Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine

DOI:

https://doi.org/10.37285/ijpsn.2015.8.2.11

Authors

  • Sudarshan Singh
  • S S Shyale
  • P Karade

Abstract

The aim of this study was to design orally disintegrating tablet (ODT) of Lamotrigine. It is an Antiepileptic drug which is widely used in epilepsy. It is also used in simple and complex partial seizures and secondary generalized tonic-clonic seizures. It is poorly water soluble drug (0.46 mg/ml). Thus, an attempt was made to enhance the water solubility by complexation with β-cyclodextrin (1:1 molar ratios). The orally disintegrating tablet of lamotrigine was prepared by direct compression method using different concentration of superdisintegrants such as Sodium starch glycollate, croscarmellose sodium by sublimating agent such as camphor. The formulations were evaluated for weight variation, hardness, friability, drug content, wetting time, in vitro disintegration time and in vitro dissolution studies. The prepared tablets were characterized by Fourier transform infrared spectroscopy and differential scanning calorimetry. The disintegration time for the complexed tablets prepared by different concentration of superdisintegrants was found to be in range of 32.54 ± 0.50 to 55.12 ± 0.57 sec and wetting time of the formulations was found to be in range of 28.47 ± 0.67 to 52.19 ± 0.72 sec. All the formulation showed almost 100 percent of drug release within 15 min. Among all the formulation F6 and F7 prepared with 18% croscarmellose sodium and camphor shows faster drug release, respectively 10 min, F6 gives good result for disintegration time, drug release, wetting time and friability. Further formulations were subjected to stability testing for 30 days at temperature of 40 ± 5 ºC/75 ± 5 %RH. Tablets showed no appreciable changes with respect to physical appearance, drug content, disintegration time and dissolution profiles. Results were statistically analyzed by one-way ANOVA at a p < 0.05. It was found that, the data at any point of time are significant at p < 0.05.

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Lamotrigine, β-Cyclodextrin, Sodium starch glycollate, Croscarmellose.

Downloads

Published

2015-05-31

How to Cite

1.
Singh S, Shyale SS, Karade P. Formulation and Evaluation of Orally Disintegrating Tablets of Lamotrigine. Scopus Indexed [Internet]. 2015 May 31 [cited 2024 Jun. 20];8(2):2881-8. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/779

Issue

Section

Research Articles

References

Alexander A, Tripathi DK, Giri TK, Khan J, Suryawanshi V and Patel RJ (2010). Technologies Influencing Rapidly Disintegrating Drug Delivery Systems: A Review. Int J Pharma Prof Res. 1(2):212-218.

Bhandari S, Mittapalli RK, Gannu R, Rao YM (2008). Orodispersible Tablets: An overview. Asian J Pharm. 1: 2-11.

Devi NK, Rani AP and Mrudula BS (2010). Formulated and Evaluated of Oral Disintegrating Tablets of Montelukast Sodium: Effect of Functionality of Superdisintegrants. J Pharm Res. 3(4): 803-808.

ICH (2003).Harmonised Tripartite Guideline Stability Testing of New Drug Substances and Products Q1a (R2). Current Step 4 Version, pp 1-23.

Indian Pharmacopoeia (2007).Govt of India, Ministry of Health and FamilyWelfare, Vol-II. Delhi; pp. 667-668.

Khinchi MP, Gupta MK, Bhandari A, Sharma N and Agarwal D (2010). Design and Development of orally Disintegrating Tablets of Famotidine Prepared by Direct Compression Method using Different Super-Disintegrants. J Appl Pharm Sci. 01(01):50-58.

Kundu S and Sahoo PK (2008). Recent Trends in the Developments of Orally Disintegrating Tablet Technology. Pharma Times 40(4): 11-20.

Martindale (2007). The Complete Drug Reference, 36th edition, Vol-1, Pharmaceutical Press. pp. pp. 485-488.

MeyersRA (2000). Interpretation of Infrared Spectra: A Practical Approach in Encyclopaedia of Analytical Chemistry, pp-1-23.

Rampure MV, Bendegumble B, Raju SA, Deshpande R and Swamy PV (2010). Formulation Design of Rapidly Disintegrating Phenobarbitone Tablets by Direct Compression Method. Int J Pharm Bio Sci. 1(4): 6.2-68.

Reddy D, Pillay V, Choonara YE and Toit LC (2009). Rapidly Disintegrating Oromucosal Drug Delivery Technologies. Pharm Dev Tech. 14(6): 588-601.

Sawarikar PP., Sridhar BK.and ShivkumarS (2010). Formulation and Evaluation of Fast Dissolving/Disintegrating Tablets of Isoxsuprine Hydrochloride. J CurrPharm Res . 3(1): 41-46.

Sayeed A. and Mohiuddin H (2011). Mouth Dissolving Tablets: An Overview. International J Res Pharm Biomed Sci. 2 (3): 959-970.

Sudarshan Singh and Dhaval Shah (2010). Development and Characterization of Mouth Dissolving Tablet of Zolmitriptan. Asian Pacific J Tropical Dis . 457-464.

Thakur RR and Mridul Kashi (2011). An Unlimited Scope for Novel Formulations as Orally Disintegrating Systems: Present and Future Prospects.J Applied Pharma Sci . 1 (01): 13-19.

Velmurugan S and Sundar Vinushitha (2010). Oral Disintegrating Tablets: An Overview. Int J Chem PharmSci. 1 (2): pp. 1-12.