US20030031705A1 - Pharmaceutical composition comprising fenofibrate - Google Patents

Pharmaceutical composition comprising fenofibrate Download PDF

Info

Publication number
US20030031705A1
US20030031705A1 US10/189,009 US18900902A US2003031705A1 US 20030031705 A1 US20030031705 A1 US 20030031705A1 US 18900902 A US18900902 A US 18900902A US 2003031705 A1 US2003031705 A1 US 2003031705A1
Authority
US
United States
Prior art keywords
fenofibrate
disintegrant
solid dispersion
pharmaceutical composition
granules
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.)
Abandoned
Application number
US10/189,009
Inventor
Bernard Sherman
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to US10/189,009 priority Critical patent/US20030031705A1/en
Publication of US20030031705A1 publication Critical patent/US20030031705A1/en
Abandoned legal-status Critical Current

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
    • A61K9/20—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

Definitions

  • the present invention relates to pharmaceutical compositions for oral administration comprising fenofibrate which enable improve dissolution and bioavailability.
  • Fenofibrate is practically insoluble in water. This causes fenofibrate to exhibit a low rate of dissolution in aqueous media (including gastrointestinal fluids), which results in inadequate bioavailability (absorption into systemic circulation) after oral ingestion.
  • micronization In this approach, the drug is milled to fine particles, typically having a mean diameter of only a few microns.
  • a second approach is to include a surfactant in the composition.
  • a composition made according to the invention of U.S. Pat. No. 4,895,726 is sold in Canada as elsewhere under the tradename Lipidil Micro.
  • the need for microcomposition and use of a surfactant adds to the cost of capsules containing fenofibrate.
  • the rate of dissolution and the bioavailability of fenofibrate can be substantially improved by making a solid dispersion of a disintegrant in the fenofibrate.
  • the solid dispersion can be made by heating and melting the fenofibrate, blending the disintegrant into the molten fenofibrate and then cooling and solidifying the mixture.
  • Fenofibrate has a melting point of about 80° C. and can be melted without decomposition.
  • a disintegrant will be understood to be a substance which is hydrophilic and swells upon absorption of water. Disintegrants are used as excipients (inactive ingredients) in pharmaceutical tablets and capsules so that, when a tablet or capsule is ingested, the disintegrant will cause the tablet or capsule to absorb gastrointestinal fluid and, as a result, to swell and disintegrate, so as to release the active drug for dissolution and absorption
  • Disintegrants with very high capacity to absorb water and swell are known as “super-disintegrants”, which include such substances as croscarmellose sodium, sodium starch glycolate and crospovidone.
  • a solid dispersion comprising a disintegrant dispersed in the fenofibrate can be made by melting the fenofibrate blending the disintegrant into the molten fenofibrate and then cooling and solidifying the mixture The solid can then be ground into granules for further processing into tablets or capsules.
  • each granule or particle of the ground-up solid dispersion will be an approximately uniform mixture of fenofibrate and disintegrant.
  • the solid dispersion is thus intrinsically different from a mixture achieved simply by physical mixing of fenofibrate in solid form and disintegrant, because in a physical mix each particle remains either pure fenofibrate or pure disintegrant.
  • ingredients other than the fenofibrate and disintegrant may be included in the molten blend and thus incorporated into the solid dispersion.
  • Such other ingredients may include, for example, water-soluble or water-insoluble ingredients which serve as surfactant, diluent, or for other purposes.
  • This mixture was then filled into 2-piece hard gelatin capsules with a net fill weight of 400 mg per capsule.
  • Each capsule thus contained 250 mg of the solid dispersion, which in turn comprised 200 mg of fenofibrate.

Abstract

The bioavailability of fenofibrate is improved by making a solid dispersion of a disentegrant in the fenofibrate. Method of making said solid dispersion comprising melting the fenofibrate, blending the disintegrant into the melt, and resolidifying the mixture.

