Drug Product Optimization
Strategies for Rapid Drug Product Formulation Development and Clinical Testing
Drug product optimization is a common step for drugs progressing through today’s development pipelines. Most new drugs require some form of formulation change during their development, whether to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration in patients, or as part of a life-cycle management strategy.
Quotient Sciences’ Translational Pharmaceutics® platform can be applied to design, manufacture, and obtain clinical data on new formulations in an accelerated timeframe. Multiple formulations can be screened, with emerging data informing the product evaluated in the next dosing period of a crossover clinical study in a 2–3-week "make-test" cycle.
Translational Pharmaceutics can be applied to drug product optimization efforts for both new chemical entities (NCEs) and during the 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 to iteratively optimize the quantitative composition of critical-to-performance excipients and dosage strengths relative to clinical performance.
Our unique approach to drug product optimization
- Saves time by reducing the chemistry, manufacturing, and controls (CMC) data package needed for your clinical assessments
- Maximizes flexibility by allowing you to fine-tune formulation compositions
- Increases the potential for success by facilitating decisions based on clinical data
- Conserves the active pharmaceutical ingredient (API) by removing 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 300 formulation optimization programs, involving the clinical evaluation of more than 1,000 formulations.
Translational Pharmaceutics has supported our customers through:
- Evaluation and selection of solubilization technologies • Optimization of modified-release systems
- Improvement of taste, palatability, and acceptability for pediatric indications
- Changing routes of delivery
- Development of combination products
- Understanding quality by design (QbD) of product and process variables
Ensysce Biosciences - Case Study
A La Jolla, CA, US-based biotech company was developing PF614-MPAR as a novel opioid combination product for the potential treatment of chronic pain designed to prevent both abuse and overdose. Lynn Kirkpatrick, CEO of Ensysce Biosciences, explains how Quotient Sciences has supported Ensysce Biosciences with a fully integrated formulation development and Phase I clinical study program, dramatically accelerating the development of PF614-MPAR.
Surface Logix - Case Study
SLx-2101, a novel PDE-5 inhibitor, was being developed by Surface Logix as an antihypertensive agent. A Phase II pilot clinical study using an immediate-release tablet had been conducted, and the data determined it was necessary to develop a modified-release formulation. Quotient Sciences’ integrated approach was used to select the optimal modified-release formulation based on clinical data from the previous dosing period in 7 months.
Boston Pharmaceuticals - Case Study
A US biotech company based in Cambridge, MA, was developing BOS172767, a Biopharmaceutics Classification System (BCS) Class II molecule, for the treatment of autoimmune diseases. The first-in-human study showed poor oral bioavailability and a significant food effect, which were preventing the project from advancing into patient studies. An enhanced formulation was required to help overcome these challenges and to identify a formulation suitable for long-term clinical development.
Endevica Bio - Case Study
Based in Columbia, MO, US, Endevica Bio is developing TCMCB07 as a novel synthetic peptide product for the potential treatment of cachexia. Russell Potterfield, CEO of Endevica Bio, explains how Quotient Sciences has supported Endevica with an integrated formulation development and Phase I clinical study program, accelerating the development of TCMCB07.
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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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Info SheetTranslational Pharmaceutics® Fact SheetQuotient Sciences helps you achieve your goals by enabling precise formulation development, streamlined manufacturing, quick pivot to clinical data and a significantly faster transition through drug development.
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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.