Double-layered absorbable solid compositions for the topical treatment of oral mucosal disorders
Bioadhesive sticker tablets which are applied directly to vaginal, rectal and/or oral mucosa are described herein. In one embodiment, the sticker tablets are applied directly to ulcers or lesions in the oral cavity. The compositions adhere immediately upon administration, swell over time, and remain adherent to the ulcer or lesion for at least 60 minutes. The compositions can be in the form of single layer, double layer, or multilayer sticker tablets. The compositions provide immediate pain relief to the patient and promote rapid healing of the ulcer or lesion. The sticker tablet compositions contain one or more bioadhesive polymers. In one embodiment, the polymers are crosslinked polycarboxylic acids and polyols. The compositions contain at least one herbal agent and/or irritating compound, and optionally, a non-herbal active agent. The compositions can deliver an non-irritating effective dose of the agent for at least 60 minutes. The compositions described herein are stable upon storage for six months or longer.
1. A solid, self-bioadhesive multilayer compression molded sticker tablet for topical application in the mouth of a human consisting essentially of:
(a) a delivery layer consisting essentially of a component selected from the group consisting of wintergreen oil, peppermint oil, spearmint oil, clove bud oil, menthol, anethole, methyl salicylate, eucalyptol extract, cassia extract, 1-menthyl acetate, sage extract, eugenol, parsley oil, oxanone, alpha-irisone, marjoram extract, orange extract, propenyl guaethol, cinnamon extract, vanillin, thymol, linalool, cinnamaldehyde glycerol acetal, lemon oil, geranium oil, peppermint oil, turpentine oil, peppermint oil, and mixtures thereof incorporated into or encapsulated into a water-swellable material such that it is releasable from the water-swellable material once placed in the mouth of the human;
wherein the water-swellable material is selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, carboxymethyl cellulose, dextran, arabinogalactan, pullulan, guar gum, hyaluronic acid, pectin, and mixtures thereof; and
wherein the water-swellable material has sufficient hydrophobicity to maintain integrity of the tablet during release of the component and
(b) a non-irritating bioadhesive layer consisting essentially of a bioadhesive polyacrylic acid;
wherein upon application to a mucosal surface of the mouth of the human, the tablet adheres to mucosal surface tissue of the mouth of the human for between about 3 and 10 hours, and
wherein upon adhesion to the mucosal surface of the human, the delivery layer releases a non-irritating therapeutically effective dose of the component to treat mucosal disease in the mouth of a human for a period of at least three hours.
2. The sticker tablet of claim 1 , wherein the component is peppermint oil.
3. The sticker tablet of claim 1 , wherein the component is menthol.