CN1132582C - 高含量泛西洛维片剂 - Google Patents
高含量泛西洛维片剂 Download PDFInfo
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- CN1132582C CN1132582C CN97191703A CN97191703A CN1132582C CN 1132582 C CN1132582 C CN 1132582C CN 97191703 A CN97191703 A CN 97191703A CN 97191703 A CN97191703 A CN 97191703A CN 1132582 C CN1132582 C CN 1132582C
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- Prior art keywords
- tablet
- famciclovir
- graininess
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- excipient
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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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K31/495—Heterocyclic 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
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/20—Antivirals for DNA viruses
- A61P31/22—Antivirals for DNA viruses for herpes viruses
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Virology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
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- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
一种以泛西洛维为活性成分的片剂,在这种片剂中,泛西洛维的百分重量为85%或者更高。
Description
技术领域
本发明涉及一种药物产品的新型制剂。
背景技术
EP-A-182024(Beecham Group p.l.c.)的实施例2披露了一种制备泛西洛维(famciclovir,一种可口服化合物)和喷西洛维的方法,喷西洛维具有抗疱疹病毒(如I型单纯疱疹病毒、II型单纯疱疹病毒和水痘带状疱疹病毒)感染,以及抗乙型肝炎病毒的抗病毒活性。喷西洛维及其抗病毒活性公开在于1986年9月7-13日在英国曼彻斯特召开的第十四届国际微生物学会议摘要(Abstracts of 14th Int.Congress of Microbiology)的摘要P.V11-5的193页中(Boyd等人)。
泛西洛维优选以含125mg、250mg、500mg或750mg活性成分的片剂形式给药。在片剂组合物中常见的是在片剂中包含赋形剂,如乳糖、淀粉羟基乙酸钠和硬脂酸镁,以使赋形剂总量至少为15%。无水乳糖通常包括在内,作为一种主要赋形剂以补偿在活性成分的压制特性中任何潜在的不稳定性。
赋形剂含量的百分数越高,则任何给定剂量的片剂尺寸越大。特别是在片剂含500mg和750mg活性成分的情况下,这种大尺寸片剂会影响病人的配合性,因为这种片剂的椭圆面将分别为18mm×8.5mm和21mm×10mm,此时片剂中含有大约76%的泛西洛维。
发明内容
目前我们发现有可能将泛西洛维配制成含少于15%赋形剂的片剂,并且已证明泛西洛维的压制特性足够稳定,允许这种片剂存在。
因此,本发明提供了一种以泛西洛维为主要成分,并且泛西洛维的百分重量为85%或者更高的药物片剂。
除非另外说明,本文中所有的百分重量值都是根据可包衣(例如膜包衣)的任一种片剂芯定义的。
合适的片剂包含少于15%,少于10%,少于5%,优选0%的无水乳糖或者其它类似的赋形剂如微晶纤维素。
合适的片剂含泛西洛维的百分重量大于85%、86%、87%、88%、89%、90%或91%。优选泛西洛维的量为最高可能的百分含量。泛西洛维可以是任意合适的药物上可接受的形式,如以盐、溶剂化物或多晶型物的形式存在。优选泛西洛维呈无水的游离碱状态。
片剂组合物中包含的常见赋形剂包括羟丙基纤维素,例如最高到5%或3%,淀粉羟基乙酸钠,例如最高含量到15%、10%、7%或5%,以及硬脂酸镁,例如最高含量到2%或1%。
在这种片剂上,可以包覆用于片剂药物中的任意合适的包衣。
这种片剂是用本领域已知的常用压片方法制备的。在优选的方法中,泛西洛维与一种赋形剂如羟丙基纤维素一起制粒,目的是为了最小化活性成分物理形式变化的影响。这种颗粒经筛选和干燥后,与另一种任意的赋形剂混合,形成一种压制混合物。将片剂压制到适合所需剂量的尺寸和重量,然后可以按需要,任选包覆。
具体实施方式
下列实施例举例说明了本发明。
实施例
括号中的百分数值是泛西洛维片剂中的百分数值,这种泛西洛维片剂目前已在大不列颠及北爱尔兰联合王国、美国和世界上其它国家的药品管理局注册。
组分 %重量/重量 %重量/重量
泛西洛维 91.42 (75.66)
羟基丙基纤维素 2.83 (2.34)
淀粉羟基乙酸钠 5.00 (5.00)
硬脂酸镁 0.75 (0.75)
无水乳糖 0 (16.25)
