Feasibility Study of Oro-dispersible Tablet Drug Development for Incrementally Modified Drugs by Domestic Pharmaceutical Industry

Abstract

Objective: To study the feasibility of oro-dispersible tablet drug development for incrementally modified drugs in five key areas including demand, marketing, sciences, technology, and regulation. Methods: This research was a mixed-method study. Quantitative research involved analysis of data from drug registration databases including 1) the consumption value of oro-dispersible tablet usage in 2019 categorized by being new drug, new generic drug, or generic drug and also categorized by being imported drugs, domestic drug products or re-packaged drugs, and 2) compound annual growth rate in the value of oro-dispersible tablet usage from 2011 to 2019. The obtained information was used to determine marketing feasibility. Qualitative research was conducted through literature review from the databases of World Health Organization and in-depth interviews using a semi-structured questionnaire via the ZOOM program. Four specific groups of informants were purposive sampled including prescribing physicians from 5 specialties, entrepreneurs in pharmaceutical industry, authorities from Food and Drug Administration, and expert pharmacists in drug research and development. Data from qualitative study were analyzed using content analysis. Results: Demand analysis revealed existing medical needs with physicians in all 5 specialties prescribing oro-dispersible tablets to enhance patient compliance. Entrepreneurs in the industry wanted to produce these oro-dispersible tablets to fulfill the needs of prescribing physicians. In terms of marketing feasibility, market for oro-dispersible tablets had been expanding with a compound annual growth rate of 20.86 percent observed from 2011 to 2019. For scientific feasibility, solubility was a key physical characteristic in the development of oro-dispersible tablets. The analysis of the top 10 drug groups with the highest usage value revealed that 8 groups, comprising 16 drugs, had potential for further development. In terms of technological feasibility, those in the industry were well-equipped and capable of producing by compression and analyzing oro-dispersible tablets. For regulatory feasibility, there existed clear guidelines and procedures for the registration of incrementally modified drugs. However, no one in the industry were able to get approval. Conclusion: The oro-dispersible tablets show potential for development as an incrementally modified drug if support on knowledge and consultations for the applicants is provided.