Robert J Hauser

US Patent:

8637458, Jan 28, 2014

Filed:

May 12, 2010

Appl. No.:

12/778719

Inventors:

Nandini Kashyap - Danbury CT, US
Robert Hauser - Columbia MD, US
Koray Ozhan - Milford CT, US
Solomon S. Steiner - Mount Kisco NY, US

Assignee:

Biodel Inc. - Danbury CT

International Classification:

A61K 38/28
C07K 14/62

US Classification:

514 59

Abstract:

A basal insulin formulation composed of insulin, preferably insulin glargine, injectable zinc and injectable iron compounds as precipitating and/or stabilizing agents has been developed for subcutaneous, intradermal or intramuscular administration. The formulation is designed to form a precipitate of insulin following injection, creating a slow releasing “basal insulin” over a period of 12 to 24 hours.

US Patent:

20100069292, Mar 18, 2010

Filed:

Sep 2, 2009

Appl. No.:

12/552855

Inventors:

Nandini Kashyap - Danbury CT, US
Robert Hauser - Columbia MD, US
Koray Ozhan - Milford CT, US
Solomon S. Steiner - Mount Kisco NY, US

International Classification:

A61K 38/28

US Classification:

514 3

Abstract:

A clear basal insulin formulation composed of insulin (preferably human recombinant insulin), buffering agents, precipitating agents, and/or stabilizing agents for subcutaneous, intradermal or intramuscular administration. The formulation is designed to form a precipitate of insulin following injection, creating a slow releasing “basal insulin” over a period of 12 to 24 hours, which can be varied by compositional changes to tailor the release profile to the needs of the individual diabetic patient

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.

US Patent:

20170128542, May 11, 2017

Filed:

Nov 9, 2016

Appl. No.:

15/347169

Inventors:

- Boston MA, US
Roderike Pohl - Sherman CT, US
Robert Feldstein - Yonkers NY, US
Robert Hauser - Columbia MD, US
Errol De Souza - Cambridge MA, US

International Classification:

A61K 38/26
A61K 47/34
A61K 9/08
A61K 47/10
A61K 47/14
A61K 47/20

Abstract:

Stabilized glucagon formulations are provided, in the form of a clear solution. The formulations include glucagon in a non-aqueous diluent and an antioxidant The diluent and antioxidant are selected to provide a glucagon formulation with increased stability when compared to glucagon without the anti-oxidant and/or the diluent and which shows a comparable onset of action and duration of glucose response.The compositions can be used to treat subjects with very low blood sugar (severe hypoglycemia) that can happen in subjects who have diabetes and use insulin.

US Patent:

20150273022, Oct 1, 2015

Filed:

Feb 10, 2015

Appl. No.:

14/618619

Inventors:

- Danbury CT, US
Pragati Ravula - Ridgefield CT, US
Ming Li - Yorktown Heights NY, US
Roderike Pohl - Sherman CT, US
Robert Hauser - Columbia MD, US

International Classification:

A61K 38/28
A61K 47/18
A61K 33/06
A61K 47/02
A61K 47/22
A61K 9/00
A61K 47/12

Abstract:

Compositions and methods for enhancing the stability of rapid acting injectable insulin formulations have been developed for subcutaneous injection. The formulations contain insulin in combination with a zinc chelator such as ethylenediaminetetraacetic acid (“EDTA”), a dissolution/stabilization agent such as citric acid, a magnesium salt, a zinc compound and, optionally, additional excipients. New presentations include rapid acting concentrated insulin formulations and a way to enhance the absorption of commercially available rapid acting analog formulations while maintaining insulin stability.