ZA200602497B - Pharmaceutical compositions of moxifloxacin and processes for their preparation - Google Patents

Pharmaceutical compositions of moxifloxacin and processes for their preparation Download PDF

Info

Publication number: ZA200602497B
Authority: ZA; South Africa
Prior art keywords: pharmaceutical composition; water insoluble; substantially water; moxifloxacin; tablet
Prior art date: 2003-09-03

Application number

ZA200602497A

Other languages

English (en)

Inventor

Singh Romi Barat

Kumar Pananchukunnath Manoj

Nagaprasad Vishnubhotla

Sethi Sanjeev Kumar

Malik Rajiv

Original Assignee

Ranbaxy Lab Ltd

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.)

2003-09-03

Filing date

2006-03-27

Publication date

2007-09-26

2006-03-27 Application filed by Ranbaxy Lab Ltd filed Critical Ranbaxy Lab Ltd

2007-09-26 Publication of ZA200602497B publication Critical patent/ZA200602497B/en

Links

238000000034 method Methods 0.000 title claims description 26
239000008194 pharmaceutical composition Substances 0.000 title claims description 24
FABPRXSRWADJSP-MEDUHNTESA-N moxifloxacin Chemical group COC1=C(N2C[C@H]3NCCC[C@H]3C2)C(F)=CC(C(C(C(O)=O)=C2)=O)=C1N2C1CC1 FABPRXSRWADJSP-MEDUHNTESA-N 0.000 title claims description 23
229960003702 moxifloxacin Drugs 0.000 title claims description 19
238000002360 preparation method Methods 0.000 title description 3
239000000546 pharmaceutical excipient Substances 0.000 claims description 36
239000000203 mixture Substances 0.000 claims description 31
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 29
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 26
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 22
229940075614 colloidal silicon dioxide Drugs 0.000 claims description 20
229920000168 Microcrystalline cellulose Polymers 0.000 claims description 19
239000000314 lubricant Substances 0.000 claims description 19
235000019813 microcrystalline cellulose Nutrition 0.000 claims description 19
239000008108 microcrystalline cellulose Substances 0.000 claims description 19
229940016286 microcrystalline cellulose Drugs 0.000 claims description 19
239000007884 disintegrant Substances 0.000 claims description 16
229920002785 Croscarmellose sodium Polymers 0.000 claims description 15
229920000881 Modified starch Polymers 0.000 claims description 15
DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 15
239000011230 binding agent Substances 0.000 claims description 15
229960001681 croscarmellose sodium Drugs 0.000 claims description 15
235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 15
235000019359 magnesium stearate Nutrition 0.000 claims description 13
150000003839 salts Chemical class 0.000 claims description 13
RBLGLDWTCZMLRW-UHFFFAOYSA-K dicalcium;phosphate;dihydrate Chemical compound O.O.[Ca+2].[Ca+2].[O-]P([O-])([O-])=O RBLGLDWTCZMLRW-UHFFFAOYSA-K 0.000 claims description 12
239000000945 filler Substances 0.000 claims description 10
235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 10
229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 10
239000001267 polyvinylpyrrolidone Substances 0.000 claims description 9
238000002156 mixing Methods 0.000 claims description 8
235000010980 cellulose Nutrition 0.000 claims description 7
229920002678 cellulose Polymers 0.000 claims description 7
239000001913 cellulose Substances 0.000 claims description 7
239000003086 colorant Substances 0.000 claims description 7
239000008187 granular material Substances 0.000 claims description 7
239000002775 capsule Substances 0.000 claims description 6
235000014113 dietary fatty acids Nutrition 0.000 claims description 6
-1 disintegerants Substances 0.000 claims description 6
239000000194 fatty acid Substances 0.000 claims description 6
229930195729 fatty acid Natural products 0.000 claims description 6
150000004665 fatty acids Chemical class 0.000 claims description 6
229920002153 Hydroxypropyl cellulose Polymers 0.000 claims description 5
GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 5
239000001863 hydroxypropyl cellulose Substances 0.000 claims description 5
235000010977 hydroxypropyl cellulose Nutrition 0.000 claims description 5
239000008101 lactose Substances 0.000 claims description 5
235000019426 modified starch Nutrition 0.000 claims description 5
235000000346 sugar Nutrition 0.000 claims description 5
150000005846 sugar alcohols Chemical class 0.000 claims description 5
150000008163 sugars Chemical class 0.000 claims description 5
239000000454 talc Substances 0.000 claims description 5
229910052623 talc Inorganic materials 0.000 claims description 5
229920002261 Corn starch Polymers 0.000 claims description 4
239000008120 corn starch Substances 0.000 claims description 3
