JP5878022B2 - 抗コリン薬を具える放出制御組成物 - Google Patents

抗コリン薬を具える放出制御組成物 Download PDF

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Publication number
JP5878022B2
JP5878022B2 JP2011551299A JP2011551299A JP5878022B2 JP 5878022 B2 JP5878022 B2 JP 5878022B2 JP 2011551299 A JP2011551299 A JP 2011551299A JP 2011551299 A JP2011551299 A JP 2011551299A JP 5878022 B2 JP5878022 B2 JP 5878022B2
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Prior art keywords
coating
anticholinergic
beads
composition
water
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Expired - Fee Related
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JP2011551299A
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Japanese (ja)
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JP2012518656A5 (enExample
JP2012518656A (ja
Inventor
ヴェンカテッシュ，ゴーピ
パリーノ，ヴィンセント
ガッティ，パオロ
ファビアーニ，フラヴィオ
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Aptalis Pharma SRL
Adare Pharma Solutions Inc
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Aptalis Pharma SRL
Aptalis Pharmatech Inc
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    • 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
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • 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
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/48—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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Pulmonology (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Rheumatology (AREA)
  • Oncology (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Communicable Diseases (AREA)
  • Otolaryngology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
JP2011551299A 2009-02-23 2010-02-23 抗コリン薬を具える放出制御組成物 Expired - Fee Related JP5878022B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US15450409P 2009-02-23 2009-02-23
US61/154,504 2009-02-23
PCT/US2010/025083 WO2010096820A1 (en) 2009-02-23 2010-02-23 Controlled release compositions comprising anti-cholinergic drugs

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2015087928A Division JP2015155441A (ja) 2009-02-23 2015-04-22 抗コリン薬を具える放出制御組成物

Publications (3)

Publication Number Publication Date
JP2012518656A JP2012518656A (ja) 2012-08-16
JP2012518656A5 JP2012518656A5 (enExample) 2013-04-11
JP5878022B2 true JP5878022B2 (ja) 2016-03-08

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JP2011551299A Expired - Fee Related JP5878022B2 (ja) 2009-02-23 2010-02-23 抗コリン薬を具える放出制御組成物
JP2015087928A Pending JP2015155441A (ja) 2009-02-23 2015-04-22 抗コリン薬を具える放出制御組成物

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JP2015087928A Pending JP2015155441A (ja) 2009-02-23 2015-04-22 抗コリン薬を具える放出制御組成物

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US (1) US20110311626A1 (enExample)
EP (1) EP2398469A4 (enExample)
JP (2) JP5878022B2 (enExample)
CA (1) CA2753416A1 (enExample)
WO (1) WO2010096820A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015155441A (ja) * 2009-02-23 2015-08-27 アプタリス ファーマテック インコーポレイテッド 抗コリン薬を具える放出制御組成物

