1
Home

Product Development


Our team has decades of product development expertise covering pre-formulation evaluation, optimal formulation identification and efficient process development. Our Product Development Scientists work closely with manufacturing teams across the world to develop formulations scalable for pilot and commercial batches for the international markets.


products
    Pre-Formulation

    We rapidly evaluate and detail drug candidate's physical and chemical profiles. These properties are vital for establishing the parameters for producing stable and reproducible product.

    Initial assessment of solid state properties

    Our initial evaluation consists of profiling the following:

  • - Crystallinity/amorphous content
  • - Hygroscopicity
  • - Particle size, shape & surface area
  • - Moisture/solvent content
  • - Mechanical screening
    Analytical Method Development
    Chemical and physical stability
  • - Heat, pH, light, humidity
    In vitro profiling
  • - LogP/LogD/pKa
  • - Solubility (physiological buffers)
  • - Enhanced solubility (solubility in co-solvents, surfactants, complexation agents, salts etc.)
  • - Intrinsic dissolution
    Formulation Development

    We provide formulation development services across multiple dosage forms.

  • - Eye Drops (solutions, suspensions, gels and emulsions)
  • - Oral Solids (tablets, capsules and dry Powder suspensions)
  • - Ointments (eye and topical / skin)
  • - Nasal Sprays
  • - Oral Liquids (syrups, solutions, suspensions and emulsions)
  • - Injectables (dry Powder and liquid)
    Analytical Services

    DRK Pharma Solutions provides exceptional support for validation and seamless transfer of analytical methods. We carry out method development for APIs, Raw Materials, In-Process and Finished Products using latest equipment by our experienced and well trained analytical chemists. All our equipment and methods are aligned with international requirements.

    Stability Studies

    We provide Accelerated and Real Time stability studies for the RLD and finished dosage forms.

    Technology Transfer

    DRK Pharma Solutions evaluates the Process optimization studies based on the manufacturer's equipment capacity and their available excipients before initiating seamless technology transfer of the product formulation and its analytical methods to pilot or commercial scale manufacturing to customer defined manufacturing site.

    We also offer list of extensive proprietary generics ready for technology transfer to the client's site or client's assigned CMO.

    DRK Pharma Solutions has international collaborations with CMO based in Europe and Asia thereby facilitating our clients to connect with the CMOs for manufacturing their products of interest.

      Regulatory Services

      DRK Pharma Solutions Regulatory Affairs provides expert clinical & regulatory support in all phases of drug development programs. This includes regulatory support of Clinical Trials, Marketing products, Generics, and OTC products.

1