JP2007515464A - 医薬組成物用ペレットの製造方法 - Google Patents

医薬組成物用ペレットの製造方法 Download PDF

Info

Publication number
JP2007515464A
JP2007515464A JP2006546298A JP2006546298A JP2007515464A JP 2007515464 A JP2007515464 A JP 2007515464A JP 2006546298 A JP2006546298 A JP 2006546298A JP 2006546298 A JP2006546298 A JP 2006546298A JP 2007515464 A JP2007515464 A JP 2007515464A
Authority
JP
Japan
Prior art keywords
amount
weight
component composition
present
particles
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.)
Pending
Application number
JP2006546298A
Other languages
English (en)
Japanese (ja)
Inventor
スパイアーズ、クリストファー
モイアー、ピーター
ウィリアムズ、リチャード
クラーク、ミッチェル
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.)
TEMREL Ltd
Original Assignee
TEMREL Ltd
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 GB0329854A external-priority patent/GB0329854D0/en
Priority claimed from GB0329851A external-priority patent/GB0329851D0/en
Application filed by TEMREL Ltd filed Critical TEMREL Ltd
Publication of JP2007515464A publication Critical patent/JP2007515464A/ja
Pending legal-status Critical Current

Links

Images

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
    • 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
    • A61K9/16—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • 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
    • A61K31/4164—1,3-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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • 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
    • A61P3/08—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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/02—Antiprotozoals, e.g. for leishmaniasis, trichomoniasis, toxoplasmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P33/00—Antiparasitic agents
    • A61P33/10—Anthelmintics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • 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
    • A61P7/06—Antianaemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Obesity (AREA)
  • Transplantation (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Emergency Medicine (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
JP2006546298A 2003-12-23 2004-12-15 医薬組成物用ペレットの製造方法 Pending JP2007515464A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0329854A GB0329854D0 (en) 2003-12-23 2003-12-23 Process for producing particles for pharmaceutical compositions
GB0329851A GB0329851D0 (en) 2003-12-23 2003-12-23 Process for producing particles for pharmaceutical compositions
PCT/GB2004/005263 WO2005060938A1 (en) 2003-12-23 2004-12-15 Process for producing pellets for pharmaceutical compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2012014751A Division JP2012087147A (ja) 2003-12-23 2012-01-27 医薬組成物用ペレットの製造方法

Publications (1)

Publication Number Publication Date
JP2007515464A true JP2007515464A (ja) 2007-06-14

Family

ID=34712711

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2006546298A Pending JP2007515464A (ja) 2003-12-23 2004-12-15 医薬組成物用ペレットの製造方法
JP2012014751A Pending JP2012087147A (ja) 2003-12-23 2012-01-27 医薬組成物用ペレットの製造方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2012014751A Pending JP2012087147A (ja) 2003-12-23 2012-01-27 医薬組成物用ペレットの製造方法

Country Status (13)

Country Link
US (4) US20070161711A1 (enExample)
EP (1) EP1696888B1 (enExample)
JP (2) JP2007515464A (enExample)
KR (1) KR20060129303A (enExample)
AR (1) AR046985A1 (enExample)
AU (1) AU2004305293A1 (enExample)
BR (1) BRPI0417985A (enExample)
CA (1) CA2551183C (enExample)
MX (1) MXPA06006887A (enExample)
NZ (1) NZ547806A (enExample)
RU (1) RU2382634C2 (enExample)
TW (1) TW200528140A (enExample)
WO (1) WO2005060938A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140141075A1 (en) 2012-11-21 2014-05-22 Warner Chilcott Company, Llc 5-aminosalicylic acid capsule formulation

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5834021A (en) * 1994-08-12 1998-11-10 Speirs; Christopher J. Prednisolone metasulphobenzoate preparation for the treatment of inflammatory bowel disease
JP2001513752A (ja) * 1996-09-12 2001-09-04 ロシュ ダイアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング 迅速崩壊ペレット
JP2002502809A (ja) * 1998-02-06 2002-01-29 エウランド インターナショナル ソシエタ ペル アチオニ 押出および球状化処理により得られた高分子微小粒子形態の医薬組成物
JP2002511777A (ja) * 1996-10-28 2002-04-16 ゼネラル ミルズ，インコーポレイテッド 調放性粒子の埋包およびカプセル化

