US 20030206942A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0206942 A1 Kulkarni et al. (43) Pub. Date: Nov. 6, 2003 (54) FAST DISSOLVING ORALLY CONSUMABLE Related U.S. Application Data FILMS CONTAINING AN ANTITUSSIVE AND A MUCOSA COATINGAGENT (63) Continuation-in-part of application No. 09/395,104, filed on Sep. 14, 1999, now Pat. No. 6,596,298. (76)76 Inventors: Neema Kulkarni, Randolph, NJ (US); (60) 25,Provisional 1998. application No. 60/101,798, filed on Sep. Lori D. Kumar, Skillman, NJ (US); Albert Sorg, Columbia, NJ (US) Publication Classification Correspondence Address: (51) Int. Cl." ....................... A61K 38/38; A61K 31/715; Barry H. Jacobsen A61K 9/70 Warner-Lambert Company (52) U.S. Cl. ............................... 424/443; 514/21; 514/54 Legal Division 201 Tabor Road (57) ABSTRACT Morris Plains, NJ 07950 (US) A consumable film adapted to adhere to and dissolve in the (21) Appl. No.: 10/423,735 oral cavity of a consumer comprising at least one water Soluble polymer, at least one antituSSive agent and a mucosa (22) Filed: Apr. 25, 2003 coating effective amount of a mucosa-coating agent. US 2003/0206942 A1 Nov. 6, 2003 EAST DISSOLVING ORALLY CONSUMABLE DETAILED DESCRIPTION FILMS CONTAINING AN ANTITUSSIVE AND A 0006 The present invention is directed to a physiological MUCOSA COATINGAGENT acceptable consumable film that is adapted to dissolve in the mouth of a consumer and adhere to the mucosa of the oral FIELD OF THE INVENTION cavity. Consumable films with mucosa coating agents are 0001. The present invention is related generally to fast particularly well-Suited for delivering an antituSSive agent to dissolving orally consumable films, more particularly to the consumer and are useful for treating or alleviating the films containing an antituSSive agent in combination with a Symptoms and/or irritations associated with Sore throats mucosa-coating agent in amounts Sufficient to impart and/or coughing. extended throat-coating and mucosa adherence properties. 0007. In one aspect of the present invention, there is provided a consumable film adapted to adhere to and dis BACKGROUND OF RELATED Solve in the mouth of a consumer including at least one TECHNOLOGIES water Soluble polymer, at least one antituSSive agent and a mucosa-coating effective amount of a mucosa-coating agent. 0002 Personal care products can be formulated in a The mucosa-coating agent is capable of forming a coating variety of dosage forms, including tablets, capsules, loz that adheres to the mucosa of the mouth and throat whereby enges or strips of edible thin film compositions. Edible thin the antituSSive agent is effectively retained in contact with film compositions applied to the oral cavity can be designed the affected areas of the mouth and throat for a period time to deliver therapeutic agents to the oral mucosa. One Such after the consumable film has dissolved. example is LISTERINE POCKETPAKSTM brand oral care 0008. The consumable film may include one or more of strip products made by Pfizer Inc. of New York are success the following ingredients, including, but not limited to, ful examples of an edible film compositions effective in water, antimicrobial agents, additional film forming agents delivering therapeutic agents particularly antimicrobial or water Soluble polymers, plasticizing agents, flavorings, agents in the form of a combination of essential oils. Sulfur precipitating agents, Saliva Stimulating agents, cool ing agents, Surfactants, Stabilizing agents, emulsifying 0.003 Conventional rapidly dissolving orally consumable agents, thickening agents, binding agents, coloring agents, films absorb water and may become Viscous and Sticky over triglycerides, polyethylene oxides, propylene glycols, time when applied to the moist Surface of the mucosa of the Sweeteners, fragrances, preservatives and the like, as oral cavity. Retention of the film may be insufficient to described in co-pending application U.S. patent application obtain the desired effect because the film rapidly disinte Ser. No. 09/395,104, by Leung et al., filed Sep. 14, 1999, grates within a relatively short time. Sometimes is it desir which is incorporated herein by reference. able to have improved covering and adherence to the 0009. In another embodiment of the present invention, mucosa Surface. Thus, there is a need in the art to develop the consumable film comprises a single layer including at consumable thin films, having good adhesion and retention least one water Soluble polymer, at least one antituSSive to the mucosa of the oral cavity for providing an effective agent and a mucosa-coating effective amount of pectin. delivery and retention System for antituSSive and mucosa coating agents. 