SSCI/Aptuit Scientists can screen for different solid forms, characterize and select the optimum form for development, develop robust phase 1 formulations, and provide cGMP phase 1 clinical material.
The clinical supplies SSCI/Aptuit develops for Phase 1 studies include solid formulations such as tablets or capsules, semi-solid formulations such as pastes, creams, ointments, and suspensions, and liquid formulations such as parenterals, IV, IM, oral solution, and lyophilized products.
SSCI/Aptuit carries out cGMP solubility, compatibility, and stability studies and uses this information to determine a formulation recipe. SSCI then works closely with a qualified external partner to perform granulation, mixing, pressing of tablets, or preparation of sterile solutions again under cGMP conditions ensuring that solid form issues are under control. As appropriate, SSCI also carries out dissolution profiling, content uniformity, tablet hardness and other cGMP QC studies on the resulting drug product.