Semler Research - Formulation Development

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