CA2339913A1 - Pharmaceutical formulations and method for making - Google Patents

Pharmaceutical formulations and method for making Download PDF

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Publication number
CA2339913A1
CA2339913A1 CA002339913A CA2339913A CA2339913A1 CA 2339913 A1 CA2339913 A1 CA 2339913A1 CA 002339913 A CA002339913 A CA 002339913A CA 2339913 A CA2339913 A CA 2339913A CA 2339913 A1 CA2339913 A1 CA 2339913A1
Authority
CA
Canada
Prior art keywords
formulation
making
pharmaceutical formulations
oral
pelletizing
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
CA002339913A
Other languages
French (fr)
Other versions
CA2339913C (en
Inventor
Torsten Hoffmann
Michael Pieroth
Gerhard Zessin
Karl-Friedrich Landgraf
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 GmbH
Original Assignee
Arzneimittelwerk Dresden GmbH
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26004678&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2339913(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from DE2000110509 external-priority patent/DE10010509A1/en
Application filed by Arzneimittelwerk Dresden GmbH filed Critical Arzneimittelwerk Dresden GmbH
Publication of CA2339913A1 publication Critical patent/CA2339913A1/en
Application granted granted Critical
Publication of CA2339913C publication Critical patent/CA2339913C/en
Anticipated expiration legal-status Critical
Expired - Fee Related 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
    • A61K9/14—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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/02—Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/06—Antiarrhythmics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Pain & Pain Management (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Pulmonology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Obesity (AREA)
  • Biochemistry (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
  • Immunology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Otolaryngology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Vascular Medicine (AREA)
  • Rheumatology (AREA)

Abstract

The invention relates to an oral pharmaceutical formulation with variably adjustable release rate, which comprises one or more active ingredients, and one or more sucrose ester of a fatty acid as the sole release-controlling agent for said active ingredient wherein when the dosage form is a granule or a pellet, the formulation is made by melting the oral formulation, and granulating or pelletizing the melt.
CA002339913A 2000-03-08 2001-03-07 Pharmaceutical formulations and method for making Expired - Fee Related CA2339913C (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE10010509.2 2000-03-08
DE2000110509 DE10010509A1 (en) 2000-03-08 2000-03-08 Oral pharmaceutical formulations with controllable release characteristics, e.g. rapid or delayed release, contain sucrose fatty acid ester as drug release controlling agent
US18796200P 2000-03-09 2000-03-09
US60/187,992 2000-03-09

Publications (2)

Publication Number Publication Date
CA2339913A1 true CA2339913A1 (en) 2001-09-08
CA2339913C CA2339913C (en) 2009-02-24

Family

ID=26004678

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002339913A Expired - Fee Related CA2339913C (en) 2000-03-08 2001-03-07 Pharmaceutical formulations and method for making

Country Status (23)

