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WO2006031420A3 - Multi-layer tablets and bioadhesive dosage forms - Google Patents

Multi-layer tablets and bioadhesive dosage forms Download PDF

Info

Publication number
WO2006031420A3
WO2006031420A3 PCT/US2005/030651 US2005030651W WO2006031420A3 WO 2006031420 A3 WO2006031420 A3 WO 2006031420A3 US 2005030651 W US2005030651 W US 2005030651W WO 2006031420 A3 WO2006031420 A3 WO 2006031420A3
Authority
WO
WIPO (PCT)
Prior art keywords
drug
layer tablets
dosage form
retention time
dosage forms
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.)
Ceased
Application number
PCT/US2005/030651
Other languages
French (fr)
Other versions
WO2006031420A2 (en
Inventor
Avinash Nangia
Jules Jacob
Edith Mathiowitz
Thomas L Ricketts
Mark R Kreitz
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.)
Spherics Inc
Original Assignee
Spherics Inc
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 US11/009,327 external-priority patent/US20050201974A1/en
Priority claimed from PCT/US2005/007525 external-priority patent/WO2005084639A2/en
Application filed by Spherics Inc filed Critical Spherics Inc
Priority to EP05792519A priority Critical patent/EP1784167A2/en
Priority to CA002578845A priority patent/CA2578845A1/en
Priority to JP2007530225A priority patent/JP2008516893A/en
Priority to AU2005285298A priority patent/AU2005285298A1/en
Priority to US11/661,541 priority patent/US20080311191A1/en
Publication of WO2006031420A2 publication Critical patent/WO2006031420A2/en
Publication of WO2006031420A3 publication Critical patent/WO2006031420A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K9/2072—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
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

Bioadhesives coatings increase the gastrointestinal retention time of orally-ingested medicaments. Certain bioadhesive coatings producing a fracture strength of at least 100 N/m2, as measured on rat intestine, when applied to at least one surface of a pharmaceutical dosage form for oral delivery of a drug, result in a gastrointestinal retention time of at least 4 hours in a fed beagle dog model, during which the drug is released from the dosage form. Multi-layer tablets, particularly those including hydrophobic excipients, are useful in administering hygroscopic and/or deliquescent drugs. In addition, varying the amount of drug in multi-layer tablets allows the release rate of the drug to be controlled.
PCT/US2005/030651 2004-08-27 2005-08-29 Multi-layer tablets and bioadhesive dosage forms Ceased WO2006031420A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP05792519A EP1784167A2 (en) 2004-08-27 2005-08-29 Multi-layer tablets and bioadhesive dosage forms
CA002578845A CA2578845A1 (en) 2004-08-27 2005-08-29 Multi-layer tablets and bioadhesive dosage forms
JP2007530225A JP2008516893A (en) 2004-08-27 2005-08-29 Multilayer tablets and bioadhesive dosage forms
AU2005285298A AU2005285298A1 (en) 2004-08-27 2005-08-29 Multi-layer tablets and bioadhesive dosage forms
US11/661,541 US20080311191A1 (en) 2004-08-27 2005-08-29 Multi-Layer Tablets and Bioadhesive Dosage Forms

Applications Claiming Priority (26)

Application Number Priority Date Filing Date Title
US60519904P 2004-08-27 2004-08-27
US60519804P 2004-08-27 2004-08-27
US60520104P 2004-08-27 2004-08-27
US60499004P 2004-08-27 2004-08-27
US60499104P 2004-08-27 2004-08-27
US60520004P 2004-08-27 2004-08-27
US60/605198 2004-08-27
US60/604990 2004-08-27
US60/604991 2004-08-27
US60/605199 2004-08-27
US60/605200 2004-08-27
US60/605201 2004-08-27
US60790504P 2004-09-08 2004-09-08
US60/607905 2004-09-08
US11/009,327 US20050201974A1 (en) 2003-12-09 2004-12-09 Bioadhesive polymers with catechol functionality
US11/009,327 2004-12-09
US63581204P 2004-12-13 2004-12-13
US60/635812 2004-12-13
US65019105P 2005-02-04 2005-02-04
US65037505P 2005-02-04 2005-02-04
US60/650375 2005-02-04
US60/650191 2005-02-04
PCT/US2005/007525 WO2005084639A2 (en) 2004-03-03 2005-03-03 Polymeric drug delivery system for hydrophobic drugs
USPCT/US2005/007525 2005-03-03
US67638305P 2005-04-29 2005-04-29
US60/676383 2005-04-29

Publications (2)

