FORMULATION AND EVALUATION OF DICLOFENAC SODIUM-LOADED CHITOSAN–ALGINATE BASED TRANSDERMAL DRUG DELIVERY SYSTEM: A COMPREHENSIVE REVIEW

Registration ID: IJNRD_325485

Published ID: IJNRD2605735

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Ajay Babu, Santosh Kumar Mishra, Akhilesh Kumar Tripathi

Diclofenac sodium, transdermal drug delivery, chitosan, alginate, natural polymers, NSAIDs, musculoskeletal disorders, permeation enhancers.

Musculoskeletal disorders (MSDs) are currently among the common factors that contribute to chronic pain and physical impairment all over the globe. Various disorders include osteoarthritis, lower back pain, muscle stiffness, and joint inflammation that impact the everyday lives of millions of people, mainly the elderly and those whose lifestyles involve significant physical work. In addition, addressing MSDs entails taking long-term pain-relievers and anti-inflammatory medications. Diclofenac sodium is among the widely-used NSAIDs owing to its effectiveness as an analgesic and anti-inflammatory agent. Nonetheless, after taking oral doses over extended periods of time, there may arise some adverse side effects from the intake of diclofenac; these include irritation in the stomach, development of ulcers in the digestive system, gastrointestinal discomfort, and poor drug absorption. The abovementioned drawbacks hinder effective treatment of chronic pain in many cases. While patch-based delivery methods have emerged as alternatives for overcoming some disadvantages of oral medications, a significant number of patches continue to be produced by using synthetically-made polymers and adhesives that may cause irritation of the skin. The objective of the current study was to develop a novel transdermal patch based on naturally derived ingredients that could effectively deliver diclofenac sodium to patients and at the same time be safe and non-irritant to skin tissues. In contrast to many other transdermal patches that use artificial components in their composition, in the current case naturally-derived biodegradable polymers such as chitosan and alginate were used due to their high level of compatibility and film-forming ability. Polyelectrolyte complexes composed of these biodegradable polymers were developed to provide controlled release of drugs while being compatible with skin tissues. Moreover, to increase permeability of the skin barrier, terpene compounds like menthol and nerolidol were used in the study as enhancers. The initial stage of the study included several analytical tests of purity and stability of diclofenac sodium and its compatibility with biodegradable polymers. Transdermal patches have been manufactured using the solvent casting technique, and various ratios of polymer composition, plasticizer concentration, and terpene were investigated to obtain the most appropriate formulation. Among all the formulated patches, the one having equal ratios of chitosan and alginate, together with glycerol and nerolidol, exhibited the highest efficiency. The optimum patch was observed to be smooth, flexible, and transparent and had good mechanical strength and superior folding resistance, implying that it would easily sustain frequent manipulation without getting damaged. There was uniform distribution of the drug within the patch, while the pH value of its surface was maintained near the skin pH level. The results from the drug release study showed that the formulated patch was able to deliver the drug gradually over a period of 24 hours. Unlike other formulations, the patch delivered the drug in a gradual and controlled manner rather than the rapid delivery method used in other formulations. This makes the patch ideal for use in pain relief over an extended period of time. Additional permeation studies demonstrated that natural terpene enhancers had a pronounced effect on increasing permeability of diclofenac through the skin. In this connection, nerolidol played an especially important role in the improvement of drug delivery because it enabled the developed formulation to deliver larger amounts of drug into tissues in comparison with permeation enhancer-free systems. Anti-inflammatory activity of the new transdermal patch was investigated using an inflammatory model in animals. It should be noted that the new system showed a high anti-inflammatory effect, its efficacy being comparable to the efficacy of standard gels based on diclofenac but in some aspects even exceeding their activity. Moreover, the effect produced by the patch lasted several hours indicating its high potential to provide drug action during an extended period of time without the necessity of repeated administration of the dosage form. As for the results of observation in patients suffering from musculoskeletal problems, they were quite positive. Pain reduction was sustained for a long time, and there were no reports on skin irritation. In summary, the current study managed to prove that using a chitosan-alginate transdermal patch composed of terpenes as permeation enhancers is a successful technique for treating musculoskeletal diseases. In addition to enhancing drug delivery into the skin, the patch offers sustained analgesia, alleviates inflammation symptoms, and has great skin compatibility. These results indicate that using natural polymers to prepare a transdermal patch could be a viable option for patients suffering from chronic pain and inflammation.

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Ajay Babu, Santosh Kumar Mishra, & Akhilesh Kumar Tripathi (May-2026). FORMULATION AND EVALUATION OF DICLOFENAC SODIUM-LOADED CHITOSAN–ALGINATE BASED TRANSDERMAL DRUG DELIVERY SYSTEM: A COMPREHENSIVE REVIEW. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 11(5), h419-h449. https://ijnrd.org/papers/IJNRD2605735.pdf

Volume 11 Issue 5, May-2026

Pages : h419-h449

Paper Reg. ID: IJNRD_325485

Published Paper Id: IJNRD2605735

Research Area: Pharmacy All

Author Type: Indian Author

Country: Barabanki, Uttar Pradesh, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2605735.pdf

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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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