CHARACTERIZATION APPROACHES IN TOPICAL CLOFAZIMINE FORMULATION FOR PSORIASIS: AN IN-DEPTH REVIEW
Topical Clofazimine Characterization for Psoriasis
DOI:
https://doi.org/10.55766/sujst6791Keywords:
Analytical Techniques, Anti-inflammatory, Clofazimine, Drug Delivery, Psoriasis, Topical FormulationAbstract
Psoriasis is a chronic, immune-mediated inflammatory skin condition that demands innovative and effective topical therapies to manage symptoms and improve patient quality of life. Clofazimine, historically used for its antimycobacterial properties, has recently gained attention for its anti-inflammatory and immunomodulatory potential in dermatological applications. This review presents a comprehensive evaluation of the formulation and characterization of topical clofazimine for psoriasis treatment. It explores critical physicochemical parameters such as particle size, solubility, and dissolution behavior, which influence skin penetration and bioavailability. The stability of clofazimine formulations is discussed in the context of environmental stressors, including pH, temperature, and photodegradation. Emphasis is placed on advanced analytical techniques-such as Fourier-transform infrared spectroscopy (FTIR), high-performance liquid chromatography (HPLC), and electron microscopy-that are essential for assessing formulation integrity, purity, and performance. Additionally, emerging drug delivery systems, including nanotechnology-based carriers, liposomes, and gels, are examined for their ability to enhance clofazimine delivery and therapeutic efficacy. The review also provides comparative insights with existing topical treatments for psoriasis, reinforcing the clinical potential of clofazimine-based formulations. Future research directions include the development of personalized delivery systems and the execution of well-designed clinical trials to validate efficacy and safety. This analysis underscores clofazimine’s promise as a targeted and effective treatment modality in the evolving landscape of psoriasis management.
References
Ahmed, F., Patel, R., & Sinha, S. (2022). Pharmacokinetic assessment of clofazimine-loaded solid lipid nanoparticles for dermal delivery. International Journal of Pharmaceutics, 618, 121658. https://doi.org/10.1016/j.ijpharm.2022.121658
Armstrong, A. W., & Read, C. (2020). Pathophysiology, clinical presentation, and treatment of psoriasis: A review. JAMA, 323(19), 1945-1960. https://doi.org/10.1001/jama.2020.4006
Bhagiyalakshmi, M., & Vinoba, M. (2025). Recent developments in chromatography for pharmaceutical analysis. In Advances in Separation Sciences (pp. 121-136). Elsevier. https://doi.org/10.1016/B978-0-323-95292-7.00004-9
Boehncke, W. H., & Schön, M. P. (2021). Psoriasis. The Lancet, 397(10281), 1301-1315. https://doi.org/10.1016/S0140-6736(20)32549-6
Bufarwa, S. M., El-Sefait, R. M., Thbayh, D. K., Belaidi, M., Al-Shemary, R. K., & Abdusamea, R. M. (2024). Antituberculosis, antimicrobial, antioxidant, cytotoxicity and anti-inflammatory activity of Schiff base derived from 2,3-diaminophenazine moiety and its metal (II) complexes: Structural elucidation, computational aspects, and biological evaluation. Reviews in Inorganic Chemistry. https://doi.org/10.1515/revic-2024-0007
Chakith, M. R. S., Pradeep, S., Gangadhar, M., Maheshwari, N. C., Pasha, S., Kollur, S. P., S. N., Shivamallu, C., & Allur Mallanna, S. (2025). Advancements in understanding and treating psoriasis: A comprehensive review of pathophysiology, diagnosis, and therapeutic approaches. PeerJ, 13, e19325. https://doi.org/10.7717/peerj.19325
Chen, Y., Zhao, L., & Feng, X. (2023). Personalized nanomedicine strategies for autoimmune skin diseases. Journal of Controlled Release, 355, 273-289. https://doi.org/10.1016/j.jconrel.2023.01.008
