Modified release formulations containing drug-ion exchange resin complexes
A tablet comprising a coated drug-ion exchange resin complex composed of methylphenidate complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated methylphenidate-ion exchange resin complex is provided. The coated methylphenidate-ion exchange resin complex is in admixture with a polymer to form a matrix. Also provided is a tablet comprising a coated drug-ion exchange resin complex composed of dexmethylphenidate complexed with a pharmaceutically acceptable ion-exchange resin and an uncoated dexmethylphenidate-ion exchange resin complex is provided. The coated dexmethylphenidate-ion exchange resin complex is in admixture with a polymer to form a matrix.
1. A solid pharmaceutical orally disintegrating tablet comprising:
(a) drug-ion exchange resin complex particles that are uncoated and which comprise methylphenidate bound to an ion exchange resin, and
(b) modified release coated drug-ion exchange resin complex particles which comprise methylphenidate 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
wherein the weight ratio of (a) to (b) is about 2:1 to about 1:10.
2. The tablet 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 tablet 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 tablet 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 tablet according to claim 1 , wherein the ion exchange resin in (a) and/or (b) is a strong acidic cation exchange resin.
6. The tablet according to claim 5 , wherein said strong acidic cation exchange resin is a sulfonated copolymer of a polystyrene crosslinked with divinylbenzyl.
7. The tablet 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. A solid pharmaceutical orally disintegrating tablet comprising:
(a) drug-ion exchange resin complex particles that are uncoated and which comprise dexmethylphenidate bound to an ion exchange resin, and
(b) modified release coated drug-ion exchange resin complex particles which comprise dexmethylphenidate 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
wherein the weight ratio of (a) to (b) is about 2:1 to about 1:10.
9. The tablet according to claim 8 , wherein the modified release coating on the coated drug-ion exchange resin complex particles is a delayed release coating.
10. The tablet according to claim 8 , 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.
11. The tablet according to claim 10 , 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.
12. The tablet according to claim 8 , wherein the ion exchange resin in (a) and/or (b) is a strong acidic cation exchange resin.
13. The tablet according to claim 12 , wherein said strong acidic cation exchange resin is a sulfonated copolymer of a polystyrene crosslinked with divinylbenzyl.
14. The tablet according to claim 8 , 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.