Medicinal composition containing benidipine hydrochloride

A technology of benidipine hydrochloride and its composition, which is applied in the field of pharmaceutical compositions containing benidipine hydrochloride, and can solve the problems of low solubility and the like

Inactive Publication Date: 2006-06-28
KYOWA HAKKO KOGYO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Also have, because the solubility of benidipine hydrochloride in aqueous solvent is very low, therefore under the situation of oral administration, be necessary to try to make medicine dissolve rapidly from pharmaceutical composition in digestive tract fluid

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] (crushing of benidipine hydrochloride original drug)

[0066] 5000g of benidipine hydrochloride original drug (Lot P-010, manufactured by Kyowa Hakko, volume average particle diameter 65.0 μm, number average particle diameter 10.3 μm) in a pulverizer sample pulverizer (KIIWG-1F type, manufactured by Fuji Power) Perform 1 pulverization process. The obtained pulverized benidipine hydrochloride crystals were further pulverized once in a jet mill (PJM-100SP, manufactured by Nippon Niyu-Maachik Kogyo Co., Ltd.) to obtain pulverized benidipine hydrochloride crystals. The average particle size of the pulverized benidipine hydrochloride crystals was determined by image analysis (Olympus SP-500 type) under a microscope by wet method of suspension in mobile paraffin. As a result, the pulverized benidipine hydrochloride crystals had a volume average particle diameter of 9.4 μm and a number average particle diameter of 4.9 μm.

[0067] (tablets are made using crushed benidipine c...

Embodiment 2

[0079] (crushing of benidipine hydrochloride original drug)

[0080] 5000g of benidipine hydrochloride (Lot P-010, manufactured by Kyowa Hakko, volume average particle diameter 65.0 μm, number average particle diameter 10.3 μm) was crushed with a pulverizer sample pulverizer (KIIWG-1F type, manufactured by Fuji Power) One pulverization treatment to obtain pulverized benidipine hydrochloride crystals. The average particle size of the pulverized benidipine hydrochloride crystals was determined by image analysis (Olympus SP-500 type) under a microscope by wet method of suspension in flowing paraffin. As a result, pulverized benidipine hydrochloride crystals had a volume average particle diameter of 14.5 μm and a number average particle diameter of 6.2 μm.

[0081] (Use crushed benidipine hydrochloride crystals to make tablets)

[0082] Tablets were obtained by using the pulverized benidipine hydrochloride crystals according to the following prescription and production method. ...

Embodiment 3

[0093] (Sieving of Benidipine Hydrochloride Original Medicine)

[0094] 5000g of benidipine hydrochloride (Lot P-010, manufactured by Kyowa Fermentation, volume average particle diameter 65.0 μm, number average particle diameter 10.3 μm) is processed with vibrating sieving machine [100mesh (150 μm) sieve], obtains Sieve the crystallization of benidipine hydrochloride. The average particle size of the sieved benidipine hydrochloride crystals was determined by the wet method of image analysis under a microscope (Olympus SP-500 type) by the flow paraffin suspension. As a result, the sieved benidipine hydrochloride crystals had a volume average particle diameter of 26.3 μm and a number average particle diameter of 6.6 μm.

[0095] (Use sieved benidipine crystals to make tablets)

[0096] Use the above-mentioned benidipine crystals after sieving to obtain tablets according to the following prescription and manufacturing method.

[0097] (tablet prescription)

[0098] Benidipine...

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Abstract

The object of the present invention is to provide a pharmaceutical composition of benidipine hydrochloride having a rapid precipitation property for promoting the rapid absorption of benidipine hydrochloride as the main component, which is characterized in that it contains a volume average particle diameter of 1.0 to 50.0 μm. Benidipine hydrochloride crystals or powders with a volume average particle diameter of 1.0-50.0 μm, wherein the powders contain benidipine hydrochloride crystals and water-soluble or hydrophilic functional additives.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing benidipine hydrochloride (Benidipine Hydrochloride), which contains benidipine hydrochloride which is used to promote the rapid absorption of benidipine hydrochloride as the main component of the drug and has rapid dissolution properties. Background technique [0002] Benidipine hydrochloride belongs to dihydropyridine calcium antagonists, because it is safe and effective as a therapeutic drug for hypertension, renal parenchymal hypertension, angina pectoris, etc., and is widely used. Moreover, benidipine hydrochloride, unlike other calcium antagonists such as nifedipine or amlodipine, is known to act on osteoblasts and osteoblasts without impairing bone formation, has an osteoprotective effect, and is known to Enhances the activity of alkaline phosphatase, generally considered an indicator of osteogenic activity, to act on bone metabolism and stimulate the function of bone blast ...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61K9/14A61K9/50A61K47/10A61K47/26A61K47/32A61K47/36A61K47/38A61P9/10A61P9/12A61P43/00
CPCA61K9/141A61K31/4545A61P9/10A61P9/12A61P19/08A61P19/10A61P43/00A61K9/14A61K47/36
Inventor 后藤知彦早川荣治竹重一彦
Owner KYOWA HAKKO KOGYO CO LTD
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