WO2013098268A3 - Tablets and dry-coated agents - Google Patents

Tablets and dry-coated agents Download PDF

Info

Publication number
WO2013098268A3
WO2013098268A3 PCT/EP2012/076794 EP2012076794W WO2013098268A3 WO 2013098268 A3 WO2013098268 A3 WO 2013098268A3 EP 2012076794 W EP2012076794 W EP 2012076794W WO 2013098268 A3 WO2013098268 A3 WO 2013098268A3
Authority
WO
WIPO (PCT)
Prior art keywords
valsartan
present
dry
tablet
saliva
Prior art date
Application number
PCT/EP2012/076794
Other languages
French (fr)
Other versions
WO2013098268A2 (en
Inventor
Masaki Ando
Takanori Ichihashi
Sayaka KOJIMA
Masato Sakurai
Rina TANAKA
Original Assignee
Novartis Ag
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 JP2011284027A external-priority patent/JP2013133291A/en
Priority claimed from JP2011284036A external-priority patent/JP2013133292A/en
Application filed by Novartis Ag filed Critical Novartis Ag
Priority to EP12806509.1A priority Critical patent/EP2797580A2/en
Priority to BR112014015620A priority patent/BR112014015620A8/en
Priority to AU2012360935A priority patent/AU2012360935A1/en
Priority to JP2014548092A priority patent/JP2015504878A/en
Priority to RU2014130743A priority patent/RU2014130743A/en
Priority to MX2014007933A priority patent/MX2014007933A/en
Priority to KR1020147017155A priority patent/KR20140108652A/en
Publication of WO2013098268A2 publication Critical patent/WO2013098268A2/en
Publication of WO2013098268A3 publication Critical patent/WO2013098268A3/en

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
    • A61K9/0012—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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

The present invention is related to the provision of a tablet that may easily be orally administered and has valsartan as active ingredient. Specifically, the present invention provides a tablet consisting of pharmaceutical composition comprising a valsartan or a pharmaceutically acceptable salt thereof, a disintegrant, a glidant and a lubricant, wherein the tablet is orally administrated through disintegration in the mouth by saliva or water in a similar amount to the saliva. The present invention is also related to the provision of a dry-coated agent that may prevent bitter taste, sufficiently improve QOL, and has valsartan as active ingredient. Specifically, the present invention provides a dry-coated agent comprising an inner core consisting of pharmaceutical composition containing valsartan or its pharmaceutically acceptable salt thereof, and an outer layer coating the inner core and consisting of coating composition containing pH adjuster which makes inside of the mouth mildly acidic.
PCT/EP2012/076794 2011-12-26 2012-12-21 Tablets and dry-coated agents WO2013098268A2 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP12806509.1A EP2797580A2 (en) 2011-12-26 2012-12-21 Tablets and dry-coated agents
BR112014015620A BR112014015620A8 (en) 2011-12-26 2012-12-21 dry coated tablets and agents
AU2012360935A AU2012360935A1 (en) 2011-12-26 2012-12-21 Tablets and dry-coated agents
JP2014548092A JP2015504878A (en) 2011-12-26 2012-12-21 Tablets and nucleated drugs
RU2014130743A RU2014130743A (en) 2011-12-26 2012-12-21 TABLETS AND DRY COATED PRODUCTS
MX2014007933A MX2014007933A (en) 2011-12-26 2012-12-21 Tablets and dry-coated agents.
KR1020147017155A KR20140108652A (en) 2011-12-26 2012-12-21 Tablets and dry-coated agents

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2011-284036 2011-12-26
JP2011284027A JP2013133291A (en) 2011-12-26 2011-12-26 Tablet
JP2011-284027 2011-12-26
JP2011284036A JP2013133292A (en) 2011-12-26 2011-12-26 Nucleated agent

Publications (2)

Publication Number Publication Date
WO2013098268A2 WO2013098268A2 (en) 2013-07-04
WO2013098268A3 true WO2013098268A3 (en) 2013-08-22

