SG11201408292YA - Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing same - Google Patents

Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing same

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Publication number
SG11201408292YA
SG11201408292YA SG11201408292YA SG11201408292YA SG11201408292YA SG 11201408292Y A SG11201408292Y A SG 11201408292YA SG 11201408292Y A SG11201408292Y A SG 11201408292YA SG 11201408292Y A SG11201408292Y A SG 11201408292YA SG 11201408292Y A SG11201408292Y A SG 11201408292YA
Authority
SG
Singapore
Prior art keywords
international
gyeonggi
inhalation formulation
dry powder
suwon
Prior art date
Application number
SG11201408292YA
Inventor
Kyeong Soo Kim
Deokkyu Lee
Dong Ho Kim
Yong Il Kim
Jae Hyun Park
Jong Soo Woo
Original Assignee
Hanmi Pharm Ind Co Ltd
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 Hanmi Pharm Ind Co Ltd filed Critical Hanmi Pharm Ind Co Ltd
Publication of SG11201408292YA publication Critical patent/SG11201408292YA/en

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Classifications

    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61K31/136—Amines having aromatic rings, e.g. ketamine, nortriptyline having the amino group directly attached to the aromatic ring, e.g. benzeneamine
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/166—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the carbon of a carboxamide group directly attached to the aromatic ring, e.g. procainamide, procarbazine, metoclopramide, labetalol
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/14—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
    • 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
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 19 December 2013 (19.12.2013) WIPOIPCT (10) International Publication Number WO 2013/187626 A1 (51) International Patent Classification: A61K 9/14 (2006.01) A61K31/56 (2006.01) A61K9/16 (2006.01) A61K31/166 (2006.01) (21) International Application Number: (22) International Filing Date: (25) Filing Language: (26) Publication Language: PCT/KR2013/004880 3 June 2013 (03.06.2013) English English (30) Priority Data: 10-2012-0063665 14 June 2012 (14.06.2012) KR (71) Applicant: HANMI PHARM. CO., LTD. [KR/KR]; #893-5, Hajeo-ri, Paltan-myeon, Hwaseong-si, Gyeong- gi-do 445-910 (KR). (72) Inventors: KIM, Kyeong Soo; 113-1902, 85, Hwasan-ro, Jangan-gu, Suwon-si, Gyeonggi-do 440-710 (KR). LEE, Deokkyu; 1222-402, 50, Mokdongdong-ro, Yangcheon- gu, Seoul 158-772 (KR). KIM, Dong Ho; 809-ho, 12, Seongnam-daero 172beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 463-853 (KR). KIM, Yong II; 147-2201, 57, Hwasan-ro, Paldal-gu, Suwon-si, Gyeonggi-do 442-872 (KR). PARK, Jae Hyun; 311-404, 460, Yeongtong-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 443-737 (KR). WOO, Jong Soo; 120-2303, 85, Hwasan-ro, Jangan-gu, Suwon-si, Gyeonggi-do 440-330 (KR). (74) Agent: FIRSTLAW P.C.; Trust Tower, 275-5, Yang- jae-Dong, Seocho-Ku, Seoul 137-739 (KR). (81) Designated States (unless otherwise indicated, for every kind of national protection available)'. AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KN, KP, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available)'. ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) (54) Title: DRY POWDER FOR INHALATION FORMULATION COMPRISING SALMETEROL XINAFOATE, FLUTIC­ ASONE PROPIONATE AND TIOTROPIUM BROMIDE, AND METHOD FOR PREPARING SAME Aerodynamic size distribution salmeterol of CJ i> 00 i-H en i-H o CJ o & O) m o & C0 M— o E 3 CO El Example 1 Example 1 (Handyhaler®) • 10 Urnim • 30 L/mim Z2 60 L/mim Ofl 90 L/mim Example 5 Comp. Ex. 2 Comp. Ex. 3 (57) Abstract: Provided is a dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tio - tropium bromide, as pharmaceutically active ingredients, and a carrier, and an inhalation formulation comprising same. The invent - ive dry powder inhalation formulation having good content uniformity and showing small changes in the aerodynamic size distribu - tion in accordance with the flow rate changes can effectively deliver said pharmaceutically active ingredients to a target site upon ad - ministration, and thus can be useful in the prevention or treatment of respiratory diseases, particularly asthma and COPD.
SG11201408292YA 2012-06-14 2013-06-03 Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing same SG11201408292YA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020120063665A KR20130140358A (en) 2012-06-14 2012-06-14 Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing the same
PCT/KR2013/004880 WO2013187626A1 (en) 2012-06-14 2013-06-03 Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing same

Publications (1)

Publication Number Publication Date
SG11201408292YA true SG11201408292YA (en) 2015-01-29

