Products and Services

RSS

Proof of Concept

• Feasibility study for the development of a solid dosage form of an active ingredient

Pre-Formulation

• Compatibility study of the excipients with the active ingredient
• Characterization of the active ingredient using analytical techniques such as SEM, XRPD, DSC, TGA, NMR, HPLC, and LC-MS, as well as physical testing methodologies such as the determination of particle size, distribution, compressibility, flow, and stability; in order to provide practical insights and quickly optimize the formulation.

Formulation Development

• Tablets, capsules, and granules
• New chemical entities, biotechnology products, and controlled substances
• Immediate or modified release dosage forms
  • Gastric protection
  • Sublingual (orally dissolving tablets)
  • Effervescent
  • Delayed or sustained release
• Formulation for patent approval
• Evaluation of formulations
  • Content and weight uniformity
  • Dissolution testing
  • Permeability studies (PAMPA and Caco-2)
  • Stability studies
  • In-vitro bioequivalence studies
  • Flow testing
  • Compression testing
  • Hardness testing
  • Disintegration testing
  • Friability testing
  • Bulk and tap density testing

Process Development

• Development of the manufacturing process of the product: direct compression, dry or wet granulation, encapsulation, and coating
• Determination of the critical manufacturing steps and parameters
• Establishment and justification of the finished product specifications
• Process implementation justification of the tests and specifications to be respected during production