0010. The term “consumable” as used herein is intended to encompass Substances including edible compounds, which upon administration to a consumer, is adequately SUMMARY tolerated without causing undue adverse effects or discom 0004. The present invention is generally directed to a fort to the consumer. consumable film, which is particularly well adapted to 0011 Unless specified otherwise, the term “% by weight” rapidly dissolve in the mouth of a consumer. In one particu as used is based on the total weight of the final product (i.e., lar aspect of the present invention, there is provided a the consumable film) as opposed to the formulation used to consumable film adapted to adhere to and dissolve in the produce the product, and thus denotes the percent of the total mouth of a consumer comprising at least one water Soluble dry weight contributed by the subject ingredient. This theo polymer, at least one antituSSive agent and a mucosa-coating retical value can differ from the experimental value, because effective amount of a mucosa-coating agent. In one embodi in practice, the consumable film typically retains Some of the ment, the mucosa-coating agent is pectin. water and/or other Substances Such as alcohol (e.g. ethanol) 0005 Another aspect of the present invention is directed that may be used in preparing the final product. to a method of preparing a Supple, non-Self-adhering film 0012. In one embodiment, the consumable film of the especially Suitable for oral delivery of at least one antituS present invention is shaped and sized for administration to Sive agent. The method comprises preparing an aqueous the oral cavity. The mucosa-coating agent is capable of phase comprising a mucosa-coating effective amount of a imparting throat Soothing and throat coating properties to the mucosa-coating agent, preparing a film-forming mixture consumable film as the film dissolves in the consumer's including at least one water Soluble polymer; combining the mouth. The dissolved film adheres to the Surface of the aqueous phase and the film forming mixture to form a mouth, typically the roof of the mouth or the tongue, and hydrated polymer gel; casting the hydrated polymer gel on coats and adheres to the mucosa of the throat, thus providing a Substrate to form a cast gel, and drying the cast gel to form maximum retention thereon for an extended period of time. the consumable film, wherein the at least one antituSSive AS a result, the consumable film of the present invention agent is added to the aqueous phase, the hydrated polymer affords an effective delivery and retention system for thera gel or both. peutic agents to localized areas within the oral cavity for US 2003/0206942 A1 Nov. 6, 2003 which treatment with the therapeutic agent is desired. Suit the consumable film is from about 0.01% to about 80% by able mucosa-coating agents include pectin, gelatin, and the weight based on the total weight of the consumable film, like, and combinations thereof. In one embodiment, the preferably from about 2.5% to about 40% by weight, and mucosa-coating agent may be present in amounts ranging more preferably from about 5% to about 30% by weight. from about 0.01% to about 5% by weight, in another embodiment, from about 0.1% to about 2% by weight, and 0017. A film can measure from about 1" by about 1.25" yet another embodiment, from about 0.1% to about 1.0% by (2.54 cmx3.18 cm) and weigh from about 60 mg to about weight of the consumable film. 190 mg. 0013 Suitable antitussive agent include alloclamide, 0018. Additional therapeutic agents that are effective for amicibone, benproperine, benzonatate, bibenzonium bro treating conditions other than coughing may be added to mide, bromoform, butamirate, butetamate, caramiphen various embodiments of the present invention, Such as an ethanedisulfonate, caramiphen edisylate, carbetapentane, antihistamine, Symphathomimetic pharmaceutically active chlophedianol, clobutinol, cloperastine, codeine, codeine agent (nasal decongestant, bronchodilator), analgesic, anti methyl bromide, codeine N-oxide, codeine phosphate, inflammatory, cough expectorant and the like, as described codeine Sulfate, cyclexanone, dextromethorphan, dibunate in co-pending application U.S. patent application Ser. No. Sodium, dihydrocodeine, dihydrocodeinone enol acetate, 09/395,104, by Leung et al., filed Sep. 14, 1999, which is dimenorfan, dimethoxanate, W.W-diphenyl-2-pip incorporated herein by reference. Other examples of Such eridinepropanol, dropropizine, drotebanol, eprazinone, ethyl additional therapeutic agents are well known in the art. dibunate, ethylmorphine, fominoben, guaiapate, hydroc 0019 Useful antihistamines include cetirizine, diphenhy odone, isoaminile, levopropoxyphene, morclofone, narce dramine, loratadine, desloratadine, feXofenadine, mon ine, normethadone, noScapine, OXeladin, oxolamine, phol telukast Sodium, and the like. codine, picoperine, pipaZethate, piperidione, prenoXcdiazine hydrochloride, racemethorphan, taZiprinone hydrochloride, 0020 Examples of doses for specific pharmaceutically tipepidine, Zipeprol, and the like and pharmaceutically active agents that can be delivered per one Strip of rapidly acceptable Salts thereof, and combinations thereof. The dissolving oral film are reviewed in Table A. antituSSive agents as utilized in the present invention may be in the free form or in any non-toxic pharmaceutically TABLE A acceptable form wherein their therapeutic activity is Pharmaceutically Active Agent Dose retained.