Choosing The Optimal Dosage Form For Your Molecule

When selecting the optimal oral dosage form for an active pharmaceutical ingredient (API) in preparation for clinical trials, several crucial factors must be weighed, encompassing aspects such as the drug profile, ease of formulation and manufacturing, dosage amount, scalability, and delivery.

Among the prevalent oral solid dosage forms, tablets and liquid-filled, hard-shell capsules (LFHCs) emerge as prominent contenders, each presenting distinct advantages and challenges. Tablets are a traditional choice with well-established manufacturing processes, often preferred for ease of formulation and precise dosage control. On the other hand, LFHCs offer notable benefits, including quick and simple dose adjustments, scalability from preclinical to commercial volumes, and suitability for poorly soluble, low-dose, and highly potent APIs.

The decision between tablets and LFHCs hinges on careful consideration of these factors, ensuring the chosen dosage form aligns seamlessly with the specific requirements of the API and the desired outcomes in the clinical trial phase.