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Claims for Patent: 8,883,217

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Claims for Patent: 8,883,217

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. 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:14/155,410
Patent Claims: 1. A solid pharmaceutical orally disintegrating tablet composition comprising (a) drug-ion exchange resin complex particles that are uncoated and which comprise amphetamine and dextroamphetamine bound to an ion exchange resin, and (b) modified release coated drug-ion exchange resin complex particles which comprise amphetamine and dextroamphetamine bound to an ion exchange resin, wherein said modified release coated drug-ion exchange resin complex particles (b) further comprise a hydrophilic polymer or water insoluble polymer or copolymer in a matrix with the drug-ion exchange resin complex, wherein the modified release coating is over the drug-ion exchange resin complex-matrix, and wherein the weight ratio of (a) to (b) is about 2:1 to about 1:10.

2. The composition according to claim 1, wherein the modified release coating on the coated drug-ion exchange resin complex particles is a delayed release coating.

3. The composition according to claim 1, wherein said modified release coated drug-ion exchange resin complex particles (b) further comprise a water insoluble polymer or copolymer in a matrix with the drug-ion exchange resin complex, wherein the modified release coating is over the drug-ion exchange resin complex-matrix.

4. The composition according to claim 3, wherein the water insoluble polymer or copolymer is selected from the group consisting of a polyvinyl acetate polymer, cellulose acetate, acrylic based polymers or copolymers, cellulose phthalate, and mixtures thereof

5. The composition according to claim 1, wherein the ion exchange resin in (a) and/or (b) is a strong acidic cation exchange resin.

6. The composition according to claim 5, wherein said strong acidic cation exchange resin is a sulfonated copolymer of a polystyrene crosslinked with divinylbenzyl.

7. The composition according to claim 1, wherein the drug-ion exchange resin complex particles of (a) and/or (b) have a particle size in the range of about 40 to about 250 microns.

8. The composition according to claim 1, wherein said amphetamine and dextroamphetamine in (a) are bound to the same cation exchange resin.

9. The composition according to claim 8, wherein said amphetamine and dextroamphetamine in (b) are bound to the same cation exchange resin.

10. An aqueous pharmaceutical liquid composition comprising: (a) drug-ion exchange resin complex particles that are uncoated and which comprise amphetamine and dextroamphetamine bound to an ion exchange resin, and (b) modified release coated drug-ion exchange resin complex particles which comprise amphetamine and dextroamphetamine bound to an ion exchange resin, wherein said modified release coated drug-ion exchange resin complex particles (b) further comprise a hydrophilic polymer or water insoluble polymer or copolymer in a matrix with the drug-ion exchange resin complex, wherein the modified release coating is over the drug-ion exchange resin complex-matrix, and wherein the weight ratio of (a) to (b) is about 2:1 to about 1:10.

11. The composition according to claim 10, wherein the modified release coating on the coated drug-ion exchange resin complex particles is a delayed release coating.

12. The composition according to claim 10, wherein said modified release coated drug-ion exchange resin complex particles (b) further comprise a water insoluble polymer or copolymer in a matrix with the drug-ion exchange resin complex, wherein the modified release coating is over the drug-ion exchange resin complex-matrix.

13. The composition according to claim 12, wherein the water insoluble polymer or copolymer is selected from the group consisting of a polyvinyl acetate polymer, cellulose acetate, acrylic based polymers or copolymers, cellulose phthalate, and mixtures thereof.

14. The composition according to claim 10, wherein the ion exchange resin is a strong acidic cation exchange resin.

15. The composition according to claim 14, wherein said strong acidic cation exchange resin is a sulfonated copolymer of a polystyrene crosslinked with divinylbenzyl.

16. The composition according to claim 10, wherein the drug-ion exchange resin complex particles of (a) and/or (b) have a particle size in the range of about 40 to about 250 microns.

17. The composition according to claim 10, wherein said amphetamine and dextroamphetamine of (a) are bound to the same cation exchange resin.

18. The composition according to claim 17, wherein said amphetamine and dextroamphetamine of (b) are bound to the same cation exchange resin.
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