Product Highlight

Procipient® | Pharmaceutical Grade DMSO for Healthcare and Topical Drug Delivery Applications by gChem

Product Highlight

Pharmaceuticals

gChem | A Trusted Partner for High-Purity DMSO Solutions

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DMSO Synthesis Grade | High-purity solvent for pharmaceutical API synthesis
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Procipient® | Pharmaceutical Grade DMSO for Healthcare and Topical Drug Delivery Applications by gChem

In this Q&A article, gChem's expert Nigel Langley explains how Procipient®, a high-purity, virtually odourless DMSO manufactured under ICH Q7 cGMP conditions, is purpose-built for demanding topical and transdermal formulations.

Rethinking DMSO for topical and transdermal drug delivery

Formulators developing topical and transdermal drug products need excipients that can solubilise the Active Pharmaceutical Ingredient (API), support consistent skin penetration and remain stable throughout shelf life. This is a particular challenge for poorly soluble APIs falling within Biopharmaceutics Classification System (BCS) Class II and Class IV, where limited aqueous solubility restricts the available formulation options.

Dimethyl Sulfoxide (DMSO) has a long history in pharmaceutical development, and as formulators look again at penetration enhancement for challenging molecules, grade selection is becoming as important as API and excipient selection itself.

Procipient®: a high-purity pharmaceutical grade DMSO purpose-built for topical formulation

gChem manufactures Procipient®, a DMSO grade developed specifically for pharmaceutical use across API synthesis, biopharmaceutical processing and, increasingly, topical and transdermal drug delivery.

Key benefits of Procipient®:

99.99% purity
Manufactured under ICH Q7 cGMP conditions
Qualified for both API and excipient applications
Virtually odourless through removal of odour-causing impurities
Suitable for API synthesis, biopharmaceutical processing, and topical/transdermal drug delivery

IMCD supplies gChem's Procipient® DMSO portfolio, connecting formulators with technical guidance across the full range of pharmaceutical applications, as introduced on IMCD's gChem Supplier Highlight.

Learn more about Procipient® in topical drug development through our expert Q&A with IMCD and gChem

To explore where Procipient® fits in topical drug development today, gChem’s expert Nigel Langley (NL), Global Technical Director, Life Sciences and IMCD's expert Lies d'Olieslager (LdO), European Technical Product Manager conducted a Questions & Answers interview.

Read on for their insights into the opportunities and challenges of using pharmaceutical-grade DMSO in topical and transdermal formulations. If you have any questions or would like to discuss your formulation needs, please get in touch with our team.

Why DMSO deserves a fresh look in topical formulation

Why should DMSO be reviewed as a product to be used in topical applications?

NL (gChem): I believe DMSO deserves a fresh look in topical applications as it offers excellent solubilisation and skin penetration-enhancing properties. Unlike excipients such as Polyethylene Glycols (PEGs), DMSO can solubilise lipophilic as well as hydrophilic APIs, the former being important for poorly soluble BCS Class II and IV compounds.

Procipient® DMSO has a long precedence of use (>20 years) in topical drug development and a well-established safety profile, so any negative perception around DMSO is more historical than reflective of its actual pharmaceutical use.

What sets Procipient® apart, and why grade selection matters

DMSO has been used for decades in pharmaceutical development. What makes Procipient® different from other DMSO products available on the market?

NL (gChem): The key difference is that Procipient® has been specifically developed for pharmaceutical applications. It is 99.99% pure, manufactured under International Council for Harmonisation (ICH) Q7 current Good Manufacturing Practice (cGMP) as it is both an API and excipient, and has a long history of pharmaceutical use. Most importantly for topical products, the odour-causing impurities have been removed, so Procipient® is essentially odourless. That combination of high purity, manufacturing control, regulatory support and no garlic odour provides formulators with a very different proposition from other United States Pharmacopeia–National Formulary (USP-NF), European Pharmacopoeia (PhEur) or technical-grade DMSO products.

Why is grade selection of DMSO products such an important consideration when developing topical and transdermal drug products?

NL (gChem): Not all DMSO grades are the same, and grade selection is particularly important when applying the formulation directly onto the skin. Purity and impurity profile can affect skin tolerability, odour and formulation stability, while tight manufacturing controls help ensure the product performs consistently from laboratory scale to commercial production. For a pharmaceutical product, I believe the DMSO grade should be selected as carefully as the API and other critical excipients, rather than simply being considered as a solvent.

The science behind Procipient®'s skin penetration performance

In your new book, ‘The Pharmaceutical Applications of Dimethyl Sulfoxide: From Skin Penetration to Cell Therapy, what do you believe are the most underappreciated opportunities for DMSO in topical drug development today?

