CN100396334C - 改善药物组合物的稳定性的方法 - Google Patents
改善药物组合物的稳定性的方法 Download PDFInfo
- Publication number
- CN100396334C CN100396334C CNB01821021XA CN01821021A CN100396334C CN 100396334 C CN100396334 C CN 100396334C CN B01821021X A CNB01821021X A CN B01821021XA CN 01821021 A CN01821021 A CN 01821021A CN 100396334 C CN100396334 C CN 100396334C
- Authority
- CN
- China
- Prior art keywords
- container
- oxirane
- pharmaceutical composition
- sterilization
- ethylene oxide
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Mechanical Engineering (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Ophthalmology & Optometry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicines Containing Plant Substances (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
组分 | |
酮替芬富马酸氢盐(酮替芬含量) | 0.0345%(0.025%) |
甘油,纯化合物 | 2.125% |
苯扎氯铵 | 0.01% |
氢氧化钠1N | 0.074% |
注射用水,加至 | 100ml |
PH | 5.32 |
重量克分子渗透浓度(mOsmol) | 240 |
样品 | I | II | III | IV | V |
0-值:pH重量克分子渗透浓度(mOsmol)%酮替芬%降解产物I%降解产物II | 5.28238100.2n.d.n.d. | 5.28238100.2n.d.n.d. | 5.2524099.8n.t.0.05 | 5.4024199.8n.d.n.d. | 5.42244102.4n.d.n.d. |
80℃下的应力测试,15小时;pH重量克分子渗透浓度(mOsmol)%酮替芬%降解产物I%降解产物II | 5.224196.8~0.05~0.1 | 4.8324491.6~1.4~3.2 | 4.7524188.61.22.8 | 5.2224194.5n.d.n.d. | 5.2424897.7n.d.n.d. |
Claims (13)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00128318.3 | 2000-12-22 | ||
EP00128318 | 2000-12-22 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1481259A CN1481259A (zh) | 2004-03-10 |
CN100396334C true CN100396334C (zh) | 2008-06-25 |
Family
ID=8170784
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB01821021XA Expired - Lifetime CN100396334C (zh) | 2000-12-22 | 2001-12-20 | 改善药物组合物的稳定性的方法 |
Country Status (15)
Country | Link |
---|---|
US (4) | US20040063607A1 (zh) |
EP (1) | EP1349580B2 (zh) |
JP (1) | JP4125957B2 (zh) |
CN (1) | CN100396334C (zh) |
AR (1) | AR032381A1 (zh) |
AT (1) | ATE367831T1 (zh) |
BR (1) | BRPI0116332B8 (zh) |
CA (1) | CA2431906A1 (zh) |
CY (1) | CY1106919T1 (zh) |
DE (1) | DE60129597T3 (zh) |
DK (1) | DK1349580T4 (zh) |
ES (1) | ES2287173T5 (zh) |
PT (1) | PT1349580E (zh) |
TW (1) | TW586946B (zh) |
WO (1) | WO2002051452A1 (zh) |
Families Citing this family (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE60143615D1 (de) * | 2000-09-13 | 2011-01-20 | Asahi Glass Co Ltd | Augentropfen |
JP4694773B2 (ja) * | 2003-06-06 | 2011-06-08 | ロート製薬株式会社 | 粘膜適用液状組成物 |
US20060199863A1 (en) * | 2003-07-31 | 2006-09-07 | Santen Pharmaceutical Co., Ltd. | Product containing prostaglandin |
CN102526064A (zh) * | 2004-12-09 | 2012-07-04 | 参天制药株式会社 | 含有分子内具有氟原子的前列腺素的制品 |
SI1829545T1 (sl) * | 2004-12-24 | 2012-08-31 | Santen Pharmaceutical Co Ltd | Produkti, vsebujoči prostaglandin F2 alfa derivat |
US20060140820A1 (en) | 2004-12-28 | 2006-06-29 | Udo Mattern | Use of a container of an inorganic additive containing plastic material |
KR20150017002A (ko) * | 2006-03-17 | 2015-02-13 | 존슨 앤드 존슨 비젼 케어, 인코포레이티드 | 산화에 불안정한 성분을 포함하는 안정화된 눈용 조성물 |
PT2068825E (pt) | 2006-10-04 | 2011-02-11 | M & P Patent Ag | Sistema de administração de libertação controlada para aplicação nasal de neurotransmissores |
EP2127638A1 (en) | 2008-05-30 | 2009-12-02 | Santen Pharmaceutical Co., Ltd | Method and composition for treating ocular hypertension and glaucoma |
EP2398443A2 (en) * | 2009-02-20 | 2011-12-28 | Micro Labs Limited | Storage stable prostaglandin product |
US8299079B2 (en) | 2009-05-22 | 2012-10-30 | Kaufman Herbert E | Preparations and methods for ameliorating or reducing presbyopia |
EP2269575A1 (en) | 2009-06-30 | 2011-01-05 | Santen Pharmaceutical Co., Ltd | Method for improving bioavailability of latanoprost |
US9757388B2 (en) | 2011-05-13 | 2017-09-12 | Acerus Pharmaceuticals Srl | Intranasal methods of treating women for anorgasmia with 0.6% and 0.72% testosterone gels |