对于500mg的剂量,芯重大约547mg;对于750mg的剂量,芯重大约820mg。
对于包衣片剂,通过包衣添加2.5%的芯重。对于500mg剂量,该包覆片剂重量为560mg;对于750mg剂量,该包覆片剂重量为840mg。
这种片剂的制备是通过干混泛西洛维和羟丙基纤维素,然后在高剪切制粒机中用水使该混合物成粒状。将该湿物质筛选、干燥和研磨。然后将该研磨后的颗粒与淀粉羟基乙酸钠和硬脂酸镁混合以制造压制混合物。压制片剂到片剂所需强度的合适尺寸和重量,然后用水性膜包覆该片剂。
得到750mg片剂的椭圆形表面大小为19mm×9mm;500mg片剂的椭圆表面大小为17mm×8mm。
Claims (21)
1.一种药物片剂,其中活性成分是泛西洛维并包括常规赋形剂,并且泛西洛维在该片剂中的百分重量为85%或者更高。
2.根据权利要求1的一种药物片剂,其包含少于15%的乳糖。
3.根据权利要求2的一种药物片剂,其包含少于5%的乳糖。
4.根据权利要求3的一种药物片剂,其含0%的乳糖。
5.根据权利要求1、2、3或4的一种药物片剂,其中在该片剂中泛西洛维的百分重量为90%或者更高。
6.根据权利要求1的一种药物片剂,其具有下述组成:
组分 %重量/重量
泛西洛维 91.42
羟丙基纤维素 2.83
淀粉羟基乙酸钠 5.00
硬脂酸镁 0.75
无水乳糖 0
7.根据权利要求1、2、3、4或6中任一项的一种药物片剂,其包含500mg或750mg的泛西洛维。
8.根据权利要求5的一种药物片剂,其包含500mg或750mg的泛西洛维。
9.一种制备根据权利要求1的片剂的方法,其中泛西洛维和赋形剂被制成颗粒状,然后压制成片剂。
10.根据权利要求9的方法,其中药物片剂含有少于15%的乳糖。
11.根据权利要求9的方法,其中药物片剂含有少于5%的乳糖。
12.根据权利要求9的方法,其中药物片剂含有0%的乳糖。
13.一种制备根据权利要求5的片剂的方法,其中泛西洛维和赋形剂被制成颗粒状,然后压制成片剂。
14.一种制备根据权利要求6的片剂的方法,其中泛西洛维和赋形剂被制成颗粒状,然后压制成片剂。
15.一种制备根据权利要求7的片剂的方法,其中泛西洛维和赋形剂被制成颗粒状,然后压制成片剂。
16.一种制备根据权利要求8的片剂的方法,其中泛西洛维和赋形剂被制成颗粒状,然后压制成片剂。
17.根据权利要求9的一种方法,其中泛西洛维先与羟丙基纤维素一起制成颗粒状,然后与任意的赋形剂混合后,再压制成片剂。
18.根据权利要求13的方法,其中泛西洛维先与羟丙基纤维素一起制成颗粒状,然后与任意的赋形剂混合后,再压制成片剂。
19.根据权利要求14的方法,其中泛西洛维先与羟丙基纤维素一起制成颗粒状,然后与任意的赋形剂混合后,再压制成片剂。
20.根据权利要求15的方法,其中泛西洛维先与羟丙基纤维素一起制成颗粒状,然后与任意的赋形剂混合后,再压制成片剂。
21.根据权利要求16的方法,其中泛西洛维先与羟丙基纤维素一起制成颗粒状,然后与任意的赋形剂混合后,再压制成片剂。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB9600847.9A GB9600847D0 (en) | 1996-01-16 | 1996-01-16 | Pharmaceuticals |
GB9600847.9 | 1996-01-16 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1208350A CN1208350A (zh) | 1999-02-17 |
CN1132582C true CN1132582C (zh) | 2003-12-31 |
Family
ID=10787105
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN97191703A Expired - Lifetime CN1132582C (zh) | 1996-01-16 | 1997-01-13 | 高含量泛西洛维片剂 |
Country Status (38)
Country | Link |
---|---|
US (1) | US6765007B1 (zh) |
EP (1) | EP0874632B1 (zh) |
JP (2) | JP4711360B2 (zh) |
KR (1) | KR100338829B1 (zh) |
CN (1) | CN1132582C (zh) |
AP (2) | AP747A (zh) |
AR (1) | AR005456A1 (zh) |
AT (1) | ATE220910T1 (zh) |
AU (1) | AU713090B2 (zh) |
BG (1) | BG63488B1 (zh) |
BR (1) | BR9706982A (zh) |
CY (1) | CY2390B1 (zh) |
CZ (1) | CZ287205B6 (zh) |
DE (1) | DE69714215T2 (zh) |
DK (1) | DK0874632T3 (zh) |
DZ (1) | DZ2159A1 (zh) |
EA (1) | EA001946B1 (zh) |
EG (1) | EG23684A (zh) |
ES (1) | ES2180922T3 (zh) |
GB (1) | GB9600847D0 (zh) |
HK (1) | HK1016473A1 (zh) |
HU (1) | HU225472B1 (zh) |
IL (1) | IL124913A0 (zh) |
MX (1) | MX9805713A (zh) |
MY (1) | MY127527A (zh) |
NO (1) | NO315689B1 (zh) |
