US20060160739A1 - GRF-containing lyophilized pharmaceutical compositions - Google Patents

GRF-containing lyophilized pharmaceutical compositions Download PDF

Info

Publication number
US20060160739A1
US20060160739A1 US11/364,079 US36407906A US2006160739A1 US 20060160739 A1 US20060160739 A1 US 20060160739A1 US 36407906 A US36407906 A US 36407906A US 2006160739 A1 US2006160739 A1 US 2006160739A1
Authority
US
United States
Prior art keywords
pharmaceutical composition
composition according
hgrf
saccharose
vial
Prior art date
Legal status (The legal status 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 status listed.)
Abandoned
Application number
US11/364,079
Other languages
English (en)
Inventor
Fabrizio Samaritani
Alessandra Del Rio
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Serono SA
Original Assignee
Applied Research Systems ARS Holding NV
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 Applied Research Systems ARS Holding NV filed Critical Applied Research Systems ARS Holding NV
Priority to US11/364,079 priority Critical patent/US20060160739A1/en
Publication of US20060160739A1 publication Critical patent/US20060160739A1/en
Priority to US11/744,073 priority patent/US8431534B2/en
Assigned to LABORATOIRES SERONO SA reassignment LABORATOIRES SERONO SA ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: APPLIED RESEARCH SYSTEMS ARS HOLDING N.V.
Abandoned legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7012—Compounds having a free or esterified carboxyl group attached, directly or through a carbon chain, to a carbon atom of the saccharide radical, e.g. glucuronic acid, neuraminic acid
    • 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
    • A61K38/25—Growth hormone-releasing factor [GH-RF] (Somatoliberin)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
US11/364,079 1999-06-30 2006-03-01 GRF-containing lyophilized pharmaceutical compositions Abandoned US20060160739A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US11/364,079 US20060160739A1 (en) 1999-06-30 2006-03-01 GRF-containing lyophilized pharmaceutical compositions
US11/744,073 US8431534B2 (en) 1999-06-30 2007-05-03 GRF-containing lyophilized pharmaceutical compositions

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP99112421A EP1064934A1 (en) 1999-06-30 1999-06-30 GRF-containing lyophilized pharmaceutical composition
EP99112421.5 1999-06-30
PCT/EP2000/006061 WO2001001965A1 (en) 1999-06-30 2000-06-29 Grf-containing lyophilized pharmaceutical compositions
US938002A 2002-04-01 2002-04-01
US11/364,079 US20060160739A1 (en) 1999-06-30 2006-03-01 GRF-containing lyophilized pharmaceutical compositions

Related Parent Applications (3)

Application Number Title Priority Date Filing Date
PCT/EP2000/006061 Continuation WO2001001965A1 (en) 1999-06-30 2000-06-29 Grf-containing lyophilized pharmaceutical compositions
US10009380 Continuation 2000-06-29
US938002A Continuation 1999-06-30 2002-04-01

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/744,073 Continuation US8431534B2 (en) 1999-06-30 2007-05-03 GRF-containing lyophilized pharmaceutical compositions

Publications (1)

Publication Number Publication Date
US20060160739A1 true US20060160739A1 (en) 2006-07-20

Family

ID=8238452

Family Applications (2)

Application Number Title Priority Date Filing Date
US11/364,079 Abandoned US20060160739A1 (en) 1999-06-30 2006-03-01 GRF-containing lyophilized pharmaceutical compositions
US11/744,073 Expired - Fee Related US8431534B2 (en) 1999-06-30 2007-05-03 GRF-containing lyophilized pharmaceutical compositions

Family Applications After (1)

Application Number Title Priority Date Filing Date
US11/744,073 Expired - Fee Related US8431534B2 (en) 1999-06-30 2007-05-03 GRF-containing lyophilized pharmaceutical compositions

Country Status (14)