US20130045958A1 (en) | 2011-05-13 | 2013-02-21 | Trimel Pharmaceuticals Corporation | Intranasal 0.15% and 0.24% testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
US20130040923A1 (en) | 2011-05-13 | 2013-02-14 | Trimel Pharmaceuticals Corporation | Intranasal lower dosage strength testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
CA2864740A1 (en) * | 2012-04-19 | 2013-10-24 | C.R. Bard, Inc. | Infusates with enhanced ph stability under ethylene oxide sterilization |
US11744838B2 (en) | 2013-03-15 | 2023-09-05 | Acerus Biopharma Inc. | Methods of treating hypogonadism with transnasal testosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event |
WO2014157727A1 (ja) | 2013-03-29 | 2014-10-02 | 株式会社AskAt | 眼疾患治療剤 |
JP7037349B2 (ja) * | 2017-06-23 | 2022-03-16 | 参天製薬株式会社 | 水溶性粘稠化剤を含有する医薬組成物 |
WO2018235935A1 (ja) * | 2017-06-23 | 2018-12-27 | 参天製薬株式会社 | 水溶性粘稠化剤を含有する医薬組成物 |
WO2019026992A1 (ja) * | 2017-08-03 | 2019-02-07 | 参天製薬株式会社 | クロルヘキシジンを含有する医薬組成物 |
BR112022024553A2 (pt) | 2020-07-16 | 2023-01-24 | Raqualia Pharma Inc | Composto com atividade inibidora de trpv4 ou um sal farmaceuticamente aceitável do mesmo e seu uso, composição farmacêutica, método para se tratar uma doença da retina acompanhada de distúrbio do fluxo sanguíneo ou distúrbio celular, kit para uso na prevenção ou tratamento das doenças, marcador de doença para uma doença da retina, método para se detectar uma doença da retina, métodos de triagem para uma substância que suprime a expressão do gene de trpv4, uma que reduz o nível de expressão de uma proteína de trpv4 e uma que inibe a atividade de trpv4 e agente para prevenir ou tratar uma doença da retina |
US20230149359A1 (en) * | 2021-11-15 | 2023-05-18 | Slayback Pharma Llc | Stable pharmaceutical compositions of clonidine |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4482585A (en) * | 1982-06-11 | 1984-11-13 | Toppan Printing Co., Ltd. | Container resistant to extremely low temperatures |
US5620425A (en) * | 1993-11-03 | 1997-04-15 | Bracco International B.V. | Method for the preparation of pre-filled plastic syringes |
EP1040840A1 (en) * | 1999-02-16 | 2000-10-04 | Ethicon, Inc. | Method of degassing absorbable suture products |
US6132679A (en) * | 1997-12-24 | 2000-10-17 | Alliedsignal, Inc. | Method and apparatus for aerating chemically-sterilized articles |
WO2000062824A1 (en) * | 1999-04-21 | 2000-10-26 | Stryker Technologies Corporation | Special cycle for ethylene oxide sterilization |
WO2000073156A1 (en) * | 1999-05-28 | 2000-12-07 | Novartis Ag | Package for a pharmaceutical product and method of sterilising the package |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
BE523577A (zh) * | 1952-10-16 | |||
GB1107600A (en) † | 1965-12-15 | 1968-03-27 | U M P Venesta Ltd | Improvements relating to collapsible tubular containers |
CH483963A (fr) * | 1968-01-11 | 1970-01-15 | U M P Venesta Ltd | Récipient tubulaire souple |
NL7009539A (zh) * | 1969-07-07 | 1971-01-11 | ||
US3728839A (en) * | 1971-04-29 | 1973-04-24 | American Cyanamid Co | Storage stable surgically absorbable polyglycolic acid products |
US5382406A (en) * | 1990-04-17 | 1995-01-17 | Abbott Laboratories | Sterile filling method |
JP3256997B2 (ja) * | 1990-08-30 | 2002-02-18 | 千寿製薬株式会社 | 安定な水性製剤 |
US5749203A (en) * | 1994-09-23 | 1998-05-12 | Kimberly-Clark Corporation | Method of packaging a medical article |
SE515221C2 (sv) * | 1996-03-20 | 2001-07-02 | Scandimed Internat Ab | Förfarande för framställning av och anordning vid en förpackning med en sterilt förpackad behållare med sterilt innehåll |
AU2042200A (en) * | 1998-12-07 | 2000-06-26 | Baylor College Of Medicine | Preventing and removing biofilm from the surface of medical devices |
-
2001
- 2001-12-13 TW TW090130924A patent/TW586946B/zh not_active IP Right Cessation
- 2001-12-20 ES ES01985427T patent/ES2287173T5/es not_active Expired - Lifetime
