Semler Research - Formulation Development

Description

Preclinical Formulation Development - Analytical Development: Assay and relative substance method development based on already existing drug substance methods with partial validation to perform the preformulation studies. - Physico chemical evaluation, solubility studies: pH dependent aqueous solubility, solubility studies in alcohols and polyols solvents, solubility in co-solvents and surfactant assisted solubility - Inherent dissolution study in various pH conditions - Salt design/screening and selection - Dissociation constant redetermination - Partition coefficient and log P determination - Polymorphism study - Particle size, surface area, bulk/tapped density determination - Stability study: Solution stability, pH depended solubility, process equipment compatibility study, filter compatibility study, solid state stability, stress stability, photo stability, accelerated stability study as per ICH guidelines - Dynamic moisture absorption study - Drug excipients interaction study in solution form - Preclinical formulation - Stability study of preclinical formulation - Closure container compatibility study Formulation Development Services for ANDA - Complete analytical development and validation as per ICH requirement. - RLD evaluation - Drug excipient interaction study - Formulation development to match the dissolution property of RLD in OGD and multimedia dissolution. - Accelerated stability in primary pack along with RLD - Scale up-identifying the critical process parameters and process optimization. - Technology transfer - Bio-batch or exhibit batch manufacturing.