WO2014074797A8 - Ultra low density pulmonary powders - Google Patents

Ultra low density pulmonary powders Download PDF

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Publication number
WO2014074797A8
WO2014074797A8 PCT/US2013/069107 US2013069107W WO2014074797A8 WO 2014074797 A8 WO2014074797 A8 WO 2014074797A8 US 2013069107 W US2013069107 W US 2013069107W WO 2014074797 A8 WO2014074797 A8 WO 2014074797A8
Authority
WO
WIPO (PCT)
Prior art keywords
low density
ultra low
powders
pulmonary powders
density pulmonary
Prior art date
Application number
PCT/US2013/069107
Other languages
French (fr)
Other versions
WO2014074797A1 (en
Inventor
Michael M. Lipp
Richard P. Batycky
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
Priority claimed from US13/679,245 external-priority patent/US8545878B1/en
Application filed by Civitas Therapeutics, Inc. filed Critical Civitas Therapeutics, Inc.
Priority to BR112015010601-3A priority Critical patent/BR112015010601B1/en
Priority to JP2015541917A priority patent/JP6348501B2/en
Priority to CA2890459A priority patent/CA2890459C/en
Priority to AU2013342248A priority patent/AU2013342248B2/en
Priority to KR1020157015346A priority patent/KR102337781B1/en
Priority to RU2015121091A priority patent/RU2670987C2/en
Priority to SG11201503547TA priority patent/SG11201503547TA/en
Priority to CN201380069936.3A priority patent/CN105120843A/en
Priority to ES13852608T priority patent/ES2880271T3/en
Priority to EP13852608.2A priority patent/EP2916826B1/en
Priority to KR1020217039998A priority patent/KR20210152020A/en
Priority to EP21170515.7A priority patent/EP3957301A1/en
Priority to MX2015005768A priority patent/MX371008B/en
Publication of WO2014074797A1 publication Critical patent/WO2014074797A1/en
Publication of WO2014074797A8 publication Critical patent/WO2014074797A8/en
Priority to US14/707,071 priority patent/US9539211B2/en
Priority to ZA2015/04060A priority patent/ZA201504060B/en
Priority to HK16100777.1A priority patent/HK1212884A1/en
Priority to HK16101182.8A priority patent/HK1213187A1/en
Priority to AU2018222983A priority patent/AU2018222983B2/en

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
    • A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
    • A61J3/074—Filling capsules; Related operations
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • 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
    • 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, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • A61K9/4816—Wall or shell material
    • 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
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/04—Methods of, or means for, filling the material into the containers or receptacles
    • B65B1/16—Methods of, or means for, filling the material into the containers or receptacles by pneumatic means, e.g. by suction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/20—Reducing volume of filled material
    • B65B1/26—Reducing volume of filled material by pneumatic means, e.g. suction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B1/00—Packaging fluent solid material, e.g. powders, granular or loose fibrous material, loose masses of small articles, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
    • B65B1/30—Devices or methods for controlling or determining the quantity or quality or the material fed or filled
    • B65B1/36—Devices or methods for controlling or determining the quantity or quality or the material fed or filled by volumetric devices or methods
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B63/00—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged
    • B65B63/02—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles
    • B65B63/028—Auxiliary devices, not otherwise provided for, for operating on articles or materials to be packaged for compressing or compacting articles or materials prior to wrapping or insertion in containers or receptacles by pneumatic means

