ALIHANGA DAMIEN
DEMANA PATRICK
| WO2001012144A1 | 2001-02-22 |
| EP1236466A1 | 2002-09-04 | |||
| US6231896B1 | 2001-05-15 | |||
| NL9300683A | 1994-11-16 | |||
| US3923984A | 1975-12-02 | |||
| US20080274179A1 | 2008-11-06 | |||
| US20120251462A1 | 2012-10-04 | |||
| US20080317681A1 | 2008-12-25 |
DONG ET AL: "Activation of rapid signaling pathways and the subsequent transcriptional regulation for the proliferation of breast cancer MCF-7 cells by the treatment with an extract of Glycyrrhiza glabra root", FOOD AND CHEMICAL TOXICOLOGY, PERGAMON, GB, vol. 45, no. 12, 23 October 2007 (2007-10-23), pages 2470 - 2478, XP022310495, ISSN: 0278-6915, DOI: 10.1016/J.FCT.2007.05.031
C MESSIER ET AL: "Licorice and its potential beneficial effects in common oro-dental diseases", ORAL DISEASES, vol. 18, no. 1, 18 August 2011 (2011-08-18), pages 32 - 39, XP055041720, ISSN: 1354-523X, DOI: 10.1111/j.1601-0825.2011.01842.x
"THE CR100 SYSTEM. ÖUSE OF CONTROLLED RELEASE FLAVOURS IN CHEWING GUM", CONFECTIONERY PRODUCTION, SPECIALISED PUBLICATIONS LTD., SURREY, GB, vol. 61, no. 4, 1 April 1995 (1995-04-01), pages 308 - 310, XP000512428, ISSN: 0010-5473
SCULLY; GORSKY; LOZADA, NUR, 2003
| CLAIMS A chewable gum composition, which includes:- a Salvia officinalis plant extract; a Glycyrrhiza glabra plant extract; and a carrier for carrying and releasing the plant extracts when chewing the chewable gum composition. A chewable gum composition as claimed in claim 1 wherein the Salvia officinalis plant extract has an extraction factor and / or strength of 5:1. A chewable gum composition as claimed in any one or more of the preceding claims wherein the Salvia officinalis plant extract comprises up to 35 % of the chewable gum composition. A chewable gum composition as claimed in any one or more of the preceding claims wherein the Salvia officinalis plant extract contains rosmarinic acid and caffeic acid. A chewable gum composition as claimed in claim 4 wherein the Salvia officinalis plant extract contains about 0.105% rosmarinic acid and 0.0126% caffeic acid. A chewable gum composition as claimed in any one or more of the preceding claims wherein the rosmarinic acid comprises up to 1% of the said chewable gum composition. A chewable gum composition as claimed in any one or more of the preceding claims wherein the caffeic acid comprises up to 1 % of the chewable gum composition. A chewable gum composition as claimed in any one or more of the preceding claims wherein The Glycyrrhiza glabra plant extract has an extraction and / or processed factor of 4:1 . A chewable gum composition as claimed in any one or more of the preceding claims wherein the Glycyrrhiza glabra plant extract comprises up to 20 % of the chewable gum composition. A chewable gum composition as claimed in any one or more of the preceding claims wherein the Glycyrrhiza glabra plant extract contains glycyrrhizic acid. A chewable gum composition as claimed in claim 10 wherein the Glycyrrhiza glabra plant extract contains about 2.383 % glycyrrhizic acid. A chewable gum composition as claimed in any one or more of the preceding claims wherein the glycyrrhizic acid comprises up to 3 % of the chewable gum composition. A chewable gum composition as claimed in any one or more of the preceding claims wherein the carrier allows modified release of the Salvia officinalis and Glycyrrhiza glabra plant extracts when chewed. A chewable gum composition as claimed in any one or more of the preceding claims wherein the carrier allows modified release of rosmarinic acid, caffeic acid and glycyrrhizic acid when chewed. A chewable gum composition as claimed in any one or more of the preceding claims wherein the carrier comprises of any one or more of the group consisting of a gum base, an elastomer, an emulsifier, a filler, a wax, an antioxidant, a softener, a sweetener, a food colouring and / or flavouring agent. A chewable gum composition as claimed in claim 15 wherein the carrier is in the form of a chewable gum. 17. A chewable gum composition as claimed in any one or more of the preceding claims wherein the percentage fraction of carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract in the said chewable gum composition is in the range of 49 % - 99 % : 0.5 % - 32 % : 0.5 % - 20 %. 