CA2481739C - Liberation reguliere de medicaments combines de guaifenesin - Google Patents

Liberation reguliere de medicaments combines de guaifenesin Download PDF

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Publication number
CA2481739C
CA2481739C CA2481739A CA2481739A CA2481739C CA 2481739 C CA2481739 C CA 2481739C CA 2481739 A CA2481739 A CA 2481739A CA 2481739 A CA2481739 A CA 2481739A CA 2481739 C CA2481739 C CA 2481739C
Authority
CA
Canada
Prior art keywords
guaifenesin
formulation
drug product
hours
modified release
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
CA2481739A
Other languages
English (en)
Other versions
CA2481739A1 (fr
Inventor
Robert D. Davis
Ralph W. Blume
Donald Jeffrey Keyser
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
RB Health US LLC
Original Assignee
Reckitt Benckiser LLC
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
Priority claimed from US10/121,706 external-priority patent/US6955821B2/en
Priority claimed from US10/406,557 external-priority patent/US7838032B2/en
Priority claimed from US10/406,574 external-priority patent/US7985420B2/en
Application filed by Reckitt Benckiser LLC filed Critical Reckitt Benckiser LLC
Publication of CA2481739A1 publication Critical patent/CA2481739A1/fr
Application granted granted Critical
Publication of CA2481739C publication Critical patent/CA2481739C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/075—Ethers or acetals
    • A61K31/085—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon
    • A61K31/09—Ethers or acetals having an ether linkage to aromatic ring nuclear carbon having two or more such linkages
    • 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
    • A61K31/435—Heterocyclic 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61P11/02—Nasal agents, e.g. decongestants
    • 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
    • A61P11/10—Expectorants

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur une nouvelle formulation pharmaceutique à libération modifiée de guaifenesin et facultativement d'un second médicament qui est, de préférence, choisi parmi dextromethorphan et pseudoephedrine. Cette formulation contient un polymère hydrophile, de préférence un hydroxypropylmethylcellulose, et un polymère insoluble dans l'eau, de préférence une résine acrylique, dans une gamme de rapports d'environ un pour un (1:1) à environ neuf pour un (9:1), mieux encore une gamme d'environ trois pour deux (3:2) à environ six pour un (6:1), et idéalement dans une gamme d'environ deux pour un (2:1) à environ quatre pour un (4:1) en poids. Cette formulation est capable de fournir une biodisponibilité thérapeutiquement efficace de guaifenesin pendant au moins douze heures après son dosage chez un sujet humain. Cette invention concerne aussi un produit à libération modifiée dotée de deux parties : une première partie présentant une formulation à libération immédiate de guaifenesin, et une seconde partie présentant une formulation à libération régulière de guaifenesin, une ou les deux parties contenant également du dextromethorphan. Le produit à libération modifiée possède une concentration en sérum de guaifenesin maximale équivalente à celle d'un comprimé de guaifenesin à libération immédiate, et est capable de fournir une biodisponibilité thérapeutiquement efficace de guaifenesin pendant au moins douze heures après son dosage chez un sujet humain.
CA2481739A 2002-04-15 2003-04-15 Liberation reguliere de medicaments combines de guaifenesin Expired - Lifetime CA2481739C (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US10/121,706 US6955821B2 (en) 2000-04-28 2002-04-15 Sustained release formulations of guaifenesin and additional drug ingredients
US10/121,706 2002-04-15
US10/406,574 2003-04-04
US10/406,557 US7838032B2 (en) 2000-04-28 2003-04-04 Sustained release of guaifenesin
US10/406,557 2003-04-04
US10/406,574 US7985420B2 (en) 2000-04-28 2003-04-04 Sustained release of guaifenesin combination drugs
PCT/US2003/011500 WO2003088952A1 (fr) 2002-04-15 2003-04-15 Liberation reguliere de medicaments combines de guaifenesin

Publications (2)

Publication Number Publication Date
CA2481739A1 CA2481739A1 (fr) 2003-10-30
CA2481739C true CA2481739C (fr) 2012-10-02

Family

ID=29255202

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2481739A Expired - Lifetime CA2481739C (fr) 2002-04-15 2003-04-15 Liberation reguliere de medicaments combines de guaifenesin

Country Status (10)

