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CL2020000124A1 - Composiciones sólidas orales de betahistina de liberación prolongada no pulsátil. - Google Patents

Composiciones sólidas orales de betahistina de liberación prolongada no pulsátil.

Info

Publication number
CL2020000124A1
CL2020000124A1 CL2020000124A CL2020000124A CL2020000124A1 CL 2020000124 A1 CL2020000124 A1 CL 2020000124A1 CL 2020000124 A CL2020000124 A CL 2020000124A CL 2020000124 A CL2020000124 A CL 2020000124A CL 2020000124 A1 CL2020000124 A1 CL 2020000124A1
Authority
CL
Chile
Prior art keywords
betahistine
dissolves
weight
hours
pulsatile
Prior art date
Application number
CL2020000124A
Other languages
English (en)
Inventor
Himanshukumar Dasharathlal Patel
Vinod Purushottam Dube
Venkataramana Naidu
Sunil Shantwan Borude
Original Assignee
Intas Pharmaceuticals 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=59829185&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CL2020000124(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Intas Pharmaceuticals Ltd filed Critical Intas Pharmaceuticals Ltd
Publication of CL2020000124A1 publication Critical patent/CL2020000124A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)

Abstract

La presente invención se refiere a una composición sólida oral de liberación prolongada de 24 horas no pulsátil que comprende una cantidad de betahistina, o de una sal farmacéuticamente aceptable de esta, equivalente a 48 mg de diclorhidrato de betahistina, junto con uno o más excipientes o portadores farmacéuticamente aceptables, donde la composición presenta un perfil de disolución de acuerdo con el cual: se disuelve hasta un 30% en peso de betahistina en 1 hora; se disuelve de un 35% a un 45% en peso de betahistina en 2 horas; se disuelve de un 46% a un 60% en peso de betahistina en 4 horas; se disuelve de un 61% a un 80% en peso de betahistina en 8 horas; se disuelve de un 81% a un 97% en peso de betahistina en 16 horas; y se disuelve de un 98% a un 100% en peso de betahistina en 24 horas. También se refiere a su uso en terapia, particularmente en el tratamiento de una enfermedad o afección vestibular, más particularmente en el tratamiento de la enfermedad de Ménière.
CL2020000124A 2017-07-20 2020-01-16 Composiciones sólidas orales de betahistina de liberación prolongada no pulsátil. CL2020000124A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN201721025857 2017-07-20

Publications (1)

Publication Number Publication Date
CL2020000124A1 true CL2020000124A1 (es) 2020-09-21

Family

ID=59829185

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2020000124A CL2020000124A1 (es) 2017-07-20 2020-01-16 Composiciones sólidas orales de betahistina de liberación prolongada no pulsátil.

Country Status (22)

Country Link
US (1) US11433058B2 (es)
EP (2) EP3431078B1 (es)
JP (1) JP7084950B2 (es)
CN (1) CN110891551A (es)
AR (1) AR112281A1 (es)
AU (1) AU2018302771B2 (es)
BR (1) BR112020000977A2 (es)
CA (1) CA3069282A1 (es)
CL (1) CL2020000124A1 (es)
CO (1) CO2020001742A2 (es)
DK (1) DK3431078T3 (es)
ES (1) ES2862209T3 (es)
HR (1) HRP20210570T1 (es)
LT (1) LT3431078T (es)
MX (1) MX2020000702A (es)
PH (1) PH12020500001A1 (es)
PL (1) PL3431078T3 (es)
PT (1) PT3431078T (es)
SA (1) SA520411067B1 (es)
UY (1) UY37798A (es)
WO (1) WO2019016668A1 (es)
ZA (1) ZA202000030B (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115266955B (zh) * 2021-04-29 2024-10-01 景忠山国药(唐山)有限公司 基于一测多评法的耳聋胶囊中成分含量的检测方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1309591B1 (it) * 1999-03-05 2002-01-24 Formenti Farmaceutici Spa Composizioni a rilascio controllato di betaistina.
KR20030034171A (ko) * 2001-07-06 2003-05-01 엔도 파마슈티걸즈, 인크. 옥시모르폰 제어 방출 제형
TWI319713B (en) * 2002-10-25 2010-01-21 Sustained-release tramadol formulations with 24-hour efficacy
SI1493435T1 (sl) * 2003-07-04 2008-10-31 Formenti Farmaceutici Spa Betahistinski sestavki s kontroliranim sproĺ äśanjem
WO2012131722A1 (en) * 2011-03-30 2012-10-04 Sun Pharma Advanced Research Company Ltd. Controlled release composition of betahistine
DE102012105528A1 (de) 2012-06-25 2014-01-02 Hennig Arzneimittel Gmbh & Co. Kg Arzneiform zur Freisetzung von Wirkstoffen
WO2014174073A1 (en) * 2013-04-26 2014-10-30 Sandoz Ag Sustained release formulations of tofacitinib

Also Published As

Publication number Publication date
SA520411067B1 (ar) 2022-09-28
UY37798A (es) 2019-01-02
US11433058B2 (en) 2022-09-06
ZA202000030B (en) 2021-08-25
ES2862209T3 (es) 2021-10-07
CN110891551A (zh) 2020-03-17
CA3069282A1 (en) 2019-01-24
EP3654954A4 (en) 2021-06-16
HRP20210570T1 (hr) 2021-09-03
JP2020528045A (ja) 2020-09-17
CO2020001742A2 (es) 2020-02-28
LT3431078T (lt) 2021-05-10
PL3431078T3 (pl) 2021-07-12
BR112020000977A2 (pt) 2020-07-14
WO2019016668A1 (en) 2019-01-24
AU2018302771A1 (en) 2020-01-16
US20210161871A1 (en) 2021-06-03
DK3431078T3 (da) 2021-04-19
EP3431078B1 (en) 2021-01-20
PH12020500001A1 (en) 2020-09-14
RU2020101925A3 (es) 2021-08-27
RU2020101925A (ru) 2021-08-20
AR112281A1 (es) 2019-10-09
AU2018302771B2 (en) 2022-05-12
PT3431078T (pt) 2021-04-21
JP7084950B2 (ja) 2022-06-15
EP3654954A1 (en) 2020-05-27
MX2020000702A (es) 2020-10-14
EP3431078A1 (en) 2019-01-23

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