WO2011156476A3 - Insulin with a basal release profile - Google Patents

Insulin with a basal release profile Download PDF

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Publication number
WO2011156476A3
WO2011156476A3 PCT/US2011/039608 US2011039608W WO2011156476A3 WO 2011156476 A3 WO2011156476 A3 WO 2011156476A3 US 2011039608 W US2011039608 W US 2011039608W WO 2011156476 A3 WO2011156476 A3 WO 2011156476A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
injection
formulation
basal
subcutaneous
Prior art date
Application number
PCT/US2011/039608
Other languages
French (fr)
Other versions
WO2011156476A2 (en
Inventor
Roderike Pohl
Nandini Kashyap
Robert Hauser
Koray Ozhan
Solomon S. Steiner
Original Assignee
Biodel Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biodel Inc. filed Critical Biodel Inc.
Publication of WO2011156476A2 publication Critical patent/WO2011156476A2/en
Publication of WO2011156476A3 publication Critical patent/WO2011156476A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins

Abstract

A basal insulin formulation composed of insulin (preferably human recombinant insulin), buffering agents, precipitating agents, and/or stabilizing agents for subcutaneous, intradermal or intramuscular administration. In one embodiment, 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. In one embodiment, the insulin formulation is prepared as a suspension for subcutaneous or intramuscular injection at neutral pH (e.g. pH 7), containing human recombinant insulin, a zinc compound, preferably zinc chloride, and a pH buffering agent, preferably sodium acetate. The suspension contains precipitated insulin particles prior to injection and provides a sustained release basal insulin profile following injection.
PCT/US2011/039608 2010-06-08 2011-06-08 Insulin with a basal release profile WO2011156476A2 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US35271010P 2010-06-08 2010-06-08
US61/352,710 2010-06-08
US35509910P 2010-06-15 2010-06-15
US61/355,099 2010-06-15

Publications (2)

Publication Number Publication Date
WO2011156476A2 WO2011156476A2 (en) 2011-12-15
WO2011156476A3 true WO2011156476A3 (en) 2012-03-08

Family

ID=44534785

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/039608 WO2011156476A2 (en) 2010-06-08 2011-06-08 Insulin with a basal release profile

Country Status (1)

Country Link
WO (1) WO2011156476A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104994864B (en) * 2012-12-19 2018-05-29 沃克哈特有限公司 Include actrapid monotard or the stable aqueous composition of its analog or derivative
WO2017163159A1 (en) 2016-03-21 2017-09-28 Wockhardt Limited Biphasic pharmaceutical composition of insulin human

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003020201A2 (en) * 2001-08-28 2003-03-13 Eli Lilly And Company Pre-mixes of glp-1 and basal insulin
US20090082255A1 (en) * 2002-06-18 2009-03-26 Sanofi-Aventis Deutschland Gmbh Acidic Insulin Preparations Having Improved Stability
WO2009089181A1 (en) * 2008-01-04 2009-07-16 Blodel, Inc. Insulin formulations for insulin release as a function of tissue glucose levels
WO2010028055A1 (en) * 2008-09-02 2010-03-11 Biodel, Inc. Insulin with a basal release profile

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2882203A (en) 1951-06-26 1959-04-14 Novo Terapeutisk Labor As Injectable insulin preparation with protracted effect
US3102077A (en) 1953-08-19 1963-08-27 Christensen Henry Marinus Preparation of insulin containing 2.75 to 8 percent zinc content

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003020201A2 (en) * 2001-08-28 2003-03-13 Eli Lilly And Company Pre-mixes of glp-1 and basal insulin
US20090082255A1 (en) * 2002-06-18 2009-03-26 Sanofi-Aventis Deutschland Gmbh Acidic Insulin Preparations Having Improved Stability
WO2009089181A1 (en) * 2008-01-04 2009-07-16 Blodel, Inc. Insulin formulations for insulin release as a function of tissue glucose levels
WO2010028055A1 (en) * 2008-09-02 2010-03-11 Biodel, Inc. Insulin with a basal release profile

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
SANOFI-AVENTIS: "Lantus (Insulin glargine) Injection, Solution", December 2006 (2006-12-01), XP002658724, Retrieved from the Internet <URL:http://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=3517> [retrieved on 20110912] *

Also Published As

Publication number Publication date
WO2011156476A2 (en) 2011-12-15

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