Search Images Maps Play YouTube News Gmail Drive More »
Advanced Patent Search | Web History | Sign in

Patents

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.

Inventors: Petr Kuzma, Stefanie Decker
Original Assignee: Endo Pharmaceuticals Solutions Inc.
Primary Examiner: Christina Bradley
Attorneys: Gilberto M. Villacorta, Jeffrey R. Lomprey, Foley & Lardner LLP
Current U.S. Classification: 514/19.9; 424/422; 424/461; 424/462

View patent at USPTO
Search USPTO Assignment Database

Citations

Cited PatentFiling dateIssue dateOriginal AssigneeTitle
US4131604Nov 23, 1977Dec 26, 1978Thermo Electron CorporationPolyurethane elastomer for heart assist devices
US4285987Nov 1, 1979Aug 25, 1981Alza CorporationProcess for manufacturing device with dispersion zone
US4386039Feb 27, 1981May 31, 1983Thermo Electron CorporationProcess for forming an optically clear polyurethane lens or cornea
US4523005Apr 17, 1984Jun 11, 1985Thermedics, Inc.Extrudable polyurethane for prosthetic devices prepared from a diisocyanate, a polytetramethylene ether polyol, and 1,4-butane diol
US4743673Dec 19, 1986May 10, 1988Tyndale Plains-Hunter, Ltd.Hydrophilic carboxy polyurethanes
US4751133May 11, 1987Jun 14, 1988Thermedics, Inc.Medical patches and processes for producing same
US4954587May 23, 1989Sep 4, 1990Ciba-Geigy CorporationDimethylacrylamide-copolymer hydrogels with high oxygen permeability
US4959217May 22, 1986Sep 25, 1990Syntex (U.S.A.) Inc.Delayed/sustained release of macromolecules
US5254662May 18, 1992Oct 19, 1993PolyMedia Industries, Inc.Biostable polyurethane products
US5266325Dec 3, 1990Nov 30, 1993Hydro Med Science Division of National Patent Development Corp.Preparation of homogeneous hydrogel copolymers
US5273752Sep 19, 1991Dec 28, 1993Alza CorporationControlled release dispenser comprising beneficial agent
US5292515Mar 31, 1993Mar 8, 1994Hydro Med Sciences, a Division of National Patent Development CorporationManufacture of water-swellable hydrophilic articles and drug delivery devices
US5342622Oct 31, 1990Aug 30, 1994The State of Victoria
Victorian College of Pharmacy Ltd.
Monash Medical Centre		Subdermal biocompatible implants
US5354835Jul 23, 1993Oct 11, 1994Saudi Basic Industries CorporationDesalination process
US5431921Mar 12, 1993Jul 11, 1995Pfizer IncDispensing device containing a hydrophobic medium
US5464933Jun 7, 1993Nov 7, 1995Duke UniversitySynthetic peptide inhibitors of HIV transmission
US5468811Aug 24, 1994Nov 21, 1995National Patent Development CorporationHydrophilic composite polymer articles formed from a settable paste comprising a mixture of hydrophilic polymer and unsaturated monomer
US5614223Jul 17, 1995Mar 25, 1997Digestive Care Inc.Intraoral medicament-releasing device
US5637309Sep 20, 1994Jun 10, 1997Shiseido Company, Ltd.Physiologically active substance-prolonged releasing-type pharmaceutical preparation
US5686411May 23, 1995Nov 11, 1997Amylin Pharmaceuticals, Inc.Amylin agonist peptides and uses therefor
US5756127Oct 29, 1996May 26, 1998Wright Medical Technology, Inc.Implantable bioresorbable string of calcium sulfate beads
US5817343May 14, 1996Oct 6, 1998Alkermes, Inc.Method for fabricating polymer-based controlled-release devices
US5854127Mar 13, 1997Dec 29, 1998Micron Technology, Inc.Method of forming a contact landing pad
US5876761Jun 6, 1995Mar 2, 1999Novartis AGSustained release formulations of water soluble peptides
US5894458Sep 12, 1996Apr 13, 1999Nippon Chemi-Con CorporationApparatus for supporting and connecting a magnetic field modulation head to be used for a photomagnetic recording including a spring plate member having a conductive part electrically connecting the head to a supporting frame
US6087334Aug 21, 1998Jul 11, 2000Amylin Pharmaceuticals, Inc.Anti-diabetic peptides
US6143718Jun 7, 1995Nov 7, 2000Amylin Pharmaceuticals, Inc.Treatment of Type II diabetes mellutis with amylin agonists
US6159490Apr 5, 2000Dec 12, 2000Implants containing bioactive peptides
