WO2007135117A3 - Soluble, stable insulin-containing formulations - Google Patents

Soluble, stable insulin-containing formulations Download PDF

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Publication number
WO2007135117A3
WO2007135117A3 PCT/EP2007/054862 EP2007054862W WO2007135117A3 WO 2007135117 A3 WO2007135117 A3 WO 2007135117A3 EP 2007054862 W EP2007054862 W EP 2007054862W WO 2007135117 A3 WO2007135117 A3 WO 2007135117A3
Authority
WO
WIPO (PCT)
Prior art keywords
insulin
formulations
containing formulations
soluble
salt
Prior art date
Application number
PCT/EP2007/054862
Other languages
French (fr)
Other versions
WO2007135117A2 (en
Inventor
Helle Birk Olsen
Niels Christian Kaarsholm
Palle Jakobsen
Per Balschmidt
Original Assignee
Novo Nordisk As
Helle Birk Olsen
Niels Christian Kaarsholm
Palle Jakobsen
Per Balschmidt
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 Novo Nordisk As, Helle Birk Olsen, Niels Christian Kaarsholm, Palle Jakobsen, Per Balschmidt filed Critical Novo Nordisk As
Publication of WO2007135117A2 publication Critical patent/WO2007135117A2/en
Publication of WO2007135117A3 publication Critical patent/WO2007135117A3/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
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • 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

The present invention relates to pharmaceutical formulations comprising insulin, an insulin analog, an insulin derivative, or a combination of any of the foregoing, and a salt of positively charged peptides, to methods of preparing such formulations, and to uses of such formulations in the treatment of diseases and conditions for which use of the insulin peptide(s) contained in such formulations is indicated. The present invention further relates to methods for increasing the stability and/or solubility of insulin in insulin-containing formulations at a pH less than 7.0 by adding a salt of salt of positively charged peptides to the insulin-containing formulations.
PCT/EP2007/054862 2006-05-24 2007-05-21 Soluble, stable insulin-containing formulations WO2007135117A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP06114514 2006-05-24
EP06114514.0 2006-05-24

Publications (2)

Publication Number Publication Date
WO2007135117A2 WO2007135117A2 (en) 2007-11-29
WO2007135117A3 true WO2007135117A3 (en) 2008-03-20

Family

ID=36936965

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/054862 WO2007135117A2 (en) 2006-05-24 2007-05-21 Soluble, stable insulin-containing formulations

Country Status (1)

Country Link
WO (1) WO2007135117A2 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1969004B1 (en) 2005-12-28 2011-08-10 Novo Nordisk A/S Compositions comprising an acylated insulin and zinc and method of making the said compositions
ES2744384T3 (en) 2007-06-13 2020-02-24 Novo Nordisk As Pharmaceutical formulation comprising an insulin derivative
RU2540922C2 (en) * 2008-10-30 2015-02-10 Ново Нордиск А/С Treating diabetes mellitus by insulin injections as little as once day
EP2585485A1 (en) * 2010-06-23 2013-05-01 Novo Nordisk A/S Insulin derivatives containing additional disulfide bonds
CN102933599A (en) 2010-06-23 2013-02-13 诺沃—诺迪斯克有限公司 Human insulin containing additional disulfide bonds
EP2585484A1 (en) 2010-06-23 2013-05-01 Novo Nordisk A/S Insulin analogues containing additional disulfide bonds
JP6049625B2 (en) 2010-10-27 2016-12-21 ノヴォ ノルディスク アー／エス Treatment of diabetes mellitus using insulin injections given at various injection intervals
EP2991672A1 (en) 2013-04-30 2016-03-09 Novo Nordisk A/S Novel administration regime
US10335464B1 (en) 2018-06-26 2019-07-02 Novo Nordisk A/S Device for titrating basal insulin

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0884053A1 (en) * 1997-06-13 1998-12-16 Eli Lilly And Company Stable insulin formulations
US6624141B1 (en) * 1999-03-17 2003-09-23 The Regents Of The University Of Michigan Protamine fragment compositions and methods of use
WO2003105888A1 (en) * 2002-06-18 2003-12-24 Aventis Pharma Deutschland Gmbh Acidic insulin preparations with improved stability
US20050176621A1 (en) * 2001-12-19 2005-08-11 Brader Mark L. Crystalline compositions for controlling blood glucose
WO2006053906A1 (en) * 2004-11-22 2006-05-26 Novo Nordisk A/S Soluble, stable insulin-containing formulations with a protamine salt

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0884053A1 (en) * 1997-06-13 1998-12-16 Eli Lilly And Company Stable insulin formulations
US6624141B1 (en) * 1999-03-17 2003-09-23 The Regents Of The University Of Michigan Protamine fragment compositions and methods of use
US20050176621A1 (en) * 2001-12-19 2005-08-11 Brader Mark L. Crystalline compositions for controlling blood glucose
WO2003105888A1 (en) * 2002-06-18 2003-12-24 Aventis Pharma Deutschland Gmbh Acidic insulin preparations with improved stability
WO2006053906A1 (en) * 2004-11-22 2006-05-26 Novo Nordisk A/S Soluble, stable insulin-containing formulations with a protamine salt

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
HVASS A ET AL: "Determination of protamine peptides in insulin drug products using reversed phase high performance liquid chromatography", JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, NEW YORK, NY, US, vol. 37, no. 3, 9 March 2005 (2005-03-09), pages 551 - 557, XP004766222, ISSN: 0731-7085 *
LIANG ET AL: "The minimal functional sequence of protamine", BIOCHEMICAL AND BIOPHYSICAL RESEARCH COMMUNICATIONS, ACADEMIC PRESS INC. ORLANDO, FL, US, vol. 336, no. 2, 21 October 2005 (2005-10-21), pages 653 - 659, XP005165760, ISSN: 0006-291X *
LIANG J F ET AL: "A less toxic heparin antagonist: Low molecular weight protamine.", BIOCHEMISTRY (MOSCOW), vol. 68, no. 1, January 2003 (2003-01-01), pages 116 - 120, XP009073353, ISSN: 0006-2979 *

Also Published As

Publication number Publication date
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