RU2012104843A - PHARMACEUTICAL COMPOSITION RIFAMPICINE - Google Patents

PHARMACEUTICAL COMPOSITION RIFAMPICINE Download PDF

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Publication number
RU2012104843A
RU2012104843A RU2012104843/15A RU2012104843A RU2012104843A RU 2012104843 A RU2012104843 A RU 2012104843A RU 2012104843/15 A RU2012104843/15 A RU 2012104843/15A RU 2012104843 A RU2012104843 A RU 2012104843A RU 2012104843 A RU2012104843 A RU 2012104843A
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RU
Russia
Prior art keywords
mixture
rifampicin
piperine
pharmaceutical composition
starch
Prior art date
Application number
RU2012104843/15A
Other languages
Russian (ru)
Inventor
Дипак Динешчандра БХАТТ
Мантан Рохиткумар ТРИВЕДИ
Индравадан Амбалал Моди
Бакулеш Мафатлал Хамар
Original Assignee
Кадила Фармасьютикалз 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.)
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Publication date
Application filed by Кадила Фармасьютикалз Лтд. filed Critical Кадила Фармасьютикалз Лтд.
Publication of RU2012104843A publication Critical patent/RU2012104843A/en

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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
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4453Non condensed piperidines, e.g. piperocaine only substituted in position 1, e.g. propipocaine, diperodon
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

1. Пероральная фармацевтическая композиция рифампицина и пиперина с повышенной биодоступностью, содержащая рифампициновую смесь, пиперин и фармацевтически приемлемые эксципиенты, где рифампицин находится в порошковой форме с насыпной плотностью более 0,4 г/см, причем рифампициновая смесь изготовлена с использованием порошка рифампицина, крахмала и стеарата магния.2. Фармацевтическая композиция по п.1, где пиперин находится в форме таблетки.3. Способ изготовления пероральной фармацевтической композиции рифампицина и пиперина по п.1, включающий стадии:A) стадию приготовления рифампициновой смеси, включающую стадии:А1) смешивание порошка рифампицина и крахмала,А2) обработки смазывающими веществами смеси со стадии(А1) путем использования стеарата магния с получением рифампициновой смеси;B) стадию изготовления таблетки пиперина, включающую стадии:В1) грануляции смеси лактозы, крахмала и лаурилсульфата натрия с использованием крахмальной пасты с последующей сушкой и выгрузкой продукта,В2) смешивания пиперина и основных гранул со стадии (В1),В3) смешивания смеси со стадии (В2) с лаурилсульфатом натрия, натриевой солью кроскармелозы и коллоидным диоксидом кремния с последующей обработкой смазывающими веществами путем использования стеарата магния,В4) комкования смеси со стадии (В3) с последующей выгрузкой продукта,В5) обработки смазывающими веществами смеси со стадии (В4) путем использования коллоидного диоксида кремния и стеарата магния,В6) прессования смеси со стадии (В5) в таблетки;C) стадию обработки смеси со стадии (А) вместе с продуктом со стадии (В) с получением фармацевтической композиции рифампицина.1. An oral pharmaceutical composition of rifampicin and piperine with increased bioavailability, containing a rifampicin mixture, piperine and pharmaceutically acceptable excipients, where rifampicin is in powder form with a bulk density of more than 0.4 g/cm, and the rifampicin mixture is made using rifampicin powder, starch and magnesium stearate.2. Pharmaceutical composition according to claim 1, wherein the piperine is in the form of a tablet. A method for preparing an oral pharmaceutical composition of rifampicin and piperine according to claim 1, comprising the steps: A) the step of preparing a rifampicin mixture, comprising the steps of: A1) mixing the powder of rifampicin and starch, A2) treating the mixture with lubricants from step (A1) by using magnesium stearate with obtaining a rifampicin mixture; B) a piperine tablet manufacturing step, including the steps: B1) granulating a mixture of lactose, starch and sodium lauryl sulfate using a starch paste, followed by drying and unloading the product, B2) mixing piperine and basic granules from stage (B1), B3) mixing the mixture from step (B2) with sodium lauryl sulfate, croscarmellose sodium and colloidal silica, followed by lubricating by using magnesium stearate, B4) clumping the mixture from step (B3) followed by discharging the product, B5) lubricating the mixture from step (B4) by using colloidal silicon dioxide and stearate magnesium, B6) compressing the mixture from step (B5) into tablets; C) the step of processing the mixture from step (A) together with the product from step (B) to obtain a pharmaceutical composition of rifampicin.

