CA2531097C - Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique - Google Patents

Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique Download PDF

Info

Publication number: CA2531097C
Authority: CA; Canada
Prior art keywords: admixture; drug; granulated; lipid; regulating
Prior art date: 2003-07-02
Legal status (The legal status 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 status listed.): Expired - Fee Related

Application number

CA2531097A

Other languages

English (en)

Other versions

CA2531097A1 (fr

Inventor

Yihong Qiu

Jacqueline Wardrop

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

AbbVie Inc

Original Assignee

Abbott Laboratories

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.)

2003-07-02

Filing date

2004-07-02

Publication date

2012-10-09

2004-07-02 Application filed by Abbott Laboratories filed Critical Abbott Laboratories

2005-01-13 Publication of CA2531097A1 publication Critical patent/CA2531097A1/fr

2012-10-09 Application granted granted Critical

2012-10-09 Publication of CA2531097C publication Critical patent/CA2531097C/fr

2024-07-02 Anticipated expiration legal-status Critical

Status Expired - Fee Related legal-status Critical Current

Links

239000003741 agents affecting lipid metabolism Substances 0.000 title claims abstract description 21
238000004519 manufacturing process Methods 0.000 title claims abstract description 11
239000000203 mixture Substances 0.000 title abstract description 25
238000009472 formulation Methods 0.000 title abstract description 12
229940079593 drug Drugs 0.000 claims abstract description 17
239000003814 drug Substances 0.000 claims abstract description 17
239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 14
239000004094 surface-active agent Substances 0.000 claims abstract description 12
238000001035 drying Methods 0.000 claims abstract description 11
239000002904 solvent Substances 0.000 claims abstract description 8
239000002552 dosage form Substances 0.000 claims abstract description 5
238000000034 method Methods 0.000 claims description 23
229960002297 fenofibrate Drugs 0.000 claims description 21
YMTINGFKWWXKFG-UHFFFAOYSA-N fenofibrate Chemical compound C1=CC(OC(C)(C)C(=O)OC(C)C)=CC=C1C(=O)C1=CC=C(Cl)C=C1 YMTINGFKWWXKFG-UHFFFAOYSA-N 0.000 claims description 20
239000002775 capsule Substances 0.000 claims description 13
229940125753 fibrate Drugs 0.000 claims description 4
239000001267 polyvinylpyrrolidone Substances 0.000 claims description 4
235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
229920002472 Starch Polymers 0.000 claims description 3
238000001704 evaporation Methods 0.000 claims description 3
GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 3
229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
239000008107 starch Substances 0.000 claims description 3
235000019698 starch Nutrition 0.000 claims description 3
239000012530 fluid Substances 0.000 claims description 2
239000008101 lactose Substances 0.000 claims description 2
239000013583 drug formulation Substances 0.000 claims 3
HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
235000019359 magnesium stearate Nutrition 0.000 claims 1
238000004090 dissolution Methods 0.000 description 11
239000000243 solution Substances 0.000 description 11
CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 6
239000002245 particle Substances 0.000 description 6
238000000338 in vitro Methods 0.000 description 5
239000007787 solid Substances 0.000 description 5
150000001875 compounds Chemical class 0.000 description 4
239000008187 granular material Substances 0.000 description 4
239000010410 layer Substances 0.000 description 4
238000012360 testing method Methods 0.000 description 4
YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 3
239000011230 binding agent Substances 0.000 description 3
