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)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (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
US36644002P 2002-03-20 2002-03-20
US36635402P 2002-03-20 2002-03-20
US36648702P 2002-03-20 2002-03-20
US36647902P 2002-03-20 2002-03-20
US36644902P 2002-03-20 2002-03-20
US36647002P 2002-03-20 2002-03-20
US60/366,479 2002-03-20
US60/366,449 2002-03-20
US60/366,487 2002-03-20
US60/366,470 2002-03-20
US60/366,354 2002-03-20
US60/366,440 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 (enExample)
JP (1) JP2005520843A (enExample)
AU (1) AU2003230689B2 (enExample)
CA (1) CA2478974C (enExample)
ES (1) ES2718455T3 (enExample)
WO (1) WO2003079885A2 (enExample)

Families Citing this family (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
EP1635762B1 (en) * 2003-06-13 2021-03-03 Civitas Therapeutics, Inc. Low dose pharmaceutical powders for inhalation
PT1713473E (pt) * 2004-02-06 2013-05-13 Meda Pharma Gmbh & Co Kg Combinação de anticolinérgicos e glucocorticóides para o tratamento a longo prazo de asma e copd
ES2909080T3 (es) 2004-04-23 2022-05-05 Cydex Pharmaceuticals Inc Formulación de DPI que contiene sulfoalquil éter ciclodextrina
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
EP2176251B1 (en) 2007-07-21 2012-02-08 Albany Molecular Research, Inc. 5-pyridinone substituted indazoles and pharmaceutical compositions thereof
EP2222639A1 (en) 2007-11-21 2010-09-01 Decode Genetics EHF Biaryl pde4 inhibitors for treating pulmonary and cardiovascular disorders
EP2240481A1 (en) 2008-01-11 2010-10-20 Albany Molecular Research, Inc. (1-azinone) -substituted pyridoindoles as mch antagonists
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
CN102361876B (zh) 2009-01-26 2015-02-04 以色列生物研究所 二环杂环螺环化合物
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
WO2014074797A1 (en) 2012-11-09 2014-05-15 Civitas Therapeutics, Inc. Ultra low density pulmonary powders
CA2898700C (en) * 2013-03-14 2022-07-19 Novartis Ag Deamorphization of spray-dried formulations via spray-blending
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
JP2018514564A (ja) * 2015-05-01 2018-06-07 サイヴィタス セラピューティックス，インコーポレイテッド 肺送達用のゾルミトリプタン粉末
EP3316865A4 (en) 2015-07-02 2019-01-23 Civitas Therapeutics, Inc. TRIPTAN POWDER FOR PULMONARY ADMINISTRATION
WO2019183245A1 (en) 2018-03-20 2019-09-26 Icahn School Of Medicine At Mount Sinai Kinase inhibitor compounds and compositions and methods of use
WO2020049505A1 (en) 2018-09-06 2020-03-12 Innopharmascreen Inc. Methods and compositions for treatment of asthma or parkinson's disease
AU2019419414A1 (en) 2018-12-31 2023-04-06 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
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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
ATE264096T1 (de) 1994-03-07 2004-04-15 Nektar Therapeutics Verfahren und mittel zur verabreichung von insulin über die lunge
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
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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
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CA2382821A1 (en) * 1999-08-25 2001-03-01 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
CN1188111C (zh) * 1999-10-29 2005-02-09 耐科塔医药公司 分散性得到改进的干粉组合物
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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
ES2718455T3 (es) 2019-07-02
AU2003230689A1 (en) 2003-10-08
EP1487411A4 (en) 2011-03-09
AU2003230689B2 (en) 2006-06-29
JP2005520843A (ja) 2005-07-14
EP1487411B1 (en) 2019-01-02
WO2003079885A3 (en) 2004-02-12
EP1487411A2 (en) 2004-12-22
CA2478974A1 (en) 2003-10-02
WO2003079885A2 (en) 2003-10-02

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Effective date: 20230320