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.
- 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
Stealth BioTherapeutics is using real-time sterile manufacturing to enable a new route of administration.
Breathing new life into Phase 1 trials. Quotient's approach is helping Pulmatrix to develop a range of inhaled dry powder chemical entities based on its iSPERSE™ technology to meet unmet medical needs in multiple respiratory diseases.
Protein kinase inhibitors (PKIs) are used in the treatment of cancer and inflammation, but food interactions are a common problem with this class of drugs. Swedish drug delivery company Xspray has used its Hybrid Nanoparticle (HyNap™) technology to improve the bioavailability of the PKI nilotinib, reducing the required dose and significantly lowering the food interaction of the drug compared with the marketed product. Dr Andreas Konar at Xspray, explained how Quotient’s Translational Pharmaceutics® platform helped to accelerate one of their development programs, to overcome insolubility challenges with protein kinase inhibitors.
Strategies for Accelerating the Development of Modified Release Oral Forms
MR 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.