CA2396145A1 - Osmotic device containing pseudoephedrine and an h1 antagonist - Google Patents

Osmotic device containing pseudoephedrine and an h1 antagonist Download PDF

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Publication number
CA2396145A1
CA2396145A1 CA002396145A CA2396145A CA2396145A1 CA 2396145 A1 CA2396145 A1 CA 2396145A1 CA 002396145 A CA002396145 A CA 002396145A CA 2396145 A CA2396145 A CA 2396145A CA 2396145 A1 CA2396145 A1 CA 2396145A1
Authority
CA
Canada
Prior art keywords
antagonist
osmotic
coated
external
external coat
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.)
Granted
Application number
CA002396145A
Other languages
French (fr)
Other versions
CA2396145C (en
Inventor
Joaquina Faour
Marcelo A. Ricci
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.)
Osmotica Kereskedelmi es Szolgaltato KFT
Original Assignee
Osmotica Corp.
Joaquina Faour
Marcelo A. Ricci
Laboratorios Phoenix U.S.A., Inc.
Osmotica Holdings Corp. A.V.V.
Osmotica (Cyprus) Limited
Osmotica Kereskedelmi Es Szolgatato Kft
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 Osmotica Corp., Joaquina Faour, Marcelo A. Ricci, Laboratorios Phoenix U.S.A., Inc., Osmotica Holdings Corp. A.V.V., Osmotica (Cyprus) Limited, Osmotica Kereskedelmi Es Szolgatato Kft filed Critical Osmotica Corp.
Publication of CA2396145A1 publication Critical patent/CA2396145A1/en
Application granted granted Critical
Publication of CA2396145C publication Critical patent/CA2396145C/en
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
    • A61K31/33—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
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/41—Heterocyclic 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
    • A61K31/415—1,2-Diazoles
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • 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
    • 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
    • A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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

Abstract

The present invention provides an osmotic device containing controlled relea se pseudoephedrine in the core in combination with a rapid release H1 antagonis t in an external coat. A wide range of H1 antagonist antihistamines, especiall y fexofenadine, can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. One embodiment of the osmotic device includes an external coat that has been spr ay coated rather than compression coated onto the device. The device with spray coated external core is smaller and easier to swallow than the similar devic e having a compression coated external coat. The device is useful for the treatment of respiratory congestion related disorders and allergy related disorders. The present devices provide PS and an H1 antagonist according to specific release profiles in combination with specific formulations.
CA002396145A 2000-01-13 2001-01-08 Osmotic device containing pseudoephedrine and an h1 antagonist Expired - Lifetime CA2396145C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US17587800P 2000-01-13 2000-01-13
US60/175,878 2000-01-13
US09/725,655 2000-11-29
US09/725,655 US6613357B2 (en) 2000-01-13 2000-11-29 Osmotic device containing pseudoephedrine and an H1 antagonist
PCT/US2001/000528 WO2001051038A1 (en) 2000-01-13 2001-01-08 Osmotic device containing pseudoephedrine and an h1 antagonist

Publications (2)

Publication Number Publication Date
CA2396145A1 true CA2396145A1 (en) 2001-07-19
CA2396145C CA2396145C (en) 2008-07-22

Family

ID=26871655

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002396145A Expired - Lifetime CA2396145C (en) 2000-01-13 2001-01-08 Osmotic device containing pseudoephedrine and an h1 antagonist

Country Status (12)

Country Link
US (1) US6613357B2 (en)
EP (1) EP1246612B1 (en)
AR (1) AR026818A1 (en)
AT (1) ATE397917T1 (en)
AU (1) AU2001226349A1 (en)
BR (1) BR0107596A (en)
CA (1) CA2396145C (en)
DE (1) DE60134387D1 (en)
ES (1) ES2307584T3 (en)
MX (1) MXPA02006867A (en)
UY (1) UY26525A1 (en)
WO (1) WO2001051038A1 (en)

