You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Claims for Patent: 8,883,217


✉ Email this page to a colleague

« Back to Dashboard


Summary 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.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.