WO2012108738A3 - 실데나필 유리염기 함유 필름 제제 및 이의 제조 방법 - Google Patents

실데나필 유리염기 함유 필름 제제 및 이의 제조 방법 Download PDF

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Publication number
WO2012108738A3
WO2012108738A3 PCT/KR2012/001049 KR2012001049W WO2012108738A3 WO 2012108738 A3 WO2012108738 A3 WO 2012108738A3 KR 2012001049 W KR2012001049 W KR 2012001049W WO 2012108738 A3 WO2012108738 A3 WO 2012108738A3
Authority
WO
WIPO (PCT)
Prior art keywords
sildenafil
free base
containing film
film preparation
producing same
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2012/001049
Other languages
English (en)
French (fr)
Other versions
WO2012108738A2 (ko
Inventor
전홍렬
이봉상
박수준
차봉근
김준기
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CTC BIO Inc
Original Assignee
CTC BIO Inc
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
Priority to ES12744173.1T priority Critical patent/ES2691629T3/es
Priority to SG2013060595A priority patent/SG192284A1/en
Priority to MX2013009240A priority patent/MX349803B/es
Priority to US13/984,756 priority patent/US9907759B2/en
Priority to BR112013020237-8A priority patent/BR112013020237A2/pt
Priority to EP12744173.1A priority patent/EP2674154B1/en
Priority to AU2012214939A priority patent/AU2012214939B2/en
Priority to MA36227A priority patent/MA34960B1/fr
Priority to CA2827069A priority patent/CA2827069C/en
Priority to EA201391156A priority patent/EA027720B1/ru
Priority to CN201280008427.5A priority patent/CN103402504B/zh
Priority to UAA201310897A priority patent/UA112540C2/uk
Application filed by CTC BIO Inc filed Critical CTC BIO Inc
Priority to JP2013553372A priority patent/JP5973467B2/ja
Publication of WO2012108738A2 publication Critical patent/WO2012108738A2/ko
Publication of WO2012108738A3 publication Critical patent/WO2012108738A3/ko
Priority to TNP2013000342A priority patent/TN2013000342A1/fr
Priority to IL227931A priority patent/IL227931A/en
Anticipated expiration legal-status Critical
Priority to ZA2013/06650A priority patent/ZA201306650B/en
Ceased legal-status Critical Current

Links

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
    • A61K9/70—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
    • 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
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K9/0012—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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Materials For Medical Uses (AREA)
  • Manufacture Of Macromolecular Shaped Articles (AREA)
  • Moulding By Coating Moulds (AREA)

Abstract

본 발명은 고함량의 실데나필 유리염기를 포함하면서도 적절한 크기와 두께를 가질 뿐만 아니라, 취급상 안정한 유연성(flexibility)을 가지고 잘 깨지지 않으며, 실데나필 유리염기가 균일하게 분산된 필름을 제조하는 방법을 제공한다. 본 발명은 또한 이러한 방법을 통해 제조된 실데나필 유리염기 함유 필름을 제공한다.
PCT/KR2012/001049 2011-02-11 2012-02-13 실데나필 유리염기 함유 필름 제제 및 이의 제조 방법 Ceased WO2012108738A2 (ko)

Priority Applications (16)

Application Number Priority Date Filing Date Title
CN201280008427.5A CN103402504B (zh) 2011-02-11 2012-02-13 包含西地那非游离碱的膜制剂及其生产方法
MX2013009240A MX349803B (es) 2011-02-11 2012-02-13 Preparación farmacéutica de película que contiene sildenafil en su forma de base libre y método para producir dicha preparación.
US13/984,756 US9907759B2 (en) 2011-02-11 2012-02-13 Sildenafil-free base-containing film preparation and method for producing same
BR112013020237-8A BR112013020237A2 (pt) 2011-02-11 2012-02-13 Processo para preparar um filme contendo base livre de sildenafila e filme contendo base livre de sildenafila
EP12744173.1A EP2674154B1 (en) 2011-02-11 2012-02-13 Sildenafil-free base-containing film preparation and method for producing same
AU2012214939A AU2012214939B2 (en) 2011-02-11 2012-02-13 Sildenafil-free base-containing film preparation and method for producing same
MA36227A MA34960B1 (fr) 2011-02-11 2012-02-13 Preparation de film contenant une base sans sidenafil et son procede
CA2827069A CA2827069C (en) 2011-02-11 2012-02-13 Sildenafil-free base-containing film preparation and method for producing same
EA201391156A EA027720B1 (ru) 2011-02-11 2012-02-13 Способ получения пленки, содержащей свободное основание силденафила
ES12744173.1T ES2691629T3 (es) 2011-02-11 2012-02-13 Preparación de película que contiene una base libre de sildenafil y procedimiento de producción de la misma
SG2013060595A SG192284A1 (en) 2011-02-11 2012-02-13 Sildenafil-free base-containing film preparation and method for producing same
UAA201310897A UA112540C2 (uk) 2011-02-11 2012-02-13 Плівкова лікарська форма, яка містить вільну основу силденафілу, і спосіб її отримання
JP2013553372A JP5973467B2 (ja) 2011-02-11 2012-02-13 シルデナフィル遊離塩基含有フィルム製剤及びその製造方法
TNP2013000342A TN2013000342A1 (en) 2011-02-11 2013-08-07 Sildenafil-free base-containing film preparation and method for producing same
IL227931A IL227931A (en) 2011-02-11 2013-08-11 A coating preparation containing sildenafil in a free base form and method of manufacture
ZA2013/06650A ZA201306650B (en) 2011-02-11 2013-09-04 Sildenafil-free base-containing film preparation and method for producing same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2011-0012516 2011-02-11
KR20110012516 2011-02-11

