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Pharmaceutical compositions comprising lercanidipine

A technology of lercanidipine and composition, which is applied in the field of controlled-release preparations and controlled-release pharmaceutical compositions, and can solve problems such as inconsistency in absorption

Inactive Publication Date: 2007-01-24
生命周斯药物公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This makes absorption inconsistent

Method used

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  • Pharmaceutical compositions comprising lercanidipine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0277] Matrix capsules with intragranular hydrocolloids

[0278] substance

[0279] 20 g of lercanidipine were dissolved in a molten mixture of polyethylene glycol 6000 and poloxamer 188 (70:30) at 90°C. 318 g of the solid dispersion were sprayed onto a mixture of 150 g of lactose and 100 g of Metolose 90SH 100 cP in the fluid bed Strea-1. The granular product was screened through a 0.7mm sieve. The granular product was sieved through a 0.7 mm sieve and filled into hard gelatin capsules.

Embodiment 2

[0281] Matrix tablet with extragranular hydrocolloids

[0282] substance

[0283] The granulated product from Example 1 was mixed in a turbula mixer with 20% Metolose HS90 15000 cP for 3 minutes and then with 0.5% magnesium stearate for 5 minutes. The granules were directly compressed into 12 mm tablets (compound cups) in a Diaf TM20. The tablet has an average weight of 623 mg and a strength of 10 mg. Average tablet hardness: 51N.

Embodiment 3

[0285] Lercanidipine Capsules

[0286] substance

[0287] 2.5 g of lercanidipine were dissolved in 22.5 g of glyceryl monocaprylate at about 100°C. The clear solution was injected into 200mg capsules (size 1CS).

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Abstract

A controlled release pharmaceutical composition comprising lercanidipine dissolved or dispersed in a solid vehicle at ambient temperature, thus forming a solid dispersion, achieves delayed release of lercanidipine over an extended period of time, reduced food effect and increased bioavailability compared to commercially available lercanidipine containing products.

Description

[0001] The present invention relates to compositions, in particular controlled release pharmaceutical compositions, which achieve a slow release of lercanidipine over a prolonged period of time compared to commercially available products containing lercanidipine, obtaining sufficient Bioavailability enables once-daily dosing, significantly reduced food effect and increased bioavailability. Furthermore, the compositions of the present invention are expected to reduce side effects associated with spikes. [0002] In particular, the present invention relates to solid pharmaceutical compositions formulated for oral administration and controlled release of lercanidipine, comprising lercanidipine dissolved or dispersed in a solid carrier. Background of the invention [0003] Lercanidipine is a dihydropyridine calcium antagonist. Like other calcium channel antagonists, it lowers blood pressure by relaxing arteriolar smooth muscle thereby reducing peripheral vascular resistance. Ler...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4418A61K9/20
Inventor P·霍尔姆T·诺林
Owner 生命周斯药物公司
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