Claims (3)

1. Пероральная фармацевтическая композиция рифампицина и пиперина с повышенной биодоступностью, содержащая рифампициновую смесь, пиперин и фармацевтически приемлемые эксципиенты, где рифампицин находится в порошковой форме с насыпной плотностью более 0,4 г/см3, причем рифампициновая смесь изготовлена с использованием порошка рифампицина, крахмала и стеарата магния.1. The oral pharmaceutical composition of rifampicin and piperine with increased bioavailability, containing a rifampicin mixture, piperine and pharmaceutically acceptable excipients, where rifampicin is in powder form with a bulk density of more than 0.4 g / cm 3 and the rifampicin mixture is made using rifampicin powder, starch and magnesium stearate. 2. Фармацевтическая композиция по п.1, где пиперин находится в форме таблетки.2. The pharmaceutical composition according to claim 1, where piperine is in tablet form. 3. Способ изготовления пероральной фармацевтической композиции рифампицина и пиперина по п.1, включающий стадии:3. A method of manufacturing an oral pharmaceutical composition of rifampicin and piperine according to claim 1, comprising the steps of: A) стадию приготовления рифампициновой смеси, включающую стадии:A) a step for preparing a rifampicin mixture, comprising the steps of: А1) смешивание порошка рифампицина и крахмала,A1) mixing rifampicin powder and starch, А2) обработки смазывающими веществами смеси со стадииA2) processing lubricants of the mixture from stage (А1) путем использования стеарата магния с получением рифампициновой смеси;(A1) by using magnesium stearate to obtain a rifampicin mixture; B) стадию изготовления таблетки пиперина, включающую стадии:B) a step for making a piperine tablet, comprising the steps of: В1) грануляции смеси лактозы, крахмала и лаурилсульфата натрия с использованием крахмальной пасты с последующей сушкой и выгрузкой продукта,B1) granulation of a mixture of lactose, starch and sodium lauryl sulfate using starch paste, followed by drying and unloading of the product, В2) смешивания пиперина и основных гранул со стадии (В1),B2) mixing piperine and basic granules from stage (B1), В3) смешивания смеси со стадии (В2) с лаурилсульфатом натрия, натриевой солью кроскармелозы и коллоидным диоксидом кремния с последующей обработкой смазывающими веществами путем использования стеарата магния,B3) mixing the mixture from step (B2) with sodium lauryl sulfate, croscarmellose sodium and colloidal silicon dioxide, followed by treatment with lubricants using magnesium stearate, В4) комкования смеси со стадии (В3) с последующей выгрузкой продукта,B4) clumping the mixture from stage (B3), followed by unloading of the product, В5) обработки смазывающими веществами смеси со стадии (В4) путем использования коллоидного диоксида кремния и стеарата магния,B5) treating the lubricants of the mixture from step (B4) by using colloidal silicon dioxide and magnesium stearate, В6) прессования смеси со стадии (В5) в таблетки;B6) compressing the mixture from step (B5) into tablets; C) стадию обработки смеси со стадии (А) вместе с продуктом со стадии (В) с получением фармацевтической композиции рифампицина. C) the step of processing the mixture from step (A) together with the product from step (B) to obtain a rifampicin pharmaceutical composition.
RU2012104843/15A 2009-07-23 2010-07-22 PHARMACEUTICAL COMPOSITION RIFAMPICINE RU2012104843A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN1698MU2009 2009-07-23
IN1698/MUM/2009 2009-07-23
PCT/IB2010/001777 WO2011010214A1 (en) 2009-07-23 2010-07-22 Pharmaceutical composition of rifampicin

Publications (1)

Publication Number Publication Date
RU2012104843A true RU2012104843A (en) 2013-08-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
RU2012104843/15A RU2012104843A (en) 2009-07-23 2010-07-22 PHARMACEUTICAL COMPOSITION RIFAMPICINE

Country Status (4)

Country Link
AP (1) AP2012006117A0 (en)
RU (1) RU2012104843A (en)
WO (1) WO2011010214A1 (en)
ZA (1) ZA201200531B (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2906979T3 (en) * 2016-12-21 2022-04-21 Tioga Pharmaceuticals Inc Solid pharmaceutical formulations of asimadoline

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0650728B1 (en) * 1993-10-29 2002-02-27 Council of Scientific and Industrial Research Pharmaceutical compositions containing piperine and an antituberculosis or antileprosydrug
US5744161A (en) * 1995-02-24 1998-04-28 Sabinsa Corporation Use of piperine as a bioavailability enhancer
IN186315B (en) * 1996-12-12 2001-08-04 Panacea Biotec Ltd
US7195769B2 (en) * 2000-08-09 2007-03-27 Panacea Biotec Limited Pharmaceutical compositions of anti-tubercular drugs and process for their preparation
EA009214B1 (en) * 2002-04-04 2007-12-28 Индравадан Амбалал Моди Pharmaceutical composition, a kit and method of treating hiv infections

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AP2012006117A0 (en) 2012-02-29
WO2011010214A1 (en) 2011-01-27
ZA201200531B (en) 2012-10-31

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Effective date: 20150428