발생일자 2014.12.02 

사건번호 1:14-cv-01451 

법원국가 UNITED STATES OF AMERICA 

관할법원명 D.C.Delaware(지방법원) 

침해권리 특허 

원고명 Reckitt Benckiser Pharmaceuticals, Inc./ Monosol Rx, LLC/ RB Pharmaceuticals Limited ( 미국 / 외국기업 )  

피고명 Teva Pharmaceuticals USA, Inc. ( 미국 / 외국기업 )  

소송유형 침해금지 

분쟁결과 분쟁중 

산업분류 장치산업 > 의료장치기술 

계쟁제품

Generic buprenorphine hydrochloride and naloxone hydrochloride sublingual film, generic version of Suboxone

지재권번호/명칭

US8017150   Polyethylene oxide-based films and drug delivery systems made therefrom 

US8475832   Sublingual and buccal film compositions 

US8603514   Uniform films for rapid dissolve dosage form incorporating taste-masking compositions 

The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film. 

What is claimed is: 

 1. A mucosally-adhesive water-soluble film product comprising: an analgesic opiate pharmaceutical active; and at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer; wherein: the water-soluble polymer component comprises greater than 75% polyethylene oxide and up to 25% hydrophilic cellulosic polymer; the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100,000 to 300,000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600,000 to 900,000; and the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component. 

 2. The film product according to claim 1, wherein said film product has a viscosity of about 1,000 cps to about 40,000 cps. 

 3. The film product according to claim 1, wherein said film product has a thickness of about 3 mils to about 6 mils. 

 4. The film product according to claim 1, further comprising an additional pharmaceutical active. 

 5. The film product according to claim 1, further comprising one or more sweeteners. 

 6. The film product according to claim 5, wherein said one or more sweeteners comprise a hydrogenated starch hydrolysate. 

 7. The film product according to claim 5, wherein said one or more sweeteners comprise the potassium salt of 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide. 

 8. The film product according to claim 1, further comprising one or more flavors. 

 9. The film product according to claim 1, further comprising one or more buffers. 

 10. A mucosally-adhesive water-soluble film product comprising: an analgesic opiate pharmaceutical active; and at least one water-soluble polymer component consisting of polyethylene oxide in combination with a hydrophilic cellulosic polymer; wherein: the water-soluble polymer component comprises the hydrophilic cellulosic polymer in a ratio of up to about 4:1 with the polyethylene oxide; the polyethylene oxide comprises one or more low molecular weight polyethylene oxides and one or more higher molecular weight polyethylene oxides, the molecular weight of the low molecular weight polyethylene oxide being in the range 100,000 to 300,000 and the molecular weight of the higher molecular weight polyethylene oxide being in the range 600,000 to 900,000; and the polyethylene oxide of low molecular weight comprises about 60% or more in the polymer component. 

 11. The film product according to claim 10, wherein said film product has a viscosity of about 1,000 cps to about 40,000 cps. 

 12. The film product according to claim 10, wherein said film product has a thickness of about 3 mils to about 6 mils. 

 13. The film product according to claim 10, further comprising an additional pharmaceutical active. 

 14. The film product according to claim 10, further comprising one or more sweeteners. 

 15. The film product according to claim 14, wherein said one or more sweeteners comprise a hydrogenated starch hydrolysate. 

 16. The film product according to claim 14, wherein said one or more sweeteners comprise the potassium salt of 3,6-dihydro-6-methyl-1-1-1,2,3-oxathiazin-4-one-2,2-dioxide. 

 17. The film product according to claim 10, further comprising one or more flavors. 

 18. The film product according to claim 10, further comprising one or more buffers. 

The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form. 

What is claimed is: 

 1. A film dosage composition comprising: a. A polymeric carrier matrix; b. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof; c. A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and d. A buffer in an amount to provide a local pH for said composition of a value sufficient to optimize absorption of said buprenorphine, wherein said local pH is from about 3 to about 3.5 in the presence of saliva. 

 2. The composition of claim 1, wherein said film dosage composition provides a bioequivalent absorption of buprenorphine to that of a tablet having an equivalent amount of buprenorphine or a pharmaceutically acceptable salt thereof. 

 3. The composition of claim 1, wherein said polymeric carrier matrix comprises at least one polymer in an amount of at least 25% by weight of said composition. 

 4. The composition of claim 1, wherein said buffer is present in an amount of from about 2:1 to about 1:5 by weight of buffer to buprenorphine. 

 5. The composition of claim 1, wherein said polymeric carrier matrix comprises at least one self-supporting film forming polymer. 

 6. The film dosage composition of claim 1, wherein said buprenorphine is present in an amount of from about 2 mg to about 16 mg per dosage. 

 7. The film dosage composition of claim 1, wherein said buffer comprises sodium citrate, citric acid, and combinations thereof. 

