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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 (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 , 0018. Additional therapeutic agents that are effective for amicibone, , , bibenzonium bro treating conditions other than coughing may be added to mide, bromoform, , butetamate, caramiphen various embodiments of the present invention, Such as an ethanedisulfonate, caramiphen edisylate, carbetapentane, antihistamine, Symphathomimetic pharmaceutically active chlophedianol, , , , codeine agent (nasal , bronchodilator), analgesic, anti methyl bromide, codeine N-oxide, codeine phosphate, inflammatory, cough expectorant and the like, as described codeine Sulfate, cyclexanone, , in co-pending application U.S. patent application Ser. No. Sodium, , dihydrocodeinone enol acetate, 09/395,104, by Leung et al., filed Sep. 14, 1999, which is dimenorfan, , W.W-diphenyl-2-pip incorporated herein by reference. Other examples of Such eridinepropanol, , drotebanol, , ethyl additional therapeutic agents are well known in the art. dibunate, , , guaiapate, hydroc 0019 Useful antihistamines include cetirizine, diphenhy odone, , , , narce dramine, loratadine, desloratadine, feXofenadine, mon ine, , , , , phol telukast Sodium, and the like. codine, picoperine, pipaZethate, , prenoXcdiazine hydrochloride, racemethorphan, taZiprinone hydrochloride, 0020 Examples of doses for specific pharmaceutically , , 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. In one embodiment, the antituSSive agent is deX tromethorphan hydrobromide. Chlorpheniramine Maleate 4-12 mg Maleate 4 mg 2 mg 0.014. The antitussive agent, whether a single antitussive Dexbropheniramine 2 mg agent or combinations thereof, is employed in an effective Hydrochloride 2.5 mg amount. An "effective amount' is an amount of the antituS Cetirizine 5-10 mg Sive agent that is Sufficient to at least reduce the occurrence Acrivastine 8 mg Maleate 1 mg of coughing and/or the adverse effects of a Sore throat, but Loratadine 5-10 mg low enough to avoid any adverse Side effects. In addition to Phenylephrine Hydrochloride 5-10 mg the particular antituSSive agent or agents chosen, the effec Dextromethorphan Hydrobromide 10–30 mg tive amount of the antituSSive agent may vary with the type Sildenafil 25-100 mg Ketoprofen 12.5-25 mg and/or Severity of the coughing condition, the age and Sumatriptan Succinate 35-70 mg physical condition of the patient being treated, the duration Zolmitriptan 2.5 mg of treatment, the type of concurrent therapy, the Specific 2 mg form (e.g., salt) of the antitussive agent employed, and the Famotidine 5-10 mg Nicotine 1-15 mg particular formulation of the consumable film which con Hydrochloride 12.5-25 mg tains the antituSSive agent. These variations can be readily Pseudoephedrine Hydrochloride 15-60 mg determined by one of ordinary skill in the art. Atorvastatin 5-80 mg Valdecoxib 5-20 mg 0.015 The amount of antitussive agent is adjusted to besylate 2.5-10 mg deliver a predetermined dose of the antituSSive agent over a Rofecoxib 5-25 mg Setraline hydrochloride 10-100 mg predetermined period of time, which may typically vary Ziprasidone 20-80 mg from 4 to 24 hours, more typically about every 12 hours. A Eletriptan 10-40 mg typical adult dose of an antituSSive agent will contain from Nitroglycerin 0.3-0.6 mg about 1 to about 130 mg, preferably from about 2.5 mg to about 65mg, more preferably from about 2.5 to about 20 and most preferably about 15 mg of the antituSSive agent (e.g., 0021. The film compositions of the present invention dextromethorphan hydrobromide). A typical child dose of an may also be used to Supply nutritionally acceptable compo antituSSive agent will contain from about 2.5 to about 10 mg nents Such as Vitamins, minerals, trace elements, and fibers and more preferably about 7.5 mg of dextromethorphan (preferably soluble fibers). hydrobromide. 0022. Examples of vitamins suitable for the incorporation 0016 Except as otherwise noted, the amount of antitus in the composition of the invention include Vitamin A, Sive agent in the consumable film according to the present Vitamin D, Vitamin E, Vitamin K, Vitamin C, folic acid, invention is designated as % by weight after the “wet' film thiamin, riboflavin, Vitamin B (6), Vitamin B (12), niacin, formulation has been dried and formed into the consumable biotin and panthotenic acid in pharmaceutical or nutrition film. Generally, the amount of the antituSSive agent used in ally acceptable form. Examples of mineral elements and US 2003/0206942 A1 Nov. 6, 2003 trace elements Suitable for the incorporation in the compo tically enhanced antiseptic properties to eradicate plaque Sition of the invention include calcium, Sodium, potassium, producing germs that cause dental plaque, gingivitis and bad phosphorous, , manganese, copper, Zinc, iron, breath. Selenium, chromium and molybdenum in pharmaceutical or nutritionally acceptable form. 0027. For embodiments incorporating essential oils, humectants are avoided due to the relatively high content of 0023 The term soluble fiber as used herein refers to oil in the consumable, So as to avoid producing an overly fibers which are able to Substantially undergo fermentation moist, Self-adhering film. In an embodiment, the consum in the colon to produce Short chain fatty acids. Examples of able film includes a plasticizing agent other than glycerin, Suitable Soluble fibers include, carubin, pectin, tragacanth, which is also a humectant, and with a Sweetener other than cereal beta-glucan and the like. They may be hydrolysed or Sorbitol, which is a mild humectant. not. 0028 Saliva stimulating agents may also be added to the 0024. Useful water soluble polymers that exhibit film consumable films of the present invention. Useful saliva forming properties include pullulan, hydroxypropylmethyl stimulating agents are disclosed in U.S. Pat. No. 4,820,506, cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, which is incorporated herein by reference in its entirety. polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, Sodium alginate, polyethylene glycol, tragacanth 0029 Suitable Sweeteners include both natural and arti gum, guar gum, acacia gum, arabic gum, polyacrylic acid, ficial SweetenerS Such as A) water-soluble Sweeteners methylmethacrylate copolymers, carboxyvinyl polymers, including monosaccharides, disaccharides, polysaccharides amylose, high amylose Starch, hydroxypropylated high amy and the like, B) water-Soluble artificial Sweeteners including lose Starch, dextrin, chitin, chitosan, levan, elsinan, collagen, Soluble Saccharin Salts and the like, C) dipeptide based Zein, gluten, Soy protein isolate, whey protein isolate, casein SweetenerS Such as