A changing landscape

Over recent years, the regulatory landscape for topicals has changed. Whether it’s a shift in speaking about products qualitatively, having higher expectations when matching a generic product to an originator, or using different performance parameters, Gloria Ho, Global Technical Marketing Manager at BASF, says the shift is due to a greater emphasis on safety and efficacy.

“Historically, oral-based products have undergone higher levels of scrutiny than topical-based products due to grandfathered regulations. We’re now seeing that both end users and regulatory bodies are looking for that additional level of quality and trust,” says Ho. “The field is more science-driven and is becoming a more regulated industry than it previously had been if we looked back 20 or 30 years.”

There are several factors driving this change.

First, governments and regulatory bodies are working to provide end users with the trust they need to know that finished formulations have undergone strict regulatory requirements.

Academia is another driver. “We’re seeing specialists looking at different ways they can improve the characterization of topical products,” Ho continues. “By understanding how to categorize products with certain techniques, and relating those to a product’s overall performance, you can better predict a product’s attributes such as physical stability or shelf life.”

A third driver is the industry itself. “Product formulators are looking for ways to make the development process more orderly. When standardized methods exist to characterize topical product attributes, then it becomes much simpler to employ a proven procedure to demonstrate product performance.”

Anticipating compatibility

The majority of BASF’s topical and transdermal portfolio is focused on excipients or inactive ingredients. Ho shares that microscopy, or the utilization of a microscope to identify micro-sized structures, has proven helpful to customers in relating ingredients to overall product performance.

“When we see undesirable behaviors such as phase separation, globule coalescence, or crystallization under the microscope, we can then make recommendations in regard to excipient substitutions or quantity adjustments so that we’re able to resolve formulation challenges,” she says. “We can also make predictions as well. For example, if we see that after three months there have been minimal changes in a cream formulation, we can anticipate we’ll have better stability compared to a different formulation in which changes are evident after just one month.”

By better understanding what influence their material has on a microstructure, BASF is able to offer its customers more reliable support.

This compatibility sits in line with consumer demand. Ho shares that the industry is currently experiencing development in products dedicated to quality-of-life diseases like psoriasis or atopic dermatitis.

“One thing we like to understand is not just how our excipients work in terms of functionality and how we can make adjustments to be able to improve the stability of that product, but also what substitutions might be feasible that are less irritating to an individual experiencing pain and irritation with their skin,” Ho says.

In short, it comes down to providing safety and efficacy without sacrificing the end user’s comfort. “We’re minimizing the risk that the end user wouldn’t want to use the product again.”

Looking to the future

As something that is considered “a continuously developing science,” Ho says topical science is “really exciting and interesting because it allows us the ability to offer a contribution to the industry.”

As topical science develops and regulations shift, BASF is committed to continuous collaboration to stay ahead of the curve.

“We work with both academic and industrial collaborators that are pioneering in this area,” Ho shares. “We view it that the possibilities at this point are endless. To stay up to date, we regularly interface with industry leaders and organizations that are actively working to build the science. By continuing to work closely with them, this interaction also provides us with an opportunity to better understand our materials which allows us to provide the most up-to-date insight to pharmaceutical formulators.”