PE20190372A1 - Comprimidos de disgregacion oral - Google Patents
Comprimidos de disgregacion oralInfo
- Publication number
- PE20190372A1 PE20190372A1 PE2018002028A PE2018002028A PE20190372A1 PE 20190372 A1 PE20190372 A1 PE 20190372A1 PE 2018002028 A PE2018002028 A PE 2018002028A PE 2018002028 A PE2018002028 A PE 2018002028A PE 20190372 A1 PE20190372 A1 PE 20190372A1
- Authority
- PE
- Peru
- Prior art keywords
- approximately
- compound
- total weight
- called
- patients
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
- A61J1/035—Blister-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
-
- 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
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
- B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
- B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
- B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
- B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
- B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Composite Materials (AREA)
- Mechanical Engineering (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Urology & Nephrology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
Se refiere a comprimidos de disgregacion oral, que contiene un compuesto de formula I: Este compuesto se denomina de forma convencional (1S, 2S, 3R, 5S)-3-[7-{[(1R, 2S)-2-(3, 4-difluorofenil)ciclopropil]amino}-5-(propiltio)-3H-[1, 2, 3]-triazolo-[4, 5-d]pirimidin-3-il]-5-(2-hidroxietoxi)ciclopentano-1, 2-diol (tambien se denomina ticagrelor); formando parte del comprimido (preferentemente en una cantidad entre 12%-17% aproximadamente del peso total) junto a un excipiente disgregante (puede ser una unica sustancia como crospovidona, croscarmelosa sodica, celulosa microcristalina, entre otros, o una mezcla de sustancias denominada premezcla de excipiente disgregante, contiendo varias de estas al menos un relleno de tipo carbohidrato y al menos un disgregante) en cantidad suficiente (si es una premezcla, debe estar presente en una cantidad entre 50%-80% aproximadamente), pudiendo anadirse un agente apelmazante (preferible si el proceso comprende un paso de granulacion, comprende entre 0.5%-1% del peso total), uno o mas lubricantes (comprende entre 1%-3% del peso total), conservantes, estabilizantes y/o antioxidantes, teniendo el comprimido una dureza entre 50 N-150 N aproximadamente y un tiempo de disgregacion menor a 3 minutos (preferiblemente menor a 60 segundos). Tambien se refiere a procesos de fabricacion, metodos de tratamiento y prevencion, y envases de tipo blister. La presente invencion es util para el tratamiento o prevencion de episodios aterotromboticos en pacientes con una enfermedad cardiovascular, y de la trombosis del stent, asi como para pacientes con problemas de disfagia que necesiten este compuesto.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201662325584P | 2016-04-21 | 2016-04-21 |
Publications (1)
Publication Number | Publication Date |
---|---|
PE20190372A1 true PE20190372A1 (es) | 2019-03-08 |
Family
ID=58640851
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PE2018002028A PE20190372A1 (es) | 2016-04-21 | 2017-04-20 | Comprimidos de disgregacion oral |
Country Status (16)
Country | Link |
---|---|
US (1) | US10729655B2 (es) |
EP (1) | EP3445338A1 (es) |
JP (2) | JP6960941B2 (es) |
KR (2) | KR102392347B1 (es) |
CN (3) | CN107595789B (es) |
AU (2) | AU2017253367B2 (es) |
BR (1) | BR112018071440A2 (es) |
CO (1) | CO2018012431A2 (es) |
EA (1) | EA201892150A1 (es) |
HK (2) | HK1248562A1 (es) |
IL (1) | IL262312B (es) |
MA (1) | MA44720A (es) |
PE (1) | PE20190372A1 (es) |
PH (1) | PH12018502226A1 (es) |
SG (2) | SG10202107682QA (es) |
WO (1) | WO2017182589A1 (es) |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111450067A (zh) * | 2019-01-18 | 2020-07-28 | 北京万全德众医药生物技术有限公司 | 一种替格瑞洛分散片及其制备方法 |
CN109700773B (zh) * | 2019-03-01 | 2021-03-16 | 石药集团中奇制药技术(石家庄)有限公司 | 一种替格瑞洛制剂组合物及其制备方法 |