238000001727 in vivo Methods 0.000 description 3
239000011859 microparticle Substances 0.000 description 3
229920003109 sodium starch glycolate Polymers 0.000 description 3
229940079832 sodium starch glycolate Drugs 0.000 description 3
239000008109 sodium starch glycolate Substances 0.000 description 3
GUBGYTABKSRVRQ-DCSYEGIMSA-N Beta-Lactose Chemical compound OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-DCSYEGIMSA-N 0.000 description 2
HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 description 2
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
229920003081 Povidone K 30 Polymers 0.000 description 2
238000010521 absorption reaction Methods 0.000 description 2
239000000306 component Substances 0.000 description 2
-1 compound fenofibrate Chemical class 0.000 description 2
238000007796 conventional method Methods 0.000 description 2
239000012738 dissolution medium Substances 0.000 description 2
MQOBSOSZFYZQOK-UHFFFAOYSA-N fenofibric acid Chemical compound C1=CC(OC(C)(C)C(O)=O)=CC=C1C(=O)C1=CC=C(Cl)C=C1 MQOBSOSZFYZQOK-UHFFFAOYSA-N 0.000 description 2
239000007903 gelatin capsule Substances 0.000 description 2
230000007935 neutral effect Effects 0.000 description 2
239000006186 oral dosage form Substances 0.000 description 2
229940032147 starch Drugs 0.000 description 2
238000000870 ultraviolet spectroscopy Methods 0.000 description 2
206010070840 Gastrointestinal tract irritation Diseases 0.000 description 1
108010010803 Gelatin Proteins 0.000 description 1
229920000168 Microcrystalline cellulose Polymers 0.000 description 1
229930006000 Sucrose Natural products 0.000 description 1
CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
239000003524 antilipemic agent Substances 0.000 description 1
239000007864 aqueous solution Substances 0.000 description 1
238000010420 art technique Methods 0.000 description 1
238000013270 controlled release Methods 0.000 description 1
230000002596 correlated effect Effects 0.000 description 1
235000013681 dietary sucrose Nutrition 0.000 description 1
238000007907 direct compression Methods 0.000 description 1
239000007884 disintegrant Substances 0.000 description 1
230000000694 effects Effects 0.000 description 1
230000008030 elimination Effects 0.000 description 1
238000003379 elimination reaction Methods 0.000 description 1
230000008020 evaporation Effects 0.000 description 1
239000000945 filler Substances 0.000 description 1
230000002496 gastric effect Effects 0.000 description 1
229920000159 gelatin Polymers 0.000 description 1
239000008273 gelatin Substances 0.000 description 1
235000019322 gelatine Nutrition 0.000 description 1
235000011852 gelatine desserts Nutrition 0.000 description 1
230000002209 hydrophobic effect Effects 0.000 description 1
230000004130 lipolysis Effects 0.000 description 1
239000000463 material Substances 0.000 description 1
239000011159 matrix material Substances 0.000 description 1
229940016286 microcrystalline cellulose Drugs 0.000 description 1
235000019813 microcrystalline cellulose Nutrition 0.000 description 1
239000008108 microcrystalline cellulose Substances 0.000 description 1
238000002156 mixing Methods 0.000 description 1
239000008194 pharmaceutical composition Substances 0.000 description 1
239000008180 pharmaceutical surfactant Substances 0.000 description 1
229920000642 polymer Polymers 0.000 description 1
239000011148 porous material Substances 0.000 description 1
239000002994 raw material Substances 0.000 description 1
239000002356 single layer Substances 0.000 description 1
238000004513 sizing Methods 0.000 description 1
239000007909 solid dosage form Substances 0.000 description 1
238000000935 solvent evaporation Methods 0.000 description 1
238000009987 spinning Methods 0.000 description 1
238000001694 spray drying Methods 0.000 description 1
229960004793 sucrose Drugs 0.000 description 1

