Robert K Hauser

US Patent:

20100227795, Sep 9, 2010

Filed:

Mar 3, 2009

Appl. No.:

12/397219

Inventors:

Solomon S. Steiner - Mount Kisco NY, US
Ming Li - Yorktown Heights NY, US
Robert Hauser - Columbia MD, US

International Classification:

A61K 38/28
A61P 3/10

US Classification:

514 3

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 or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection. In the preferred embodiment, the insulin is provided as a clear liquid, neutral pH, in a multi-use sterile vial. In an alternative embodiment, the insulin is provided as a 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.

US Patent:

20110097386, Apr 28, 2011

Filed:

Mar 1, 2010

Appl. No.:

12/715203

Inventors:

Solomon S. Steiner - Mount Kisco NY, US
Robert Hauser - Columbia MD, US
Ming Li - Yorktown Heights NY, US
Robert Feldstein - Yonkers NY, US

International Classification:

A61K 38/26
A61K 9/127
A61P 3/08

US Classification:

424450, 514 117

Abstract:

A formulation composed of a sugar such as glucose and a surfactant such as myristoyl lysophosphocholine (LMPC) has been designed to stabilize both hydrophilic and hydrophobic portions of the glucagon molecule, under prolonged physiological conditions, in a formulation that is sufficiently similar to the pH and osmolarity of plasma so as not to induce or to minimize site irritation. The combination of a simple sugar and an surfactant stabilizes the glucagon molecule in an aqueous solution for seven days at 37 C.

US Patent:

20110237510, Sep 29, 2011

Filed:

Sep 27, 2010

Appl. No.:

12/891240

Inventors:

Solomon S. Steiner - Mount Kisco NY, US
Robert Hauser - Columbia MD, US
Ming Li - Yorktown Heights NY, US
Robert Feldstein - Yonkers NY, US

International Classification:

A61K 38/26
A61P 3/08
B65D 85/00

US Classification:

514 117, 2065241

Abstract:

A formulation composed of a sugar such as glucose and a surfactant such as myristoyl lysophosphocholine (LMPC) has been designed to stabilize both hydrophilic and hydrophobic portions of the glucagon molecule, under prolonged physiological conditions, in a formulation that is sufficiently similar to the pH and osmolarity of plasma so as not to induce or to minimize site irritation. The combination of a simple sugar and an surfactant stabilizes the glucagon molecule in an aqueous solution for seven days at 37 C.

US Patent:

20120178675, Jul 12, 2012

Filed:

Jul 5, 2011

Appl. No.:

13/176435

Inventors:

Solomon Steiner - Mount Kisco NY, US
Robert Hauser - Columbia MD, US
Richard Seibert - Carmel NY, US
Ming Li - Yorktown Heights NY, US

International Classification:

A61K 38/28
A61P 25/00
A61P 3/10

US Classification:

514 64

Abstract:

Compositions and methods for modulating the pharmacokinetics and pharmacodynamics of rapid acting injectable insulin formulations are described herein. In the preferred embodiment, the formulations are administered via subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid (“EDTA”) and a dissolution/stabilization agent, and optionally additional excipients. Calcium disodium EDTA is less likely to remove calcium from the body, and typically has less pain on injection in the subcutaneous tissue. Modulating the type and quantity of EDTA can change the insulin absorption profile. Increasing the quantity of citrate can further enhance absorption and chemically stabilize the formulation. In the preferred embodiment, the formulation contains human insulin, calcium disodium EDTA and a dissolution/stabilization agent such as citric acid or sodium citrate. These formulations are rapidly absorbed into the blood stream when administered by subcutaneous injection.

Author:

Robert Mason Hauser

ISBN #:

0123330505

Author:

Robert Mason Hauser

ISBN #:

0126378509

Author:

Robert Mason Hauser

ISBN #:

0309062802

Author:

Robert Mason Hauser

ISBN #:

0309062772

Author:

Robert Mason Hauser

ISBN #:

0309064899

Author:

Robert Hauser

ISBN #:

0123330602

Author:

Robert Hauser

ISBN #:

0788132881

Author:

Robert Hauser

ISBN #:

3719023087