Dissemond, J., Marzano, A. V., Hampton, P. J., & Ortega-Loayza, A. G. (2023). Pyoderma gangrenosum: Treatment options. Drugs, 83(14), 1255-1267. https://doi.org/10.1007/s40265-023-01931-3
Eichinger, J. M., Shan, D. M., Greenzaid, J. D., Anakwenze, L., & Feldman, S. R. (2024). Clinical pharmacokinetics and pharmacodynamics of oral systemic nonbiologic therapies for psoriasis patients. Expert Opinion on Drug Metabolism & Toxicology, 20(4), 249-262. https://doi.org/10.1080/17425255.2024.2335310
Ghasemiyeh, P., & Mohammadi-Samani, S. (2021). Potential of nanotechnology in topical delivery of clofazimine for psoriasis. Drug Development and Industrial Pharmacy, 47(4), 543-552. https://doi.org/10.1080/03639045.2021.1892411
Girão, M. J. B. C., Gomes, J. P., Mendes, J. R., Teixeira, P., & Viveiros, M. (2020). Clofazimine: Current status and future perspectives. Journal of Antimicrobial Chemotherapy, 75(3), 579-592. https://doi.org/10.1093/jac/dkz536
Gisondi, P., Del Giglio, M., & Girolomoni, G. (2021). Treatment approaches to moderate to severe psoriasis. International Journal of Molecular Sciences, 22(18), 9794. https://doi.org/10.3390/ijms22189794
Gupta, P., Rai, N., Verma, A., & Gautam, V. (2024). Microscopy-based methods for characterization, drug delivery, and understanding the dynamics of nanoparticles. Medicinal Research Reviews, 44(1), 138-168. https://doi.org/10.1002/med.21981
Huang, J., Wang, Z., & Liu, T. (2023). Evaluation of dermal retention and irritation of clofazimine nanoemulsion. Drug Delivery and Translational Research, 13(1), 140-150. https://doi.org/10.1007/s13346-022-01197-w
Kandagatla, H. P., Kathawala, M. H., Syed, A., Verbić, T. Ž Avdeef, A., Kuentz, M., & Serajuddin, A. T. (2025). Highly increasing solubility of clofazimine, an extremely water-insoluble basic drug, in lipid-based SEDDS using digestion products of long-chain lipids. Journal of Pharmaceutical Sciences, 114(6), 103782. https://doi.org/10.1016/j.xphs.2025.103782
Kumar, V., Sharma, S., & Gupta, R. (2023). Novel nanoformulations for topical drug delivery in chronic inflammatory skin diseases. Pharmaceutical Research, 40, 303-320. https://doi.org/10.1007/s11095-023-03491-4
Li, Q., Zhang, J., & Tan, Y. (2022). Anti-inflammatory efficacy of liposome-encapsulated clofazimine in imiquimod-induced psoriasis model. European Journal of Pharmaceutics and Biopharmaceutics, 177, 52-60. https://doi.org/10.1016/j.ejpb.2022.08.003
Lynch, J. M., Corniuk, R. N., Brignac, K. C., Jung, M. R., Sellona, K., Marchiani, J., & Weatherford, W. (2024). Differential scanning calorimetry (DSC): An important tool for polymer identification and characterization of plastic marine debris. Environmental Pollution, 346, 123607. https://doi.org/10.1016/j.envpol.2024.123607
Mehta, A., Joshi, N., & Rathod, V. (2023). Case series on dermatological repositioning of clofazimine: Evidence and insights. Dermatologic Therapy, 36(2), e15724. https://doi.org/10.1111/dth.15724
Mishra, P. R., Al Shaal, L., Müller, R. H., & Keck, C. M. (2020). Physicochemical and formulation aspects of nanocrystals for dermal application. International Journal of Pharmaceutics, 586, 119555. https://doi.org/10.1016/j.ijpharm.2020.119555
Moreira, L. M. C. D. C., Oliveira, A. C. D. J., Chaves, L. L., Soares, M. F. D. L. R., & Soares-Sobrinho, J. L. (2024). From challenges to solution: The evolving landscape of leprosy management. Advanced Therapeutics, 7(12), 2400249. https://doi.org/10.1002/adtp.202400249