Publication Number Publication Date
WO2006031420A2 WO2006031420A2 (en) 2006-03-23
WO2006031420A3 true WO2006031420A3 (en) 2006-11-30

Family

ID=35703299

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/030651 Ceased WO2006031420A2 (en) 2004-08-27 2005-08-29 Multi-layer tablets and bioadhesive dosage forms

Country Status (4)

Country Link
EP (1) EP1784167A2 (en)
AU (1) AU2005285298A1 (en)
CA (1) CA2578845A1 (en)
WO (1) WO2006031420A2 (en)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100226855A1 (en) * 2006-03-02 2010-09-09 Spherics, Inc. Rate-Controlled Oral Dosage Formulations
US8974825B2 (en) 2007-07-06 2015-03-10 Lupin Limited Pharmaceutical compositions for gastrointestinal drug delivery
US20120027855A1 (en) 2007-07-06 2012-02-02 Lupin Limited Pharmaceutical compositions for gastrointestinal drug delivery
EP2942053A1 (en) 2007-07-06 2015-11-11 Lupin Limited Pharmaceutical compositions for gastrointestinal drug delivery
JP2013169146A (en) * 2012-02-17 2013-09-02 Kabaya Shokuhin Kk New refreshing confectionery and method for producing the same
TWI439288B (en) * 2012-10-05 2014-06-01 Univ China Medical Medicinal carriers and preparation method and uses thereof
JP2015533174A (en) * 2012-10-11 2015-11-19 セラヴィダ，インコーポレイテッド Pharmaceutical formulation of pilocarpine
WO2015167434A1 (en) * 2014-04-28 2015-11-05 Eduardo Fernandez Compositions for nutritional supplementation
CN114177155B (en) * 2020-09-08 2023-10-03 越洋医药开发(广州)有限公司 Ibuprofen controlled release tablet and preparation method thereof
CN116159037B (en) * 2023-04-25 2023-08-01 四川省川龙动科药业有限公司 Targeted pellet composition for preventing and treating piglet colitis and preparation method thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1994000112A1 (en) * 1992-06-24 1994-01-06 Astra Aktiebolag An oral formulation for gastric antibacterial treatment as well as a process thereof and the use
US6123965A (en) * 1996-01-26 2000-09-26 Brown University Research Foundation Methods and compositions for enhancing the bioadhesive properties of polymers
US6156348A (en) * 1996-06-25 2000-12-05 Brown University Research Foundation Methods and compositions for enhancing the bioadhesive properties of polymers using organic excipients
US6197346B1 (en) * 1992-04-24 2001-03-06 Brown Universtiy Research Foundation Bioadhesive microspheres and their use as drug delivery and imaging systems
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US6391294B1 (en) * 1997-08-21 2002-05-21 Reckitt Benckiser Healthcare (Uk) Limited In situ formation of polymeric material
US6391335B1 (en) * 1998-04-29 2002-05-21 Cima Labs Inc. Effervescent drug delivery system for oral administration
US20030113371A1 (en) * 2001-08-21 2003-06-19 Council Of Scientific & Industrial Research Composition and method for maintaining blood glucose level by employing the hydrophilic matrix based oral controlled release antidiabetic composition

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6197346B1 (en) * 1992-04-24 2001-03-06 Brown Universtiy Research Foundation Bioadhesive microspheres and their use as drug delivery and imaging systems
WO1994000112A1 (en) * 1992-06-24 1994-01-06 Astra Aktiebolag An oral formulation for gastric antibacterial treatment as well as a process thereof and the use
US6123965A (en) * 1996-01-26 2000-09-26 Brown University Research Foundation Methods and compositions for enhancing the bioadhesive properties of polymers
US6156348A (en) * 1996-06-25 2000-12-05 Brown University Research Foundation Methods and compositions for enhancing the bioadhesive properties of polymers using organic excipients
US6391294B1 (en) * 1997-08-21 2002-05-21 Reckitt Benckiser Healthcare (Uk) Limited In situ formation of polymeric material
US6391335B1 (en) * 1998-04-29 2002-05-21 Cima Labs Inc. Effervescent drug delivery system for oral administration
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US20030113371A1 (en) * 2001-08-21 2003-06-19 Council Of Scientific & Industrial Research Composition and method for maintaining blood glucose level by employing the hydrophilic matrix based oral controlled release antidiabetic composition

Also Published As

Publication number Publication date
EP1784167A2 (en) 2007-05-16
CA2578845A1 (en) 2006-03-23
WO2006031420A2 (en) 2006-03-23
AU2005285298A1 (en) 2006-03-23

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