L-aspartic acid derived Sweeteners and combinations thereof. In one embodiment of the present including aspartame, neotame and the like, D) derivatives of invention the film comprises pullulan as a water Soluble naturally occurring water-Soluble Sweeteners including polymer. The amount of the water soluble polymer will chlorinated derivatives of Sucrose, Sucralose and the like, E) typically be from about 0.01% to about 99% by weight, protein based Sweeteners including thaumatoccous danielli preferably from about 30% to about 80% by weight, more (Thaumatin I and II) and the like, and combinations thereof. preferably from about 45% to about 70% by weight of the 0030. In general, an effective amount of auxiliary Sweet consumable film and most preferably from about 60% to ener is utilized to provide the level of Sweetness desired for about 65% by weight of the consumable film. a particular composition, and this amount will vary with the 0.025 In another embodiment of the present invention, particular Sweetener selected. The effective amount will the consumable film may further include antimicrobial normally be from about 0.01% to about 10% by weight of agents including, but not limited to, essential oils as is the consumable film when using an easily extractable Sweet described in co-pending U.S. patent application Ser. No. ener. The water-Soluble Sweeteners are usually used in 09/395,104, by Leung et al., filed Sep. 14, 1999, which is amounts of from about 0.01% to about 10% by weight, and incorporated herein by reference. Useful essential oils car preferably in amounts of from about 2.0% to about 5.0% by vacrol, thymol, eucalyptol, , methyl Salicylate, weight of the consumable film. The other Sweeteners eugenol, gerianol, Verbenone, and the like and combinations described above, other than water-Soluble Sweeteners are thereof. One of the preferred combinations of essential oils generally used in amounts of from about 0.01% to about for use in the present invention is utilized in LISTERINE(R) 10% by weight, preferably from about 2% to about 8% by brand mouthwash and oral care Strips, which is a well known weight, and more preferably from about 3% to about 6% by example of antiseptic oral composition that has proven weight of the consumable film. effective in killing microorganisms in the oral cavity con 0031 A preservative may also be added to the consum tribute to the formation of plaque, gingivitis and bad breath. able films. The preservative is added in amounts from about ESSential oils include precisely balanced amounts of thymol, 0.001% to about 5%, preferably from about 0.01% to about methyl salicylate, menthol and eucalyptol (hereinafter “the 1% by weight of the consumable film. Preferred preserva preferred essential oils”) having antimicrobial activity. tives include Sodium benzoate, potassium Sorbate and the like, and combinations thereof. Other suitable preservatives 0026. The amounts of the essential oils used in the include, but are not limited to, Salts of edetate, (also known consumable film of the present invention can vary as long as as Salts of ethylenediaminetetraacetic acid, or EDTA, Such a they are in amounts Sufficient to provide antimicrobial efficacy. Generally, the amount of essential oils is up to disodium EDTA). about 30% and preferably from about 0.05% to about 18% 0032) Another embodiment of the present invention is by weight of the consumable film. In one preferred embodi directed to methods of preparing consumable films of the ment, the amount of thymol, methyl Salicylate and eucalyp present invention. Generally, at least one antituSSive agent tol is each from about 0.01% to about 4% by weight, and a mucosa-coating effective amount of a mucosa-coating preferably from about 0.05% to about 3.0% by weight and agent are dissolved in water to form an aqueous phase. The more preferably from about 0.07% to about 2.0% by weight aqueous phase may further include Sweeteners, dyes, and the of the consumable film. Menthol may be present in an like. A film forming mixture comprising at least one water amount of from about 0.01% to about 15% by weight of the Soluble polymer (e.g., pullulan) is prepared. The aqueous composition, preferably from about 2.0% to about 9.0% by phase and the film forming mixture are combined and weight and more preferably from about 3% to about 9% by thoroughly mixed to form a hydrated polymer gel. Option weight of the consumable film. In certain embodiments, the ally, an organic phase comprising organic ingredients. Such essential oils are combined in amounts to provide Synergis as essential oils and other oils (e.g. glycerine, olive oil) US 2003/0206942 A1 Nov. 6, 2003 flavorants, surfactants (e.g., Polysorbate 80, Atmos 300, particular, the essential oils. Such as menthol and thymol can Atsurf 596K); and the like, may be combined with the be mixed optionally in combination with oils to form an oil aqueous phase, the film forming mixture or the hydrated mixture. Other essentials oils. Such as methyl Salicylate and polymer gel. The resulting hydrated polymer gel is cast on eucalyptol, and Surfactants can then be added to the oil a Suitable Substrate to form a cast gel. The cast gel is then mixture. The oil mixture is then added to the hydrated dried to form the consumable film. polymer gel and mixed until a uniform gel is formed. The 0033. In another embodiment there is provided a method uniform gel is then cast on a Suitable Substrate, and there of preparing the consumable film, it may be desirable to first after dried to form the consumable film. form the film forming mixture by first hydrating the water 0040. In one embodiment for preparing the consumable Soluble polymer with water. The aqueous phase is then film, the water soluble polymer may be hydrated without prepared by dissolving the other water Soluble ingredients heating the water to reduce energy costs in the manufactur Such as the antituSSive agent, the mucosa-coating agent (e.g., ing process. Moreover, Since heating may result in undesir pectin), Sweeteners, dyes, and the like in water. Separately, able losses of volatile ingredients to evaporation, it would be the organic ingredients Such as essential oils and other oils preferable to avoid heating during the hydration process. For (e.g. glycerine, olive oil) flavorants, Surfactants (e.g., essential oil-containing films, the heat may also affect the Polysorbate 80, Atmos 300, Atsurf 596K); and the like are germ killing activity of the composition due to the loss of mixed together. The final formulation is then produced by essential oils. mixing the film forming polymer phase with the aqueous 0041 While not wishing to be bound by any theory, it is phase, then adding the organic phase. The combined mixture