WO2001013891A2 - Modulation of release from dry powder formulations - Google Patents

Modulation of release from dry powder formulations Download PDF

Info

Publication number
WO2001013891A2
WO2001013891A2 PCT/US2000/023048 US0023048W WO0113891A2 WO 2001013891 A2 WO2001013891 A2 WO 2001013891A2 US 0023048 W US0023048 W US 0023048W WO 0113891 A2 WO0113891 A2 WO 0113891A2
Authority
WO
WIPO (PCT)
Prior art keywords
particles
phospholipids
microns
transition temperature
phospholipid
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.)
Ceased
Application number
PCT/US2000/023048
Other languages
English (en)
French (fr)
Other versions
WO2001013891A3 (en
Inventor
Sujit K. Basu
Jeffrey S. Hrkach
Giovanni Caponetti
Michael M. Lipp
Katharina Elbert
Wen-I Li
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.)
Advanced Inhalation Research Inc
Original Assignee
Advanced Inhalation Research 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 Advanced Inhalation Research Inc filed Critical Advanced Inhalation Research Inc
Priority to JP2001518029A priority Critical patent/JP2003507410A/ja
Priority to EP00957674A priority patent/EP1210067A2/en
Priority to CA002382821A priority patent/CA2382821A1/en
Priority to AU69259/00A priority patent/AU763041B2/en
Publication of WO2001013891A2 publication Critical patent/WO2001013891A2/en
Publication of WO2001013891A3 publication Critical patent/WO2001013891A3/en
Anticipated expiration legal-status Critical
Ceased 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • 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
    • 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

Definitions

  • the particles can be prepared by spray-drying methods. They are administered to the respiratory system of a subject using, for example, a dry powder inhaler.
  • Figure 6 is a schematic representation of particle behavior for particles having a matrix transition temperature which is less than about 37° Celsius (C) and for particles having a matrix transition temperature which is greater than about 37° C.
  • Figure 7 is a plot showing the comparison of two albuterol sulfate formulations on carbachol-induced lung resistance in guinea pigs.
  • the phospholipid can be present in the particles in an amount ranging from about 1 to about 99 weight %. Preferably, it can be present in the particles in an amount ranging from about 10 to about 80 weight %.
  • phospholipids include, but are not limited to, phosphatidic acids, phosphatidylcholines, phosphatidylethanolamines, phosphatidylglycerols, phosphatidylserines, phosphatidylinositols or a combination thereof.
  • Modified phospholipids for example, phospholipids having their head group modified, e.g., alkylated or polyethylene glycol (PEG)-modified, also can be employed.
  • the larger aerodynamically light particles preferably having a VMGD of at least about 5 ⁇ m, also can potentially more successfully avoid phagocytic engulfrnent by alveolar macrophages and clearance from the lungs, due to size exclusion of the particles from the phagocytes' cytosolic space. Phagocytosis of particles by alveolar macrophages diminishes precipitously as particle diameter increases beyond about 3 ⁇ m.
  • the particles have an envelope mass density, also referred to herein as "mass density" of less than about 0.4 g/cm 3 .
  • Particles also having a mean diameter of between about 5 ⁇ m and about 30 ⁇ m are preferred.
  • Mass density and the relationship between mass density, mean diameter and aerodynamic diameter are discussed in U. S. Application No. 08/655,570, filed on May 24, 1996, which is incorporated herein by reference in its entirety.
  • the aerodynamic diameter of particles having a mass density less than about 0.4 g/cm 3 and a mean diameter of between about 5 ⁇ m and about 30 ⁇ m is between about 1 ⁇ m and about 5 ⁇ m.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
PCT/US2000/023048 1999-08-25 2000-08-23 Modulation of release from dry powder formulations Ceased WO2001013891A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2001518029A JP2003507410A (ja) 1999-08-25 2000-08-23 乾燥粉末製剤からの放出調節
EP00957674A EP1210067A2 (en) 1999-08-25 2000-08-23 Modulation of release from dry powder formulations
CA002382821A CA2382821A1 (en) 1999-08-25 2000-08-23 Modulation of release from dry powder formulations
AU69259/00A AU763041B2 (en) 1999-08-25 2000-08-23 Modulation of release from dry powder formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15074299P 1999-08-25 1999-08-25
US60/150,742 1999-08-25

Publications (2)

Publication Number Publication Date
WO2001013891A2 true WO2001013891A2 (en) 2001-03-01
WO2001013891A3 WO2001013891A3 (en) 2001-07-26

Family

ID=22535816

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2000/023048 Ceased WO2001013891A2 (en) 1999-08-25 2000-08-23 Modulation of release from dry powder formulations

Country Status (6)

Country Link
US (1) US20040018243A1 (enExample)
EP (1) EP1210067A2 (enExample)
JP (1) JP2003507410A (enExample)
AU (1) AU763041B2 (enExample)
CA (1) CA2382821A1 (enExample)
WO (1) WO2001013891A2 (enExample)

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WO2003077891A1 (fr) * 2002-03-18 2003-09-25 Yamanouchi Pharmaceutical Co., Ltd. Compositions medicales en poudre pour inhalation et procede de production de celles-ci
WO2003079885A2 (en) 2002-03-20 2003-10-02 Advanced Inhalation Research, Inc. Inhalable sustained therapeutic formulations
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JP2005511629A (ja) * 2001-11-20 2005-04-28 アドバンスト インハレーション リサーチ，インコーポレイテッド 持続作用生成物送達用組成物
JP2005514393A (ja) * 2001-12-19 2005-05-19 ネクター セラピューティクス アミノグリコシドの肺への供給
US7141236B2 (en) 2000-07-28 2006-11-28 Nektar Therapeutics Methods and compositions for delivering macromolecules to or via the respiratory tract
WO2006124446A3 (en) * 2005-05-12 2007-06-14 Nektar Therapeutics Sustained release microparticles for pulmonary delivery
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CN104487075A (zh) 2012-02-29 2015-04-01 普马特里克斯公司 可吸入干粉剂
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US20150224202A1 (en) * 2014-02-03 2015-08-13 The Board Of Trustees Of The Leland Stanford Junior University Formulations and uses for microparticle delivery of zinc protoporphyrins
CN110087653A (zh) 2016-10-27 2019-08-02 普尔莫凯恩股份有限公司 用于治疗肺高血压的组合疗法
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