Country Link
US (2) US20060160739A1 (da)
EP (2) EP1064934A1 (da)
JP (1) JP4880845B2 (da)
AR (1) AR024613A1 (da)
AT (1) ATE249207T1 (da)
AU (1) AU778208C (da)
CA (1) CA2374933C (da)
DE (1) DE60005188T2 (da)
DK (1) DK1189600T3 (da)
ES (1) ES2204661T3 (da)
IL (2) IL147413A0 (da)
PT (1) PT1189600E (da)
SI (1) SI1189600T1 (da)
WO (1) WO2001001965A1 (da)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080249017A1 (en) * 2007-04-04 2008-10-09 Theratechnologies Inc. Pharmaceutical formulations of ghrh molecules
US20090023646A1 (en) * 2002-09-18 2009-01-22 Centre Hospitalier De L'universite De Montreal (Chum) GHRH analogues
US20100222607A1 (en) * 2007-09-07 2010-09-02 The Nisshin Oillio Group, Ltd. Fractionation method of 1,3-disaturated-2-unsaturated triglyceride

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1301200A2 (en) * 2000-05-19 2003-04-16 Bionebraska, Inc. Peptide pharmaceutical formulations

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4963529A (en) * 1984-12-24 1990-10-16 Sumitomo Pharmaceuticals Company, Limited Stable growth hormone releasing factor preparation
US5017557A (en) * 1987-07-24 1991-05-21 Industria Farmaceutica Serono S.P.A. Treatment of infertility with somatotrophin releasing factor
US5385738A (en) * 1983-10-14 1995-01-31 Sumitomo Pharmaceuticals Company, Ltd. Sustained-release injection
US5863549A (en) * 1992-10-14 1999-01-26 Hoffmann-La Roche Inc. Methods for the sustained release of biologically active compounds
US6284282B1 (en) * 1998-04-29 2001-09-04 Genentech, Inc. Method of spray freeze drying proteins for pharmaceutical administration

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5822445B2 (ja) * 1982-07-08 1983-05-09 株式会社 ミドリ十字 安定な固体の人血漿コリンエステラ−ゼ製剤の製法
JPH0725696B2 (ja) * 1986-05-29 1995-03-22 株式会社ミドリ十字 プラスミノ−ゲンの安定化方法
US4880777A (en) * 1987-09-01 1989-11-14 Eastman Kodak Company Synthetic peptides having growth hormone releasing activity
WO1990011070A1 (en) * 1989-03-17 1990-10-04 Pitman-Moore, Inc. Controlled release delivery device for macromolecular proteins
JPH0383931A (ja) * 1989-08-29 1991-04-09 Sumitomo Pharmaceut Co Ltd 低刺激性ｇｒｆ経鼻投与製剤
US5132401A (en) * 1989-09-19 1992-07-21 George Washington University, Office Of Sponsored Research MB-35 a peptide enhancing the production of growth hormone and prolactin from the anterior pituitary
JPH04264020A (ja) * 1991-02-18 1992-09-18 Yamanouchi Pharmaceut Co Ltd 安定な凍結乾燥製剤
EP0580778B1 (en) * 1991-04-19 1999-08-11 LDS Technologies, Inc. Convertible microemulsion formulations
JP3140797B2 (ja) * 1991-04-26 2001-03-05 生化学工業株式会社 安定化コンドロイチナーゼａｂｃ、その保存方法及び治療剤
YU87892A (sh) * 1991-10-01 1995-12-04 Eli Lilly And Company Lilly Corporate Center Injektibilne formulacije produženog otpuštanja i postupci za njihovo dobijanje i primenu
JP3083931B2 (ja) 1993-02-24 2000-09-04 大阪瓦斯株式会社 吸収式冷凍機の故障診断システム
IS1796B (is) 1993-06-24 2001-12-31 Ab Astra Fjölpeptíð lyfjablanda til innöndunar sem einnig inniheldur eykjaefnasamband
DE69420872T2 (de) 1994-06-17 2000-01-13 Applied Research Systems Hgh enthaltende pharmazeutische zubereitungen
US6524557B1 (en) * 1994-12-22 2003-02-25 Astrazeneca Ab Aerosol formulations of peptides and proteins
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2226575C (en) * 1995-07-27 2011-10-18 Genentech, Inc. Stabile isotonic lyophilized protein formulation
EP0880969A1 (en) * 1997-05-28 1998-12-02 Applied Research Systems ARS Holdings N.V. Pharmaceutical compositions of peptides having low solubility in physiological medium
US6759393B1 (en) * 1999-04-12 2004-07-06 Pfizer Inc. Growth hormone and growth hormone releasing hormone compositions
JP4330280B2 (ja) 2001-01-12 2009-09-16 株式会社小松製作所 エンジンの燃料噴射制御方法及びその制御装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5385738A (en) * 1983-10-14 1995-01-31 Sumitomo Pharmaceuticals Company, Ltd. Sustained-release injection
US4963529A (en) * 1984-12-24 1990-10-16 Sumitomo Pharmaceuticals Company, Limited Stable growth hormone releasing factor preparation
US5017557A (en) * 1987-07-24 1991-05-21 Industria Farmaceutica Serono S.P.A. Treatment of infertility with somatotrophin releasing factor
US5863549A (en) * 1992-10-14 1999-01-26 Hoffmann-La Roche Inc. Methods for the sustained release of biologically active compounds
US6284282B1 (en) * 1998-04-29 2001-09-04 Genentech, Inc. Method of spray freeze drying proteins for pharmaceutical administration

