AR066000A1 - Procedimiento para preparar comprimidos de dihidrocloruro de pramipexol - Google Patents

Procedimiento para preparar comprimidos de dihidrocloruro de pramipexol

Info

Publication number
AR066000A1
AR066000A1 ARP080101470A ARP080101470A AR066000A1 AR 066000 A1 AR066000 A1 AR 066000A1 AR P080101470 A ARP080101470 A AR P080101470A AR P080101470 A ARP080101470 A AR P080101470A AR 066000 A1 AR066000 A1 AR 066000A1
Authority
AR
Argentina
Prior art keywords
tablets
ingredients
tablet
intragranular
dihydrochloride
Prior art date
Application number
ARP080101470A
Other languages
English (en)
Inventor
Noel Cotton
Original Assignee
Boehringer Ingelheim Int
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 Boehringer Ingelheim Int filed Critical Boehringer Ingelheim Int
Publication of AR066000A1 publication Critical patent/AR066000A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/428Thiazoles condensed with carbocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16Anti-Parkinson drugs

Abstract

Un proceso para preparar comprimidos de dihidrocloruro de pramipexol. En particular, la presente se refiere a un proceso para preparar comprimidos de dihidrocloruro de pramipexol, en el que los comprimidos muestran propiedades mejoradas deestabilidad de conservacion. Reivindicacion 1: Un proceso para preparar comprimidos de dihidrocloruro de pramipexol que comprenden ingredientes de formacion de comprimidos intragranulares, dihidrocloruro de pramipexol o una sal farmacéuticamenteaceptable del mismo, una suspension de ligante, y agentes de formacion de comprimidos extragranulares, en el que al menos una porcion del proceso se realiza en un sistema cerrado, caracterizado porque comprende las etapas de: (a) ajustar el tamanode los ingredientes de formacion de comprimidos intragranulares para formar partículas de tamano uniforme de ingredientes de formacion de comprimidos intragranulares, (b) mezclar las partículas de ingredientes de formacion de comprimidosintragranulares en un granulador-mezclador, (c) disolver el dihidrocloruro de pramipexol, o una sal farmacéuticamente aceptable, en agua para formar una disolucion acuosa de dihidrocloruro de pramipexol, y anadir la disolucion de dihidrocloruro depramipexol sobre las partículas de los ingredientes de formacion de comprimidos intragranulares en el granulador-mezclador, (d) preparar una suspension de ligante y anadir la suspension de ligante al granulador-mezclador, (e) mezclar las partículasde los ingredientes de formacion de comprimidos intragranulares, la disolucion de dihidrocloruro de pramipexol y la suspension de ligante en el granulador-mezclador para formar una premezcla, (f) granular dicha premezcla para formar una premezclagranulada, (g) secar dicha premezcla granulada hasta un contenido en humedad final de aproximadamente 1,5% a aproximadamente 2,5, (h) mezclar dicha premezcla granulada de la etapa (g) con los agentes de formacion de comprimidos extragranulares ymezclar para formar una mezcla final, (i) comprimir la mezcla final en comprimidos utilizando una prensa de comprimidos.
ARP080101470A 2007-04-10 2008-04-09 Procedimiento para preparar comprimidos de dihidrocloruro de pramipexol AR066000A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US11/733,602 US20080254117A1 (en) 2007-04-10 2007-04-10 Process for preparing pramipexole dihydrochloride tablets

Publications (1)

Publication Number Publication Date
AR066000A1 true AR066000A1 (es) 2009-07-15

Family

ID=39791070

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP080101470A AR066000A1 (es) 2007-04-10 2008-04-09 Procedimiento para preparar comprimidos de dihidrocloruro de pramipexol

Country Status (5)

