattern is protected by an upwardly flowing column of air in order that the spray pattern may more fully develop before the entrance thereinto of particles to be coated.

U.S. Pat. No. 4,701,353 to Stanislaus M.P. Mutsers et al. discloses an apparatus whereby the liquid spray material is discharged out of a central channel as a vertically closed, conical film with a thrust exceeding the thrust of the gas streams for the purpose of causing the conical film to be nebulized to very fine droplets with the air of the surrounding gas stream. The resultant spray pattern is not protected about its initial base end by an upwardly moving column of air disposed thereabout.

U.S. Pat. No. 4,960,224 to Gustav A. Magg et al. discloses an atomizing nozzle constructed in a manner to eliminate the need to provide a metering pump or flow meter for each atomizing nozzle of an associated fluidized coating bed with the control of the flow through each atomizing nozzle being accomplished by varying the

internal bone size of the flow control tubes. However, this patent fails to disclose structure for shielding the resultant spray pattern from immediate entrance thereinto of particles to be coated before the spray pattern is reasonably developed.

U.S. Pat. No. 4,858,552 to Werner Glatt et al. discloses an apparatus whereby a fluidized current carries particles, while still plastic, upwardly through a channel device for agglomerated material disposed at a distance above the perforated base causing the particles to impinge on the underside of a rotatable means provided for shaping the agglomerated material. The Glatt et al. apparatus does not disclose structure by which the particles to be coated are shielded against entry into the initially forming spray pattern.

U.S. Pat. No. 3,196,827 to D.E. Wurster et al. discloses a tubular partition defining an upbed therein into which an air and spray discharge pattern is directed and wherein a downbed of particles in near weightless suspension is disposed outwardly of the tubular partition, the spray nozzle being disposed below the bottom of the partition above the associated air distribution plate or screen. With this device, particles being coated are also free to immediately enter the lower beginning portion of the spray pattern.

(c) Dragee coating, as described in: Silesia Confiserie Manual #2 Special Handbook for Dragee and U.S. Pat. Nos. 5,171,589; 4,649,855; 3,831,262; 5,334,244; 3,095,326; 4,105,801; 4,753,790; 4,250,195; 3,554,767; 2,304,246; 2,460,698; 3,208,405; 3,635,735; 4,238,510 and British Patent Nos. 922,495 and 1,047,349.

The disposable, one-handed flosser, stimulator/pick dental devices of the present invention can be coated with coatings containing dry-to-the-touch, saliva soluble, flavor-absorbing coatings using various confectionery coating drums which introduce the mixture onto the surfaces of the dental devices while the devices are in motion within the coating drum. Two general types of machines can be adapted to the coating process of the present invention. The first tumbles dental devices within a

horizontally rotatable drum while the dry-to-the-touch, saliva soluble, flavor- absorbing coatings are sprayed into the drum. The second uses a vertical flow of air to circulate the devices past a vertically disposed spray nozzle used to introduce the dry-to-the-touch, saliva soluble, flavor-absorbing coatings into the drum.

Three types of dragee coating processes that are adaptable to coating disposable, one-handed flosser, stimulator and pick dental devices with dry-to-the- touch, saliva soluble, flavor-absorbing coatings are detailed below:

1. Dragee Kettle:

For most applications the exact thickness of the coated layer is not critical and many different types of coating machines may be used to apply a crude, yet effective coating to the device. An older once popular type of coating machine is called a dragee kettle and examples of these machines are disclosed in U.S. Pat. Nos. 3,831,262 and 5,334,244. This machine includes a large drum-like vessel which is typically rotated about a horizontal axis. The vessel includes a coating chamber which is partially filled with the devices to be coated so that as the vessel rotates, the devices roll and tumble along the inside wall of the coating chamber. During this tumbling motion, dry-to-the- touch, saliva soluble, flavor-absorbing, coating emulsions in the form of aqueous suspensions of liquids are sprayed through nozzles and into contact with the rolling devices within the coating chamber. During the coating process, a current of temperature-controlled air circulates in the coating chamber of the dragee kettle, which helps evaporate the water of the coating emulsion so that the dry-to-the-touch, saliva soluble, flavor-absorbing coating effectively dries and adheres to the devices.

