Simvastatin-Encapsulated Topical Liposomal Gel for Augmented Wound Healing: Optimization Using the Box-Behnken Model, Evaluations, and In Vivo Studies

Author:

Rahamathulla Mohamed1ORCID,Pokale Rahul2ORCID,Al-ebini Yousef34ORCID,Osmani Riyaz Ali M.2ORCID,Thajudeen Kamal Y.5ORCID,Gundawar Ravi6ORCID,Ahmed Mohammed Muqtader7,Farhana Syeda Ayesha8ORCID,Shivanandappa Thippeswamy Boreddy9

Affiliation:

1. Department of Pharmaceutics, College of Pharmacy, King Khalid University, Abha 61421, Saudi Arabia

2. Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru 570015, Karnataka, India

3. Department of Cosmetic Science, Faculty of Allied Medical Sciences, Al-Ahliyya Amman University, Amman 19328, Jordan

4. Faculty of Dentistry, Al-Ahliyya Amman University, Amman 19328, Jordan

5. Department of Pharmacognosy, College of Pharmacy, King Khalid University, Abha 61441, Saudi Arabia

6. Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India

7. Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj 11942, Saudi Arabia

8. Department of Pharmaceutics, College of Pharmacy, Qassim University, Buraidah 51452, Saudi Arabia

9. Department of Biomedical Science, College of Pharmacy, Shaqra University, Al-Dawadmi Campus, Al-Dawadmi 11961, Saudi Arabia

Abstract

Statins function beyond regulating cholesterol and, when administered systemically, can promote wound healing. However, studies have yet to explore the topical use of statins for wound healing. The present study demonstrated the topical administration of SIM and aimed to formulate, evaluate, and optimize Simvastatin (SIM)-encapsulated liposome gel carrier systems to facilitate successful topical wound healing. Liposomes containing SIM were formulated and optimized via a response surface methodology (RSM) using the thin-film hydration method. The effects of formulation variables, including the 1,2-dioleoyloxy-3-trimethylammoniumpropan (DOTAP) concentration, Span 80 concentration, and cholesterol concentration, on zeta potential (mV), entrapment efficacy (%), and particle size (nm) were studied. The optimized liposome formulation (F-07) exhibited a zeta potential value of 16.56 ± 2.51 mV, revealing robust stability and a high SIM encapsulation efficiency of 95.6 ± 4.2%, whereas its particle size of 190.3 ± 3.3 nm confirmed its stability and structural integrity. The optimized liposome gel demonstrated pseudoplastic flow behavior. This property is advantageous in topical drug delivery systems because of its ease of application, improved spreadability, and enhanced penetration, demonstrating prolonged SIM release. The assessment of the wound healing efficacy of the optimized liposomal gel formulation demonstrated a substantial decrease in wound size in mice on the sixteenth day post-wounding. These findings suggest that the use of liposomal gels is a potential drug delivery strategy for incorporating SIM, thereby augmenting its effectiveness in promoting wound healing.

Funder

Deanship of Scientific Research at King Khalid University, Saudi Arabia

Publisher

MDPI AG

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