MX2016014771A - Forma de dosificacion oralmente desintegrante para administracion de avanafil, y metodos de fabricacion y uso asociados. - Google Patents
Forma de dosificacion oralmente desintegrante para administracion de avanafil, y metodos de fabricacion y uso asociados.Info
- Publication number
- MX2016014771A MX2016014771A MX2016014771A MX2016014771A MX2016014771A MX 2016014771 A MX2016014771 A MX 2016014771A MX 2016014771 A MX2016014771 A MX 2016014771A MX 2016014771 A MX2016014771 A MX 2016014771A MX 2016014771 A MX2016014771 A MX 2016014771A
- Authority
- MX
- Mexico
- Prior art keywords
- orally disintegrating
- formulations
- active agent
- avanafil
- absorption
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 4
- 239000002552 dosage form Substances 0.000 title abstract 3
- WEAJZXNPAWBCOA-INIZCTEOSA-N avanafil Chemical compound C1=C(Cl)C(OC)=CC=C1CNC1=NC(N2[C@@H](CCC2)CO)=NC=C1C(=O)NCC1=NC=CC=N1 WEAJZXNPAWBCOA-INIZCTEOSA-N 0.000 title abstract 2
- 229960000307 avanafil Drugs 0.000 title abstract 2
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract 6
- 238000010521 absorption reaction Methods 0.000 abstract 4
- 239000013543 active substance Substances 0.000 abstract 3
- 238000009472 formulation Methods 0.000 abstract 3
- 239000006191 orally-disintegrating tablet Substances 0.000 abstract 3
- 210000001198 duodenum Anatomy 0.000 abstract 2
- 230000002708 enhancing effect Effects 0.000 abstract 2
- 229940099471 Phosphodiesterase inhibitor Drugs 0.000 abstract 1
- 230000002183 duodenal effect Effects 0.000 abstract 1
- 210000000214 mouth Anatomy 0.000 abstract 1
- 239000002590 phosphodiesterase V inhibitor Substances 0.000 abstract 1
- 239000002571 phosphodiesterase inhibitor Substances 0.000 abstract 1
- 230000000704 physical effect Effects 0.000 abstract 1
- 210000002784 stomach Anatomy 0.000 abstract 1
- 239000003826 tablet Substances 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2095—Tabletting 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)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Nutrition Science (AREA)
- Zoology (AREA)
- Physiology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Se proporcionan formulaciones para la administración oral de avanafil, un inhibidor de fosfodiesterasa Tipo V (``inhibidor de PDE V´´) y análogos del mismo. Las formulaciones son tabletas oralmente desintegrantes (ODTs) que rápidamente se disuelven o se desintegran en la cavidad oral. Las tabletas contienen una composición aumentadora de absorción que incrementa la absorción duodenal del agente activo, después de la transferencia desde el ambiente de bajo pH del estómago al pH más básico del duodeno. Se proporcionan métodos para administrar el agente activo usando las formas de dosificación. La invención también abarca un método para seleccionar componentes y composiciones para incorporarse en las formulaciones que facilitará la absorción incrementada del agente activo en el duodeno y de esta manera sirven como ``composiciones aumentadoras de absorción´´ en la presente. También se proporcionan métodos para fabricar tabletas oralmente desintegrantes para optimizar las propiedades físicas de las formas de dosificación, particularmente dureza y tiempo de desintegración.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461994349P | 2014-05-16 | 2014-05-16 | |
| PCT/US2015/031198 WO2015176008A1 (en) | 2014-05-16 | 2015-05-15 | Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2016014771A true MX2016014771A (es) | 2017-02-28 |
Family
ID=53284563
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2016014771A MX2016014771A (es) | 2014-05-16 | 2015-05-15 | Forma de dosificacion oralmente desintegrante para administracion de avanafil, y metodos de fabricacion y uso asociados. |
Country Status (8)
| Country | Link |
|---|---|
| US (5) | US10028916B2 (es) |
| EP (1) | EP3142640A1 (es) |
| AU (1) | AU2015258836B2 (es) |
| BR (1) | BR112016026667A8 (es) |
| CA (1) | CA2949094A1 (es) |
| MX (1) | MX2016014771A (es) |
