With 15 years of experience in formulation research and technology transfer, I’ve seen how critical it is to finalize the right APIs/Drug Substances.
Here are the main factors that guide the decision:
Market & Competition – Check market size, demand, pricing trends, and timing of generic entry.
Pharmacopoeial Support – Confirm if the API has a monograph in USP, EP, BP, or IP.
Supplier Trend Data – Review particle size distribution (PSD), impurity profile, stability, and batch-to-batch consistency.
Patent & IP Freedom – Ensure no infringement on composition, polymorph, or process patents.
Technical Feasibility – Evaluate BCS class, solubility, dose load, excipient compatibility, and polymorphic form.
Risk Factors – Consider nitrosamine risk, elemental impurities, and long-term supply chain reliability.
Trial Formulation & Stability – Prepare small batches, check manufacturability, and load on stability studies.
Projects that adhere to this framework usually move smoothly through development, scale-up, and regulatory filing. Ignoring even one of these can lead to costly delays.
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Resource Person: Vijay Agrawal