One problem with the dragee kettle coating machine is that typically the dental devices are not the only surfaces coated within the coating chamber. Even when a carefully controlled spraying schedule is followed (such as spraying at very short intervals while the dragee kettle rotates), much of the

sprayed coating material still ends up on the inside wall of the coating chamber, as well as throughout the evaporation/venting ducting. This over- spraying creates numerous contamination and cleaning problems, and further increases the cost of the coating since much of the coating material is lost during the coating process.

The above-described dragee kettle type coating machine is limited to coating flosser, stimulator and pick dental devices which do not require much precision in the thickness of the multi-coated layer because the thickness of the coating of the devices will vary in the same batch. This process may be used to coat many different flavor-adsorbing devices, as long as uniform coating distribution and thickness are not required.

2. Perforated Pan:

The next generation of device coating machines after the dragee kettle is called a perforated pan coating machine. This machine has improved the device coating process and is the most common type of dragee coating machine in use today. The perforated pan machine includes a rotatable perforated drum which rotates about a horizontal axis within a housing, and further includes a plurality of nozzles positioned within the drum. The nozzles create a spray of dry-to-the-touch, saliva soluble, flavor-absorbing coating within the drum so that any dental devices located within the drum will tumble about into and out of the spray pattern and, over a period time, will accumulate a coating throughout their surface. An important improvement of the perforated pan coating machine over the dragee kettle is that the perforated pan machine allows air directed through the housing (using appropriate ducting) to pass through the perforated drum and quickly reach the dental devices tumbling therein. The perforations of the drum effectively expose the tumbling devices to the current of air, resulting in more uniform distribution of drying air for each device. The drum further includes solid baffles which are used to enhance mixing of the device bed in an effort to improve the

distribution of the dry-to-the-touch, saliva soluble, flavor-absorbing coating being sprayed onto the dental devices of the invention.

3. Fluidized Bed Coating Machines:

Another type of device coating apparatus is called a fluidized bed coating machine (also known as a Wurster machine, after inventor Dale Wurster). These have been discussed above. Several examples of the Wurster coating machine are disclosed in U.S. Pat. Nos. 3,196,827; 3,110,626; 3,880,116; 4,330,502; 4,535,006 and 5,236,503.

The Wurster coating machine is typically used to layer and coat granules or pellets of solid materials, including pharmaceutical drugs.

As described above, the Wurster machine generates an upward stream of air or other gases such as nitrogen to circulate a device through a vertical spray of dry-to-the-touch, saliva soluble, flavor-absorbing coating within a product container. As the dental device cycles through the spray, a minute amount of coating material is deposited on its surface. The number of cycles the dental device completes determines the thickness of the final saliva soluble, flavor-absorbing coating layer.

One preferred embodiment of the present invention includes the use of drageeing kettles, where the axis of rotation is tilted to the horizontal. As a rule, such kettles have a pear-, tulip- or onion-shape in cross section. They are usually mounted on one side and have, on the side opposite to the mounting, a filling opening which, during operation, can be closed by a lid.

In such a kettle with an axis of rotation inclined to the horizontal, there is obtained a relatively complicated, three-dimensional movement, which, for example, is described in detail in an article by K.H. Bauer in "Pharmazeutische Industrie", 39, 149-156/1977. Because of the fact that, in

this case, the direction of action of the gravitational force differs from that of the centrifugal force or of the frictional force emanating from the walls of the container, in such a kettle the dry-to-the-touch, saliva soluble, flavor- absorbing coating in its deepest lying region is, roughly following the mantle line of the drageeing kettle, transported obliquely upwards as ascending material in the direction of the rotation of the kettle. It thereby obliquely reaches a zenith from which, as descending or running off material, it flows back counter to the rotational movement of the kettle. Because of the tilt of the kettle therefore, the descending material has a movement component towards the axis of the kettle so that, on average, it is closer to the axis of kettle rotation than the ascending material. As is to be seen from the above- cited article, due to this three-dimensional rolling movement of the dry-to-the- touch, saliva soluble, flavor-absorbing coating, there is achieved a better mixing up and thus a more uniform coating of the dental devices of the invention, than in the case of the use of a kettle with a horizontal axis of rotation.

