Formulation and Evaluation of Levetiracetam Extended Release Tablets
Corresponding Author(s) : Sudarshan Singh
International Journal of Pharmaceutical Sciences and Nanotechnology,
Vol 6 No 1 (2013): April-June 2013
Abstract
Extended release formulation of levetiracetam is approved by the food and drug administration as an add-on to other antiepileptic drugs for adults with partial onset seizures. The main objective of present study was to developed and evaluate matrix tablet of levetiracetam by using various grade of hydroxypropylmethylcellulose (HPMC) polymer. Various trials were taken by using HPMC K4M, K15M, and K100M. Different parameters like Physical properties, FTIR, DSC, in vitro drug release profile and swelling index were determined. In vitro drug release was performed in phosphate buffer pH 6.8. The in vitro release profile was compared with model independent method. Stability studies were performed as per ICH guidelines for 1 month at (40 °C ± 2 °C/75 % ± 5 % RH).
Data analysis was performed for determination of drug mechanism and order of drug release. The in vitro drug release profile of optimized formulation was compared with marketed formulation LEVERAXR. The regression value for zero order, first order, Higuchi and Korsmeyer Peppas was found to be 0.9604, 0.9245, 0.9889 and 0.9729, respectively. Similarity factor (f2) and dissimilarity factor (f1) was found to be 88.61 and 1.82, respectively. The FTIR and DSC study shows that there is no chemical interaction between levetiracetam and excipients. From the data analysis, it was concluded that optimized formulation follow Higuchi model having diffusion mechanism. The order of drug release was considered zero order release. Stability study shows that there was no remarkable change in drug release after 1 month. It is concluded that the formulation is stable at accelerated conditions.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
References
Arya RK, Chaurasia H, Bharadwaj P, Garud N and palani S (2011). Development and evaluation of buccal tablets of salbutamol sulphate. International Research Journal of Pharmacy 2: 159- 1622.
Aulton M E (2007). Pharmaceutics the Design and manufacture of medicines, 3rd ed. Churchill Living Stone Elsevier 175 - 177, 336 - 360.
Beckett AH and Stenlake JB (2001). UV-visible Spectrophotometry: Practical Pharmaceutical Chemistry; 4th ed. Part-II, C.B.S.Publishers, Delhi, pp 285-297.
Box GEP, Gunter WG, Hunter and JS Hunter (1978). Statistics for experimenters. An introduction to design, data analysis and model building. John Wiley and Sons. New York. pp 672.
British Pharmacopoeia (2009). The Department of Health, London: The Stationary Office, pp 137-138.
Cornel JA(1981). Experiments with Mixtures: Design, Models and the Analysis of Mixture Data, 1st ed. New York, Wiley.
Daniel C (1976). Applications of Statistics to Industrial Experiments, 2nd ed. New York, Wiley.
Singh et al: Formulation and Evaluation of Levetiracetam Extended Release Tablets 1965
Dass Suvakanta, Padala Narasimha Murthy, Nath Lilakanta and Chowdhury Prasanta (2010) Kinetic modelling on drug release from controlled drug delivery systems. Acta Polonie Pharmaceutica-Drug Research, 217-233.
Davies OL (1978). The Design and Analysis of Industrial Experiments, 2nd ed. New York, Longman Group, pp 259-261.FDA. Guidelines on General Principles of Process Validation.
Rockville, MD: Division of Manufacturing and Product Quality (HFN-320) Center for Drugs and Biologics, 1987.
Ganesh GNK, Manjusha P, Gowthamarajan K, Suresh KR, Senthil V, Jawahar N and Venkatesh N(2011). Design and development of buccal drug delivery system for labetalol using natural polymer. International Journal of Pharmaceutical Research and Development 3(3): 6, 37- 49.
Gavaskar B, Venkateswarlu E, Kumaraswamy D, Dooda D and Nagaraju M (2010). Formulation and evaluation of mucoadhesive tablets of baclofen. International Journal of Pharmacy and Technology 2: 396 - 409.
Hussein Omidian, Seyed-Ali Hasherni, Fahinieh Askari, Siavash Nafisi(1994). Swelling and crosslink density measurements for hydrogels. Iranian J. of Polymer Science and Technology 2 (3): 115-119.
Indian Pharmacopoeia (2010). Govt. of India, Ministry of Health & Family Welfare, Ghaziabad: Indian Pharmacopoeial Commission, pp 714-716, 749-752, 1195.
International Conference on Harmonization (ICH) guidelines (2005).Department of Health and Human Services, Design for stability
testing of new drug substance and products, 2339 - 2340.
Kulkarni G T, Gowathamarajan K, Rao B G, Suresh B(2004).Stability testing of Pharmaceutical product: An overview. Indian Journal of Pharmaceutical Scienc 38 (4): 194 - 202.
Lachman L (1987). The Theory and Practice of Industrial Pharmacy.3rd ed., pp 336- 413.
Lachmann L, Lieberman HA and Joseph LK (2009). The Theory and practice of industrial pharmacy: In Preformulation, 2nd ed., CBS Publisher and Distributors Pvt., Ltd, 171 - 196.
Leon Lachman, Lieberman HA and Kanig JL(1987). The Theory and Practice of Industrial Pharmacy, 3rd ed. Varghese Publishing House, pp 320-324.
Mark Gibson (2004). Pharmaceutical Preformulation and Formulation. CRC Press, pp 424-431.
Martin Patrick, J Sinko (2010). Physical Pharmacy and pharmaceutical sciences: In Micromeritics, Wolters Kluwer,Lippincott Williams and Wilkins New Delhi, South Asian Edition 6th ed., 451, 461 - 466, 533 - 560.
Moore (2007). Statistical Design and Analysis of Stability Studies Published by CRC Press, pp 330.
Paulo C and Jose M S L (2001). Modelling and comparison of dissolution profile, European Journal of Pharmaceutical Sciences 13: 123 - 133.
Pavia DL, Lampman GM and Kriz GS. Introduction to Spectroscopy; 3rd ed. library of congress catalogue, Washington, pp 26-27.
Perioli L, Ambrogi V, Rubini B, Giovangoli S, Ricci M, Blasi P and Rossi C (2004). Novel mucoadhesive buccal formulation containing metronidazole for the treatment of periodontal disease. Journal of Controlled Release 95: 521-533.
Prasanth VV, Mudiyala Sirisha, Mathew Sam T and Mathapan Rinku (2011). Buccal tablet-as mucoadhesive drug delivery: An over view. Journal of Pharmacy Research 706-709.
Remington (2000). The science and Practice of Pharmacy, 19th ed. 1660, pp 1676-1995.
Sharma BK (2007). Instrumental Methods of Chemical Analysis 5th ed. Goel Publication House, Meerut, pp 133-161.
Skoog AD, Holler FJ, Stanley RC (2010). Instrumental Analysis, Cengage Learing India Private Limited, New Delhi, 8th ed., 488,978 – 986.
Subramanyam CVS (2008). Text book of pharmaceutical, 2nd ed., 211- 224.
United State Pharmacopoeia (2008). 31st ed. USP Convention
Rockville 1882.
