Controlled release formulations of octreotide
AssigneeEndo Pharmaceuticals Solutions Inc.
InventorsPetr Kuzma, Stefanie 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.
Claims12
1-26. (canceled)
A method of treating a patient suffering from a condition associated with carcinoid tumors or suffering from one or more symptoms associated with such condition, the method comprising:
- implanting subcutaneously into a patient in need thereof at least one implant comprising a hydrophilic polymer and a pharmaceutical formulation comprising octreotide acetate, 0.5 to 20% w/w of hydroxypropylcellulose, and 0.5 to 5% w/w of magnesium stearate, wherein the at least one implant is implanted in a dry state;
- wherein the hydrophilic polymer comprises a copolymer of at least two hydrophilic, ethylenically unsaturated monomers, wherein the at least two hydrophilic, ethylenically unsaturated monomers are 2-hydroxyethyl methacrylate and hydroxypropyl methacrylate, and wherein the copolymer comprises about 20% by weight of 2-hydroxyethyl methacrylate and about 80% by weight hydroxypropylmethacrylate;
- wherein the pharmaceutical formulation is contained within the hydrophilic polymer;
- wherein the pharmaceutical formulation contains between about 20 to about 150 milligrams of octreotide acetate;
- and
- wherein the at least one implant releases a therapeutically effective amount of the octreotide acetate to the patient at a rate of about 30 to 300 μg/day to provide an in vivo average Css in the patient of about 0.1 ng/ml to about 9 ng/ml of octreotide over a period of at least about two months to about two years.
Dependencies are inferred from the claim text.