Description

    FIELD OF INVENTION
  • The present invention relates to pharmaceutical compositions for oral administration comprising fenofibrate which enable improve dissolution and bioavailability. [0001]
    • BACKGROUND
  • Fenofibrate is practically insoluble in water. This causes fenofibrate to exhibit a low rate of dissolution in aqueous media (including gastrointestinal fluids), which results in inadequate bioavailability (absorption into systemic circulation) after oral ingestion. [0002]
  • In order to make a composition comprising fenofibrate that will enable maximum bioavailability, it is necessary to incorporate into the composition a feature that increases the rate of dissolution of the drug to enable it to dissolve in the gastrointestinal fluids. [0003]
  • Several ways of increasing the rate of dissolution of drugs having low solubility in water are known in the prior art. [0004]
  • One approach is micronization. In this approach, the drug is milled to fine particles, typically having a mean diameter of only a few microns. A second approach is to include a surfactant in the composition. [0005]
  • For the drug fenofibrate, neither micronization alone nor use of a surfactant alone enables maximum bioavailability. U.S. Pat. No. 4,895,726 discloses that the rate of dissolution and the bioavailability of fenofibrate can be maximized by comicronization of fenofibrate. In this process the fenofibrate is first mixed with the surfactant and then the mixture is micronized. [0006]
  • A composition made according to the invention of U.S. Pat. No. 4,895,726 is sold in Canada as elsewhere under the tradename Lipidil Micro. The need for microcomposition and use of a surfactant adds to the cost of capsules containing fenofibrate. [0007]
  • In view of the limitations of the prior art, it is an object of the present invention to enable maximum bioavailability of fenofibrate without the need for micronization and without the need for use of a surfactant. [0008]
    • DESCRIPTION OF THE INVENTION
  • It has been found the rate of dissolution and the bioavailability of fenofibrate can be substantially improved by making a solid dispersion of a disintegrant in the fenofibrate. The solid dispersion can be made by heating and melting the fenofibrate, blending the disintegrant into the molten fenofibrate and then cooling and solidifying the mixture. [0009]
  • Fenofibrate has a melting point of about 80° C. and can be melted without decomposition. [0010]
  • A disintegrant will be understood to be a substance which is hydrophilic and swells upon absorption of water. Disintegrants are used as excipients (inactive ingredients) in pharmaceutical tablets and capsules so that, when a tablet or capsule is ingested, the disintegrant will cause the tablet or capsule to absorb gastrointestinal fluid and, as a result, to swell and disintegrate, so as to release the active drug for dissolution and absorption [0011]
  • The most commonly used disintegrant is starch. [0012]
  • Disintegrants with very high capacity to absorb water and swell are known as “super-disintegrants”, which include such substances as croscarmellose sodium, sodium starch glycolate and crospovidone. [0013]
  • As aforesaid, a solid dispersion comprising a disintegrant dispersed in the fenofibrate can be made by melting the fenofibrate blending the disintegrant into the molten fenofibrate and then cooling and solidifying the mixture The solid can then be ground into granules for further processing into tablets or capsules. [0014]
  • Because of the very intimate mixing achieved by mixing the disintegrant into the fenofibrate in the molten state, it follows that each granule or particle of the ground-up solid dispersion will be an approximately uniform mixture of fenofibrate and disintegrant. [0015]
  • The solid dispersion is thus intrinsically different from a mixture achieved simply by physical mixing of fenofibrate in solid form and disintegrant, because in a physical mix each particle remains either pure fenofibrate or pure disintegrant. [0016]
  • It will be understood that in the process of making a solid dispersion, within the scope of the present invention, ingredients other than the fenofibrate and disintegrant may be included in the molten blend and thus incorporated into the solid dispersion. Such other ingredients may include, for example, water-soluble or water-insoluble ingredients which serve as surfactant, diluent, or for other purposes. [0017]
  • Alternatively, other ingredients may be mixed with the granules of solid dispersion, and the mix so achieved may be further processed into tablets or capsules. [0018]
  • The invention will be further illustrated by the following example, which is intended to be illustrative but not limiting of the scope of the invention.[0019]
    • EXAMPLE 1
  • 4800 g of fenofibrate was placed in a stainless steel pot, which was slowly heated until the fenofibrate was melted. 1200 g of croscamellose sodium was then blended into the molten fenofibrate, and the mix was then poured into trays and allowed to cool and solidify to form a solid dispersion. [0020]
  • The solid was then removed from the trays and milled through a #10 screen to produce granules. [0021]
  • 5 kilos of the resulting granules were then mixed with other ingredients as follows: [0022]
    solid dispersion granules  5.0 kilos
    lactose monohydrate 2.84 kilos
    stearic acid 0.14 kilos
    colloidal silicon dioxide 0.02 kilos
    8.00 kilos
  • This mixture was then filled into 2-piece hard gelatin capsules with a net fill weight of 400 mg per capsule. Each capsule thus contained 250 mg of the solid dispersion, which in turn comprised 200 mg of fenofibrate. [0023]
  • For these capsules, it was found that the dissolution rate and bioavailability was equivalent to that of commercially available Lipidil Micro capsules containing 200 mg of co-micronized fenofibrate and surfactant. [0024]
    Figure US20030031705A1-20030213-P00001
    Figure US20030031705A1-20030213-P00002
    Figure US20030031705A1-20030213-P00003
    Figure US20030031705A1-20030213-P00004
    Figure US20030031705A1-20030213-P00005
    Figure US20030031705A1-20030213-P00006
    Figure US20030031705A1-20030213-P00007