believed that the film forming ingredients Such as the water is formed into an emulsion or a hydrated polymer gel. Soluble polymers can be hydrated and mixed without heating 0034. The resulting hydrated polymer gel is then cast on due to an ionic effect known as the Donnan equilibrium. a Suitable Substrate and dried to form a film. The consumable Hydrating the water Soluble polymers in the presence of film is preferably air-dried and dried under warm air and cut electrolytes in solution effectively lowers the viscosity of the to a desired dimension, packaged and Stored. The packaged polymer gel being formed, thus increasing the efficiency of film may contain moisture in amounts of from about 0.1% the hydrating process. The water-Soluble ingredients of the to about 10% by weight, and more preferably from about 4% formulation provide the electrolytes, which are dissolved in to about 7% by weight. the hydration solution prior to addition to the water-soluble 0035. The film forming mixture may further include polymers. High shear mixing also accelerates hydration, Stabilizing agents Such as Xanthan gum, locust bean gum, which delumps the powders, providing greater Surface area carrageenan, and the like, and combinations thereof. These for water contact. In addition, local heating effects, gener ingredients are mixed and then hydrated in warm water, ated in the Shear regions, provide energy for hydration preferably deionized water until a gel is formed which may without Substantially raising the temperature of the mass. take from about 30 to about 48 hours. The water is prefer ably heated to a temperature of from about 20° C. to about EXAMPLE 1. 40° C. to promote hydration. The amount of water is 0042. The ingredients listed in Table 1 were combined to typically from about 40% to about 80% by weight of the gel. provide a consumable film of the present invention in The resulting hydrated gel is then chilled to a temperature of accordance with the following procedure: from about 20° C. to about 30° C. for about 1 hour to about 0043 A) Dextromethorphan HBr was mixed and 48 hours. dissolved in 90% water at 75 C. to yield an aqueous 0.036 The aqueous phase may, in addition to the antitus phase. Amberlite IRP69 was added to the aqueous Sive agent and the mucosa coating effective amount of the phase and stirred for about 4 to 5 hours at about 70 mucosa-coating agent Such as pectin, include additives Such C. to 80° C. Pectin was added to the aqueous phase as coloring agents, copper gluconate and Sweetener. Typi very slowly and mixed at high Speed. The aqueous cally the aqueous phase contains from about 5% to about phase was allowed to cool to about 50 C. and q.S. 80% by weight based on the total weight of the final gel with water to replace loSS due to evaporation. Potas sium Sorbate, SweetenerS and dye were then added to mixture. the aqueous phase and mixed thoroughly. 0037. If sodium saccharin as a selected Sweetener and 0044 B) The film-forming ingredients, xanthan copper gluconate as a Selected Sulfur precipitating agent are gum, locust bean gum, carrageenan and pullulan used in the formulation, it is preferable to dissolve them were mixed together in a separate container to form Separately in Solution to avoid precipitation. a film forming mixture. 0.038. In another embodiment of the present invention, 0045 C) The film forming mixture was slowly the water soluble polymer is in the form of a powder which added to the aqueous phase of A), followed by is added to the aqueous phase to form a hydrated polymer overnight mixing at a slow rate to provide a hydrated gel. The resulting hydrated polymer gel is thoroughly Stirred polymer gel. at about room temperature for about 30 minutes to about 48 0046 D) The flavorants, glycerine, menthol, and hours, and then deaerated to remove at least Substantially all Surfactants were combined and mixed in a separate the air bubbles. The uniform mixture is cast on a suitable container until dissolved to yield an organic phase. Substrate, and thereafter dried to form the desired film. 0047 E). was mixed together in the 0.039 For consumable films containing essential oils, the remaining 10% water in a separate container. Suc essential oils are further added to the organic phase and the culence was then added to the resulting mixture and mixing the organic phase with the hydrated polymer gel. In dissolved. US 2003/0206942 A1 Nov. 6, 2003

0.048 F). The mixtures of steps D) and E) were added 0.052 C) The film forming mixture was slowly to the hydrated polymer gel and mixed uniformly to added to the aqueous phase of A), followed by yield a final polymer gel mixture. The final polymer overnight mixing at a slow rate to provide a hydrated gel mixture was poured on a mold and cast to form polymer gel. a film of a desired thickness at room temperature. 0.053 D) The flavorants and menthol were com The consumable film was dried under warm air and bined and mixed in a separate container until dis cut to a desired dimension (dictated by e.g., dosage Solved to yield an organic phase. and mouthfeel). The consumable film was Seg mented into 1" x 1.25" (2.54 cmx3.18 cm) dosage 0054 E) Mannitol and sucralose were mixed units, each of which had a thickness of 0.009+0.002 together in the remaining 10% water in a separate of an inch (0.23+0.05 of a mm) and a weight of 70+3 container. Succulence was then added to the result mg. ing mixture and dissolved. 0.055 F). The mixtures of steps D) and E) were added TABLE 1. to the hydrated polymer gel and mixed uniformly to yield a final polymer gel mixture. The final polymer % w/w mg/ % w/wik Actual gel mixture was poured on a mold and cast to form Material dose Dry Film Batch g/batch a film of a desired thickness at room temperature. The consumable film was dried under warm air and Dextromethorphan HBr 15.OOOO 22.3940 7.653938.2695 Amberlite IRP69 16.OOOO 23.887O 8.164240.8208 cut to a desired dimension (dictated by e.g., dosage Pectin USP O.35OO 0.5225 O.1786 O.893O and mouthfeel). The consumable film was Seg Xanthan Gum O.O766 O.1165 O.O396 O.1980 mented into 1"x1.25" (2.54 cmx3.18 cm) dosage Locust Bean Gum O.O901 O.1345 O.O46O O.2299 units, each of which had a thickness of 0.009+0.002 Carrageenan O.3861 O.5764 O.197O O.9851 Pullulan 20.5919 30.7424 10.507252.5361 of an inch (0.23+0.05 of a mm) and a weight of 70+3 Potassium sorbate O.O772 O.1153 O.O394 O.1970 mg. Acesulfame Potassium salt O.6435 O.96O7 O.3284 16418 Aspartame NF 18018 2.69(OO O.919.4 4.5969 TABLE 2 Purified water 65.8213.29.1085 Menthol 2.5740 3.8428 1.3134 6.5670 mg/ % w/w % w/w Peppermint Flavor 0.2579 O.3850 O.1316 O.658O Material dose* Dry Film Actual Batch g/batch Cherry Flavor (Givudan) 0.2579 O.3850 O.1316 O.658O Cherry Flavor Blend (IFF) 