Lessons from compounding for product development

Assessment starts with the patient, route, required dose and available authorised product. Document swallowing difficulty, device use, age-related excipient restrictions and allergies. Another dosage form may meet the need, but the change requires formulation, dose-delivery and clinical-suitability evidence. Sharing an active ingredient alone does not establish therapeutic equivalence.

The same rpm in a different mixer does not establish equivalent mixing. Scale, impeller diameter, time, geometry and temperature affect the process. Assess packaging-material or excipient-supplier changes against the attributes they could alter. Document applicability in F-013 before reusing the previous dating decision.

Master record F-002 specifies what should happen. Batch record F-003 records what happened: lots, weights, times, equipment, tests, yield, label and signatures. Enter records when work occurs. A correction retains the original information and adds reason, date and identity. Do not pre-sign results or release decisions.

Repeated requests are a signal to investigate, not proof of market size or efficacy. Record a denominator, available solutions and why they do not meet the need. Define dosage form, concentration, device, duration and critical quality attributes. Then assess feasibility, scaling, testing and the appropriate regulatory route.