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The importance of formulation studies in drug development

Formulation studies require time, money and expertise, and the race to clinic and beyond may tempt drug companies, especially smaller ones, to take shortcuts that end up costing more later.

However, investing in formulation and process development during the early phases of a drug’s development can yield dividends in the long run. Although initiation of a clinical program may be quicker and cheaper, in the longer term it may be more difficult to make rationale choices for formulation and process development for any follow-on clinical program. 

Small companies may not have a clear understanding of the target product profile, and going into the clinic with poorly formulated or poorly characterised drugs that can lead to erroneous or misleading data sets. CMC (chemistry, manufacturing, and controls) is an area that can often be neglected, particularly where an asset has been acquired from a larger pharma partner. Using predictive models as a substitute for experimental data in the early stages of drug development can save time and money, allowing the development program to move to wet chemistry more quickly. For example, screening a series of analogues to determine bioavailability, solubility, or even potential genotoxicity signals by quantitative structure-activity relationship can be of tremendous value in early development and accelerate lead optimisation efforts enabling faster development.

Additionally, small companies sometimes fail to understand scale-up and tech transfer requirements, particularly where they plan to commercialise a product. Software is important to aid development, ranging from programs to calculate basic physicochemical parameters for drug substances to bioavailability development toolkits and excipient interactions software. There are also strategies developed by contract research organisations that allow the rapid in-vivo screening of numerous formulation prototypes to aid rapid formulation selection prior to the start of any formal clinical program.

A three-pronged approach is recommended. First, have a well-defined contract with specific activities, deliverables, and timelines. Second, ensure a CMO project manager is assigned to the project and there is a regular project meeting timetable with agenda, action items, and minutes, etc. Finally, there should be a senior-level relationship for resolution of any issues that can’t be resolved by the team.

If the small company has specific, specialised, internal capabilities with respect to aspects of its development program, it is likely to be cost effective to keep these in-house, especially if these activities are not germane to the drug product’s quality assessment and the data are not required to be developed under CGMPs, which would carry a heavy overhead. Routine GMP activities can be outsourced. 

ICON specialises in the strategy and delivery of early phase clinical development for informed, timely decision making. To speak with one of our experts, please contact us. 

 

This blog is an edited version of “Seeking Early Answers to Formulation Questions” which appeared in BioPharm International on 1st March 2020 and “Fast vs. Formulated?” which appeared on PharmTech.com on 2nd March 2020. To view the full articles, please visit http://www.biopharminternational.com and http://www.pharmtech.com.

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