2.2350 3.3367 1.1404 5.7022 Dextromethorphan HBr 15.0000 22.9235 7.8353 39.1765 Warm Sensation (Mane) O.5518 O.8238 O.281 6 1.4O78 Amberlite IRP64 16.0000 24.4518 8.3576 41.7882 Artificial Masking Agent O.4139 O.6179 O.2112 1.0560 Pectin USP O.35OO O.S349 O.1828 O.9141 Flavor (Robertet) Xanthan Gum O.O769 0.1175 O.O4O2 O.2008 Succulence (IFF) 0.2579 O.3850 O.1316 O.658O Locust Bean Gum O.O901 0.1377 O.0471 O.2353 FD&C Red #40 O.O1O2 O.O152 O.OO52 O.O260 Carrageenan O.3861 O.S901 O.2O17 10084 Polysorbate 80 NF 0.4504 O.6724 O.2298 11491 Pullulan 20.5919 31.4693 10.7562 53.7812 Atmos 300 0.4504 O.6724 O.2298 11491 Potassium sorbate O.O772 O.118O O.O403 O.2O16 Glycerine 19305 2.8821 O.9851 49253 Purified water 65.81.99 329.0995 Mannitol USP 2.5740 3.8428 1.3134 6.5670 Menthol 2.5740 3.9337 1.3445 6.7227 Peppermint Flavor 0.2579 O.3941 O.1347 O.6736 Total 66.9821 1 OOOOOO 10O.OOOOO.OOOO Cherry Flavor (Givudan) 0.2579 O.3941 O.1347 O.6736 Sour Cherry (IFF) 2.2350 3.4156 1.1675 5.8373 *Assuming that all water is evaporated Warm Sensation (Mane) O.5518 O.8433 O.2882 1.4412 Artificial Masking Agent 0.4139 O.6325 O.2162 1.0810 Flavor (Robertet) EXAMPLE 2 Succulence (IFF) 0.2579 O.3941 O.1347 O.6736 FD&C Red #40 O.OO98 O.O150 O.OO51 O.O256 Glycerine 19305 2.9503 10084 5.042O 0049. The ingredients listed in Table 2 were combined to Mannitol USP 2.5740 3.9337 1.3445 6.7227 provide a consumable film of the present invention in Sucralose 18OOO 2.7508 O.94O2 4.7O12 accordance with the following procedure: Total 65.4349 10O.OOOO 1OOOOOO SOO.OOOO 0050 A) Dextromethorphan HBr was mixed and dissolved in 90% water at 75 C. to yield an aqueous *Assuming that all water is evaporated phase. Amberlite IRP64 was added to the aqueous phase and stirred for about 4 to 5 hours at about 70 EXAMPLE 3 C. to 80° C. Pectin was mixed with glycerine and the 0056) The ingredients listed in Table 3 were combined to mixture was added very slowly to the aqueous phase provide a consumable film of the present invention in and then mixed thoroughly at a high rate. The accordance with the procedure of Example 1. acqueous phase was allowed to cool to about 50 C. and q.S. with water to replace loSS due to evapora TABLE 3 tion. Potassium Sorbate and dye were then added to the aqueous phase and mixed thoroughly. mg/ % w/wik % w/w Material dose* Dry Film Actual Batch g/batch 0051 B) The film-forming ingredients, xanthan Dextromethorphan HBr 15.0000 22.6123 7.7289 38.6445 gum, locust bean gum, carrageenan and pullulan Amberlite IRP69 16.OOOO 24.1197 8.2442 41.2208 were mixed together in a separate container to form Pectin USP O.35OO O.5276 O.1803 O.9017 a film forming mixture. US 2003/0206942 A1 Nov. 6, 2003

EXAMPLE 5 TABLE 3-continued 0.058. The ingredients listed in Table 5 were combined to mg/ % w/wik % w/w provide a consumable film of the present invention in Material dose* Dry Film Actual Batch g/batch accordance with the following procedure: Xanthan Gum O.O769 O.1159 O.O396 O.1981 0059 A) Dextromethorphan HBr was mixed and Locust Bean Gum O.O901 O.1358 O.O464 O.2321 dissolved in 90% water at 75 C. to yield an aqueous Carrageenan O.3861 O.582O O.1989 O.9947 phase. Amberlite IRP69 was added to the aqueous Pullulan 20.5919 31.042O 10.61O2 53.0509 phase and stirred for about 4 to 5 hours at about 70 Potassium sorbate O.O772 O. 1164 O.O398 O.1989 C. to 80° C. Pectin was added to the aqueous phase Purified water 65.81.99 329.0995 Menthol 2.5740 3.88O3 1.3263 6.631.4 very slowly and mixed at a high mixing rate. The Peppermint Flavor 0.2579 O.388 O.1329 O6644 acqueous phase was allowed to cool to about 50 C. Cherry Flavor (Givudan) 0.2579 O.388 O.1329 O6644 and q.S. with water to replace loSS due to evapora Cherry Flavor Blend 2.2350 3.3692 1.1516 5.758O tion. Potassium Sorbate and dye were then added to (IFF) the aqueous phase and mixed thoroughly. Warm Sensation (Mane) O.5518 O.8318 O.2843 1.4216 Artificial Masking Agent 0.4139 O.6239 O.2133 1.0663 0060 B) The film-forming ingredients, xanthan Flavor (Robertet) gum, locust bean gum, carrageenan and PURE Succulence (IFF) 0.2579 O.3888 O.1329 O6644 COTETM B793 (available from Grain Processing FD&C Red #40 O.OO98 O.O148 O.OOSO O.O252 Corporation of Muscatine, Iowa) were mixed Polysorbate 80 NF 0.4504 O.6790 O.2321 11604 together in a separate container to form a film Atmos 300 0.4504 O.6790 O.2321 11604 forming mixture. Glycerine 19305 2.9102 O.9947 49735 Mannitol USP 2.5740 3.88O3 1.3263 6.631.4 0061 C) The film forming mixture was slowly Sucralose 18OOO 2.7135 0.9275 4.6373 added to the aqueous phase of A), followed by overnight mixing at a low mixing rate to provide a Total 66.3357 10O.OOOO 10O.OOOO SOOOOOO hydrated polymer gel. *Assuming that all water is evaporated 0062 D) The flavorants, glycerine, olive oil, men thol, and Surfactants were combined and mixed in a Separate container until dissolved to yield an organic EXAMPLE 4 phase. 0057 The ingredients listed in Table 4 were combined to 0063 E) Mannitol and sucralose were mixed provide a consumable film of the present invention in together in the remaining 10% water in a separate accordance with the procedure of Example 2, except glyc container. Succulence was then added to the result erine and Surfactants were also added to the flavorants and ing mixture and dissolved. menthol in step D). 0064 F) The mixtures of steps D) and E) were added to the hydrated polymer gel and mixed uniformly to TABLE 4 yield a final polymer gel mixture. The final polymer mg/ % w/wik % w/w gel mixture was poured on a mold and cast to form Material dose* Dry Film Actual Batch g/batch a film of a desired thickness at room temperature. The consumable film was dried under warm air and Dextromethorphan HBr 15.0000 22.6123 7.7289 38.6445 Amberlite IRP64 16.OOOO 24.1197 8.2442 41.2208 cut to a desired dimension (dictated by e.g., dosage Pectin USP O.35OO 0.5276 O.1803 O.9017 and mouthfeel). The consumable film was Seg Xanthan Gum O.O769 O.1159 O.O396 O.1981 mented into 1"x1.25" (2.54 cmx3.18 cm) dosage Locust Bean Gum O.O901 O.1358 O.O464 O.2321 units, each of which had a thickness of 0.009+0.002 Carrageenan O.3861 O.582O O.1989 O.9947 Pullulan 20.5919 31.042O 10.61O2 53.0509 of an inch (0.23+0.05 of a mm) and a weight of 70+3 Potassium sorbate O.O772 O. 1164 O.O398 O.1989 mg. Purified water 65.81.99 329.0995 Menthol 2.5740 3.88O3 1.3263 6.631.4 TABLE 5 Peppermint Flavor 0.2579 O.3888 O.1329 O6644 Cherry Flavor (Givudan) 0.2579 O.3888 O.1329 O6644 mg/ % w/wik % w/w Sour Cherry (IFF) 2.2350 3.3692 1.1516 5.758O Material dose* Dry Film Actual Batch g/batch Warm Sensation (Mane) O.5518 O.8318 O.2843 1.4216 Artificial Masking Agent 0.4139 O.6239 O.2133 1.0663 Dextromethorphan HBr 15.0000 19.5740 10.6759 106.7593 Flavor (Robertet) Amberlite IRP69 16.OOO1 20.8790 113877 113.8771 Succulence (IFF) 0.2579 O.3888 O.1329 O6644 Pectin USP O.3499 O.4566 O.2490 2.4905 FD&C Red #40 O.OO98 O.O148 O.OOSO O.O252 Xanthan Gum O.O769 O.1003 0.0547 0.5470 Polysorbate 80 NF 0.4504 O.6790 O.2321 11604 Locust Bean Gum O.O901 0.1175 O.O641 O.6409 Atmos 300 0.4504 O.6790 O.2321 11604 Carrageenan O.3860 0.5037 0.2747 2.7474 Glycerine 19305 2.9102 O.9947 49735 PURE-COTE TM B793 20.5919 26.8711 14.6559 146.5586 Mannitol USP 2.5740 3.88O3 1.3263 6.631.4 Potassium sorbate O.O772 O.1008 0.0550 O.5498 Sucralose 18OOO 2.7135 0.9275 4.6373 Purified water 45.4586 454.5856 Menthol 2.574O 3.3589 1832O 18.32O2 Total 66.3357 10O.OOOO 1OOOOOO SOOOOOO Peppermint Flavor O.2579 0.3366 O.1836 18357 Cherry Flavor (Givudan) 0.2579 0.3366 O.1836 18357 *Assuming that all water is evaporated Sour Cherry (IFF) 2.2350 2.91.65 15907 15.9070 US 2003/0206942 A1 Nov. 6, 2003