SKZIMSDWAIZNDD-WJMOHVQJSA-N 7-[(4as,7as)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid;hydrate;hydrochloride Chemical compound O.Cl.COC1=C(N2C[C@H]3NCCC[C@H]3C2)C(F)=CC(C(C(C(O)=O)=C2)=O)=C1N2C1CC1 SKZIMSDWAIZNDD-WJMOHVQJSA-N 0.000 claims description 2
239000011248 coating agent Substances 0.000 claims description 2
238000000576 coating method Methods 0.000 claims description 2
238000004519 manufacturing process Methods 0.000 claims description 2
239000003826 tablet Substances 0.000 claims 6
239000008213 purified water Substances 0.000 description 12
229920002554 vinyl polymer Polymers 0.000 description 11
238000009472 formulation Methods 0.000 description 6
239000004615 ingredient Substances 0.000 description 5
229960005112 moxifloxacin hydrochloride Drugs 0.000 description 5
IDIIJJHBXUESQI-DFIJPDEKSA-N moxifloxacin hydrochloride Chemical compound Cl.COC1=C(N2C[C@H]3NCCC[C@H]3C2)C(F)=CC(C(C(C(O)=O)=C2)=O)=C1N2C1CC1 IDIIJJHBXUESQI-DFIJPDEKSA-N 0.000 description 5
235000019739 Dicalciumphosphate Nutrition 0.000 description 4
229940062316 avelox Drugs 0.000 description 4
239000001506 calcium phosphate Substances 0.000 description 4
NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 4
229940038472 dicalcium phosphate Drugs 0.000 description 4
229910000390 dicalcium phosphate Inorganic materials 0.000 description 4
238000005469 granulation Methods 0.000 description 4
230000003179 granulation Effects 0.000 description 4
239000007916 tablet composition Substances 0.000 description 4
QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical class CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
229920002472 Starch Polymers 0.000 description 3
239000006185 dispersion Substances 0.000 description 3
239000002552 dosage form Substances 0.000 description 3
239000008107 starch Substances 0.000 description 3
235000019698 starch Nutrition 0.000 description 3
VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical class Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
239000002253 acid Substances 0.000 description 2
MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 2
238000009826 distribution Methods 0.000 description 2
239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 2
235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 2
229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 2
UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 2
JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical class CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
239000006186 oral dosage form Substances 0.000 description 2
229940124531 pharmaceutical excipient Drugs 0.000 description 2
239000000825 pharmaceutical preparation Substances 0.000 description 2
229920006316 polyvinylpyrrolidine Polymers 0.000 description 2
239000012453 solvate Substances 0.000 description 2
HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
206010061736 Bronchitis bacterial Diseases 0.000 description 1
235000019759 Maize starch Nutrition 0.000 description 1
WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
206010035664 Pneumonia Diseases 0.000 description 1
239000002202 Polyethylene glycol Substances 0.000 description 1
QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical class OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 1
235000011054 acetic acid Nutrition 0.000 description 1
230000001154 acute effect Effects 0.000 description 1
229960005475 antiinfective agent Drugs 0.000 description 1
239000004599 antimicrobial Substances 0.000 description 1
230000001580 bacterial effect Effects 0.000 description 1
239000002585 base Substances 0.000 description 1
229960003405 ciprofloxacin Drugs 0.000 description 1
150000001875 compounds Chemical class 0.000 description 1
230000001186 cumulative effect Effects 0.000 description 1
230000001419 dependent effect Effects 0.000 description 1
238000004090 dissolution Methods 0.000 description 1
239000002706 dry binder Substances 0.000 description 1
239000012458 free base Substances 0.000 description 1
235000011167 hydrochloric acid Nutrition 0.000 description 1
208000015181 infectious disease Diseases 0.000 description 1
239000004310 lactic acid Chemical class 0.000 description 1
235000014655 lactic acid Nutrition 0.000 description 1
238000012986 modification Methods 0.000 description 1
230000004048 modification Effects 0.000 description 1
229940006361 moxifloxacin 400 mg Drugs 0.000 description 1
229920001223 polyethylene glycol Polymers 0.000 description 1
239000000377 silicon dioxide Substances 0.000 description 1
201000009890 sinusitis Diseases 0.000 description 1
239000001117 sulphuric acid Chemical class 0.000 description 1
235000011149 sulphuric acid Nutrition 0.000 description 1