Family

ID=47436010

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2012/076794 WO2013098268A2 (en) 2011-12-26 2012-12-21 Tablets and dry-coated agents

Country Status (8)

Country Link
EP (1) EP2797580A2 (en)
JP (1) JP2015504878A (en)
KR (1) KR20140108652A (en)
AU (1) AU2012360935A1 (en)
BR (1) BR112014015620A8 (en)
MX (1) MX2014007933A (en)
RU (1) RU2014130743A (en)
WO (1) WO2013098268A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI690333B (en) * 2015-06-29 2020-04-11 日商大賽璐股份有限公司 Manufacturing method of easy-to-take solid preparation (with nuclear ingot) and easy-to-take solid preparation
US20230414542A1 (en) * 2020-11-13 2023-12-28 Sila Srl Orally dispersible compound containing an ester or salt of n-butyric acid and process for production
CN112807286A (en) * 2021-01-20 2021-05-18 海南皇隆制药股份有限公司 Preparation method of valsartan dispersible tablet and valsartan dispersible tablet
CN112826806A (en) * 2021-01-20 2021-05-25 海南皇隆制药股份有限公司 Preparation method of valsartan tablets and valsartan tablets

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997049394A2 (en) * 1996-06-27 1997-12-31 Novartis Ag Sold oral dosage forms of valsartan
WO2007052307A2 (en) * 2005-10-31 2007-05-10 Lupin Limited Stable solid oral dosage forms of valsartan
WO2009045795A2 (en) * 2007-09-28 2009-04-09 Novartis Ag Galenical formulations of aliskiren and valsartan
WO2009064681A2 (en) * 2007-11-12 2009-05-22 Novartis Ag Liquid compositions comprising valsartan
JP2009114113A (en) * 2007-11-06 2009-05-28 Nipro Corp Intraorally disintegrable tablet and method for producing the same
WO2010065489A1 (en) * 2008-12-02 2010-06-10 Sciele Pharma, Inc. Alpha2-adrenergic agonist and angiotensin ii receptor antagonist composition

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE134624T1 (en) 1990-02-19 1996-03-15 Ciba Geigy Ag ACYL COMPOUNDS
EP0553777B1 (en) 1992-01-29 2002-04-24 Takeda Chemical Industries, Ltd. Fast dissolving tablet and its production
CA2179382C (en) 1994-01-31 2009-11-10 Takao Mizumoto Intrabuccally dissolving compressed moldings and production process thereof
CA2311734C (en) * 2000-04-12 2011-03-08 Bristol-Myers Squibb Company Flash-melt oral dosage formulation
KR20040037138A (en) * 2001-09-28 2004-05-04 가부시키가이샤산와카가쿠켄큐쇼 Press-Coated Fast-Dissolving/Disintegrating Molded Product
PE20120542A1 (en) * 2006-06-27 2012-05-14 Novartis Ag SOLID DOSAGE FORMS OF VALSARTAN, AMLODIPINE AND HYDROCHLOROTHIAZIDE AND METHOD OF PREPARING THEM
JP5296456B2 (en) * 2008-08-26 2013-09-25 大日本住友製薬株式会社 Irbesartan-containing pharmaceutical composition with good dissolution and orally disintegrating tablet
WO2010146551A2 (en) * 2009-06-16 2010-12-23 Ranbaxy Laboratories Limited Orally disintegrating compositions comprising antihypertensive agents
JP2013023463A (en) * 2011-07-20 2013-02-04 Ohara Yakuhin Kogyo Kk Method for producing physiologically active substance-containing granule

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997049394A2 (en) * 1996-06-27 1997-12-31 Novartis Ag Sold oral dosage forms of valsartan
WO2007052307A2 (en) * 2005-10-31 2007-05-10 Lupin Limited Stable solid oral dosage forms of valsartan
WO2009045795A2 (en) * 2007-09-28 2009-04-09 Novartis Ag Galenical formulations of aliskiren and valsartan
JP2009114113A (en) * 2007-11-06 2009-05-28 Nipro Corp Intraorally disintegrable tablet and method for producing the same
WO2009064681A2 (en) * 2007-11-12 2009-05-22 Novartis Ag Liquid compositions comprising valsartan
WO2010065489A1 (en) * 2008-12-02 2010-06-10 Sciele Pharma, Inc. Alpha2-adrenergic agonist and angiotensin ii receptor antagonist composition

