Effect of Superdisintegrants on the Enhancement
Dissolution Characteristics for Lamotrigine
Volume 3 - Issue 4
Raghavendra Kumar Gunda1* and Prasad Rao Manchineni2
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- 1Department of Pharmaceutics, M.A.M college of Pharmacy, India
- 2Department of Pharmaceutical Analysis, M.A.M college of Pharmacy, India
*Corresponding author:
Raghavendra Kumar Gunda, Department of Pharmaceutics, M.A.M college of Pharmacy, India
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|