Publications (2)

Publication Number Publication Date
WO2012108738A2 WO2012108738A2 (ko) 2012-08-16
WO2012108738A3 true WO2012108738A3 (ko) 2012-10-26

Family

ID=46639094

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2012/001049 Ceased WO2012108738A2 (ko) 2011-02-11 2012-02-13 실데나필 유리염기 함유 필름 제제 및 이의 제조 방법

Country Status (19)

Country Link
US (1) US9907759B2 (ko)
EP (1) EP2674154B1 (ko)
JP (1) JP5973467B2 (ko)
KR (1) KR102010577B1 (ko)
CN (2) CN105250242B (ko)
AU (1) AU2012214939B2 (ko)
BR (1) BR112013020237A2 (ko)
CA (1) CA2827069C (ko)
EA (2) EA027720B1 (ko)
ES (1) ES2691629T3 (ko)
IL (1) IL227931A (ko)
MA (1) MA34960B1 (ko)
MX (1) MX349803B (ko)
MY (1) MY163288A (ko)
SG (1) SG192284A1 (ko)
TN (1) TN2013000342A1 (ko)
UA (1) UA112540C2 (ko)
WO (1) WO2012108738A2 (ko)
ZA (1) ZA201306650B (ko)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105209025A (zh) * 2013-04-11 2015-12-30 西梯茜生命工学股份有限公司 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
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2864322C (en) 2012-02-28 2016-08-09 Seoul Pharma. Co., Ltd. High-content fast dissolving film with masking of bitter taste comprising sildenafil as active ingredient
KR101643572B1 (ko) * 2013-03-07 2016-07-29 에스케이케미칼주식회사 고함량의 약물을 함유하는 구강 붕해 필름 및 이의 제조방법
US11116769B2 (en) 2013-04-11 2021-09-14 Ctc Bio, Inc. Tadalafil free base-containing film dosage form containing polyethylene glycol-based polymer and/or vinyl pyrrolidone-based polymer as dispersion stabilizer
EP2995301B1 (en) * 2013-05-10 2019-08-07 CTC Bio, Inc. Film preparation containing donepezil-free base and method for producing same
CN104352462A (zh) * 2014-10-22 2015-02-18 张艳芬 一种提高昔多芬药物功效的方法
ES2584248B1 (es) * 2015-03-24 2017-04-19 Farmalider, S.A. Composición farmacéutica de citrato de sildenafilo en forma de suspensión para uso oral
CA3059529A1 (en) 2017-04-14 2018-10-18 Capsugel Belgium Nv Process for making pullulan
CN110678170A (zh) 2017-04-14 2020-01-10 比利时胶囊公司 普鲁兰多糖胶囊
CN109010324B (zh) * 2018-08-30 2021-07-02 南京康川济医药科技有限公司 一种西地那非口溶膜剂及其制备方法

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6552024B1 (en) * 1999-01-21 2003-04-22 Lavipharm Laboratories Inc. Compositions and methods for mucosal delivery
US20050042177A1 (en) * 2003-07-23 2005-02-24 Elan Pharma International Ltd. Novel compositions of sildenafil free base
US20090047330A1 (en) * 2007-08-17 2009-02-19 Ramesh Bangalore Oral fast dissolving films for erectile dysfunction bioactive agents
KR20090049883A (ko) * 2007-11-14 2009-05-19 경북대학교 산학협력단 구연산 실데나필을 경피적으로 전달하기 위한 조절 약물전달체 및 이를 포함하는 경피 패치
US20100173940A1 (en) * 2006-10-02 2010-07-08 Labtec Gesellschaft Fur Technologische Forschung Und Entwicklung Mbh Non-mucoadhesive film dosage forms
KR20110041412A (ko) * 2009-10-15 2011-04-21 (주)씨엘팜 Ｐｄｅ5 억제제를 함유하는 구강 용해성 필름