Country Link
EP (1) EP1267828B1 (en)
JP (1) JP2003528829A (en)
KR (1) KR20020083171A (en)
CN (1) CN1212831C (en)
AT (1) ATE334659T1 (en)
AU (1) AU2001250365A1 (en)
BG (1) BG107064A (en)
BR (1) BR0109036A (en)
CA (1) CA2339913C (en)
CZ (1) CZ20023009A3 (en)
DE (1) DE50110617D1 (en)
EA (1) EA200200951A1 (en)
EE (1) EE200200504A (en)
GE (1) GEP20053455B (en)
HK (1) HK1054697A1 (en)
HR (1) HRP20020804B1 (en)
HU (1) HUP0204513A3 (en)
IS (1) IS6511A (en)
NO (1) NO20024237L (en)
NZ (1) NZ521215A (en)
PL (1) PL202935B1 (en)
SK (1) SK13252002A3 (en)
WO (1) WO2001066081A2 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1490031A1 (en) * 2002-03-07 2004-12-29 Vectura Limited Fast melt multiparticulate formulations for oral delivery
CA2509259A1 (en) * 2003-01-23 2004-08-05 Amorepacific Corporation Sustained-release preparations and method for producing the same
DE10341264A1 (en) * 2003-09-04 2005-03-24 Grünenthal GmbH Melt-formulated, multiparticulate oral dosage form
JP2007533733A (en) * 2004-04-22 2007-11-22 モル リサーチ アプリケーションズ リミテッド How to control food intake
AU2009270768A1 (en) * 2008-07-18 2010-01-21 Valeant Pharmaceuticals International Modified release formulation and methods of use
US8715715B2 (en) * 2008-11-03 2014-05-06 Nal Pharmaceuticals Ltd. Dosage form for insertion into the mouth
DE102009013613A1 (en) 2009-03-17 2010-09-23 Ratiopharm Gmbh Dry processing of retigabine
DE102009013612A1 (en) 2009-03-17 2010-09-23 Ratiopharm Gmbh Retigabine tablets, preferably with modified release
DE102009013611A1 (en) 2009-03-17 2010-09-23 Ratiopharm Gmbh Solid retigabine in non-crystalline form
BR112012018173A2 (en) * 2010-01-20 2017-08-29 Valeant Pharmaceuticals Int "MODIFIED RELEASE FORMULATION AND METHOD OF USE"
EP2729176A1 (en) 2011-07-05 2014-05-14 Contera Pharma APS The use of serotonin receptor agonists for treatment of movement disorders
US9616025B2 (en) * 2013-10-29 2017-04-11 Echo Pharmaceuticals B.V. Compressed tablet containing Δ9-tetrahydrocannabinol, method for its manufacture and use of such tablet in oral treatment
US11331268B2 (en) * 2016-11-18 2022-05-17 The University Of Western Australia Taste masking product
CN107441055A (en) * 2017-08-03 2017-12-08 山东则正医药技术有限公司 A kind of preparation method of controlled release drug
CN108853044B (en) * 2018-07-06 2020-11-06 郑州明泽医药科技有限公司 Nifedipine sustained release tablet and preparation method thereof
CN109679147B (en) * 2018-12-28 2021-05-11 广西科技师范学院 Plant microfine fiber sucrose fatty acid ester enrichment and preparation method thereof
GB201904767D0 (en) 2019-04-04 2019-05-22 Orexo Ab New pharmaceutical compositions
WO2021145625A1 (en) * 2020-01-13 2021-07-22 한국유나이티드제약 주식회사 Pharmaceutical composition comprising r-thioctic acid or pharmaceutically acceptable salt thereof and enteric coating base material
CN111513192A (en) * 2020-05-19 2020-08-11 北京中联华康科技有限公司 Esterified cysteamine hydrochloride stable powder and preparation method and application thereof
CN114983964B (en) * 2022-06-24 2024-05-03 广东恒健制药有限公司 Cefdinir granule and preparation method thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS63101320A (en) * 1986-10-17 1988-05-06 Dainippon Pharmaceut Co Ltd Calcium valproate preparation
JPH07267850A (en) * 1994-03-28 1995-10-17 Eisai Co Ltd Medicine composition prevented in unpleasant taste and method for producing the same
JP4078567B2 (en) * 1997-04-25 2008-04-23 東和薬品株式会社 Sustained release microcapsules and production method thereof
JP4299384B2 (en) * 1997-07-15 2009-07-22 富山化学工業株式会社 Anti-elution delay fine granules
HU230889B1 (en) * 1998-03-26 2018-12-28 Astellas Pharma Inc. Sustained release preparations
DE19840152A1 (en) * 1998-09-03 2000-03-09 Dresden Arzneimittel Pharmaceutical compositions containing calcium valproate with a delayed release of active substance, process for their preparation and their use
DE19916383A1 (en) * 1999-03-31 2000-10-05 Schering Ag Pharmaceutical composition with an extrusion

Also Published As

Publication number Publication date
WO2001066081A2 (en) 2001-09-13
WO2001066081A3 (en) 2002-03-14
NO20024237D0 (en) 2002-09-05
PL362547A1 (en) 2004-11-02
AU2001250365A1 (en) 2001-09-17
HRP20020804B1 (en) 2008-06-30
HRP20020804A2 (en) 2004-12-31
HUP0204513A2 (en) 2003-05-28
HK1054697A1 (en) 2003-12-12
EP1267828B1 (en) 2006-08-02
NZ521215A (en) 2005-04-29
SK13252002A3 (en) 2003-07-01
EE200200504A (en) 2004-02-16
NO20024237L (en) 2002-09-05
PL202935B1 (en) 2009-08-31
EP1267828A2 (en) 2003-01-02
EA200200951A1 (en) 2003-02-27
GEP20053455B (en) 2005-02-25
CZ20023009A3 (en) 2003-06-18
CN1418091A (en) 2003-05-14
CN1212831C (en) 2005-08-03
IS6511A (en) 2002-08-20
KR20020083171A (en) 2002-11-01
BR0109036A (en) 2003-03-18
ATE334659T1 (en) 2006-08-15
BG107064A (en) 2003-04-30
JP2003528829A (en) 2003-09-30
HUP0204513A3 (en) 2004-06-28
CA2339913C (en) 2009-02-24
DE50110617D1 (en) 2006-09-14

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