CA2396145A1 - Osmotic device containing pseudoephedrine and an h1 antagonist - Google Patents
Osmotic device containing pseudoephedrine and an h1 antagonist Download PDFInfo
- 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
Links
- 230000003204 osmotic effect Effects 0.000 title abstract 4
- 239000000938 histamine H1 antagonist Substances 0.000 title abstract 3
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 title abstract 2
- KWGRBVOPPLSCSI-WCBMZHEXSA-N pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 title abstract 2
- 229960003908 pseudoephedrine Drugs 0.000 title abstract 2
- 238000007906 compression Methods 0.000 abstract 2
- 230000006835 compression Effects 0.000 abstract 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 2
- 206010020751 Hypersensitivity Diseases 0.000 abstract 1
- 208000026935 allergic disease Diseases 0.000 abstract 1
- 230000007815 allergy Effects 0.000 abstract 1
- 239000000739 antihistaminic agent Substances 0.000 abstract 1
- 229940125715 antihistaminic agent Drugs 0.000 abstract 1
- 208000035475 disorder Diseases 0.000 abstract 1
- RWTNPBWLLIMQHL-UHFFFAOYSA-N fexofenadine Chemical compound C1=CC(C(C)(C(O)=O)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 RWTNPBWLLIMQHL-UHFFFAOYSA-N 0.000 abstract 1
- 229960003592 fexofenadine Drugs 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 230000000241 respiratory effect Effects 0.000 abstract 1
- 239000007921 spray Substances 0.000 abstract 1
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.
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) |
Families Citing this family (39)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2307887A1 (en) * | 1997-10-31 | 1999-05-14 | Monsanto Company | Gellan gum tablet coating |
PE20020324A1 (en) * | 2000-10-06 | 2002-06-18 | Boehringer Ingelheim Int | NEW PHARMACEUTICAL COMPOSITIONS CONTAINING EPINASTIN AND PSEUDOEPHEDRINE |
ATE330586T1 (en) * | 2001-03-14 | 2006-07-15 | Pfizer Prod Inc | PHARMACEUTICAL TABLET AND METHOD FOR PRODUCING THE SAME |
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 |
BR0313175A (en) * | 2002-08-02 | 2005-06-14 | Boehringer Ingelheim Int | Pharmaceutical formulations comprising combinations of epinastine, pseudoephedrine and methylphedrine |
AU2002351655A1 (en) * | 2002-08-29 | 2004-03-19 | Osmotica Corp. | Device for release of a drug containing oseltamivir and a h1 antagonist |
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 |
NZ546148A (en) | 2003-09-26 | 2009-05-31 | Alza Corp | 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 |
US8252331B2 (en) * | 2004-12-03 | 2012-08-28 | Osmotica Kereskedelmi és Szolgáltató, KFT | Osmotic device containing amantadine and an osmotic salt |
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 |
DE602006018529D1 (en) | 2005-12-29 | 2011-01-05 | Osmotica Kereskedelmi Es Szolgaltato Kft | MULTILAYER 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 |
CA2658170A1 (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 |
WO2009003724A1 (en) * | 2007-07-03 | 2009-01-08 | Synthon B.V. | Tolterodine bead |
US8450349B2 (en) | 2007-09-13 | 2013-05-28 | E5 Pharma LLC | Long acting dual release product containing carbinoxamine and pseudoephedrine |
EP2364143A1 (en) * | 2008-10-31 | 2011-09-14 | McNeil-PPC, Inc. | Osmotic tablet with a compressed outer coating |
WO2010078541A1 (en) * | 2009-01-05 | 2010-07-08 | Mcneil-Ppc, Inc. | Tablet containing coated particles of cetirizine, pseudoephedrine, and/or naproxen |
WO2010078543A1 (en) * | 2009-01-05 | 2010-07-08 | Mcneil-Ppc, Inc. | Tablet containing cetirizine pseudoephedrine, and naproxen containing a barrier layer |
US8246988B2 (en) * | 2009-01-05 | 2012-08-21 | Mcneil-Ppc, Inc. | Three layer tablet containing cetirizine, pseudoephedrine, and naproxen |