The dry-to-the-touch, saliva soluble, flavor-absorbing coating is periodically introduced into the coating drum, thereby applying successive coats to the flosser, pick and stimulator dental devices of the invention which are being maintained in constant motion by the movement of the coating drums. Each coating application is followed up by a drying/tumbling interval during which substantially all of the moisture in the emulsion is expelled from the coated dental devices via the use of controlled air flow and the application of controlled heat. The duration the dry-to-the-touch, saliva soluble, flavor- absorbing coating is introduced into the coating drum usually ranges from between about 10 and about 120 seconds and preferably from between about 20 and about 75 seconds. The duration between sprays for drying the coating generally ranges from between about 2 and about 4 minutes. After this spray cycle, the dry-to-the-touch, saliva soluble, flavor-absorbing coating on the dental devices loses substantially all of the moisture as the discrete dry-to-the-

touch, saliva soluble flavor coating layer forms and dries. Care must be taken not to over dry or overheat the coated dental devices of the invention before a subsequent coating is added. Evidence of overheating or over drying is the presence of flakes of coating material in the pan coating drum.

4. Vibrating Screen Coating Machines:

Another type of flosser, stimulator and pick dental device coating apparatus is called a vibrating screen drying machine. In such an apparatus, the devices to be coated and dried are conveyed through a drying section, providing a flow of either cool air or warm air, on a vibrating screen which "bounces" the parts into the air by the high amplitude vibration of the screen. The saliva soluble, flavor-absorbing coating can be applied by a variety of methods, two examples of which will suffice to illustrate the breadth of possibilities available to one skilled in the art:

(1) the devices are immersed into the solution and transferred to a draining screen or screen conveyer for the removal of excess coating before being transported to the vibrating screen (itself often in the form of a moving conveyer) for drying, or

(2) spray devices are placed at strategic locations along the moving, vibrating screen to apply a series of "coats" between drying stages.

The total number of dry-to-the-touch, saliva soluble, flavor-absorbing coatings on the disposable, one-handed flosser, pick and stimulator dental devices of the invention generally ranges from between about 1 and about 50 coatings and preferably from between about 4 and about 10 coatings.

Unlike the traditional coating of confectioneries when using the foregoing confectionery coating methods; the primary flavor components are preferably excluded from the various saliva soluble coatings and introduced into the coating after the coating is applied to the device, when the device is contained in a flavor-sealed package fitted with a flavor reservoir. That is,

subsequently, flavor adsorption is achieved from a flavor reservoir when the coated devices are held under flavor-sealed conditions in the presence of a flavor reservoir. This post-addition of flavor offers several advantages over current confectionery coating methods:

• Substantial cost savings by the more efficient post-addition of flavor to the various dental devices of the invention, thereby incurring no loss of flavor during the coating process;

• Use of post-added volatile flavors that cannot be used during the typical confectionery coating processes described above; and

• Long-term flavor stability attributed to the use of flavor-sealed packaging to affect flavor adsorption, which adsorption is preferably carried out in a purged- flavor-sealed package. Such packaging does not allow the entrance of air into the package, thereby avoiding degradation of the volatile flavor notes released from the flavor reservoir and absorbed by the saliva soluble coating on the various dental devices. Typically, degradation of such volatile flavor is usually experienced in the presence of air/oxygen.

All of the various confectionery coating apparatus and methods described above can be adapted by one skilled in the art to coat disposable, one-handed flosser, stimulator and pick dental devices with dry-to-the-touch, saliva soluble, flavor- absorbing coatings.

PREFERRED EMBODIMENTS OF THE INVENTION

In a particularly preferred embodiment of the invention, the dry-to-the-touch, flavor-absorbing, saliva soluble coatings of the invention, suitable for coating dental flossers, dental stimulators, dental picks and proxy brushes, also contain a film- forming agent. Preferably, at least one film-forming agent is utilized in the preparation of the coating mixture. Representative film- forming agents include

