Should developers choose a cosmetic or pharmaceutical-grade excipient for topical formulations?

As regulations continue to change around the quality and risk of cosmetic- and pharmaceutical-grade excipients, developers have an important choice to make when investing in quality, risk, and public safety.

Hear from Gloria Ho, the Global Technical Marketing Manager at BASF Pharma Solutions, on the benefits of choosing a pharmaceutical-grade solution.

From past to present

The current conversation around cosmetic and pharmaceutical-grade excipients has a lot to do with their history.

“When oral and intravenous-based products were introduced, they were medicinal in nature,” says Gloria Ho, Global Technical Marketing Manager, Pharma Solutions. “When we see a manufacturer or developer working with those, they’ll automatically default to using a pharmaceutical-grade excipient.”

With topicals, the case is different. “Historically, many early balms or salves were produced for both cosmetic and medical purposes. But even if they were produced for medicinal purposes, it was done with cosmetic-grade materials.”

As expected, there are distinct differences between the requirements surrounding cosmetic and pharmaceutical-grade excipients. The first is Good Manufacturing Practice (GMP) requirements. “As a pharmaceutical-grade supplier, we’re held to much higher GMP requirements than a cosmetic-grade supplier. For example, cosmetic-grade suppliers may only offer limited supply chain transparency as required by ISO or EFfCI regulations.”

Ho also talks about requirements like process and cleaning validations to avoid cross-contamination. “Pharmaceutical-grade suppliers need to have batch records for reviewing, maintain supplier qualification, and particularly focus on change control and supply chain transparency.” Furthermore, some forms of regulatory documentation such as an elemental impurity analysis is unique to pharmaceutical-grade products.

Another difference is around internal and external audits. With pharmaceutical-grade excipients, these audits are routinely requested and conducted. With a cosmetic-grade supplier, that’s not the case.

As a result, a manufacturer choosing a pharmaceutical-grade excipient does so with the reassurance these checks and balances are included. If a pharmaceutical manufacturer chooses a cosmetic-grade excipient, it takes on that responsibility.

Higher standards at a higher cost

It’s worth noting that higher standards may come with a bigger investment but, as Ho states, it’s worth it for pharmaceutical manufacturers committed to minimizing risk, maintaining standards, and upholding brand reputation.

Ho notes that these high standards “are really built into the cost of the excipient or product, whereby paying a premium means you have more checks and balances in the manufacturing that you’re not guaranteed if you purchase a lower-grade material.”

Going the pharmaceutical-grade route also comes with an additional level of support, like working with a regulatory team member who can provide specific documentation associated with a product. “Because we are responsible for the compliance of the ingredients with the respective legislation, you’ll receive heightened support,” Ho says.

A conversation shaped by regulations

Naturally, as the industry has evolved, regulatory bodies have followed suit, and Ho shares how we’re seeing heightened scrutiny when it comes to the materials used in different types of formulations.

“If we look 20 or 30 years in the past, the emphasis or requirements to get a product approved were not as stringent as what we see today. Now, we have much higher regulatory standards, particularly when we think about generic products that must meet microstructure requirements.”

While there aren’t strict requirements for a developer to use a pharmaceutical-grade excipient, regulatory bodies are pushing towards that.

These changes aren’t specific to the US, either. “If we look to Brazil, for example, their regulatory body Anvisa has no strict requirement to use solely pharma-grade products,” Ho says.

“They’re certainly looking towards providing a recommendation for their developers to consider the quality differences between a pharmaceutical and cosmetic-grade because those differences mean that you, as a developer, have to assume significantly more responsibility if you want to purchase a lesser-quality product.”

Looking to the future

Thinking ahead, Ho says that we’re currently seeing manufacturers that were once flexible migrating towards suppliers offering pharmaceutical-grade excipients with stricter requirements.

“I do anticipate that, because of public safety, we will continue to move in this direction because the purpose of these regulatory bodies is to ensure the safety of the end consumer,” she says.

“The best way to do that is to guarantee that a medicinal product contains high-quality ingredients. A medicinal product that’s used for oral purposes or parenteral purposes should contain pharmaceutical grade ingredients. Topical grade products shouldn’t be considered lesser because they too are being used for medicinal purposes.”

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Source: BASF, website Should developers choose a cosmetic or… | BASF Pharma

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