very slowly to the aqueous phase and mixed at a high TABLE 5-continued mixing rate. The aqueous phase was allowed to cool mg/ % w/wik % w/w to about 50 C. and q.S. with water to replace loss Material dose* Dry Film Actual Batch g/batch due to evaporation. The dye was then added to the aqueous phase and mixed thoroughly. Warm Sensation (Mane) 0.5518 O.72OO 0.3927 3.927O Artificial Masking Agent 0.4140 O.54O2 O.2946 2.9463 Flavor (Robertet) 0068 B) The film-forming ingredients, xanthan Succulence (IFF) O.2579 O.3366 O.1836 18357 gum, locust bean gum, carrageenan and pullulan FD&C Red #40 O.OO99 O.O129 O.OOFO O.O704 Polysorbate 80 NF O4505 0.5878 O.32O6 3.2060 were mixed together in a separate container to form Atmos 300 O4505 0.5878 O.32O6 3.2060 a film forming mixture. Glycerine 8.7335 113966 6.21.58 62.1585 Olive Oil 3.499.34 4.5586 2.4863 24.8634 0069 C). The film forming mixture was slowly Mannitol USP 2.5740 3.3589 1832O 18.32O2 added to the aqueous phase of A), followed by Sucralose 18001 2.3490 1.2812 12.8116 overnight mixing at a low mixing rate to provide a Total 76.6324 10O.OOOO 1OOOOOO 10OOOOOO hydrated polymer gel. *Assuming that all water is evaporated 0070 D) The flavorants, menthol, and surfactants were combined and mixed in a separate container EXAMPLE 6 until dissolved to yield an organic phase. 0065. The ingredients listed in Table 6 were combined to 0071 E) Mannitol and sucralose were mixed provide a consumable film of the present invention in together in the remaining 10% water in a separate accordance with the procedure of Example 5 except pectin container. Succulence was then added to the result was dispersed in 15% glycerine prior to being added to the aqueous phase in Step A). ing mixture and dissolved. 0.072 F) The mixtures of steps D) and E) were added TABLE 6 to the hydrated polymer gel and mixed uniformly to mg/ % w/wik % w/w yield a final polymer gel mixture. The final polymer Material dose* Dry Film Actual Batch g/batch gel mixture was poured on a mold and cast to form Dextromethorphan HBr 15.0000 18.5409 10.3611 103.61O7 a film of a desired thickness at room temperature. Amberlite IRP69 16.OOO1 19.7771 11.0519 110.51.86 The consumable film was dried under warm air and Pectin USP O.3499 O.4325 O.2417 2.417O cut to a desired dimension (dictated by e.g., dosage Xanthan Gum O.O769 O.O950 O.O531 O.5.309 Locust Bean Gum O.O901 O.1113 O.O622 O622O and mouthfeel). Carrageenan O.3860 0.4771 O.2666 2.6664 PURE-COTE TM B793 20.5919 25.4529 14.2236 142.2363 TABLE 7 Potassium sorbate O.O772 0.0955 O.O534 OS335 Purified water 44.1179 451.1788 mg/ % w/wik % w/w Menthol 2.5740 3.1817 1.778O 17.7799 Peppermint Flavor 0.2579 O.3188 O.1782 1.7816 Material dose* Dry Film Actual Batch G/batch Cherry Flavor (Givudan) 0.2579 O.3188 O.1782 1.7816 Dextromethorphan HBr 15.0000 22.5510 7.708O 19.2699 Sour Cherry (IFF) 2.2350 2.7626 1.5438 15.4379 Amberlite IRP64 16.0000 24.0544 8.2218 20.5545 Warm Sensation (Mane) O.5518 O.682O O3811 3.8112 Artificial Masking Agent 0.4140 0.5117 O.2859 2.8594 Pectin USP O.35OO O.5262 0.1799 O.4496 Flavor (Robertet) Xanthan Gum O.O769 O. 1156 O.O395 O.O988 Succulence (IFF) 0.2579 O.3188 O.1782 1.7816 Locust Bean Gum O.O901 O.1355 O.O463 0.1157 FD&C Red #40 O.OO99 O.O122 O.OO68 O.O684 Carrageenan O.3861 0.5805 O.1984 O.4960 Polysorbate 80 NF O.4505 O.S568 O3111 3.1114 Pullulan 20.5919 30.9579 10.5814 26.4536 Atmos 300 O.4505 O.S568 O3111 3.1114 Potassium sorbate O.O772 O.1161 O.O397 O.O992 Glycerine 11.6446 14.3935 8.0434 80.4337 Purified water 65.81.99 164.5498 Olive Oil 4.8519 5.9973 3.3514 33.5140 Menthol 2.5740 3.8698 1.3227 3.3067 Mannitol USP 2.5740 3.1817 1.778O 17.7799 Peppermint Flavor 0.2579 0.3877 O.1325 O.3313 Sucralose 18OO1 2.2250 1.2434 12.4337 Cherry Flavor (Givudan) 0.2579 0.3877 O.1325 O.3313 Total 8O.9021 1 OO.OOOO 1OOOOOO 10OOOOOO Sour Cherry (IFF) 2.2350 3.36O1 1.1485 2.8712 Warm Sensation (Mane) O.5518 O.8296 O.2835 O.7089 *Assuming that all water is evaporated Artificial Masking Agent 0.4139 O.6223 0.2127 0.5317 Flavor (Robertet) Succulence (IFF) 0.2579 0.3877 O.1325 O.3313 EXAMPLE 7 Carmine O.1900 O.2856 O.O976 O.2441 Polysorbate 80 NF 0.4504 0.6771 O.2314 0.5786 0.066 The ingredients listed in Table 7 were combined to Atsurf 596K 0.4504 0.6771 O.2314 0.5786 provide a consumable film of the present invention in Glycerine 19305 2.9023 O.9920 2.4800 accordance with the following procedure: Mannitol USP 2.5740 3.8698 1.3227 3.3067 0067 A) Dextromethorphan HBr was mixed and Sucralose 18OOO 2.7061 O.92SO 2.3124 dissolved in 90% water at 75 C. to yield an aqueous Total 66.5159 10O.OOOO 1OOOOOO 2SO.OOOO phase. Amberlite IRP69 was added to the aqueous phase and stirred for about 4 to 5 hours at about 70 *Assuming that all water is evaporated C. to 80°C. Pectin dispersed in glycerine was added US 2003/0206942 A1 Nov. 6, 2003

EXAMPLE 8 gel mixture was poured on a mold and cast to form a film of a desired thickness at room temperature. 0073. The ingredients listed in Table 8 were combined to The consumable film was dried under warm air and provide a consumable film of the present invention in cut to a desired dimension (dictated by e.g., dosage accordance with the procedure of Example 7. and mouthfeel). TABLE 8 TABLE 9 mg/ % w/wik % w/w mg/ % w/wik % w/w Material dose : Dry Film Actual Batch g/batch Material dose* Dry Film Actual Batch batch

