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Details for Patent: 8,900,498

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Details for Patent: 8,900,498

Title:Process for manufacturing a resulting multi-layer pharmaceutical film
Abstract: 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.
Inventor(s): Yang; Robert K. (Henderson, NV), Fuisz; Richard C. (Beverly Hills, CA), Myers; Garry L. (Kingsport, TN), Fuisz; Joseph M. (Surfside, FL)
Assignee: MonoSol Rx, LLC (Warrren, NJ)
Filing Date:Aug 23, 2013
Application Number:13/974,401
Claims:1. A process for manufacturing a resulting multi-layer pharmaceutical film suitable for commercialization and regulatory approval, said resulting multi-layer pharmaceutical film having a substantially uniform distribution of a pharmaceutical active, comprising the steps of: (a) forming a Non-Newtonian visco-elastic polymer matrix by mixing said matrix comprising a polymer selected from the group consisting of water-soluble polymers, water-swellable polymers and combinations thereof, a solvent selected from the group consisting of water, a polar organic solvent and combinations thereof, which polymer matrix is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-10.sup.5 sec.sup.-1; (b) casting said polymer matrix; (c) conveying said polymer matrix through a drying apparatus and evaporating at least a portion of said solvent to rapidly form a first visco-elastic film within about the first 4 minutes while maintaining a temperature differential between the polymer matrix and the drying apparatus environment of at least 5.degree. C., wherein the temperature of the polymer matrix is 100.degree. C. or less; (d) depositing a layer comprising a pharmaceutical active onto said first visco-elastic film to form the resulting multi-layer pharmaceutical film; (e) sampling said resulting multi-layer pharmaceutical film at different locations of said resulting multi-layer pharmaceutical film, wherein said sampled resulting multi-layer pharmaceutical film has a water content of 10% or less; and (f) performing analytical chemical tests for content uniformity of said pharmaceutical active in substantially equal sized individual dosage units of said sampled resulting multi-layer pharmaceutical film, said tests indicating that the uniformity of content in the amount of the pharmaceutical active varies by no more than 10%.

2. The process of claim 1, wherein said drying apparatus uses air currents, which have forces below a yield value of the polymer matrix during drying.

3. The process of claim 1, wherein said polymer comprises a polymer selected from the group consisting of cellulose, a cellulose derivative, pullulan, polyvinyl pyrrolidone, polyvinyl alcohol, polyethylene glycol, carboxyvinyl copolymers, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, sodium alginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid,\ methylmethacrylate copolymer, carboxyvinyl copolymers, starch, gelatin, and combinations thereof, alone or in combination with polyethylene oxide.

4. The process of claim 1, wherein the pharmaceutical active is selected from the group consisting of ace-inhibitors, anti-anginal 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, antilipid 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, antiuricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, 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-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics, anti-nauseants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, uterine relaxants, anti-obesity drugs, erythropoietic drugs, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.

5. The process of claim 1, wherein said pharmaceutical active is selected from the group consisting of antigens, allergens, spores, microorganisms, seeds, enzymes, vitamins, bioactive active, amino acid preparations, sildenafils, tadalafils, vardenafils, apomorphines, yohimbine hydrochlorides, alprostadils, anti-diabetic agents, non-steroidal anti-inflammatory agents, biological response modifiers, anti-Alzheimer's agents, anesthetic agents, analgesic agents and combinations thereof.

6. The process of claim 1, wherein the pharmaceutical active is a protein or a glycoprotein.

7. The process of claim 1, wherein the pharmaceutical active is insulin.

8. The process of claim 1, wherein the pharmaceutical active is an opiate or opiate-derivative.

9. The process of claim 1, wherein the pharmaceutical active is an anti-emetic.

10. The process of claim 1, wherein said resulting multi-layer pharmaceutical film provides administration of said pharmaceutical active to an individual through a mucosal membrane of said individual.

11. The process of claim 1, wherein said resulting multi-layer pharmaceutical film provides administration of said pharmaceutical active to an individual through the buccal cavity of said individual.

12. The process of claim 1, wherein said resulting multi-layer pharmaceutical film provides administration of said pharmaceutical active to an individual through gingival application of said resulting multi-layer pharmaceutical film.

13. The process of claim 1, wherein said resulting multi-layer pharmaceutical film provides administration of said pharmaceutical active to an individual through sublingual application of said resulting multi-layer pharmaceutical film.

14. The process of claim 1, wherein said resulting multi-layer pharmaceutical film provides administration of said pharmaceutical active to an individual by administration within the body of the individual during surgery.

15. The process of claim 1, wherein said pharmaceutical active is a hormone.

16. The process of claim 1, wherein said pharmaceutical active is taste-masked.

17. The process of claim 1, wherein said pharmaceutical active is coated with a controlled release composition.

18. The process of claim 17, wherein said controlled release composition provides at least one of the following: an immediate release, a delayed release, a sustained release or a sequential release.

19. The process of claim 1, wherein said deposited layer is a second visco-elastic film.

20. The process of claim 19, wherein said deposited layer is coated onto said first visco-elastic film.

21. The process of claim 19, wherein said deposited layer is cast onto said first visco-elastic film.

22. The process of claim 19, wherein said deposited layer is extruded onto said first visco-elastic film.

23. The process of claim 19, wherein said deposited layer is sprayed onto said first visco-elastic film.

24. The process of claim 19, wherein said deposited layer is laminated onto said first visco-elastic film.

25. The process of claim 19, wherein said pharmaceutical active in said deposited layer is different from said pharmaceutical active in said first visco-elastic film.

26. The process of claim 1, wherein said pharmaceutical active is in the form of a particle.

27. The process of claim 1, wherein said matrix comprises a dispersion.

28. A process for manufacturing a resulting multi-layer pharmaceutical film suitable for commercialization and regulatory approval, said resulting multi-layer pharmaceutical film having a substantially uniform distribution of pharmaceutical active, comprising the steps of: (a) forming a Non-Newtonian visco-elastic polymer matrix by mixing said matrix comprising a polymer selected from the group consisting of water-soluble polymers, water-swellable polymers and combinations thereof, a solvent selected from the group consisting of water, a polar organic solvent and combinations thereof, which polymer matrix is a shear-thinning pseudoplastic fluid when exposed to shear rates of 10-10.sup.5 sec.sup.-1; (b) casting said polymer matrix; (c) conveying said polymer matrix through a drying apparatus and evaporating at least a portion of said solvent to rapidly form a visco-elastic film within about the first 4 minutes, wherein the temperature of the polymer matrix is 100.degree. C. or less; (d) depositing a layer comprising an pharmaceutical active onto said visco-elastic film to form the resulting multi-layer pharmaceutical film; (e) sampling said resulting multi-layer pharmaceutical film at different locations of said resulting multi-layer pharmaceutical film, wherein said sampled resulting multi-layer pharmaceutical film has a water content of 10% or less; and (f) performing analytical chemical tests for content uniformity of said multi-layer pharmaceutical active in substantially equal sized individual dosage units of said sampled resulting pharmaceutical film, said tests indicating that the uniformity of content in the amount of the pharmaceutical active varies by no more than 10%.
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