WO2001013891A2 - Modulation of release from dry powder formulations - Google Patents
Modulation of release from dry powder formulations Download PDFInfo
- 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
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)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Otolaryngology (AREA)
- Emergency Medicine (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)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU69259/00A AU763041B2 (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 |
EP00957674A EP1210067A2 (en) | 1999-08-25 | 2000-08-23 | Modulation of release from dry powder formulations |
JP2001518029A JP2003507410A (en) | 1999-08-25 | 2000-08-23 | Controlled 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 WO2001013891A2 (en) | 1999-08-25 | 2000-08-23 | Modulation of release from dry powder formulations |
Country Status (6)
Country | Link |
---|---|
US (1) | US20040018243A1 (en) |
EP (1) | EP1210067A2 (en) |
JP (1) | JP2003507410A (en) |
AU (1) | AU763041B2 (en) |
CA (1) | CA2382821A1 (en) |
WO (1) | WO2001013891A2 (en) |
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WO2002067902A2 (en) * | 2001-02-23 | 2002-09-06 | Advanced Inhalation Research, Inc. | Modulation of release from dry powder formulations |
WO2002094283A2 (en) * | 2001-05-21 | 2002-11-28 | Britannia Pharmaceuticals Limited | Use of phospholipids in the treatment of degenerative lung disease such as copd or cystic fibrosis and to enhance delivery of drugs |
WO2003015756A1 (en) * | 2001-08-17 | 2003-02-27 | Upperton Limited | Preparation of microparticles |
WO2003077891A1 (en) * | 2002-03-18 | 2003-09-25 | Yamanouchi Pharmaceutical Co., Ltd. | Powdery medicinal compositions for inhalation and process for producing the same |
WO2003079885A2 (en) | 2002-03-20 | 2003-10-02 | Advanced Inhalation Research, Inc. | Inhalable sustained therapeutic formulations |
WO2004054556A1 (en) * | 2002-12-13 | 2004-07-01 | Adagit | Pharmaceutical porous particles |
JP2005511629A (en) * | 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 | Long-acting product delivery composition |
JP2005514393A (en) * | 2001-12-19 | 2005-05-19 | ネクター セラピューティクス | Supplying aminoglycosides to the lung |
WO2006124446A2 (en) * | 2005-05-12 | 2006-11-23 | Nektar Therapeutics | Sustained release microparticles for pulmonary delivery |
US7141236B2 (en) | 2000-07-28 | 2006-11-28 | Nektar Therapeutics | Methods and compositions for delivering macromolecules to or via the respiratory tract |
CN100365039C (en) * | 2003-01-31 | 2008-01-30 | 日本瑞翁株式会社 | Polymerizable composition, thermoplastic resin composition, crosslinked resin, and crosslinked resin composite materials |
EP1952805A1 (en) | 2007-01-23 | 2008-08-06 | KTB-Tumorforschungs GmbH | Tablet containing hydrogenated phospholipids |
WO2009015037A2 (en) | 2007-07-21 | 2009-01-29 | Albany Molecular Research, Inc. | 5-pyridinone substituted indazoles |
EP2088154A1 (en) | 2004-03-09 | 2009-08-12 | Ironwood Pharmaceuticals, Inc. | Methods and compositions for the treatment of gastrointestinal disorders |
WO2010059836A1 (en) | 2008-11-20 | 2010-05-27 | Decode Genetics Ehf | Substituted aza-bridged bicyclics for cardiovascular and cns disease |
WO2010084499A2 (en) | 2009-01-26 | 2010-07-29 | Israel Institute For Biological Research | Bicyclic heterocyclic spiro compounds |
EP2476680A1 (en) | 2008-01-11 | 2012-07-18 | Albany Molecular Research, Inc. | (1-Azinone)-Substituted Pyridoindoles |
