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Formulation Development , Early Development , Translational Pharmaceutics

How to adjust dosage forms used in Phase I to Phase II and beyond

Formulation Development Services at Quotient Sciences

As a new molecule progresses through drug development, the way it is formulated as the drug product or dosage form will change for it to successfully achieve key clinical milestones. 

In early development, the first-in-human (FIH) clinical trial is often a single-center study and typically involves dosing a small number of healthy subjects over a short duration of days or weeks. In this study, the drug is administered in increasing doses and as such, a “fit-for-phase” drug product with high dose flexibility is often used, such as a simple solution, suspension, or powder-in-capsule. 

This type of drug product can usually be prepared on-site, at a small scale, and with limited stability studies and analytical release testing. Simple pharmacy preparations may be sufficient for FIH clinical studies, but when moving beyond Phase I into later stages of clinical development, these products are unsuitable for both patient convenience and scalability to meet larger batch size requirements for Phase II trials.

Scaling batch sizes for Phase II and Phase III trials

Subsequent Phase II and Phase III patient trials involve a larger number of patients and often take place at multiple clinical sites, across states and countries, and over a longer period. To support these trials, the development team will need to bridge to an optimized drug product, such as a solid oral dosage form like a tablet, to ensure patient compliance and suitability for shipping globally. Product batch sizes manufactured to support Phase II and Phase III trials will need to increase to support the increased number of patients. If the molecule is successful in clinical studies, batch sizes will be scaled up to meet the demand for a commercially approved product.

Requirements for different product formats at each stage of development can result in delays and budget overruns when it comes to product optimization and scaling up. Sometimes, CMC delays can be prevented by careful planning, and integrating development activities and technology considerations in the formulation design process. 

Bringing new molecules to market as quickly as possible

To improve R&D productivity and bring new molecules to market as quickly as possible, drug companies are actively seeking new ways of streamlining drug development using alternative outsourcing models. At Quotient Sciences, we coordinate drug product manufacturing requirements with a clinical development plan, to make and test formulations in a streamlined fashion. This leads to significant time efficiencies and cost savings. 

Druggability Technologies (DRGT; now Tavanta Therapeutics) was a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs to deliver measurable improvement in clinical utility. They used the Quotient Sciences Translational Pharmaceutics® platform to advance the development of DRGT-46, a fast-acting formulation of celecoxib. 

Clinical data was able to help DRGT drive formulation selection in real-time, allowing the company to efficiently bridge from a Phase I drug product to a dosage form suitable for patients in late-stage clinical trials. Continue reading the DRGT-46 case study to learn more about how Translational Pharmaceutics® was applied. 

When you are looking for a partner who can help develop your drug product from first-in-human through to proof-of-concept and beyond, rely on Quotient Sciences. Contact us today to get started with your program.