CA2478974C - Inhalable sustained therapeutic formulations - Google Patents

Inhalable sustained therapeutic formulations Download PDF

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Publication number
CA2478974C
CA2478974C CA2478974A CA2478974A CA2478974C CA 2478974 C CA2478974 C CA 2478974C CA 2478974 A CA2478974 A CA 2478974A CA 2478974 A CA2478974 A CA 2478974A CA 2478974 C CA2478974 C CA 2478974C
Authority
CA
Canada
Prior art keywords
particles
leucine
weight percent
present
therapeutic
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.)
Expired - Lifetime
Application number
CA2478974A
Other languages
English (en)
French (fr)
Other versions
CA2478974A1 (en
Inventor
Sujit K. Basu
Giovanni Caponetti
Robert Clarke
Katharina J. Elbert
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.)
Civitas Therapeutics Inc
Original Assignee
Civitas Therapeutics 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 Civitas Therapeutics Inc filed Critical Civitas Therapeutics Inc
Publication of CA2478974A1 publication Critical patent/CA2478974A1/en
Application granted granted Critical
Publication of CA2478974C publication Critical patent/CA2478974C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/66—Phosphorus compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2478974A 2002-03-20 2003-03-19 Inhalable sustained therapeutic formulations Expired - Lifetime CA2478974C (en)

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US36635402P 2002-03-20 2002-03-20
US36644902P 2002-03-20 2002-03-20
US36647002P 2002-03-20 2002-03-20
US36648702P 2002-03-20 2002-03-20
US36644002P 2002-03-20 2002-03-20
US36647902P 2002-03-20 2002-03-20
US60/366,470 2002-03-20
US60/366,487 2002-03-20
US60/366,479 2002-03-20
US60/366,354 2002-03-20
US60/366,440 2002-03-20
US60/366,449 2002-03-20
PCT/US2003/008537 WO2003079885A2 (en) 2002-03-20 2003-03-19 Inhalable sustained therapeutic formulations

Publications (2)

Publication Number Publication Date
CA2478974A1 CA2478974A1 (en) 2003-10-02
CA2478974C true CA2478974C (en) 2014-12-16

Family

ID=28458072

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2478974A Expired - Lifetime CA2478974C (en) 2002-03-20 2003-03-19 Inhalable sustained therapeutic formulations

Country Status (6)

Country Link
EP (1) EP1487411B1 (https=)
JP (1) JP2005520843A (https=)
AU (1) AU2003230689B2 (https=)
CA (1) CA2478974C (https=)
ES (1) ES2718455T3 (https=)
WO (1) WO2003079885A2 (https=)

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US7754242B2 (en) * 2002-03-20 2010-07-13 Alkermes, Inc. Inhalable sustained therapeutic formulations
US7772188B2 (en) 2003-01-28 2010-08-10 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
CA2528064C (en) 2003-06-13 2010-01-12 Advanced Inhalation Research, Inc. Low dose pharmaceutical powders for inhalation
EP1713473B1 (en) * 2004-02-06 2013-03-13 MEDA Pharma GmbH & Co. KG The combination of anticholinergics and glucocorticoids for the long-term treatment of asthma and copd
PL2708225T3 (pl) 2004-04-23 2019-07-31 Cydex Pharmaceuticals, Inc. Formulacja DPI zawierająca eter sulfoalkilowy cyklodekstryny
ITMI20051999A1 (it) 2005-10-21 2007-04-22 Eratech S R L Formulazioni inalatorie di farmaci in fora di polvere secca per somministrazione come tale o con nebulizzatore e dotate di elevata erogabilita' respirabilita' e stabilita'
US7629331B2 (en) 2005-10-26 2009-12-08 Cydex Pharmaceuticals, Inc. Sulfoalkyl ether cyclodextrin compositions and methods of preparation thereof
KR20100044225A (ko) 2007-07-21 2010-04-29 알바니 몰레큘라 리써치, 인크. 5-피리디논 치환된 인다졸
KR20100098653A (ko) 2007-11-21 2010-09-08 디코드 제네틱스 이에이치에프 염증의 치료를 위한 바이아릴 ｐｄｅ４ 억제제
US8716308B2 (en) 2008-01-11 2014-05-06 Albany Molecular Research, Inc. (1-azinone)-substituted pyridoindoles
EP2172190A1 (en) * 2008-10-02 2010-04-07 Laboratorios Liconsa, S.A. Inhalable particles comprising tiotropium
WO2010059836A1 (en) 2008-11-20 2010-05-27 Decode Genetics Ehf Substituted aza-bridged bicyclics for cardiovascular and cns disease
AU2010207486B2 (en) 2009-01-26 2013-03-07 Israel Institute For Biological Research Bicyclic heterocyclic spiro compounds
JP5257200B2 (ja) * 2009-03-30 2013-08-07 三菱エンジニアリングプラスチックス株式会社 導電性樹脂組成物及び導電性樹脂成形品
CN102768278B (zh) * 2012-05-31 2014-06-25 华中农业大学 用于检测β-受体兴奋剂的单克隆抗体及酶联免疫方法与试剂盒
BR112015010601B1 (pt) 2012-11-09 2022-07-19 Civitas Therapeutics, Inc. Composição farmacêutica e uso da composição
KR102074543B1 (ko) * 2013-03-14 2020-02-06 노파르티스 아게 분무-블렌딩을 통한 분무-건조 제제의 탈무정형화
MA40910A (fr) * 2014-11-07 2017-09-12 Civitas Therapeutics Inc Poudres de rapamycine pour administration pulmonaire
US10077420B2 (en) 2014-12-02 2018-09-18 Histogenics Corporation Cell and tissue culture container
WO2016142708A2 (en) * 2015-03-10 2016-09-15 Cipla Limited Pharmaceutical composition
KR20180002750A (ko) * 2015-05-01 2018-01-08 키비타스 테라퓨틱스, 인코포레이티드. 폐 전달용 졸미트립탄 분말
AU2016287582B2 (en) 2015-07-02 2020-03-12 Civitas Therapeutics, Inc. Triptan powders for pulmonary delivery
JP2021518413A (ja) 2018-03-20 2021-08-02 アイカーン スクール オブ メディシン アット マウント サイナイ キナーゼ阻害剤化合物及び組成物ならびに使用方法
AU2019334202A1 (en) 2018-09-06 2021-03-25 Innopharmascreen, Inc. Methods and compositions for treatment of asthma or parkinson's disease
WO2020142485A1 (en) 2018-12-31 2020-07-09 Icahn School Of Medicine At Mount Sinai Kinase inhibitor compounds and compositions and methods of use
IT202000030437A1 (it) * 2020-12-10 2022-06-10 Zambon Spa Metodo per la realizzazione di una polvere inalabile comprendente voriconazolo

