KR950702827A - 부프로피온 함유 서방형 정제(sustained release tablets containing bupropion) - Google Patents

부프로피온 함유 서방형 정제(sustained release tablets containing bupropion) Download PDF

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KR950702827A
KR950702827A KR1019950700497A KR19950700497A KR950702827A KR 950702827 A KR950702827 A KR 950702827A KR 1019950700497 A KR1019950700497 A KR 1019950700497A KR 19950700497 A KR19950700497 A KR 19950700497A KR 950702827 A KR950702827 A KR 950702827A
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hydrochloride
sustained
bupropion hydrochloride
tablet
release tablet
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KR1019950700497A
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KR100294154B1 (ko
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제니 수 갈로웨이 러드위그
조엘 엘모어 2세 셔튼
윌리엄 르로이 2세 바쓰
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엘. 디. 젠킨스
더 웰컴 파운데이션 리미티드(The Wellcome Foundation Limited)
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids

Abstract

본 발명은 1년 이상의 가사시간을 가지며, 염산부프로피온, 히드록시프로필메틸셀룰로오스 및 염산 시스테인 또는 염산 글리신을 함유하는 조절된 서방형 정제에 관한 것으로서, 상기 정제는 인체내에서 염산부프로피온의 방출을 유효하게 조절하기 위한 표면적:부피비를 갖는다.

Description

부프로피온 함유 서방형 정제(SUSTAINED RELEASE TABLETS CONTAINING BUPROPION)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 본 발명의 바람직한 정제 형태의 상면도이다.
제2도는 제1도의 정제의 측면도이다.
제3도는 제1도를 3-3 라인을 따라 절단한 횡단면도이다.
제4도는 본 발명의 50㎎ 정제 실시예에 의해 제공된 투여시간으로부터 24시간에 걸쳐 일회 투여량이 2개의 50㎎의 염산부프로피온(SR) 정제로서, 투여후 성인 남자에 대한(유리 염기로서) 들로나눈 플라스마 부프로피온 농도를 ng/ml의 단위로 보여주는 그래프이다.
제5도는 본 발명의 100㎎ 정제 실시예에 의해 제공된 24시간에 걸친 일의 투여랑이 1개의 100㎎ 염산브프로피온(SR) 정제로서, 투여후 성인 남자에 대한(유리 염기로서) 플라스마 부프로피온 농도를 ng/ml의 단위로 보여주는 그래프이다.

Claims (21)

