The Amsis Pharma Consultancy is based in Cambridge and specialises in advising on formulation and Clinical supply issues particularly in smaller companies. The company also offers interim services in project management or technical writing . If the material is intended to act on the lung, then local delivery is desirable. If the material cannot be formulated to resist acid hydrolysis in the stomach, then it may need to be delivered parenterally or via the pulmonary route. Development costs and risks associated with inhaled formulations are significantly higher than oral but have potentially less barriers for systemic delivery.
Injections have problems with sterile processing and potentially with stability.
Clinical Phase 1. Different formulations may be needed for dose ranging. Packaging and blinding for clinical trials plays a significant part as well as blinding competitor products. The biggest expense however, is the vast resources required in establishing trial centres, in patient recruitment and in data monitoring. All of the medium and larger pharmaceutical companies have in-house formulation groups.