1Department of Pharmaceutics, C.L. Baid Metha College of Pharmacy, Old Mahabalipuram Rd, Jothi Nagar, Thoraipakkam, Affiliated to The TN Dr. M.G.R. Medical University, Chennai, Tamil Nadu, India, 600097
2Department of Pharmacology, National Institute of Siddha under Ministry of Ayush, Affiliated to The TN Dr. M.G.R. Medical University, Chennai – 600047
3Department of Pharmacy Practice, C.L. Baid Metha College of Pharmacy, Old Mahabalipuram Rd, Jothi Nagar, Thoraipakkam, Affiliated to The TN Dr. M.G.R. Medical University, Chennai, Tamil Nadu, India, 600097
4Department of Pharmacology, Mohan Babu University, Tirupati, India
*Corresponding Author E-mail: rkumaravelrajan@gmail.com
Online Published on 30 April, 2025.
The mini-tablets formulations have high patient compliances especially paediatrics and geriatrics The present investigation was to develop and compare HPMC K100 M and HPMC K4 M, a combination of processing variables of 32 factorial design factors, in the formulation of 100mg lamotrigine sustained drug release of mini-tablets for paediatric usage. The amount of lamotrigine in each little tablet is 25mg, and they were made using the direct compression method. Dependent variables included drug release and tensile strength. Drug release was sustained for at least 12 hours across all formulations. The drug release was proportional to the HPMC K4M and HPMC K100M concentrations. The dosages of 2, 4, and 6mg were also kept constant. When mini-tablets prepared with combination of polymers (12mg), F8 exhibits a tensile strength of 3.42N/m2 (6mg). Through numerical optimization, HPMC K4M = 11.0mg and HPMC K100 M = 4.50mg were discovered, resulting in 95.4 percent drug release and 3.1 (N/m2) tensile strength. An in vivo study with the optimized formulation in rats showed (AUC 0-t) and (AUMC 0-t) of 1123.4 (h)* (µg/ml) and 3313 h2* (µg/ml) respectively. Cmax and Tmax were 375.0µg/ml and 4 h.
Lamotrigine, Mini tablets, Extended release, Factorial design, Paediatric, Design of Experiment (DoE)
