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Claims for Patent: 9,238,076

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Claims for Patent: 9,238,076

Title:Polymer-based sustained release device
Abstract: This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, 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 sugar.
Inventor(s): Wright; Steven G. (Madeira, OH), Christensen; Troy (Mason, OH), Yeoh; Thean (Salem, CT), Rickey; Michael E. (Morrow, OH), Hotz; Joyce M. (Cincinnati, OH), Kumar; Rajesh (Marlborough, MA), Fineman; Mark (San Deigo, CA), Smith; Christine (San Diego, CA), Ong; John (San Diego, CA), Lokensgard; David M. (San Diego, CA), Costantino; Henry R. (Woodinville, WA)
Assignee: Alkermes Pharma Ireland Limited (Dublin, IE) Amylin Pharmaceuticals, LLC (San Diego, CA)
Application Number:13/743,117
Patent Claims: 1. A composition suitable for the treatment of Type-2 diabetes, consisting essentially of: purified 50:50 DL PLG 4A polymer; about 3% to about 5% (w/w) exendin-4; and about 2% (w/w) sucrose; wherein a total pore volume of the composition is about 0.1 mL/g or less as determined using mercury intrusion porosimetry to provide a release profile having a ratio of maximum serum concentration of the exendin-4 during the period of release (C.sub.max) to average serum concentration of the exendin-4 during the period of release (C.sub.ave) of about 3 or less.

2. A method of treating a patient suffering from Type 2 diabetes, comprising: administering a therapeutically effective amount of the composition of claim 1.

3. The composition of claim 1, wherein the exendin-4 is present at about 5% (w/w) of the weight of the composition.

4. The composition of claim 1, wherein the polymer has an inherent viscosity of between about 0.3 and 0.5 dL/g.

5. The composition of claim 1, which is suspended in an injection vehicle comprising sodium carboxymethylcellulose at 3.0% (w/v), sodium chloride at 0.9% (w/v), and Polysorbate 20 NF (Tween 20) at 0.1% (v/v) in water.

6. The method of claim 2, wherein the composition is administered by injection.
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