Omoteso, O. A., Fadaka, A. O., Walker, R. B., & Khamanga, S. M. (2025). Innovative strategies for combating multidrug-resistant tuberculosis: Advances in drug delivery systems and treatment. Microorganisms, 13(4), 722. https://doi.org/10.3390/microorganisms13040722
Papadopoulou, S. N. A., Anastasiou, E. A., Adamantidi, T., Ofrydopoulou, A., Letsiou, S., & Tsoupras, A. (2025). A comprehensive review on the beneficial roles of vitamin D in skin health as a bio-functional ingredient in nutricosmetic, cosmeceutical, and cosmetic applications. Applied Sciences, 15(2), 796. https://doi.org/10.3390/app15020796
Papp, K. A., Gooderham, M., Jenkins, R., & Ferris, L. K. (2021). Selective TYK2 inhibition and the future of psoriasis treatment. Journal of the American Academy of Dermatology, 85(2), 432-440. https://doi.org/10.1016/j.jaad.2021.02.055
Parisi, R., Symmons, D. P. M., Griffiths, C. E. M., & Ashcroft, D. M. (2020). Global epidemiology of psoriasis: A systematic review of incidence and prevalence. Journal of Investigative Dermatology, 140(4), 678-685.e6. https://doi.org/10.1016/j.jid.2019.08.026
Patil, S., Kumbhar, A., & Sawant, K. (2022). Permeation enhancement and skin targeting of clofazimine via nanoemulsions. Colloids and Surfaces B: Biointerfaces, 214, 112482. https://doi.org/10.1016/j.colsurfb.2022.112482
Philpott, L. (2024). Beyond the rash: Supporting customers with psoriasis. Australian Journal of Pharmacy, 105(1244).
Ponsonby-Thomas, E., Lau, C., Tan, S., Salim, M., & Boyd, B. J. (2024). Stability of extemporaneously prepared clofazimine oral suspensions. Journal of Pharmacy Practice and Research, 54(1), 55-60. https://doi.org/10.1002/jppr.1893
Rahman, N., Bhatia, A., & Singh, H. (2024). Translational roadmap for topical anti-inflammatory drug delivery systems. Current Drug Delivery, 21(1), 45-59. https://doi.org/10.2174/1567201820666231222090045
Santos, A. C., Morais, F., Simões, A., Pereira, I., Sequeira, J. A., Pereira-Silva, M., & Ribeiro, A. (2019). Nanotechnology for the development of new cosmetic formulations. Expert Opinion on Drug Delivery, 16(4), 313-330. https://doi.org/10.1080/17425247.2019.1585426
Singh, A., & Bali, A. (2016). Formulation and characterization of transdermal patches for controlled delivery of duloxetine hydrochloride. Journal of Analytical Science and Technology, 7, 1-13. https://doi.org/10.1186/s40543-016-0105-6
Singh, S., Jain, P., & Varma, R. (2023). Bridging preclinical efficacy to clinical readiness in nanoformulated psoriasis therapies. Expert Opinion on Drug Delivery, 20(4), 497-508. https://doi.org/10.1080/17425247.2023.2178234
Sternicka, J., Nowicki, R. J., Bieniaszewski, L., & Purzycka-Bohdan, D. (2025). Off-label treatment in inflammatory skin diseases-European point of view. Journal of Clinical Medicine, 14(7), 2376. https://doi.org/10.3390/jcm14072376
Tong, L. Z., Desai, R. M., Olsen, R., & Davis, M. (2024). The pathophysiology, diagnosis and management of chronic inflammatory skin diseases. Discovery Medicine, 36(189), 1933-1954. https://doi.org/10.24976/Discov.Med.202436189.180
Topalović, I. A., Marković, O. S., Pešić, M. P., Kathawala, M. H., Kuentz, M., Avdeef, A., & Verbić, T. Ž. (2024). Effects of different weak small organic acids on clofazimine solubility in aqueous media. Pharmaceutics, 16(12), 1545. https://doi.org/10.3390/pharmaceutics16121545
Wang, Y., Liu, H., & Cheng, Z. (2022). Recent advances in nanotechnology-enabled topical delivery systems for inflammatory skin diseases. Acta Pharmaceutica Sinica B, 12(2), 891-908. https://doi.org/10.1016/j.apsb.2021.09.014
Zhang, H., Lin, S., & Xu, X. (2023). Clofazimine-loaded liposomes for enhanced skin delivery: Formulation development and mechanistic insights. International Journal of Nanomedicine, 18, 567-579. https://doi.org/10.2147/IJN.S399841








