BACKGROUND Various products and methods for deodorizing the vaginal cavity have previously been suggested. Prior products and methods, however, have certain disadvantages. For example, common douches require copious amounts of liquids and are, therefore, messy to administer. Deodorizing suppositories are also messy in that, after application, they tend to run.

It would therefore be desirable to provide a vaginal deodorizers, and methods for vaginal deodorizing, which can be applied discreetly, for example in a public restroom, or anytime and which can be applied and used without creating a messy condition.

Dissolvable films have been previously disclosed for use in delivering pharmaceutically-active ingredients to humans. For example, dissolvable films have been disclosed for delivering effective amounts of contraceptive pharmaceutical agents. Typically such films comprise a binder such as polyvinyl alcohol, a lubricant such as glycerin, a solvent for the polyvinyl alcohol and glycerin such as water, the active ingredient nonoxynol-9 and at least one preservative. Water is utilized as a solvent since the nonoxynol-9 is water soluble and can be readily dissolved into a mixture or slurry prior to formation, of the film. 0 ingredients have been disclosed, dissolvable films have not previously been used or suggested for reasons other than delivering effective agents, such as pharmaceutically active agents.

SUMMARY OF THE INVENTION One aspect of the present invention is directed to various embodiments comprising dissolvable, vaginal deodorizing films. The <BR> <BR> disclosed films are pliable, i. e. , they can be folded repeatedly without breaking, which facilitate placement as well as comfort during use. The films have relatively small mass relative to other known deodorizers such as douches and suppositories, and they begin to dissolve upon placement and typically completely dissolve in about 15-20 minutes. The films of the present invention do not include ah effective amount of any pharmaceutically active agent. The purpose of this aspect of the invention is to provide a dissolvable, pliable film for vaginal deodorizing and specifically excludes pharmaceutically effective amounts of pharmaceutical agents.

A second aspect of the present invention is directed to various embodiments comprising methods of vaginal deodorizing utilizing the films disclosed in the previous paragraph. The present invention advantageously provides methods of vaginal deodorizing and specifically exclude pharmaceutically effective amounts of pharmaceutical agents.

DETAILED DESCRIPTION One preferred embodiment of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant a minor ai4l' : " i : ae ;'i :'su : t ; at., i. f. vx. n. _i' : iuli :'i nos r amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient.

According to preferred embodiments of the present invention, the films are hydrophilic.

One embodiment of this aspect of the present invention comprises a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically-active fragrance.

Another preferred embodiment of the present invention comprises a method of vaginal deodorizing comprising-the steps of providing a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, a minor amount of surfactant for film forming, minor amounts of preservatives for shelf stability, at least one fragrance and preferably no other active ingredient, or, at most, less than an effective amount of any pharmaceutically active ingredient, and placing said film within the vaginal cavity. According to preferred embodiments of the present invention, the films are hydrophilic.

One embodiment of this aspect of the present invention utilizes a pliable film comprising at least one binding agent, at least one lubricant, a solvent for the binding agent and the lubricant, and an effective amount of at least one non- pharmaceutically active fragrance, but less than a pharmaceutically effective amount of any pharmaceutically active agent.

The comfort and convenience of the present invention rW veiob lotheszu"iuasg tnaz n. JIdx zxetis R@ {ds of vaginal deodorizing are enhanced by the fact that the films are pliable, and are therefore not felt by the user after placement. Additionally, the films have relatively little mass, preferably about. 2 grams.

Therefore, upon dissolution in the vaginal cavity, will not tend to result in a messy discharge. This preferred weight of the films of the present invention is significantly less than that of popular deodorizing suppositories. For example, samples of known suppositories sold under the name NORFORMSO were weighed and found to have an average weight of 1.88 grams, almost nine times the weight of the film of the preferred embodiment of the present invention.

The binding agent which provides a plasticizer effect may "comprise'polyvinyl alcohol, methylcellulose compounds such as hydroxypropyl methylcellulose (HPMC) or other gelatin or starch-based binders-either alone or in combination. The final film preferably comprises about 60% to 97% by weight of the binding agent and most preferably about 50% to 70% by weight. Unless otherwise noted herein, all percentages noted herein are by weight.

The lubricant can comprise one or more of glycerin, propylene glycol, polyethylene glycols, fish oil, vegetable oil, and combinations thereof. The lubricant is preferably present in the amount of about 1% to 4% and most preferably about 2% to 3% in the final film.

In order to properly blend the binding agent and lubricant, a solvent such as water or an organic solvent such as ethanol is preferably employed. The initial formulation may comprise about 50%- 65% and the final film preferably comprises about 2% to 15% of solvent and most preferably about 3% to 7%. If desired, more than o slövie n beX i ; u It is also in the scope, of the present invention to include preservatives such as methyl paraben, propyl paraben, ethylenediamine-tetraacetic acid (EDTA), diazolidnyl urea, stearic acid, benzoic acid, sodium benzoate and combinations thereof in order to enhance shelf stability and prevent microbial contamination. Any such preservatives are present in amounts sufficient for shelf- stability of the product but in amounts which are less than amounts which would make them pharmaceutically effective. For example, preservatives can be present in amounts less than about 1%, or preferably less than about. 5% in the final film.