Claims (4)

What is claimed is:
1. A solid pharmaceutical composition comprising a solid dispersion of a disintegrant in fenofibrate.
2. A composition as in claim 1 wherein the disintegrant is selected from croscarmellose sodium, sodium starch glycolate and crospovidone.
3. A process of making a composition as in either of claims 1 or 2, which comprises the steps of melting the fenofibrate, blending the disintegrant into the molten fenofibrate, and solidifying the mixture.
4. A process as in claim 3 which further comprises the steps of grinding the resulting solid into granules and further processing the granules into capsules or tablets.
US10/189,009 1997-09-19 2002-07-05 Pharmaceutical composition comprising fenofibrate Abandoned US20030031705A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US10/189,009 US20030031705A1 (en) 1997-09-19 2002-07-05 Pharmaceutical composition comprising fenofibrate

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CA002214895A CA2214895C (en) 1997-09-19 1997-09-19 Improved pharmaceutical composition comprising fenofibrate
CA2,214,895 1997-09-19
US09/154,521 US6444225B1 (en) 1997-09-19 1998-09-16 Pharmaceutical composition comprising fenofibrate
US10/189,009 US20030031705A1 (en) 1997-09-19 2002-07-05 Pharmaceutical composition comprising fenofibrate

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US09/154,521 Continuation US6444225B1 (en) 1997-09-19 1998-09-16 Pharmaceutical composition comprising fenofibrate

Publications (1)

Publication Number Publication Date
US20030031705A1 true US20030031705A1 (en) 2003-02-13

Family

ID=4161415

Family Applications (2)

Application Number Title Priority Date Filing Date
US09/154,521 Expired - Fee Related US6444225B1 (en) 1997-09-19 1998-09-16 Pharmaceutical composition comprising fenofibrate
US10/189,009 Abandoned US20030031705A1 (en) 1997-09-19 2002-07-05 Pharmaceutical composition comprising fenofibrate

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US09/154,521 Expired - Fee Related US6444225B1 (en) 1997-09-19 1998-09-16 Pharmaceutical composition comprising fenofibrate

Country Status (5)

Country Link
US (2) US6444225B1 (en)
EP (1) EP0904781A3 (en)
JP (1) JPH11152227A (en)
AU (1) AU731176B2 (en)
CA (1) CA2214895C (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030224058A1 (en) * 2002-05-24 2003-12-04 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20040058009A1 (en) * 2002-05-24 2004-03-25 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20070264348A1 (en) * 2002-05-24 2007-11-15 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20080241070A1 (en) * 2000-09-21 2008-10-02 Elan Pharma International Ltd. Fenofibrate dosage forms
US20090012184A1 (en) * 2005-02-11 2009-01-08 Abbott Gmbh & Co. Kg Production of Dosage Forms Comprising a Solid Dispersion of a Microcrystalline Agent

