JP2017534611A - 吸入可能な製剤 - Google Patents
吸入可能な製剤 Download PDFInfo
- Publication number
- JP2017534611A JP2017534611A JP2017519634A JP2017519634A JP2017534611A JP 2017534611 A JP2017534611 A JP 2017534611A JP 2017519634 A JP2017519634 A JP 2017519634A JP 2017519634 A JP2017519634 A JP 2017519634A JP 2017534611 A JP2017534611 A JP 2017534611A
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- JP
- Japan
- Prior art keywords
- propellant
- inhalable
- formulation
- active pharmaceutical
- pharmaceutical ingredient
- 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.)
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- 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
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
- A61K9/124—Aerosols; Foams characterised by the propellant
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
- A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids
Landscapes
- Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Endocrinology (AREA)
- Diabetes (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Abstract
Description
容器に入った、液化噴射剤中の医薬品有効成分の懸濁液を加熱する工程、
前記噴射剤を蒸発させる工程、及び
その結果得られた粉末を集める工程
を含む方法を提供する。
Claims (20)
- 吸入可能な医薬品有効成分を調製する方法であって、
容器に入った、液化噴射剤中の医薬品有効成分の懸濁液を加熱する工程、
前記噴射剤を蒸発させる工程、及び
その結果得られた粉末を集める工程
を含む、方法。 - 前記噴射剤が、ハイドロフルオロアルカン(HFA)噴射剤である、請求項1に記載の方法。
- 前記噴射剤が、HFA134a又はHFA227である、請求項2に記載の方法。
- 前記懸濁液が、前記加熱工程の間撹拌される、請求項1〜3のいずれか1項に記載の方法。
- 前記加熱が、30〜50℃の温度で行われる、請求項1〜4のいずれか1項に記載の方法。
- 前記加熱が、35〜45℃の温度で行われる、請求項5に記載の方法。
- 前記加熱が、38〜42℃の温度で行われる、請求項6に記載の方法。
- 前記加熱が、6時間〜5日間行われる、請求項1〜7のいずれか1項に記載の方法。
- 前記加熱が、24〜84時間行われる、請求項1〜8のいずれか1項に記載の方法。
- 前記加熱が、12〜72時間行われる、請求項1〜8のいずれか1項に記載の方法。
- 前記吸入可能な医薬品有効成分が、吸入グルココルチコステロイド、β2-作動薬、抗コリン薬又はそれらの組み合わせである、請求項1〜10のいずれか1項に記載の方法。
- 前記吸入可能な医薬品有効成分が、1〜5μmの空気動力学的中央粒子径を有する、請求項1〜11のいずれか1項に記載の方法。
- 前記吸入可能な医薬品有効成分が、フルチカゾン(薬学的に許容されるその塩又は溶媒和物を含む)である、請求項12に記載の方法。
- 前記懸濁液が、医薬品有効成分と噴射剤の合計重量に基づいて、1〜30%の医薬品有効成分を含む、請求項1〜13のいずれか1項に記載の方法。
- 前記方法が、前記医薬品有効成分の非晶質含有量を減らすのに効果的である、請求項1〜14のいずれか1項に記載の方法。
- 請求項1〜15のいずれか1項に記載の方法によって得られる、吸入可能な医薬品有効成分。
- 請求項16に記載の吸入可能な医薬品有効成分、及び、一以上の薬学的に許容される賦形剤を含む、吸入可能な医薬製剤。
- 前記製剤が乾燥粉末製剤であり、前記賦形剤が粗い粒子状キャリアである、請求項17に記載の吸入可能な医薬製剤。
- 前記製剤が加圧式定量吸入器用粉末製剤であり、前記賦形剤がHFA噴射剤である、請求項17に記載の吸入可能な医薬製剤。
- 前記製剤で使用されるHFA噴射剤が、前記方法で使用される噴射剤と同一である、請求項19に記載の吸入可能な医薬製剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462064684P | 2014-10-16 | 2014-10-16 | |
US62/064,684 | 2014-10-16 | ||
PCT/US2015/055916 WO2016061445A1 (en) | 2014-10-16 | 2015-10-16 | Inhalable formulation |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2017534611A true JP2017534611A (ja) | 2017-11-24 |
JP6653323B2 JP6653323B2 (ja) | 2020-02-26 |
Family
ID=54361199
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017519634A Expired - Fee Related JP6653323B2 (ja) | 2014-10-16 | 2015-10-16 | 吸入可能な製剤 |
Country Status (15)
Country | Link |
---|---|
US (1) | US10653704B2 (ja) |
EP (1) | EP3206667A1 (ja) |
JP (1) | JP6653323B2 (ja) |
KR (1) | KR20170070151A (ja) |
CN (1) | CN107106515A (ja) |
AR (1) | AR102304A1 (ja) |
AU (1) | AU2015331912A1 (ja) |
BR (1) | BR112017007589A2 (ja) |
CA (1) | CA2963143A1 (ja) |
CO (1) | CO2017004789A2 (ja) |
EA (1) | EA201790832A1 (ja) |
IL (1) | IL251664A0 (ja) |
MX (1) | MX2017004765A (ja) |
PE (1) | PE20170919A1 (ja) |
WO (1) | WO2016061445A1 (ja) |