CA3098818A1 (en) | 2020-08-19 | 2022-02-19 | Astrazeneca Ab | Combination treatment |
US20220387328A1 (en) | 2021-06-04 | 2022-12-08 | Glaxosmithkline Consumer Healthcare Holdings (Us) Llc | Dosage form for nicotine replacement therapy |
CA3232273A1 (en) * | 2021-10-04 | 2023-04-13 | Nava Zisapel | Methods and products for treating subjects with autism spectrum disorders |
WO2024089196A1 (en) | 2022-10-28 | 2024-05-02 | Astrazeneca Ab | Recombinant apyrase protein for use in the treatment of an ischemic event at a dose of 40-240 mg |
CN116370423A (zh) * | 2023-02-28 | 2023-07-04 | 天津力生制药股份有限公司 | 一种替格瑞洛口腔崩解片及其制备方法 |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2246013A1 (de) | 1972-09-20 | 1974-03-28 | Boehringer Mannheim Gmbh | Verfahren zur herstellung von poroesen tabletten |
TWI229674B (en) | 1998-12-04 | 2005-03-21 | Astra Pharma Prod | Novel triazolo[4,5-d]pyrimidine compounds, pharmaceutical composition containing the same, their process for preparation and uses |
GB0013407D0 (en) | 2000-06-02 | 2000-07-26 | Astrazeneca Ab | Forms of a chemical compound |
ATE333269T1 (de) * | 2001-05-10 | 2006-08-15 | Astellas Pharma Inc | In der mundhöhle schnell zerfallende tabletten und prozess zu deren herstellung |
US7390503B1 (en) | 2003-08-22 | 2008-06-24 | Barr Laboratories, Inc. | Ondansetron orally disintegrating tablets |
CN2717851Y (zh) * | 2004-05-14 | 2005-08-17 | 重庆康刻尔制药有限公司 | 一种药品包装板 |
TWI482772B (zh) | 2006-08-21 | 2015-05-01 | Astrazeneca Ab | 適合口服且包含三唑并[4,5-d]嘧啶衍生物之組合物 |
CN102058889A (zh) * | 2010-11-05 | 2011-05-18 | 王定豪 | 包含抗凝血类药物的分散片及其应用 |
FR2968992B1 (fr) | 2010-12-16 | 2013-02-08 | Sanofi Aventis | Comprime pharmaceutique orodispersible a base de zolpidem |
US20130160408A1 (en) | 2011-12-22 | 2013-06-27 | Gregor N. Neff | Blister Pack and Method |
JP5956475B2 (ja) | 2012-02-03 | 2016-07-27 | 旭化成株式会社 | 苦味マスク顆粒含有口腔内崩壊錠 |
CZ2012705A3 (cs) * | 2012-10-16 | 2014-04-23 | Zentiva, K.S. | Pevná orální farmaceutická formulace obsahující ticagrelor |
WO2015110952A1 (en) | 2014-01-21 | 2015-07-30 | Wockhardt Limited | Solid oral pharmaceutical compositions comprising ticagrelor or salt thereof |
CN104650091B (zh) * | 2014-01-24 | 2016-10-05 | 福州乾正药业有限公司 | 替格瑞洛的微粉化及其晶型,以及制备方法和药物应用 |
EA201691582A1 (ru) * | 2014-02-07 | 2017-01-30 | Оспекс Фармасьютикалз, Инк. | Новые фармацевтические препараты |
-
2017
- 2017-04-20 EA EA201892150A patent/EA201892150A1/ru unknown
- 2017-04-20 KR KR1020187033221A patent/KR102392347B1/ko active IP Right Grant
- 2017-04-20 WO PCT/EP2017/059443 patent/WO2017182589A1/en active Application Filing
- 2017-04-20 CN CN201710898954.2A patent/CN107595789B/zh active Active
- 2017-04-20 IL IL262312A patent/IL262312B/en unknown
- 2017-04-20 MA MA044720A patent/MA44720A/fr unknown
- 2017-04-20 CN CN201780000516.8A patent/CN107530288B/zh active Active
- 2017-04-20 EP EP17720055.7A patent/EP3445338A1/en active Pending
- 2017-04-20 AU AU2017253367A patent/AU2017253367B2/en active Active
- 2017-04-20 JP JP2018555237A patent/JP6960941B2/ja active Active
- 2017-04-20 KR KR1020227013818A patent/KR102488486B1/ko active IP Right Grant
- 2017-04-20 US US16/095,090 patent/US10729655B2/en active Active
- 2017-04-20 PE PE2018002028A patent/PE20190372A1/es unknown
- 2017-04-20 BR BR112018071440A patent/BR112018071440A2/pt active Search and Examination
- 2017-04-20 SG SG10202107682QA patent/SG10202107682QA/en unknown
- 2017-04-20 SG SG11201808996SA patent/SG11201808996SA/en unknown
- 2017-04-20 CN CN201710899077.0A patent/CN107595790B/zh active Active
-
2018
- 2018-06-28 HK HK18108311.5A patent/HK1248562A1/zh unknown
- 2018-07-17 HK HK18109185.6A patent/HK1249732A1/zh unknown
- 2018-10-18 PH PH12018502226A patent/PH12018502226A1/en unknown
- 2018-11-19 CO CONC2018/0012431A patent/CO2018012431A2/es unknown
-
2020
- 2020-03-18 AU AU2020201930A patent/AU2020201930B2/en active Active
-
2021
- 2021-10-12 JP JP2021167539A patent/JP7254871B2/ja active Active
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