Rapid Acting Injectable Insulin Compositions

a technology of insulin composition and injection, which is applied in the direction of peptide/protein ingredients, extracellular fluid disorder, metabolic disorder, etc., can solve the problems of interfering with the ability of proteins, abnormally high blood glucose level of patients with diabetes, and inadequate insulin levels, etc., to achieve rapid onset of action, improve stability, and rapid absorbed into the blood stream
US20080090753A1Inactive Publication Date: 2008-04-17BIODEL
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Patent Information

Authority / Receiving Office
US Ā· United States
Patent Type
Applications(United States)
Current Assignee / Owner
BIODEL
Publication Date
2008-04-17
Estimated Expiration
Not applicable Ā· inactive patent

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Abstract

Injectable insulin formulations with improved stability and rapid onset of action are described herein. The formulations may be for subcutaneous, intradermal or intramuscular administration, In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a chelator and dissolution agent, and optionally additional excipients. In the preferred embodiment, the formulation contains human insulin, a zinc chelator such as EDTA and a dissolution agent such as citric acid. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a dry powder in a sterile vial. This is mixed with a diluent containing a pharmaceutically acceptable carrier, such as water, a zinc chelator such as EDTA and a dissolution agent such as citric acid shortly before or at the time of administration. In another embodiment, the insulin is stored as a frozen mixture, ready for use upon thawing.
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Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation in part of U.S. Ser. No. 11 / 077,604 filed Mar. 11, 2005, which claims priority to U.S. Ser. No. 60 / 552,637, entitled ā€œSublingual Drug Delivery Compositionsā€ to Roderike Pohl and Solomon S. Steiner filed Mar. 12, 2004, and U.S. Ser. No. 60 / 609,194, entitled ā€œSublingual Drug Delivery Compositionsā€ to Roderike Pohl and Solomon S. Steiner filed Sep. 9, 2004.FIELD OF THE INVENTION

[0002] The invention is in the general field of injectable rapid acting drug delivery insulin formulations. BACKGROUND OF THE INVENTION

[0003] Diabetes Overview

[0004] Glucose is a simple sugar used by all the cells of the body to produce energy and support life. Humans need a minimum level of glucose in their blood at all times to stay alive. The primary manner in which the body produces blood glucose is through the digestion of food. When a person is not getting this glucose from food digestion, glucose is produced from stores i...

Claims

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