CN104316631A - 一种检测包衣的固体口服剂型中外露核芯物质的存在的方法 - Google Patents

一种检测包衣的固体口服剂型中外露核芯物质的存在的方法 Download PDF

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Publication number
CN104316631A
CN104316631A CN201410475255.3A CN201410475255A CN104316631A CN 104316631 A CN104316631 A CN 104316631A CN 201410475255 A CN201410475255 A CN 201410475255A CN 104316631 A CN104316631 A CN 104316631A
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CN
China
Prior art keywords
coating
dissolution
dosage form
tablets
dissolution medium
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.)
Pending
Application number
CN201410475255.3A
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English (en)
Chinese (zh)
Inventor
R·赫斯亚
T·米斯拉
K·萨兰蒂斯
P·博纳西亚
C·G·黄
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.)
Sunovion Pharmaceuticals Inc
Original Assignee
Sepracor 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 Sepracor Inc filed Critical Sepracor Inc
Publication of CN104316631A publication Critical patent/CN104316631A/zh
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/22Anxiolytics
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00Chemistry: analytical and immunological testing
    • Y10T436/14Heterocyclic carbon compound [i.e., O, S, N, Se, Te, as only ring hetero atom]
    • Y10T436/145555Hetero-N
    • Y10T436/147777Plural nitrogen in the same ring [e.g., barbituates, creatinine, etc.]

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Neurosurgery (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Anesthesiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
CN201410475255.3A 2009-01-30 2010-01-28 一种检测包衣的固体口服剂型中外露核芯物质的存在的方法 Pending CN104316631A (zh)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14862109P 2009-01-30 2009-01-30
US61/148,621 2009-01-30

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201080009681.8A Division CN102355892B (zh) 2009-01-30 2010-01-28 6-(5-氯-2-吡啶基)-5-[(4-甲基-1-哌嗪基)羰氧基]-7-氧代-6,7-二氢-5H-吡咯并[3,4-b]吡嗪的包衣片剂及测量包衣有效性的方法

Publications (1)

Publication Number Publication Date
CN104316631A true CN104316631A (zh) 2015-01-28

Family

ID=42091495

Family Applications (2)

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CN201410475255.3A Pending CN104316631A (zh) 2009-01-30 2010-01-28 一种检测包衣的固体口服剂型中外露核芯物质的存在的方法
CN201080009681.8A Expired - Fee Related CN102355892B (zh) 2009-01-30 2010-01-28 6-(5-氯-2-吡啶基)-5-[(4-甲基-1-哌嗪基)羰氧基]-7-氧代-6,7-二氢-5H-吡咯并[3,4-b]吡嗪的包衣片剂及测量包衣有效性的方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201080009681.8A Expired - Fee Related CN102355892B (zh) 2009-01-30 2010-01-28 6-(5-氯-2-吡啶基)-5-[(4-甲基-1-哌嗪基)羰氧基]-7-氧代-6,7-二氢-5H-吡咯并[3,4-b]吡嗪的包衣片剂及测量包衣有效性的方法

Country Status (7)

Country Link
US (2) US20100221338A1 (enExample)
EP (2) EP3632417A1 (enExample)
JP (1) JP2012516348A (enExample)
CN (2) CN104316631A (enExample)
AU (1) AU2010208240A1 (enExample)
CA (1) CA2750059C (enExample)
WO (1) WO2010088385A1 (enExample)

Families Citing this family (9)

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US8268832B2 (en) 2007-12-19 2012-09-18 Sunovion Pharmaceuticals Inc. Maleate salts of 6-(5-chloro-2-Pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8198277B2 (en) 2007-12-19 2012-06-12 Sunovion Pharmaceuticals Inc. L-malate salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8198278B2 (en) 2007-12-19 2012-06-12 Sunovion Pharmaceuticals Inc. Besylate salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8212036B2 (en) 2007-12-19 2012-07-03 Sunovion Pharmaceuticals Inc. Maleate salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8269005B2 (en) 2007-12-19 2012-09-18 Sunovion Pharmaceuticals Inc. L-malate salts of 6-(5-chloro-2-Pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-Oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US20110053945A1 (en) * 2007-12-19 2011-03-03 Sepracor Inc. Salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihy-dro-5h-pyrrolo[3,4-b]pyrazine
US20110009416A1 (en) * 2009-07-07 2011-01-13 Sepracor Inc. PH INDEPENDENT FORMULATIONS OF 6-(5-CHLORO-2-PYRIDYL)-5-[(4-METHYL-1-PIPERAZINYL)CARBONYLOXY]-7-OXO-6,7-DIHYDRO-5H-PYRROLO[3,4-b]PYRAZINE
CN103408967A (zh) * 2013-07-09 2013-11-27 吴江市冰心文教用品有限公司 一种天然可食用颜料
CN118069976B (zh) * 2024-03-11 2024-08-20 华中科技大学 一种老化sbs改性沥青双组分同步再生剂最佳掺量计算方法

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WO2006044202A2 (en) * 2004-10-19 2006-04-27 State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University Enteric coated compositions that release active ingredient(s) in gastric fluid and intestinal fluid

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AR208414A1 (es) 1974-11-07 1976-12-27 Rhone Poulenc Ind Procedimiento para obtener nuevos derivados de la((acil-4piperazinil-1)carboniloxi-5 pirrolinona-2)
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WO1993010787A1 (en) 1991-12-02 1993-06-10 Sepracor, Inc. Methods and compositions for treating sleep disorders, convulsive seizures, and other disorders using optically pure (+) zopiclone
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US8198278B2 (en) * 2007-12-19 2012-06-12 Sunovion Pharmaceuticals Inc. Besylate salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8269005B2 (en) * 2007-12-19 2012-09-18 Sunovion Pharmaceuticals Inc. L-malate salts of 6-(5-chloro-2-Pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-Oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8198277B2 (en) * 2007-12-19 2012-06-12 Sunovion Pharmaceuticals Inc. L-malate salts of 6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
US8268832B2 (en) * 2007-12-19 2012-09-18 Sunovion Pharmaceuticals Inc. Maleate salts of 6-(5-chloro-2-Pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine
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US20020034544A1 (en) * 2000-03-31 2002-03-21 Annette Skinhoj Controlled release pharmaceutical composition for oral use containing midodrine and/or active metabolite, desglymidodrine
WO2006044202A2 (en) * 2004-10-19 2006-04-27 State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University Enteric coated compositions that release active ingredient(s) in gastric fluid and intestinal fluid

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Also Published As

Publication number Publication date
WO2010088385A1 (en) 2010-08-05
EP2391354A1 (en) 2011-12-07
US9114086B2 (en) 2015-08-25
CA2750059A1 (en) 2010-08-05
EP3632417A1 (en) 2020-04-08
CN102355892A (zh) 2012-02-15
US20140271858A1 (en) 2014-09-18
US20100221338A1 (en) 2010-09-02
EP2391354B1 (en) 2019-11-27
AU2010208240A1 (en) 2011-09-22
CN102355892B (zh) 2014-10-22
JP2012516348A (ja) 2012-07-19
CA2750059C (en) 2014-11-18

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Application publication date: 20150128