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GT199900061A (es) * 1998-05-15 2000-10-14 Pfizer Formulaciones farmaceuticas.
JP4173670B2 (ja) * 2002-03-08 2008-10-29 旭化成ファーマ株式会社 口腔内崩壊製剤
JP5148801B2 (ja) * 2002-09-09 2013-02-20 エスエス製薬株式会社 催眠用固形製剤
FR2850275B1 (fr) * 2003-01-24 2005-04-08 Scherer Technologies Inc R P Capsules molles a macher contenant une substance active a gout masque
JP4547994B2 (ja) 2004-06-02 2010-09-22 救急薬品工業株式会社 塊状物質含有積層フィルム状の可食性口腔内投与剤の製造方法および塊状物質含有積層フィルム状の可食性口腔内投与剤
US20080317863A1 (en) 2005-02-10 2008-12-25 Christer Nystrom Pharmaceutical Compositions Useful in the Transmucosal Administration of Drugs
KR20090034882A (ko) * 2006-06-16 2009-04-08 테이트 앤 라일 인그리디언츠 아메리카스, 인코포레이티드 풀룰란 필름 및 식용 포장에서의 이들의 용도
KR101074271B1 (ko) * 2009-06-25 2011-10-17 (주)차바이오앤디오스텍 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6552024B1 (en) * 1999-01-21 2003-04-22 Lavipharm Laboratories Inc. Compositions and methods for mucosal delivery
US20050042177A1 (en) * 2003-07-23 2005-02-24 Elan Pharma International Ltd. Novel compositions of sildenafil free base
US20100173940A1 (en) * 2006-10-02 2010-07-08 Labtec Gesellschaft Fur Technologische Forschung Und Entwicklung Mbh Non-mucoadhesive film dosage forms
US20090047330A1 (en) * 2007-08-17 2009-02-19 Ramesh Bangalore Oral fast dissolving films for erectile dysfunction bioactive agents
KR20090049883A (ko) * 2007-11-14 2009-05-19 경북대학교 산학협력단 구연산 실데나필을 경피적으로 전달하기 위한 조절 약물전달체 및 이를 포함하는 경피 패치
KR20110041412A (ko) * 2009-10-15 2011-04-21 (주)씨엘팜 Ｐｄｅ5 억제제를 함유하는 구강 용해성 필름

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105209025A (zh) * 2013-04-11 2015-12-30 西梯茜生命工学股份有限公司 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
CN105209025B (zh) * 2013-04-11 2019-06-18 西梯茜生命工学股份有限公司 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
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate

Also Published As

Publication number Publication date
EP2674154B1 (en) 2018-08-01
WO2012108738A2 (ko) 2012-08-16
CA2827069A1 (en) 2012-08-16
KR102010577B1 (ko) 2019-08-13
EP2674154A4 (en) 2015-04-01
TN2013000342A1 (en) 2015-01-20
MA34960B1 (fr) 2014-03-01
CA2827069C (en) 2021-02-16
MY163288A (en) 2017-08-30
US9907759B2 (en) 2018-03-06
CN105250242A (zh) 2016-01-20
AU2012214939A1 (en) 2013-09-19
US20130323307A1 (en) 2013-12-05
EA201391156A1 (ru) 2014-02-28
KR20120101301A (ko) 2012-09-13
MX2013009240A (es) 2013-08-29
MX349803B (es) 2017-08-14
AU2012214939B2 (en) 2016-11-17
IL227931A (en) 2017-03-30
ZA201306650B (en) 2015-06-24
JP5973467B2 (ja) 2016-08-23
ES2691629T3 (es) 2018-11-28
SG192284A1 (en) 2013-09-30
CN103402504B (zh) 2015-10-14
IL227931A0 (en) 2013-09-30
CN103402504A (zh) 2013-11-20
UA112540C2 (uk) 2016-09-26
BR112013020237A2 (pt) 2021-03-16
EA027720B1 (ru) 2017-08-31
JP2014505098A (ja) 2014-02-27
EP2674154A2 (en) 2013-12-18
EA201500604A1 (ru) 2015-09-30
CN105250242B (zh) 2018-09-21

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