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Claims for Patent: 8,790,700

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Claims for Patent: 8,790,700

Title:Modified release formulations containing drug-ion exchange resin complexes
Abstract: An aqueous liquid suspension containing a coated drug-ion exchange resin complex comprising a core composed of an amphetamine complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated amphetamine-ion exchange resin complex is provided. The coated amphetamine-ion exchange resin complex is in admixture with a polymer to form a matrix. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making the coated complex and the liquid suspension are described.
Inventor(s): Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ)
Assignee: TRIS Pharma, Inc. (Monmouth Junction, NJ)
Application Number:14/044,105
Patent Claims: 1. A modified release aqueous oral liquid suspension comprising: (A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising: (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated drug-ion exchange resin complex comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; and (D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base.

2. The modified release aqueous oral liquid suspension according to claim 1, wherein the uncoated drug-ion exchange resin complex (B) is of a size capable of passing through a number 40 mesh screen.

3. The modified release aqueous oral liquid suspension according to claim 1, wherein the ion exchange resin of each (A) and (B) is a sulfonated copolymer comprising styrene and divinylbenzene.

4. The modified release aqueous oral liquid suspension according to claim 1, wherein multiple drugs of (A) comprises (i) codeine and (ii) chlorpheniramine.

5. The modified release aqueous oral liquid suspension according to claim 4, wherein said multiple drugs of (B) comprise (i) codeine and (ii) chlorpheniramine.

6. The modified release aqueous oral liquid suspension according to claim 1, wherein said drugs of (C) comprise (i) codeine and (ii) chlorpheniramine.

7. The orally ingestible aqueous liquid suspension composition according to claim 1 wherein said cured high tensile strength, water permeable, water insoluble non-ionic polymeric diffusion barrier coating has an elongation factor of between about 125% and about 400%.

8. The modified release aqueous oral liquid suspension according to claim 1, wherein said cured high tensile strength, water permeable, water insoluble non-ionic polymeric diffusion barrier coating is applied as an aqueous dispersion comprising about 30% solids comprising polyvinylacetate, polyvinylpyrrolidone and an effective amount of a surfactant, said polyvinylacetate and polyvinylpyrrolidone being in a dry weight ratio about 10:1.

9. The modified release aqueous oral liquid suspension according to claim 1, wherein said plasticizer comprises about 5% to about 10% w/w of solids in said cured coating.

10. The modified release aqueous oral liquid suspension according to claim 1, wherein said plasticizer comprises triacetin.

11. The modified release aqueous oral liquid suspension according to claim 1, wherein said cured high tensile strength, water permeable, water insoluble non-ionic polymeric diffusion barrier coating further comprises sodium lauryl sulfate.

12. The modified release aqueous oral liquid suspension according to claim 1, wherein said cured, high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating comprises about 35% to about 50% by weight of said drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix of (A).

13. The modified release aqueous oral liquid suspension according to claim 1, wherein said water insoluble polymer or copolymer or the hydrophilic polymer in said matrix is present in an amount of about 5 to about 20% by weight, based on the weight of said drug-ion exchange resin complex of (A).

14. The modified release aqueous oral liquid suspension according to claim 1, wherein said ion exchange resin used to form the complex of (A) and said ion exchange resin used to form the complex of (B) are independently selected from among strong pharmaceutically acceptable ion resins.

15. The modified release aqueous oral liquid suspension according to claim 1, wherein said coated drug-ion exchange resin complex-matrix of (A) includes a hydrophilic polymer.

16. The modified release aqueous oral liquid suspension according to claim 15, wherein said hydrophilic polymer comprises a polyvinylpyrrolidone.

17. The modified release aqueous oral liquid suspension according to claim 1, wherein said particulate matrix comprises said particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer.

18. The modified release aqueous oral liquid suspension according to claim 17, wherein said water insoluble polymer or copolymer comprises polyvinylacetate with a stabilizer comprising polyvinylpyrrolidone and an effective amount of a surfactant.

19. A modified release aqueous oral liquid suspension comprising: (A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix of (i), said cured aqueous based barrier coating comprising: (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and (iii) pseudoephedrine; (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and (iii) pseudoephedrine; (C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and (iii) pseudoephedrine; and (D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base.

20. The modified release aqueous oral liquid suspension according to claim 19, wherein said ion exchange resin used to form the complex of each of (A) and (B) is a sulfonated copolymer comprising styrene and a divinylbenzene.

21. The modified release aqueous oral liquid suspension according to claim 19, wherein said particulate drug-ion exchange resin complex-(hydrophilic polymer) matrix comprises polyvinylpyrrolidone.

22. The modified release aqueous oral liquid suspension according to claim 19, wherein said cured, high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating comprises about 35% to about 50% by weight of the matrix of (A)(i).

23. The modified release aqueous oral liquid suspension according to claim 19, wherein said cured, high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating comprises about 50% by weight of the matrix of (A)(i).

24. A modified release aqueous oral liquid suspension comprising: (A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix defined in (i), said cured aqueous based barrier coating comprising: (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said particulate drug-ion exchange resin complex comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine, and optionally (iii) pseudoephedrine; and (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated particulate drug-ion exchange resin complex comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine, and optionally (iii) pseudoephedrine; and a pharmaceutically acceptable aqueous suspension base, wherein said components (A) and (B) are in said aqueous base.

25. The modified release aqueous oral liquid suspension according to claim 24, wherein said drug-ion exchange resin complex-matrix includes a hydrophilic polymer which comprises polyvinylpyrrolidone.

26. The modified release aqueous oral liquid suspension according to claim 24, wherein said multiple drugs in the coated drug-ion exchange resin complex-matrix of (A) comprises (i) codeine and (ii) chlorpheniramine and said multiple drugs in the coated drug-ion exchange resin complex-matrix of (B) comprises (i) codeine and (ii) chlorpheniramine.

27. A modified release aqueous oral liquid suspension comprising: (A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising: (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine, and (iii) pseudoephedrine; and (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine, and (iii) pseudoephedrine; and a pharmaceutically acceptable aqueous suspension base, wherein said components (A) and (B) are in said aqueous base.

28. The modified release aqueous oral liquid suspension according to claim 27, wherein said drug-ion exchange resin complex-matrix includes a hydrophilic polymer which comprises a polyvinylpyrrolidone.

29. The modified release aqueous oral liquid suspension according to claim 27, wherein said multiple drugs in the coated drug-ion exchange resin complex-matrix of (A) comprises (i) hydrocodone, (ii) chlorpheniramine and (iii) pseudoephedrine, and said multiple drugs in the coated drug-ion exchange resin complex-matrix of (B) comprises (i) hydrocodone, (ii) chlorpheniramine, and (iii) pseudoephedrine.
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