Controlled release formulations of octreotide
AssigneeIndevus Pharmaceuticals, Inc.
InventorsPetr Kuzma, Stephanie Decker
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Abstract
A formulation of octreotide or pharmaceutically acceptable salts thereof, which provides controlled release of a therapeutically effective amount of octreotide for a period of at least about two months. Methods of treating acromegaly, decreasing growth hormone, decreasing IGF-1, and treating conditions associated with carcinoid tumors and VIPomas by administering a controlled release formulation of octreotide are provided herein.
Claims28
An implant comprising a hydrogel and octreotide, wherein said octreotide is contained within said hydrogel, wherein said hydrogel comprises a copolymer obtained from the copolymerization of a mixture comprising at least two hydrophilic, ethylenically unsaturated-monomers, wherein said implant contains from about 20 to about 150 milligrams of octreotide, in free form or salt form, wherein said implant further comprises hydroxypropylcellulose, and wherein said implant provides an in vivo average Css of about 0.1 ng/ml to about 9 ng/ml of octreotide in a patient over a period of at least about two months.
A method of treating acromegaly or one or more symptoms associated with acromegaly, said method comprising implanting subcutaneously into a patient in need thereof at least one implant comprising a hydrogel and octreotide, wherein said octreotide is contained within said hydrogel, wherein said hydrogel comprises a copolymer obtained from the copolymerization of a mixture comprising at least two hydrophilic, ethylenically unsaturated-monomers, wherein said implant contains between about 20 to about 150 milligrams of octreotide in free form or salt form, wherein said implant further comprises hydroxypropylcellulose, and wherein said implant releases an effective amount of octreotide to said patient over a period of at least about two months.
An implant comprising octreotide in free form or salt form, and hydroxypropylcellulose, wherein said octreotide and said hydroxypropylcellulose are contained within a hydrogel comprising a hydrophilic copolymer obtained from the copolymerization of a mixture comprising at least two hydrophilic, ethylenically unsaturated monomers, wherein said implant releases octreotide at a rate of about 30 μg to about 250 μg per day over a period of about six months in vitro.
An implant comprising a hydrogel, octreotide in free form or salt form, and hydroxypropylcellulose, wherein said octreotide and said hydroxypropylcellulose are contained within said hydrogel, said hydrogel comprising a hydrophilic copolymer obtained from the copolymerization of a mixture comprising at least two hydrophilic, ethylenically unsaturated monomers, wherein said implant releases said octreotide at a rate of about 10 μg to about 1000 μg per day over a period of about six months.
Dependencies are inferred from the claim text.