18. A chewable gum composition as claimed in any one or more of the preceding claims wherein the percentage fraction of carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract in the chewable gum composition is about 90% : 6.4 % : 3.6 %. 19. A chewable gum composition as claimed in any one or more of the preceding claims which includes pharmaceutical excipients selected from any one or more of the group consisting of a glidant, a lubricant, a binder, a taste masking agent, a flavourant absorbing agent and a flavourant. 20. A chewable gum composition as claimed in claim 19 wherein the glidant is selected from any one or more of the group consisting of talc (magnesium hydrous silicate), and colloidal silicon dioxide. 21. A chewable gum composition as claimed in any one or more of claims 19 and 20 wherein the lubricant is selected from any one or more of the group consisting of magnesium stearate, stearic acid, sodium stearyl fumerate and sodium behenate. 22. A chewable gum composition as claimed in any one or more of claims 19 to 21 wherein the binder is selected from any one or more of the group consisting of hydroxypropylcellulose, methylcellulose, hypromellose, polyvinylpyrrolidone (povidone) and copovidone. A chewable gum composition as claimed in any one or more of claims 19 to 22 wherein the taste masking agent is in the form of citric acid monohydrate. 24. A chewable gum composition as claimed in any one or more of claims 19 to 23 wherein the flavour absorbing agent is in the form of calcium carbonate. 25. A chewable gum composition as claimed in any one or more of claims 19 to 24 wherein the flavourant is selected from any one or more of the group consisting of wild cherry and spearmint liquid. 26. A chewable gum composition as claimed in any one or more of claims 19 to 25 wherein the percentage fraction of the carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract : glidant : lubricant : binder : taste masking agent : flavourant absorbing agent : flavourant in the chewable gum composition is in the range of 40 - 90% : 0.5 - 30 % : 0.5 - 20 % : 1 - 5 % : 0.1 - 3 % : 1 - 10 % : 0,1 - 3 % : 1 - 5 % : 0.1 - 5 %. 27. A chewable gum composition as claimed in any one or more of claims 19 to 25 wherein the percentage fraction of the carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract : glidant : lubricant : binder : taste masking agent : flavourant absorbing agent : flavourant in the chewable gum composition is 78.25% : 5.55 % : 3.26 % : 2.24 % : 0.25 % : 5 % : 0.3 % : 2.25 % : 2.88 %. 28. A chewable gum composition as claimed in any one or more of the preceding claims wherein the chewable gum composition is in the form of a solid oral dosage form. 29. A chewable gum composition as claimed in claim 28 wherein the solid oral dosage form includes a conventional chewable tablet. 30. A chewable gum composition as claimed in claim 29 wherein the tablet is film coated. 31. A chewable gum composition as claimed in any one or more of claims 29 and 30 wherein the film coating comprises between 1 % and 6 % of the total tablet mass. 32. A chewable gum composition as claimed in any one or more of claims 29 to 31 wherein the tablet is sugar coated. A chewable gum composition for the treatment of oral canker sores in humans substantially as described herein. A use of a Salvia officinalis based plant extract and a Glycyrrhiza glabra based plant extract for the manufacture of a chewable gum composition for the treatment of oral canker sores in humans substantially as described herein. A use of a chewable gum composition for the treatment of oral canker sores in humans substantially as described herein. |
TECHNICAL FIELD
The invention relates to a chewable gum composition. BACKGROUND ART Recurrent Aphtous Stomatitis (RAS), Recurrent Aphtous Ulceration (RAU), canker sores, aphthae or aphtous ulcers, is an inflammatory condition of unknown aetiology characterised by painful recurrent, single or multiple ulcerations of the oral mucosa. Canker sores are the most common of all non - traumatic ulcerative and vesicular lesions of the oral cavity (Natah et al., 2004). The exact cause of canker sores remains unkown, hence the difficulty in determining a curative treatment.
