Quality by Design Approach for Development of Lyophilized Dry Emulsion Tablets (LDET)

Abstract

Lyophilized dry emulsion tablets (LDETs) are one of the most promising approaches to enhance the bioavailability of poorly water-soluble drugs. Rapid disintegration of these tablets when brought in contact with saliva provides additional benefits such as reduced side effects & first-pass metabolism. To achieve successful production of these complex dosage forms, different material attributes of both the drugs as well as excipients are screened. Along with this, several processing parameters of the manufacturing operations are optimized to consistently produce the final drug product with desired qualities. These operations were strictly monitored & controlled to achieve safe, efficacious, acceptable, drug products in accordance with regulatory standards. It is possible to render the Lyophilization process of dry emulsion to have fewer issues with the freezing process, water-to-ice transition, and polymorphic changes in API when subjected to freeze-drying, duration of secondary drying, by improvising the manufacturing process & critical formulation variables during a key stage of lyophilization.

The main goal of this review is to put forth the foundation for applying the QbD system principles to the design & development of LDETs. This involves executing a preliminary & systematic risk assessment of critical material attributes & process parameters in association with CQAs for both the in-process and finished product. Furthermore, examples of freeze-dried emulsion tablets are used to discuss & support the applicability of the QbD methodology based on its intended use.