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 |
RU2673818C2 (en) | 2012-11-30 | 2018-11-30 | Экьюра Фармасьютикалз, Инк. | 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 |
EP3122337A4 (en) | 2014-03-26 | 2017-11-08 | 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 |
US10213394B1 (en) | 2018-02-15 | 2019-02-26 | 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 |
US20190247331A1 (en) | 2018-02-15 | 2019-08-15 | Osmotica Kereskedelmi és Szolgáltató Korlátolt Felelõsségû Társaság | Composition and method for treating neurological disease |
CN109589491B (en) * | 2019-01-29 | 2024-01-09 | 上海安翰医疗技术有限公司 | Automatic drug delivery device |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4810502A (en) * | 1987-02-27 | 1989-03-07 | Alza Corporation | Pseudoephedrine brompheniramine therapy |
US4915954A (en) * | 1987-09-03 | 1990-04-10 | Alza Corporation | Dosage form for delivering a drug at two different rates |
US4990535A (en) * | 1989-05-03 | 1991-02-05 | Schering Corporation | Pharmaceutical composition comprising loratadine, ibuprofen and pseudoephedrine |
EP0542926B1 (en) * | 1990-08-07 | 1995-02-15 | Pfizer Inc. | Use of interfacially-polymerized membranes in delivery devices |
US5314697A (en) * | 1992-10-23 | 1994-05-24 | Schering Corporation | Stable extended release oral dosage composition comprising loratadine and pseudoephedrine |
EP0811374A1 (en) * | 1996-05-29 | 1997-12-10 | Pfizer Inc. | Combination dosage form comprising cetirizine and pseudoephedrine |
US5837379A (en) * | 1997-01-31 | 1998-11-17 | Andrx Pharmaceuticals, Inc. | Once daily pharmaceutical tablet having a unitary core |
ATE250929T1 (en) * | 1997-05-30 | 2003-10-15 | Osmotica Corp | MULTI-LAYER OSMOSIS DEVICE |
IN186245B (en) * | 1997-09-19 | 2001-07-14 | Ranbaxy Lab Ltd | |
IN188720B (en) * | 1997-11-06 | 2002-11-02 | Panacea Biotec Ltd | |
JP2003509439A (en) * | 1999-09-14 | 2003-03-11 | スミスクライン・ビーチャム・コーポレイション | How to make water-coated beadlets |
US6267986B1 (en) * | 1999-09-24 | 2001-07-31 | Ranbaxy Laboratories Limited | Process for the preparation of a controlled drug delivery system containing pseudoephedrine and a long acting antihistamine |
-
2000
- 2000-11-29 US US09/725,655 patent/US6613357B2/en not_active Expired - Lifetime
-
2001
- 2001-01-08 AT AT01900942T patent/ATE397917T1/en not_active IP Right Cessation
- 2001-01-08 CA CA002396145A patent/CA2396145C/en not_active Expired - Lifetime
- 2001-01-08 EP EP01900942A patent/EP1246612B1/en not_active Expired - Lifetime
- 2001-01-08 WO PCT/US2001/000528 patent/WO2001051038A1/en active Application Filing
- 2001-01-08 BR BR0107596-9A patent/BR0107596A/en not_active Application Discontinuation
- 2001-01-08 MX MXPA02006867A patent/MXPA02006867A/en active IP Right Grant
- 2001-01-08 DE DE60134387T patent/DE60134387D1/en not_active Expired - Lifetime
- 2001-01-08 AU AU2001226349A patent/AU2001226349A1/en not_active Abandoned
- 2001-01-08 ES ES01900942T patent/ES2307584T3/en not_active Expired - Lifetime
- 2001-01-09 AR ARP010100085A patent/AR026818A1/en not_active Application Discontinuation
- 2001-01-09 UY UY26525A patent/UY26525A1/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
US20020102305A1 (en) | 2002-08-01 |
UY26525A1 (en) | 2001-09-28 |
CA2396145C (en) | 2008-07-22 |
DE60134387D1 (en) | 2008-07-24 |
EP1246612B1 (en) | 2008-06-11 |
ATE397917T1 (en) | 2008-07-15 |
AR026818A1 (en) | 2003-02-26 |
WO2001051038A1 (en) | 2001-07-19 |
AU2001226349A1 (en) | 2001-07-24 |
ES2307584T3 (en) | 2008-12-01 |
EP1246612A1 (en) | 2002-10-09 |
MXPA02006867A (en) | 2004-04-02 |
US6613357B2 (en) | 2003-09-02 |
BR0107596A (en) | 2002-11-19 |
EP1246612A4 (en) | 2006-04-05 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request |