Modified release formulations containing drug-ion exchange resin complexes
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.
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.