Compatibility of Ramipril and Lercanidipine Drug Substances in a Single Solid Dosage Form

Abstract

The chemical properties of ramipril and lercanidipine drug substances were studied to select the conditions necessary for technology development of solid dosage forms. Mixtures containing two or three ingredients were formulated to study the chemical compatibility of the substances and their compatibility with the excipients and were placed into storage. Analyses of these mixtures showed that the substances could be compatible in a single dosage form. Samples of intermediates (mixtures, granulates, tableting masses, tablet cores) and finished products (film-coated tablets) were manufactured, placed into storage, and analyzed to find the optimum processing factors. It was proven that the tableting process and the coexistence of ramipril and lercanidipine in any kinds of intermediates had significant effects on the ingrowth of impurities. The need to use bilayer tablet technology was justified.