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Derwent World Patents Index; AN 2007288124, XP002699240, KATAYAMA NAOHISA: "intraorally disintegrable tablet and method for producing the same" *

Also Published As

Publication number Publication date
RU2014130743A (en) 2016-02-20
MX2014007933A (en) 2014-07-30
JP2015504878A (en) 2015-02-16
KR20140108652A (en) 2014-09-12
WO2013098268A2 (en) 2013-07-04
EP2797580A2 (en) 2014-11-05
BR112014015620A2 (en) 2017-06-13
AU2012360935A1 (en) 2014-07-17
BR112014015620A8 (en) 2017-07-04

Similar Documents

Publication Publication Date Title
MY157189A (en) Capsule formulation
WO2013183062A3 (en) Palatable formulations of ibuprofen
EA200702627A1 (en) DOSED FORMS FOR ORAL APPLICATION, CONTAINING PROGESTERONS, AND METHODS OF THEIR MANUFACTURING AND USE
MX2010011381A (en) Compositions comprising weakly basic drugs and controlled-release dosage forms.
WO2014027975A3 (en) Novel orally administered pharmaceutical formulations
JP2015523407A5 (en)
NZ595467A (en) Sublingual pharmaceutical composition comprising a neutral oil
TN2010000135A1 (en) Galenical formulations of organic compounds
MX2010007281A (en) Pharmaceutical compositions of amlodipine and valsartan.
WO2013098268A3 (en) Tablets and dry-coated agents
TN2011000307A1 (en) Galenic formulation of organic compounds
WO2014144407A8 (en) Dual use oral pharmaceutical composition tablets of sulfate salts and methods of use thereof
WO2011093818A3 (en) Pharmaceutical compositions comprising salmeterol and fluticasone
WO2011093815A3 (en) Pharmaceutical compositions comprising formoterol and mometasone
GR1008228B (en) Pharmaceutical composition comprising a dual reuptake inhibitor and method for the preparation thereof
WO2010033954A3 (en) Fixed dose combination in form of a bilayered or monolayered tablet of aliskiren and amlodipine
NZ611026A (en) Pharmaceutical composition comprising citrate and bicarbonate salts, and use thereof for treating cystinuria
MX2015015681A (en) Pharmaceutical composition comprising fingolimod.
WO2010035245A3 (en) Extended release dosage form of ropinirole
ATE546133T1 (en) ORAL DOSAGE FORM WITH TRIS-SUBSTITUTED GLYCERIN COMPOUNDS
WO2011161223A3 (en) Pharmaceutical oral dosage forms comprising lercanidipine and enalapril and their pharmaceutically acceptable salts
WO2011093812A3 (en) Pharmaceutical formulation comprising tiotropium and budesonide in dry powder form
WO2011128628A3 (en) Gelled oral pharmaceutical compositions
WO2011126327A3 (en) Pharmaceutical composition with controlled-release properties comprising mosapride or levodropropizine, and preparing method thereof
WO2011093814A3 (en) A pharmaceutical combination comprising formoterol and ciclesonide

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 12806509

Country of ref document: EP

Kind code of ref document: A2

WWE Wipo information: entry into national phase

Ref document number: 2012806509

Country of ref document: EP

ENP Entry into the national phase

Ref document number: 20147017155

Country of ref document: KR

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2014548092

Country of ref document: JP

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: MX/A/2014/007933

Country of ref document: MX

ENP Entry into the national phase

Ref document number: 2012360935

Country of ref document: AU

Date of ref document: 20121221

Kind code of ref document: A

ENP Entry into the national phase

Ref document number: 2014130743

Country of ref document: RU

Kind code of ref document: A

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112014015620

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 112014015620

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20140624