Formulation Development Services

Nanosyn has state of the art equipment, facilities, and highly experienced staff to help customers develop suitable and stable formulations for various routes of administration. We start with a comprehensive physico-chemical characterization of your Drug. This helps in the development and optimization of the formulations for toxicological and/or clinical studies.This service is complimented with our in-house Analytical Development group providing method development, testing, and characterization of the dosage form along with the development of suitable quality and regulatory compliant specifications. We can optimize formulations and manufacturing processes by conducting DOE to map out the design space for optimizing formulation excipients and critical manufacturing process parameters to help scale-up to commercial batch manufacturing.

Pre-formulation Activities

  • Solubility of Drug in different media, pH and solvents
  • Stability Testing of Drug under various temperature and humidity conditions
  • Ionization constants
  • Partition and Distribution coefficients
  • Hygroscopicity
  • Excipient compatibility studies
  • Intrinsic Dissolution of the Drug
  • Solid state analysis (crystallinity, polymorphs, salt forms, particle size, particle shape etc.)
  • Development of Analytical methods (HPLC and Detection)

Formulation Development and Manufacturing Activities

  • Manufacture prototypes and stability testing
  • Formulation selection for toxicological and/or clinical studies
  • Manufacturing process development
  • Design Specifications and critical quality parameters
  • Development of Methods and Specifications
  • Packaging Evaluation
  • Technology Transfers

Dosage Forms

  • Oral Immediate Release – Tablets, Solutions, Emulsions,Suspensions and Capsules
  • Oral Controlled Release – Matrix based release,Multi-particulate systems, Polymer Film Coatings, pH Dependent Release
  • Topical and Transdermals – Gels, Creams, Ointments, Lotions
  • Sterile Liquids – Solutions, Emulsions, Colloids, Liposomes
  • Powders
  • Sterile liquid dosage formulations (iv, sc, ip, im, ophthalmic, nasal)

Ready for help with Formulation?

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