Compatibility of Ramipril and Lercanidipine Drug Substances in a Single Solid Dosage Form
- Авторы: Shadrin A.1, Flisyuk E.1, Kirillova E.1
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Учреждения:
- St. Petersburg State Chemical Pharmaceutical Academy, Ministry of Health of Russia
- Выпуск: Том 51, № 12 (2018)
- Страницы: 1096-1101
- Раздел: Drug Synthesis Methods and Manufacturing Technology
- URL: https://journals.rcsi.science/0091-150X/article/view/244927
- DOI: https://doi.org/10.1007/s11094-018-1747-z
- ID: 244927
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Аннотация
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.
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Об авторах
A. Shadrin
St. Petersburg State Chemical Pharmaceutical Academy, Ministry of Health of Russia
Автор, ответственный за переписку.
Email: aleksey.shadrin@pharminnotech.com
Россия, 14 Prof. Popov St., St. Petersburg, 197376
E. Flisyuk
St. Petersburg State Chemical Pharmaceutical Academy, Ministry of Health of Russia
Email: aleksey.shadrin@pharminnotech.com
Россия, 14 Prof. Popov St., St. Petersburg, 197376
E. Kirillova
St. Petersburg State Chemical Pharmaceutical Academy, Ministry of Health of Russia
Email: aleksey.shadrin@pharminnotech.com
Россия, 14 Prof. Popov St., St. Petersburg, 197376