NZ (1) | NZ326769A (zh) |
OA (1) | OA10812A (zh) |
PE (1) | PE35498A1 (zh) |
PL (1) | PL187291B1 (zh) |
PT (1) | PT874632E (zh) |
SK (1) | SK282132B6 (zh) |
TR (1) | TR199800954T2 (zh) |
TW (1) | TW434016B (zh) |
UA (1) | UA63897C2 (zh) |
UY (2) | UY24437A1 (zh) |
WO (1) | WO1997025990A1 (zh) |
ZA (1) | ZA97310B (zh) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2007037790A2 (en) * | 2005-06-08 | 2007-04-05 | Elan Corporation, Plc | Modified release famciclovir compositions |
CN102470237A (zh) | 2009-06-26 | 2012-05-23 | 塔里斯生物医药公司 | 用于可植入药物递送装置的固体药物片剂 |
JP2015063521A (ja) * | 2013-09-02 | 2015-04-09 | 科研製薬株式会社 | 高い薬物含有率を有する錠剤及びその製造方法 |
CN104434852B (zh) * | 2013-09-18 | 2018-11-20 | 北京韩美药品有限公司 | 泛昔洛韦直压片及其制备方法 |
CN112587491B (zh) * | 2021-01-03 | 2022-08-23 | 迪沙药业集团有限公司 | 一种泛昔洛韦片组合物 |
Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2671970A1 (fr) * | 1991-01-30 | 1992-07-31 | Wellcome Found | Comprimes dispersables dans l'eau. |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3421800C1 (de) * | 1984-06-12 | 1986-04-17 | Maschinen und Werkzeugbau Michael Brümmer GmbH, 8804 Dinkelsbühl | Elastische Walze zum Behandeln einer thermoplastischen Folie |
EP0182024B1 (en) * | 1984-09-20 | 1991-04-03 | Beecham Group Plc | Purine derivatives and their pharmaceutical use |
RU2126255C1 (ru) | 1991-05-15 | 1999-02-20 | Йель Юниверсити | Способ получения противоопухолевого эффекта у млекопитающих |
GB9303157D0 (en) * | 1993-02-17 | 1993-03-31 | Scotia Holdings Plc | Treatment of a group of related disorders |
IL111138A (en) | 1993-10-05 | 1997-04-15 | Smithkline Beecham Plc | Pharmaceutical compositions comprising penciclovir and/or its bioprecursor and/or its derivatives for the treatment and prophylaxis of post-herpetic neuralgia |
JP3702594B2 (ja) * | 1997-08-07 | 2005-10-05 | 株式会社明電舎 | パラメータ調節方法及び装置 |
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1996
- 1996-01-16 GB GBGB9600847.9A patent/GB9600847D0/en active Pending
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1997
- 1997-01-02 AP APAP/P/1997/000911A patent/AP747A/en active
- 1997-01-10 UY UY24437A patent/UY24437A1/es not_active IP Right Cessation
- 1997-01-13 SK SK956-98A patent/SK282132B6/sk not_active IP Right Cessation
- 1997-01-13 EP EP97901539A patent/EP0874632B1/en not_active Expired - Lifetime
- 1997-01-13 AP APAP/P/1998/001298A patent/AP1114A/en active
- 1997-01-13 UA UA98063199A patent/UA63897C2/uk unknown
- 1997-01-13 AT AT97901539T patent/ATE220910T1/de active
