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Injectable liquid composition or injectable drypowder containing revaprazan or its salt

A liquid composition and composition technology, applied in the fields of injectable liquid composition and injectable dry powder, can solve the problems of low absorption rate and achieve excellent stability

Active Publication Date: 2013-07-31
YUHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, when revaprazan is taken orally, its absorption rate is also relatively low

Method used

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  • Injectable liquid composition or injectable drypowder containing revaprazan or its salt
  • Injectable liquid composition or injectable drypowder containing revaprazan or its salt
  • Injectable liquid composition or injectable drypowder containing revaprazan or its salt

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-9

[0029] Embodiment 1-9 injection and dry powder for injection

[0030] The inclusion complex of revaprazan hydrochloride and 2-hydroxypropyl-β-cyclodextrin was prepared according to the ingredients and contents shown in Table 1. Revaprazan hydrochloride was added to each ethanol solution of 2-hydroxypropyl-β-cyclodextrin. The resulting mixture was then stirred until complete dissolution. Ethanol was used to obtain a solution with a concentration of 10 w / v% of the obtained components (ie revaprazan + 2-hydroxypropyl-β-cyclodextrin). The resulting solutions were dried at 35° C. under reduced pressure to obtain white powders, respectively.

[0031] Table 1

[0032] Example

[0033] 7

[0034] Water for injection was added to the inclusion complex to obtain a solution, which was subjected to sterile filtration (Pall Co., Acro50 breather filter with Emflon II membrane, pore size: 0.22 μm) to obtain Valrazan hydrochloride (60mg / 3mL) injection. Likewise, the r...

Embodiment 10-18

[0035] Embodiment 10-18 injection and dry powder for injection

[0036]An inclusion complex of revaprazan hydrochloride and 2-hydroxypropyl-β-cyclodextrin was prepared in the same manner as in Examples 1-9. Add water for injection to the inclusion complex, and then add 180 mg of Solutol to it TM HS15 (ie 6v / v%). The resulting solution was subjected to sterile filtration (Pall Corporation, USA, Acro50 breather filter with Emflon II membrane, pore size: 0.22 μm) to obtain an injection containing revaprazan hydrochloride (60 mg / 3 mL). Likewise, the resulting solutions were freeze-dried to obtain dry powders for injection, respectively.

Embodiment 19-24

[0037] Example 19-24 injection and dry powder for injection

[0038] According to the ingredients and contents shown in Table 2, the inclusion complex of revaprazan hydrochloride and 2-hydroxypropyl-β-cyclodextrin was prepared in the same manner as in Examples 1-9. Water for injection is added to the inclusion complex, and then Solutol is added thereto according to the concentration shown in Table 2 TM HS15. The resulting solution was subjected to sterile filtration (Pall Corporation, USA, Acro50 breather filter with Emflon II membrane, pore size: 0.22 μm) to obtain an injection containing revaprazan hydrochloride (60 mg / 3 mL). Likewise, the resulting solutions were freeze-dried to obtain dry powders for injection, respectively.

[0039] Table 2

[0040]

[0041]

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Abstract

The present invention provides a liquid composition for injection comprising an inclusion complex of revaprazan or its salt and sulfobutylether-beta-cyclodextrin or 2-hydroxypropyl-beta-cyclodextrin in an aqueous medium; and a dry powder for injection obtained by drying the liquid composition for injection.

Description

technical field [0001] The present invention relates to an injectable liquid composition or injectable dry powder comprising revaprazan or a salt thereof. Specifically, the present invention relates to a liquid composition for injection, wherein revaprazan or a salt thereof is dissolved in an aqueous medium by forming an inclusion complex with a certain β-cyclodextrin derivative; and a A dry powder for injection obtained by drying the liquid composition. Background technique [0002] The chemical name is 5,6-dimethyl-2-(4-fluorophenylamino)-4-(1-methyl-1,2,3,4-tetrahydroisoquinolin-2-yl)pyrimidine Revaprazan is shown in Formula 1 below. Revaprazan can be used in the form of acid addition salts including, for example, HCl salts (see International Publication No. WO1996 / 05177). [0003] Formula 1 [0004] [0005] Revaprazan or its salts reversibly bind to the H of the proton pump present in parietal cells + / K + exchange site (H + / K + ATPase) to bind competitivel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/506A61K47/48A61K9/16A61K9/08
CPCC08B37/0015A61K31/506A61K9/19A61K47/34A61K47/22C08L5/16A61K47/26B82Y5/00A61K47/44A61K47/48969A61K47/14A61K47/10A61K9/0019A61K47/6951
Inventor 梁俊模朴成培姜正基朴明用
Owner YUHAN
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