EP2628727A2 (en) | 2007-11-21 | 2013-08-21 | Decode Genetics EHF | Biaryl PDE4 inhibitors for treating pulmonary and cardiovascular disorders |
US8664187B2 (en) | 2004-06-18 | 2014-03-04 | Novartis Ag | Methods of treatment of endobronchial infections |
US8668934B2 (en) | 2003-05-28 | 2014-03-11 | Novartis Ag | Pharmaceutical formulation comprising a water-insoluble active agent |
US9138407B2 (en) | 2005-10-21 | 2015-09-22 | Eratech S.R.L. | Inhalatory pharmaceutical compositions in form of dry powders, solutions or suspensions obtained from the same and process for their preparation |
CN107096014A (en) * | 2010-09-29 | 2017-08-29 | 普马特里克斯营业公司 | Monovalent metal cation dry powder doses are used in suction |
WO2017223502A1 (en) * | 2016-06-24 | 2017-12-28 | Civitas Therapeutics, Inc. | Surfactant formulations for inhalation |
WO2019183245A1 (en) | 2018-03-20 | 2019-09-26 | Icahn School Of Medicine At Mount Sinai | Kinase inhibitor compounds and compositions and methods of use |
WO2020142485A1 (en) | 2018-12-31 | 2020-07-09 | Icahn School Of Medicine At Mount Sinai | Kinase inhibitor compounds and compositions and methods of use |
US10806770B2 (en) | 2014-10-31 | 2020-10-20 | Monash University | Powder formulation |
US10966943B2 (en) | 2018-09-06 | 2021-04-06 | Innopharmascreen Inc. | Methods and compositions for treatment of asthma or parkinson's disease |
EP3727418A4 (en) * | 2017-12-21 | 2021-10-27 | Civitas Therapeutics, Inc. | Surfactant formulations for inhalation |
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US20060165606A1 (en) | 1997-09-29 | 2006-07-27 | Nektar Therapeutics | Pulmonary delivery particles comprising water insoluble or crystalline active agents |
US6749835B1 (en) | 1999-08-25 | 2004-06-15 | Advanced Inhalation Research, Inc. | Formulation for spray-drying large porous particles |
US7678364B2 (en) | 1999-08-25 | 2010-03-16 | Alkermes, Inc. | Particles for inhalation having sustained release properties |
US7871598B1 (en) | 2000-05-10 | 2011-01-18 | Novartis Ag | Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use |
US7132100B2 (en) | 2002-06-14 | 2006-11-07 | Medimmune, Inc. | Stabilized liquid anti-RSV antibody formulations |
US7425618B2 (en) * | 2002-06-14 | 2008-09-16 | Medimmune, Inc. | Stabilized anti-respiratory syncytial virus (RSV) antibody formulations |
DE102007019186B4 (en) * | 2007-04-20 | 2011-11-17 | Qiagen Instruments Ag | Pipetting device and method for operating the pipetting device |
WO2013130767A1 (en) | 2012-02-29 | 2013-09-06 | Pulmatrix, Inc. | Inhalable dry powders |
US9815815B2 (en) | 2013-01-10 | 2017-11-14 | Pulmokine, Inc. | Non-selective kinase inhibitors |
JP6483714B2 (en) * | 2013-10-11 | 2019-03-13 | ローレンス エス. ジスマン, | Spray-dried formulation |
EP3102216A4 (en) * | 2014-02-03 | 2017-08-09 | The Board of Trustees of The Leland Stanford Junior University | Formulations for microparticle delivery of zinc protoporphyrins |
MX2019004855A (en) | 2016-10-27 | 2019-09-19 | Pulmokine Inc | Combination therapy for treating pulmonary hypertension. |
JP7335263B2 (en) | 2017-12-21 | 2023-08-29 | キウィタス セラピューティクス,インコーポレイテッド | Surfactant formulations for inhalation |
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Also Published As
Publication number | Publication date |
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CA2382821A1 (en) | 2001-03-01 |
AU6925900A (en) | 2001-03-19 |
EP1210067A2 (en) | 2002-06-05 |
JP2003507410A (en) | 2003-02-25 |
AU763041B2 (en) | 2003-07-10 |
WO2001013891A3 (en) | 2001-07-26 |
US20040018243A1 (en) | 2004-01-29 |
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