WO2014168455A1 - 분산안정화제로 폴리에틸렌글리콜계 고분자 및/또는 비닐피롤리돈계 고분자를 포함하는 타다라필 유리염기 함유 필름 제형 - Google Patents
분산안정화제로 폴리에틸렌글리콜계 고분자 및/또는 비닐피롤리돈계 고분자를 포함하는 타다라필 유리염기 함유 필름 제형 Download PDFInfo
- Publication number
- WO2014168455A1 WO2014168455A1 PCT/KR2014/003160 KR2014003160W WO2014168455A1 WO 2014168455 A1 WO2014168455 A1 WO 2014168455A1 KR 2014003160 W KR2014003160 W KR 2014003160W WO 2014168455 A1 WO2014168455 A1 WO 2014168455A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- free base
- polymer
- tadalafil free
- tadalafil
- polyethylene glycol
- Prior art date
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Classifications
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- 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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- 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
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
Abstract
Description
Claims (13)
- 타다라필(Tadalafil) 유리염기을 유효성분으로 포함하는 필름 제형으로서, 분산안정화제로 폴리에틸렌글리콜계 고분자, 비닐피롤리돈계 고분자 또는 이들의 혼합물을 포함하는 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제2항에 있어서, 상기 호모폴리머의 분자량은 200 - 10,000 (g/mol)인 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제2항에 있어서, 상기 모노머는 화학식 1의 R이 수소인 폴리에틸렌글리콜(PEG)인 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제2항에 있어서, 상기 폴리에틸렌글리콜계 고분자는 폴리비닐알콜-폴리에틸렌글리콜 코폴리머인 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제1항에 있어서, 상기 비닐피롤리돈계 고분자는 비닐피롤리돈의 호모폴리머 또는 코폴리머인 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제6항에 있어서, 상기 비닐피롤리돈계 고분자는 폴리비닐피롤리돈 또는 비닐피롤리돈-비닐아세테이트 코폴리머인 것을 특징으로 하는 타다라필 유리염기 함유 필름.
- 제1항에 있어서, 상기 분산안정화제는 건조된 필름의 총 중량 기준으로 0.2 - 20 중량% 포함하는 것을 특징으로 하는, 타다라필 유리염기 함유 필름.
- 제1항에 있어서, 건조된 필름의 총 중량 기준으로 계면활성제, 가소제 및 분산안정화제의 총 중량은 1 - 90 중량%인 것을 특징으로 하는, 타다라필 유리염기 함유 필름.
- 제9항에 있어서, 계면활성제, 가소제 및 분산안정화제 총 중량 기준으로 폴리에틸렌글리콜계 고분자, 비닐피롤리돈계 고분자 또는 이들의 혼합물은 5 - 90 중량% 포함하는 것을 특징으로 하는, 타다라필 유리염기 함유 필름.
- 유효성분으로 타다라필(Tadalafil) 유리염기을 포함하고, 분산안정화제로서 폴리에틸렌글리콜계 고분자, 비닐피롤리돈계 고분자 또는 이들의 혼합물을 포함하는 것을 특징으로 하는 타다라필 유리염기 함유 필름 제조액.
- 제11항에 있어서, 필름의 제조액 중 용매의 90% 이상이 물인 것을 특징으로 하는, 타다라필 유리염기 함유 필름 제조액.
- 분산안정화제로 폴리에틸렌글리콜계 고분자, 비닐피롤리돈계 고분자 또는 이들의 혼합물을 첨가하여 타다라필 유리염기를 분산시킨 고분자 용액을 건조하여 제조하는 것을 특징으로 하는, 타다라필 유리염기 함유 필름 제조방법.
Priority Applications (13)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201480020466.6A CN105209025B (zh) | 2013-04-11 | 2014-04-11 | 包括聚乙二醇类聚合物和/或乙烯基吡咯烷酮类聚合物作为分散稳定剂的含他达拉非游离碱的膜剂形式 |
EA201591950A EA033893B1 (ru) | 2013-04-11 | 2014-04-11 | Лекарственная форма в виде пленки, содержащей свободное основание тадалафила и полимер на основе полиэтиленгликоля и/или полимер на основе винилпирролидона в качестве агента, стабилизирующего дисперсию, раствор для получения пленки и способ получения пленки |
US14/783,670 US20160074396A1 (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
SG11201508391SA SG11201508391SA (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
JP2016507892A JP6470257B2 (ja) | 2013-04-11 | 2014-04-11 | 分散安定化剤としてポリエチレングリコール系高分子及び/またはビニルピロリドン系高分子を含むタダラフィル遊離塩基含有フィルム剤形 |
BR112015025859A BR112015025859A2 (pt) | 2013-04-11 | 2014-04-11 | forma de dosagem de filme contendo base livre de tadalafila contendo polímero à base de polietilenoglicol e/ou polímero à base de vinilpirrolidona como estabilizador de dispersão |
EP14782874.3A EP2985020B1 (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
AP2015008840A AP2015008840A0 (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
MX2015013840A MX2015013840A (es) | 2013-04-11 | 2014-04-11 | Forma farmaceutica en pelicula que contiene tadalafilo en forma de base libre con polimero de polietilenglicol y/o polimero de vinil pirrolidona como estabilizante de dispersion. |
AU2014251532A AU2014251532B2 (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
ZA2015/08272A ZA201508272B (en) | 2013-04-11 | 2015-11-10 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
US16/688,515 US20200085818A1 (en) | 2013-04-11 | 2019-11-19 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
US17/017,915 US11116769B2 (en) | 2013-04-11 | 2020-09-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR20130040084 | 2013-04-11 | ||