Country Link
US (4) US20080254117A1 (es)
AR (1) AR066000A1 (es)
CL (1) CL2008001014A1 (es)
TW (1) TW200906397A (es)
WO (1) WO2008122638A2 (es)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TR200906997A1 (tr) 2009-09-11 2011-03-21 Sanovel �La� San. Ve T�C. A. �. Pramipeksol farmasötik bileşimleri.
JP2013526601A (ja) 2010-05-24 2013-06-24 ルピン・リミテッド プラミペキソールの徐放性製剤
WO2012140604A1 (en) * 2011-04-15 2012-10-18 Sandoz Ag Stable formulations of pramipexole hydrochloride
WO2013034173A1 (en) * 2011-09-06 2013-03-14 Synthon Bv Pramipexole extended release tablets
JP7271437B2 (ja) 2017-04-10 2023-05-11 チェイス セラピューティクス コーポレイション Nk1拮抗薬組み合わせおよびシヌクレイノパチーを治療する方法
US11266633B2 (en) 2017-06-30 2022-03-08 Chase Therapeutics Corporation NK-1 antagonist compositions and methods for use in treating depression

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3572485D1 (en) * 1984-12-22 1989-09-28 Thomae Gmbh Dr K Tetrahydro-benzothiazoles, their production and their use as intermediates or drugs
DE3937271A1 (de) * 1989-11-09 1991-05-16 Boehringer Ingelheim Kg Transdermale applikation von 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazol
DE19830201A1 (de) * 1998-07-07 2000-01-13 Boehringer Ingelheim Pharma Mittel mit antidepressiver Wirkung
CA2301899C (en) * 1998-07-27 2008-11-18 Boehringer Ingelheim Pharma Kg Agent with an antidepressant activity
JP2004505917A (ja) * 2000-08-08 2004-02-26 テバ ファーマシューティカル インダストリーズ リミティド 安定なペルゴリドメシラート及びその作成の方法
DE10148233A1 (de) * 2001-09-28 2003-04-10 Boehringer Ingelheim Pharma Verbindungen zur Reduzierung übermäßiger Nahrungsaufnahme
MXPA04006163A (es) * 2001-12-20 2004-11-01 Pharmacia Corp Formas de dosis de liberacion sostenida del orden-cero y metodo de fabricacion de las mismas.
US20030215498A1 (en) * 2002-05-17 2003-11-20 Harland Ronald S. Rapidly disintegrating comressed tablets comprising biologically active compounds
ES2199061B1 (es) * 2002-06-10 2005-02-16 Laboratorios Vita, S.A. Comprimidos bucodispersables y procedimiento para su obtencion.
CN101780080B (zh) * 2003-01-16 2014-06-04 阿卡蒂亚药品公司 用于神经退行性疾病的治疗的选择性五羟色胺2a/2c受体反向激动剂
CN1819819B (zh) * 2003-05-07 2011-03-09 株式会社三养社 用于制备速熔片的高度可塑性颗粒
DE10333393A1 (de) * 2003-07-23 2005-02-24 Lts Lohmann Therapie-Systeme Ag Transdermales Therapeutisches System mit dem Wirkstoff Pramipexol
RS51527B2 (sr) * 2004-08-13 2018-02-28 Boehringer Ingelheim Int Tabletna formulacija sa produženim otpuštanjem koja sadrži pramipeksol ili njegovu farmaceutski prihvatljivu so, postupak za proizvodnju iste i njena primena
US20070148238A1 (en) * 2005-06-23 2007-06-28 Spherics, Inc. Dosage forms for movement disorder treatment
WO2008023027A2 (en) * 2006-08-24 2008-02-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Process for preparing pramipexole dihydrochloride tablets with high storage stability
US20080254118A1 (en) * 2007-04-11 2008-10-16 Hans-Werner Wernersbach Process for preparing pramipexole dihydrochloride tablets

Also Published As

Publication number Publication date
US20080254117A1 (en) 2008-10-16
US20130221561A1 (en) 2013-08-29
TW200906397A (en) 2009-02-16
WO2008122638A2 (en) 2008-10-16
WO2008122638A3 (en) 2008-12-04
US20100252949A1 (en) 2010-10-07
US20120267817A1 (en) 2012-10-25
CL2008001014A1 (es) 2009-01-16

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