 8. The film dosage composition of claim 1, wherein said buffer comprises acetic acid, sodium acetate, and combinations thereof. 

 9. A method of treating narcotic dependence of a user, comprising the steps of: a. providing a composition comprising: i. A polymeric carrier matrix; ii. A therapeutically effective amount of buprenorphine or a pharmaceutically acceptable salt thereof; iii. A therapeutically effective amount of naloxone or a pharmaceutically acceptable salt thereof; and iv. A buffer in an amount to provide a local pH of about 3 to about 3.5 for said composition of a value sufficient to optimize absorption of said buprenorphine and also sufficient to inhibit absorption of said naloxone; and b. administering said composition to the oral cavity of a user. 

 10. The composition of claim 9, wherein said method provides a bioequivalent absorption of buprenorphine to that of a tablet having an equivalent amount of buprenorphine or a pharmaceutically acceptable salt thereof. 

 11. The method of claim 9, wherein said film dosage composition is administered to the user through buccal administration, sublingual administration, and combinations thereof. 

 12. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of at least 1 minute. 

 13. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of between about 1 and 1.5 minutes. 

 14. The method of claim 9, wherein said film dosage composition remains in the oral cavity of the user for a period of up to 3 minutes. 

 15. An orally dissolving film formulation comprising buprenorphine and naloxone, wherein said formulation provides an in vivo plasma profile having a Cmax of between about 0.624 ng/ml and about 5.638 ng/ml for buprenorphine and an in vivo plasma profile having a Cmax of between about 41.04 pg/ml to about 323.75 pg/ml for naloxone. 

 16. The formulation of claim 15, wherein said formulation provides a mean AUC of between about 5.431 hrng/ml to about 56.238 hrng/ml for buprenorphine. 

 17. The formulation of claim 15, wherein said formulation provides a mean AUC of between about 102.88 hrpg/ml to about 812.00 hrpg/ml for naloxone. 

 18. The formulation of claim 15, wherein said formulation comprises about 2 to about 16 mg of buprenorphine or a salt thereof. 

 19. The formulation of claim 15, wherein said formulation comprises about 0.5 to about 4 mg of naloxone or a salt thereof. 

The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method. 

The invention claimed is: 

 1. A drug delivery composition comprising: (i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; (ii) a particulate active substantially uniformly stationed in the matrix; and (iii) a taste-masking agent coated or intimately associated with said particulate to provide taste-masking of the active; wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. 

 2. The drug delivery composition of claim 1, wherein the size of said combined particulate and taste-masking agent have a particle size of 150 microns or less. 

 3. The drug delivery composition of claim 1, wherein the size of said combined particulate and taste-masking agent have a particle size of 100 microns or less. 

 4. The drug delivery composition of claim 1, wherein said taste-masking agent is a thin film coating over portions of said active. 

 5. The drug delivery composition of claim 1, wherein the taste-masking agent is a polymer. 

 6. The drug delivery composition of claim 1, wherein the taste-masking agent is a water-soluble polymer. 

 7. The drug delivery composition of claim 6, wherein said water-soluble polymer has an average molecular weight of equal to or greater than about 40,000. 

 8. The drug delivery composition of claim 1, wherein the taste-masking agent is selected from the group consisting of acrylic polymers, cellulosic polymers, vinyl polymers, crown ethers, hydrogenated oils and waxes, and combinations thereof. 

 9. The drug delivery composition of claim 1, wherein said variation of drug content is less than 5% by weight per film dosage unit. 

 10. The drug delivery composition of claim 1, wherein said variation of drug content is less than 2% by weight per film dosage unit. 

 11. The drug delivery composition of claim 1, wherein said variation of drug content is less than 0.5% by weight per film dosage unit. 

 12. The drug delivery composition of claim 1, wherein said taste-masking agent is present in the amount of about 15-80% by weight of the particle. 

 13. The drug delivery composition of claim 1, wherein said taste-masking agent is present in the amount of about 20-60% by weight of the particle. 

 14. The drug delivery composition of claim 1, wherein said taste-masking agent is present in the amount of about 25-35% by weight of the particle. 

 15. The drug delivery composition of claim 1, wherein said active is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H.sub.2 antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapies, anti-pyretics, psychopharmacological drugs and combinations thereof. 

 16. A thin film drug delivery composition comprising: (a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. 

 17. The drug delivery composition of claim 16, wherein said thin film drug delivery composition is extruded. 

 18. The drug delivery composition of claim 16, wherein the taste-masking agent is a thin film coating over the particulate active component. 

 19. The drug delivery composition of claim 16, wherein the taste-masking agent is a water-soluble polymer. 

 20. The drug delivery composition of claim 16, wherein the composition is free of added plasticizers, surfactants, or polyalcohols. 

