WO2009117130A3 - Extended release forumulation containing a wax - Google Patents

Extended release forumulation containing a wax Download PDF

Info

Publication number
WO2009117130A3
WO2009117130A3 PCT/US2009/001744 US2009001744W WO2009117130A3 WO 2009117130 A3 WO2009117130 A3 WO 2009117130A3 US 2009001744 W US2009001744 W US 2009001744W WO 2009117130 A3 WO2009117130 A3 WO 2009117130A3
Authority
WO
WIPO (PCT)
Prior art keywords
extended release
wax
forumulation
release portion
disclosed
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/US2009/001744
Other languages
French (fr)
Other versions
WO2009117130A2 (en
Inventor
Sarat C. Chattaraj
Pavan Bhat
Glenn A. Redelman
David J. Wargo
William Addicks
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.)
Mylan Pharmaceuticals Inc
Original Assignee
Mylan Pharmaceuticals 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
Application filed by Mylan Pharmaceuticals Inc filed Critical Mylan Pharmaceuticals Inc
Priority to CN2009801182220A priority Critical patent/CN102036656A/en
Priority to JP2011500811A priority patent/JP2011515400A/en
Priority to NZ588695A priority patent/NZ588695A/en
Priority to BRPI0908596A priority patent/BRPI0908596A2/en
Priority to AU2009226091A priority patent/AU2009226091B2/en
Priority to CA2718697A priority patent/CA2718697C/en
Priority to EP09722765.6A priority patent/EP2276465B1/en
Priority to ES09722765.6T priority patent/ES2525005T3/en
Priority to HK11101196.7A priority patent/HK1147192B/en
Priority to MX2010010280A priority patent/MX2010010280A/en
Publication of WO2009117130A2 publication Critical patent/WO2009117130A2/en
Publication of WO2009117130A3 publication Critical patent/WO2009117130A3/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
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • 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
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Botany (AREA)
  • Zoology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Extended release pharmaceutical formulations are disclosed wherein the formulations contain an extended release portion and an immediate release portion, the extended release portion comprising an active pharmaceutical ingredient and a wax. Methods of making such extended release pharmaceutical formulations are also disclosed.
PCT/US2009/001744 2008-03-21 2009-03-18 Extended release forumulation containing a wax Ceased WO2009117130A2 (en)

Priority Applications (10)

Application Number Priority Date Filing Date Title
CN2009801182220A CN102036656A (en) 2008-03-21 2009-03-18 Sustained-release formulations containing waxes
JP2011500811A JP2011515400A (en) 2008-03-21 2009-03-18 Sustained release formulation containing wax
NZ588695A NZ588695A (en) 2008-03-21 2009-03-18 Extended release forumulation containing a wax and ciprofloxacin
BRPI0908596A BRPI0908596A2 (en) 2008-03-21 2009-03-18 prolonged release formulation and pharmaceutical composition
AU2009226091A AU2009226091B2 (en) 2008-03-21 2009-03-18 Extended release formulation containing a wax
CA2718697A CA2718697C (en) 2008-03-21 2009-03-18 Extended release formulation containing a wax
EP09722765.6A EP2276465B1 (en) 2008-03-21 2009-03-18 Extended release formulation containing a wax
ES09722765.6T ES2525005T3 (en) 2008-03-21 2009-03-18 Extended release formulation containing a wax
HK11101196.7A HK1147192B (en) 2008-03-21 2009-03-18 Extended release formulation containing a wax
MX2010010280A MX2010010280A (en) 2008-03-21 2009-03-18 Extended release forumulation containing a wax.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US7033208P 2008-03-21 2008-03-21
US61/070,332 2008-03-21

Publications (2)

Publication Number Publication Date
WO2009117130A2 WO2009117130A2 (en) 2009-09-24
WO2009117130A3 true WO2009117130A3 (en) 2010-01-28

Family

ID=41051034

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/001744 Ceased WO2009117130A2 (en) 2008-03-21 2009-03-18 Extended release forumulation containing a wax

Country Status (12)

Country Link
US (1) US20090238873A1 (en)
EP (2) EP2366380A1 (en)
JP (1) JP2011515400A (en)
KR (1) KR101609279B1 (en)
CN (2) CN104922683A (en)
AU (1) AU2009226091B2 (en)
BR (1) BRPI0908596A2 (en)
CA (1) CA2718697C (en)
ES (1) ES2525005T3 (en)
MX (1) MX2010010280A (en)
NZ (2) NZ588695A (en)
WO (1) WO2009117130A2 (en)