Family Cites Families (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB8828477D0 (en) | 1988-12-06 | 1989-01-05 | Riker Laboratories Inc | Medical aerosol formulations |
GB9027234D0 (en) | 1990-12-15 | 1991-02-06 | Harris Pharma Ltd | An inhalation device |
ES2079210T3 (es) | 1991-12-12 | 1996-01-01 | Glaxo Group Ltd | Formulacion farmaceutica de aerosol. |
GB9526392D0 (en) | 1995-12-22 | 1996-02-21 | Glaxo Group Ltd | Medicaments |
GB9616237D0 (en) | 1996-08-01 | 1996-09-11 | Norton Healthcare Ltd | Aerosol formulations |
DE10043509A1 (de) | 2000-09-01 | 2002-03-14 | Asta Medica Ag | Feste Peptidzubereitungen für die Inhalation und deren Herstellung |
SE0004750D0 (sv) | 2000-12-19 | 2000-12-19 | Astrazeneca Ab | Novel formulation |
US20050152845A1 (en) * | 2002-02-04 | 2005-07-14 | Keith Biggadike | Amorphous fluticasone 2-furoate, pharmaceutical compositions thereof and its conversion to the crystalline unsolvated form |
CN100589849C (zh) | 2004-02-24 | 2010-02-17 | 微计量技术有限公司 | 基于合成射流的药物输送方法和装置 |
WO2007008427A2 (en) * | 2005-07-08 | 2007-01-18 | Xemplar Pharmaceuticals, Llc | Aerosol compositions and methods |
US8196576B2 (en) | 2007-02-28 | 2012-06-12 | Microdose Therapeutx, Inc. | Inhaler |
GB0919465D0 (en) | 2009-11-06 | 2009-12-23 | Norton Healthcare Ltd | Airflow adaptor for a breath-actuated dry powder inhaler |
US9393202B2 (en) | 2013-04-26 | 2016-07-19 | Chiesi Farmaceutici S.P.A | Particle size reduction of an antimuscarinic compound |
AR102305A1 (es) * | 2014-10-16 | 2017-02-15 | Teva Branded Pharmaceutical Products R&D Inc | Procedimiento para preparar formulación farmacéutica inhalable de polvo seco |
-
2015
- 2015-10-16 US US15/519,460 patent/US10653704B2/en not_active Expired - Fee Related
- 2015-10-16 BR BR112017007589A patent/BR112017007589A2/pt not_active Application Discontinuation
- 2015-10-16 CA CA2963143A patent/CA2963143A1/en not_active Abandoned
- 2015-10-16 CN CN201580055461.1A patent/CN107106515A/zh active Pending
- 2015-10-16 AR ARP150103365A patent/AR102304A1/es unknown
- 2015-10-16 AU AU2015331912A patent/AU2015331912A1/en not_active Abandoned
- 2015-10-16 PE PE2017000540A patent/PE20170919A1/es not_active Application Discontinuation
- 2015-10-16 JP JP2017519634A patent/JP6653323B2/ja not_active Expired - Fee Related
- 2015-10-16 MX MX2017004765A patent/MX2017004765A/es unknown
- 2015-10-16 KR KR1020177012881A patent/KR20170070151A/ko unknown
- 2015-10-16 EP EP15787397.7A patent/EP3206667A1/en not_active Withdrawn
- 2015-10-16 EA EA201790832A patent/EA201790832A1/ru unknown
- 2015-10-16 WO PCT/US2015/055916 patent/WO2016061445A1/en active Application Filing
-
2017
- 2017-04-09 IL IL251664A patent/IL251664A0/en unknown
- 2017-05-12 CO CONC2017/0004789A patent/CO2017004789A2/es unknown
Also Published As
Publication number | Publication date |
---|---|
CN107106515A (zh) | 2017-08-29 |
EA201790832A1 (ru) | 2017-09-29 |
US10653704B2 (en) | 2020-05-19 |
CA2963143A1 (en) | 2016-04-21 |
CO2017004789A2 (es) | 2017-09-20 |
WO2016061445A1 (en) | 2016-04-21 |
MX2017004765A (es) | 2017-07-27 |
US20170239269A1 (en) | 2017-08-24 |
BR112017007589A2 (pt) | 2018-01-30 |
IL251664A0 (en) | 2017-06-29 |
AR102304A1 (es) | 2017-02-15 |
AU2015331912A1 (en) | 2017-05-25 |
KR20170070151A (ko) | 2017-06-21 |
PE20170919A1 (es) | 2017-07-12 |
JP6653323B2 (ja) | 2020-02-26 |
EP3206667A1 (en) | 2017-08-23 |
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