CA2658512A1 - Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles - Google Patents

Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles Download PDF

Info

Publication number
CA2658512A1
CA2658512A1 CA002658512A CA2658512A CA2658512A1 CA 2658512 A1 CA2658512 A1 CA 2658512A1 CA 002658512 A CA002658512 A CA 002658512A CA 2658512 A CA2658512 A CA 2658512A CA 2658512 A1 CA2658512 A1 CA 2658512A1
Authority
CA
Canada
Prior art keywords
dosage form
particle
protective coating
coating
lyophilizing
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.)
Abandoned
Application number
CA002658512A
Other languages
English (en)
French (fr)
Inventor
Ehab Hamed
Lisa Hillman
Rajendra K. Khankari
Derek Moe
Tam Nguyen
Vikas Agarwal
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.)
Teva Sante SAS
Cima Labs Inc
Original Assignee
Individual
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 EP06291198A external-priority patent/EP1891938A1/en
Priority claimed from EP06291458A external-priority patent/EP1905429A1/en
Application filed by Individual filed Critical Individual
Publication of CA2658512A1 publication Critical patent/CA2658512A1/en
Abandoned 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
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • 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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
CA002658512A 2006-07-24 2007-07-24 Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles Abandoned CA2658512A1 (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
EP06291198.7 2006-07-24
EP06291198A EP1891938A1 (en) 2006-07-24 2006-07-24 High dose orally dissolvable/disintegrable lyophilized dosage form
EP06291458.5 2006-09-18
EP06291458A EP1905429A1 (en) 2006-09-18 2006-09-18 Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles
US11/880,503 2007-07-23
US11/880,503 US20080031947A1 (en) 2006-07-24 2007-07-23 Orally dissolvable/disintegrable lyophilized dosage forms containing protected
PCT/US2007/016690 WO2008013833A2 (en) 2006-07-24 2007-07-24 Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles

Publications (1)

Publication Number Publication Date
CA2658512A1 true CA2658512A1 (en) 2008-01-31

Family

ID=39029455

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002658512A Abandoned CA2658512A1 (en) 2006-07-24 2007-07-24 Orally dissolvable/disintegrable lyophilized dosage forms containing protected particles
CA002658109A Abandoned CA2658109A1 (en) 2006-07-24 2007-07-24 High dose orally dissolvable/disintegrable lyophilized dosage form

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002658109A Abandoned CA2658109A1 (en) 2006-07-24 2007-07-24 High dose orally dissolvable/disintegrable lyophilized dosage form

Country Status (6)

Country Link
US (2) US20080031947A1 (enExample)
EP (2) EP2068824A2 (enExample)
JP (2) JP2009544706A (enExample)
CA (2) CA2658512A1 (enExample)
MX (2) MX2009000861A (enExample)
WO (2) WO2008013833A2 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080031947A1 (en) * 2006-07-24 2008-02-07 Cima Labs Inc. Orally dissolvable/disintegrable lyophilized dosage forms containing protected
EP2328558A2 (en) * 2008-08-08 2011-06-08 McNeil-PPC, Inc. Use of sucralose as a granulating agent
EP2359812A1 (en) * 2010-01-18 2011-08-24 Cephalon France Oral lyophilised compositions
EP2525783A1 (en) * 2010-01-18 2012-11-28 Cephalon France Improved oral lysophilisates containing pvp/va
EP2645943A1 (en) 2010-12-02 2013-10-09 Agile Endosurgery, Inc. Surgical tool
US9730885B2 (en) 2012-07-12 2017-08-15 Mallinckrodt Llc Extended release, abuse deterrent pharmaceutical compositions
US11058642B2 (en) * 2013-04-22 2021-07-13 Tower Laboratories Ltd Tablets with improved friability
US9650338B1 (en) 2016-07-29 2017-05-16 VDM Biochemicals, Inc. Opioid antagonist compounds and methods of making and using
WO2018191794A1 (en) 2017-04-20 2018-10-25 Zeenar Enterprises Pty Ltd Liquid crystalline dosage form for administering a statin
AU2018255718A1 (en) 2017-04-20 2019-12-05 Zeenar Enterprises Pty Ltd Fast disintegrating tablet
CN111432804A (zh) * 2017-11-27 2020-07-17 帝斯曼知识产权资产管理有限公司 冻干的多微粒固体剂型
CA3157405A1 (en) 2019-11-18 2021-05-27 Donald D. EVANS II Lyophilized cake in straight-walled vial