NL (gChem): I'm hoping the book will provide educational awareness and a fresh perspective for the use of pharmaceutical grade DMSO (Procipient®) in topical drug development. The book addresses the toxicology concerns and demonstrates the utility of DMSO as a skin penetration enhancer and solubiliser. The areas where I see drug delivery opportunities in the future are in the wider use of DMSO in both transdermal patches and microneedles. A further opportunity for DMSO is its ability to maintain the microstructure of a semi-solid formulation by keeping the API solubilised over its shelf life and in the desired phase. This is critical for maintaining a stable, robust formulation and for ensuring the desired efficacy of the drug product.

DMSO is often described as the gold standard skin penetration enhancer. What are the key mechanisms that allow Procipient® to improve dermal drug delivery?

NL (gChem): DMSO is widely regarded as a benchmark skin penetration enhancer due to its ability to increase membrane fluidity at lower concentrations and form transient aqueous pathways at higher concentrations. These effects reduce the barrier properties of the stratum corneum, facilitating the movement of compounds through both lipid and aqueous domains of the skin. The overall result is enhanced delivery of the active ingredient into and across the skin, while maintaining a formulation profile that remains practical and acceptable for patient use.

In our lab studies/topical concept development using a BCS Class II model compound, Procipient® demonstrated significantly improved skin penetration. What implications does this have for the development of challenging topical drug products?

LdO (IMCD): In our topicals centre of excellence in Mumbai, we worked on a range of formulation trials evaluating the effect of Procipient® on skin permeation, using in vitro release testing with a Franz diffusion apparatus. Adding Procipient® to the formulation had a positive effect on drug release and penetration. Increasing the percentage of Procipient® increased the permeability of the API. The use of 1.5% Procipient® exhibited release comparable to the marketed product, and increasing the percentage of Procipient® demonstrated faster and higher release of the API. A key takeaway for us here is that Procipient® delivers a synergy of effects that cover the key challenges in topical drug development: a poorly soluble API needs to be both dissolved and to cross the skin barrier effectively. Importantly, this potentially reduces the need to compromise between solubility, formulation stability and skin delivery.

Weighing performance against stability and tolerability

When evaluating a penetration enhancer, why is formulation stability just as important as delivery performance?

LdO (IMCD): If a penetration enhancer can deliver excellent skin penetration in a laboratory study, but compromises the formulation stability, that performance will not translate to a viable drug product. Changes in solubility, crystallisation, phase separation or API degradation can alter the amount of drug available for absorption and make delivery performance inconsistent over time. Ultimately, functionality — whilst key — still needs to be stable to deliver consistent performance throughout its shelf life.

How can formulators balance penetration enhancement with tolerability when designing modern topical products?

LdO (IMCD): Balancing penetration enhancement is a case of reviewing efficacy and tolerability. A penetration enhancer needs to improve the API delivery without excessively disrupting the skin barrier, which can lead to irritation, dryness or reduced patient acceptance. As most topical drugs are used on compromised skin over extended periods of time, patient acceptance and therapy adherence are key. All pharmaceutical formulations are ever moving towards more patient-focused solutions that deliver the right amount of drug to the right place, while preserving the skin's natural barrier and ensuring the product remains comfortable to use.

Formulating topical drugs with increased API penetration delivers more active per application, potentially lowering the need for multi-day dosing. Another benefit would be faster and better clinical results for the patient. This quicker symptom relief will convince the patient that the treatment really works, having a direct effect on non-adherence. Improved API delivery using penetration enhancers makes it possible for formulators to move away from occlusive ointments to lighter, more fast-absorbing formulations.

Expanding the range of molecules viable for topical delivery

Apremilast has historically been administered orally. What makes it an attractive candidate for topical development, and what formulation challenges does apremilast present for topical delivery?

LdO (IMCD): Apremilast is used in the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. It is currently available in tablet form; however, there are no commercially available topical formulations for the management of psoriasis. There is a strong rationale for dermal formulation, which include many adverse effects from the oral therapy's first-pass metabolism.

Moving from oral to topical delivery could potentially offer a more targeted route of administration, delivering apremilast directly to the site where it is needed while potentially reducing systemic exposure. Due to the fact that apremilast has low solubility and poor skin permeability, putting this into a conventional topical formulation is unlikely to be successful. This makes apremilast particularly interesting as a model for demonstrating the potential of Procipient® as a solubilising vehicle and penetration-enabling excipient, making it an interesting molecule for next-generation topical formulations.

Could penetration enhancers such as Procipient® expand the range of molecules considered viable for topical delivery?

LdO (IMCD): Potentially, yes. One of the major limitations in topical drug development is that whilst many APIs have the right pharmacological properties, they struggle to be delivered in sufficient quantities. Procipient® can potentially help widen the formulation window by addressing multiple challenges that many formulators face. This could mean that formulators feel confident to revisit molecules that have historically been difficult to formulate topically, creating a world of opportunities previously considered not possible.

Discuss pharmaceutical grade DMSO for topical formulation with IMCD experts

Want to learn more about Procipient® DMSO, request a sample or discuss your topical formulation challenges with an expert? Fill in the form, and one of our experts will get in touch with you.