EP1643975A2 - 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 lipidiqueInfo
- Publication number
- EP1643975A2 EP1643975A2 EP04777483A EP04777483A EP1643975A2 EP 1643975 A2 EP1643975 A2 EP 1643975A2 EP 04777483 A EP04777483 A EP 04777483A EP 04777483 A EP04777483 A EP 04777483A EP 1643975 A2 EP1643975 A2 EP 1643975A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- admixture
- granulated
- drag
- drug
- lipid
- Prior art date
- 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.)
- Withdrawn
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 31
- 239000003741 agents affecting lipid metabolism Substances 0.000 title claims abstract description 16
- 238000009472 formulation Methods 0.000 title claims abstract description 16
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 11
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 15
- 239000004094 surface-active agent Substances 0.000 claims abstract description 12
- 229940079593 drug Drugs 0.000 claims abstract description 11
- 239000003814 drug Substances 0.000 claims abstract description 11
- 238000001035 drying Methods 0.000 claims abstract description 11
- 239000002904 solvent Substances 0.000 claims abstract description 7
- 239000002552 dosage form Substances 0.000 claims abstract description 5
- 238000000034 method Methods 0.000 claims description 31
- 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
- 229920000036 polyvinylpyrrolidone Polymers 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
- 239000008107 starch Substances 0.000 claims description 3
- 235000019698 starch Nutrition 0.000 claims description 3
- 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 2
- 239000012530 fluid Substances 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 208000031226 Hyperlipidaemia Diseases 0.000 claims 3
- 239000013583 drug formulation Substances 0.000 claims 2
- 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
- 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 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
- -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
- 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
Definitions
- the present invention relates to a new process for preparing solid formulations of lipid- regulating drugs.
- U.S. Patent No. 4,961,890 discloses a process for preparing a controlled release formulation containing fenofibrate in an intermediate layer in the form of crystalline microparticles included within pores of an inert matrix.
- the formulation is prepared by a process involving the sequential steps of dampening said inert core with a solution based on said binder, then projecting said fenofibrate microparticles in a single layer onto said dampened core, and thereafter drying, before said solution based on said binder dissolves said fenofibrate microparticles, and repeating said three steps in sequence until said intermediate layer is formed.
- EP0793958A2 discloses a process for producing a fenofibrate solid dosage form utilizing fenofibrate, a surface active drug and polyvinyl pyrrolidone in which the fenofibrate particles are mixed with a polyvinyl pyrrolidone solution. The thus obtained mixture is granulated with an aqueous solution of one or more surface active drugs, and the granules thus produced are dried.
- PCT Publication No. WO 82/01649 discloses a fenofibrate formulation having granules that are comprised of a neutral core that is a mixture of saccharose and starch.
- the neutral core is covered with a first layer of fenofibrate, admixed with an excipient and with a second micropor- ous outer layer of an edible polymer.
- U.S. Patent No. 5,645,856 discloses the use of a carrier for hydrophobic drugs, including fenofibrate, and pharmaceutical compositions based thereon.
- the carrier comprises a digestible oil and a pharmaceutically-acceptable surfactant component for dispersing the oil in vivo upon administration of the carrier, which comprises a hydrophilic surfactant, said surfactant component being such as not to substantially inhibit the in vivo lipolysis of the digestible oil.
- 6,383,517 discloses a process for preparing a solid formulation of fenofibrate comprising dissolving the fenofibrate in a surfactant solution, premixing an excipient, wet granulating the mixture, drying the mixture and forming a finished dosage form.
- the prior art processes obtain small particles of fenofibrate by the use of co- micronization steps and/or require the presence of surfactants. These processes result in formulations that may not have maximized dissolution characteristics, and may cause gastro intestinal irritation.
- the present invention is directed to a process for preparing a solid formulation of a lipid- regulating drug.
- the process comprises dissolving the lipid-regulating drug in a solvent free of surfactants, premixing one or more excipients to generate an admixture, wet granulating the lipid- regulating drug solution and the premix to form a granulated drug admixture and drying the mixture.
- the dried granulated admixture may then be sized and formed into a final dosage form.
- the mixture may be granulated by techniques well-known in the art, preferably by a fluidized bed or by means of a low shear or high shear mixer.
