EA200400862A1 - Твёрдая лекарственная форма, содержащая сердцевинную таблетку с активным фармацевтическим ингредиентом, покрытую кольцеобразной оболочкой из спрессованного порошкообразного или гранулированного материала, способ приготовления такой лекарственной формы и устройство для её приготовления - Google Patents

Твёрдая лекарственная форма, содержащая сердцевинную таблетку с активным фармацевтическим ингредиентом, покрытую кольцеобразной оболочкой из спрессованного порошкообразного или гранулированного материала, способ приготовления такой лекарственной формы и устройство для её приготовления

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Publication number
EA200400862A1
EA200400862A1 EA200400862A EA200400862A EA200400862A1 EA 200400862 A1 EA200400862 A1 EA 200400862A1 EA 200400862 A EA200400862 A EA 200400862A EA 200400862 A EA200400862 A EA 200400862A EA 200400862 A1 EA200400862 A1 EA 200400862A1
Authority
EA
Eurasian Patent Office
Prior art keywords
dosage form
solid dosage
present
punch
administration
Prior art date
Application number
EA200400862A
Other languages
English (en)
Other versions
EA006053B1 (ru
Inventor
Е. Ицхак Лернер
Веред Розенбергер
Офер Аква
Моше Флэшнер-Барек
Original Assignee
Тева Фармасьютикал Индастриес Лтд.
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 Тева Фармасьютикал Индастриес Лтд. filed Critical Тева Фармасьютикал Индастриес Лтд.
Publication of EA200400862A1 publication Critical patent/EA200400862A1/ru
Publication of EA006053B1 publication Critical patent/EA006053B1/ru

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    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • 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
    • A61J3/005—Coating of tablets or the like
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/433—Thidiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/2072—Pills, 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
    • 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
    • A61K9/2072—Pills, 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/34—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Mechanical Engineering (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Emergency Medicine (AREA)
  • Rheumatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Настоящим изобретением предлагается твердая лекарственная форма для введения в организм пациента путем перорального приема, включающая сердцевинную таблетку, которая заключена в кольцеобразную оболочку из спрессованного порошкообразного или гранулированного материала. В одном из предпочтительных вариантов осуществления твердой лекарственной формы по предлагаемому изобретению обеспечено уменьшение вероятности контакта активного ингредиента этой твердой лекарственной формы с выстилающей слизистой оболочкой желудочно-кишечного тракта, что представляет особое преимущество при приеме лекарственных веществ, обладающих ульцерогенным действием. Настоящим изобретением предлагается также устройство (инструментарий), в состав которого входят колоннообразный форм-блок (пуансон) и пуансонный узел, включающий пуансон кольцеобразного сечения и центральный стержень, а также способ приготовления такой твердой лекарственной формы.Отчет о международном поиске был опубликован 2004.02.12.
EA200400862A 2001-12-24 2002-11-12 Твёрдая лекарственная форма, способ её изготовления и устройство EA006053B1 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US34244201P 2001-12-24 2001-12-24
US36182102P 2002-03-04 2002-03-04
PCT/US2002/036081 WO2003057136A2 (en) 2001-12-24 2002-11-12 Dosage form with a core tablet of active ingredient sheathed in a compressed annular body of powder or granular material, and process and tooling for producing it

Publications (2)

Publication Number Publication Date
EA200400862A1 true EA200400862A1 (ru) 2004-12-30
EA006053B1 EA006053B1 (ru) 2005-08-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EA200400862A EA006053B1 (ru) 2001-12-24 2002-11-12 Твёрдая лекарственная форма, способ её изготовления и устройство

Country Status (14)

Country Link
US (2) US7611722B2 (ru)
EP (2) EP2172192A1 (ru)
JP (1) JP4414228B2 (ru)
KR (1) KR100897837B1 (ru)
CN (1) CN1620284B (ru)
BR (1) BR0215413A (ru)
CA (1) CA2470495A1 (ru)
EA (1) EA006053B1 (ru)
HU (1) HUP0600680A3 (ru)
IL (1) IL162459A0 (ru)
MX (1) MXPA04006310A (ru)
NO (1) NO20043152L (ru)
NZ (3) NZ552513A (ru)
WO (1) WO2003057136A2 (ru)

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US20050112202A1 (en) 2005-05-26
HUP0600680A3 (en) 2008-04-28
WO2003057136A2 (en) 2003-07-17
EA006053B1 (ru) 2005-08-25
JP2005517678A (ja) 2005-06-16
EP1465606A2 (en) 2004-10-13
IL162459A0 (en) 2005-11-20
EP2172192A1 (en) 2010-04-07
HUP0600680A2 (en) 2007-02-28
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US7611722B2 (en) 2009-11-03
EP1465606A4 (en) 2009-04-22
WO2003057136A3 (en) 2004-02-12
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BR0215413A (pt) 2004-12-14
AU2002352613A1 (en) 2003-07-24
CN1620284A (zh) 2005-05-25
MXPA04006310A (es) 2005-04-19
JP4414228B2 (ja) 2010-02-10
NZ552514A (en) 2008-08-29
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NZ552513A (en) 2008-08-29
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