Currently available treatments are symptomatic and aimed at reducing pain, the healing period, reducing the number and size of ulcers, and also prevention of recurrence (Scully, Gorsky & Lozada - Nur, 2003).
The current primary option for treating this condition includes oral topical dosage forms such as pastes, gels, mouthwashes, creams and ointments.
A downside of these conventional medicines lies in the fact that they are usually easily removed from the site of action due to tongue and saliva movement, and in addition, are difficult to apply when the ulcer is located in the arched opening at the back of the mouth leading to the pharynx (Patel, Liu & Brown, 201 1 ). Another disadvantange is the quick release and sudden termination of active substance availability at the required site of action.
The inventors having considered the above propose a chewable gum composition as disclosed hereunder.
SUMMARY OF THE INVENTION
According to the invention there is provided a chewable gum composition, which includes:- a Salvia officinalis plant extract;
a Glycyrrhiza glabra plant extract; and
a carrier for carrying and releasing the plant extracts when chewing the chewable gum composition.
In this specification, unless the context dictates otherwise, percentage fraction will be understood to mean weight by weight (W/W) percentages.
Any portion of the leaves and / or roots and / or stems of Salvia officinalis may be used to manufacture the Salvia officinalis based plant extract.
The Salvia officinalis plant extract may have an extract factor and / or strength of 5:1 meaning that 5 units of Salvia officinalis plant material is used to produce 1 unit of Salvia officinalis plant extract.
The Salvia officinalis plant extract may comprise up to 35 % of the chewable gum composition.
The Salvia officinalis plant extract may comprise between 8 mg and 450 mg of the chewable gum composition.
The Salvia officinalis plant extract may contain rosmarinic acid and caffeic acid. The Salvia officinalis plant extract may contain about 0.105% rosmarinic acid and 0.0126% caffeic acid when using a 5:1 Salvia officinalis plant extract. Any portion of the leaves and / or roots and / or stems of Glycyrrhiza glabra may be used to manufacture the Glycyrrhiza glabra based plant extract.
The Glycyrrhiza glabra plant extract may have an extraction and / or processed factor of 4:1 meaning that 4 units of Glycyrrhiza glabra plant material is used to produce 1 unit of Glycyrrhiza glabra plant extract.
The Glycyrrhiza glabra plant extract may comprise up to 20 % of the chewable gum composition.
The Glycyrrhiza glabra plant extract may comprise between 4 mg and 250 mg of the chewable gum composition.
The Glycyrrhiza glabra plant extract may contain glycyrrhizic acid.
The Glycyrrhiza glabra plant extract may contain about 2.383 % glycyrrhizic acid when using a 4:1 Glycyrrhiza glabra plant extraction.
The rosmarinic acid may comprise between 0.01 mg and 1 mg of the chewable gum composition.
The rosmarinic acid may comprise up to 1 % of the chewable gum composition.
The caffeic acid may comprise between 0.01 mg and 1 mg of the chewable gum composition.
The caffeic acid may comprise up to 1 % of the chewable gum composition.
The glycyrrhizic acid may comprise between 0.1 mg and 6 mg of the chewable gum composition.
The glycyrrhizic acid may comprise up to 3 % of the chewable gum composition. The carrier may be in the form of any suitable excipient for allowing the sustained and / or modified release of the plant extracts when chewing the chewable gum composition.
The carrier may be in the form of a chewable gum. The carrier may comprise any one or more of the group consisting of a gum base, an elastomer, an emulsifier, a filler, a wax, an antioxidant, a softener, a sweetener, a food colouring and / or flavouring agent.
The percentage fraction of carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract in the chewable gum composition may be in the range of 49 % - 99 % : 0.5 % - 32 % : 0.5 % - 20 %.
The percentage fraction of carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract in the chewable gum composition may be about 90% : 6.4 % : 3.6 %
The chewable gum composition may further also include any one or more pharmaceutical excipients commonly used for formulating a solid oral dosage form, such as a chewable tablet, selected from the group consisting of a glidant, a lubricant, a binder, a taste masking agent, a flavour absorbing agent and a flavourant.
