RU2012119070A - PROLONGED EXEMPTION TABLET CONTAINING THEOBROMINE - Google Patents

PROLONGED EXEMPTION TABLET CONTAINING THEOBROMINE Download PDF

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RU2012119070A
RU2012119070A RU2012119070/15A RU2012119070A RU2012119070A RU 2012119070 A RU2012119070 A RU 2012119070A RU 2012119070/15 A RU2012119070/15 A RU 2012119070/15A RU 2012119070 A RU2012119070 A RU 2012119070A RU 2012119070 A RU2012119070 A RU 2012119070A
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Russia
Prior art keywords
sustained release
release layer
layer
theobromine
quick
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RU2012119070/15A
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Russian (ru)
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RU2506947C2 (en
Inventor
Джин АУХ
Чан-Хван КИМ
Чан-Кюн ХАН
Хён-Гун ДЖОН
Ян-Джоон КИМ
Джон-Гиал КИМ
Джу-Ён ЁУН
Джун-Хва ЛЕЕ
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Ахн-Гоок Фармасьютикал Ко., Лтд.
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    • 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
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/14—Antitussive agents

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (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

1. Таблетка пролонгированного высвобождения, содержащая теобромин, состоящая из слоя пролонгированного высвобождения и слоя быстрого высвобождения,где слой пролонгированного высвобождения состоит из 40-60 мас.% теобромина или его солей, 14-19 мас.% основы пролонгированного высвобождения, состоящей из полиэтиленоксида и гидроксипропилметилцеллюлозы, 1-2 мас.% связующего агента и 0,5-1 мас.% модификатора скольжения,где слой быстрого высвобождения состоит из 10-30 мас.% теобромина или его солей, 0,5-2 мас.% разрыхлителя, состоящего из одного или нескольких компонентов, выбранных из кроскармеллозы натрия, кросповидона и натриевой соли гликолята крахмала, 0,3-1,5 мас.% связующего агента и 0,1-0,5 мас.% модификатора скольжения.2. Таблетка пролонгированного высвобождения по п.1, где содержание теобромина или его солей в слое пролонгированного высвобождения и в слое быстрого высвобождения суммарно составляет 300 мг или 600 мг.3. Таблетка пролонгированного высвобождения по п.1 или 2, где основа пролонгированного высвобождения включает от 6 до 10 мас.% полиэтиленоксида с молекулярной массой 900000-1000000 и от 8 до 12 мас.% гидроксипропилметилцеллюлозы с вязкостью 4000 сПз.4. Таблетка пролонгированного высвобождения по п.1 или 2, где слой пролонгированного высвобождения и слой быстрого высвобождения образованы из двухслойных структур, наслоенных в направлении как вверх, так и вниз, или трехслойной структуры, которая имеет верхний и нижний слои, представляющие собой слои быстрого высвобождения, а слой пролонгированного высвобождения находится между ними.1. A sustained release tablet containing theobromine, consisting of a sustained release layer and a quick release layer, wherein the sustained release layer consists of 40-60 wt.% Of theobromine or its salts, 14-19 wt.% Of a sustained release base consisting of polyethylene oxide and hydroxypropylmethyl cellulose, 1-2 wt.% a binding agent and 0.5-1 wt.% slip modifier, where the quick release layer consists of 10-30 wt.% of theobromine or its salts, 0.5-2 wt.% of a disintegrant, consisting from one or more their components selected from croscarmellose sodium, crospovidone and the sodium salt of starch glycolate, 0.3-1.5 wt.% binding agent and 0.1-0.5 wt.% slip modifier. 2. A sustained release tablet according to claim 1, wherein the content of theobromine or its salts in the sustained release layer and in the rapid release layer total 300 mg or 600 mg. A sustained release tablet according to claim 1 or 2, wherein the sustained release base comprises from 6 to 10 wt.% Polyethylene oxide with a molecular weight of 900,000-1000000 and from 8 to 12 wt.% Hydroxypropylmethyl cellulose with a viscosity of 4000 cps. 4. The sustained-release tablet according to claim 1 or 2, wherein the extended-release layer and the quick-release layer are formed from two-layer structures layered both up and down, or a three-layer structure, which has an upper and lower layer, which are quick-release layers, and a sustained release layer is in between.

