Composition and method using solid-phase particles for sustained in vivo release of a biologically active agent
First Claim
1. A pharmaceutical composition for the sustained release in vivo of a biologically active agent, comprising:
- a) microcarrier particles of about one millimeter or less containing an effective amount of a biologically active agent encapsulated within a first polymer which biocompatible and selected from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polyacetyls, polycyanoacrylates, polyetheresters, poly(dioxanone)s, poly(alkylene alkylate)s, copolymers of polyethylene glycol and polyorthoester, biodegradable polyurethanes, blends and copolymers thereof, wherein the microcarriers sustain the in vivo release of the biologically active agent, andb) microparticles of about one millimeter or less of a second polymer which is biocompatible and biodegradable, wherein said microparticles are substantially free of the biologically active agent, and which are separate form but commingled with the microcarrier particles of a) and are present in an amount sufficient to elongate the release period of biologically active agent from the microcarrier particles of a).
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Accused Products
Abstract
Composition for the sustained release of a biologically active agent in vivo. The composition comprises microcarriers containing a first solid-phase biocompatible material and a biologically active agent, wherein said microcarriers sustain the in vivo release of the biologically active agent. The composition also contains particles of a second biocompatible solid-phase material wherein the second solid-phase material further sustains the in vivo release of the biologically active agent.
The invention also relates to a method for sustaining effective serum levels of a biologically active agent in a subject, including forming an injectable dose containing an effective amount of a biologically active agent, wherein the agent is contained in a microcarrier, with a release-period sustaining amount of a solid-phase material. The method further includes administering the injectable dose to the subject.
342 Citations
18 Claims
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1. A pharmaceutical composition for the sustained release in vivo of a biologically active agent, comprising:
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a) microcarrier particles of about one millimeter or less containing an effective amount of a biologically active agent encapsulated within a first polymer which biocompatible and selected from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polyacetyls, polycyanoacrylates, polyetheresters, poly(dioxanone)s, poly(alkylene alkylate)s, copolymers of polyethylene glycol and polyorthoester, biodegradable polyurethanes, blends and copolymers thereof, wherein the microcarriers sustain the in vivo release of the biologically active agent, and b) microparticles of about one millimeter or less of a second polymer which is biocompatible and biodegradable, wherein said microparticles are substantially free of the biologically active agent, and which are separate form but commingled with the microcarrier particles of a) and are present in an amount sufficient to elongate the release period of biologically active agent from the microcarrier particles of a). - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 11)
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10. A method for the sustained release in vivo of a biologically active agent comprising administering to a subject an effective amount of a sustained release composition comprising:
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a) microcarrier particles of about one millimeter or less containing a biologically active agent encapsulated within a first polymer which is biocompatible and selected from the group consisting of poly(lactide)s, poly(glycolide)s, poly(lactide-co-glycolide)s, poly)lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s, polycaprolactone, polycarbonates, polyesteramides, polyanhydrides, poly(amino acids), polyorthoesters, polyacetyls, polycyanoacrylates, polyetheresters, poly(dioxanone)s, poly(alkylene alkylate)s, copolymers of polyethylene glycol and polyorthoester, biodegradable polyurethanes, blends and copolymers thereof, wherein the microcarrier particles sustain the in vivo release of the biologically active agent, b) microparticles of a second polymer which is biocompatible and biodegradable, wherein said microparticles are substantially free of the biologically active agent, and which are separate from but commingled with the microcarrier particles of a) and are present in an amount sufficient to elongate the release period of biologically active agent from the microcarrier particles of a), and a physiologically acceptable vehicle. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18)
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Specification