The glidant in turn may be selected from any one or more of the group consisting of talc (magnesium hydrous silicate), and colloidal silicon dioxide. The lubricant may be selected from any one or more of the group consisting of magnesium stearate, stearic acid, sodium stearyl fumerate and sodium behenate.
The binder may be selected from any one or more of the group consisting of hydroxypropylcellulose, methylcellulose, hypromellose, polyvinylpyrrolidone (povidone) and copovidone. The taste masking agent may be in the form of citric acid monohydrate.
The flavour absorbing agent may be in the form of calcium carbonate. The flavourant may be selected from any one or more of the group consisting of wild cherry and spearmint liquid.
The percentage fraction of the carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract : glidant : lubricant : binder : taste masking agent : flavourant absorbing agent : flavourant in the chewable gum composition may be in the range of 40 - 90% : 0.5 - 30 % : 0.5 - 20 % : 1 - 5 % : 0.1 - 3 % : 1 - 10 % : 0,1 - 3 % : 1 - 5 % : 0.1 - 5 %. The percentage fraction of the carrier : Salvia officinalis based plant extract :
Glycyrrhiza glabra based plant extract : glidant : lubricant : binder : taste masking agent : flavourant absorbing agent : flavourant in the chewable gum composition may be 78.27% : 5.55 % : 3.26 % : 2.24 % : 0.25 % : 5 % : 0.3 % : 2.25 % : 2.88 %. The weight ratio of the carrier : Salvia officinalis based plant extract : Glycyrrhiza glabra based plant extract : glidant : lubricant : binder : taste masking agent : flavourant absorbing agent : flavourant in the chewable gum composition may be 1 173.88 mg : 83.33 mg : 48.93 mg : 33.69 mg : 3.75 mg : 75 mg : 4.5 mg : 33.69 mg : 43.23 mg.
The chewable gum composition may be in the form of a solid oral dosage form, such as a conventional chewable tablet. The composition may be film and / or sugar coated to enhance the stability / and or organoleptic properties thereof. The film coating may comprise any commonly used excipient used in the pharma industry for coating tablets, such as hydroxypropyl methylcellulose (HPMC). The film coating may comprise between 1 % and 6 % of the total dosage mass.
DETAILED DESCRIPTION OF THE INVENTION
The invention will now be described according a non - limiting example only. According to the invention there is provided a chewable gum composition presented preferably in tablet form to a user, for treating oral canker sores.
In accordance with a preferred embodiment of the invention the chewable gum composition will be composed according to the formula set out hereunder:
EXAMPLE 1
Ingredient W/W %
Gum base 78.27
Salvia officinalis plant extract 5.55
Glycyrrhiza glabra plant extract 3.26
Talc 2.24
Magnesium stearate 0.25
PVP (K 30) 5.00
Citric acid monohydrate 0.30
Calcium carbonate 2.25
Wilde cherry flavour 1 .00
Spearmint oil flavour 1 .88 EXAMPLE 2
Ingredient W/W %
Gum base 84.58
Rosmarinic acid 0.105
Caffeic acid 0.0126
Glycyrrhizic acid 2.383
Talc 2.24
Magnesium stearate 0.25
PVP (K 30) 5.00
Citric acid monohydrate 0.30
Calcium carbonate 2.25
Wilde cherry flavour 1 .00
Spearmint oil flavour 1 .88
It shall be understood that the examples are provided for illustrating the invention further and to assist a person skilled in the art with understanding the invention and are not meant to be construed as unduly limiting the reasonable scope of the invention.
Advantages of oral cavity drug delivery:
- ease of administration
- rapid onset of action and continuous drug delivery
- avoidance of the harsh conditions within the gastrointestinal tract
- rapid reach of therapeutic concentrations of the drug
- bypass of hepatic first - pass metabolism which decrease drug bioavailability enhances patient compliance due to ease of administration
easy access to delivery site, the delivery site having a fairly large contact surface leading to increased quantities of drug being absorbed at a faster rate of absorption.
The Applicant considers the invention advantageous in that a chewable gum composition in tablet form is provided for releasing Glycyrrhiza glabra and Salvia officinalis plant extracts and thereby the active ingredients rosmarinic acid, caffeic acid and glycyrrhizic in the oral cavity when chewing the said composition for treating conditions such as oral canker sores.
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