Rapid Formulation Optimization
Many 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 of 'Rapid Formulation Development and Clinical Testing' is designed to accelerate formulation optimization and overcome the challenges of conventional development methods.
This approach can be applied to reformulation efforts for both new chemical entities and during life cycle management of existing drugs. It 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:
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.
- 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
Supporting customers
We have supported our customers 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
White papers and case studies
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Case StudiesEnsysce Biosciences Case StudyRequest a copy of our latest case study with Ensysce Biosciences about how our integrated strategies helped them achieve their regulatory milestones faster for PF614-MPAR, an Extended Release product.
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Case StudiesDCS classification of NCE - Case studyUS Biotech wanted to determine the DCS (Developability Classification System) designation for their small molecule. This included project scope and outcomes of the project.
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WhitepaperStrategies for Accelerating the Development of Modified Release Oral FormsMR drug delivery can also have commercial benefits and is prevalent as part of product life-cycle management (LCM). Modest reformulation of an already approved drug from an IR to MR format allows both line and patent extension opportunities and continued market exclusivity.
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WhitepaperAccelerating the Development of Enabled Formulations for Poorly Soluble Drugs using Translational PharmaceuticsThis white paper describes the benefits of our approach to poorly soluble drugs in terms of drug product performance and clinical decision-making, including case studies that demonstrate significant time and cost savings.