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2758459B1 (en) * 1997-01-17 1999-05-07 Pharma Pass FENOFIBRATE PHARMACEUTICAL COMPOSITION HAVING HIGH BIODAVAILABILITY AND PROCESS FOR PREPARING THE SAME
CZ20011739A3 (en) 1998-11-20 2001-10-17 Rtp Pharma Inc. Dispersible phospholipid-stabilized micro-particles
CA2270306C (en) * 1999-04-27 2000-09-26 Bernard Charles Sherman Pharmaceutical compositions comprising co-micronized fenofibrate
US6982281B1 (en) 2000-11-17 2006-01-03 Lipocine Inc Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs
CA2393585C (en) * 1999-12-09 2007-07-03 The Boots Company Plc Therapeutic agents
US6531158B1 (en) * 2000-08-09 2003-03-11 Impax Laboratories, Inc. Drug delivery system for enhanced bioavailability of hydrophobic active ingredients
FR2819720B1 (en) 2001-01-22 2004-03-12 Fournier Lab Sa NEW FENOFIBRATE TABLETS
US7189412B2 (en) 2001-03-01 2007-03-13 Aska Pharmaceutical Co., Ltd. Fenofibrate-containing composition
US7056906B2 (en) 2001-09-21 2006-06-06 Schering Corporation Combinations of hormone replacement therapy composition(s) and sterol absorption inhibitor(s) and treatments for vascular conditions in post-menopausal women
ATE418551T1 (en) 2003-03-07 2009-01-15 Schering Corp SUBSTITUTED AZETIDINONE DERIVATIVES, THEIR PHARMACEUTICAL FORMULATIONS AND THEIR USE IN THE TREATMENT OF HYPERCHOLESTEROLEMIA
US7235543B2 (en) 2003-03-07 2007-06-26 Schering Corporation Substituted azetidinone compounds, processes for preparing the same, formulations and uses thereof
WO2006023295A2 (en) * 2004-08-20 2006-03-02 Abbott Laboratories Pharmaceutical compositions comprising effervescent agents and fenofibrate
WO2008104846A2 (en) * 2007-02-26 2008-09-04 Wockhardt Research Centre Pharmaceutical compositions of fenofibrate
US9180110B2 (en) 2007-02-26 2015-11-10 Wockhardt Ltd. Pharmaceutical compositions of fenofibrate
EP2251038B1 (en) * 2008-03-11 2017-05-10 ASKA Pharmaceutical Co., Ltd. Solid dispersion, pharmaceutical compositions containing the same, and processes for the production of both
US11304960B2 (en) 2009-01-08 2022-04-19 Chandrashekar Giliyar Steroidal compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
US20170246187A1 (en) 2014-08-28 2017-08-31 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
US9498485B2 (en) 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
CA3078723A1 (en) 2016-11-28 2018-05-31 Nachiappan Chidambaram Oral testosterone undecanoate therapy

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4879301A (en) * 1987-04-28 1989-11-07 Hoei Pharmaceutical Co., Ltd. Antiallergic and antiinflammatory benzothiazolinone derivatives
US5545628A (en) * 1995-01-10 1996-08-13 Galephar P.R. Inc. Pharmaceutical composition containing fenofibrate
US5667807A (en) * 1994-05-30 1997-09-16 Bayer Aktiengesellschaft Thermal granulation process
US5776495A (en) * 1994-07-26 1998-07-07 Laboratoires Effik Process for the production of dry pharmaceutical forms and the thus obtained pharmaceutical compositions
US5939099A (en) * 1995-02-14 1999-08-17 Basf Aktiengesellschaft Solid active extrusion compound preparations containing low-substituted hydroxypropylcellulose
US5945127A (en) * 1995-03-21 1999-08-31 Basf Aktiengesellschaft Storage-stable drug form
US6018033A (en) * 1997-05-13 2000-01-25 Purdue Research Foundation Hydrophilic, hydrophobic, and thermoreversible saccharide gels and forms, and methods for producing same

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2627696B1 (en) * 1988-02-26 1991-09-13 Fournier Innovation Synergie NEW GALENIC FORM OF FENOFIBRATE
US5190970A (en) * 1990-10-19 1993-03-02 E. R. Squibb & Sons, Inc. Method for preventing onset of or treating Type II diabetes employing a cholesterol lowering drug alone or in combination with an ace inhibitor
JP3722293B2 (en) * 1991-12-18 2005-11-30 ワーナー−ランバート・カンパニー、リミテッド、ライアビリティ、カンパニー Novel pharmaceutical solid dispersion
US5948438A (en) * 1995-01-09 1999-09-07 Edward Mendell Co., Inc. Pharmaceutical formulations having improved disintegration and/or absorptivity
NZ286451A (en) * 1996-04-24 1998-04-27 Bernard Charles Sherman Controlled release pharmaceutical composition containing granules comprising drug, water-insoluble polymer and meltable carrier
US5883109A (en) * 1996-07-24 1999-03-16 Bristol-Myers Squibb Company Method for lowering serum lipid levels employing an MTP inhibitor in combination with another cholesterol lowering drug