Dextromethorphan HBr 15.0000 22.5772 7.7169 38.5846 Dextromethorphan 10.990O 18.3460 5.5038 27.51.89 Amberlite IRP64 16.OOOO 24.08.23 8.2314 41.1569 (Spectrum) rp Pectin USP O.35OO O.5268 O.18O1 O.90O3 Pectin USP 0.5250 O.8764 O.2629 1.3.146 Xanthan Gum O.O769 0.1157 O.O396 O.1978 Carmine O.1900 O.3172 O.O952 O.4758 Locust Bean Gum O.O901 O.1356 O.O464 O.231.8 Xanthan Gum 0.1154 O.1926 0.0578 O.2888 Carrageenan O.3861 O.5811 O.1986 O.9932 Locust Bean Gum O.1352 O.2256 0.0677 O.3384 Pullulan 20.5919 30.9938 10.5937 52.96.86 Carrageenan 0.5792 O.96.68 O.29OO 1.45O2 Carmine O.1900 O.2860 O.O977 O4887 Pullulan 30.8879 51.5621 15.4686 77.3431 Purified water 65.81.99 329.0995 Purified water 70 35O.OOOO Menthol 2.5740 3.8742 13242 6.6211 Menthol 2.5740 4.2969 1.2891 6.4453 Peppermint Flavor 0.2579 O.3882 O-1327 O6634 Peppermint Flavor O.8OOO 1.3355 O.4006 2.OO32 Cherry Flavor (Givudan) 0.2579 O.3882 O-1327 O6634 Cherry Flavor (Givudan) 0.8000 1.3355 O.4006 2.OO32 Sour Cherry (IFF) 2.2350 3.3640 1.1498 5.7491 Sour Cherry (IFF) 2.2350 3.7310 11193 5.5964 Warm Sensation (Mane) O.5518 O.8305 O.2839 1.4.194 Artificial Masking Agent 0.4139 O.6230 O.2129 1.0647 Warm Sensation (Mane) O.8OOO 1.3355 O.4006 2.OO32 SAS Artificial Masking Agent O.8000 1.3355 O.4006 2.OO32 Flavor (Robertet) Flavor (Robertet) Succulence (IFF) 0.2579 O.3882 O-1327 O6634 Succulence (IFF) 0.2579 O.4305 O.1292 O.6458 Polysorbate 80 NF 0.4504 0.6779 O.2317 1.1586 Atmos 300 0.4504 0.6779 O.2317 1.1586 Polysorbate 80 NF 0.4504 0.7519 O.2256 1.1278 Glycerine 19305 2.9057 O.9932 4.9658 Atmos 300 0.4504 0.7519 O.2256 1.1278 Glycerine 2.04OO 3.4054 1.0216 5.1082 Mannitol USP 2.5740 3.8742 13242 6.6211 Sucralose 18OOO 2.7093. O.926O 4.63O1 Sucralose 2.7OOO 4.5072 1.3522 6.7608 Mannitol USP 2.5740 4.2969 1.2891 6.4453 Total 66.4387 10O.OOOO 1OOOOOO SOOOOOO Total 59.9042 10O.OOOO 1OOOOOO SOO.OOOO : Assuming that all water is evaporated *Assuming that all water is evaporated

EXAMPLE 9 EXAMPLE 10 0.074 The ingredients listed in Table 9 were combined to 0081. The ingredients listed in Table 10 were combined provide a consumable film of the present invention in to provide a consumable film of the present invention in accordance with the following procedure: accordance with the procedure of Example 7. 0075 A) Dextromethorphan HBr was mixed and dissolved in 90% water to yield an aqueous phase. TABLE 10 Pectin dispersed in glycerine was added very slowly to the aqueous phase and mixed at a high mixing mg? % w/w % w/w rate. The aqueous phase was allowed to cool to about Material dose*: Dry Film Actual Batch g/batch 50° C. and 9.S. with Water to replace loss due to Dextromethophan 10.990O 26.6157 9.2695 18:5390 evaporation. The dye was then added to the aqueous (milled) phase and mixed thoroughly. Amberlite IRP69 2.4OOO 5.8123 2.0243 4.04486 Pectin USP O.2698 0.6534 O.2276 O.4551 0076 B) The film-forming ingredients, xanthan Carmine 0.1464 0.3546 O.1235 O.2470 gum, locust bean gum, carrageenan and pullulan Xanthan Gum O.O594 O.1439 O.OSO1 O.10O2 were mixed together in a separate container to form Locust Bean Gum O.O694 O.1681 0.0585 O.1171 a film forming mixture Carrageenan 0.2975 0.7205 O.2509 O.5O19 Pullulan 15.8694 38.4327 13.385O 26.77O1 0.077 C). The film forming mixture was slowly Purified water 65.1728 130.3456 added to the aqueous phase of A), followed by Mentholpermint Flavor O.19872.574O O.48126.2337 O.16762.1710 O.33524.3421 overnight mixing at a low mixing rate to provide a Cherry Flavor (Givudan) 0.1987 0.4812 O.1676 O.3352 hydrated polymer gel. Sour Cherry (IFF) 1.7225 4.1716 1.4528 2.9057 Warm Sensation (Mane) O.4252 1.O298 O.3586 0.7173 0078 D) The flavorants, menthol, and surfactants Artificial Masking Agent 0.3190 0.7726 O.2691 O.5381 were combined and mixed in a separate container Flavor (Robertet) until dissolved to yield an organic phase. olysorbateSCS e 8. 8. E. 8. 0079 E) Mannitol and sucralose were mixed t 79 13. 95. together in the remaining 10% water in a separate Mannitolycerine USP 19837 4.8041 1.6732 3.3463 container. Succulence was then added to the result- Sucralose 1.3873 3.3598 1.17O1 2.34O2 ing mixture and dissolved. Total 41.2914 10O.OOOO 10O.OOOO 2OOOOOO 0080 F). The mixtures of steps D) and E) were added to the hydrated polymer gel and mixed uniformly to *Assuming that all water is evaporated yield a final polymer gel mixture. The final polymer US 2003/0206942 A1 Nov. 6, 2003

EXAMPLE 11 0082 The ingredients listed in Table 11 were combined TABLE 11-continued tO provide a consumable film of the present invention in % w/w accordance with the following procedure: mg/ % w/wik Actual Material dose Dry Film Batch g/batch 0.083 A) Dextromethorphan HBr was mixed and dissolved in 90% water to yield an aqueous phase at Atmos 300 O.6OOO O.8965 O.2869 1.4345 Glycerine 2.OOOO 2.9885 O.9563 4.7816 75 C. The Amberlite resin was added to the aqueous Sucralose 2.7OOO 40345 1.2910 6.4552 phase and mixed for about 4 hours at 70° C. to 80 Mannitol USP 3.8OOO 5.6781 1817O 9.0850 C. The aqueous phase was allowed to cool to 50 C. Sodium Chloride 1.OOOO 1.4942 O.4782 2.3908 and q.S. with water to replace loSS due to evapora tion. Total 66.9233 10O.OOOO 10O.OOOO SOO.OOOO 0084 B) Pectin was dispersed in glycerine and the *Assuming that all water is evaporated resulting mixture was added very slowly to the aqueous phase and mixed at a high mixing rate. EXAMPLE 12 0085 C) The film-forming ingredients, xanthan gum, locust bean gum, carrageenan and pullulan 0089. The ingredients listed in Table 12 were combined were mixed together in a separate container to form to provide a consumable film of the present invention in a film forming mixture. The film forming mixture accordance with the following procedure: was slowly added to the aqueous phase while mixing rapidly. The resulting mixture was mixed overnight 0090 A) Dextromethorphan HBr was mixed and at low Speed. dissolved in 90% water at 75 C. to yield an aqueous phase. Sodium bicarbonate was added and mixed for 0.086 D) In a separate container, sodium chloride, about 1 hour. Amberlite IRP69 was added to the mannitol and Sucralose was added to the remaining aqueous phase and Stirred for about 2 hours at about 10% water. Succulence was then added to the mix 70° C. to 80° C. The resulting mixture was allowed ture to yield a slurry. The slurry was added to the to cool to 50° C. and q.S. with water for losses due resulting mixture of Step C). to evaporation. The dye was then added to the 0087 E). The flavorants, menthol, and surfactants aqueous phase and mixed thoroughly. were combined and mixed in a separate container until dissolved. 0091 B) The film-forming ingredients, xanthan gum, locust bean gum, carrageenan and pullulan 0088 F). The mixtures of steps D) and E) were were added slowly and rapidly mixed together in a mixed uniformly to yield a final polymer gel mix Separate container to form a film forming mixture. ture. The final polymer gel mixture was poured on a The mixture was mixed overnight at a low speed. mold and cast to form a film of a desired thickness Pectin dispersed in glycerine was added very slowly at room temperature. The consumable film was dried to the a film forming mixture and mixed at a high under warm air and cut to a desired dimension mixing rate. (dictated by e.g., dosage and mouthfeel). 