- the final oral dosage form may be prepared by techniques well-known to those skilled in the art by sizing the mixture and dry blending the resultant particles with excipients into the final oral dosage form, preferably as a tablet or capsule.
- the formulation thus produced may be administered directly as a granulated product, diluted into an appropriate vehicle for administration, encapsulated into hard gelatin shells or capsules for administration, or administered by other means obvious to those skilled in the art.
- the lipid regulating drug may be any suitable pharmaceutically active compound, preferably a fibrate and more preferably fenofibrate.
- the bulk lipid-regulating drug can be prepared by any available method, as for example the compound fenofibrate may be prepared by the procedure disclosed in U.S. Patent No.
- lipid-regulating drug is then dissolved in a solution with a suitable solvent such as, for example, acetone, methylene chloride, ethanol or chloroform in amounts ranging from 0.5 to
- a premix of excipients is prepared by conventional techniques. Suitable excipients include, for example, binders, fillers and disintegrants such as lactose, starch, polyvinyl pyrrolidone, sodium starch glycolate and microcrystalline cellulose.
- the lipid-regulating drug solution and excipient premix are then mixed together.
- the resulting mixture is then granulated, for example, in a fluidized bed or a low or high shear mixer and dried by well-known solvent evaporation techniques, as for example, spray drying, fluid bed, tray drying, rotary atomizing, spinning disk drying, or evaporation under atmospheric or reduced pressure.
- the resultant material may then be sized, if necessary and formulated into a finished dosage form, for example, a tablet or capsule by conventional techniques such as direct compression or other means.
- a finished dosage form for example, a tablet or capsule by conventional techniques such as direct compression or other means.
- the elimination of the surfactant results in a process having reduced raw material and capital costs, ease of manufacture, potential reduction of gastrointestinal side effects and the ability to prepare tablets and capsules more readily.
- Example 2 Fenofibrate (25g) was dissolved in 10 mL acetone. Lactose anhydrous (57g), Aircel pH 101 (lOg), Povidone K30 (4g) and sodium starch glycolate (4g) were premixed. The premix was mixed with above solution. The wet mass was tray dried in an oven at 40-55 C. The dried solid was milled, sieved through a screen and the 30-120 mesh portion collected. The collected particles were filled into a hard gelatin capsule.
- Example 3 In vitro dissolution rates of the capsules produced in Examples 1 and 2 were compared with that of the reference, Lipanthyl, the marketed capsule product, which contains the same amount of the active. USP apparatus II was used for testing.
- in vitro dissolution profiles of the reference capsules and capsules of the present invention are shown in Figure 1. The data indicate that the dissolution rate of representative capsules of the present invention are comparable to the reference capsules. Based on U.S. Patent No. 4,895,726, in vitro dissolution results can be correlated to in vivo absorption in humans. Thus, equivalent or increased dissolution in vitro can result in bioavailability equivalent to the reference in humans.
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)
Abstract
L'invention concerne un procédé de préparation d'un produit formulé d'un médicament de régulation du métabolisme lipidique, qui consiste à dissoudre ledit médicament de régulation du métabolisme lipidique dans un solvant exempt de tensioactif, à pré-mélanger un excipient, à granuler par voie humide le mélange solution médicamenteuse/excipient, à faire sécher le mélange et à former une forme posologique finale.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US61362203A | 2003-07-02 | 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 (1)
| Publication Number | Publication Date |
|---|---|
| EP1643975A2 true EP1643975A2 (fr) | 2006-04-12 |
Family
ID=33564305
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP04777483A Withdrawn EP1643975A2 (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)
| 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
Non-Patent Citations (1)
| Title |
|---|
| See references of WO2005002541A2 * |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2005002541A2 (fr) | 2005-01-13 |
| CA2531097C (fr) | 2012-10-09 |
| JP2012149078A (ja) | 2012-08-09 |
| 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 |
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Legal Events
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| DAX | Request for extension of the european patent (deleted) | ||
| 17Q | First examination report despatched |
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| RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: ABBVIE INC. |
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| STAA | Information on the status of an ep patent application or granted ep patent |
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| 18D | Application deemed to be withdrawn |
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