| RU (1) | RU2740903C2 (es) |
| WO (1) | WO2015176008A1 (es) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105663066A (zh) * | 2016-04-07 | 2016-06-15 | 山东省药学科学院 | 一种阿伐那非片剂及其制备方法 |
| CA3039562A1 (en) | 2016-10-24 | 2018-05-03 | Janssen Sciences Ireland Unlimited Company | Dispersible compositions |
| EP3612167A4 (en) * | 2017-04-20 | 2021-03-03 | Zeenar Enterprises Pty Ltd | METHOD FOR PREPARING AN ORAL DISINTEGRATION DOSAGE FORM |
| US11638698B2 (en) | 2017-04-20 | 2023-05-02 | Zeenar Enterprises Pty Ltd | Liquid crystalline dosage form for administering a statin |
| AU2018255718A1 (en) * | 2017-04-20 | 2019-12-05 | Zeenar Enterprises Pty Ltd | Fast disintegrating tablet |
| JP7280350B2 (ja) * | 2018-09-14 | 2023-05-23 | カラ セラピューティクス インコーポレイテッド | κオピオイド受容体作動薬の経口製剤 |
| CN109696502A (zh) * | 2019-02-22 | 2019-04-30 | 重庆安格龙翔医药科技有限公司 | 气相色谱检测阿伐那非中苯及异亚丙基丙酮残留的方法 |
| EP4121083A4 (en) | 2020-03-18 | 2023-11-29 | Cara Therapeutics, Inc. | OLIGOSACCHARIDE FORMULATIONS OF KAPPA OPIOID RECEPTOR AGONISTS |
| CN116407511A (zh) * | 2021-12-31 | 2023-07-11 | 南京艾德凯腾生物医药有限责任公司 | 一种阿伐那非冻干片及其制备方法 |
| CN118777531A (zh) * | 2024-08-06 | 2024-10-15 | 北京沃邦医药科技有限公司 | 一种阿伐那非中间体异构体的高效液相色谱检测方法 |
| CN118777476A (zh) * | 2024-08-06 | 2024-10-15 | 北京沃邦医药科技有限公司 | 一种阿伐那非异构体的高效液相色谱检测方法 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6743443B1 (en) | 1998-10-05 | 2004-06-01 | Eisai Co., Ltd. | Tablets immediately disintegrating in the oral cavity |
| GB0204771D0 (en) | 2002-02-28 | 2002-04-17 | Phoqus Ltd | Fast disintegrating tablets |
| US7390503B1 (en) * | 2003-08-22 | 2008-06-24 | Barr Laboratories, Inc. | Ondansetron orally disintegrating tablets |
| DE102005009241A1 (de) | 2005-03-01 | 2006-09-07 | Bayer Healthcare Ag | Arzneiformen mit kontrollierter Bioverfügbarkeit |
| US20110182946A1 (en) * | 2008-03-17 | 2011-07-28 | Board Of Regents, The University Of Texas System | Formation of Nanostructured Particles of Poorly Water Soluble Drugs and Recovery by Mechanical Techniques |
| CN102988318A (zh) * | 2008-11-25 | 2013-03-27 | 田边三菱制药株式会社 | 口腔速崩片及其制备方法 |
| WO2013019056A1 (en) | 2011-08-01 | 2013-02-07 | Sam-A Pharm. Co., Ltd. | Novel granule formulation containing sildenafil or pharmaceutically acceptable salts thereof as an active ingredient |
| US20150216798A1 (en) * | 2012-08-17 | 2015-08-06 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Novel orally administered pharmaceutical formulations |
-
2015
- 2015-05-15 CA CA2949094A patent/CA2949094A1/en not_active Abandoned
- 2015-05-15 RU RU2016149464A patent/RU2740903C2/ru active
- 2015-05-15 MX MX2016014771A patent/MX2016014771A/es unknown
- 2015-05-15 WO PCT/US2015/031198 patent/WO2015176008A1/en not_active Ceased
- 2015-05-15 EP EP15727160.2A patent/EP3142640A1/en not_active Withdrawn
- 2015-05-15 US US14/714,028 patent/US10028916B2/en active Active
- 2015-05-15 AU AU2015258836A patent/AU2015258836B2/en not_active Ceased
- 2015-05-15 BR BR112016026667A patent/BR112016026667A8/pt not_active IP Right Cessation
-
2018
- 2018-06-21 US US16/014,093 patent/US20190133955A1/en not_active Abandoned
-
2019
- 2019-10-02 US US16/590,703 patent/US20200030239A1/en not_active Abandoned
-
2021
- 2021-08-19 US US17/406,165 patent/US20210378964A1/en not_active Abandoned
-
2024
- 2024-07-30 US US18/788,497 patent/US20240382426A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US10028916B2 (en) | 2018-07-24 |
| RU2740903C2 (ru) | 2021-01-21 |
| AU2015258836B2 (en) | 2020-07-16 |
| BR112016026667A8 (pt) | 2021-07-06 |
| US20210378964A1 (en) | 2021-12-09 |
| US20190133955A1 (en) | 2019-05-09 |
| BR112016026667A2 (pt) | 2017-08-15 |
| EP3142640A1 (en) | 2017-03-22 |
| US20160331687A1 (en) | 2016-11-17 |
| US20240382426A1 (en) | 2024-11-21 |
| RU2016149464A (ru) | 2018-06-19 |
| CA2949094A1 (en) | 2015-11-19 |
| WO2015176008A1 (en) | 2015-11-19 |
| RU2016149464A3 (es) | 2018-08-22 |
| AU2015258836A1 (en) | 2016-12-01 |
| US20200030239A1 (en) | 2020-01-30 |
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