US6313254May 17, 1999Nov 6, 2001Cardiac CRC Nominees PTY LTDPolysiloxane-containing polyurethane elastomeric compositions
US6337318Feb 19, 1999Jan 8, 2002Peptech, Ltd.Sustained GnRH peptide-release formulation
US6361797Dec 7, 2000Mar 26, 2002Hydro Med Sciences, Inc.Hydrogel compositions useful for the sustained release of macromolecules and methods of making same
US6417164Nov 6, 2000Jul 9, 2002Amylin Pharmaceuticals, Inc.Treatment of type II diabetes mellitus with amylin agonists
US6579851Mar 14, 2001Jun 17, 2003Amylin Pharmaceuticals, Inc.Effects of glucagon-like peptide-1 (7-36) on antro-pyloro-duodenal motility
US6602694Jun 27, 2001Aug 5, 2003Amylin Pharmaceuticals, IncUncoupling protein 4 (UCP-4)
US6770623May 31, 2000Aug 3, 2004Eli Lilly and CompanyStabilized teriparatide solutions
US6872700Jan 14, 2000Mar 29, 2005Amylin Pharmaceuticals, Inc.Methods for glucagon suppression
US6942264Feb 10, 2003Sep 13, 2005Disposable pet waste receptacle
US6969480Feb 13, 2003Nov 29, 2005matRegen Corp.Method of producing structures using centrifugal forces
US7008927May 29, 2001Mar 7, 2006Kaken Pharmaceutical Co., Ltd.Pralmorelin-containing nasal drop preparations
US7056887Dec 18, 2002Jun 6, 2006Amylin Pharmaceuticals, Inc.Treatment of acute coronary syndrome with GLP-1
US7101853May 6, 1997Sep 5, 2006Amylin Pharmaceuticals, Inc.Method for treating or preventing gastritis using amylin or amylin agonists
US7105489Dec 11, 2002Sep 12, 2006Amylin Pharmaceuticals, Inc.Methods and compositions for treating polycystic ovary syndrome
US7115569Oct 15, 2004Oct 3, 2006Amylin Pharmaceuticals, Inc.Exendins, exendin agonists, and methods for their use
US7118737Jul 12, 2001Oct 10, 2006Amylin Pharmaceuticals, Inc.Polymer-modified synthetic proteins
US7153825Mar 18, 2005Dec 26, 2006Amylin Pharmaceuticals, Inc.Methods for glucagon suppression using modified exendins
US7220721Nov 13, 1998May 22, 2007Amylin Pharmaceuticals, Inc.Exendin agonist peptides
US7259136Mar 5, 2002Aug 21, 2007Amylin Pharmaceuticals, Inc.Compositions and methods for treating peripheral vascular disease
US7271238Aug 26, 2003Sep 18, 2007Amylin Pharmaceuticals, Inc.Amylin agonist peptides and uses therefor
US7452868Mar 10, 2006Nov 18, 2008Indevus Pharmaceuticals, Inc.Controlled release formulations of octreotide
US20020141985Dec 14, 2001Amylin Parmaceuticals, Inc.Peptide YY and peptide YY agonists for treatment of metabolic disorders
US20030036504Jan 9, 2001Amylin Pharmaceuticals, Inc.Use of exendins and agonists thereof for modulation of triglyceride levels and treatment of dyslipidemia
US20040002454Dec 18, 2002Amylin Pharmaceuticals, Inc.Treatment of acute coronary syndrome with GLP-1
US20050037078Aug 10, 2004Valera PharmaceuticalsLong term drug delivery devices with polyurethane based polymers and their manufacture
US20050287320Aug 18, 2005matRegen Corp.Method of producing structures using centrifugal forces
US20060019903Jun 17, 2005Compositions and methods for treating precocious puberty
US20060030528Aug 5, 2005Amylin Pharmaceuticals, Inc.Compositions and methods for treating peripheral vascular disease
US20060035836Oct 20, 2005Amylin Pharmaceuticals, Inc.Treatment of acute coronary syndrome with an exendin
US20060067911Apr 22, 2005MEDERIO AGMetered medication dose
US20060122106Jun 13, 2003Prevention and/or treatment of inflammatory bowel disease using pyy or agonists thereof
US20060148713Mar 3, 2006Amylin Pharmaceuticals, Inc.Use of exendins and agonists thereof for the reduction of food intake
US20060204540Mar 10, 2006Controlled release formulations of octreotide
US20060233747Jun 5, 2006Amylin Pharmaceuticals, Inc.Polymer-modified synthetic proteins
US20060293232Aug 17, 2005Amylin Pharmaceuticals, Inc.Hybrid polypeptides with selectable properties
US20070010656Aug 28, 2006Amylin Pharmaceuticals, Inc.Novel exendin agonist compounds
US20080311170Apr 25, 2008IMPLANT DEVICE RELEASE AGENTS AND METHODS OF USING SAME
US20090035343Jul 11, 2008DELIVERY OF DRY FORMULATIONS OF OCTREOTIDE

