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Formulation of Extended-release Beads of Lamotrigine Based on Alginate and Cassia Fistula Seed Gum by QbD Approach

Author(s):

Dixita Jain, Akshay Sodani, Swapnanil Ray, Pranab Ghosh and Gouranga Nandi*   Pages 1 - 16 ( 16 )

Abstract:


Aim: This study was focused on the formulation of multi-unit extended-release peroral delivery device of lamotrigine for better management of epilepsy.

Background: The single-unit extended-release peroral preparations often suffer from all-or-none effect. A significant number of multi-unit delivery systems have been reported as solution to this problem. But most of them are found to be composed with synthetic, semi-synthetic or their combination having physiological toxicity as well as negative environmental impact. Therefore, fabrication and formulation of multi-unit extended-release peroral preparations with natural nontoxic biodegradable polymers employing green manufacturing process are being appreciated worldwide.

Objective: Lamotrigine-loaded extended release multi-unit beads have been fabricated with incorporation of a natural polysaccharide Cassia fistula seed gum in calcium-cross-linked alginate matrix employing a simple green process and 23 full factorial design.

Methods: The total polymer concentration, polymer ratio and [CaCl2] were considered as independent formulation variables with two different levels of each for the experiment-design. The extended-release beads were then prepared by ionotropic gelation method using calcium chloride as crosslinker-ions provider. The beads were then evaluated for drug encapsulation efficiency and drug-release. ANOVA of all the dependent variables such as DEE, cumulative % drug release at 2h, 5h, 12h, rate constant and dissolution similarity factor (f2) were done by 23 full factorial design using Design-Expert software along with numerical optimization of the independent variables in order to meet USP-reference release profile.

Results: The optimized batch showed excellent outcomes with DEE of 84.7±2.7 (%), CPR2h of 8.41±2.96 (%), CPR5h of 36.8±4.7 (%), CPR12h of 87.3±3.64 (%) and f2 of 65.9.

Conclusion: This approach of development of multi-unit oral device utilizing natural polysaccharides might be inspiring towards the world-wide effort for green manufacturing of sustained-release drug products by QbD route.

Keywords:

lamotrigine, extended-release, multi-unit, beads, Cassia fistula seed gum, polysaccharides

Affiliation:

Department of Pharmacy, BCDA College of Pharmacy & Technology, 78, Jessore Road (S), Hridaypur, Barasat, Kolkata – 7000127, Department of Pharmacy, BCDA College of Pharmacy & Technology, 78, Jessore Road (S), Hridaypur, Barasat, Kolkata – 7000127, Department of Pharmacy, BCDA College of Pharmacy & Technology, 78, Jessore Road (S), Hridaypur, Barasat, Kolkata – 7000127, Department of Chemistry, University of North Bengal, Raja Rammohunpur, Dist. – Darjeeling, West Bengal, Pin – 734013, Department of Pharmaceutical Technology, Division of Pharmaceutics, University of North Bengal, Raja Rammohunpur, Dist. – Darjeeling, West Bengal, Pin – 734013



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