CN104168895B - 包含西地那非作为活性成分的掩蔽苦味的高含量快速溶解膜 - Google Patents

包含西地那非作为活性成分的掩蔽苦味的高含量快速溶解膜 Download PDF

Info

Publication number
CN104168895B
CN104168895B CN201380010759.1A CN201380010759A CN104168895B CN 104168895 B CN104168895 B CN 104168895B CN 201380010759 A CN201380010759 A CN 201380010759A CN 104168895 B CN104168895 B CN 104168895B
Authority
CN
China
Prior art keywords
film
sildenafil
active ingredient
bitterness
formulation
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.)
Active
Application number
CN201380010759.1A
Other languages
English (en)
Chinese (zh)
Other versions
CN104168895A (zh
Inventor
郑贤俊
长益现
金挞根
李真厚
严镇熹
金铉洙
郑景泰
延圭正
朴振奎
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.)
Seoul Pharma Co Ltd
Original Assignee
Seoul Pharma Co Ltd
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 claimed from KR1020120020316A external-priority patent/KR101328350B1/ko
Priority claimed from KR1020120117233A external-priority patent/KR101440808B1/ko
Application filed by Seoul Pharma Co Ltd filed Critical Seoul Pharma Co Ltd
Publication of CN104168895A publication Critical patent/CN104168895A/zh
Application granted granted Critical
Publication of CN104168895B publication Critical patent/CN104168895B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Endocrinology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
CN201380010759.1A 2012-02-28 2013-02-28 包含西地那非作为活性成分的掩蔽苦味的高含量快速溶解膜 Active CN104168895B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
KR1020120020316A KR101328350B1 (ko) 2012-02-28 2012-02-28 실데나필 또는 이의 약제학적으로 허용되는 염을 유효성분으로 함유하는 고미가 은폐된 약제학적 조성물
KR10-2012-0020316 2012-02-28
KR1020120117233A KR101440808B1 (ko) 2012-10-22 2012-10-22 실데나필 또는 이의 약제학적으로 허용되는 염을 고함량으로 포함하는 속용필름
KR10-2012-0117233 2012-10-22
PCT/KR2013/001679 WO2013129889A2 (ko) 2012-02-28 2013-02-28 실데나필을 유효성분으로 함유하며 고미가 은폐된 고함량 속용필름

Publications (2)

Publication Number Publication Date
CN104168895A CN104168895A (zh) 2014-11-26
CN104168895B true CN104168895B (zh) 2020-02-21

Family

ID=49083410

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201380010759.1A Active CN104168895B (zh) 2012-02-28 2013-02-28 包含西地那非作为活性成分的掩蔽苦味的高含量快速溶解膜

Country Status (7)

