BRPI0311877B8 - formulação farmacêutica ácida de insulina com estabilidade aperfeiçoada - Google Patents
formulação farmacêutica ácida de insulina com estabilidade aperfeiçoadaInfo
- Publication number
- BRPI0311877B8 BRPI0311877B8 BRPI0311877A BR0311877A BRPI0311877B8 BR PI0311877 B8 BRPI0311877 B8 BR PI0311877B8 BR PI0311877 A BRPI0311877 A BR PI0311877A BR 0311877 A BR0311877 A BR 0311877A BR PI0311877 B8 BRPI0311877 B8 BR PI0311877B8
- Authority
- BR
- Brazil
- Prior art keywords
- insulin
- pharmaceutical formulation
- combinations
- improved stability
- acidic
- Prior art date
Links
Classifications
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- 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
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7032—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
- A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
- A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Emergency Medicine (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
"preparações ácidas de insulina com estabilidade aperfeiçoada". a invenção refere-se a uma formulação farmacêutica contendo um polipeptídio escolhido a partir de um grupo contendo insulina, um metabólito de insulina, um análogo de insulina, um derivado de insulina ou combinações destes; um tensoativo ou combinações de vários tensoativos; eventualmente um conservante ou combinações de vários conservantes; e eventualmente um agente isotônico, tampão ou outras substâncias auxiliares ou combinações das mesmas, sendo que a formulação farmacêutica apresenta um valor de ph na faixa ácida.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10227232A DE10227232A1 (de) | 2002-06-18 | 2002-06-18 | Saure Insulinzubereitungen mit verbesserter Stabilität |
PCT/EP2003/005887 WO2003105888A1 (de) | 2002-06-18 | 2003-06-05 | Saure insulinzubereitungen mit verbesserter stabilität |
Publications (3)
Publication Number | Publication Date |
---|---|
BR0311877A BR0311877A (pt) | 2005-04-05 |
BRPI0311877B1 BRPI0311877B1 (pt) | 2017-04-11 |
BRPI0311877B8 true BRPI0311877B8 (pt) | 2021-05-25 |
Family
ID=29723248
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0311877A BRPI0311877B8 (pt) | 2002-06-18 | 2003-06-05 | formulação farmacêutica ácida de insulina com estabilidade aperfeiçoada |
Country Status (38)
Country | Link |
---|---|
US (4) | US20040048783A1 (pt) |
EP (2) | EP1517697B1 (pt) |
JP (2) | JP5237522B2 (pt) |
KR (1) | KR101040029B1 (pt) |
CN (2) | CN102133393B (pt) |
AR (1) | AR039688A1 (pt) |
AU (1) | AU2003238471B2 (pt) |
BR (1) | BRPI0311877B8 (pt) |
CA (1) | CA2490116C (pt) |
CR (1) | CR7614A (pt) |
CY (1) | CY1113537T1 (pt) |
DE (1) | DE10227232A1 (pt) |
DK (1) | DK1517697T3 (pt) |
EC (1) | ECSP045496A (pt) |
ES (2) | ES2817879T3 (pt) |
HN (1) | HN2003000184A (pt) |
HR (1) | HRP20041200B1 (pt) |
IL (1) | IL165788A (pt) |
MA (1) | MA27205A1 (pt) |
ME (1) | ME00180B (pt) |
MX (1) | MXPA04012233A (pt) |
MY (1) | MY142354A (pt) |
NO (1) | NO328567B1 (pt) |
NZ (1) | NZ537211A (pt) |
OA (1) | OA12870A (pt) |
PA (1) | PA8575701A1 (pt) |
PE (1) | PE20040560A1 (pt) |
PL (1) | PL208773B1 (pt) |
PT (2) | PT2305288T (pt) |
RS (1) | RS52388B (pt) |
RU (1) | RU2313362C2 (pt) |
SV (1) | SV2004001556A (pt) |
TN (1) | TNSN04249A1 (pt) |
TW (1) | TWI315201B (pt) |
UA (1) | UA79477C2 (pt) |
UY (1) | UY27854A1 (pt) |
WO (1) | WO2003105888A1 (pt) |
ZA (1) | ZA200409273B (pt) |
Families Citing this family (81)
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DE10227232A1 (de) * | 2002-06-18 | 2004-01-15 | Aventis Pharma Deutschland Gmbh | Saure Insulinzubereitungen mit verbesserter Stabilität |
ES2398318T3 (es) * | 2004-03-12 | 2013-03-15 | Biodel, Inc. | Composiciones de suministro de fármacos de acción rápida |
WO2005115303A1 (en) * | 2004-05-24 | 2005-12-08 | Wockhardt Limited | Purification of insulin-like material by reverse phase chromatography |
UA75030C2 (en) * | 2005-11-30 | 2006-03-15 | Viktor Oleksandrovych Bykov | Method for obtaining stable aqueous solutions of drugs |
WO2007135117A2 (en) * | 2006-05-24 | 2007-11-29 | Novo Nordisk A/S | Soluble, stable insulin-containing formulations |
DE102006031955A1 (de) | 2006-07-11 | 2008-01-17 | Sanofi-Aventis Deutschland Gmbh | Verfahren zur Herstellung von Insulinanaloga mit dibasischem B-Kettenende |
DE102006031962A1 (de) * | 2006-07-11 | 2008-01-17 | Sanofi-Aventis Deutschland Gmbh | Amidiertes Insulin Glargin |
JP2010525033A (ja) * | 2007-04-30 | 2010-07-22 | ノボ・ノルデイスク・エー/エス | 高濃縮のインスリン溶液及び組成物 |
