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

Equipment

• 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)
• FTIR(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