 21. The drug delivery composition of claim 1, wherein the taste-masking agent is selected from the group consisting of carboxymethyl cellulose; methyl cellulose; ethyl cellulose; hydroxyl methyl cellulose; hydroxyethyl cellulose; hydroxypropyl cellulose; hydroxypropylmethyl cellulose; hydroxymethylpropyl cellulose; gum arabic; xanthan gum; tragacanth; acacia; carageenan; guar gum; locust bean gum; pectin; alginates; gelatinized, modified or unmodified starch; polyvinyl alcohol; polyacrylic acid; polyvinyl pyrrolidone; poly(meth)acrylate; poly(meth)copolymers; dextrin; dextran; proteins; whey protein isolate; casein; levin; collagen; chitin; chitosin; polydextrose and combinations thereof. 

 22. The drug delivery composition of claim 1, wherein said active is selected from the group consisting of ace-inhibitors, antianginal drugs, anti-arrhythmias, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anti-convulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents, anti-manics, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, anti-uricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction therapies, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, smoking cessation aids, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, terine relaxants, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof. 

 23. The drug delivery composition of claim 1, wherein the film forming matrix has the viscosity in an amount sufficient to substantially prevent an active from settling out during mixing or coating. 

 24. The drug delivery composition of claim 1, wherein said taste-masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 25. The drug delivery composition of claim 1, wherein said active is an opiate or opiate derivative. 

 26. The drug delivery composition of claim 16, wherein said taste-masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 27. The drug delivery composition of claim 16, wherein said active is an opiate or opiate derivative. 

 28. A drug delivery composition comprising: (i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; (ii) a particulate active substantially uniformly stationed in the matrix; and (iii) a taste-masking agent coated or intimately associated with said particulate to provide taste-masking of the active; wherein the combined particulate and taste-masking agent have a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the coated particulate active has a shape selected from the group consisting of spherically shaped particles, ellipsoidally shaped particles, irregularly shaped particles, and combinations thereof. 

 29. The drug delivery composition of claim 28, wherein the size of said combined particulate and taste-masking agent have a particle size of 150 microns or less. 

 30. The drug delivery composition of claim 28, wherein the size of said combined particulate and taste-masking agent have a particle size of 100 microns or less. 

 31. The drug delivery composition of claim 28, wherein said taste-masking agent is a thin film coating over portions of said active. 

 32. The drug delivery composition of claim 28, wherein the taste-masking agent is a polymer. 

 33. The drug delivery composition of claim 28, wherein the taste-masking agent is a water-soluble polymer. 

 34. The drug delivery composition of claim 33, wherein said water-soluble polymer has an average molecular weight of equal to or greater than about 40,000. 

 35. The drug delivery composition of claim 28, wherein the taste-masking agent is selected from the group consisting of acrylic polymers, cellulosic polymers, vinyl polymers, crown ethers, hydrogenated oils and waxes, and combinations thereof. 

 36. The drug delivery composition of claim 28, wherein said variation of drug content is less than 5% by weight per film dosage unit. 

 37. The drug delivery composition of claim 28, wherein said variation of drug content is less than 2% by weight per film dosage unit. 

 38. The drug delivery composition of claim 28, wherein said variation of drug content is less than 0.5% by weight per film dosage unit. 

 39. The drug delivery composition of claim 28, wherein said taste-masking agent is present in the amount of about 15-80% by weight of the particle. 

 40. The drug delivery composition of claim 28, wherein said taste-masking agent is present in the amount of about 20-60% by weight of the particle. 

 41. The drug delivery composition of claim 28, wherein said taste-masking agent is present in the amount of about 25-35% by weight of the particle. 

 42. The drug delivery composition of claim 28, wherein said active is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H.sub.2 antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapies, anti-pyretics, psychopharmacological drugs and combinations thereof. 

 43. The drug delivery composition of claim 28, wherein the taste-masking agent is selected from the group consisting of carboxymethyl cellulose; methyl cellulose; ethyl cellulose; hydroxyl methyl cellulose; hydroxyethyl cellulose; hydroxypropyl cellulose; hydroxypropylmethyl cellulose; hydroxymethylpropyl cellulose; gum arabic; xanthan gum; tragacanth; acacia; carageenan; guar gum; locust bean gum; pectin; alginates; gelatinized, modified or unmodified starch; polyvinyl alcohol; polyacrylic acid; polyvinyl pyrrolidone; poly(meth)acrylate; poly(meth)copolymers; dextrin; dextran; proteins; whey protein isolate; casein; levin; collagen; chitin; chitosin; polydextrose and combinations thereof. 

 44. The drug delivery composition of claim 28, wherein said active is selected from the group consisting of ace-inhibitors, antianginal drugs, anti-arrhythmias, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anti-convulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents, anti-manics, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, anti-uricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, enzymes, erectile dysfunction therapies, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, smoking cessation aids, sympatholytics, tremor preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, terine relaxants, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof. 

