Novel amlodipine and benazepril capsule

Abstract

The invention relates to an oral hard capsule and particularly relates to a tablet capsule formed by filling benazepril tablets and amlodipine tablets in a capsule. The tablet capsule provided by the invention is composed of a capsule and tablets filled in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body, and the capsule is internally filled with at least one tablet with the benazepril as an active ingredient and at least one tablet with amlodipine as an active ingredient. The active ingredients in the capsule are not in mutual contact with each other, so that no chemical compatibility and byproducts are generated between the ingredients, the stability of a product is improved, a degradation product generated after the benazepril and the amlodipine are in contact is reduced, and relevant substances of the product provided by the invention are still controlled within the amount alone brought by the benazepril (seven) and the benazepril (seven).

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with benazepril tablets and amlodipine tablets. Background technique [0002] Benazepril and Amlodipine Tablets (Lotrel) English name: Benazepril and Amlodipine Tablets (Lotrel), developed by Novartis Pharmaceuticals. During amlodipine monotherapy or benazepril monotherapy, patients whose blood pressure cannot be adequately controlled can be changed. Combined treatment with this product. [0003] The 7 impurities of Benazepril are: Benazepril Impurity A ((3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2,3,4,5- tetrahydro-2-oxo-1H-1-benzazepine-1-acetic acid, monohydrochloride; -propyl)amino-2,3,4,5-tetra hydro-2-oxo-1H-1-benzazepine)-1-acetic acid, monohydrochloride); benazepril impurity C((3S)-3-[[ (1S)-1-carboxy-3-phenylpropyl]amino-2,3,4,5-tetr ahydro-2-oxo-1H-1-benzazepine]-1-acetic acid; benazepril impurity D3-(1 -Ethoxycarbonyl-3-cyclohexyl-(1S)-pro...

AI Technical Summary

Problems solved by technology

[0005] Benazepril and amlodipine under light conditions and high temperature conditions, new impurities will be produced between the active ingredients of benazepril and amlodipine, and between the above-mentioned impurities, resulting in the stability of the benazepril and amlodipine compound preparation Poor safety, short validity period, greatly increased safety risks

[0006] Of course, if the active ingredients are in contact with each other, there are still the following disadvantages: 1. Due to the influence of multi-component mixing uniformity, it is difficult to quantify each component accurately; 2. During product testing, it is difficult to measure the content of each component due to mutual interference, which affects qualitative and quantitative analysis. Results; 3. During long-term storage, due to possible chemical compatibility changes among the components, by-products are likely to be produced, reducing the effect or increasing side effects, and the product stability is not ideal.

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