Family Cites Families (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CH558659A (fr) * 1969-11-26 1975-02-14 Orsymonde Procede pour la preparation d'une composition lyophilisee a usage hygienique.
GB1447988A (en) * 1973-04-03 1976-09-02 Orsymonde Pharmaceutical compositions
FR2539626B2 (fr) * 1983-01-25 1985-06-21 Lafon Labor Nouveau procede de preparation de formes galeniques utiles notamment en therapeutique, dietetique, cosmetique et diagnostic, et formes obtenues selon ce procede
FR2561916B1 (fr) * 1984-03-30 1987-12-11 Lafon Labor Forme galenique pour administration orale et son procede de preparation par lyophilisation d'une emission huile dans eau
GB8724763D0 (en) * 1987-10-22 1987-11-25 Aps Research Ltd Sustained-release formulations
DE3824399A1 (de) * 1988-07-19 1990-01-25 Ford Werke Ag Regelbares ringreibgetriebe
FR2634376B1 (fr) * 1988-07-21 1992-04-17 Farmalyoc Nouvelle forme unitaire, solide et poreuse comprenant des microparticules et/ou des nanoparticules, ainsi que sa preparation
US5178878A (en) * 1989-10-02 1993-01-12 Cima Labs, Inc. Effervescent dosage form with microparticles
US5223264A (en) * 1989-10-02 1993-06-29 Cima Labs, Inc. Pediatric effervescent dosage form
US5558880A (en) * 1989-12-22 1996-09-24 Janssen Pharmaceutica Inc. Pharmaceutical and other dosage forms
US5188825A (en) * 1989-12-28 1993-02-23 Iles Martin C Freeze-dried dosage forms and methods for preparing the same
US5843347A (en) * 1993-03-23 1998-12-01 Laboratoire L. Lafon Extrusion and freeze-drying method for preparing particles containing an active ingredient
CA2128821A1 (en) * 1993-07-27 1995-01-28 Dilip J. Gole Freeze-dried pharmaceutical dosage form and process for separation thereof
DK9500167U3 (da) * 1995-04-27 1996-01-12 Brdr Christensens Haner A S Afspærringsindretning af "double-block-and-bleed"-typen
US5599846A (en) * 1996-06-28 1997-02-04 Jame Fine Chemicals, Inc. Phenylephrine tannate compositions
US6024981A (en) * 1997-04-16 2000-02-15 Cima Labs Inc. Rapidly dissolving robust dosage form
US5976577A (en) * 1997-07-11 1999-11-02 Rp Scherer Corporation Process for preparing fast dispersing solid oral dosage form
US6479496B1 (en) * 1998-09-10 2002-11-12 Cv Therapeutics, Inc. Methods for treating angina with ranolazine
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AU2023401A (en) * 1999-12-01 2001-06-12 Natco Pharma Limited A rapid acting freeze dired oral pharmaceutical composition for treating migraine
US6754511B1 (en) * 2000-02-04 2004-06-22 Harris Corporation Linear signal separation using polarization diversity
US6316029B1 (en) * 2000-05-18 2001-11-13 Flak Pharma International, Ltd. Rapidly disintegrating solid oral dosage form
JP2003055197A (ja) * 2001-06-07 2003-02-26 Tanabe Seiyaku Co Ltd 機能性粒子含有口腔内速崩壊性製剤
CA2449731A1 (en) * 2001-06-07 2002-12-19 Tanabe Seiyaku Co., Ltd. Functional grain-containing preparations quickly disintegrated in the oral cavity
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CA2497176A1 (en) * 2002-09-04 2004-03-18 Ranbaxy Laboratories Limited Taste masked dosage forms and processes for their preparation
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US20050123596A1 (en) * 2003-09-23 2005-06-09 Kohane Daniel S. pH-triggered microparticles
US7294347B2 (en) * 2004-06-21 2007-11-13 Council Of Scientific And Industrial Research Coating compositions for bitterness inhibition
US20060024370A1 (en) * 2004-07-29 2006-02-02 Cephalon France Modafinil oral lyophilizate
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US20080031947A1 (en) * 2006-07-24 2008-02-07 Cima Labs Inc. Orally dissolvable/disintegrable lyophilized dosage forms containing protected

Also Published As

Publication number Publication date
CA2658109A1 (en) 2008-01-31
EP2068824A2 (en) 2009-06-17
EP2068826A2 (en) 2009-06-17
US20080031947A1 (en) 2008-02-07
MX2009000849A (es) 2009-06-30
WO2008013833A2 (en) 2008-01-31
WO2008013808A2 (en) 2008-01-31
WO2008013833A3 (en) 2008-07-17
WO2008013808A3 (en) 2008-05-15
MX2009000861A (es) 2009-06-19
JP2009544707A (ja) 2009-12-17
JP2009544706A (ja) 2009-12-17
US20080031949A1 (en) 2008-02-07

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Discontinued

Effective date: 20150306