CA2531097A1 - Process for preparing formulations of lipid-regulating drugs - Google Patents

Process for preparing formulations of lipid-regulating drugs Download PDF

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Publication number
CA2531097A1
CA2531097A1 CA002531097A CA2531097A CA2531097A1 CA 2531097 A1 CA2531097 A1 CA 2531097A1 CA 002531097 A CA002531097 A CA 002531097A CA 2531097 A CA2531097 A CA 2531097A CA 2531097 A1 CA2531097 A1 CA 2531097A1
Authority
CA
Canada
Prior art keywords
admixture
drug
granulated
lipid
excipient
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.)
Granted
Application number
CA002531097A
Other languages
French (fr)
Other versions
CA2531097C (en
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.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Yihong Qiu
Jacqueline Wardrop
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.)
Filing date
Publication date
Application filed by Abbott Laboratories, Yihong Qiu, Jacqueline Wardrop filed Critical Abbott Laboratories
Publication of CA2531097A1 publication Critical patent/CA2531097A1/en
Application granted granted Critical
Publication of CA2531097C publication Critical patent/CA2531097C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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

Abstract

A process for preparing a formulation of a lipid-regulating drug comprising dissolving said lipid-regulating drug in a solvent free of surfactant, premixing an excipient, wet granulating the drug solution/excipient mixture, drying the mixture and forming a final dosage form.

Claims (18)

1. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture;
and drying the granulated admixture.
2. The process of claim 1 wherein the lipid-regulating drug is a fibrate.
3. The process of claim 2 wherein the fibrate is fenofibrate.
4. The process of claim 1 wherein the drying step includes evaporating the solvent.
5. The process of claim 4 wherein the evaporating is performed under vacuum.
6. The process of claim 1 wherein the drying step is accomplished using a fluid bed, tray dryer or rotary atomizer.
7. The process of claim 1 comprising the additional step of adding other excipients.
8. The process of claim 1 comprising the additional step of forming a final dosage form.
9. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture;
drying the granulated admixture; and tableting the dried granulated admixture.
10. A process for preparing a drug formulation comprising the steps of:
dissolving a lipid-regulating drug in a solvent free of surfactant to form a drug solution;
premixing an excipient to generate an admixture;
wet granulating the admixture and the drug solution to form a granulated drug admixture;
drying the granulated admixture; and filling capsules with the dried granulated admixture.
11. The process of claim 1 wherein the excipient is one or more members selected from the group consisting of lactose, starch, polyvinyl pyrrolidone, magnesium stearate, and other pharmaceutically-acceptable excipients.
12. The process of claim 1 wherein the admixture is granulated in a fluidized bed.
13. The process of claim 1 wherein the admixture is granulated in a low shear or high shear mixer.
14. A composition prepared by the process of claim 1.
15. A composition prepared by the process of claim 3.
16. A method for treating of hyperlipidernia comprising the step of administering the final drug formulation prepared by the process of claim 9.
17. A method for treating of hyperlipidernia comprising the step of administering the final drug formulation prepared by the process of claim 10.
18. A method for treating of hyperlipidernia comprising the administration of the formulation prepared by the process of claim 3.
CA2531097A 2003-07-02 2004-07-02 Process for preparing formulations of lipid-regulating drugs Expired - Fee Related CA2531097C (en)

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 (en) 2003-07-02 2004-07-02 Process for preparing formulations of lipid-regulating drugs

Publications (2)

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

Family

ID=33564305

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2531097A Expired - Fee Related CA2531097C (en) 2003-07-02 2004-07-02 Process for preparing formulations of lipid-regulating drugs

Country Status (5)

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

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2494112B1 (en) * 1980-11-19 1986-01-10 Laruelle Claude
JPH04103525A (en) * 1990-08-22 1992-04-06 Sanwa Kagaku Kenkyusho Co Ltd Production of sustainable pharmaceutical preparation for poorly water-soluble medicine
DE4317127A1 (en) * 1993-05-19 1994-11-24 Merz & Co Gmbh & Co Use of etofibrate and pharmaceutical compositions containing etofibrate for the treatment of diabetic angio-and retinopathy
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 (en) * 1999-07-09 2004-05-28 Ethypharm Lab Prod Ethiques PHARMACEUTICAL COMPOSITION CONTAINING MICRONIZED FENOFIBRATE, A SURFACTANT AND A BINDING CELLULOSIC DERIVATIVE AND PREPARATION METHOD

Also Published As

Publication number Publication date
EP1643975A2 (en) 2006-04-12
JP2012149078A (en) 2012-08-09
MXPA06000111A (en) 2006-04-27
JP5134818B2 (en) 2013-01-30
WO2005002541A2 (en) 2005-01-13
WO2005002541A3 (en) 2005-09-15
CA2531097C (en) 2012-10-09
JP2007530415A (en) 2007-11-01

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MKLA Lapsed

Effective date: 20150702