Delayed/sustained release of macromolecules
First Claim
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1. A drug delivery device for the controlled administration of a macromolecular drug, said device comprising:
- (a) a pharmaceutically acceptable carrier;
(b) a macromolecular drug having a molecular weight greater than about 1,000 mixed with said carrier; and
(c) an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane, wherein said membrane;
(i) comprises a homopolymer or a copolymer material surrounding said carrier and drug, and(ii) has an initial water content such that it is substantially non-permeable to said macromolecular drug.
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Abstract
This invention concerns novel, delayed/sustained release devices and compositions, including methods of their manufacture and use. The compositions include macromolecules, particularly polypeptide pharmaceuticals, and an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane.
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Citations
48 Claims
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1. A drug delivery device for the controlled administration of a macromolecular drug, said device comprising:
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(a) a pharmaceutically acceptable carrier; (b) a macromolecular drug having a molecular weight greater than about 1,000 mixed with said carrier; and (c) an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane, wherein said membrane; (i) comprises a homopolymer or a copolymer material surrounding said carrier and drug, and (ii) has an initial water content such that it is substantially non-permeable to said macromolecular drug. - View Dependent Claims (2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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7. A device for the delayed/sustained release of a compound, said device comprising:
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(a) a macromolecular compound having a molecular weight greater than about 1,000; (b) a carrier having said macromolecular compound mixed therewith; and (c) an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane, wherein said membrane; (i) comprises a homopolymer or a copolymer material surrounding said carrier and macromolecular compound, (ii) is substantially non-permeable to said macromolecular compound when in said initially partially-hydrated state, and (iii) is hydratable, when placed in a delivery environment, to become permeable to said macromolecular compound. - View Dependent Claims (48)
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24. A pharmaceutical formulation for controlled release of a luteinizing hormone-releasing hormone analog, said formulation comprising:
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(a) a pharmaceutically acceptable carrier; (b) an effective amount of at least one luteinizing hormone-releasing hormone analog or a pharmaceutically acceptable salt thereof disposed in contact with said carrier; and (c) an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane surrounding said carrier, said membrane being; (i) initially hydrated to a water content of about 5% to less than about 30% by weight before placement in a delivery environment, and (ii) hydratable to an equilibrium water content of about 30% to about 80% by weight when in a delivery environment. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 42, 43, 44, 45, 46, 47)
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40. A drug delivery device for the controlled administration of a macromolecular drug, said device comprising:
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(a) a pharmaceutically acceptable carrier; (b) a macromolecular drug having a molecular weight greater than about 1,000 disposed in contact with said carrier; and (c) an initially partially-hydrated, non-biodegradable, hydrogel rate-limiting membrane, wherein said membrane; (i) comprises a homopolymer or a copolymer material surrounding said carrier, and (ii) has an initial water content such that it is structurally manipulable. - View Dependent Claims (41)
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Specification