Method of manufacturing an implantable device

• US 8,475,820 B2
• Filed: 07/27/2010
• Issued: 07/02/2013
• Est. Priority Date: 06/25/2008
• Status: Active Grant

• Current Assignee: Endo Pharmaceuticals Solutions Incorporated (Endo International PLC)
• Original Assignee: Endo Pharmaceuticals Solutions Incorporated (Endo International PLC)
• Inventors: Kuzma, Petr, Decker, Stefanie, Quandt, Harry
• Primary Examiner(s): Chandra, Gyan
• Application Number:
  US12/844,357
• Publication Number:
  US 20100292144A1
• Time in Patent Office: 1,071 Days
• Field of Search: None
• US Class Current: 424/422
• CPC Class Codes: A61K 38/26 Glucagons
• CPC Class Codes: A61K 47/22 Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/40 Cyclodextrins; Derivatives thereof
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/0092 Hollow drug-filled fibres, tubes of the core-shell type, coated fibres, coated rods, microtubules or nanotubes
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/08 for decreasing, blocking or antagonising the activity of the anterior pituitary hormones
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

Described herein are implantable devices, formulations and methods of making implantable devices for the release of a polypeptide from an implantable device, and methods of use thereof.

Claims

1. A method of manufacturing an implantable device comprising:

mixing one or more polymerizable monomeric substances and a release agent to form a mixture, wherein the release agent has a molecular weight ranging from about 1000 Daltons to about 2000 Daltons;

placing said mixture in a mold, and polymerizing the polymerizable monomeric substances to form the implantable device.

2. The method of claim 1, wherein the one or more polymerizable monomeric substances comprises one or more compounds selected from the goup consisting of:

2-hydroxyethyl methacrylate, ethyleneglycol dimethacrylate, and trimethylolpropane trimethacrylate.

3. The method of claim 1, wherein the release agent comprises polyoxyethylene (23) lauryl ether, polyoxyetheylene(20)sorbitan trioleate, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, or D-α

-tocopheryl polyethylene glycol 1000 succinate (Vitamin E TPGS).

4. The method of claim 1, wherein the mixture further comprises one or more components selected from the group consisting of:

benzoin methyl ether, di(4-tert-butylcyclohexyl) peroxydicarbonate, and isopropyl alcohol.

5. The method of claim 1 further comprising removing the implantable device from the mold after the polymerizing.

6. The method of claim 1, wherein the polymerizing comprises initiating by ultraviolet irradiation.

7. The method of claim 1 further comprising charging the implantable device with a desired amount of a therapeutic polypeptide agent.

8. The method of claim 7, wherein the therapeutic polypeptide agent is combined with a wetting agent to form a solid formulation prior to being charged into the implantable device.