Country Link
EP (1) EP1503739A4 (fr)
JP (1) JP5466346B2 (fr)
CN (1) CN1655766B (fr)
AU (1) AU2003237807B2 (fr)
CA (1) CA2481739C (fr)
EA (1) EA007156B1 (fr)
IL (1) IL164438A0 (fr)
MX (1) MXPA04010225A (fr)
WO (1) WO2003088952A1 (fr)
ZA (1) ZA200409171B (fr)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MY142204A (en) 2002-07-25 2010-10-29 Pharmacia Corp Pramipexole once-daily dosage form
KR20060076319A (ko) * 2003-09-24 2006-07-04 콤비네이토릭스, 인코포레이티드 약물 조합들을 투여하는 치료 요법
CA2476101A1 (fr) * 2004-08-12 2006-02-12 Bernard Charles Sherman Capsules a liberation prolongee comprenant du chlorhydrate de venlafaxine
NZ553587A (en) * 2004-08-13 2010-12-24 Boehringer Ingelheim Int Extended release tablet formulation containing pramipexole or a pharmacutically acceptable salt thereof
CN103214484B (zh) 2005-12-13 2016-07-06 因塞特控股公司 作为两面神激酶抑制剂的杂芳基取代的吡咯并[2,3-b]吡啶和吡咯并[2,3-b]嘧啶
CN1994285B (zh) * 2006-01-04 2011-03-16 上海医药工业研究院 愈创木酚甘油醚缓释微丸及其制备方法
US20080176955A1 (en) * 2007-01-16 2008-07-24 Victory Pharma, Inc. Combined administration of benzonatate and guaifenesin
CN101658507B (zh) * 2008-08-26 2011-12-07 北京科信必成医药科技发展有限公司 一种愈创木酚甘油醚和伪麻黄碱的复方缓释制剂
SG173528A1 (en) 2009-02-04 2011-09-29 Astellas Pharma Inc Pharmaceutical composition for oral administration
EP3354652B1 (fr) 2010-03-10 2020-05-06 Incyte Holdings Corporation Dérivés de pipéridine-4-yl azétidine utilisés en tant qu'inhibiteurs de jak1
US9339478B2 (en) 2011-02-04 2016-05-17 Reckitt Benckiser Llc Pharmaceutical formulation
MY165963A (en) 2011-06-20 2018-05-18 Incyte Holdings Corp Azetidinyl phenyl, pyridyl or pyrazinyl carboxamide derivatives as jak inhibitors
CN102755304A (zh) * 2012-08-03 2012-10-31 四川百利药业有限责任公司 一种愈美胶囊的制备方法
TWI761825B (zh) 2012-11-15 2022-04-21 美商英塞特控股公司 盧梭利替尼之緩釋性劑型
SG11201600815WA (en) 2013-08-07 2016-03-30 Incyte Corp Sustained release dosage forms for a jak1 inhibitor
GB201506755D0 (en) 2015-04-21 2015-06-03 Reckitt Benckiser Llc Novel pharmaceutical formulation
CN105982860B (zh) * 2015-02-11 2020-04-14 北京科信必成医药科技发展有限公司 愈创甘油醚无水吞服掩味颗粒
US11278506B2 (en) 2015-10-09 2022-03-22 Rb Health (Us) Llc Pharmaceutical formulation
US11833155B2 (en) 2020-06-03 2023-12-05 Incyte Corporation Combination therapy for treatment of myeloproliferative neoplasms

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4552899A (en) * 1984-04-09 1985-11-12 Analgesic Associates Cough/cold mixtures comprising non-steroidal anti-inflammatory drugs
US5032406A (en) 1989-02-21 1991-07-16 Norwich Eaton Pharmaceuticals, Inc. Dual-action tablet
WO2000033818A1 (fr) * 1998-12-11 2000-06-15 Nostrum Pharmaceuticals, Inc. Comprime a liberation prolongee contenant un hydrocolloide et un ether de cellulose
CN101288663A (zh) * 1999-09-14 2008-10-22 史密丝克莱恩比彻姆公司 制备水性包被小球粒的方法
US6372525B1 (en) * 1999-12-20 2002-04-16 Taiwan Semiconductor Manufacturing Company Wafer-level antenna effect detection pattern for VLSI
US6372252B1 (en) * 2000-04-28 2002-04-16 Adams Laboratories, Inc. Guaifenesin sustained release formulation and tablets
US20020022058A1 (en) * 2000-07-08 2002-02-21 Lovercheck Dale R. Unit dose of material in system and method

Also Published As

Publication number Publication date
AU2003237807B2 (en) 2008-10-23
CA2481739A1 (fr) 2003-10-30
EA200401369A1 (ru) 2005-06-30
EA007156B1 (ru) 2006-08-25
EP1503739A1 (fr) 2005-02-09
WO2003088952A1 (fr) 2003-10-30
MXPA04010225A (es) 2005-07-05
EP1503739A4 (fr) 2006-06-21
JP2005528402A (ja) 2005-09-22
IL164438A0 (en) 2005-12-18
CN1655766B (zh) 2012-05-30
JP5466346B2 (ja) 2014-04-09
AU2003237807A1 (en) 2003-11-03
ZA200409171B (en) 2005-07-27
CN1655766A (zh) 2005-08-17

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Effective date: 20230417