.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 8,877,252

« Back to Dashboard

Details for Patent: 8,877,252

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), Costantino; Henry R. (Woodinville, WA)
Assignee: Alkermes Pharma Ireland Limited (Dublin, IE)
Filing Date:Nov 22, 2013
Application Number:14/087,132
Claims:1. A method of preparing a composition for the sustained release of a glucoregulatory peptide comprising the steps of: a) forming a mixture by combining: an aqueous phase comprising a sugar and a water-soluble glucoregulatory peptide, with an oil phase comprising a biocompatible polymer and a solvent for the biocompatible polymer; b) forming a water-in-oil emulsion of the mixture from step a), wherein the inner emulsion droplet size is less than about 0.5 microns; c) adding a coacervation agent to the mixture to form embryonic microparticles, wherein the coacervation agent is silicone oil added in an amount sufficient to achieve a silicone oil to polymer solvent ratio of from about 0.75:1 to about 2:1; d) transferring the embryonic microparticles to a quench solvent to harden the microparticles; e) collecting the hardened microparticles; and f) drying the hardened microparticles, wherein the glucoregulatory peptide is present in the composition at a concentration of about 0.01% to about 10% w/w based on the total weight of the composition, and the sugar is present in the composition at a concentration of about 0.01% to about 5% w/w based on the total weight of the composition.

2. The method of claim 1, wherein water-in-oil emulsion of step b) is formed by homogenization.

3. The method of claim 1, wherein the inner emulsion droplet size is less than or equal to about 0.4 microns.

4. The method of claim 3, wherein the inner emulsion droplet size is from about 0.2 to about 0.4 microns.

5. The method of claim 1, wherein the glucoregulatory peptide is selected from GLP-1, GLP-2, exendin-3, exendin-4, and combinations thereof.

6. The method of claim 1, wherein the sugar is selected from sucrose, mannitol, and combinations thereof.

7. The method of claim 1, wherein the biocompatible polymer is selected from the group consisting of poly(lactides), poly(glycolides), poly(lactide-co-glycolides), poly(lactic acid)s, poly(glycolic acid)s, poly(lactic acid-co-glycolic acid)s and blends and copolymers thereof.

8. The method of claim 1, wherein the biocompatible polymer is present in the oil phase at about 10% w/v or less.

9. The method of claim 1, wherein in step c), the silicone oil is added in an amount sufficient to achieve a silicone oil to polymer solvent ratio of from about 1:1 to about 1.5:1.

10. The method of claim 9, wherein the ratio of silicone oil to polymer solvent is about 0.5:1.

11. The method of claim 1, wherein the solvent biocompatible polymer is methylene chloride.

12. The method of claim 1, wherein the quench solvent is a heptane/ethanol solvent mixture.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc