SA517381018B1 - مادة تادالافيل الفموية القابلة للتشتثت وطريقة إعدادها - Google Patents

مادة تادالافيل الفموية القابلة للتشتثت وطريقة إعدادها

Info

Publication number
SA517381018B1
SA517381018B1 SA517381018A SA517381018A SA517381018B1 SA 517381018 B1 SA517381018 B1 SA 517381018B1 SA 517381018 A SA517381018 A SA 517381018A SA 517381018 A SA517381018 A SA 517381018A SA 517381018 B1 SA517381018 B1 SA 517381018B1
Authority
SA
Saudi Arabia
Prior art keywords
film
oral dispersible
tadalafil
dispersible film
preparing
Prior art date
Application number
SA517381018A
Other languages
English (en)
Inventor
هون كيم جونج
هي يوم جين
وون تشوي دونج
سو كيم هيون
يونج جانج وون
هي تشو يونج
Original Assignee
.سيؤول فارما، كو.، ليمتد
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
Application filed by .سيؤول فارما، كو.، ليمتد filed Critical .سيؤول فارما، كو.، ليمتد
Publication of SA517381018B1 publication Critical patent/SA517381018B1/ar

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
    • A61K31/4985—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
    • 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
    • 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)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

يتعلق الكشف الحالي بتركيبات لإعداد مادة فموية قابلة للتشتيت oral dispersible وملحها المقبول صيدليًا ومادة خافضة للتوتر السطحي surfactant وملدن plasticizer وعامل تحلية sweetening agent ومادة فموية قابلة للتشتيت وطرق لإعدادها. يمكن للمادة الفموية القابلة للتشتيت للاختراع الحالي تحسين معدل تحلل مادة التادالافيل tadalafil بدون عمليات معقدة كما أنها تتميز باستقرار كبير مقارنة بحبوب Cialis السابقة بسبب تثبيط إنشاء المركبات ذات الصلة بغض النظر عن وجود تغليف. وإضافة إلى ذلك، يمكن الحفاظ على الخصائص العليا للمادة بما في ذلك منع تسرب المادة وضمان المرونة flexibility ومنع تسرب الزيت prevention of oil leakage من تركيبة المادة عندما تشتمل على محتوى خاص من جليكول بولي ثيلين 400 polyethylene glycol 400 مثل الملدنات plasticizers.
SA517381018A 2014-09-02 2017-03-01 مادة تادالافيل الفموية القابلة للتشتثت وطريقة إعدادها SA517381018B1 (ar)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020140115985A KR101538985B1 (ko) 2014-09-02 2014-09-02 타다라필 구강붕해필름 및 이의 제조방법
PCT/KR2015/009151 WO2016036093A1 (en) 2014-09-02 2015-08-31 Tadalafil oral dispersible film and preparing method thereof

Publications (1)

Publication Number Publication Date
SA517381018B1 true SA517381018B1 (ar) 2021-05-18

Family

ID=53876039

Family Applications (1)

Application Number Title Priority Date Filing Date
SA517381018A SA517381018B1 (ar) 2014-09-02 2017-03-01 مادة تادالافيل الفموية القابلة للتشتثت وطريقة إعدادها

Country Status (8)

Country Link
EP (1) EP3188720B1 (ar)
JP (1) JP6417480B2 (ar)
KR (1) KR101538985B1 (ar)
CN (1) CN107106508B (ar)
AU (1) AU2015312672B2 (ar)
PH (1) PH12017500388B1 (ar)
SA (1) SA517381018B1 (ar)
WO (1) WO2016036093A1 (ar)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101634382B1 (ko) 2015-10-20 2016-06-28 미래제약 주식회사 타다라필 경구용 액제
US20210346385A1 (en) * 2018-09-21 2021-11-11 MSB Holdings, Inc Taste-masked dosage forms
KR102110179B1 (ko) 2019-07-18 2020-05-13 주식회사 서울제약 타다라필 또는 그의 약제학적으로 허용되는 염 함유 구강붕해필름
KR102291180B1 (ko) * 2019-12-18 2021-08-18 충남대학교산학협력단 구강내 속붕해 필름형 제제 및 이의 제조방법
KR20230120924A (ko) 2022-02-10 2023-08-17 주식회사 서울제약 유단백가수분해물을 포함하는 구강붕해필름

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2310166T3 (es) 1999-08-03 2009-01-01 Lilly Icos Llc Composicion farmaceutica que contiene tadalafil.
US20080009502A1 (en) * 2006-07-07 2008-01-10 Access Business Group International Llc Tadalafil solid composites
KR100855566B1 (ko) * 2006-09-12 2008-09-03 (주) 아모젠 경구용 소모성 필름
CN101678114A (zh) * 2007-04-25 2010-03-24 特瓦制药工业有限公司 固体剂型
DE102007028869A1 (de) * 2007-06-22 2008-12-24 Ratiopharm Gmbh Verfahren zur Herstellung eines Arzneimittels enthaltend Tadalafil
KR100905027B1 (ko) * 2007-10-03 2009-06-30 (주)씨엘팜 식용 필름
KR101074271B1 (ko) * 2009-06-25 2011-10-17 (주)차바이오앤디오스텍 불쾌한 맛을 효과적으로 은폐한 경구용 속용 필름
US20110263606A1 (en) * 2010-04-26 2011-10-27 Horst Zerbe Solid oral dosage forms comprising tadalafil
WO2012053006A2 (en) * 2010-10-18 2012-04-26 Panacea Biotec Ltd Improved oral fast dissolving films comprising combination of polymers and method of preparation thereof
KR101077468B1 (ko) * 2011-03-04 2011-11-07 (주)차바이오앤디오스텍 안정한 경구용 속용 필름 제제
WO2013129889A2 (ko) * 2012-02-28 2013-09-06 주식회사 서울제약 실데나필을 유효성분으로 함유하며 고미가 은폐된 고함량 속용필름
FR2999086B1 (fr) * 2012-12-10 2015-04-10 Ethypharm Sa Composition orale et/ou buccale sous forme de film fin d'un principe actif faiblement soluble, son procede de preparation et son utilisation
MX2015013840A (es) * 2013-04-11 2016-06-02 Ctc Bio Inc 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.
PL3111929T3 (pl) * 2014-06-24 2019-01-31 Wooshin Labottach Co., Ltd. Ulegający rozpadowi w jamie ustnej preparat w postaci błony zawierający tadalafil i sposób jego wytwarzania

Also Published As

Publication number Publication date
PH12017500388A1 (en) 2017-07-17
EP3188720A1 (en) 2017-07-12
CN107106508B (zh) 2020-11-13
WO2016036093A1 (en) 2016-03-10
JP6417480B2 (ja) 2018-11-07
EP3188720A4 (en) 2017-08-30
AU2015312672B2 (en) 2018-05-10
PH12017500388B1 (en) 2017-07-17
EP3188720B1 (en) 2021-04-21
KR101538985B1 (ko) 2015-07-24
AU2015312672A1 (en) 2017-03-23
JP2017526751A (ja) 2017-09-14
CN107106508A (zh) 2017-08-29

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