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090023646A1 (en) * 2002-09-18 2009-01-22 Centre Hospitalier De L'universite De Montreal (Chum) GHRH analogues
US20080249017A1 (en) * 2007-04-04 2008-10-09 Theratechnologies Inc. Pharmaceutical formulations of ghrh molecules
US20100222607A1 (en) * 2007-09-07 2010-09-02 The Nisshin Oillio Group, Ltd. Fractionation method of 1,3-disaturated-2-unsaturated triglyceride

Also Published As

Publication number Publication date
CA2374933C (en) 2010-10-12
AU6266300A (en) 2001-01-22
DE60005188T2 (de) 2004-04-01
DK1189600T3 (da) 2004-01-26
AR024613A1 (es) 2002-10-16
JP2003503443A (ja) 2003-01-28
US20070203069A1 (en) 2007-08-30
WO2001001965A1 (en) 2001-01-11
IL147413A (en) 2006-10-31
AU778208B2 (en) 2004-11-25
ATE249207T1 (de) 2003-09-15
IL147413A0 (en) 2002-08-14
PT1189600E (pt) 2003-12-31
EP1189600B1 (en) 2003-09-10
DE60005188D1 (de) 2003-10-16
CA2374933A1 (en) 2001-01-11
EP1189600A1 (en) 2002-03-27
JP4880845B2 (ja) 2012-02-22
AU778208C (en) 2006-03-09
ES2204661T3 (es) 2004-05-01
US8431534B2 (en) 2013-04-30
SI1189600T1 (en) 2003-12-31
EP1064934A1 (en) 2001-01-03

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Legal Events

Date Code Title Description
STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION

AS Assignment

Owner name: LABORATOIRES SERONO SA, SWITZERLAND

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:APPLIED RESEARCH SYSTEMS ARS HOLDING N.V.;REEL/FRAME:019966/0026

Effective date: 20070827

Owner name: LABORATOIRES SERONO SA,SWITZERLAND

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:APPLIED RESEARCH SYSTEMS ARS HOLDING N.V.;REEL/FRAME:019966/0026

Effective date: 20070827

XAS Not any more in us assignment database

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:APPLIED RESEARCH SYSTEMS ARS HOLDING N.V.;REEL/FRAME:019808/0379