PE20100471A1 - Composicion de liberacion pulsatil de sildenafil y proceso para prepararla - Google Patents

Composicion de liberacion pulsatil de sildenafil y proceso para prepararla

Info

Publication number
PE20100471A1
PE20100471A1 PE2009001294A PE2009001294A PE20100471A1 PE 20100471 A1 PE20100471 A1 PE 20100471A1 PE 2009001294 A PE2009001294 A PE 2009001294A PE 2009001294 A PE2009001294 A PE 2009001294A PE 20100471 A1 PE20100471 A1 PE 20100471A1
Authority
PE
Peru
Prior art keywords
sidenafil
polymer
sodium
fraction
sildenafil
Prior art date
Application number
PE2009001294A
Other languages
English (en)
Inventor
Esteban Alejandro Fiore
Original Assignee
Rhein Siegfried Sa De Cv
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42242382&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20100471(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Rhein Siegfried Sa De Cv filed Critical Rhein Siegfried Sa De Cv
Publication of PE20100471A1 publication Critical patent/PE20100471A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gynecology & Obstetrics (AREA)
  • Cardiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

REFERIDA A UNA COMPOSICION FARMACEUTICA DE SIDENAFIL DE LIBERACION PULSATIL QUE COMPRENDE UNA FRACCION DE LIBERACION INMEDIATA QUE CONTIENE DE 5 A 100 MG DE SIDENAFIL Y UNA FRACCION DE LIBERACION CONTROLADA QUE CONTIENE DE 25 A 150 MG DE SIDENAFIL, DONDE LA FRACCION DE LIBERACION CONTROLADA ESTA COMPUESTA POR PARTICULAS RECUBIERTAS QUE CONTIENEN: a) UN AGENTE SUPERDESINTEGRANTE TAL COMO CROSPOVIDONA, CROSCARMELOSA SODICA Y ALMIDON GLICOLATO DE SODIO, b) UN RECUBRIMIENTO FORMADO POR UN POLIMERO DE SOLUBILIDAD PH-DEPENDIENTE TAL COMO COPOLIMEROS DEL ACIDO METACRILICO, FTALATO DE CELULOSA, ENTRE OTROS, Y UN POLIMERO DE SOLUBILIDAD PH-INDEPENDIENTE TAL COMO COPOLIMEROS DE AMONIO METACRILATO, ETILCELULOSA, POLIVINILACETATO, ENTRE OTROS, Y c) OPCIONALMENTE OTROS EXCIPIENTES. DICHA COMPOSICION CONTIENE UNA CANTIDAD DE SILDENAFILO MAYOR AL 45%. TAMBIEN ESTA REFERIDA A UN METODO DE PREPARACION
PE2009001294A 2008-12-12 2009-12-07 Composicion de liberacion pulsatil de sildenafil y proceso para prepararla PE20100471A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/003466 WO2010067140A1 (es) 2008-12-12 2008-12-12 Composicion de liberacion pulsatil de sildenafil y proceso para prepararla

Publications (1)

Publication Number Publication Date
PE20100471A1 true PE20100471A1 (es) 2010-07-22

Family

ID=42242382

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2009001294A PE20100471A1 (es) 2008-12-12 2009-12-07 Composicion de liberacion pulsatil de sildenafil y proceso para prepararla

Country Status (13)

Country Link
US (1) US20110244050A1 (es)
EP (1) EP2374460A4 (es)
AR (1) AR071970A1 (es)
BR (1) BRPI0823356A2 (es)
CL (1) CL2009002173A1 (es)
CR (1) CR20110322A (es)
EC (1) ECSP11011194A (es)
MX (1) MX339136B (es)
NI (1) NI201100119A (es)
PA (1) PA8853801A1 (es)
PE (1) PE20100471A1 (es)
UY (1) UY32304A (es)
WO (1) WO2010067140A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9498441B2 (en) 2012-01-27 2016-11-22 Siegfried Rhein S.A. De C.V. Nitazoxadine composition and process to prepare same
EA019381B1 (ru) * 2012-07-20 2014-03-31 Открытое акционерное общество "Химико-фармацевтический комбинат "Акрихин" Таблетка, содержащая ингибитор фосфодиэстеразы пятого типа, способ ее получения и ее применение
KR101340733B1 (ko) * 2012-12-31 2013-12-12 (주) 에프엔지리서치 신규한 마이크로그래뉼 제형
CA2910865C (en) 2014-07-15 2016-11-29 Isa Odidi Compositions and methods for reducing overdose
WO2017168174A1 (en) * 2016-04-02 2017-10-05 N4 Pharma Uk Limited New pharmaceutical forms of sildenafil
EP3522920A2 (en) 2016-10-10 2019-08-14 Transgene SA Immunotherapeutic product and mdsc modulator combination therapy
WO2023037394A1 (en) * 2021-09-13 2023-03-16 Amman Pharmaceutical Industries Company A pharmaceutical composition of sildenafil and a formulation thereof

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9013750D0 (en) 1990-06-20 1990-08-08 Pfizer Ltd Therapeutic agents
GB9301192D0 (en) 1993-06-09 1993-06-09 Trott Francis W Flower shaped mechanised table
GB9612514D0 (en) 1996-06-14 1996-08-14 Pfizer Ltd Novel process
DE69721559T2 (de) 1997-01-06 2003-11-27 Pfizer Geschmacksmaskierte pharmazeutische dosisform mit schneller freisetzung
CA2235642C (en) 1998-05-15 2007-11-13 Torcan Chemical Ltd. Processes for preparing sildenafil
UA67802C2 (uk) * 1998-10-23 2004-07-15 Пфайзер Рісьоч Енд Дівелепмент Компані, Н.В./С.А. Фармацевтична композиція з контрольованим вивільненням інгібітора цгмф фде-5 (варіанти), спосіб її одержання та спосіб лікування еректильної дисфункції
US6627223B2 (en) * 2000-02-11 2003-09-30 Eurand Pharmaceuticals Ltd. Timed pulsatile drug delivery systems
MXPA03008293A (es) * 2001-03-13 2003-12-11 Penwest Pharmaceuticals Co Formas de dosis cronoterapeuticas.
AU2005319367B2 (en) * 2004-12-20 2012-05-24 Collegium Pharmaceutical, Inc. Pharmaceutical compositions for sleep disorders
FR2891459B1 (fr) * 2005-09-30 2007-12-28 Flamel Technologies Sa Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant
KR101468053B1 (ko) * 2006-08-31 2014-12-02 앱탈리스 파마테크, 인코포레이티드 약 염기성 약물의 고용체를 포함하는 약물 전달 시스템

Also Published As

Publication number Publication date
PA8853801A1 (es) 2010-07-27
CL2009002173A1 (es) 2010-04-09
ECSP11011194A (es) 2011-09-30
NI201100119A (es) 2012-08-03
BRPI0823356A2 (pt) 2015-06-16
UY32304A (es) 2010-05-31
CR20110322A (es) 2011-10-25
US20110244050A1 (en) 2011-10-06
EP2374460A1 (en) 2011-10-12
MX339136B (es) 2016-05-13
MX2011005752A (es) 2011-08-12
WO2010067140A1 (es) 2010-06-17
EP2374460A4 (en) 2013-08-21
AR071970A1 (es) 2010-07-28

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