Feasibility study of sustained release dosage forms for incrementally modified drug by domestics pharmaceutical industry in Thailand.

Background: Incrementally modified drugs (IMDs) are anticipated to improve drug efficacy and compliance. Compared to new chemical entities, the research and development costs for IMDs are lower. The domestics industry currently focuses on manufacturing both generic and new generic drugs. To promote the growth of the industry, it is crucial to investigate the feasibility of developing IMDs.

Methods: This necessitates evaluating all five aspects, including needs, market, scientific, technological, and regulatory feasibility from January to December 2022. A mixed methods approach, combining literature review and in-depth interviews conducted online via Zoom. Qualitative data analysis will be performed through thematic analysis.

Results: Needs: medical needs, six out of seven physicians expressed a preference for sustained release (SR). The domestics industry is actively engaged in the research and development of SR as well. Market feasibility: The compound annual growth rate for SR in 2019 was found to be 3.97 percent, SR encompassing all nine of the 14-drug group. Scientific feasibility is not a concern as the industry has the capability to develop drugs. Technological feasibility: The IMDs technology readiness level is at level 4 (high level). The manufacturing of SR utilizes a matrix technique, membrane system, and pellets. Regulatory feasibility: Although have registration guidelines for IMDs, no industry has successfully registered IMDs yet.

Conclusions: SR has demonstrated feasibility for IMDs development in all aspects except for the challenging issue of drug registration.