Country Link
US (1) US10092651B2 (enExample)
EP (1) EP2821066B1 (enExample)
JP (1) JP5941558B2 (enExample)
CN (1) CN104168895B (enExample)
CA (1) CA2864322C (enExample)
IN (1) IN2014MN01706A (enExample)
WO (1) WO2013129889A2 (enExample)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103989661B (zh) * 2014-05-26 2016-04-20 苏州大学 西地那非口腔速溶膜剂及其制备方法
KR101538985B1 (ko) * 2014-09-02 2015-07-24 주식회사 서울제약 타다라필 구강붕해필름 및 이의 제조방법
JP2017537127A (ja) * 2014-12-09 2017-12-14 モノソル アールエックス リミテッド ライアビリティ カンパニー 線状多糖をベースとするフィルム製品
CN104586820B (zh) * 2015-01-13 2021-04-09 齐鲁制药有限公司 具有高载药量的西地那非口腔速溶薄膜组合物
CN104546807B (zh) * 2015-01-21 2020-09-01 齐鲁制药有限公司 奥氮平口腔速溶膜剂
JP6792546B2 (ja) 2015-02-25 2020-11-25 エーザイ・アール・アンド・ディー・マネジメント株式会社 キノリン誘導体の苦味抑制方法
CN108135894B (zh) 2015-08-20 2021-02-19 卫材R&D管理有限公司 肿瘤治疗剂
WO2017214187A1 (en) * 2016-06-07 2017-12-14 Aridis Pharmaceuticals, Inc. Method for preparation of quick dissolving thin films containing bioactive material with enhanced thermal stability
RU2750539C2 (ru) 2017-02-08 2021-06-29 Эйсай Ар Энд Ди Менеджмент Ко., Лтд. Фармацевтическая композиция для лечения опухоли
WO2018166432A1 (en) * 2017-03-13 2018-09-20 Nano And Advanced Materials Institute Limited High loading and fast disintegration film for fast drug absorption
CN106860404A (zh) * 2017-04-13 2017-06-20 中国药科大学 一种枸橼酸西地那非掩味树脂复合物及其应用
AU2018269996A1 (en) 2017-05-16 2019-11-21 Eisai R&D Management Co., Ltd. Treatment of hepatocellular carcinoma
CN109717282A (zh) * 2017-10-30 2019-05-07 上海冠生园食品有限公司 一种富含花青素的糖果及其制备方法
US20210007977A1 (en) * 2018-02-19 2021-01-14 Monell Chemical Senses Center Compositions and methods of ameliorating pharmaceutical aversiveness with salts
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
CN111466564A (zh) * 2019-01-24 2020-07-31 甄崇礼 含有天然活性多糖的口腔速溶膜剂及其制备方法
CN110128429A (zh) * 2019-04-30 2019-08-16 孙常全 一种西地那非-安赛蜜盐型及其制备方法和用途
MX2022002444A (es) * 2019-09-04 2022-03-22 Seasons Biotechnology Taizhou Co Ltd Granulo recubierto, dispersion solida y preparacion que contiene hidrobromuro de vortioxetina enmascarante de sabor oral.
US11179331B1 (en) 2020-04-21 2021-11-23 Cure Pharmaceutcai Holding Corp Oral soluble film containing sildenafil citrate
GR20200100430A (el) * 2020-06-01 2022-01-13 Κυριακος Ηλια Κυπραιος Ταχεως διαλυομενες στοματικες ταινιες για τη χορηγηση δια της στοματικης οδου φαρμακων και λοιπων βιοδραστικων ουσιων σε ανθρωπους
US20240065303A1 (en) * 2020-12-22 2024-02-29 Solugen, Inc. Bitter masking agent
CN115252587A (zh) * 2022-08-19 2022-11-01 南京泛太化工医药研究所 一种口腔速溶膜及其制备方法
CN116270553B (zh) * 2023-02-01 2024-05-07 北京悦康科创医药科技股份有限公司 一种爱地那非口溶膜剂及其制备方法
CN119280194B (zh) * 2024-09-06 2025-10-28 广州朗圣药业有限公司 一种西地那非口溶膜剂及其制备方法与应用

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US20060100214A1 (en) * 2002-08-21 2006-05-11 Wei Tian Fast dissolving and taste masked oral dosage form comprising sildenafil
CN101626756A (zh) * 2006-10-02 2010-01-13 拉伯泰克技术研发有限公司 非粘膜粘着性膜剂型

