Effect of Superdisintegrants on the Enhancement Dissolution Characteristics for Lamotrigine

Volume 3 - Issue 4

Raghavendra Kumar Gunda¹* and Prasad Rao Manchineni²

Received: March 16, 2020;   Published: April 20, 2020

DOI: 10.32474/DDIPIJ.2020.03.000166

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Abstract

The purpose of present investigation to study the effect of various superdisintegrants on the dissolution characteristics of Lamotrigine by formulating oral disintegrating tablets (ODT). Lamotrigine, an antiepileptic agent, belongs to type –II as per Biopharmaceutical Classification System (BCS) exerts Low aqueous solubility and high permeability behavior. ODT formulations of Lamotrigine were prepared using different quantities of Sodium Starch Glycolate (SSG) & Crospovidone (CP) employed as Superdisintegrants by Direct Compression technique as per 32 Factorial Design. Nine trials were formulated by considering amount of Crospovidone (X1), amount of SSG (X2) as Independent variables. The developed Formulations were evaluated for Pharmaceutical Product Performance. The t10%, t50%, t90%, Wetting time, Disintegration time were taken as Dependant variables. Results shows that all the formulations were lie within the acceptance criterion and the In-vitro dissolution profiles were subjected to kinetic modeling. The Polynomial equations were derived for dependant variables and are verified for validity by formulating Countercheck trials.

Conclusion: Formulation (F4) containing 35 mg of Sodium Starch Glycolate & 40 mg of Crospovidone was found to be best one among all and also similar to the Marketed product (LAMICTAL-25) (f2= 73.17, f1= 3.65 & No significant difference, t= 0.0218) to marketed product.

Keywords: Lamotrigine; Super disintegrates; Crospovidone; Sodium starch glycolate; Sodium; Wetting time; Disintegration time; Non-Fickian diffusion

Abbreviations: ODT: Oral Disintegrating Tablet; SD: Solid Dispersion; PEG: Poly Ethylene Glycol; CP: Crospovidone; SSG: Sodium Starch Glycolate; X1: Amount of Crospovidone; X2: Amount of Sodium Starch Glycolate; mg: milligram; mL: milliliter; IPQC: In- Process Quality Control; % CDR: Percentage Cumulative Drug Release; RPM: Revolutions per minute; BCS: Biopharmaceutical Classification System; UR: Un Released; Min: Minute; ºC: Degree Centigrade; mm: millimeter; t50%: Time taken to release 50% drug from dosage form; t90%: Time taken to release 90% drug from dosage form; WT: Wetting time; DT: Disintegration time dissimilarity factor; f1: Dissimilarity factor; f2: Similarity factor

Abstract| Introduction| Materials and Methods| Evaluation of Lamotrigine Fast Dissolving Tablets| Results and Discussion| Conclusion| References|