The films of the present invention may also be formed utilizing ingredients helpful in the processing of the film. For example, both examples discussed below comprise minor amounts of a surfactant octoxynol-9, for example, about 1-6%, more preferably less than 2% in the final film.

In addition to the ingredients noted above, the deodorizing films of the present invention can also comprise inert, non- pharmaceutically active ingredients such as dyes.

The following are non-limiting examples of films and films used in practicing the present invention.

EXAMPLE 1 FRESH FLOWERS SCENTED VAGINAL DEODORIZING FILM Batch Raw Material Description Ouantity 60. 5% Purified Water 90.75 kg.

23.96 Gal.

34. 15% Polyvinyl Alcohol film former 51.225 kg.

1. 200- Octoxynol-9 surfactant L. 8 kg. 2_WO 2004/103232" : , , i, , ; ; j. : - : ; ; ; . ROIUSPCT/US2004/014953 2. v-o 11 . u f ; gb RoIUSPlCTIUS2Oo4lol4953 solvent lubricant 1. 5% Fragrance: Fresh Flowers 2.25 kg.

0. 326 Methyl Paraben, NF 0. 489 kg. preservative 0. 324% Propyl Paraben Color: FD&C Red # 40 0.00045 kg.

0.45 gms.

EXAMPLE 2 BABY POWDER SCENTED VAGINAL DEODORIZING FILM Batch Raw Material Description Ouantitv 60. 5% Purified Water 90.75 kg.

23.96 gal.

34. 15% Polyvinyl Alcohol' 51. 21 kg.

1. 2% Octoxynol-9 1.8 kg.

2. 0% Glycerin 99.7%, USP 3.0 kg.

1. 5% Fragrance: Baby Powder 2.25 kg.

0. 326% Methyl Paraben, NF 0. 489 kg.

0. 326% Propyl Paraben, NF 0.489 kg.

0. 004% Color: FD & C Blue # 1 0.006 kg.

The deodorizing films and films useful with the present invention can advantageously be manufactured on a bulk scale. In order to achieve the desired concentration of fragrance in the film, preferred embodiments are manufactured on a weight by weight concentration of the total product. While the following description utilizes water-soluble ingredients, based upon the solubility of the fragrance, the base can be formulated to be either water soluble or non-water soluble. uoMpou. ncrrny Ingredients are individually weighed or otherwise measured.

Some formulas may require an emulsion to be formed, based on the solubility of the ingredients. Some ingredients may need to be combined in a series of smaller tanks, prior to being added to a larger tank, again depending on solubility, temperature and mixing characteristics. The ingredients are preferably mixed and/or heated accordingly until a homogeneous solution or mixture is achieved.

Because certain ingredients will require heat to aid dissolution, the tanks can be heated to reduce mixing time and increase ingredient solubility. The bulk can be used hot or cooled based on viscosity and physical, characteristics required for the next phase of ' manufacturing.

Distribution and/or transfer onto belt : The second step involves the transfer of the bulk evenly and at the desired thickness onto a belt or sheet of material that will be passed into an oven or otherwise treated to remove the majority of the solvent, e. g. water, from the blend. The belt itself can be made of a number of different materials including stainless steel, teflon, aluminum, a high temperature chemical resistant polymer, or metal alloy among others. The belt's physical dimensions are based on the width of the bulk film roll desired, and the temperature of the oven. There are a number of ways to cast or spread a bulk solution onto the belt evenly and in a manner which advantageously free from bubbles and striations. The following are some of these methods. (1) The bulk can be pumped onto the belt and spread with a blade or brush type device into an even displacement. WO 2004/103232 f wli°'v'""'"'CT/US2004/014953, (WO. 202. e'''p&m... i6tS dO/U. aPp44 ? 53,. d head pressure, e. g. from about 10-200 psi. , onto the belt with dimensions that provide an even displacement of liquid bulk. (3) The bulk can be sprayed through a series of nozzles onto the belt. (4) The bulk can be spread thinly and evenly by mechanical means. (5) The bulk can be poured onto the belt and allowed to run or be blown by forced air to an even distribution. The conveyor type belt system is set to move the product at a controlled speed to achieve the desired drying of the product. For example, the belt can advance the product from 2 to 35 feet per minute depending on the moisture in the product, drying rate, and the desired thickness.

Evaporation : The belt passes through an oven or other type environmental chamber at a controlled speed, humidity, ventilation, and temperature to eliminate enough of the solvent to produce a film of the desired consistency. To accomplish this, the belt speed and oven temperature is controlled to avoid any degradation of the components while eliminating enough solvent from the formulation to achieve the desired pliability of the finished film. The optimal conditions are typically between about 35°C and 100°C. The result is sheets of film approximately the width of the belt and the desired thickness.

The physical dimensions of the finished product typically can range in size from about 10-80 millimeters square, depending on the size of the dose to be delivered. The films of the present invention generally should have thicknesses not greater than about O :"0rirfki'e's","f'23q'j'.. : p, ,. Uiar, %' "irY''ai, nches, and most preferably about 0.001 to about 0.010 of an inch, and a weight of not greater than about 1 g preferably not greater than about 0. 75 g, more preferably. 1 to about. 5 grams, most preferably weigh about. 2 grams. The films of the present invention can be formed in various shapes without departing from the scope of the present invention.