Formulation and Assessment of Lipid-based Nanoformulation of Luliconazole
Amit Sinhal1*, Rajendra Wagh2
1Department of Pharmaceutics, Prof. Ravindra Nikam College of Pharmacy, Gondur, Dhule, Affiliated to Kavayitri
Bahinabai Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India.
2Department of Pharmaceutical Chemistry, ARA College of Pharmacy, Nagaon, Dhule, Affiliated to Kavayitri Bahinabai
Chaudhari North Maharashtra University, Jalgaon, Maharashtra, India.
Received: 24th December, 2023; Revised: 10th January, 2024; Accepted: 28th February, 2024; Available Online: 25th March, 2024
ABSTRACT
The luliconazole preformulation study aimed to determine the best way to administer medicine using SNEDDS. The plain white powder, luciconazole, showed a number of different crystal structures and was very soluble in isopropyl myristate and oleic acid, as confirmed through partition coefficients in n-octanol. With a robust linear standard curve at 295 nm, UV spectroscopy verified its dependability for analysis. Luliconazole and the necessary excipients for SNEDDS formulation were found to be compatible according to fourier-transform infrared spectroscopy (FTIR) spectra. Using a 32-factorial design enhanced the efficacy and stability of SN-7 batches, especially when diluted with water. Thermal studies revealed formulation dynamics- critical thermal behaviors and crystalline structures (DSC and XRD). The end SNEDDS showed a strong suppression of Candida albicans growth and a higher viscosity, allowing for longer surface retention. Ethical approval facilitated comparative evaluations against a commercial formulation. High-performance liquid chromatography (HPLC) analysis validated SN-7’s purity, enabling a benchmark for monitoring luliconazole plasma concentrations post-application and ex-vivo permeation studies, vital for potential fungal infection treatments. A rigorous three-month stability study affirmed SN-7’s unwavering properties across diverse environmental conditions, ensuring sustained effectiveness. An IEAC-approved skin irritation study on albino wistar rats endorsed SN-7’s minimal irritancy, underscoring its safety and comfort, which is pivotal for pharmaceutical acceptance in topical drug delivery.
Keywords: Luliconazole, SNEDDS, DSC, XRD, TEM, Skin irritation test. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.62
How to cite this article: Sinhal A, Wagh R. Formulation and Assessment of Lipid-based Nanoformulation of Luliconazole. International Journal of Drug Delivery Technology. 2024;14(1):429-441.
REFERENCES
- Hadgraft J. Passive enhancement strategies in topical and transdermal drug International journal of pharmaceutics. 1999 Jul 5;184(1):1-6.
- Kreilgaard M. Influence of microemulsions on cutaneous drug delivery. Advanced drug delivery reviews. 2002 Nov 1; 54: S77-98.
- Singh SK, Durrani MJ, Reddy IK, Khan MA. Effect of permeation enhancers on the release of ketoprofen through transdermal drug delivery Die Pharmazie. 1996 Oct 1; 51(10):741-4.
- Panchagnula Transdermal delivery of drugs. Indian journal of pharmacology. 1997 May 1; 29(3):140-56.
- Sinha VR, Kaur Permeation enhancers for transdermal drug delivery. Drug development and industrial pharmacy. 2000 Jan 1; 26(11):1131-40.
- Tortora GJ, Derrickson Principles of anatomy and physiology. John Wiley & Sons; 2018 May 15.
- Mithal BM, Saha A handbook of cosmetics. VallabhPrakashan, New Delhi. 2000; 141:110-2.
- Jain NK, Controlled and novel drug delivery. New Delhi:CBS publishers & distributors; 1997.
- Mishra V, Singh M, Nayak P, Sriram P, Suttee Carbon Nanotubes as Emerging Nanocarriers in Drug Delivery: An Overview. International Journal of Pharmaceutical Quality Assurance. 2020;11(3):373-378.
- Pragati S, Ashok S. M, Satheesh. Solid lipid nanoparticles a promising drug International Journal of Pharmaceutical Science and Technology. 2009; 1:509-18.
- Pund S, Dhande M, Jayatpal S, Tupe A, Deore S, Tare Scale-up and postapproval changes (SUPAC) guidelines for industry: A comprehensive review. Multidisciplinary Reviews. 2024 Jan 18;7(4):2024071.
- Shivatare R, Jangra S, Gaikwad A, Kewatkar S, Bhutale N, Suryavanshi DS, Tare Development and validation of ICPMS methods for simultaneous determination of elemental impurities in topical cream containing ximenynic acid. Future Journal of Pharmaceutical Sciences. 2023 Jun 2;9(1):47.
- Patra JK, Das G, Fraceto LF, Campos EV, Rodriguez-Torres MD, Acosta-Torres LS, Diaz-Torres LA, Grillo R, Swamy MK, Sharma S, Habtemariam S. Nano based drug delivery systems: recent developments and future prospects. Journal of nanobiotechnology. 2018 Dec; 16(1):1-33.
- Thakur K, Sharma G, Singh B, Katare OP. Topical drug delivery of anti-infectives employing lipid-based nanocarriers: Dermatokinetics as an important tool. Current Pharmaceutical Design. 2018 Dec 1; 24(43):5108-28.
- Mohammed BS, Al-Gawhari FJ. Preparation of Posaconazole Nanosponges for Improved Topical Delivery System. International Journal of Drug Delivery Technology. 2022;12(1):8-14.
- Challa TR, Reshma K. Experimental Design Statistically by Design Expert Software: A Model Poorly Soluble Drug with Dissolution Enhancement and Optimization. International Journal of Drug Delivery Technology. 2022;12(3):1367-1375.