Pharmaceutical development of fixed dose combinations tablets by active coating technology

The principles of the quality management system in the of fixed dose combinations pharmaceutical development by the active film coating technology: film coating technology as a method for fixed dose combinations tablets producing, which involves coating a solid dosage unit using a solution or suspension containing a pharmaceutical substance. The target profile formulation and a strategy for identifying critical quality attributes summarized. Thus, the active coating technology used to obtain a combination of different release profiles of active substances in one tablet: immediate release from the coat followed by prolonged release from the tablet core. An analysis of the data showed, that the quality target product profile of fix dose tablets is based on general data in accordance with the EAEU Pharmacopoeia, the State Pharmacopoeia of the RF and other regulatory documents. Thus, the target profile contains a combination of two release methods: immediate and prolonged. In the pharmaceutical development of fixed dose combinations tablets by using active film coating technology, the indicators “Assay”, “Dissolution”, “Impurities”, and “Water” are used as critical quality attributes. They affect the composition and/or parameters of the technological process and tested at all stages of pharmaceutical development. For tablets produced using active film coating, uniformity of dosage should be considered as a critical quality attributes characterized by high risk, since the formulation and technological factors determining uniformity of dosage of a pharmaceutical substance in an active film coating differ from tablets obtained by pressing.