Claims for Patent: 7,033,998

Summary for Patent: 7,033,998

Title:	Alcohol-free transdermal insulin composition and processes for manufacture and use thereof
Abstract:	The instant invention discloses a dermal delivery system composition comprising an aqueous base vehicle including American Emu oil, Isopropyl Palmitate (PROTACHEM IPP), PEG-8 (a polyethylene glycol available under the trade name PROTACHEM 400), methylsulfonylmethane (MSM) and SEPIGEL 305 (a combination including polyacrylamide/C.sub.13 C.sub.14 Iso-paraffin and Laureth-7) in combination with a therapeutically affective amount of at least one species of insulin, and to processes for the manufacture and use thereof.
Inventor(s):	Fishman; Robert (Pembroke Pines, FL)
Assignee:	All Natural FMG, Inc. (North Palm Beach, FL)
Application Number:	10/412,637
Patent Claims:	1. An alcohol-free insulin composition effective for transdermal delivery consisting essentially of: about 3% Emu Oil, about 3% Isopropyl Palmitate, about 4% PEG-8, about 0.75% methylsulfonylmethane, and a gelling agent including a combination of about 40% polvacrylamide about 15% C.sub.13 C.sub.14 Iso-paraffin, about 5% Laureth-7 and sterile water sufficient to make 100% in an amount effective for gelling, a therapeutically effective amount of at least one species of insulin, and sterile water sufficient to make 100%. 2. A composition for treating diabetes in a patient comprising: about 3% Emu Oil, about 3% Isopropyl Palmitate, about 4% PEG-8, about 0.75% methylsulfonylmethane, and a gelling agent including a combination of about 40% polyacrylamide, about 15% C.sub.13 C.sub.14 Iso-paraffin, about 5% Laureth-7 and sterile water sufficient to make 100% in an amount effective for gelling, a therapeutically effective amount of at least one species of insulin, and sterile water sufficient to make 100%. 3. A process for manufacturing an alcohol-free insulin composition effective for transdermal delivery comprising: providing a therapeutically effective amount of at least one species of insulin; providing about 3% Emu oil in a high speed mixing apparatus; adding said insulin to said EMU oil and mixing until a homogeneously blended composition is formed; adding about 3% Isopropyl Palmitate and about 4% PEG-8 to said homogeneously blend, and mixing for approximately 30 minutes; adding sterile water and mixing for approximately 5 minutes, to homogeneity; adding about 3% of a gelling agent including a combination of about 40% polyacrylamide, about 15% C.sub.13 C.sub.14 Iso-paraffin, about 5% Laureth-7 and sterile water sufficient to make 100%, and blending to achieve homogeneity and a gel-like consistency; and adding additional said gelling agent in 1% increments, if necessary, until desired gel consistency is achieved. 4. The product produced by the process of claim 3.

Details for Patent 7,033,998

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-22