Claims

1. A method of treating a patient suffering from one or more symptoms associated with carcinoid tumors, said method comprising:

implanting subcutaneously into a patient in need thereof at least one implant comprising a hydrogel and a pharmaceutical formulation comprising octreotide;

wherein said pharmaceutical formulation is contained within said hydrogel, which hydrogel comprises a copolymer obtained from the copolymerization of a mixture comprising at least two hydrophilic, ethylenically unsaturated monomers;

wherein said pharmaceutical formulation contains between about 20 to about 150 milligrams of octreotide, in free form or salt form;

wherein said pharmaceutical formulation further comprises hydroxypropylcellulose; and
wherein said at least one implant releases a therapeutically effective amount of said octreotide to said patient over a period of at least about two months.

2. The method of claim 1, wherein said effective amount of said octreotide provides an in vivo average Css in said patient of about 0.1 ng/ml to about 9 ng/ml of octreotide.

3. The method of claim 1, wherein said pharmaceutical formulation contains from about 40 to about 90 milligrams of octreotide.

4. The method of claim 1, wherein said octreotide is octreotide acetate.

5. The method of claim 4, wherein said pharmaceutical formulation contains about 50 milligrams of said octreotide acetate.

6. The method of claim 4, wherein said pharmaceutical formulation contains about 80 milligrams of said octreotide acetate.

7. The method of claim 2, wherein said effective amount of said octreotide provides an in vivo average Css in said patient of about 1 ng/ml to about 2 ng/ml of octreotide.

8. The method of claim 1, wherein said at least one implant releases a therapeutically effective amount of octreotide over a period of about two months to about two years.

9. The method of claim 1, wherein said at least one implant releases a therapeutically effective amount of said octreotide over about six months.

10. The method of claim 1, wherein said at least two hydrophilic, ethylenically unsaturated monomers are 2-hydroxyethyl methacrylate and hydroxypropyl methacrylate.

11. The method of claim 1, wherein said copolymer comprises about 20% of 2-hydroxyethyl methacrylate and about 80% hydroxypropylmethacrylate.

12. The method of claim 1, wherein the pharmaceutical formulation contains about 0.5 to 20% w/w of the hydroxypropylcellulose.

13. The method of claim 1, wherein said pharmaceutical formulation further comprises magnesium stearate.

14. The method of claim 13, wherein the pharmaceutical formulation contains about 0.5 to 5% w/w of the magnesium stearate.

15. The method of claim 1, wherein said at least one implant releases said octreotide at a rate of about 10 ug to about 1000 ug per day over a period of about six months.

16. The method of claim 1, wherein said at least one implant is two or more implants.

17. The method of claim 1, wherein said at least one implant releases said octreotide at a rate of about 30 μg to about 250 μg per day in vitro.

18. The method of claim 1, wherein the at least one implant is implanted in a dry state.

19. The method of claim 1, wherein the at least one implant is implanted in a hydrated state.

20. The method of claim 1, wherein said copolymer comprises about 40% of 2-hydroxyethyl methacrylate and about 60% hydroxypropylmethacrylate.

Drawings