Modified release formulations containing drug-ion exchange resin complexes
First Claim
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, andwherein the weight ratio of (a) to (b) is about 2:
- 1 to about 1;
10.
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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.
183 Citations
18 Claims
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
- 1 to about 1;
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10. An aqueous pharmaceutical liquid composition comprising:
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(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. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18)
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Specification