White Paper

Strategies for Accelerating the Development of Modified Release Oral Forms

Formulation optimization

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

RapidFACT® (Rapid Formulation Development and Clinical Testing)

Most new drugs emerging from the industry pipeline have suboptimal properties and require formulation optimization to achieve their full potential.

Quotient Sciences’ Translational Pharmaceutics® can be applied to design, manufacture and optimize new formulations based on clinical data. This innovative approach, RapidFACT® (Rapid Formulation Development and Clinical Testing), is designed to accelerate formulation optimization and overcome the challenges of conventional development methods.

RapidFACT can be applied to reformulation efforts for both new chemical entities and during life cycle management of existing drugs. RapidFACT also allows for the unique inclusion of a formulation design space in initial regulatory submissions and clinical protocols. This design space provides you with flexibility to iteratively optimize the quantitative composition of critical-to-performance excipients and dosage strengths relative to clinical performance.

Our 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 moving drug product 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

Formulation optimization

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