Title:
SINGLE-LAYER-TABLET COMBINED PREPARATION CONTAINING TELMISARTAN
Document Type and Number:
WIPO Patent Application WO/2018/030559
Kind Code:
A1
Abstract:
The present invention relates to a combined preparation containing telmisartan, capable of being prepared into a single-layer tablet and, more specifically, to an antihypertensive combined preparation containing, as active ingredients: telmisartan; and amlodipine as a calcium channel blocker or other antihypertensive drugs of hydrochlorothiazide as a diuretic, wherein telmisartan forms a granule with a binder, a disintegrating agent, a lubricant, and an excipient, which comprises an aluminum magnesium silicate compound and anhydrous dibasic calcium phosphate, telmisartan is contained in a weight ratio, in which telmisartan : the aluminum magnesium silicate compound = 1 : 0.2-0.5, and telmisartan and the other antihypertensive drugs are contained together in the same layer. The telmisartan combined preparation of the present invention: even if prepared into a single-layer tablet, has no difficulty in the elution of each ingredient; particularly, guarantees safety and efficacy by exhibiting elution equivalence and bioequivalence of telmisartan and Twynsta tabletTM or Micardis plus tabletTM, which is an original medicine guaranteeing safety and efficacy; is also very stable by not generating impurities; has an advantage of allowing various packing methods such as a PE bottle and a PTP package in the packing of a tablet by being highly stable in the presence of moisture; and, further, has effects of reducing preparation costs and time by being simply preparable into a single layer through a direct compression method.
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Inventors:
PARK SUCK YONG (KR)
JI HYUN KU (KR)
CHOI JU HWAN (KR)
CHOI SUNG UP (KR)
CHO SEONG WAN (KR)
KIM IN SU (KR)
HWANG SUNG JOO (KR)
JI HYUN KU (KR)
CHOI JU HWAN (KR)
CHOI SUNG UP (KR)
CHO SEONG WAN (KR)
KIM IN SU (KR)
HWANG SUNG JOO (KR)
Application Number:
PCT/KR2016/008842
Publication Date:
February 15, 2018
Filing Date:
August 11, 2016
Export Citation:
Assignee:
INTRO PHARM &TECH (KR)
International Classes:
A61K9/20; A61K31/4184; A61K31/4422; A61K31/549
Foreign References:
| KR20130056818A | 2013-05-30 | |||
| KR20080016801A | 2008-02-22 | |||
| KR101302883B1 | 2013-09-05 | |||
| KR20070085801A | 2007-08-27 | |||
| KR100851770B1 | 2008-08-13 |
Attorney, Agent or Firm:
KOH, Bong Jin (KR)
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