0092 C) The film forming mixture was slowly TABLE 11 added to the aqueous phase of A), followed by % w/w overnight mixing at a low mixing rate to provide a mg/ % w/wik Actual hydrated polymer gel. Material dose Dry Film Batch g/batch Dextromethorphan HBr 15.OOOO 22.41.37 7.1724 35.8619 0.093 D) In another container the remaining 10% Sodium Bicarbonate 4.OOOO 5.977O 19126 9.5632 water was added to dissolve mannitol and Sucralose. Amberlite IRP69 8.OOOO 11.954O 3.8253 19.1264 Succulence was then added and mixed to dissolve. Pectin USP O.35OO O.S230 O.1674 O.8368 Yellow #6 O.O2OO O.O299 O.OO96 O.O478 The resulting mixture was added to the hydrated Xanthan Gum O.OSOO 0.0747 O.O239 O.1195 polymer gel. Locust Bean Gum O.1OOO O.1494 O.O.478 O.2391 Carrageenan OSOOO 0.7471 O.239 1.1954 0094) E) The flavorants, menthol, and surfactants Pullulan 23.3333 34.8657 11.1570 55.7852 Purified water 68.OOOO 34.O.OOOO were combined and mixed in a separate container Menthol 2.5700 3.84O2 1.2289 6.1443 until dissolved to yield an organic phase. Tangerine Oil OSOOO 0.7471 O.239 1.1954 Natural and Artificial O3OOO O.4483 O.1434 0.7172 0.095 F). The mixtures of steps D) and E) were added Orange Artificial Lemon Oil O3OOO O.4483 O.1434 0.7172 together and mixed uniformly to yield a final poly Warm Sensation (Mane) O4OOO O. 5977 O.1913 O.9563 mergel mixture. The final polymer gel mixture was Artificial Masking Agent OSOOOO 0.7471 O.239 1.1954 poured on a mold and cast to form a film of a desired Flavor (Robertet) Succulence (IFF) O3OOO O.4483 O.1434 0.7172 thickness at room temperature. The consumable film Polysorbate 80 NF O.6OOO O.8965 O.2869 1.4345 was dried under warm air and cut to a desired dimension (dictated by e.g., dosage and mouthfeel). US 2003/0206942 A1 Nov. 6, 2003

TABLE 12 TABLE 13-continued

mg/ % w/wik Actual mg/ % w/wik Actual Material dose Dry Film Batch g/batch Material dose Dry Film Batch g/batch Dextromethorphan HBr 15.0000 27.3219 9.6903 484.5135 Sucralose 2.7OOO 3.9953 1.2785 6.3925 Amberlite IRP69 8.OOOO 14.5717 5.1681 258.4O72 Mannitol USP 3.8OOO 5.6230 1.7994 8.9969 Pectin USP O.2698 O.4914 O.1743 8.7148 Sodium Chloride 1.OOOO 14797 O.4735 2.3676 Sodium bicarbonate 4.OOOO 7.2858 2.5841 129.2O36 anhydrous Total 67.5791 10O.OOOO 10O.OOOO SOO.OOOO Carmine O.1464 O.2667 O.O946 4.7289 Xanthan Gum O.O594 O.1082 O.O384 1911.87 *Assuming that all water is evaporated Locust Bean Gum O.O694 O.1264 O.0448 2.2417 Carrageenan 0.2975 O.5419 O.1922 9.6095 Pullulan 15.8690 28.9047 10.2517 512.583O EXAMPLE 1.4 Purified water 64.5329 3226.645O Menthol 2.5740 4,6884 16629 83.1425 O097 The ingredients listed in Table 14 were combined Peppermint Flavor O.1987 O.3619 O.1284 6.4.182 to provide a consumable film of the present invention in Cherry Flavor (Givudan) 0.1987 O.3619 O.1284 6.4.182 Cherry Flavor Blend 1.7225 3.1375 1.1128 55.6383 accordance with the following procedure: (IFF) Warm Sensation (Mane) O.4252 0.7745 0.2747 13.7343 0.098 A) Dextromethorphan HBr was mixed and Artificial Masking Agent 0.3190 O.5810 O.2O61 10.3040 dissolved in 90% water to yield an aqueous phase at Flavor (Robertet) 75 C. Sodium hydroxide was added to the aqueous Succulence (IFF) O.1987 O.3619 O.1284 6.4.182 phase and thoroughly mixed. The Amberlite resin Polysorbate 80 NF O.3470 O.632O O.2242 11.2084 Atmos 300 O.3470 O.632O O.2242 11.2084 was then added to the aqueous phase and mixed for Glycerine 14877 2.71OO O.9611 48.0573 about 4 hours at 70° C. to 80 C. The aqueous phase Mannitol USP 19837 3.6132 1.2815 64.O753 was allowed to cool to 50° C. and q.S. with water to Sucralose 1.3873 2.5269 O.8962 448110 replace loSS due to evaporation. Total 54.9011 1 OOOOOO 10O.OOOO SOOOOOOOO 0099 B) Pectin was added very slowly to the aque ous phase while mixing at a high mixing rate. *Assuming that all water is evaporated 010.0 C) The film-forming ingredients, xanthan gum, locust bean gum, carrageenan and pullulan EXAMPLE 13 were mixed together in a separate container to form 0096) The ingredients listed in Table 13 were combined a film forming mixture. The film forming mixture to provide a consumable film of the present invention in was slowly added to the aqueous phase while mixing accordance with the procedure of Example 11, except rapidly. The resulting mixture was mixed overnight methyl Salicylate, eucalyptol, and thymol were also added to at low Speed. the flavorants, menthol, and Surfactants in Step E). 0101 D) In a separate container, mannitol and Sucralose were added to the remaining 10% water. TABLE 13 Succulence was then added to the mixture to yield a Slurry. The Slurry was added to the resulting mixture % w/w mg/ % w/wik Actual of step C). Material dose Dry Film Batch g/batch 0102) E) The flavorants, menthol, and surfactants Dextromethorphan HBr 15.OOOO 22.1962 7.1028 35.5139 were combined and mixed in a separate container Sodium Bicarbonate 4.OOOO 5.91.90 18941 9.4704 until dissolved. Amberlite IRP69 8.OOOO 11.838O 3.7882 189408 Pectin USP O.35OO 0.5179 0.1657 O8287 0103) F). The mixtures of steps D) and E) were Yellow #6 O.O2OO O.O296 O.OO95 O.O474 mixed uniformly to yield a final polymer gel mix Xanthan Gum O.OSOO O.O740 O.O237 O.1184 Locust Bean Gum O.1OOO O.1480 O.O.474 O.2368 ture. The final polymer gel mixture was poured on a Carrageenan OSOOO 0.7399 O.2368 1.1838 mold and cast to form a film of a desired thickness Pullulan 23.3333 34.5274 11.0488 55.2438 at room temperature. The consumable film was dried Purified water 68.OOOO 34.O.OOOO under warm air and cut to a desired dimension Thymol O.1698 O.2513 O.O804 O4O2O Methyl Salicylate O.2430 O.3596 O.115 0.5753 (dictated by e.g., dosage and mouthfeel). Eucalyptol O.2430 O.3596 O.115 0.5753 Menthol 2.5700 3.8O3O 1.2169 6.0847 TABLE 1.4 Tangerine Oil OSOOO 0.7399 O.2368 1.1838 Natural and Artificial O3OOO O.4439 O.142 O.7103 mg/ % w/wik % w/w Orange Material dose* Dry Film Actual Batch g/batch Artificial Lemon Oil O3OOO O.4439 O.142 O.7103 Warm Sensation (Mane) O4OOO O.5919 O.1894 O.9470 Dextromethorphan HBr 15.0000 23.1042 7.3933 36.9667 Artificial Masking Agent OSOOOO 0.7399 O.2368 1.1838 Sodium hydroxide 1N S.OOOO 7.7014 2.4644 12.3222 Flavor (Robertet) solution Succulence (IFF) O3OOO O.4439 O.142 O.7103 Amberlite IRP69 8.OOOO 123222 3.9431 19.7156 Polysorbate 80 NF O.6OOO O.8878 O.284 1.42O6 Pectin USP O.35OO O.S391 0.1725 O8626 Atmos 300 O.6OOO O.8878 O.284 1.42O6 Yellow #6 O.O2OO O.O3O8 O.OO99 O.O493 Glycerine 2.OOOO 2.9595 O.9470 4.7352 Xanthan Gum 0.05OO O.0770 O.O246 O.1232 US 2003/0206942 A1 Nov. 6, 2003

