[Offer to Sell] 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. Phase I Formulation Development Services Based on available information on physico-chemical properties, dose, early animal Pk study final "plug and play" formulation development service will be provided. - Analytical Development: Assay and relative substance and dissolution method development based on already existing drug substance methods with partial validation to perform the preformulation studies - Drug excipient interaction study: 10-20 common excipients (GRAS and pharmacopeial materials) quantities as per the limit in IIG for similar kind of formulation or as required designing a particular dosage form. - Optimizing capsule or tablet of a typical size for oral dosage forms. - Setting product specifications with respect to dissolution - Bench scale formulation manufacturing (50 gm Batch, batch size might vary based on the availability of the drug substance)-identifying critical process parameters. - Setting up specification for API - Manufacturing of feasibility batches (200.0g to 500.0 g) - Identifying final formulations-based on the required specification - Clinical material manufacturing and packing as per GMP. - Informal stability study in HDPE bottle and various blister packing Phase II-III formulation Development Services Based on available information from the phase I formulation development study - Complete analytical validation as per ICH guidelines - Development of discriminating dissolution media - Formulation development with three batches of API, finalizing the trade dress of the formulation. - Final preformulation: drug excipients interaction, process equipment interaction studies. - Scale-up manufacturing and process optimization and validation, and manufacturing exhibit batch. - Setting up final product specification for QC - Supporting CMC of new drug application. 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 |
|||||||||||||||||
 |
|||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||
|
|||||||||||||||||
|
| Home | Privacy
Statement | Terms
of Use | Advertising | Partners | Contact
Us | Help
© Copyright 2001-2026, b2b-board.com. All Rights Reserved.
|