  1. 염산부프로피온 및 히드록시프로필 메틸셀룰로오스를 포함하는 서방형정제로서, 히드록시프로필 메틸셀룰로오스의 양 대 염산부프로피온의 양은 각각 0.19:1내지 1.1:1이며, 상기 정제는 1시간대에 염산부프로피온 총량의 20내지 60%, 4시간내에 염산부프로피온 총량의 50내지 95% 8시간내에 염산부프로피온 총량의 75% 이상을 물중에 방출할 수 있는 서방형 정제.
  2. 제1항에 있어서, 히드록시프로필 메틸셀룰로오스의 양 대 염산부프로피온의 양이 0.26:1 내지 0.68:1이고, 상기 정제는 1시간내에 염산부프로피온 총량의 25내지 50%, 4시간내에 염산부프로피온 총량의 60내지 95%를 물중에 방출할 수 있는 서방형 정제.
  3. 제1항 또는 제2항에 있어서, 염산부프로피온이 25내지 500㎎의 양으로 존재하는 서방형 정제.
  4. 제3항에 있어서, 염산부프로피온 50내지 150㎎을 함유하는 서방형 정제.
  5. 제1항 내지 제4항중 어느 한 항에 있어서, 상기 정제가 3:1 내지 25:1㎝-1의 표면적 대 부피비를 갖는 서방형 정제.
  6. 제5항에 있어서, 상기 표면적 대 부피비가 7:1내지 16:1㎝-1인 서방형 정제.
  7. 제1항 내지 제6항중 어느 한 항에 있어서, 염산 글리신 또는 염산 시스테인을 포함하는 서방형 정제.
  8. 제7항에 있어서, 염산부프로피온 1부에 대한 염산 시스테인 또는 염산 글리신의 양이 0.02 내지 0.27인 서방형 정제.
  9. 제7항 또는 제8항에 있어서, 염산부프로피온 1부에 대한 염산 시스테인 또는 염산 글리신의 양이 0.05내지 0.16인 서방형 정제.
  10. 제1항 내지 제9항중 어느 한 항에 있어서, 상기 정제가 15내지 25℃ 및 35% 내지 60%상대 습도에서 1년간 저장되는 경우 염산부프로피온의 분해율이 10% 이하인 서방형 정제.
  11. 제10항에 있어서, 염산부프로피온의 분해율이 5%이항인 서방형 정제.
  12. 제1항 내지 제11항중 어느 한 항에 있어서, 상기 정제가 순간 방출 필름 피복물을 갖는 서방형 정제.
  13. 제1항 내지 제12항중 어느 한 항에 있어서, 염산부프로피온 50㎎을 함유하는 서방형 정제.
  14. 제1항 내지 제13항중 어느 한 항에 있어서, 염산부프로피온 100㎎을 함유하는 서방형 정제.
  15. 제1항 내지 제14항중 어느 한 항에 있어서, 염산부프로피온 150㎎을 함유하는 서방형 정제.
  16. 제13항에 있어서, 염산부프로피온을 1시간내에 30내지 50%, 4시간내에는 70내지 95%, 8시간내에 이상을 방출하며, 상기 정제의 표면적 : 부피비가 13:1내지 16:1cm-1인 서방형 정제.
  17. 제14항에 있어서, 염산부프로피온을 1시간내에 25내지 45%, 4시간내에는 60내지 85%, 8시간내에는 89% 이상을 방출하며, 상기 정제의 표면적:부피비가 9:1내지 12:1cm-1인 서방형 정제.
  18. 제15항에 있어서, 염산부프로피온을 1시간내에 25내지 45%, 4시간내에는 60내지 75%, 8시간내에는 85% 이상을 방출하며, 상기 정제의 표면적:부피비가 7:1내지 10:1cm-1인 서방형 정제.
  19. 염산부프로피온 100㎎, 히드록시프로필 메틸셀룰로오스 19내지 110㎎ 및 염산 시스테인 또는 염산 글리신 2.7내지 27㎎을 포함하는 서방형 정제.
  20. 염산부프로피온 100㎎, 히드록시프로필 메틸셀룰로오스 26내지 68㎎ 및 염산 시스테인 또는 염산 글리신 5내지 16.2㎎을 포함하는 서방형 정제.
  21. 제1항 내지 제20항중 어느 한 항에 있어서, 인체의 우울증 치료에 사용하기 위한 서방형 정제.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950700497A 1992-08-14 1993-08-13 부프로피온함유서방형정제 KR100294154B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB929217295A GB9217295D0 (en) 1992-08-14 1992-08-14 Controlled released tablets
GB9217295.6 1992-08-14
PCT/GB1993/001722 WO1994004138A1 (en) 1992-08-14 1993-08-13 Sustained release tablets containing bupropion

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KR950702827A true KR950702827A (ko) 1995-08-23
KR100294154B1 KR100294154B1 (ko) 2001-09-17

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US (1) US5427798A (ko)
EP (1) EP0656775B1 (ko)
JP (1) JPH08500110A (ko)
KR (1) KR100294154B1 (ko)
AT (1) ATE161422T1 (ko)
AU (1) AU677595B2 (ko)
CA (1) CA2142320C (ko)
CY (1) CY2143B1 (ko)
DE (1) DE69316015T2 (ko)
ES (1) ES2111168T3 (ko)
GB (1) GB9217295D0 (ko)
GR (1) GR3025794T3 (ko)
HK (1) HK1004323A1 (ko)
IL (1) IL106693A (ko)
LU (1) LU90656I2 (ko)
MX (1) MX9304967A (ko)
NZ (1) NZ254947A (ko)
SG (1) SG43911A1 (ko)
TW (1) TW260607B (ko)
WO (1) WO1994004138A1 (ko)
ZA (1) ZA935942B (ko)

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AU4725893A (en) 1994-03-15
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