 45. The drug delivery composition of claim 28, wherein the film forming matrix has the viscosity in an amount sufficient to substantially prevent an active from settling out during mixing or coating. 

 46. The drug delivery composition of claim 28, wherein said taste-masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 47. The drug delivery composition of claim 28, wherein said active is an opiate or opiate derivative. 

 48. A thin film drug delivery composition comprising: (a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the at least one water-soluble polymer comprises about 20% to about 100% by weight polyethylene oxide. 

 49. The drug delivery composition of claim 48, wherein said thin film drug delivery composition is extruded. 

 50. The drug delivery composition of claim 48, wherein the taste-masking agent is a thin film coating over the particulate active component. 

 51. The drug delivery composition of claim 48, wherein the taste-masking agent is a water-soluble polymer. 

 52. The drug delivery composition of claim 48, wherein the composition is free of added plasticizers, surfactants, or polyalcohols. 

 53. The drug delivery composition of claim 48, wherein said taste-masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 54. The drug delivery composition of claim 48, wherein said active is an opiate or opiate derivative. 

 55. A thin film drug delivery composition comprising: (a) a cast film comprising an edible water-soluble or water swellable film-forming matrix comprising at least one water-soluble or water swellable polymer comprising polyethylene oxide alone or in combination with a hydrophilic cellulosic polymer; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; and (b) a coated particulate active component substantially uniformly stationed in the matrix; wherein the coating on the particulate active component is a taste-masking agent, and wherein the active component is substantially uniformly distributed in the film composition; wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active; and wherein the at least one water-soluble polymer comprises a hydrophilic cellulosic polymer in a ratio of up to about 4:1 with polyethylene oxide. 

 56. The drug delivery composition of claim 55, wherein said thin film drug delivery composition is extruded. 

 57. The drug delivery composition of claim 55, wherein the taste-masking agent is a thin film coating over the particulate active component. 

 58. The drug delivery composition of claim 55, wherein the taste-masking agent is a water-soluble polymer. 

 59. The drug delivery composition of claim 55, wherein the composition is free of added plasticizers, surfactants, or polyalcohols. 

 60. The drug delivery composition of claim 55, wherein said taste-masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 61. The drug delivery composition of claim 55, wherein said active is an opiate or opiate derivative. 

 62. A drug delivery composition comprising: (i) a cast film comprising a flowable water-soluble or water swellable film-forming matrix comprising one or more substantially water soluble or water swellable polymers; and a desired amount of at least one active; wherein said matrix has a viscosity sufficient to aid in substantially maintaining non-self-aggregating uniformity of the active in the matrix; (ii) a particulate active substantially uniformly stationed in the matrix; and (iii) a taste-masking agent selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof to provide taste-masking of the active; wherein the particulate active has a particle size of 200 microns or less and said flowable water-soluble or water swellable film-forming matrix is capable of being dried without loss of substantial uniformity in the stationing of said particulate active therein; and wherein the uniformity subsequent to casting and drying of the matrix is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. 

 63. The drug delivery composition of claim 62, wherein the particulate active has a particle size of 150 microns or less. 

 64. The drug delivery composition of claim 62, wherein the particulate active has a particle size of 100 microns or less. 

 65. The drug delivery composition of claim 62, wherein said variation of drug content is less than 5% by weight per film dosage unit. 

 66. The drug delivery composition of claim 62, wherein said variation of drug content is less than 2% by weight per film dosage unit. 

 67. The drug delivery composition of claim 62, wherein said variation of drug content is less than 0.5% by weight per film dosage unit. 

 68. The drug delivery composition of claim 62, wherein the particulate active has a shape selected from the group consisting of spherically shaped particles, ellipsoidally shaped particles, irregularly shaped particles, and combinations thereof. 

 69. The drug delivery composition of claim 62, wherein said taste-masking agent is present in the amount of about 0.1-30% by weight of the drug delivery composition. 

 70. The drug delivery composition of claim 62, wherein said taste-masking agent is present in the amount of about 0.01-10% by weight of the drug delivery composition. 

 71. The drug delivery composition of claim 62, wherein said active is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H.sub.2 antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapies, anti-pyretics, psychopharmacological drugs and combinations thereof. 

 72. The drug delivery composition of claim 62, wherein the film forming matrix has the viscosity in an amount sufficient to substantially prevent an active from settling out during mixing or coating. 

 73. The drug delivery composition of claim 62, wherein said active is an opiate or opiate derivative. 

 74. The drug delivery composition of claim 73, wherein said taste masking agent is peppermint oil. 

 75. The drug delivery composition of claim 1, wherein said active is an opiate or opiate derivative and said taste masking agent is selected from the group consisting of flavors, sweeteners, flavor enhancers, and combinations thereof. 

 76. The drug delivery composition of claim 75, wherein said taste masking agent is peppermint oil.