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US652024A (en) 1898-12-08 1900-06-19 James Gray Valve mechanism for automatic water-heaters.
TW271400B (enExample) * 1992-07-30 1996-03-01 Pfizer
GB9311920D0 (en) 1993-06-09 1993-07-28 Pfizer Ltd Therapeutic agents
GB9401090D0 (en) 1994-01-21 1994-03-16 Glaxo Lab Sa Chemical compounds
US5605889A (en) 1994-04-29 1997-02-25 Pfizer Inc. Method of administering azithromycin
DK1174431T3 (da) 1997-11-12 2012-08-20 Bayer Pharma AG 2-phenyl-substitueret imidazo triazinon som phoshodiesterase-inhibitorer
KR100353014B1 (ko) 1998-11-11 2002-09-18 동아제약 주식회사 발기부전 치료에 효과를 갖는 피라졸로피리미디논 화합물
US6552024B1 (en) 1999-01-21 2003-04-22 Lavipharm Laboratories Inc. Compositions and methods for mucosal delivery
US7067116B1 (en) 2000-03-23 2006-06-27 Warner-Lambert Company Llc Fast dissolving orally consumable solid film containing a taste masking agent and pharmaceutically active agent at weight ratio of 1:3 to 3:1
DE10207394B4 (de) 2002-02-21 2007-03-29 Lts Lohmann Therapie-Systeme Ag Geschmacksmaskierte oblatenförmige Arzneizubereitung
KR20060031552A (ko) 2004-10-08 2006-04-12 박영국 취수선을 이용한 해양 심층수 취수 방법
US20070092553A1 (en) 2005-10-21 2007-04-26 Pfab Lp Compositions and methods of making rapidly dissolving lonically masked formulations
CA2629904C (en) * 2005-11-28 2018-07-10 Imaginot Pty Ltd. Oral therapeutic compound delivery system
ES2355306T3 (es) * 2006-03-16 2011-03-24 Novartis Ag Forma de dosificación sólida que contiene un agente activo de sabor enmascarado.
KR101304343B1 (ko) 2006-04-06 2013-09-11 한미사이언스 주식회사 Ｐｄｅ-5 억제제의 경구용 속용제형
US20080233174A1 (en) 2007-01-12 2008-09-25 Monosol Rx, Llc High dose film compositions and methods of preparation
US20080220029A1 (en) 2007-03-05 2008-09-11 Charlene Ng Fast-dissolving/disintegrating film preparation having high proportion of active
US20090047330A1 (en) 2007-08-17 2009-02-19 Ramesh Bangalore Oral fast dissolving films for erectile dysfunction bioactive agents
US20100297232A1 (en) * 2009-05-19 2010-11-25 Monosol Rx, Llc Ondansetron film compositions
KR101074271B1 (ko) 2009-06-25 2011-10-17 (주)차바이오앤디오스텍 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름
DE102010049708A1 (de) * 2010-10-28 2012-05-03 Hexal Ag Orale pharmazeutische Filmformulierung für bitter schmeckende Arzneistoffe
EP2674154B1 (en) * 2011-02-11 2018-08-01 CTC Bio, Inc. Sildenafil-free base-containing film preparation and method for producing same
KR101188594B1 (ko) * 2011-12-06 2012-10-08 (주)씨엘팜 쓴맛이 차단된 실데나필 시트르산의 구강내 속붕해 필름제형

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US20060100214A1 (en) * 2002-08-21 2006-05-11 Wei Tian Fast dissolving and taste masked oral dosage form comprising sildenafil
CN101626756A (zh) * 2006-10-02 2010-01-13 拉伯泰克技术研发有限公司 非粘膜粘着性膜剂型

Also Published As

Publication number Publication date
WO2013129889A9 (ko) 2014-10-16
US10092651B2 (en) 2018-10-09
CN104168895A (zh) 2014-11-26
US20150025084A1 (en) 2015-01-22
CA2864322A1 (en) 2013-09-06
WO2013129889A2 (ko) 2013-09-06
WO2013129889A3 (ko) 2013-10-24
JP2015504916A (ja) 2015-02-16
IN2014MN01706A (enExample) 2015-05-29
JP5941558B2 (ja) 2016-06-29
EP2821066A2 (en) 2015-01-07
EP2821066A4 (en) 2015-10-21
EP2821066B1 (en) 2018-04-25
CA2864322C (en) 2016-08-09

Similar Documents

Publication Publication Date Title
CN104168895B (zh) 包含西地那非作为活性成分的掩蔽苦味的高含量快速溶解膜
EP2431028B1 (en) Fast-dissolving oral film for effectively concealing unpleasant tastes
EP1143940B1 (en) Compositions and methods for mucosal delivery
CN114983980A (zh) 含右美托咪定的膜制剂及其制造方法
KR101328350B1 (ko) 실데나필 또는 이의 약제학적으로 허용되는 염을 유효성분으로 함유하는 고미가 은폐된 약제학적 조성물
KR101440808B1 (ko) 실데나필 또는 이의 약제학적으로 허용되는 염을 고함량으로 포함하는 속용필름
TWI905080B (zh) 含右美托咪啶(dexmedetomidine)之膜調配物及其製造方法
AU2016318594A1 (en) Methods and compositions for soft anticholinergic zwitterions
HK1161981A (en) Quickly soluble oral film dosage containing steviosides as a unpleasant taste masking agent

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant