Novel nicotinamide skin-adhesive hot melt extrudates for treatment of acne

ABSTRACT

Objectives: Hot melt extrusion is a continuous process with wide industrial applicability. Till current date, there have been no reports on the formulation of extrudates for topical treatment of dermatological diseases.

Methods: The aim of the present work was to prepare and characterize medicated hot melt extrudates based on Soluplus polymer and nicotinamide, and to explore their applicability in acne treatment. The extrudates were characterized using DSC, FTIR, XRD, and DVS. The extrudates were also tested for their skin adhesion potential, ability to deposit nicotinamide in different skin layers, and their clinical efficacy in acne patients.

Results: The 10% nicotinamide extrudates exhibited amorphous nature which was reserved during storage, with no chemical interaction between nicotinamide and Soluplus. Upon contrasting the skin adhesion and drug deposition of extrudates and nicotinamide gel, it was evident that the extrudates displayed significantly higher adhesion and drug deposition reaching 4.8 folds, 5.3 folds, and 4.3 folds more in the stratum corneum, epidermis and dermis, respectively. Furthermore, the extrudates significantly reduced the total number of acne lesions in patients by 61.3% compared to 42.14% with the nicotinamide gel.

Conclusion: Soluplus extrudates are promising topical drug delivery means for the treatment of dermatological diseases.

KEYWORDS:

• Nicotinamide
• acne
• topical extrudates
• Soluplus
• hot melt extrusion

Acknowledgments

M Nasr would like to acknowledge the Daniel Turnberg foundation for supporting their visit to the University of Bradford.

Declaration of interest

M Nasr received a travel grant from Daniel Turnberg foundation, UK to visit the host laboratory. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Supplementary material

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Additional information

Funding

This manuscript was not funded.