KR20010075314A - 급성 통증 치료용 펜타닐 조성물 - Google Patents
급성 통증 치료용 펜타닐 조성물 Download PDFInfo
- Publication number
- KR20010075314A KR20010075314A KR1020017003714A KR20017003714A KR20010075314A KR 20010075314 A KR20010075314 A KR 20010075314A KR 1020017003714 A KR1020017003714 A KR 1020017003714A KR 20017003714 A KR20017003714 A KR 20017003714A KR 20010075314 A KR20010075314 A KR 20010075314A
- Authority
- KR
- South Korea
- Prior art keywords
- composition
- fentanyl
- carrier particles
- cellulose
- weight
- Prior art date
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Classifications
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Abstract
Description
유 속(㎖/분) | 펜타닐 제거 % | ||
A | B | C | |
>15 | <50 | <50 | >95 |
Claims (20)
- 캐리어 입자의 표면에 점착된 펜타닐 또는 그것의 약제학적으로 수용가능한 염의 미소입자의 수분이 없는 주문된 혼합물을 포함하며, 상기 캐리어 입자는 상기 펜타닐의 미소입자보다 실질적으로 크며 기본적으로 수용성이고 생 점착 및/또는 점막점착 촉진제가 주로 캐리어 입자의 표면에 점착되는 것을 특징으로 하는, 설하 투여에 의해 급성 통증을 치료하기 위한 약제학적 조성물.
- 제 1항에 있어서, 0.05-20중량%의 펜타닐을 포함하는 조성물.
- 제 1항 또는 제 2항에 있어서, 0.05-5중량%, 바람직하게는 0.1-1중량%의 펜타닐을 포함하는 조성물.
- 제 1-3항 중 어느 한 항에 있어서, 펜타닐의 입자가 10㎛이하의 중량에 기초한 평균 직경을 갖는 조성물.
- 제 1-4항 중 어느 한 항에 있어서, 캐리어 입자의 평균 시브 직경이 750㎛이하, 바람직하게는 100-600㎛인 조성물.
- 제 1-5항 중 어느 한 항에 있어서, 캐리어가 압축될 때 쉽게 단편화되는 부서지기 쉬운 물질을 포함하는 조성물.
- 제 1항에 있어서, 캐리어 입자가 총 조성물에 기초하여 0.1-25중량%, 바람직하게는 1-15중량%의 생/점막점착 촉진제를 포함하는 조성물.
- 제 7항에 있어서, 생/점막점착 촉진제가 아크릴성 폴리머, 셀룰로오즈 유도체, 점막점착 특성을 갖는 천연 폴리머 및 이들의 혼합물로 이루어진 그룹으로부터 선택되는 조성물.
- 제 8항에 있어서, 생/점막점착 촉진제가 셀룰로오즈 유도체로 이루어진 그룹으로부터 선택되고, 하이드록시프로필메틸 셀룰로오즈, 하이드록시에틸 셀룰로오즈, 하이드록시프로필 셀룰로오즈, 소듐 카르복시메틸 셀룰로오즈, 메틸 셀룰로오즈, 에틸 하이드록시에틸 셀룰로오즈, 카르복시메틸 셀룰로오즈, 마이크로크리스탈린 셀룰로오즈 및 모디피드 셀룰로오즈 검 ; 크로스카라멜로스 ; 모디피드 스타치 ; 아크릴 폴리머 컴프라이징 카보머 및 데리베이티브 ; 폴리에틸렌 옥사이드 ; 키토산 ; 젤라틴 ; 소듐 알지네이트 ; 펙틴 ; 스클러로글루칸, 잔탄 검 ; 구아 검 ; 폴리-코-(메틸 피닐 에테르-말레익 안하이드라이드) ; 이들의 혼합물을 포함하는 조성물.
- 제 1-9항 중 어느 한 항에 있어서, 펜타닐과 적절하게 혼합된 미세하게 분산된 형태의 약제학적으로 수용가능한 계면활성제를 더 포함하는 조성물.
- 제 10항에 있어서, 계면활성제가 조성물의 0.5-5중량%, 바람직하게는 0.5-3중량%의 양으로 존재하는 조성물.
- 제 10항 또는 제 11항에 있어서, 계면활성제가 소듐라우릴 설페이트, 폴리소르베이트, 담즙산 염 및 이들의 혼합물로 이루어진 그룹으로부터 선택되는 조성물.
- 제 1-12항 중 어느 한 항에 있어서, 캐리어 입자가 수용성의 약제학적으로 수용가능한 카보하이드레이트 및/또는 무기염을 포함하는 조성물.