- 1997-01-13 ES ES97901539T patent/ES2180922T3/es not_active Expired - Lifetime
- 1997-01-13 TR TR1998/00954T patent/TR199800954T2/xx unknown
- 1997-01-13 HU HU9901021A patent/HU225472B1/hu unknown
- 1997-01-13 EA EA199800573A patent/EA001946B1/ru not_active IP Right Cessation
- 1997-01-13 PL PL97327922A patent/PL187291B1/pl unknown
- 1997-01-13 IL IL12491397A patent/IL124913A0/xx not_active IP Right Cessation
- 1997-01-13 US US09/101,926 patent/US6765007B1/en not_active Expired - Lifetime
- 1997-01-13 CZ CZ19982254A patent/CZ287205B6/cs not_active IP Right Cessation
- 1997-01-13 BR BR9706982A patent/BR9706982A/pt not_active IP Right Cessation
- 1997-01-13 DE DE69714215T patent/DE69714215T2/de not_active Expired - Lifetime
- 1997-01-13 DK DK97901539T patent/DK0874632T3/da active
- 1997-01-13 KR KR1019980705371A patent/KR100338829B1/ko not_active IP Right Cessation
- 1997-01-13 WO PCT/EP1997/000195 patent/WO1997025990A1/en active IP Right Grant
- 1997-01-13 JP JP52569297A patent/JP4711360B2/ja not_active Expired - Lifetime
- 1997-01-13 CN CN97191703A patent/CN1132582C/zh not_active Expired - Lifetime
- 1997-01-13 AU AU15418/97A patent/AU713090B2/en not_active Expired
- 1997-01-13 PT PT97901539T patent/PT874632E/pt unknown
- 1997-01-13 NZ NZ326769A patent/NZ326769A/xx not_active IP Right Cessation
- 1997-01-14 EG EG4697A patent/EG23684A/xx active
- 1997-01-14 AR ARP970100130A patent/AR005456A1/es active IP Right Grant
- 1997-01-14 TW TW086100335A patent/TW434016B/zh not_active IP Right Cessation
- 1997-01-15 DZ DZ970004A patent/DZ2159A1/fr active
- 1997-01-15 ZA ZA9700310A patent/ZA97310B/xx unknown
- 1997-01-15 PE PE1997000022A patent/PE35498A1/es not_active IP Right Cessation
- 1997-01-15 MY MYPI97000137A patent/MY127527A/en unknown
- 1997-05-16 UY UY24556A patent/UY24556A1/es not_active IP Right Cessation
-
1998
- 1998-07-15 NO NO19983259A patent/NO315689B1/no not_active IP Right Cessation
- 1998-07-15 MX MX9805713A patent/MX9805713A/es unknown
- 1998-07-15 BG BG102638A patent/BG63488B1/bg unknown
- 1998-07-16 OA OA9800116A patent/OA10812A/en unknown
-
1999
- 1999-04-08 HK HK99101423A patent/HK1016473A1/xx not_active IP Right Cessation
-
2003
- 2003-11-28 CY CY0300085A patent/CY2390B1/xx unknown
-
2008
- 2008-11-19 JP JP2008295818A patent/JP2009091362A/ja active Pending
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FR2671970A1 (fr) * | 1991-01-30 | 1992-07-31 | Wellcome Found | Comprimes dispersables dans l'eau. |
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