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4069819A (en) 1973-04-13 1978-01-24 Societa Farmaceutici S.P.A. Inhalation device
US4511258A (en) 1983-03-25 1985-04-16 Koflo Corporation Static material mixing apparatus
IT1228459B (it) 1989-02-23 1991-06-19 Phidea S R L Inalatore con svuotamento regolare e completo della capsula.
US5174988A (en) * 1989-07-27 1992-12-29 Scientific Development & Research, Inc. Phospholipid delivery system
NZ281112A (en) 1994-03-07 1998-04-27 Inhale Therapeutic Syst Powdered insulin delivered as an aerosol
GB9501841D0 (en) * 1995-01-31 1995-03-22 Co Ordinated Drug Dev Improvements in and relating to carrier particles for use in dry powder inhalers
US5985309A (en) 1996-05-24 1999-11-16 Massachusetts Institute Of Technology Preparation of particles for inhalation
US5855913A (en) 1997-01-16 1999-01-05 Massachusetts Instite Of Technology Particles incorporating surfactants for pulmonary drug delivery
GB9827145D0 (en) * 1998-12-09 1999-02-03 Co Ordinated Drug Dev Improvements in or relating to powders
WO2000061178A1 (en) * 1999-04-13 2000-10-19 Inhale Therapeutics Systems, Inc. Pulmonary administration of dry powder formulations for treating infertility
US6858199B1 (en) 2000-06-09 2005-02-22 Advanced Inhalation Research, Inc. High efficient delivery of a large therapeutic mass aerosol
AU763041B2 (en) * 1999-08-25 2003-07-10 Alkermes, Inc. Modulation of release from dry powder formulations
US20010036481A1 (en) 1999-08-25 2001-11-01 Advanced Inhalation Research, Inc. Modulation of release from dry powder formulations
US6586008B1 (en) * 1999-08-25 2003-07-01 Advanced Inhalation Research, Inc. Use of simple amino acids to form porous particles during spray drying
DE60025019T2 (de) * 1999-10-29 2006-08-24 Nektar Therapeutics, San Carlos Trockenpulverzusammensetzungen mit verbesserter dispersivität
US6766799B2 (en) 2001-04-16 2004-07-27 Advanced Inhalation Research, Inc. Inhalation device
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US7008644B2 (en) 2002-03-20 2006-03-07 Advanced Inhalation Research, Inc. Method and apparatus for producing dry particles

Also Published As

Publication number Publication date
CA2478974A1 (en) 2003-10-02
JP2005520843A (ja) 2005-07-14
EP1487411A4 (en) 2011-03-09
AU2003230689A1 (en) 2003-10-08
EP1487411B1 (en) 2019-01-02
ES2718455T3 (es) 2019-07-02
EP1487411A2 (en) 2004-12-22
AU2003230689B2 (en) 2006-06-29
WO2003079885A3 (en) 2004-02-12
WO2003079885A2 (en) 2003-10-02

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EEER Examination request
MKEX Expiry

Effective date: 20230320