Drug product optimization

How do I optimize and validate my formulation? Quotient is your answer.

Most new drugs emerging from the industry pipeline have suboptimal properties and require formulation optimization to achieve their full potential. Quotient Sciences’ Translational Pharmaceutics® platform is an innovative approach to identify and overcome these challenges, which enables formulations to be designed, manufactured and optimized rapidly based on clinical data.

By integrating formulation development and real-time adaptive GMP manufacturing with clinical research, we accelerate the screening and optimization of formulations — for both new chemical entities and life cycle management of existing drugs. Because of our unique inclusion of a design space in initial regulatory submissions and clinical protocols, you will gain complete flexibility to screen quantitative levels of critical-to-performance excipients and dosage strengths.

Our Translational Pharmaceutics approach:

  • Saves time by reducing the CMC data package needed for your clinical assessments
  • Maximizes flexibility by allowing you to fine-tune formulation compositions
  • Increases potential for success by facilitating decisions based on clinical data
  • Conserves API by removing production scale-up from the critical path

Our team works with you to design a customized program to deliver your objectives in the most timely and cost-efficient way. We have completed more than 125 formulation optimization programs, involving the clinical evaluation of more than 400 formulations.

We have supported our clients through:

  • Evaluation and selection of solubilization technologies
  • Optimization of modified release systems
  • Improvement of taste, palatability and acceptability
  • Changing routes of delivery
  • Development of combination products
  • Understanding quality by design of product and process variables

Drug product optimization

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