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BR0318167A - controlled release formulation containing a hydrophobic material as the controlled release agent - Google Patents

controlled release formulation containing a hydrophobic material as the controlled release agent

Info

Publication number
BR0318167A
BR0318167A BRPI0318167-7A BR0318167A BR0318167A BR 0318167 A BR0318167 A BR 0318167A BR 0318167 A BR0318167 A BR 0318167A BR 0318167 A BR0318167 A BR 0318167A
Authority
BR
Brazil
Prior art keywords
hydrophobic material
pharmaceutical composition
controlled release
present
medicament
Prior art date
Application number
BRPI0318167-7A
Other languages
Portuguese (pt)
Inventor
Mulye Nirmal
Original Assignee
Nostrum Pharmaceuticals Inc
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 Nostrum Pharmaceuticals Inc filed Critical Nostrum Pharmaceuticals Inc
Publication of BR0318167A publication Critical patent/BR0318167A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

"FORMULAçãO DE LIBERAçãO CONTROLADA CONTENDO UM MATERIAL HIDROFóBICO COMO O AGENTE DE LIBERAçãO CONTROLADA". A presente invenção está direcionada a uma composição farmacêutica de liberação-controlada na forma de dosagem oral consistindo essencialmente de uma quantidade farmaceuticamente eficaz de um medicamento e um material hidrofóbico na ausência de uma lactose ou polímero de carboidrato hidrofóbico, o referido medicamento estando presente em uma quantidade maior do que cerca de 25% da composição farmacêutica e tendo uma solubilidade em água maior do que cerca de 1 grama por 10 mL de água em 25<198>C, o referido material hidrofóbico tendo um ponto de fusão variando de pelo menos cerca de 40<198>C a cerca de 100<198>C em 1 atm de pressão, e estando presente em uma quantidade variando de cerca de 3% a cerca de 20% em peso da composição farmacêutica e em uma quantidade menor do que a do medicamento, e o referido material hidrofóbico não estando presente no revestimento da referida composição farmacêutica; a referida composição farmacêutica sendo preparada por compressão direta na falta de fusão do material hidrofóbico ou utilizando-se o misturador de cisalhar elevado. A presente invenção está também direcionada a um método para a preparação da referida composição farmacêutica."Controlled Release Formulation Containing Hydrophobic Material as the Controlled Release Agent". The present invention is directed to a release-controlled pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a hydrophobic lactose or carbohydrate polymer, said medicament being present in a greater than about 25% of the pharmaceutical composition and having a water solubility of greater than about 1 gram per 10 ml of water at 25 ° C, said hydrophobic material having a melting point ranging from at least about from 40Â ° C to about 100Â ° C at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than about of the medicament, and said hydrophobic material not being present in the coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of melting of the hydrophobic material or using the high shear mixer. The present invention is also directed to a method for preparing said pharmaceutical composition.

BRPI0318167-7A 2003-03-04 2003-03-04 controlled release formulation containing a hydrophobic material as the controlled release agent BR0318167A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/006505 WO2004078164A1 (en) 2003-03-04 2003-03-04 Control release formulation containing a hydrophobic material as the sustained release agent

Publications (1)

Publication Number Publication Date
BR0318167A true BR0318167A (en) 2006-02-21

Family

ID=32961106

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0318167-7A BR0318167A (en) 2003-03-04 2003-03-04 controlled release formulation containing a hydrophobic material as the controlled release agent

Country Status (8)

Country Link
EP (1) EP1599189A4 (en)
JP (1) JP2006514672A (en)
AU (1) AU2003225649C1 (en)
BR (1) BR0318167A (en)
CA (1) CA2518442A1 (en)
MX (1) MXPA05009469A (en)
NZ (1) NZ542176A (en)
WO (1) WO2004078164A1 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102005049001A1 (en) * 2005-10-11 2007-04-12 Basf Ag Process for the preparation of direct tablet ibuprofen formulations
JP2011500688A (en) * 2007-10-18 2011-01-06 デュレクト コーポレーション Biodegradable implants with controlled bulk density
CN105456217A (en) * 2014-08-27 2016-04-06 捷思英达医药技术(上海)有限公司 Divalproex sodium sustained-release agent composition and preparation method thereof
US20170273923A1 (en) * 2016-03-23 2017-09-28 Sun Pharmaceutical Industries Ltd. Method of administering divalproex

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3343253A1 (en) * 1983-08-11 1985-02-21 Neill Bailey San Antonio Tex. Walsdorf Fluoride tablet with delayed release of active ingredient and process for its production
IL109770A0 (en) * 1993-05-29 1994-11-28 Smithkline Beecham Corp Thermal infusion process for preparing controlled release solid dosage forms of medicaments for oral administration and controlled release solid dosage forms of medicaments prepared thereby
FR2745500B1 (en) * 1996-03-04 1998-04-03 Synthelabo SUSTAINED RELEASE PHARMACEUTICAL FORMULATIONS CONTAINING MIZOLASTINE
CA2277220A1 (en) * 1997-01-10 1998-07-16 Abbott Laboratories Tablet for the controlled release of active agents
IL125244A (en) * 1998-07-07 2002-12-01 Yissum Res Dev Co Pharmaceutical compositions containing low-melting waxes
DE19847618A1 (en) * 1998-10-15 2000-04-20 Basf Ag Production of solid dosage forms, used for e.g. pharmaceuticals or insecticides, by preparation of plastic mixture from polymeric binder and active agent under controlled conditions
US6413546B1 (en) * 1999-03-18 2002-07-02 Indena, S.P.A. Tablets incorporating isoflavone plant extracts and methods of manufacturing them
AR025609A1 (en) * 1999-09-13 2002-12-04 Hoffmann La Roche SOLID LIPID FORMULATIONS

Also Published As

Publication number Publication date
CA2518442A1 (en) 2004-09-16
NZ542176A (en) 2007-12-21
JP2006514672A (en) 2006-05-11
AU2003225649C1 (en) 2009-10-22
EP1599189A1 (en) 2005-11-30
AU2003225649B2 (en) 2009-03-12
MXPA05009469A (en) 2005-12-12
WO2004078164A1 (en) 2004-09-16
EP1599189A4 (en) 2009-07-01
AU2003225649A1 (en) 2004-09-28

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Legal Events

Date Code Title Description
B08F Application fees: dismissal - article 86 of industrial property law

Free format text: REFERENTE 8A. ANUIDADE(S).

B08K Lapse as no evidence of payment of the annual fee has been furnished to inpi (acc. art. 87)

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2129 DE 25/10/2011.