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2916984B2 (ja) * 1993-12-27 1999-07-05 エスエス製薬株式会社 粒状製剤の製造法
JPH09208458A (ja) * 1996-02-02 1997-08-12 Ss Pharmaceut Co Ltd 不快な味がマスキングされた製剤
US6472421B1 (en) * 1998-11-13 2002-10-29 Nymox Corporation Methods for treating, preventing, and reducing the risk of the onset of alzheimer's disease using an HMG CoA reductase inhibitor
US20030180352A1 (en) * 1999-11-23 2003-09-25 Patel Mahesh V. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US6720000B2 (en) * 2001-03-19 2004-04-13 Three Rivers Pharmaceutical, Llc Process for producing wet ribavirin pellets
AU2002353316A1 (en) * 2001-12-21 2003-07-09 Pfizer Products Inc. Methods for wet granulating azithromycin
CA2491355A1 (en) 2002-07-05 2004-01-15 Temrel Limited Controlled release compositions comprising coated pellets having non-uniform coating thicknesses
BRPI0408323A (pt) * 2003-03-14 2006-03-07 Nirmal Mulye processo para a preparação de compimidos de liberação prolongada

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5834021A (en) * 1994-08-12 1998-11-10 Speirs; Christopher J. Prednisolone metasulphobenzoate preparation for the treatment of inflammatory bowel disease
JP2001513752A (ja) * 1996-09-12 2001-09-04 ロシュ ダイアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング 迅速崩壊ペレット
JP2002511777A (ja) * 1996-10-28 2002-04-16 ゼネラル ミルズ，インコーポレイテッド 調放性粒子の埋包およびカプセル化
JP2002502809A (ja) * 1998-02-06 2002-01-29 エウランド インターナショナル ソシエタ ペル アチオニ 押出および球状化処理により得られた高分子微小粒子形態の医薬組成物

Also Published As

Publication number Publication date
MXPA06006887A (es) 2006-09-04
AR046985A1 (es) 2006-01-04
CA2551183C (en) 2013-05-28
NZ547806A (en) 2009-11-27
US20070161711A1 (en) 2007-07-12
US20130249131A1 (en) 2013-09-26
AU2004305293A1 (en) 2005-07-07
WO2005060938A1 (en) 2005-07-07
TW200528140A (en) 2005-09-01
RU2382634C2 (ru) 2010-02-27
EP1696888B1 (en) 2015-04-08
RU2006126642A (ru) 2008-01-27
BRPI0417985A (pt) 2007-04-17
US20140239526A1 (en) 2014-08-28
CA2551183A1 (en) 2005-07-07
KR20060129303A (ko) 2006-12-15
US20110210460A1 (en) 2011-09-01
EP1696888A1 (en) 2006-09-06
JP2012087147A (ja) 2012-05-10

Similar Documents

Publication Publication Date Title
CN101137350B (zh) 包含利福昔明的胃稳定药物制剂
KR100270491B1 (ko) 약제 송출 시스템 및 그의 제조방법
RU2336865C2 (ru) Композиция с контролируемым высвобождением
JP2720932B2 (ja) 経口投与用アセトアミノフエン錠剤の製造法及びアセトアミノフエン二層錠剤
CN1178650C (zh) 搅动非依赖性多元缓释药物制剂及其制备方法
US6610328B2 (en) Amoxicillin-clarithromycin antibiotic composition
US9125803B2 (en) Gastric release pulse system for drug delivery
CN1244119A (zh) 迅速释放和掩蔽味觉的药物剂型
EP1318792A2 (en) Sustained release composition containing clarithromycin
US6627222B2 (en) Amoxicillin-dicloxacillin antibiotic composition
JP2006528699A (ja) 抗生物質組成物
WO2006082523A2 (en) Pharmaceutical sustained release composition of metformin
CA2511208A1 (en) Controlled release pharmaceutical compositions of tamsulosin
EP2701689B1 (en) Pharmaceutical compositions of raltegravir, methods of preparation and use thereof
CN101478958A (zh) 包含哌啶烷醇和减充血剂的组合的药物组合物
JP2012087147A (ja) 医薬組成物用ペレットの製造方法
CN1897922B (zh) 生产用于药物组合物的颗粒的方法
JPH024575B2 (enExample)
WO2004050064A1 (en) Method of manufacturing controlled release formulation using pelletizer
WO2008015686A1 (en) Stable multiparticulate formulations of didanosine
HK1024185A (en) Rapidly releasing and taste-masking pharmaceutical dosage form

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20071204

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20110303

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110526

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110602

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110628

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110705

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20110715

A602 Written permission of extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A602

Effective date: 20110725

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20110902

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20110929

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120127

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20120209