discussion, and from the accompanying claims, that various TABLE 14-continued changes, modifications, and variations can be made therein without departing from the Spirit and Scope of the invention mg/ % w/wik % w/w Material dose* Dry Film Actual Batch g/batch as defined in the following claims. Locust Bean Gum O.1OOO O.1540 O.O493 O.2464 Carrageenan O.SOOO 0.770 O.2464 1.2322 We claim: Pullulan 23.3333 35.9398 11.5007 57.5037 1. A consumable film adapted to adhere to and dissolve in Purified water 68.OOOO 34OOOOO Menthol 2.5700 3.9585 1.2667 6.3336 the oral cavity of a consumer comprising at least one water Tangerine Oil O.SOOO 0.770 O.2464 1.2322 Soluble polymer, at least one antituSSive agent and a mucosa Natural and Artificial O.3OOO O.462 O.1479 O.7393 coating effective amount of a mucosa-coating agent. Orange 2. The consumable film of claim 1 wherein the mucosa Artificial Lemon Oil O.3OOO O.462 O.1479 O.7393 Warm Sensation (Mane) O.4000 O. 616 O.1972 O.9858 coating agent Soothes and coats the throat when released Artificial Masking Agent 0.5000 0.770 O.2464 1.2322 from the consumable film. Flavor (Robertet) 3. The consumable film of claim 1 wherein the mucosa Succulence (IFF) O.3OOO O.462 O.1479 O.7393 coating effective amount of the mucosa-coating agent is Polysorbate 80 NF O.6OOO O.9242 0.2957 14787 Atmos 300 O.6OOO O.9242 0.2957 14787 from about 0.01% to about 5% by weight based on the total Sucralose 2.7OOO 4.1588 1.33O8 6.6540 weight of the consumable film. Mannitol USP 3.8OOO 5.853 1873O 9.3649 4. The consumable film of claim 1 wherein the mucosa coating effective amount of the mucosa-coating agent is Total 64.9233 10O.OOOO 10O.OOOO SOOOOOO from about 0.1% to about 1.0% by weight based on the total *Assuming that all water is evaporated weight of the consumable film. 5. The consumable film of claim 1 wherein the mucosa EXAMPLE 1.5 coating agent is Selected from the group consisting of pectin, gelatin and combinations thereof. 0104. The ingredients listed in Table 15 were combined 6. The consumable film of claim 1 wherein the mucosa to provide a consumable film of the present invention in coating agent is pectin. accordance with the procedure Example 14, except methyl 7. The consumable film of claim 1 wherein the at least one Salicylate, eucalyptol, and thymol were also added to the water Soluble polymer is Selected from the group consisting flavorants, menthol, and Surfactants in Step E). of pullulan, hydroxypropylmethyl cellulose; hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, TABLE 1.5 carboxymethyl cellulose, polyvinyl alcohol, Sodium algi % w/w nate, polyethylene glycol, tragacanth gum, guar gum, acacia % w/wik Actual gum, arabic gum, polyacrylic acid, methylmethacrylate Material mg/dose* Dry Film Batch g/batch copolymer, carboxyvinyl polymer, amylose, high amylose Dextromethorphan HBr 15.OOOO 22.7690 7.2861 36.43O4 Starch, hydroxypropylated high amylose Starch, dextrin, Sodium hydroxide 1N 4.OOOO 7.5897 2.4287 12.1435 chitin, chitosan, levan, elsinan, collagen, Zein, gluten, Soy solution protein isolate, whey protein isolate, casein and combina Amberlite IRP69 8.OOOO 12.1435 3.8859 19.4295 tions thereof. Pectin USP O.35OO O.5.313 O.17OO O.85OO Yellow #6 O.O2OO O.O3O4 O.O097 O.0486 8. The consumable film of claim 7 wherein said at least Xanthan Gum O.OSOO O.O759 O.O243 O.1214 one water Soluble polymer is pullulan. Locust Bean Gum O.1OOO O.1518 O.O486 O.2429 9. The consumable film of claim 8 wherein the amount of Carrageenan OSOOO O.7590 O.2429 1.2143 Pullulan 23.3333 35.41.84 11.3339 56.6694 pullulan is from about 0.01% to about 99% by weight based Purified water 68.OOOO 34OOOOO on the total weight of the consumable film. Thymol O.1698 O.2577 O.O825 O4124 10. The consumable film of claim 1 wherein the antitus Methyl Salicylate O.2430 O.3689 O.118O O.5902 Eucalyptol O.2430 O.3689 O.118O O.5902 Sive agent is Selected from the group consisting of allocla Menthol 2.87OO 4.3565 13941 6.97O3 mide, amicibone, beinproperine, benzonatate, bibenzonium Tangerine Oil OSOOO O.7590 O.2429 1.2143 bromide, bromoform, butamirate, butetamate, caramiphen Natural and Artificial O3OOO O4554 O.1457 O.7286 ethanedisulfonate, caramiphen edisylate, carbetapentane, Orange Artificial Lemon Oil O3OOO O4554 O.1457 O.7286 chlophedianol, clobutinol, cloperastine, codeine, codeine Warm Sensation (Mane) O4OOO O.6O72 O.1943 O. 9715 methyl bromide, codeine N-oxide, codeine phosphate, Artificial Masking Agent OSOOOO O.7590 O.2429 1.2143 codeine Sulfate, cyclexanone, dextromethorphan, dibunate Flavor (Robertet) Sodium, dihydrocodeine, dihydrocodeinone enol acetate, Succulence (IFF) O3OOO O4554 O.1457 O.7286 Polysorbate 80 NF O.6OOO O.9108 O.2914 1.4572 dimenorfan, dimethoxanate, dropropizine, drotebanol, Atmos 300 O.6OOO O.9108 O.2914 1.4572 eprazinone, ethyl dibunate, ethylmorphine, fominoben, gua Sucralose 2.7OOO 4.0984 13115 6.55.75 iapate, , isoaminile, levopropoxyphene, mor Mannitol USP 3.8OOO 5.7681 18458 9.2290 clofone, narceline, normethadone, noScapine, OXeladin, OXolamine, , picoperine, pipazethate, piperidi Total 67.5791 1 OOOOOO 10O.OOOO SOOOOOO one, hydrochloride, racemethorphan, *Assuming that all water is evaporated taZiprinone hydrochloride, tipepidine, Zipeprol and pharma ceutically acceptable Salts thereof, and combinations 0105 The forgoing discussion discloses and describes thereof. merely exemplary embodiments of the present invention. 11. The consumable film of claim 1 wherein the at least One skilled in the art will readily recognize from Such one antituSSive agent is dextromethorphan hydrobromide. US 2003/0206942 A1 Nov. 6, 2003

12. The consumable film of claim 1 wherein the antitus 16. The consumable film of claim 14 wherein said essen Sive agent is present in amounts of from about 2.5 mg to tial oil is menthol. about 20 mg. 17. The consumable film of claim 1 in the form of a single 13. The consumable film of claim 1 wherein the antitus layer. Sive agent is present in amounts of from about 7.5 mg to about 15 mg. 18. The consumable film of claim 1 further comprising at 14. The consumable film of claim 1 further comprising an least one additional therapeutic agent. antimicrobial effective amount of at least one essential oil 19. A consumable film adapted to adhere to and dissolve Selected from the group consisting of carvacrol, thymol, in the oral cavity of a consumer comprising at least one eucalyptol, menthol, methyl Salicylate, eugenol, gerianol, water Soluble polymer, at least one antituSSive agent and a Verbenone and combinations thereof. mucosa-coating effective amount of a mucosa-coating agent, 15. The consumable film of claim 14 wherein the anti wherein Said mucosa-coating agent is Selected from the microbial effective amount of the at least one essential oil is group consisting of pectin, gelatin and combinations thereof. up to about 30% by weight based on the total weight of the consumable film.