Claims (4)

1. Таблетка пролонгированного высвобождения, содержащая теобромин, состоящая из слоя пролонгированного высвобождения и слоя быстрого высвобождения,1. A sustained release tablet containing theobromine, consisting of a sustained release layer and a quick release layer, где слой пролонгированного высвобождения состоит из 40-60 мас.% теобромина или его солей, 14-19 мас.% основы пролонгированного высвобождения, состоящей из полиэтиленоксида и гидроксипропилметилцеллюлозы, 1-2 мас.% связующего агента и 0,5-1 мас.% модификатора скольжения,where the sustained release layer consists of 40-60 wt.% theobromine or its salts, 14-19 wt.% the basis of the prolonged release, consisting of polyethylene oxide and hydroxypropyl methylcellulose, 1-2 wt.% a binding agent and 0.5-1 wt.% slip modifier где слой быстрого высвобождения состоит из 10-30 мас.% теобромина или его солей, 0,5-2 мас.% разрыхлителя, состоящего из одного или нескольких компонентов, выбранных из кроскармеллозы натрия, кросповидона и натриевой соли гликолята крахмала, 0,3-1,5 мас.% связующего агента и 0,1-0,5 мас.% модификатора скольжения.where the quick release layer consists of 10-30 wt.% theobromine or its salts, 0.5-2 wt.% disintegrant, consisting of one or more components selected from croscarmellose sodium, crospovidone and sodium starch glycolate, 0.3- 1.5 wt.% A binder and 0.1-0.5 wt.% Slip modifier. 2. Таблетка пролонгированного высвобождения по п.1, где содержание теобромина или его солей в слое пролонгированного высвобождения и в слое быстрого высвобождения суммарно составляет 300 мг или 600 мг.2. The sustained release tablet according to claim 1, wherein the content of theobromine or its salts in the extended release layer and in the quick release layer is 300 mg or 600 mg in total. 3. Таблетка пролонгированного высвобождения по п.1 или 2, где основа пролонгированного высвобождения включает от 6 до 10 мас.% полиэтиленоксида с молекулярной массой 900000-1000000 и от 8 до 12 мас.% гидроксипропилметилцеллюлозы с вязкостью 4000 сПз.3. A sustained release tablet according to claim 1 or 2, wherein the sustained release base comprises from 6 to 10 wt.% Polyethylene oxide with a molecular weight of 900,000-1000000 and from 8 to 12 wt.% Hydroxypropyl methylcellulose with a viscosity of 4000 cps. 4. Таблетка пролонгированного высвобождения по п.1 или 2, где слой пролонгированного высвобождения и слой быстрого высвобождения образованы из двухслойных структур, наслоенных в направлении как вверх, так и вниз, или трехслойной структуры, которая имеет верхний и нижний слои, представляющие собой слои быстрого высвобождения, а слой пролонгированного высвобождения находится между ними. 4. The sustained release tablet according to claim 1 or 2, wherein the extended release layer and the quick release layer are formed from two-layer structures layered in both up and down directions, or a three-layer structure that has upper and lower layers, which are quick layers release, and a sustained release layer is located between them.
RU2012119070/15A 2009-11-02 2010-09-01 Prolonged release tablet containing theobromin RU2506947C2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR1020090105137A KR101137467B1 (en) 2009-11-02 2009-11-02 Extended-release tablet containing theobromine
KR10-2009-0105137 2009-11-02
PCT/KR2010/005911 WO2011052884A2 (en) 2009-11-02 2010-09-01 Sustained release tablet containing theobromine

Publications (2)

Publication Number Publication Date
RU2012119070A true RU2012119070A (en) 2013-12-10
RU2506947C2 RU2506947C2 (en) 2014-02-20

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KR (1) KR101137467B1 (en)
CN (1) CN102711740B (en)
BR (1) BR112012010325B8 (en)
RU (1) RU2506947C2 (en)
TR (1) TR201205029T1 (en)
UA (1) UA103558C2 (en)
WO (1) WO2011052884A2 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101220830B1 (en) * 2010-08-18 2013-01-10 안국약품 주식회사 Sustained-release granules of theobromine and its preparing method

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AR040680A1 (en) * 2002-07-25 2005-04-13 Pharmacia Corp COMPOSITION OF SUSTAINED RELEASE TABLETS
DE10353196A1 (en) * 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Multilayer dosage form with a matrix influencing the delivery of a modulatory substance
KR20070017335A (en) * 2004-03-22 2007-02-09 노파르티스 아게 Oral matrix formulations comprising licarbazepine
JP2008534531A (en) * 2005-03-29 2008-08-28 エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング Multiparticulate pharmaceutical dosage form with pellets having a matrix that affects the delivery of the modulator
KR100762847B1 (en) * 2006-01-27 2007-10-04 씨제이 주식회사 Multiple unit type sustained release oral formulation and process for the preparation thereof

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KR20110048367A (en) 2011-05-11
WO2011052884A2 (en) 2011-05-05
BR112012010325B8 (en) 2021-05-25
UA103558C2 (en) 2013-10-25
BR112012010325B1 (en) 2021-01-26
CN102711740A (en) 2012-10-03
KR101137467B1 (en) 2012-04-20
WO2011052884A3 (en) 2011-07-14
CN102711740B (en) 2014-02-12
TR201205029T1 (en) 2012-09-21
RU2506947C2 (en) 2014-02-20
BR112012010325A2 (en) 2016-03-29

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