Integrated project development
> Pre-formulation development: physical and chemical characteristics of the proposed drug are analyzed to allow selection of optimal excipients and dosage forms.
> Formulation design: based on the product's physicochemical/release characteristics and other important aspects, a range of theoretical formulations is proposed to determine how they affect the final product's characteristics such as in vitro/in vivo performance and stability.
> Compatibility tests: If necessary a compatibility test (i.e. stability at stressed condition) can be conducted in order to determine functional ingredients/excipient compatibility.
> Prototype development: APR's contract development team develop a prototype in the laboratory using data from pre-formulation development/design and compatibility tests. Generally, only minor modifications to the prototype are required when the process is scaled up to large-scale manufacturing
> Preliminary stability studies: using International Conference on Harmonization (ICH) guidelines and validated analytical methods, the prototype is tested to determine if the selected formulation(s) can be considered stable in terms of chemical , physical and microbiological point of view. The exact nature of tests carried out depends on the product and individual customer requests.