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4879301A (en) * 1987-04-28 1989-11-07 Hoei Pharmaceutical Co., Ltd. Antiallergic and antiinflammatory benzothiazolinone derivatives
US5667807A (en) * 1994-05-30 1997-09-16 Bayer Aktiengesellschaft Thermal granulation process
US5776495A (en) * 1994-07-26 1998-07-07 Laboratoires Effik Process for the production of dry pharmaceutical forms and the thus obtained pharmaceutical compositions
US5545628A (en) * 1995-01-10 1996-08-13 Galephar P.R. Inc. Pharmaceutical composition containing fenofibrate
US5939099A (en) * 1995-02-14 1999-08-17 Basf Aktiengesellschaft Solid active extrusion compound preparations containing low-substituted hydroxypropylcellulose
US5945127A (en) * 1995-03-21 1999-08-31 Basf Aktiengesellschaft Storage-stable drug form
US6018033A (en) * 1997-05-13 2000-01-25 Purdue Research Foundation Hydrophilic, hydrophobic, and thermoreversible saccharide gels and forms, and methods for producing same

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080241070A1 (en) * 2000-09-21 2008-10-02 Elan Pharma International Ltd. Fenofibrate dosage forms
US20080095851A1 (en) * 2002-05-24 2008-04-24 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20040087656A1 (en) * 2002-05-24 2004-05-06 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20050276974A1 (en) * 2002-05-24 2005-12-15 Elan Pharma Internationl, Ltd. Nanoparticulate fibrate formulations
US20070264348A1 (en) * 2002-05-24 2007-11-15 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20070298115A1 (en) * 2002-05-24 2007-12-27 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20030224058A1 (en) * 2002-05-24 2003-12-04 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20080138424A1 (en) * 2002-05-24 2008-06-12 Elan Pharma Internationa, Ltd. Nanoparticulate fibrate formulations
US20040058009A1 (en) * 2002-05-24 2004-03-25 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US7927627B2 (en) 2002-05-24 2011-04-19 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US7931917B2 (en) 2002-05-24 2011-04-26 Elan Pharma International, Ltd. Nanoparticulate fibrate formulations
US20090012184A1 (en) * 2005-02-11 2009-01-08 Abbott Gmbh & Co. Kg Production of Dosage Forms Comprising a Solid Dispersion of a Microcrystalline Agent
US10653625B2 (en) * 2005-02-11 2020-05-19 AbbVie Deutschland GmbH & Co. KG Production of dosage forms comprising a solid dispersion of a microcrystalline agent

Also Published As

Publication number Publication date
AU8607398A (en) 1999-04-15
AU731176B2 (en) 2001-03-22
US6444225B1 (en) 2002-09-03
JPH11152227A (en) 1999-06-08
CA2214895A1 (en) 1998-11-27
CA2214895C (en) 1999-04-20
EP0904781A2 (en) 1999-03-31
EP0904781A3 (en) 1999-11-03

Similar Documents

Publication Publication Date Title
US6444225B1 (en) Pharmaceutical composition comprising fenofibrate
US5980942A (en) Zero-order sustained release matrix tablet formulations of carbamazepine
KR20070119700A (en) Formulations containing fenofibrate and surfactant mixture
US6132772A (en) Extended-release solid oral dosage forms of drugs having low solubility in water
JP2008540644A (en) New granulation method and granulated material produced therefrom
JP2008531509A (en) Tablets with improved dispersibility of pharmaceutical ingredients
US20070014854A1 (en) Novel granulation process
EP1683516A2 (en) Stable pharmaceutical formulations of zonisamide and methods for their manufacture
US20070014864A1 (en) Novel pharmaceutical granulate
JPH0428243B2 (en)
US6197787B1 (en) Pharmaceutical formulations containing poorly soluble drug substances
CA2270306C (en) Pharmaceutical compositions comprising co-micronized fenofibrate
EP1467713B1 (en) Tabletting process
US5879714A (en) Controlled-release pharmaceutical compositions
US7615547B2 (en) Granulates containing liposoluble substances and a process for the preparation thereof
KR890000182B1 (en) Pharmaceutical composition containing a liquid lubricant
US20070014853A1 (en) Pharmaceutical dosage form containing novel pharmaceutical granulate
US20090304791A1 (en) Solid oral forms of ebastine
EP0642786B1 (en) Method for the manufacture of a laxative composition
JP2006517929A (en) Method for producing agglomerates using melt agglomeration
CA2253769C (en) Pharmaceutical compositions comprising fenofibrate
EP2919754A1 (en) Dispersible tablet
JPH09309829A (en) Oral administration preparation containing nitrendipine and its production
US20150283083A1 (en) Dispersible Tablet
GR et al. Solid Dispersion of Nabumetone in Ethyl Cellulose an Approach to Enhance the Solubility and Dissolution Rate

Legal Events

Date Code Title Description
STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION