Alkermes Controlled Therapeutics, Inc.

Alkermes Pharma Ireland Limited

Alkermes Controlled Therapeutics, Inc. I

M Gary I Riley

Stephen E Zale

Joyce M Hotz

J Michael Ramstack

OluFunmi Lily Johnson

James R Dasch

Henry R Costantino

Paul A Burke

Susan A Steitz-Abadi

The invention relates to compositions and methods for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein a biologically active polypeptide, and a corticosteroid to modify the release profile and provide increased bioavailability.

Microencapsulation and sustained release of biologically active polypeptides

Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20&#xb0; C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.

Preparation of injectable suspensions having improved injectability

The present invention relates to a method for the sustained release in vivo of a biologically active agent comprising administering to a subject in need of treatment an effective amount of a sustained release composition comprising a biocompatible polymer having the biologically active agent incorporated therein, and a bisphosphonate wherein the bisphosphonate compound is present in an amount sufficient to modify the release profile of the biologically active agent from the sustained release composition. Pharmaceutical compositions suitable for use in the method of the invention are also disclosed.

Method of modifying the release profile of sustained release compositions

Injectable compositions having improved injectability. The injectable compositions include microparticles suspended in an aqueous injection vehicle having a viscosity of at least 20 cp at 20&deg; C. The increased viscosity of the injection vehicle that constitutes the fluid phase of the suspension significantly reduces in vivo injectability failures. The injectable compositions can be made by mixing dry microparticles with an aqueous injection vehicle to form a suspension, and then mixing the suspension with a viscosity enhancing agent to increase the viscosity of the fluid phase of the suspension to the desired level for improved injectability.

Growing community of inventors

Cambridge, MA, United States of America

M Gary I Riley