Focusing on the Fundamentals of Formulation

Chemistry professor wearing a lab coat and gloves, demonstrating a vibrant chemical solution in a beaker to engaged students during an interactive experiment in a university laboratory | Image Credit: ©DusanJelicic - stock.adobe.com

It is important to learn and continue learning.

While context is essential, hearing different perspectives enhances clarity. It strengthens validation of what is known and supports learning if it’s not. Information flows at us in many forms of printed, digital, or in-person meetings. However, with this information overload, there still exists a unique challenge: time; it continues its angst, causing a gap in fundamental knowledge. This can impact negatively in reasoning and even more so if questioning does not feel encouraged. Retention is another consideration. Memory can lapse from not utilizing knowledge; there are times when you are only as good as your last project, and sometimes one needs to reactivate the neural pathways.

In response to the perceived need for continued learning in the industry, Pharmaceutical Technology®’s Editorial Advisory Board (EAB), along with the editorial team, decided to help keep our readers activated by selecting central topics, all within the construct of the magazine’s focus, to assist with learning while perusing the monthly print issue and digital content available on PharmTech.com. I am happy to lead the topics of development and manufacturing in this task (stay tuned, its coming soon), and with such diverse expertise within the EAB, we are happy to take this journey with you.

Getting down to basics in development

While a broad subject area, the development segment will encompass five key topics: pre-formulation, formulation, scale-up, and post-formulation. Initially, with pre-formulation, such subtopics as drug discovery will be explored as we look at its process and where the industry is today. The well-known image showing the stages of the drug discovery process carrying its hefty price tag of approximately $1 billion along with the time taken to market will resonate well here. Considering the wider audience, this article series will visit the alternate stages in bringing a generic drug to the market. The complexity of a drug can impact time and cost, as more R&D work is needed to meet bioequivalence.

Pharmacokinetics (ADME [absorption, distribution, metabolism, and excretion]) grips efficacy and safety of medicines. It is the way one understands how a drug will behave in the body, its complexities and mechanisms of delivery, and where underlying illness and stubborn gastrointestinal challenges can impact performance.

Clinical trials are a significant cost in the development process; therefore, this series will cover its growing complexity, the dreaded placebo effect, and running trials in today’s climate, especially with the shift to decentralized trials. While medicine prices remain questionable, and in a variable state, the cost of bringing a drug to market is high. The specific cost of trials is challenged with potential losses and the realization that, unfortunately, not all will be successful.

Focusing on formulation

Drug delivery and experimental design are significant fields in drug formulation, given the multifaceted subtopics and typical approaches. While newer technologies exist and there have been updates in design and function, standard technologies and their relevance to the industry today will be evaluated. As drug solubility is challenged, complexity arises, but there is support, with shared information, through research, and an added foresight of success when a drug is already marketed.

The quality-by-design pathway will be discussed, including considerations on API, excipient, and process characteristics, and ultimately, developing a robust dosage form delivering its target product profile. Moving from batch to continuous manufacturing, developing a new dosage form, or switching manufacturing processes requires a good design. Decisions, such as choice of excipient, could impact success. Patient centricity has been advancing in the industry, and while other factors exist, developing a suitable dosage form can influence continued patient uptake and adherence.

Scale up and beyond

Following on from formulation development and success at the bench, scale-up is a challenging phase in development and manufacturing. The fundamentals series will cover considerations in scale up and possible change protocols as one moves from pilot stage to manufacturing and troubleshooting.

While cost features heavily in all earlier sections, it can significantly show its effect in the segment on post-formulation, where we will discuss topics covering improvements, stability, Phase IV, and lean manufacturing. Sometimes these learnings will resonate with that wonderful term “hindsight” and could aid in future decision making. Time and speed to market continue to challenge excellence and cost.

Regulatory topics will feature prominently in this series. Decision making can be impacted due to the regulatory route and delays. Also, quality, particularly as analytical testing has advanced, has its consequential impact on a risk-averse landscape.

As we take this journey, we would also like to hear from you! If there are any topics you find challenging or any experiences you would like to share, we welcome your thoughts/comments. Send comments and questions to ptprojects@mmhgroup.com.

About the author

Evonne Brennan, evonne@evonnebrennan.com, is an experienced educator and consultant delivering tailored tuition and courses in pharmaceutical formulation and processing. Evonne is a member of Pharmaceutical Technology®’s Editorial Advisory Board.

Article details

Pharmaceutical Technology®
Vol. 49, No. 7
September 2025
Pages: 20–21

Citation

When referring to this article, please cite it as Brennan, E. Focusing on the Fundamentals of Formulation. Pharmaceutical Technology 2025 49 (7).