Alkermes Controlled Therapeutics, Inc.

Alkermes, Inc.

Other

Alkermas Controlled Therapeutics, Inc.

Henry E Auer

Howard Bernstein

M Amin Khan

OluFunmi Lily Johnson

Medha M Ganmukhi

Stephen E Zale

Larry Richard Brown

Mark A Tracy

Paul A Burke

Michael S Healy

James E Seely

Wayne R Gombotz

Peter M Rubinelli

Richard M Synenki

Small diameter particles of biologically active molecules are produced by atomizing solutions of the molecules through a nozzle into very cold liquified gases, which immediately freeze the atomized droplets. The resulting frozen particles having diameters of approximately 10 to 90 micrometers are lyophilized to produce porous particles, suspended in a non-solvent for the molecules, and exposed to ultrasonic energy or homogenization to produce particles having diameters of 0.1 to 10 micrometers with greater than 70 to 95% of the initial biological activity of the molecules in solution.

Process for producing small particles of biologically active molecules

A device for the sustained release in vivo of a water soluble, biologically active agent wherein the agent is susceptible to aggregation comprising a drug delivery device and aggregation-stabilized, biologically active agent wherein the aggregation-stabilized agent is disposed within the drug delivery device.

Device for the sustained release of aggregation-stabilized, biologically active agent

A pharmaceutical composition for the sustained release of human growth hormone from a polymer matrix is disclosed. The pharmaceutical composition comprises a biocompatible polymer, particles of metal cation-complexed human growth hormone wherein said particles are dispersed within the biocompatible polymer and an aqueous injection vehicle.

Composition for sustained release of human growth hormone

The method of the invention for producing a composition for the sustained release of biologically active hGH includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, metal cation-stabilized hGH in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said hGH particles.

The present invention provides a stable and bioactive recombinant small-loop modified somatotropin which has its small-loop cysteines changed to other amino acids or deleted altogether and a method for producing such a small-loop modified somatotropin. Also provided by the present invention are DNA sequences coding for such small-loop modified somatotropins, plasmids containing such sequences, and organisms containing such plasmids. Furthermore, pharmaceutical compositions including small-loop modified somatotropins and methods for using such pharmaceutical compositions are disclosed.

Stable and bioactive modified porcine somatotropin and pharmaceutical

The method of using the sustained release composition of the present invention comprises providing a therapeutically effective blood level of biologically active, non-aggregated human growth hormone in a subject for a sustained period by administering to the subject a dose of said sustained release composition.

A composition, and methods of forming and using said composition, for the sustained release of biologically active, stabilized human growth hormone (hGH). The sustained release composition of this invention comprises a polymeric matrix of a biocompatible polymer and particles of biologically active, stabilized hGH, wherein said particles are dispersed within the biocompatible polymer. The method of the invention for producing a composition for the sustained release of biologically active hGH, includes dissolving a biocompatible polymer in a polymer solvent to form a polymer solution, dispersing particles of biologically active, stabilized hGH in the polymer solution, and then solidifying the polymer to form a polymeric matrix containing a dispersion of said hGH particles. The method for using a composition of the invention is a method for providing a therapeutically effective blood level of biologically active, non-aggregated hGH in a subject for a sustained period. In this method, a subject is administered an effective dose of the sustained release composition of the present invention. The method of using the sustained release composition of the present invention comprises providing a therapeutically effective blood level of biologically active, non-aggregated human growth hormone in a subject for a sustained period by administering to the subject a dose of said sustained release composition.

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Chicago, IL, United States of America

Henry E Auer