Classifications

- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—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
- A61K31/33—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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4709—Non-condensed quinolines and containing further heterocyclic rings
- 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
- A61K9/2009—Inorganic compounds
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
- 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

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Inorganic Chemistry (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Medicinal Preparation (AREA)

ZA200602497A 2003-09-03 2006-03-27 Pharmaceutical compositions of moxifloxacin and processes for their preparation ZA200602497B (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
IN1099DE2003		2003-09-03

Publications (1)

Publication Number	Publication Date
ZA200602497B true ZA200602497B (en)	2007-09-26

Family

ID=34259939

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
ZA200602497A ZA200602497B (en)	2003-09-03	2006-03-27	Pharmaceutical compositions of moxifloxacin and processes for their preparation

Country Status (3)

Country	Link
EP (1)	EP1663226A1 (de)
WO (1)	WO2005020998A1 (de)
ZA (1)	ZA200602497B (de)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2006015545A1 (fr) *	2004-08-11	2006-02-16	Shenzhen Tys R & D Co., Ltd.	Capsule de gelatine de moxifloxacin et procede pour sa preparation
WO2007033522A1 (fr) *	2005-09-21	2007-03-29	Shenzhen Tys R & D Co., Ltd.	Formulation de gélule contenant de la moxifloxacine et son procédé de préparation
CN100363001C (zh) *	2005-09-21	2008-01-23	深圳市天一时科技开发有限公司	一种莫西沙星胶囊剂及其制备方法
WO2007033515A1 (fr) *	2005-09-21	2007-03-29	Shenzhen Tys R & D Co., Ltd.	Formulation orale contenant de la moxifloxacine et son procédé de préparation
EP2291177A2 (de) *	2008-05-05	2011-03-09	Farmaprojects, S.A.	Stabile pharmazeutische zusammensetzungen und ihre herstellungsverfahren im industriemassstab
WO2010066385A1 (de)	2008-12-08	2010-06-17	Ratiopharm Gmbh	Kompaktiertes moxifloxacin
CN102247313A (zh) *	2010-06-11	2011-11-23	北京润德康医药技术有限公司	一种以莫西沙星为活性成分的口服缓释固体制剂
BRPI1106900A2 (pt)	2011-12-26	2013-11-05	Ems Sa	Composição farmacêutica sólida compreendendo antibótico da familia das quinolonas e processo de sua obtenção
GR1008169B (el) *	2013-03-19	2014-04-08	"Φαρματεν Α.Β.Ε.Ε.",	Φαρμακευτικο σκευασμα περιεχον εναν αντιβακτηριακο παραγοντα φθοριοκινολονης και μεθοδος για την παρασκευη αυτου
CN104622821B (zh) *	2013-11-13	2018-04-10	武汉先路医药科技有限公司	解决溶出行为受制粒时间影响问题的莫西沙星片剂配方
CN106074413A (zh) *	2016-07-20	2016-11-09	南通雅本化学有限公司	一种含有莫西沙星的药物组合物
CN109045034B (zh) *	2018-09-29	2021-04-13	哈尔滨珍宝制药有限公司	一种盐酸莫西沙星药物组合物及其制备方法和应用
WO2021257461A1 (en) *	2020-06-15	2021-12-23	Mylan Laboratories Limited	Combination antibacterial composition and method for antibacterial therapy
EP4164645A4 (de) *	2020-06-15	2024-07-10	The Global Alliance for TB Drug Development, Inc.	Antibakterielle kombinationszusammensetzung und antibakterielles therapieverfahren

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE3906365A1 (de) *	1988-07-15	1990-01-18	Bayer Ag	7-(1-pyrrolidinyl)-3-chinolon- und -naphthyridoncarbonsaeure-derivate, verfahren sowie substituierte (oxa)diazabicyclooctane und -nonane als zwischenprodukte zu ihrer herstellung, und sie enthaltende antibakterielle mittel und futterzusatzstoffe
TR200101310T2 (tr) *	1998-11-10	2001-10-22	Bayer Aktiengesellschaft	Farmasötik moksifloksasin preparatı.

2004
- 2004-09-03 EP EP04769278A patent/EP1663226A1/de not_active Withdrawn
- 2004-09-03 WO PCT/IB2004/002875 patent/WO2005020998A1/en not_active Ceased
2006
- 2006-03-27 ZA ZA200602497A patent/ZA200602497B/en unknown

Also Published As

Publication number	Publication date
EP1663226A1 (de)	2006-06-07
WO2005020998A1 (en)	2005-03-10

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