WO2009063320A3 - Composición farmacéutica sólida de didanosina - Google Patents

Composición farmacéutica sólida de didanosina Download PDF

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Publication number
WO2009063320A3
WO2009063320A3 PCT/IB2008/003527 IB2008003527W WO2009063320A3 WO 2009063320 A3 WO2009063320 A3 WO 2009063320A3 IB 2008003527 W IB2008003527 W IB 2008003527W WO 2009063320 A3 WO2009063320 A3 WO 2009063320A3
Authority
WO
WIPO (PCT)
Prior art keywords
didanosine
pharmaceutical composition
composition
relates
solid pharmaceutical
Prior art date
Application number
PCT/IB2008/003527
Other languages
English (en)
French (fr)
Other versions
WO2009063320A2 (es
Inventor
José Ramon TICÓ GRAU
José Maria SUÑÉ NEGRE
Original Assignee
Blanver Farmoquimica, Ltda
Fundacao Oswaldo Cruz (Fiocruz)-Instituto De Tecnologia Em Farmacos (Farmanguinhos)
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 Blanver Farmoquimica, Ltda, Fundacao Oswaldo Cruz (Fiocruz)-Instituto De Tecnologia Em Farmacos (Farmanguinhos) filed Critical Blanver Farmoquimica, Ltda
Priority to EP08849054A priority Critical patent/EP2221049A2/en
Priority to BRPI0819752 priority patent/BRPI0819752A2/pt
Publication of WO2009063320A2 publication Critical patent/WO2009063320A2/es
Publication of WO2009063320A3 publication Critical patent/WO2009063320A3/es

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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • 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
    • 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
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

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

Abstract

La presente invención se refiere a una nueva composición farmaceutica sólida de didanosina que comprende cristales de didanosina con un tamano medio de particula comprendido entre 50 y 500 micras, recubiertos por una capa de un recubrimiento enterico. La composición farmaceutica de Ia invención se puede preparar mediante un procedimiento simple, que comprende el recubrimiento de los cristales de didanosina con una capa enterica. Dicha composición y presenta una buena estabilidad del principio activo, asi como una liberación apropiada en las condiciones presentes en Ia parte alta del tracto gastrointestinal. Tambien se refiere al uso de dicha composición para Ia preparación de formas farmaceuticas sólidas de didanosina para su administración por via oral. La invención tambien se refiere a comprimidos y a capsulas de gelatina dura que contienen dicha composición.
PCT/IB2008/003527 2007-11-14 2008-11-13 Composición farmacéutica sólida de didanosina WO2009063320A2 (es)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP08849054A EP2221049A2 (en) 2007-11-14 2008-11-13 Solid pharmaceutical composition of ded anosine
BRPI0819752 BRPI0819752A2 (pt) 2007-11-14 2008-11-13 Composição farmaceutica sólida de didanosina, processo para a preparação da composição, utilização de composição, cápsula de gelatina dura e comprimido

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ES200703002A ES2331501B1 (es) 2007-11-14 2007-11-14 Composicion farmaceutica solida de didanosina.
ESP200703002 2007-11-14

Publications (2)

Publication Number Publication Date
WO2009063320A2 WO2009063320A2 (es) 2009-05-22
WO2009063320A3 true WO2009063320A3 (es) 2010-03-18

Family

ID=40568487

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2008/003527 WO2009063320A2 (es) 2007-11-14 2008-11-13 Composición farmacéutica sólida de didanosina

Country Status (4)

Country Link
EP (1) EP2221049A2 (es)
BR (1) BRPI0819752A2 (es)
ES (1) ES2331501B1 (es)
WO (1) WO2009063320A2 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2012010482A (es) * 2010-03-10 2013-03-12 Nogra Pharma Ltd Composiciones para lavado de colon y metodos de elaboracion y uso de las mismas.

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999061002A1 (en) * 1998-05-22 1999-12-02 Bristol-Myers Squibb Company Enteric coated pharmaceutical composition and method of manufacturing
WO2000003696A1 (en) * 1998-07-17 2000-01-27 Bristol-Myers Squibb Company Enteric coated pharmaceutical tablet and method of manufacturing
WO2006054175A2 (en) * 2004-11-18 2006-05-26 Aurobindo Pharma Limited Stable dosage forms of acid labile drug

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010024660A1 (en) * 1999-09-29 2001-09-27 Ismat Ullah Enteric coated pharmaceutical composition and method of manufacturing

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999061002A1 (en) * 1998-05-22 1999-12-02 Bristol-Myers Squibb Company Enteric coated pharmaceutical composition and method of manufacturing
WO2000003696A1 (en) * 1998-07-17 2000-01-27 Bristol-Myers Squibb Company Enteric coated pharmaceutical tablet and method of manufacturing
WO2006054175A2 (en) * 2004-11-18 2006-05-26 Aurobindo Pharma Limited Stable dosage forms of acid labile drug

Also Published As

Publication number Publication date
ES2331501B1 (es) 2010-10-21
WO2009063320A2 (es) 2009-05-22
ES2331501A1 (es) 2010-01-05
BRPI0819752A2 (pt) 2015-05-05
EP2221049A2 (en) 2010-08-25

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