Engineering Oral Solid Dosage Forms to Enhance Therapeutic Efficiency and Patient Acceptability

Oral solid dosage forms are the most widely used drug delivery platform; however, achieving consistent clinical performance and patient acceptability remains a significant formulation challenge. Factors such as sub optimal API properties, food effects, dose related variability, and patient adherence can strongly influence therapeutic outcomes and product success. This session will discuss a science based approach to engineering oral solid dosage forms to improve therapeutic efficiency and patient use. The presentation will cover how formulation scientists translate target patient and clinical requirements into formulation design, select appropriate drug delivery technologies, including enabling and modified release platforms, and balance product performance with manufacturability. Non confidential examples will illustrate how rational drug delivery design can reduce variability, manage food effects, and improve dosing convenience across innovator and 505(b)(2)/complex generic development programs, providing practical insights into developing robust, patient focused oral solid dosage forms.