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ATE330586T1 (en) * 2001-03-14 2006-07-15 Pfizer Prod Inc PHARMACEUTICAL TABLET AND METHOD FOR PRODUCING THE SAME
WO2004019917A1 (en) * 2002-08-29 2004-03-11 Osmotica Corp. Device for release of a drug containing oseltamivir and a h1 antagonist
JP2010180238A (en) * 2001-11-22 2010-08-19 Daiichi Sankyo Healthcare Co Ltd Composition for rhinitis
JP4549618B2 (en) * 2001-11-22 2010-09-22 第一三共ヘルスケア株式会社 Composition for rhinitis
EP1350512A1 (en) * 2002-04-03 2003-10-08 BOEHRINGER INGELHEIM INTERNATIONAL GmbH Combinations of epinastine, belladonna and pseudoephedrine as new pharmaceutical formulations
US20050232995A1 (en) 2002-07-29 2005-10-20 Yam Nyomi V Methods and dosage forms for controlled delivery of paliperidone and risperidone
JP2006501211A (en) * 2002-08-02 2006-01-12 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング Pharmaceutical composition containing a combination of epinastine, pseudoephedrine and methylephedrine
WO2004087095A2 (en) * 2003-03-31 2004-10-14 Osmotica Costa Rica, Sociedad Anonima Osmotic controlled release device containing zafirlukast and an h1-antagonist
US7611728B2 (en) * 2003-09-05 2009-11-03 Supernus Pharmaceuticals, Inc. Osmotic delivery of therapeutic compounds by solubility enhancement
AU2004314693B2 (en) 2003-09-26 2011-04-07 Alza Corporation Drug coating providing high drug loading and methods for providing the same
US7201920B2 (en) 2003-11-26 2007-04-10 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse of opioid containing dosage forms
US20050208108A1 (en) * 2004-03-19 2005-09-22 Jannusch Leonard C Thermoplastic films and methods for making
US8541026B2 (en) 2004-09-24 2013-09-24 Abbvie Inc. Sustained release formulations of opioid and nonopioid analgesics
US8574626B2 (en) 2004-12-03 2013-11-05 Osmotica Kereskedelmi és Szolgáltató KFT Osmotic device containing amantadine and an osmotic salt
AR053986A1 (en) 2004-12-03 2007-05-30 Osmotica Pharmaceutical Argent OSMOTIC DEVICE CONTAINING AMANTADINE AND AN OSMOTIC SALT
US8252331B2 (en) * 2004-12-03 2012-08-28 Osmotica Kereskedelmi és Szolgáltató, KFT Osmotic device containing amantadine and an osmotic salt
EP1970055B1 (en) * 2005-12-29 2010-11-24 Osmotica Kereskedelmi És Szolgáltató Kft Multi-layered tablet with triple release combination
JP2009542669A (en) * 2006-06-30 2009-12-03 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 Pharmaceutical composition comprising a combination of piperidinoalkanol and a decongestant
AU2007272951A1 (en) * 2006-07-11 2008-01-17 Mutual Pharmaceutical Company, Inc. Controlled-release formulations
US20080085311A1 (en) * 2006-10-05 2008-04-10 Tripathi Sanjay S Antihistamine-decongestant combinations
US20100143471A1 (en) * 2007-03-21 2010-06-10 Lupin Limited Novel reduced dose pharmaceutical compositions of fexofenadine and pseudoephedrine
CL2008001970A1 (en) * 2007-07-03 2009-03-27 Synthon Bv Bead with a microcrystalline cellulose core, a water soluble coating with a vinyl pyrrolidine polymer, a layer with tolterodine and a binder, and a controlled release layer with a polyacrylate; process to prepare it; dosage form, useful in urinary disorders such as overactive bladder.
US8450349B2 (en) 2007-09-13 2013-05-28 E5 Pharma LLC Long acting dual release product containing carbinoxamine and pseudoephedrine
US20100112052A1 (en) * 2008-10-31 2010-05-06 Vincent Chen Osmotic tablet with a compressed outer coating
US8252330B2 (en) * 2009-01-05 2012-08-28 Mcneil-Ppc, Inc. Tablet containing coated particles of cetirizine, pseudoephedrine, and/or naproxen
US8246988B2 (en) * 2009-01-05 2012-08-21 Mcneil-Ppc, Inc. Three layer tablet containing cetirizine, pseudoephedrine, and naproxen
CA2748728C (en) * 2009-01-05 2017-01-03 Mcneil-Ppc, Inc. Tablet containing cetirizine, pseudoephedrine, and naproxen containing a barrier layer
US20120100221A1 (en) 2009-06-02 2012-04-26 Ranbaxy Laboratories Limited Pharmaceutical compositions containing a combination of an antihistamine and a decongestant
AU2010300641B2 (en) 2009-09-30 2016-03-17 Acura Pharmaceuticals, Inc. Methods and compositions for deterring abuse
EP2925304B1 (en) 2012-11-30 2018-09-05 Acura Pharmaceuticals, Inc. Self-regulated release of active pharmaceutical ingredient
CN103554985B (en) * 2013-10-18 2015-11-18 苏州大学 A kind of can the molecule release system of the biswitch response limiting of opening and closing, preparation method and application repeatedly
WO2015145459A1 (en) 2014-03-26 2015-10-01 Sun Pharma Advanced Research Company Ltd. Abuse deterrent immediate release coated reservoir solid dosage form
WO2017040607A1 (en) 2015-08-31 2017-03-09 Acura Pharmaceuticals, Inc. Methods and compositions for self-regulated release of active pharmaceutical ingredient
US20190247331A1 (en) 2018-02-15 2019-08-15 Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság Composition and method for treating neurological disease
US10213393B1 (en) 2018-02-15 2019-02-26 Osmotica Kereskedelmi és Szolgáltató Korlátolt Feleõsségû Társaság Composition and method for treating neurological disease
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Also Published As

Publication number Publication date
EP1246612A1 (en) 2002-10-09
DE60134387D1 (en) 2008-07-24
WO2001051038A1 (en) 2001-07-19
EP1246612A4 (en) 2006-04-05
AU2001226349A1 (en) 2001-07-24
MXPA02006867A (en) 2004-04-02
ATE397917T1 (en) 2008-07-15
BR0107596A (en) 2002-11-19
US20020102305A1 (en) 2002-08-01
AR026818A1 (en) 2003-02-26
ES2307584T3 (en) 2008-12-01
EP1246612B1 (en) 2008-06-11
US6613357B2 (en) 2003-09-02
UY26525A1 (en) 2001-09-28
CA2396145C (en) 2008-07-22

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