- 제 13항에 있어서, 캐리어 입자가 만니톨, 락토오즈, 칼슘포스페이트 및 당으로 이루어진 물질 중 하나 이상을 포함하는 조성물.
- 제 1-14항 중 어느 한 항에 있어서, 캐리어 입자가 설하 점막상에서 펜타닐 미소입자의 분산을 촉진시키는, 최소한 하나의 약제학적 붕해제를 함유하는 조성물.
- 제 15항에 있어서, 붕해제가 가교결합된 폴리비닐피롤리돈, 카르복시메틸 전분, 천연전분, 미소결정 셀룰로오즈, 셀룰로오즈 검 및 이들의 혼합물로 이루어진그룹으로부터 선택되는 조성물.
- 제 15항 또는 제 16항에 있어서, 붕해제가 조성물의 1-10중량%의 양으로 존재하는 조성물.
- 미소 입자가 캐리어 입자의 표면에 점착되며, 캐리어 입자는 상기 미소입자보다 실질적으로 크고 기본적으로 수용성이며, 생점착 및/또는 점막점착 촉진제는 주로 캐리어 입자의 표면에 점착되는, 설하 투여에 의해 급성 통증을 치료하기 위한, 기본적으로 수분이 없는 약제학적 조성물을 제조하는데 사용하는, 미소 입자 형태로의 펜타닐 또는 그것의 약제학적으로 수용가능한 염의 용도.
- 급성 통증 치료 방법에 있어서, 펜타닐의 미소입자보다 실질적으로 크며, 기본적으로 수용성이고 생 및/또는 점막점착 촉진제가 그 표면에 점착되는 캐리어 입자의 표면에 점착된 미소 입자 형태의 펜타닐 또는 그것의 약제학적으로 수용가능한 염을 효과적인 양으로 함유하는, 기본적으로 수분이 없는 약제학적 조성물을 최소한 하나의 복용량 단위로 급성통증에 시달리는 환자에게 설하투여 하는 것을 특징으로 하는 급성통증치료 방법.
- 제 19항에 있어서, 펜타닐이 복용량 단위당 0.05-20mg, 바람직하게는 0.1-5mg의 양으로 투여되는 방법.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9803239A SE9803239D0 (sv) | 1998-09-24 | 1998-09-24 | Composition for the treatment of acute pain |
SE9803239-4 | 1998-09-24 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20010075314A true KR20010075314A (ko) | 2001-08-09 |
KR100760531B1 KR100760531B1 (ko) | 2007-10-04 |
Family
ID=20412701
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020017003714A KR100760531B1 (ko) | 1998-09-24 | 1999-09-24 | 급성 통증 치료용 펜타닐 조성물 |
Country Status (26)
Country | Link |
---|---|
US (1) | US6759059B1 (ko) |
EP (1) | EP1115384B1 (ko) |
JP (2) | JP2002526440A (ko) |
KR (1) | KR100760531B1 (ko) |
CN (1) | CN1170524C (ko) |
AT (1) | ATE247950T1 (ko) |
AU (1) | AU764473B2 (ko) |
BG (1) | BG65363B1 (ko) |
BR (1) | BR9913948B1 (ko) |
CA (1) | CA2345064C (ko) |
CZ (1) | CZ301562B6 (ko) |
DE (1) | DE69910803T2 (ko) |
DK (1) | DK1115384T3 (ko) |
EE (1) | EE200100176A (ko) |
ES (1) | ES2207295T3 (ko) |
HU (2) | HU230688B1 (ko) |
IL (2) | IL142126A0 (ko) |
NO (1) | NO332228B1 (ko) |
NZ (1) | NZ510646A (ko) |
PL (1) | PL197078B1 (ko) |
PT (1) | PT1115384E (ko) |
RU (1) | RU2232580C2 (ko) |
SE (1) | SE9803239D0 (ko) |
SK (1) | SK283503B6 (ko) |
TR (1) | TR200100812T2 (ko) |
WO (1) | WO2000016751A1 (ko) |
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GB8332556D0 (en) * | 1983-12-06 | 1984-01-11 | Reckitt & Colmann Prod Ltd | Analgesic compositions |
US5288497A (en) * | 1985-05-01 | 1994-02-22 | The University Of Utah | Compositions of oral dissolvable medicaments |
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SE9803240D0 (sv) * | 1998-09-24 | 1998-09-24 | Diabact Ab | A pharmaceutical composition having a rapid action |
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KR101406918B1 (ko) * | 2006-06-09 | 2014-06-19 | 에씨팜 | 아편계 진통제의 저 용량 설하정 및 제조 프로세스 |
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