SG11201903261VA - Oral composite tablet comprising ezetimibe and rosuvastatin - Google Patents

Oral composite tablet comprising ezetimibe and rosuvastatin

Info

Publication number
SG11201903261VA
SG11201903261VA SG11201903261VA SG11201903261VA SG11201903261VA SG 11201903261V A SG11201903261V A SG 11201903261VA SG 11201903261V A SG11201903261V A SG 11201903261VA SG 11201903261V A SG11201903261V A SG 11201903261VA SG 11201903261V A SG11201903261V A SG 11201903261VA
Authority
SG
Singapore
Prior art keywords
gyeonggi
international
rosuvastatin
ezetimibe
suwon
Prior art date
Application number
SG11201903261VA
Inventor
Han Byul Song
Jung Hyun Cho
Jin Cheul Kim
Youg Il Kim
Jae Hyun Park
Jong Soo Woo
Original Assignee
Hanmi Pharmaceutical 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 Pharmaceutical Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Publication of SG11201903261VA publication Critical patent/SG11201903261VA/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property 111111111111111111111010111 01111101011101011111011111111111110111111111111111111111 Organization International Bureau (10) International Publication Number (43) International Publication Date ......0\"\" WO 2018/101681 Al 07 June 2018 (07.06.2018) W I P0 I P C T (51) International Patent Classification: UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, A61K 9/20 (2006.01) A61K 31/505 (2006.01) TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, A61K 31/397 (2006.01) EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, (21) International Application Number: MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, PCT/KR2017/013508 TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (22) International Filing Date: 24 November 2017 (24.11.2017) Published: — (25) Filing Language: English with international search report (Art. 21(3)) (26) Publication Language: English (30) Priority Data: 10-2016-0160513 29 November 2016 (29.11.2016) KR (71) Applicant: HANMI PHARM. CO ., LTD. [KR/KR]; 214, Muha-ro, Paltan-myeon, Hwaseong-si, Gyeonggi-do 18536 (KR). _ (72) Inventors: SONG, Han Byul; 101-1204, 95, Deogyeong-daero 407beon-gil, Jangan-gu, Suwon-si, Gyeonggi-do 16356 (KR). CHO, Jung Hyun; 119-1004, _ 382-37, Dongtanwoncheon-ro, Hwaseong-si, Gyeonggi-do 18396 (KR). KIM, Jin Cheul; 506-401, 16, Dangsan-ro 42- gil, Yeongdeungpo-gu, Seoul 07216 (KR). KIM, Youg Il; = 732-504, 52, Jeongja-ro 42beon-gil, Jangan-gu, Suwon-si, = _ Gyeonggi-do 16325 (KR). PARK, Jae Hyun; 311-404, = 460, Yeongtong-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do 16707 (KR). WOO, Jong Soo; 120-2303, 85, Hwasan-ro, Jangan-gu, Suwon-si, Gyeonggi-do 16420 (KR). = Agent: Y.P.LEE, MOCK & PARTNERS; 12F Daelim (74) _ Acrotel, 13 Eonju-ro 30-gil, Gangnam-gu, Seoul 06292 — (KR). = Designated States (unless otherwise indicated, for every (81) 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, DJ, DK, DM, DO, = DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KW, KZ, LA, LC, LK, LR, LS, 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, SA, 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. = Designated States (unless otherwise indicated, for every (84) kind of regional protection available): ARIPO (BW, GH, = 1-1 GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, Il QC (54) Title: ORAL COMPOSITE TABLET COMPRISING EZETIMIBE AND ROSUVASTATIN SO 1-1 (57) : An oral composite tablet and a method of preparing the same are provided. The oral composite tablet includes: an 1-1 © ezetimibe wet granule portion including ezetimibe; and a rosuvastatin mixture portion including rosuvastatin or a pharmaceutically ---- acceptable salt thereof, wherein the ezetimibe wet granule portion includes, as a binder, povidone having a weight average molecular GC weight of about 30,000 to about 50,000, and the rosuvastatin mixture portion includes a diluents including a water-soluble diluent and 1-1 © a water-insoluble diluent, the water-insoluble diluent having a particle size (d90) of about 98 i.tm to about 229 i.tm corresponding to f'1 90% in a cumulative particles size distribution of total particles. C
SG11201903261VA 2016-11-29 2017-11-24 Oral composite tablet comprising ezetimibe and rosuvastatin SG11201903261VA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020160160513A KR102206535B1 (en) 2016-11-29 2016-11-29 Oral composite tablet comprising ezetimibe and rosuvastatin
PCT/KR2017/013508 WO2018101681A1 (en) 2016-11-29 2017-11-24 Oral composite tablet comprising ezetimibe and rosuvastatin

Publications (1)

Publication Number Publication Date
SG11201903261VA true SG11201903261VA (en) 2019-05-30

Family

ID=62241643

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201903261VA SG11201903261VA (en) 2016-11-29 2017-11-24 Oral composite tablet comprising ezetimibe and rosuvastatin

Country Status (8)

Country Link
KR (1) KR102206535B1 (en)
BR (1) BR112019010706A2 (en)
CL (1) CL2019001424A1 (en)
EC (1) ECSP19037610A (en)
MX (1) MX2019006148A (en)
MY (1) MY197281A (en)
SG (1) SG11201903261VA (en)
WO (1) WO2018101681A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112022001783A2 (en) 2019-07-31 2022-03-22 Tecnimede Soc Tecnico Medicinal Sa Immediate release multi-unit solid oral compositions, their methods and uses.

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009024889A2 (en) 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
WO2013166117A1 (en) 2012-05-01 2013-11-07 Althera Life Sciences, Llc Oral tablet formulation consisting of fixed combination of rosuvastatin and ezetimibe for treatment of hyperlipidemia and cardiovascular diseases
KR20150079373A (en) * 2013-12-30 2015-07-08 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin
KR101977785B1 (en) * 2014-06-25 2019-05-14 한미약품 주식회사 Composite formulation for oral administration comprising ezetimibe and rosuvastatin and a process for the preparation thereof
KR101834559B1 (en) * 2015-02-27 2018-03-06 한미약품 주식회사 Solid composite formulation for oral administration comprising ezetimibe and rosuvastatin

Also Published As

Publication number Publication date
KR20180060705A (en) 2018-06-07
ECSP19037610A (en) 2019-06-30
WO2018101681A1 (en) 2018-06-07
BR112019010706A2 (en) 2019-10-01
CL2019001424A1 (en) 2019-10-04
MX2019006148A (en) 2019-08-14
KR102206535B1 (en) 2021-01-22
MY197281A (en) 2023-06-09

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