JP5352596B2 (ja) * | 2008-01-04 | 2013-11-27 | バイオデル, インコーポレイテッド | 組織グルコースレベルの関数としてのインスリン放出のためのインスリン製剤 |
EP2229407B1 (de) | 2008-01-09 | 2016-11-16 | Sanofi-Aventis Deutschland GmbH | Neue insulinderivate mit extrem verzögertem zeit- / wirkungsprofil |
JP5695909B2 (ja) | 2008-01-09 | 2015-04-08 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | 極度に遅延した時間作用プロファイルを有する新規なインスリン誘導体 |
ES2550308T3 (es) * | 2008-08-29 | 2015-11-06 | Genzyme Corporation | Formulaciones peptídicas de liberación controlada |
WO2010028055A1 (en) * | 2008-09-02 | 2010-03-11 | Biodel, Inc. | Insulin with a basal release profile |
HUE037449T2 (hu) | 2008-10-17 | 2018-08-28 | Sanofi Aventis Deutschland | Egy inzulin és egy GLP-1 agonista kombinációja |
US9060927B2 (en) * | 2009-03-03 | 2015-06-23 | Biodel Inc. | Insulin formulations for rapid uptake |
JP5735960B2 (ja) * | 2009-07-06 | 2015-06-17 | サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング | メチオニンを含むインスリン製剤 |
AR080669A1 (es) | 2009-11-13 | 2012-05-02 | Sanofi Aventis Deutschland | Composicion farmaceutica que comprende un agonista de glp-1, una insulina y metionina |
WO2011058082A1 (de) | 2009-11-13 | 2011-05-19 | Sanofi-Aventis Deutschland Gmbh | Pharmazeutische zusammensetzung umfassend einen glp-1-agonisten und methionin |
TW201138808A (en) | 2010-05-03 | 2011-11-16 | Bristol Myers Squibb Co | Serum albumin binding molecules |
US8637458B2 (en) | 2010-05-12 | 2014-01-28 | Biodel Inc. | Insulin with a stable basal release profile |
AU2011202239C1 (en) * | 2010-05-19 | 2017-03-16 | Sanofi | Long-acting formulations of insulins |
WO2011156476A2 (en) * | 2010-06-08 | 2011-12-15 | Biodel Inc. | Insulin with a basal release profile |
ES2606554T3 (es) | 2010-08-30 | 2017-03-24 | Sanofi-Aventis Deutschland Gmbh | Uso de AVE0010 para la fabricación de un medicamento para el tratamiento de la diabetes mellitus de tipo 2 |
CN102188367B (zh) * | 2011-01-05 | 2012-11-07 | 山东新时代药业有限公司 | 一种甘精胰岛素注射液及其制备方法 |
PE20140969A1 (es) | 2011-01-20 | 2014-07-24 | Zealand Pharma As | Combinacion de analogos del glucagon acilados con analogos de insulina |
US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
DK2741765T3 (en) * | 2011-08-10 | 2016-06-13 | Adocia | Injectable solution of at least one type of basal insulin |
BR112014004726A2 (pt) | 2011-08-29 | 2017-04-04 | Sanofi Aventis Deutschland | combinação farmacêutica para uso no controle glicêmico em pacientes de diabetes tipo 2 |
TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
US11707408B2 (en) | 2011-10-25 | 2023-07-25 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US10350139B2 (en) | 2011-10-25 | 2019-07-16 | Corning Incorporated | Pharmaceutical glass packaging assuring pharmaceutical sterility |
BR112014016889A8 (pt) | 2012-01-09 | 2017-07-04 | Adocia | composição sob a forma de uma solução aquosa injetável, sujo ph está compreendido entre 6,0 e 8,0 e, formulação de dose unitária com ph compreendido entre 7 e 7,8 |
US20150314003A2 (en) | 2012-08-09 | 2015-11-05 | Adocia | Injectable solution at ph 7 comprising at least one basal insulin the isoelectric point of which is between 5.8 and 8.5 and a hydrophobized anionic polymer |
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MX360420B (es) | 2012-12-19 | 2018-10-31 | Wockhardt Ltd | Una composicion acuosa estable que comprende insulina humana o un analogo o derivado de la misma. |
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US9700485B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
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US9717648B2 (en) | 2013-04-24 | 2017-08-01 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
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US9603775B2 (en) | 2013-04-24 | 2017-03-28 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US9700486B2 (en) | 2013-04-24 | 2017-07-11 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US9707155B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US9707154B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US9707153B2 (en) | 2013-04-24 | 2017-07-18 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
US9849066B2 (en) | 2013-04-24 | 2017-12-26 | Corning Incorporated | Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients |
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WO2015086729A1 (en) | 2013-12-13 | 2015-06-18 | Sanofi | Dual glp-1/gip receptor agonists |
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