Classifications

- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
- 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
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
- 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
- A61K9/1635—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
- A61K9/14—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics

Landscapes

Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Life Sciences & Earth Sciences (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Veterinary Medicine (AREA)
Animal Behavior & Ethology (AREA)
Epidemiology (AREA)
Biophysics (AREA)
Molecular Biology (AREA)
Emergency Medicine (AREA)
Diabetes (AREA)
Hematology (AREA)
Obesity (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Medicinal Preparation (AREA)

CA2531097A 2003-07-02 2004-07-02 Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique Expired - Fee Related CA2531097C (fr)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US61362203A	2003-07-02	2003-07-02
US10/613,622		2003-07-02
PCT/US2004/021361 WO2005002541A2 (fr)	2003-07-02	2004-07-02	Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique

Publications (2)

Publication Number	Publication Date
CA2531097A1 CA2531097A1 (fr)	2005-01-13
CA2531097C true CA2531097C (fr)	2012-10-09

Family

ID=33564305

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
CA2531097A Expired - Fee Related CA2531097C (fr)	2003-07-02	2004-07-02	Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique

Country Status (5)

Country	Link
EP (1)	EP1643975A2 (fr)
JP (2)	JP5134818B2 (fr)
CA (1)	CA2531097C (fr)
MX (1)	MXPA06000111A (fr)
WO (1)	WO2005002541A2 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
FR2494112B1 (fr) *	1980-11-19	1986-01-10	Laruelle Claude
JPH04103525A (ja) *	1990-08-22	1992-04-06	Sanwa Kagaku Kenkyusho Co Ltd	難水溶性薬物の持続性製剤化方法
DE4317127A1 (de) *	1993-05-19	1994-11-24	Merz & Co Gmbh & Co	Verwendung von Etofibrat und pharmazeutische Zusammensetzungen, enthaltend Etofibrat, zur Behandlung der diabetischen Angio- und Retinopathie
GB9806312D0 (en) *	1998-03-24	1998-05-20	Smithkline Beecham Plc	Novel formulations
US6383517B1 (en) *	1999-01-29	2002-05-07	Abbott Laboratories	Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption
FR2795961B1 (fr) *	1999-07-09	2004-05-28	Ethypharm Lab Prod Ethiques	Composition pharmaceutique contenant du fenofibrate micronise, un tensioactif et un derive cellulosique liant et procede de preparation

2004
- 2004-07-02 CA CA2531097A patent/CA2531097C/fr not_active Expired - Fee Related
- 2004-07-02 MX MXPA06000111A patent/MXPA06000111A/es active IP Right Grant
- 2004-07-02 EP EP04777483A patent/EP1643975A2/fr not_active Withdrawn
- 2004-07-02 WO PCT/US2004/021361 patent/WO2005002541A2/fr not_active Ceased
- 2004-07-02 JP JP2006518798A patent/JP5134818B2/ja not_active Expired - Fee Related
2012
- 2012-03-21 JP JP2012063143A patent/JP2012149078A/ja active Pending

Also Published As

Publication number	Publication date
WO2005002541A2 (fr)	2005-01-13
JP2012149078A (ja)	2012-08-09
EP1643975A2 (fr)	2006-04-12
MXPA06000111A (es)	2006-04-27
CA2531097A1 (fr)	2005-01-13
WO2005002541A3 (fr)	2005-09-15
JP2007530415A (ja)	2007-11-01
JP5134818B2 (ja)	2013-01-30

Legal Events

Date	Code	Title	Description
2009-06-25	EEER	Examination request
2015-08-13	MKLA	Lapsed	Effective date: 20150702

Publication	Publication Date	Title
US6180138B1 (en)	2001-01-30	Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption
US6383517B1 (en)	2002-05-07	Process for preparing solid formulations of lipid-regulating agents with enhanced dissolution and absorption
US6465011B2 (en)	2002-10-15	Formulations comprising lipid-regulating agents
US4343789A (en)	1982-08-10	Sustained release pharmaceutical composition of solid medical material
KR100766644B1 (ko)	2007-10-15	페노피브레이트를 포함하는 약학적 조성물
US7976869B2 (en)	2011-07-12	Fenofibrate tablets
US6368622B2 (en)	2002-04-09	Process for preparing solid formulations of lipid regulating agents with enhanced dissolution and absorption
US20090292016A1 (en)	2009-11-26	Stable Pharmaceutical Compositions Containing Pravastatin
WO2000072829A1 (fr)	2000-12-07	Formulations comprenant des agents regulateurs des lipides
US8062664B2 (en)	2011-11-22	Process for preparing formulations of lipid-regulating drugs
US20100021393A1 (en)	2010-01-28	Pharmaceutical Compositions Comprising Effervescent Agents and Fenofibrate
CA2531097C (fr)	2012-10-09	Procede de preparation de produits formules de medicaments de regulation du metabolisme lipidique
US20060177512A1 (en)	2006-08-10	Process for preparing formulations of lipid-regulating drugs
WO2004010979A1 (fr)	2004-02-05	Procede de preparation de formulations orales de modafinil
WO2010131265A1 (fr)	2010-11-18	Nouvelles compositions pharmaceutiques de fénofibrate de choline
AU2002314915A1 (en)	2003-01-08	Stable pharmaceutical compositions containing pravastatin