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CA2638240C (en) * 2008-08-29 2010-02-02 Alexander Macgregor Method of treating dysglycemia and glucose excursions
WO2011128914A2 (en) 2010-04-15 2011-10-20 Cadila Healthcare Limited Extended release pharmaceutical compositions of pramipexole
CN102247313A (en) * 2010-06-11 2011-11-23 北京润德康医药技术有限公司 Oral-administration slow release solid preparation by taking Moxifloxacin as active ingredient
WO2011161504A1 (en) * 2010-06-23 2011-12-29 Micro Labs Limited Extended release formulations containing darifenacin or pharmaceutically acceptable salts thereof
CN101982166A (en) * 2010-10-27 2011-03-02 北京华禧联合科技发展有限公司 Slow release formulation of moxifloxacin and preparation method thereof
CN102119912A (en) * 2011-01-25 2011-07-13 南京白敬宇制药有限责任公司 Preparation method of water-insoluble pharmaceutical slow release preparation
US20120270860A1 (en) 2011-04-19 2012-10-25 Gihyun Yoon Methods for treating or preventing alcohol-related disorders or craving-related disorders
US10702485B2 (en) 2011-07-09 2020-07-07 Syntrix Biosystems Inc. Compositions and methods for overcoming resistance to tramadol
GB201118182D0 (en) * 2011-10-21 2011-12-07 Jagotec Ag Improvements in or relating to organic compounds
WO2013090452A1 (en) 2011-12-12 2013-06-20 Orbis Biosciences, Inc. Sustained release particle formulations
JP2015507003A (en) * 2012-02-20 2015-03-05 ルピン・リミテッドＬｕｐｉｎ Ｌｉｍｉｔｅｄ Dronedaron double-layer tablets
DE102012102414A1 (en) * 2012-03-21 2013-10-10 Michael Dittgen Composition, used to treat diabetes mellitus, includes antidiabetic drug as active substance, preferably metformin or its salt, where the composition is divided into two compartments, which include drug and three groups of adjuvants
WO2014011830A1 (en) 2012-07-12 2014-01-16 Mallinckrodt Llc Extended release, abuse deterrent pharmaceutical compositions
DE102013009114A1 (en) 2013-05-29 2014-12-04 Franz Gerstheimer Pharmaceutical composition to overcome metabolic problems
KR101597004B1 (en) 2013-07-25 2016-02-23 씨제이헬스케어 주식회사 Pharmaceutical combination comprising sustained-release type metformin and immediate-release type HMG-CoA reductase inhibitor
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
CN103690506B (en) * 2013-11-08 2015-05-13 舒泰神（北京）生物制药股份有限公司 Trospium chloride slow-release composition and preparation method thereof
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP3169315B1 (en) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Immediate release abuse deterrent liquid fill dosage form
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form
JP2019515045A (en) * 2016-05-03 2019-06-06 スペクトリックス セラピューティクス， エルエルシーＳｐｅｃｔｒｉｘ Ｔｈｅｒａｐｅｕｔｉｃｓ， Ｌｌｃ Compositions and Methods for Providing Thyroid Hormone or Analogs Thereof
CN106420738B (en) * 2016-10-14 2018-02-09 杨彦玲 A sustained-release preparation of levamlodipine or its salt and its preparation method
ES3040411T3 (en) 2018-03-22 2025-10-30 Incarda Therapeutics Inc A novel method to slow ventricular rate
KR102715550B1 (en) 2018-12-10 2024-10-10 신성대학교 산학협력단 Wax Particle Comprising Active Ingredient and the Fabrication Method Thereof
US11000488B2 (en) 2019-03-22 2021-05-11 Syntrix Biosystems Inc. Treating pain using desmetramadol
CN110464710A (en) * 2019-09-02 2019-11-19 新华制药（高密）有限公司 A kind of diltiazem hydrochloride * piece and preparation method thereof
KR102530612B1 (en) 2020-08-21 2023-05-09 한국휴텍스제약 주식회사 The preparation method of pharmaceutical composition comprising diltiazem as an active ingredient using self-granulation technique
CN114805947B (en) * 2022-04-26 2023-04-11 四川大学 Super-hydrophobic antibacterial composite membrane and preparation method thereof
CN118078758B (en) * 2024-02-26 2025-12-16 沈阳药科大学 Andrographolide anhydrous swallow granule and preparation method thereof

