KR100715354B1 - 유연물질의 발생이 억제된 안정한 가바펜틴 제제 및 그의제조 방법 - Google Patents
유연물질의 발생이 억제된 안정한 가바펜틴 제제 및 그의제조 방법 Download PDFInfo
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- KR100715354B1 KR100715354B1 KR1020050080180A KR20050080180A KR100715354B1 KR 100715354 B1 KR100715354 B1 KR 100715354B1 KR 1020050080180 A KR1020050080180 A KR 1020050080180A KR 20050080180 A KR20050080180 A KR 20050080180A KR 100715354 B1 KR100715354 B1 KR 100715354B1
- Authority
- KR
- South Korea
- Prior art keywords
- gabapentin
- binder
- poloxamer
- alcohol
- stabilizer
- Prior art date
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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
- A61K9/1682—Processes
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
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- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
공정명 | 성분명 | 실시예 1 | 비교예 1 | 비교예 2 | 비교예 3 |
과립공정 | 스프레이 과 립 화 | 습 식 과립화 | 습 식 과립화 | 스프레이 과 립 화 | |
전혼합 | 가바펜틴 | 600.0 | 600.0 | 600.0 | 600.0 |
미정질 셀룰로즈 | - | 95.0 | 95.0 | 95.0 | |
코포비돈 | - | 20.0 | 20.0 | 20.0 | |
저치환히드록시프로필셀룰로즈 | 51.0 | - | - | - | |
결합액 | 히드록시프로필셀룰로즈 | 30.0 | 30.0 | 30.0 | 30.0 |
폴록사머 407 | 21.0 | - | - | - | |
물 | - | 120.0 | - | ||
에탄올 | 300.0 | - | 270.0 | 270.0 | |
후혼합 | 전분 글리콜산 나트륨 | 51.0 | 50.0 | 50.0 | 50.0 |
미정질 셀룰로즈 | 51.0 | - | - | - | |
폴록사머 407 | - | 20.0 | 20.0 | 20.0 | |
스테아르산 마그네슘 | 12.0 | 10.0 | 10.0 | 10.0 | |
필름 코팅 | OpadryROY-C-7000A | 15.0 | 16.0 | 16.0 | 16.0 |
OpaglosR2 Clear 97W-19196 | 4.5 | 4.0 | 4.0 | 4.0 | |
합계 | 835.5 | 845.0 | 845.0 | 845.0 | |
※ 물 및 에탄올은 휘발되므로 합계에 포함시키지 않았다. |
구분 | 기간 | 실시예 1 | 비교예 1 | 비교예 2 | 비교예 3 |
가바펜틴 함량 | 초기 | 99.61% | 99.81% | 99.81% | 99.76% |
1주일 경과후 | 99.46% | 97.56% | 98.58% | 98.73% | |
유연물질(락탐) 함량 | 초기 | 0.015% | 0.010% | 0.016% | 0.010% |
1주일 경과후 | 0.39% | 1.89% | 1.28% | 0.84% | |
유연물질의 증가비 | 26 | 189 | 80 | 84 |
Claims (8)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020050080180A KR100715354B1 (ko) | 2005-08-30 | 2005-08-30 | 유연물질의 발생이 억제된 안정한 가바펜틴 제제 및 그의제조 방법 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020050080180A KR100715354B1 (ko) | 2005-08-30 | 2005-08-30 | 유연물질의 발생이 억제된 안정한 가바펜틴 제제 및 그의제조 방법 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20070028669A KR20070028669A (ko) | 2007-03-13 |
KR100715354B1 true KR100715354B1 (ko) | 2007-05-08 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020050080180A KR100715354B1 (ko) | 2005-08-30 | 2005-08-30 | 유연물질의 발생이 억제된 안정한 가바펜틴 제제 및 그의제조 방법 |
Country Status (1)
Country | Link |
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KR (1) | KR100715354B1 (ko) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102334701B1 (ko) * | 2019-11-29 | 2021-12-06 | 한국유나이티드제약 주식회사 | 프로톤펌프억제제와 모사프리드를 함유하는 유핵정 제제 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6294198B1 (en) | 1999-08-24 | 2001-09-25 | Purepac Pharmaceutical Co. | Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same |
WO2005011666A1 (en) | 2003-08-05 | 2005-02-10 | Ranbaxy Laboratories Limited | Stable sustained release oral dosage form of gabapentin |
-
2005
- 2005-08-30 KR KR1020050080180A patent/KR100715354B1/ko active IP Right Grant
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6294198B1 (en) | 1999-08-24 | 2001-09-25 | Purepac Pharmaceutical Co. | Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same |
WO2005011666A1 (en) | 2003-08-05 | 2005-02-10 | Ranbaxy Laboratories Limited | Stable sustained release oral dosage form of gabapentin |
Also Published As
Publication number | Publication date |
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KR20070028669A (ko) | 2007-03-13 |
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