Modified release formulations containing drug-ion exchange resin complexes
First Claim
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1. A modified release aqueous oral liquid suspension comprising:
- (A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises(i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen,said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and(ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising;
(a) about 70% w/w to about 90% w/w polyvinylacetate polymer,(b) a stabilizer, and(c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine;
(B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated drug-ion exchange resin complex comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine;
(C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; and
(D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base.
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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. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making the coated complex and the liquid suspension are described.
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Citations
29 Claims
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1. A modified release aqueous oral liquid suspension comprising:
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(A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising; (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated drug-ion exchange resin complex comprise (i) codeine and (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; (C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine and optionally (iii) pseudoephedrine; and (D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A modified release aqueous oral liquid suspension comprising:
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(A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix of (i), said cured aqueous based barrier coating comprising; (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and
(iii) pseudoephedrine;(B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and
(iii) pseudoephedrine;(C) multiple drugs which are not complexed with an ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine; and
(iii) pseudoephedrine; and(D) a pharmaceutically acceptable aqueous suspension base, wherein said components (A), (B) and (C) are in said aqueous base. - View Dependent Claims (20, 21, 22, 23)
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24. A modified release aqueous oral liquid suspension comprising:
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(A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix defined in (i), said cured aqueous based barrier coating comprising; (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said particulate drug-ion exchange resin complex comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine, and optionally (iii) pseudoephedrine; and (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs in said uncoated particulate drug-ion exchange resin complex comprise (i) codeine, (ii) chlorpheniramine or dexchlorpheniramine, and optionally (iii) pseudoephedrine; and a pharmaceutically acceptable aqueous suspension base, wherein said components (A) and (B) are in said aqueous base. - View Dependent Claims (25, 26)
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27. A modified release aqueous oral liquid suspension comprising:
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(A) a particulate diffusion barrier coated, drug-ion exchange resin complex-matrix which comprises (i) a particulate matrix comprising a particulate drug-ion exchange resin complex and a water insoluble polymer or copolymer or a hydrophilic polymer, said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix capable of passing through a number 40 mesh screen, said particulate drug-ion exchange resin complex comprising multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said water insoluble polymer or copolymer, or hydrophilic polymer, is present in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix in an amount of about 3% to about 30% by weight, based on the weight of said particulate drug-ion exchange resin complex, and (ii) a cured high tensile strength, water permeable, water insoluble, non ionic polymeric diffusion barrier coating over said particulate drug-ion exchange resin complex (water insoluble polymer or copolymer or said hydrophilic polymer) matrix in (i), said cured aqueous based barrier coating comprising; (a) about 70% w/w to about 90% w/w polyvinylacetate polymer, (b) a stabilizer, and (c) about 2.5 to about 20% w/w of plasticizer effective to enhance the tensile strength of said cured barrier coating, whereby said cured coating provides about a twelve hour release profile to the drug in said particulate drug-ion exchange resin complex-(water insoluble polymer or copolymer or hydrophilic polymer) matrix, wherein the weight percentage is based on the weight of the cured barrier coating layer, wherein said multiple drugs in said coated drug-ion exchange resin complex-matrix comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine, and (iii) pseudoephedrine; and (B) an uncoated particulate drug-ion exchange resin complex which comprises multiple drugs bound to a pharmaceutically acceptable water insoluble ion exchange resin, wherein said multiple drugs comprise (i) hydrocodone, (ii) chlorpheniramine or dexchlorpheniramine, and (iii) pseudoephedrine; and a pharmaceutically acceptable aqueous suspension base, wherein said components (A) and (B) are in said aqueous base. - View Dependent Claims (28, 29)
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Specification