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

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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
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China
Prior art keywords
film
sildenafil
active ingredient
bitterness
formulation
Prior art date
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CN201380010759.1A
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English (en)
Chinese (zh)
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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
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Seoul Pharma Co Ltd
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Seoul Pharma Co Ltd
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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
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    • 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

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  • 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
KR10-2012-0020316 2012-02-28
KR1020120020316A KR101328350B1 (ko) 2012-02-28 2012-02-28 실데나필 또는 이의 약제학적으로 허용되는 염을 유효성분으로 함유하는 고미가 은폐된 약제학적 조성물
KR10-2012-0117233 2012-10-22
KR1020120117233A KR101440808B1 (ko) 2012-10-22 2012-10-22 실데나필 또는 이의 약제학적으로 허용되는 염을 고함량으로 포함하는 속용필름
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)

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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
KR20170117374A (ko) * 2014-12-09 2017-10-23 모노졸 알엑스, 엘엘씨 선형 다당류-기반 필름 생성물
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
US20180028662A1 (en) 2015-02-25 2018-02-01 Eisai R&D Management Co., Ltd. Method for Suppressing Bitterness of Quinoline Derivative
CN108135894B (zh) 2015-08-20 2021-02-19 卫材R&D管理有限公司 肿瘤治疗剂
US20210322537A1 (en) * 2016-06-07 2021-10-21 Aridis Pharmaceuticals, Inc. Method For Preparation of Quick Dissolving Thin Films Containing Bioactive Material With Enhanced Thermal Stability
CN110072528B (zh) 2017-02-08 2022-04-26 卫材R&D管理有限公司 治疗肿瘤的药物组合物
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
WO2018212202A1 (en) 2017-05-16 2018-11-22 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
WO2019161322A1 (en) * 2018-02-19 2019-08-22 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
CN112438979B (zh) * 2019-09-04 2022-05-27 普济生物科技（台州）有限公司 用于口腔掩味的含氢溴酸沃替西汀的包衣颗粒、固体分散体和制剂
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
MX2023007464A (es) * 2020-12-22 2023-08-30 Solugen Inc Agente de enmascaramiento amargo.
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
KR20250177169A (ko) * 2024-06-14 2025-12-23 한미약품 주식회사 프레가발린 또는 이의 약학적으로 허용가능한 염을 포함하는 구강붕해정
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

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US20060100214A1 (en) * 2002-08-21 2006-05-11 Wei Tian Fast dissolving and taste masked oral dosage form comprising sildenafil
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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
CA2864322A1 (en) 2013-09-06
JP2015504916A (ja) 2015-02-16
CN104168895A (zh) 2014-11-26
WO2013129889A9 (ko) 2014-10-16
US20150025084A1 (en) 2015-01-22
EP2821066B1 (en) 2018-04-25
EP2821066A2 (en) 2015-01-07
WO2013129889A2 (ko) 2013-09-06
JP5941558B2 (ja) 2016-06-29
EP2821066A4 (en) 2015-10-21
US10092651B2 (en) 2018-10-09
WO2013129889A3 (ko) 2013-10-24
IN2014MN01706A (enExample) 2015-05-29
CA2864322C (en) 2016-08-09

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