hydroxypropyl cellulose, methyl cellulose (i.e., methyl ether of cellulose), ethyl cellulose, hydroxypropyl methyl cellulose, hydroxymethyl cellulose, carboxymethyl cellulose, gelatin, mixtures thereof, and the like. Preferably, a branched chained film- forming agent such as hydroxypropyl cellulose, is utilized. Preferably, the hydroxypropyl cellulose has a Brookfield viscosity of not less than 145 cps for a 10% aqueous solution at 25 ⁰ C. The coating can contain more than one film-forming agent and as such, for example, hydroxypropyl cellulose and methyl cellulose may be utilized. In such a combination the branched chained film-forming agent (e.g., hydroxypropyl cellulose) can be used in amounts of about 0.05 to about 1.5 wt. % with about 0.01 to about 0.5 wt. % being preferred, and the straight chained film- forming agent (e.g., methyl cellulose) can be used in amounts of about 0.5 about 1.0 wt. % with about 0.1 to about 0.5 wt. % being preferred.

Another particularly preferred embodiment of the invention utilizes the unique flavor absorbing and retention properties of various dry-film forming agents and various surfactants, coated onto the dental flossers, dental stimulators, dental picks and proxy brushes of the invention, as described above. The modified cellulose film forming agent and the surfactants function as attractants for volatile flavor molecules, to such an extent that they will absorb and hold a high percentage of flavor molecules from volatile sources after the film formers and surfactants have been coated onto the devices of the invention. This property of absorbing and holding flavor molecules provides much of the consumer satisfaction associated with the one-handed dental devices of the present invention, as stable, absorbed, flavor molecules are released from the saliva soluble coating when it dissolves in the saliva, thereby releasing the absorbed flavor which is now accessible to olfactory organs in the oral cavity.

In the preferred embodiment of the invention, in order to avoid the loss of volatile flavor molecules during the high temperature/high velocity air contact of the coatings during drying with the various dragee methods, the flosser, stimulator and pick dental devices are coated to the desired thickness with a dry-film forming composition minus flavoring agents. Similarly, the proxy brushes are spray coated

during proxy brush manufacturing and assembly minus flavor agents. Volatile flavors are then post-added to these various coated, one-handed, dental devices by containing the coated devices in a flavor-sealed package fitted with a flavor reservoir where the package is purged with an inert gas prior to coating.

Alternatively, an alcoholic solution of the flavor oils is sprayed or otherwise introduced onto the moving flosser or stimulator/pick dental devices in the dragee kettle for distribution across the surfaces of the coated dental devices. In the same manner that an alcoholic solution of perfume oils can be applied to the skin and dry off leaving almost all the perfume oils absorbed into the skin, the alcoholic carrier of the flavor oils volatilizes off at very low temperatures which essentially eliminates the loss of volatile flavor oils. The thin film of flavor oils so deposited on the previously laid down device coating is almost instantly absorbed due to the adsorption properties of the dry-film forming agents and/or surfactants. Surprisingly, any dis-uniformity in flavor oil across the surface of the disposable, coated, one-handed dental device is quickly made uniform by the inexorable principles of equilibrium as the oils move from points of higher concentration in the coating to those of lower concentration until equilibrium is reached throughout the coating.

It is self-evident in the forgoing preferred embodiments that non-volatile flavor components, such as sweeteners, must be added to the initial un-flavored coatings as they cannot be effectively transferred by the equilibrium techniques used to transfer the volatile flavors from the flavor reservoir to the coated devices.

Other substances can be added to the dry-to-the-touch, saliva soluble, flavor- absorbing coatings of the invention including:

(a) An additional non- volatile or very low volatile flavoring agent may be present in the emulsion in an amount within the range of from about 0.1 to about 10.0 wt. %, and preferably from about 0.5 to about 3.0 wt. %, of the emulsion. Such flavoring agents may comprise essential oils, synthetic

flavors, or mixtures thereof including, but not limited to, oils derived from plants and fruits such as citrus oils, fruit essences, peppermint oil, spearmint oil, clove oil, oil of wintergreen, anise and the like. Artificial flavoring components are also contemplated for use in coating emulsions of the present invention. Those skilled in the art will recognize that natural and artificial flavoring agents may be combined in any sensorially acceptable blend. All such flavors and flavor blends are contemplated by the present invention.

(b) Colorants used may include dyes, pigments, lakes and natural colors. The colorant may be blended with melted wax, preferably carnauba wax, which melts at 80°-90°C, then cooled and ground to a find particle size that will pass at least 99% through a #100 mesh sieve (less than 150 microns).

Other waxes that may be used include beeswax, candelilla wax, spermaceti wax, and mixtures of the foregoing. Another method of blending is to powder blend the colorant with the wax. In either method, the preferred ratios are 1 - 30% colorant and 70.99% wax, and more preferably 5-15% colorant and 85- 95% wax. It is preferable to use powdered colorants that have a particle size that will pass at least 99.9% through a #325 mesh sieve (small than 45 microns) so that the blended color/wax will still pass at least 99% through a #100 mesh sieve, having a particle size of 150 microns or less.

(c) Artificial sweeteners such as the soluble saccharin salts, i.e., sodium or calcium saccharin salts, cyclamate salts, acesulfam-K, and the like, and the free acid form of saccharin may optionally be added to the dry-to-the- touch, saliva soluble, flavor-absorbing coatings of the invention. Dipeptide sweeteners such as L-aspartyl-L-phenylalanine methyl ester and materials described in U.S. Pat. No. 3,492,131, and the like may also be used. These sweeteners may be used in amounts of about 0.005 wt. % to about 0.5 wt. % based on the weight of the total coating emulsion, and preferably about 0.05 wt. % to about 0.25 wt. %. Usually the first coating emulsion can contain about 0.02 wt. % to about 0.06 wt. % and most preferably 0.05 wt. % of

artificial sweetener. A second emulsion can usually contain about 0.05 wt. % to about 0.2 wt. %, based on the weight of the coating emulsion, with about 0.08 wt. % to about 0.15 wt. % being preferred of artificial sweetener.

In a particularly preferred embodiment of the invention, the polyalcohol sweetener, xylitol, in a mixture with mono-, di- and triglycerides of the fatty acids of: palmitic, stearic and oleic acids, is included in the dry-to-the-touch, saliva soluble, flavor-absorbing coatings of the invention. Xylitol can be represented by the structured formula:

CH ₂ -OH

H— C— OH HO— C-H H— C— OH CH ₂ -OH

Xylitol is commercially available both in solid form and in the form of aqueous concentrated solutions. However, contrary to the saccharose shell, that of xylitol deteriorates rapidly with time. In particular, already after a few hours a xylitol shell cracks and its outer surface initially smooth becomes wrinkled; at the same time even the intimate constitution of the shell, initially sufficiently microcrystalline, changes into a course, rough structure fastidious to the palate and in chewing. A xylitol/dry-to-the-touch, saliva soluble, flavor-absorbing coating offers the peculiar advantage of being refreshing to the mouth (owing to an appreciable negative heat of solution); however, this advantage does not compensate the aforesaid drawbacks.

Those mixtures of glycerides are preferred which exhibit a strong prevalence of a determined glyceride. Mono- and diglycerides suitable for the purposes of this invention may present a melting point ranging from about 40° to about 7O ⁰ C, keeping in mind that the melting point can be lowered (owing to formation of eutectics) by addition of a triglyceride having a convenient melting point. The preferred fatty

substance is cocoa butter which, as is known, melts around 35 ⁰ C.

Suitable post-added flavoring to be absorbed by the saliva soluble, flavor- absorbing coating on the devices of the present invention are absorbed in an amount within the range of from about 0.1 to about 5% and preferably from about 0.2 to about 4% by weight of the saliva soluble coating. Such volatile flavoring contained in the flavor reservoir may comprise oils derived from plants, leaves, flowers, fruit, etc. Representative flavor oils of this type include citrus oils such as lemon oil, orange oil, lime oil, grapefruit oil, fruit essences such as apple essence, pear essence, peach essence, strawberry essence, apricot essence, raspberry essence, cherry essence, plum essence, pineapple essence, as well as the following essential oils: peppermint oil, spearmint oil, mixtures of peppermint oil and spearmint oil, clove oil, bay oil, anise oil, eucalyptus oil, thyme oil, cedar leaf oil, cinnamon oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, and methylsalicylate (oil of wintergreen). Various synthetic flavors comparable to those described above, including, mixed fruit, may also be absorbed by the dry-to-the-touch, saliva soluble coatings of the invention with or without conventional preservatives.

The flavor-sealed packaging suitable for effecting transfer of the volatile flavor from the flavor reservoir to the saliva soluble coatings on the various coated dental devices of the invention is preferably:

(1) Resistant to flavor,

(2) Resistant to oxygen or water penetration,

(3) Can be sealed to a hermetic-seal condition via heat or some other sealing means, and

(4) Maintains a flavor-seal long-term, i.e., maintains flavor stability for a minimum of 24 and preferably 36 months.

Suitable packaging materials included co-extruded, laminated, molded, blow- molded, Barex® resin-based materials that are heat-sealable or flavor-sealable by

other means.

Preferably, the flavor-sealed packaging for the saliva soluble, flavor- adsorbing, coated dental devices of the present invention is purged with an inert gas prior to sealing. This purging step replaces air with an inert gas such as nitrogen.

This purged, flavor-sealed packaging, which is fitted with a flavor reservoir, provides a suitable environment for the volatile flavors contained in the flavor reservoir to transfer from the reservoir to the saliva soluble coatings on the devices of the invention.

Such transfer is effected in a relatively short time period. The flavor- absorbing substances in the device coatings take on the volatile flavor molecules and hold them in the device coatings until the flavor-sealed package is opened.

Alternatively, the volatile flavors can be added to the devices, post-coating and post- wrapping, e.g., in a paper wrapper, via flavor transfer to the BarrierMulsion™/Sialagogue-coated devices. These Hi-Impact Devices are stored under flavor-sealed conditions until the devices are used. The source of the volatile flavor, a proprietary, flavor reservoir, releases the volatile flavor, which is absorbed by the BarrierMulsion™ coatings on various dental flosses and dental tapes. The BarrierMulsion™ coating functions as a virtual magnet for volatile flavor during flavor transfer, which occurs automatically in the flavor chamber following the opening of the flavor reservoir. The volatile flavor in the saliva soluble BarrierMulsion™/Sialagogue coating is released into interproximal areas as the Hi- Impact dental flosses and dental tapes are worked between teeth. When these volatile flavors combine with BarrierMulsions™ and Sialagogues and are then released into the oral cavity, unprecedented flavor impact, mouthfeel, and tingling sensations are experienced by the user. For example, paper-wrapped Hi-Impact samples of Listerine® lavored dental tapes with a Soft Abrasives® overcoating, have been tested and have been found to deliver flavor at levels well beyond traditional flavored dental

flosses and tapes. For two-handed Hi-Impact Dental Tape and/or Dental Floss, the preferred flavor package comprises a commercially available and resealable Barex® package, containing the desired volatile flavor(s). A refillable dispenser, such as an apothecary jar or the like, together with a refill poly bag containing paper-wrapped unflavored devices, and a Barex sealed flavor reservoir is employed so that the volatile flavors remain freshly available for treatment of the unflavored devices. The use of unflavored refillables combined with replaceable flavor-sealed flavor reservoirs to affect flavor transfer after the dispenser package has been refilled, provides the opportunity to maintain the high levels of desired volatile flavors indefinitely. When the flavor level decreases, one simply adds another flavor reservoir to the container. The use of an attractive apothecary dispenser (or the like) provides the floss or tape user (i.e., at home or in a dental professional's office) with a readily accessible storage device for floss or tape that has flavors that simply cannot be duplicated by traditional flavored flosses, or flosses coated with encapsulated flavor components. The delivery of highly volatile flavors by the floss or tapes of the present invention will encourage flossing, making this task much more pleasant than heretofore known. The volatile flavor in the BarrierMulsion™/Sialagogue coating is released into interproximal areas as the Hi-Impact dental flosses and dental tapes are worked between teeth. When these volatile flavors combine with BarrierMulsions™ and Sialagogues and are then released into the oral cavity, unprecedented flavor impact, mouthfeel, and tingling sensations are experienced by the customer. Refills include BarrierMulsion™/Sialagogue-coated devices without flavor. These are packaged in inexpensive packaging, such as paper wrappers. The flavor reservoir, sealed in Barex, is included with the refill and is unwrapped and dropped in the dispenser before adding the devices. Flavor transfer is carried out over a period of time, for example, overnight, while the dispenser is closed. Refillable dispensers such as apothecary- type jars, canisters, crocks and metal containers with suitable sealing lids, are preferred dispensers for Hi-Impact devices. Both the resealable packages and refillable dispensers are components of this embodiment of the invention.

Any consumable or chewable product that can be coated with or contain

BarrierMulsion™, with or without sialagogues, provided the consumable can be stored or manufactured under flavor transfer conditions is a candidate for the application of this Hi-Impact Technology. This presumes one or more of the following Hi-Impact features may be important to the manufacturer or the user of the consumable; (a) flavor impact; (b) off- flavor masking; (c) manufacturing without flavor loss constraints; (d) mouthfeel (including the feeling of "clean"); (e) tingling sensations; and the like.

Examples of Types of Consumables;

(a) Confectioneries: Hi-Impact mints in a small apothecary jar with a Flavor Reservoir. Hi-Impact Technology takes suckable candys and sugar-free candies to a new level of flavor pleasure. Efficacious confectioneries, such as cough drops, dry mouth lozenges and chewing gums (preferably Dragee coated). Generally, these "efficacious confectioneries" will be far more appealing than current versions.

(b) Supplements/vitamins (especially chewable versions).

(c) Medicaments including: Antacids, ingestibles/chewables, Rx pills, capsules, self-help products such as Nicorette® chewing gum, and the like.

The invention will be further understood by those skilled in the art upon reviewing the Examples set forth below.

Example 1:

Fifteen grams of Klucel LF (hydroxypropylcellulose) is added slowly to 100 grams of water heated to 9O ⁰ C. A solution of PEG 1450 (300 grams water with 10 grams PEG) was heated to 4O ⁰ C. Three grams of sodium saccharin was then added to the PEG solution with stirring. The Klucel suspension was cooled to 5O ⁰ C and the PEG solution added with stirring. The resulting solution is then sprayed in 5 aliquots

with 4 minute intervals onto 1 ,000 plastic flossers contained in a rotating drum fitted with fins and a hot air tube delivering 40 degree air while tumbling at 21 RPM. The flossers were tumbled with hot air until the glistening effect of liquid coating was not evident after each aliquot. The flossers had a coating of 14 mg per flosser, which subsequently absorbed volatile flavors when placed in a flavor-sealed package that was purged with nitrogen and sealed and stored under flavor-sealed conditions with a flavor reservoir containing a volatile flavor.

Example 2:

An aqueous suspension of hydroxypropylcellulose (100 grams water with 15 grams HPC) is heated to 9O ⁰ C. A second container is heated with 300 grams water and 12 grams poloxamer 407 with heating to 4O ⁰ C. Four grams of sodium saccharin is added to the surfactant solution. The aqueous HPC solution is cooled to 5O ⁰ C and the surfactant solution is then added with stirring . After cooling to 3O ⁰ C the combined solutions are sprayed in 4 aliquots with 5 minute drying intervals onto 10,000 round wooden toothpicks on a vibrating screen. Warm air at 4O ⁰ C is directed up through the screen while the vibrating toothpicks are dried. The toothpicks have a coating of 2.4 mg each and show no marks or lines due to uneven coating. The toothpicks are stored under flavor-sealed conditions after purging with nitrogen and being provided with a flavor reservoir with a volatile flavor. The coated toothpicks had adsorbed substantial flavor when subsequently removed from the flavor-sealed package.

The invention is described further in the various Examples and Tables set out below.

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Table 1

Discussion of Examples 1-8:

Various dental devices of the invention, such as described in Examples 1 through 8, were preferred by a wide margin over the uncoated versions in various consumer tests. During use, the coated dental stimulators and toothpicks continued to release flavor as they were worked from one interproximal site to the next. The flavor appeared to be absorbed throughout the wooden stimulators and toothpicks.

Consumers tended to "chew" these devices in order to "release" the remaining absorbed flavor. Some devices were used for upwards of 20 to 30 minutes before they were discarded.

The coated proxy brushes of the invention, deliver the highest level of saliva soluble coatings to interproximal sites. The coated proxy brushes of the invention also deliver the greatest flavor impact to interproximal sites of the various devices of the invention.

Set out in Table 2 below are illustrative examples of additional commercial one- handed devices treated with the dry-to-the-touch, flavor-absorbing coatings of the present invention.

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Table 2

Table 3