PE20100471A1 - Composicion de liberacion pulsatil de sildenafil y proceso para prepararla - Google Patents
Composicion de liberacion pulsatil de sildenafil y proceso para prepararlaInfo
- 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
Links
- 238000000034 method Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 title abstract 2
- BNRNXUUZRGQAQC-UHFFFAOYSA-N sildenafil Chemical compound CCCC1=NN(C)C(C(N2)=O)=C1N=C2C(C(=CC=1)OCC)=CC=1S(=O)(=O)N1CCN(C)CC1 BNRNXUUZRGQAQC-UHFFFAOYSA-N 0.000 title 2
- 230000000541 pulsatile effect Effects 0.000 title 1
- 229960003310 sildenafil Drugs 0.000 title 1
- 229920000642 polymer Polymers 0.000 abstract 4
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 abstract 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 2
- 238000000576 coating method Methods 0.000 abstract 2
- 229960000913 crospovidone Drugs 0.000 abstract 2
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 2
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 2
- 229910052708 sodium Inorganic materials 0.000 abstract 2
- 239000011734 sodium Substances 0.000 abstract 2
- 229940079832 sodium starch glycolate Drugs 0.000 abstract 2
- 229920003109 sodium starch glycolate Polymers 0.000 abstract 2
- 239000008109 sodium starch glycolate Substances 0.000 abstract 2
- -1 ETILCELLULOSE Polymers 0.000 abstract 1
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 238000013270 controlled release Methods 0.000 abstract 1
- 229920001577 copolymer Polymers 0.000 abstract 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
- WCYWZMWISLQXQU-UHFFFAOYSA-N methyl Chemical class [CH3] WCYWZMWISLQXQU-UHFFFAOYSA-N 0.000 abstract 1
- 239000002245 particle Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 229920002689 polyvinyl acetate Polymers 0.000 abstract 1
- 239000011118 polyvinyl acetate Substances 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 229940023144 sodium glycolate Drugs 0.000 abstract 1
Classifications
-
- 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
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K9/167—Agglomerates; 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
- A61K9/1676—Agglomerates; 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
-
- 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
- A61K9/2027—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
- A61K9/20—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
- A61K9/48—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
- A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- 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
- A61K9/5084—Mixtures 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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
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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2808019B1 (en) * | 2012-01-27 | 2019-09-25 | Siegfried Rhein S.A. De C.V. | Improved nitazoxanide composition and preparation method thereof |
| 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9013750D0 (en) | 1990-06-20 | 1990-08-08 | Pfizer Ltd | Therapeutic agents |
| GB9311920D0 (en) * | 1993-06-09 | 1993-07-28 | Pfizer Ltd | Therapeutic agents |
| GB9612514D0 (en) | 1996-06-14 | 1996-08-14 | Pfizer Ltd | Novel process |
| HUP0002744A3 (en) | 1997-01-06 | 2001-01-29 | Pfizer | Rapidly releasing and taste-masking pharmaceutical dosage form |
| 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 |
| EA008224B1 (ru) * | 2001-03-13 | 2007-04-27 | Пенвест Фармасьютикалз Ко. | Хронотерапевтические дозированные формы |
| JP2008524332A (ja) * | 2004-12-20 | 2008-07-10 | コレジウム ファーマシューティカル, インク. | 睡眠傷害のための医薬組成物 |
| 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 |
| WO2008027993A2 (en) * | 2006-08-31 | 2008-03-06 | Eurand, Inc. | Drug delivery systems comprising solid solutions of weakly basic drugs |
-
2008
- 2008-12-12 BR BRPI0823356-0A patent/BRPI0823356A2/pt not_active Application Discontinuation
- 2008-12-12 MX MX2011005752A patent/MX339136B/es active IP Right Grant
- 2008-12-12 EP EP08878690.0A patent/EP2374460A4/en not_active Withdrawn
- 2008-12-12 WO PCT/IB2008/003466 patent/WO2010067140A1/es not_active Ceased
- 2008-12-12 US US13/139,261 patent/US20110244050A1/en not_active Abandoned
-
2009
- 2009-05-29 AR ARP090101956A patent/AR071970A1/es unknown
- 2009-12-07 PE PE2009001294A patent/PE20100471A1/es not_active Application Discontinuation
- 2009-12-07 UY UY0001032304A patent/UY32304A/es not_active Application Discontinuation
- 2009-12-11 CL CL2009002173A patent/CL2009002173A1/es unknown
- 2009-12-11 PA PA20098853801A patent/PA8853801A1/es unknown
-
2011
- 2011-06-10 NI NI201100119A patent/NI201100119A/es unknown
- 2011-06-10 CR CR20110322A patent/CR20110322A/es unknown
- 2011-07-11 EC EC2011011194A patent/ECSP11011194A/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| UY32304A (es) | 2010-05-31 |
| WO2010067140A1 (es) | 2010-06-17 |
| MX339136B (es) | 2016-05-13 |
| NI201100119A (es) | 2012-08-03 |
| ECSP11011194A (es) | 2011-09-30 |
| MX2011005752A (es) | 2011-08-12 |
| AR071970A1 (es) | 2010-07-28 |
| US20110244050A1 (en) | 2011-10-06 |
| EP2374460A1 (en) | 2011-10-12 |
| CR20110322A (es) | 2011-10-25 |
| EP2374460A4 (en) | 2013-08-21 |
| PA8853801A1 (es) | 2010-07-27 |
| CL2009002173A1 (es) | 2010-04-09 |
| BRPI0823356A2 (pt) | 2015-06-16 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA | Abandonment or withdrawal |