- 2001-12-20 DE DE60129597T patent/DE60129597T3/de not_active Expired - Lifetime
- 2001-12-20 AT AT01985427T patent/ATE367831T1/de active
- 2001-12-20 EP EP01985427A patent/EP1349580B2/en not_active Expired - Lifetime
- 2001-12-20 CA CA002431906A patent/CA2431906A1/en not_active Abandoned
- 2001-12-20 AR ARP010105949A patent/AR032381A1/es unknown
- 2001-12-20 PT PT01985427T patent/PT1349580E/pt unknown
- 2001-12-20 CN CNB01821021XA patent/CN100396334C/zh not_active Expired - Lifetime
- 2001-12-20 JP JP2002552593A patent/JP4125957B2/ja not_active Expired - Fee Related
- 2001-12-20 DK DK01985427.2T patent/DK1349580T4/da active
- 2001-12-20 US US10/451,088 patent/US20040063607A1/en not_active Abandoned
- 2001-12-20 WO PCT/EP2001/015126 patent/WO2002051452A1/en active IP Right Grant
- 2001-12-20 BR BRPI0116332A patent/BRPI0116332B8/pt not_active IP Right Cessation
-
2007
- 2007-10-08 CY CY20071101289T patent/CY1106919T1/el unknown
-
2008
- 2008-01-18 US US12/016,428 patent/US20080300277A1/en not_active Abandoned
-
2011
- 2011-03-29 US US13/074,183 patent/US20110173928A1/en not_active Abandoned
-
2012
- 2012-12-14 US US13/714,631 patent/US20130097969A1/en not_active Abandoned
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4482585A (en) * | 1982-06-11 | 1984-11-13 | Toppan Printing Co., Ltd. | Container resistant to extremely low temperatures |
US5620425A (en) * | 1993-11-03 | 1997-04-15 | Bracco International B.V. | Method for the preparation of pre-filled plastic syringes |
US6132679A (en) * | 1997-12-24 | 2000-10-17 | Alliedsignal, Inc. | Method and apparatus for aerating chemically-sterilized articles |
EP1040840A1 (en) * | 1999-02-16 | 2000-10-04 | Ethicon, Inc. | Method of degassing absorbable suture products |
WO2000062824A1 (en) * | 1999-04-21 | 2000-10-26 | Stryker Technologies Corporation | Special cycle for ethylene oxide sterilization |
WO2000073156A1 (en) * | 1999-05-28 | 2000-12-07 | Novartis Ag | Package for a pharmaceutical product and method of sterilising the package |
Also Published As
Publication number | Publication date |
---|---|
DE60129597T2 (de) | 2008-04-17 |
AR032381A1 (es) | 2003-11-05 |
JP4125957B2 (ja) | 2008-07-30 |
DE60129597D1 (de) | 2007-09-06 |
ES2287173T5 (es) | 2012-10-03 |
DK1349580T4 (da) | 2012-10-08 |
DK1349580T3 (da) | 2007-10-01 |
EP1349580B2 (en) | 2012-07-04 |
DE60129597T3 (de) | 2012-11-29 |
BR0116332A (pt) | 2004-03-02 |
PT1349580E (pt) | 2007-10-25 |
US20080300277A1 (en) | 2008-12-04 |
EP1349580A1 (en) | 2003-10-08 |
BRPI0116332B8 (pt) | 2021-06-22 |
WO2002051452A1 (en) | 2002-07-04 |
EP1349580B1 (en) | 2007-07-25 |
US20130097969A1 (en) | 2013-04-25 |
US20110173928A1 (en) | 2011-07-21 |
TW586946B (en) | 2004-05-11 |
BR0116332B1 (pt) | 2014-08-19 |
CA2431906A1 (en) | 2002-07-04 |
JP2004516099A (ja) | 2004-06-03 |
CY1106919T1 (el) | 2012-09-26 |
ES2287173T3 (es) | 2007-12-16 |
ATE367831T1 (de) | 2007-08-15 |
US20040063607A1 (en) | 2004-04-01 |
CN1481259A (zh) | 2004-03-10 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
C06 | Publication | ||
PB01 | Publication | ||
C10 | Entry into substantive examination | ||
SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
GR01 | Patent grant | ||
C56 | Change in the name or address of the patentee |
Owner name: NOVARTIS CO., LTD. Free format text: FORMER NAME: NOVARTIS AG |
|
CP01 | Change in the name or title of a patent holder |
Address after: Basel Patentee after: Novartis Ag Address before: Basel Patentee before: Novartis AG |
|
TR01 | Transfer of patent right |
Effective date of registration: 20191209 Address after: Fribourg Patentee after: Alcon Company Address before: Basel Patentee before: Novartis Co., Ltd. |
|
TR01 | Transfer of patent right | ||
CX01 | Expiry of patent term |
Granted publication date: 20080625 |
|
CX01 | Expiry of patent term |