RU2007133793A - COMPOSITIONS WITH CONTROLLED ALFUZOSINE RELEASE - Google Patents

COMPOSITIONS WITH CONTROLLED ALFUZOSINE RELEASE Download PDF

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Publication number
RU2007133793A
RU2007133793A RU2007133793/15A RU2007133793A RU2007133793A RU 2007133793 A RU2007133793 A RU 2007133793A RU 2007133793/15 A RU2007133793/15 A RU 2007133793/15A RU 2007133793 A RU2007133793 A RU 2007133793A RU 2007133793 A RU2007133793 A RU 2007133793A
Authority
RU
Russia
Prior art keywords
hpmc
composition according
mixture
subparagraph
polyvinylpyrrolidone
Prior art date
Application number
RU2007133793/15A
Other languages
Russian (ru)
Other versions
RU2423107C2 (en
Inventor
Витторино РАВЕЛЛИ (IT)
Витторино РАВЕЛЛИ
Фабрицио НИККОЛАИ (IT)
Фабрицио НИККОЛАИ
Original Assignee
Пх Энд Т С.П.А. (It)
Пх Энд Т С.П.А.
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 Пх Энд Т С.П.А. (It), Пх Энд Т С.П.А. filed Critical Пх Энд Т С.П.А. (It)
Publication of RU2007133793A publication Critical patent/RU2007133793A/en
Application granted granted Critical
Publication of RU2423107C2 publication Critical patent/RU2423107C2/en

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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
    • A61K9/20—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
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K9/2004—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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate

Claims (10)

1. Твердая фармацевтическая композиция в составе таблетки, содержащей гидрохлорид альфузозина, поливинилпирролидон, лактозу и смесь HPMC K100, HPMC K100M и HPMC K15M (гидроксипропилметилцеллюлоза).1. A solid pharmaceutical composition of a tablet containing alfuzosin hydrochloride, polyvinylpyrrolidone, lactose and a mixture of HPMC K100, HPMC K100M and HPMC K15M (hydroxypropyl methylcellulose). 2. Фармацевтическая композиция по п.1, где таблетка покрыта нерастворимым пленкообразующим полимером.2. The pharmaceutical composition according to claim 1, where the tablet is coated with an insoluble film-forming polymer. 3. Композиция по п.2, в которой нерастворимый пленкообразующий полимер присутствует в количестве от 0,5 до 10% от массы таблетки.3. The composition according to claim 2, in which the insoluble film-forming polymer is present in an amount of from 0.5 to 10% by weight of the tablet. 4. Композиция по п.1, в которой упомянутая смесь состоит из 5-10% HPMC K100, 15-25% HPMC K100M и 20-35% HPMC K15M.4. The composition according to claim 1, in which the said mixture consists of 5-10% HPMC K100, 15-25% HPMC K100M and 20-35% HPMC K15M. 5. Композиция по п.4, в которой упомянутая смесь содержит 7,87% HPMC K100, 19,68% HPMC K100M и 27,56% HPMC K15M.5. The composition according to claim 4, in which said mixture contains 7.87% HPMC K100, 19.68% HPMC K100M and 27.56% HPMC K15M. 6. Композиция по п.1, содержащая 1-4% поливинилпирролидона.6. The composition according to claim 1, containing 1-4% polyvinylpyrrolidone. 7. Композиция по п.1, содержащая 15-25% лактозы.7. The composition according to claim 1, containing 15-25% lactose. 8. Композиция по п.1, дополнительно содержащая вспомогательный ингредиент, выбранный из разбавителей, смазывающих веществ и пленкообразующих средств.8. The composition according to claim 1, additionally containing an auxiliary ingredient selected from diluents, lubricants and film-forming agents. 9. Способ изготовления твердой композиции по пп.1-8, включающий следующие стадии:9. A method of manufacturing a solid composition according to claims 1 to 8, comprising the following stages: (a) приготовление смеси, содержащей гидроксипропилметилцеллюлозу, альфузозин и поливинилпирролидон;(a) preparing a mixture comprising hydroxypropyl methylcellulose, alfuzosin and polyvinylpyrrolidone; (b) влажное гранулирование смеси согласно подпункту (a) через экструдер с проволочными ячейками размером 14 меш;(b) wet granulating the mixture according to subparagraph (a) through a 14 mesh wire mesh extruder; (с) добавление лактозы и других вспомогательных ингредиентов, в частности, разбавителей, смазывающих веществ, к гранулированной смеси согласно подпункту (b);(c) adding lactose and other auxiliary ingredients, in particular diluents, lubricants, to the granular mixture according to subparagraph (b); (d) прессование продукта согласно подпункту (c)(d) compressing the product according to subparagraph (c) и, необязательно,and optionally (e) нанесение на полученные таблетки пленочного покрытия из водонерастворимого водопроницаемого полимера.(e) coating the resulting tablets with a film coating of a water-insoluble permeable polymer. 10. Применение твердого состава по пп.1-9 для изготовления лекарственного средства для лечения гипертрофии простаты. 10. The use of a solid composition according to claims 1 to 9 for the manufacture of a medicinal product for the treatment of prostatic hypertrophy.
RU2007133793/15A 2005-03-11 2006-03-06 Compositions with controlled release of alfuzosin RU2423107C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI2005A000391 2005-03-11
IT000391A ITMI20050391A1 (en) 2005-03-11 2005-03-11 CONTROLLED RELEASE FORMULATIONS OF ALFUZOSIN

Publications (2)

Publication Number Publication Date
RU2007133793A true RU2007133793A (en) 2009-03-20
RU2423107C2 RU2423107C2 (en) 2011-07-10

Family

ID=36939083

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2007133793/15A RU2423107C2 (en) 2005-03-11 2006-03-06 Compositions with controlled release of alfuzosin

Country Status (6)

Country Link
KR (1) KR20070110068A (en)
CN (1) CN101137351A (en)
IT (1) ITMI20050391A1 (en)
RU (1) RU2423107C2 (en)
TR (1) TR200706209T1 (en)
WO (1) WO2006094736A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080095844A1 (en) * 2006-10-23 2008-04-24 Rajhans Sujay Kamalakar Sustained release pharmaceutical compositions of alfuzosin and process for preparation thereof
US20080160081A1 (en) * 2006-12-11 2008-07-03 Mutual Pharmaceutical Company, Inc. Alfuzosin formulations, methods of making, and methods of use
CN101095681B (en) * 2007-07-13 2011-04-20 沈阳药大制剂新技术有限公司 Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same
CN105287422A (en) * 2015-12-07 2016-02-03 黑龙江省智诚医药科技有限公司 Alfuzosin hydrochloride sustained release tablets and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2752737B1 (en) * 1996-08-29 1998-10-02 Synthelabo CONTROLLED RELEASE TABLET OF ALFUZOSINE HYDROCHLORIDE
PT938318E (en) * 1996-08-29 2001-10-30 Jagotec Ag TABLET WITH CONTROLLED FREEDOM OF ALFUZOSINE CHLORIDRATE
FR2820319B3 (en) * 2001-02-08 2003-12-05 Ellipse Pharmaceuticals PROCESS FOR PRODUCING A FLOATING TABLET INCLUDING ALFUZOSINE AND TABLET OBTAINED

Also Published As

Publication number Publication date
KR20070110068A (en) 2007-11-15
TR200706209T1 (en) 2007-12-24
ITMI20050391A1 (en) 2006-09-12
CN101137351A (en) 2008-03-05
RU2423107C2 (en) 2011-07-10
WO2006094736A3 (en) 2007-01-04
WO2006094736A2 (en) 2006-09-14

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