Formulation Development

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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