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
- Multi Station Tablet Press(D & B Tooling with instrumentation)
- V blender
- Planetary Mixture
- High Speed Mixture and Granulator
- Dry Granulator
- Pan Coater
- USP dissolution Apparatus with auto sampler
- Tablet: USP Hardness Tester, USP Disintegrator and USP Friability Tester
- Stability Chambers (Complies with ICH Guidelines)
- HPLC(Waters Alliance 2695) with PDA Detector
- Differential Scanning Calorimetry (Shimadzu)
- Thermo Gravimetric Analyzer (TGA)(Shimadzu)
- UV-Vis Spectrophotometer
- Moisture Analyzer
- Diffusion Cells, For Permeation Studies
- Cell Culture Facilty for Permeation Studies using Caco2 and MDCK Cell Lines