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BR112012012999A2 (pt) 2009-11-30 2019-04-02 Aptalis Pharmatech Inc Composição farmacêutica, e composição de tablete de desintegração oral (odt) outablete de dispersão rápida (rdt)
GR1007628B (el) * 2011-07-27 2012-06-29 Φαρματεν Αβεε, Φαρμακευτικο σκευασμα περιεχον εναν αντιμουσκαρινικο παραγοντα και μεθοδος για την παρασκευη αυτου
US20150086626A1 (en) * 2012-04-17 2015-03-26 Mylan, Inc Stable dosage forms of skeletal muscle relaxants with extended release coating
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
WO2015056851A1 (ko) * 2013-10-18 2015-04-23 주식회사 한독 아리피프라졸 함유 구강 붕해 정제 및 이의 제조 방법
US10172797B2 (en) 2013-12-17 2019-01-08 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
ES2809458T3 (es) 2014-07-17 2021-03-04 Pharmaceutical Manufacturing Res Services Inc Forma de dosificación llena de líquido, disuasoria del abuso y de liberación inmediata
WO2016064873A1 (en) 2014-10-20 2016-04-28 Pharmaceutical Manufacturing Research Services, Inc. Extended release abuse deterrent liquid fill dosage form
KR20180125573A (ko) * 2016-03-31 2018-11-23 인터셉트 파마슈티컬즈, 인크. 유효 성분의 화학적 안정성이 뛰어난 필름 코팅정
WO2019157066A1 (en) * 2018-02-06 2019-08-15 Robert Niichel A multiparticulate including pharmaceutical or probiotic active ingredients
JP7273976B2 (ja) 2018-09-21 2023-05-15 アムニール コンプレックス プロダクツ リサーチ エルエルシー トリヘキシフェニジルを含む徐放性組成物
US11154505B1 (en) 2021-02-03 2021-10-26 Kashiv Specialty Pharmaceuticals, Llc Extended release compositions comprising trihexyphenidyl
CN113244238B (zh) * 2021-06-16 2022-05-20 北京斯利安药业有限公司 含盐酸苯海索和叶酸的口崩片及其制备方法
US11648207B1 (en) * 2021-12-15 2023-05-16 Intas Pharmaceuticals Ltd. Extended release pharmaceutical composition of Clozapine
US12303604B1 (en) 2024-10-16 2025-05-20 Currax Pharmaceuticals Llc Pharmaceutical formulations comprising naltrexone and/or bupropion

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ATE133331T1 (de) * 1991-11-13 1996-02-15 Glaxo Canada Vorrichtung zur kontrollierten wirkstoffreigabe
ES2245320T3 (es) * 1999-11-11 2006-01-01 Pfizer Health Ab Formulacion farmaceutica que contiene tolterodina y su uso.
MXPA03009588A (es) * 2001-04-18 2004-12-06 Nostrum Pharmaceuticals Inc Un recubrimiento novedoso para una composicion farmaceutica de liberacion sostenida.
US6500454B1 (en) * 2001-10-04 2002-12-31 Eurand Pharmaceuticals Ltd. Timed, sustained release systems for propranolol
US20030091630A1 (en) * 2001-10-25 2003-05-15 Jenny Louie-Helm Formulation of an erodible, gastric retentive oral dosage form using in vitro disintegration test data
SE0203065D0 (sv) * 2002-10-16 2002-10-16 Diabact Ab Gastric acid secretion inhibiting composition
US20060024361A1 (en) * 2004-07-28 2006-02-02 Isa Odidi Disintegrant assisted controlled release technology
FR2891459B1 (fr) * 2005-09-30 2007-12-28 Flamel Technologies Sa Microparticules a liberation modifiee d'au moins un principe actif et forme galenique orale en comprenant
KR101468053B1 (ko) * 2006-08-31 2014-12-02 앱탈리스 파마테크, 인코포레이티드 약 염기성 약물의 고용체를 포함하는 약물 전달 시스템
WO2009006413A1 (en) * 2007-06-30 2009-01-08 Auspex Pharmaceuticals, Inc. Substituted pyrrolidines
US8486452B2 (en) * 2007-07-20 2013-07-16 Mylan Pharmaceuticals Inc. Stabilized tolterodine tartrate formulations
EP2175843B1 (en) * 2007-08-08 2014-10-08 Inventia Healthcare Private Limited Extended release compositions comprising tolterodine
EP2398469A4 (en) * 2009-02-23 2013-09-04 Aptalis Pharmatech Inc ANTICHOLINERGIC CONTAINING DELAYED RELEASE COMPOSITION

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015155441A (ja) * 2009-02-23 2015-08-27 アプタリス ファーマテック インコーポレイテッド 抗コリン薬を具える放出制御組成物

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Publication number Publication date
WO2010096820A1 (en) 2010-08-26
EP2398469A1 (en) 2011-12-28
US20110311626A1 (en) 2011-12-22
EP2398469A4 (en) 2013-09-04
CA2753416A1 (en) 2010-08-26
JP2015155441A (ja) 2015-08-27
JP2012518656A (ja) 2012-08-16

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