Citations (6)

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EP0823255A1 (en) * 1995-04-03 1998-02-11 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical composition containing sucralfate
WO2002100438A1 (en) * 2001-06-12 2002-12-19 Blue Cross Laboratories Limited Oral controlled release drug delivery system with husk powder from lepidium sativum seeds
US20050220877A1 (en) * 2004-03-31 2005-10-06 Patel Ashish A Bilayer tablet comprising an antihistamine and a decongestant
US20050226928A1 (en) * 2002-09-20 2005-10-13 Unchalee Lodin Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US20070237824A1 (en) * 2000-06-26 2007-10-11 Bayer Healthcare Aktiengesellschaft Sustained-Release Preparations Of Quinolone Antibiotics
WO2008008434A1 (en) * 2006-07-11 2008-01-17 Mutual Pharmaceutical Company, Inc. Controlled-release formulations

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US2951729A (en) * 1944-03-23 1960-09-06 Charles W Skarstrom Gas bearing
US2951792A (en) * 1959-11-18 1960-09-06 Smith Kline French Lab Sustained release pharmaceutical tablets
JP3962108B2 (en) * 1995-04-03 2007-08-22 中外製薬株式会社 Sucralfate-containing pharmaceutical composition
NZ501248A (en) * 1997-08-26 2001-06-29 Aventis Pharma Inc Pharmaceutical composition for combination of piperidinoalkanol-decongestant
JPH11209306A (en) * 1998-01-20 1999-08-03 Nichiko Pharmaceutical Co Ltd Production of sustained-release preparation containing medicine in high proportion
WO2003101431A1 (en) * 2002-06-04 2003-12-11 J.B. Chemicals & Pharmaceuticals Ltd. Pharmaceutical composition for controlled drug delivery system
WO2006116247A1 (en) * 2005-04-25 2006-11-02 Teva Pharmaceuticals Usa, Inc. Extended release formulations
US20070178155A1 (en) * 2006-01-31 2007-08-02 Jiang David Yihai Preparation for gastric buoyant sustained drug release dosage form
US8765178B2 (en) * 2006-07-19 2014-07-01 Watson Laboratories, Inc. Controlled release formulations and associated methods

Patent Citations (6)

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Publication number Priority date Publication date Assignee Title
EP0823255A1 (en) * 1995-04-03 1998-02-11 Chugai Seiyaku Kabushiki Kaisha Pharmaceutical composition containing sucralfate
US20070237824A1 (en) * 2000-06-26 2007-10-11 Bayer Healthcare Aktiengesellschaft Sustained-Release Preparations Of Quinolone Antibiotics
WO2002100438A1 (en) * 2001-06-12 2002-12-19 Blue Cross Laboratories Limited Oral controlled release drug delivery system with husk powder from lepidium sativum seeds
US20050226928A1 (en) * 2002-09-20 2005-10-13 Unchalee Lodin Novel pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
US20050220877A1 (en) * 2004-03-31 2005-10-06 Patel Ashish A Bilayer tablet comprising an antihistamine and a decongestant
WO2008008434A1 (en) * 2006-07-11 2008-01-17 Mutual Pharmaceutical Company, Inc. Controlled-release formulations

Also Published As

Publication number Publication date
KR101609279B1 (en) 2016-04-05
NZ588695A (en) 2012-11-30
HK1147192A1 (en) 2011-08-05
EP2276465B1 (en) 2014-10-22
CN104922683A (en) 2015-09-23
CA2718697A1 (en) 2009-09-24
KR20100129776A (en) 2010-12-09
MX2010010280A (en) 2010-12-15
CA2718697C (en) 2014-09-23
EP2366380A1 (en) 2011-09-21
US20090238873A1 (en) 2009-09-24
ES2525005T3 (en) 2014-12-16
JP2011515400A (en) 2011-05-19
CN102036656A (en) 2011-04-27
EP2276465A2 (en) 2011-01-26
NZ602968A (en) 2014-04-30
WO2009117130A2 (en) 2009-09-24
AU2009226091B2 (en) 2014-07-10
AU2009226091A1 (en) 2009-09-24
BRPI0908596A2 (en) 2015-09-15

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