Abstract

The invention provides pharmaceutical compositions for pulmonary delivery comprising particles containing a pharmaceutical agent and having a geometric size of greater than about 5 μm and a tap density of less than about 0.075 g/cm3. The invention also provides methods for delivering the pharmaceutical compositions of the invention to the respiratory tract of a patient.
PCT/US2013/069107 2012-11-09 2013-11-06 Ultra low density pulmonary powders WO2014074797A1 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
BR112015010601-3A BR112015010601B1 (en) 2012-11-09 2013-11-06 PHARMACEUTICAL COMPOSITION AND USE OF THE COMPOSITION
MX2015005768A MX371008B (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders.
ES13852608T ES2880271T3 (en) 2012-11-09 2013-11-08 Ultra low density lung powders
KR1020217039998A KR20210152020A (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
AU2013342248A AU2013342248B2 (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
KR1020157015346A KR102337781B1 (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
RU2015121091A RU2670987C2 (en) 2012-11-09 2013-11-08 Ultra low density inhalation powders
SG11201503547TA SG11201503547TA (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
CN201380069936.3A CN105120843A (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
JP2015541917A JP6348501B2 (en) 2012-11-09 2013-11-08 Very low density lung powder
EP13852608.2A EP2916826B1 (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
CA2890459A CA2890459C (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
EP21170515.7A EP3957301A1 (en) 2012-11-09 2013-11-08 Ultra low density pulmonary powders
US14/707,071 US9539211B2 (en) 2012-11-09 2015-05-08 Ultra low density pulmonary powders
ZA2015/04060A ZA201504060B (en) 2012-11-09 2015-06-05 Ultra low density pulmonary powders
HK16100777.1A HK1212884A1 (en) 2012-11-09 2016-01-22 Ultra low density pulmonary powders
HK16101182.8A HK1213187A1 (en) 2012-11-09 2016-02-02 Ultra low density pulmonary powders
AU2018222983A AU2018222983B2 (en) 2012-11-09 2018-08-30 Ultra Low Density Pulmonary Powders

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US201261724781P 2012-11-09 2012-11-09
US61/724,781 2012-11-09
US13/679,245 US8545878B1 (en) 2012-11-09 2012-11-16 Capsules containing high doses of levodopa for pulmonary use
US13/679,245 2012-11-16
US13/945,160 2013-07-18
US13/945,160 US8685442B1 (en) 2012-11-09 2013-07-18 Capsules containing high doses of levodopa for pulmonary use
US201361884436P 2013-09-30 2013-09-30
US201361884319P 2013-09-30 2013-09-30
US201361884315P 2013-09-30 2013-09-30
US61/884,436 2013-09-30
US61/884,315 2013-09-30
US61/884,319 2013-09-30

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/707,071 Continuation US9539211B2 (en) 2012-11-09 2015-05-08 Ultra low density pulmonary powders

Publications (2)

Publication Number Publication Date
WO2014074797A1 WO2014074797A1 (en) 2014-05-15
WO2014074797A8 true WO2014074797A8 (en) 2014-06-26

Family

ID=50685169

Family Applications (3)

Application Number Title Priority Date Filing Date
PCT/US2013/069107 WO2014074797A1 (en) 2012-11-09 2013-11-06 Ultra low density pulmonary powders
PCT/US2013/069102 WO2014074795A1 (en) 2012-11-09 2013-11-08 High dose levodopa capsules for pulmonary use
PCT/US2013/069104 WO2014074796A1 (en) 2012-11-09 2013-11-08 Dosator for filling a capsule with powder

Family Applications After (2)

Application Number Title Priority Date Filing Date
PCT/US2013/069102 WO2014074795A1 (en) 2012-11-09 2013-11-08 High dose levodopa capsules for pulmonary use
PCT/US2013/069104 WO2014074796A1 (en) 2012-11-09 2013-11-08 Dosator for filling a capsule with powder

Country Status (19)

Country Link
US (3) US9539211B2 (en)
EP (5) EP2925611B1 (en)
JP (6) JP6836834B2 (en)
KR (6) KR102257164B1 (en)
CN (4) CN105120843A (en)
AU (6) AU2013342248B2 (en)
BR (2) BR112015010601B1 (en)
CA (3) CA2890454C (en)
DK (1) DK2916821T3 (en)
ES (2) ES2844153T3 (en)
HK (5) HK1212884A1 (en)
MX (3) MX371008B (en)
NZ (4) NZ708684A (en)
PL (1) PL2916821T3 (en)
PT (1) PT2916821T (en)
RU (2) RU2670987C2 (en)
SG (5) SG11201503547TA (en)
WO (3) WO2014074797A1 (en)
ZA (2) ZA201504058B (en)

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BR112015010601B1 (en) 2012-11-09 2022-07-19 Civitas Therapeutics, Inc. PHARMACEUTICAL COMPOSITION AND USE OF THE COMPOSITION
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CN108995838A (en) * 2018-09-10 2018-12-14 江西克莱威纳米碳材料有限公司 A kind of powder tinning system
CN109178367B (en) * 2018-10-15 2021-01-26 楚天科技股份有限公司 Filling head and filling device for powder split charging
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