Family

ID=49758405

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201408292YA SG11201408292YA (en) 2012-06-14 2013-06-03 Dry powder for inhalation formulation comprising salmeterol xinafoate, fluticasone propionate and tiotropium bromide, and method for preparing same

Country Status (19)

Country Link
US (2) US9283232B2 (en)
EP (1) EP2861219A4 (en)
JP (1) JP2015519394A (en)
KR (1) KR20130140358A (en)
CN (1) CN104363895A (en)
AU (1) AU2013275113A1 (en)
BR (1) BR112014030910A2 (en)
CA (1) CA2876283A1 (en)
HK (1) HK1206602A1 (en)
IL (1) IL236198A0 (en)
IN (1) IN2014DN11257A (en)
MX (1) MX2014014755A (en)
NZ (1) NZ703788A (en)
PH (1) PH12014502746A1 (en)
RU (1) RU2015100905A (en)
SG (1) SG11201408292YA (en)
TW (1) TWI565481B (en)
WO (1) WO2013187626A1 (en)
ZA (1) ZA201500208B (en)

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BR112016030972B1 (en) 2014-06-30 2020-12-15 Proveris Scientific Corporation SAMPLING APPLIANCE FOR DETERMINING THE QUANTITY AND UNIFORMITY OF A DOSE OF MEDICINAL PRODUCT PROVIDED AND RELATED METHODS
KR20160038767A (en) * 2014-09-30 2016-04-07 한미약품 주식회사 Dry powder for inhalation formulation with improved stability of combined active ingredients
MA41378A (en) * 2015-01-20 2017-11-28 Teva Branded Pharmaceutical Prod R & D Inc DRY POWDER INHALER CONSISTING OF FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE
KR20160117069A (en) 2015-03-31 2016-10-10 한미약품 주식회사 Capsule for inhalation with improved stability of combined active ingredients
WO2016178704A1 (en) * 2015-05-01 2016-11-10 Board Of Regents, The University Of Texas System Multidrug brittle matrix compositions
EP3426329A4 (en) * 2016-03-09 2019-11-13 Proveris Scientific Corporation Methods for measuring dose content uniformity performance of inhaler and nasal devices
CN108066329B (en) * 2016-11-11 2021-11-16 江苏恒瑞医药股份有限公司 Preparation method of microparticles of fluticasone or derivatives thereof for inhalation
KR102330428B1 (en) * 2019-10-14 2021-11-24 한미약품 주식회사 Dry powder for inhalation formulation and preparation method thereof
AU2021296221A1 (en) * 2020-06-26 2023-02-02 Mylan Pharma Uk Limited Formulations including 5-(3-(3-hydroxyphenoxy)azetidin-1-yl)-5-methyl-2,2-diphenylhexanamide
CN115266987B (en) * 2022-07-31 2023-06-30 浙江知一药业有限责任公司 Pharmaceutical composition for treating respiratory diseases

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GB0003935D0 (en) * 2000-02-08 2000-04-12 King S College London Formulation for dry powder inhaler
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GB0312148D0 (en) 2003-05-28 2003-07-02 Aventis Pharma Ltd Stabilized pharmaceutical products
SE527190C2 (en) * 2003-06-19 2006-01-17 Microdrug Ag Administration of metered dry powder combined doses of finely divided dry medication powders involves selecting first and second medicaments for forming of pharmaceutical, combined doses
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EP2124915A2 (en) * 2007-02-19 2009-12-02 Cipla Limited Pharmaceutical combinations of at least two bronchodilators or of a bronchodilator with a corticosteroid
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Also Published As

Publication number Publication date
WO2013187626A1 (en) 2013-12-19
CA2876283A1 (en) 2013-12-19
PH12014502746B1 (en) 2015-02-02
TWI565481B (en) 2017-01-11
US9549936B2 (en) 2017-01-24
RU2015100905A (en) 2016-08-10
TW201402154A (en) 2014-01-16
BR112014030910A2 (en) 2017-06-27
AU2013275113A1 (en) 2015-02-05
US20150283151A1 (en) 2015-10-08
HK1206602A1 (en) 2016-01-15
US9283232B2 (en) 2016-03-15
IN2014DN11257A (en) 2015-10-09
ZA201500208B (en) 2016-10-26
PH12014502746A1 (en) 2015-02-02
EP2861219A4 (en) 2015-10-28
NZ703788A (en) 2016-10-28
KR20130140358A (en) 2013-12-24
JP2015519394A (en) 2015-07-09
IL236198A0 (en) 2015-01-29
US20150157566A1 (en) 2015-06-11
CN104363895A (en) 2015-02-18
MX2014014755A (en) 2015-02-24
EP2861219A1 (en) 2015-04-22

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