KR10-2013-0040084 | 2013-04-11 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/783,670 A-371-Of-International US20160074396A1 (en) | 2013-04-11 | 2014-04-11 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
US16/688,515 Continuation US20200085818A1 (en) | 2013-04-11 | 2019-11-19 | Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2014168455A1 true WO2014168455A1 (ko) | 2014-10-16 |
Family
ID=51689788
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/KR2014/003160 WO2014168455A1 (ko) | 2013-04-11 | 2014-04-11 | 분산안정화제로 폴리에틸렌글리콜계 고분자 및/또는 비닐피롤리돈계 고분자를 포함하는 타다라필 유리염기 함유 필름 제형 |
Country Status (15)
Country | Link |
---|---|
US (2) | US20160074396A1 (ko) |
EP (1) | EP2985020B1 (ko) |
JP (1) | JP6470257B2 (ko) |
KR (1) | KR102223105B1 (ko) |
CN (1) | CN105209025B (ko) |
AP (1) | AP2015008840A0 (ko) |
AU (1) | AU2014251532B2 (ko) |
BR (1) | BR112015025859A2 (ko) |
CL (1) | CL2015003004A1 (ko) |
EA (1) | EA033893B1 (ko) |
MX (1) | MX2015013840A (ko) |
MY (1) | MY173159A (ko) |
SG (1) | SG11201508391SA (ko) |
WO (1) | WO2014168455A1 (ko) |
ZA (1) | ZA201508272B (ko) |
Cited By (1)
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US20210137919A1 (en) * | 2018-02-07 | 2021-05-13 | Smawa Gmbh | Pharmaceutical formulations, method for producing a pharmaceutical formulation, and medicament comprising same |
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KR101538985B1 (ko) * | 2014-09-02 | 2015-07-24 | 주식회사 서울제약 | 타다라필 구강붕해필름 및 이의 제조방법 |
KR101634382B1 (ko) | 2015-10-20 | 2016-06-28 | 미래제약 주식회사 | 타다라필 경구용 액제 |
CN106176685A (zh) * | 2016-07-29 | 2016-12-07 | 齐鲁制药有限公司 | 一种包含他达拉非的口溶膜剂及其制备方法 |
CZ2017781A3 (cs) * | 2017-12-05 | 2019-06-12 | Zentiva, K.S. | Těžko rozpustné terapeutická činidla,která patřící do BCS skupiny II nebo IV, suspendovaná v kapalné formulaci a/nebo v konečné nanovláknité struktuře |
US10828254B2 (en) * | 2018-09-28 | 2020-11-10 | Intelgenx Corp. | Oral film formulation for modulating absorption profile |
KR102110179B1 (ko) | 2019-07-18 | 2020-05-13 | 주식회사 서울제약 | 타다라필 또는 그의 약제학적으로 허용되는 염 함유 구강붕해필름 |
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2014
- 2014-04-11 CN CN201480020466.6A patent/CN105209025B/zh active Active
- 2014-04-11 MY MYPI2015703590A patent/MY173159A/en unknown
- 2014-04-11 AP AP2015008840A patent/AP2015008840A0/xx unknown
- 2014-04-11 MX MX2015013840A patent/MX2015013840A/es active IP Right Grant
- 2014-04-11 AU AU2014251532A patent/AU2014251532B2/en not_active Ceased
- 2014-04-11 EP EP14782874.3A patent/EP2985020B1/en active Active
- 2014-04-11 US US14/783,670 patent/US20160074396A1/en not_active Abandoned
- 2014-04-11 EA EA201591950A patent/EA033893B1/ru not_active IP Right Cessation
- 2014-04-11 JP JP2016507892A patent/JP6470257B2/ja active Active
- 2014-04-11 WO PCT/KR2014/003160 patent/WO2014168455A1/ko active Application Filing
- 2014-04-11 KR KR1020140043850A patent/KR102223105B1/ko active IP Right Grant
- 2014-04-11 SG SG11201508391SA patent/SG11201508391SA/en unknown
- 2014-04-11 BR BR112015025859A patent/BR112015025859A2/pt active Search and Examination
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2015
- 2015-10-08 CL CL2015003004A patent/CL2015003004A1/es unknown
- 2015-11-10 ZA ZA2015/08272A patent/ZA201508272B/en unknown
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2019
- 2019-11-19 US US16/688,515 patent/US20200085818A1/en not_active Abandoned
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AU2014251532B2 (en) | 2019-05-23 |
MY173159A (en) | 2019-12-31 |
AP2015008840A0 (en) | 2015-11-30 |
EA033893B1 (ru) | 2019-12-06 |
EP2985020A1 (en) | 2016-02-17 |
MX2015013840A (es) | 2016-06-02 |
SG11201508391SA (en) | 2015-11-27 |
EP2985020A4 (en) | 2016-10-12 |
ZA201508272B (en) | 2018-05-30 |
KR20140123027A (ko) | 2014-10-21 |
US20200085818A1 (en) | 2020-03-19 |
JP2016516784A (ja) | 2016-06-09 |
US20160074396A1 (en) | 2016-03-17 |
KR102223105B1 (ko) | 2021-03-04 |
EP2985020B1 (en) | 2021-06-23 |
EA201591950A1 (ru) | 2016-04-29 |
CN105209025B (zh) | 2019-06-18 |
BR112015025859A2 (pt) | 2017-07-25 |
CN105209025A (zh) | 2015-12-30 |
AU2014251532A1 (en) | 2015-11-12 |
JP6470257B2 (ja) | 2019-02-13 |
CL2015003004A1 (es) | 2016-05-13 |
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