Development and In Vitro Evaluation of Buccal Effervescent Tablet Containing Ropinirole Hydrochloride
Keywords:Buccal delivery, Kyron T-314, Ropinirole hydrochloride, Superdisintegrants
The buccal delivery is an attractive route to improve the clinical efficacy of ropinirole hydrochloride (RH) for the treatment of Parkinson and restless syndrome since this drug undergoes extensive first-pass effect, which has only 50% bioavailability after oral administration. The purpose of this study was to develop and optimize the formulation of fast disintegrating buccal effervescent tablets of RH using four types of superdisintegrants. The direct compression method was used to develop four different formulas containing RH using Kyron T-314, crospovidone, croscarmellose sodium, and sodium starch glycolate separately as a superdisintegrant. Sodium bicarbonate and citric acid were added to the formulations to produce effervescence, while sodium carbonate was used as a pH adjusting agent. All the prepared formulas were evaluated, in terms of weight variation, friability, content dose uniformity, hardness, disintegration, and dissolution test. The best formulation was selected for the subsequent study. The obtained results from pre-compression studies were in acceptable range according to British Pharmacopoeia. All formulas passed through the quality control test and significant difference (P < 0.05) was observed for the formula four compared to other formulas, due to the presence of Kyron T-314 as a superdisintegrant in formulation number 4. RH cloud be prepared as a buccal effervescent tablet and superdisintegrant provide fast disintegration of the tablet to exert rapid action.
Bhimani, J. G., S. D. Patel and S. S. Srinivasm. 2014. Formulation and evaluation of fast disintegrating sublingual tablets of ropinirole hydrochloride. Int. J. Pharm. Sci. Rev. Res. 29: 268-275.
Durfee, S., J. Messina and R. Khankari. 2006. Fentanyl effervescent buccal tablets. Am. J. Drug Deliv. 4: 1-5.
Gayke, A. U., S. B. Aglawe, R. M. Gadekar and T. P. Bagul. 2017. Formulation and evaluation of controlled release tablet of ropinirole HCL. Am. J. PharmTech Res. 7: 344-361.
Jayesh, H. J., J. P. Amit, K. S. Dhaval and K. S. Sudarshan. 2012. Formulation and Evaluation of Buccal Tablet of Ropinirole Hydrochloride. Inventi Raoid: Pharm Tech Publisher, Bhopal.
Jyothi, G. and P. K. Lakshmi. 2011. Comparative evaluation of natural and synthetic superdisintegrants with newer superdisintegrant kyron T-314. Acta. Pharm. Sci. 53: 35-44.
Kumar, M. K., K. Nagaraju, S. Bhanja and M. Sudhakar. 2014. Formulation and evaluation of sublingual tablets of terazosin hydro-chloride. Int. J. Pharm. Sci. Res. 5: 417-427.
Kumudhavalli, M. V., K. A. Babu and B. Jaykar. 2011. DU validated spectrophotometric determination of ropinirole in formulation. Asian. J. Biochem. Pharm. Res. 1: 302-306.
Mallikarjuna, S. C., D. V. Prasad and V. R. Gupta. 2008. Development of fast dispersible aceclofenac tablets: Effect of functionality of superdisintegrants. Indian J. Pharm. Sci. 70: 180-185.
Mohan, M., M. Senthikumar and D. Hariharan. 2012. Formulation and evaluation of ropinirole HCL extended release matrix tablets. Int. J. Pharm. Sci. Res. 2: 242-251.
Mundada, A. S. and B. R. Gandhi. 2010. Evaluation of KYRON T-314 (polacrillin potassium) as a novel super disintegrant. Int. J. Drug Deliv. 3(1): 109-114.
Rao, R. 2013. Formulation and evaluation of ropinirole buccal patches using different mucoadhesive polymers. RGUHS J. Pharm. Sci. 3: 32-39.
Rowe, R. C., P. J. Sheskey and S. C. Owen. 2006. Handbook of Pharmaceutical Excipients. 5th ed. Pharmaceutical Press, London. p532-534.
Sandri, G., M. C. Bonferoni, F. Ferrari, S. Rossi and C. Caramella. 2006. Differentiating factors between oral fast-dissolving technologies. Am. J. Drug Deliv. 4: 249-262.
Sharma, R., M. Yasir and A. Gupta. 2010. Formulation and evaluation of fast disintegrating sublingual tablets of glipizide: An attempt to treat diabetic coma. Int. J. ChemTech. Res. 1: 2026-2033.
Tangri, P. and N. V. S. Madhav. 2012. Formulation and evaluation of atorvastatin loaded extended release tablets. Der. Pharm. Lett. 4: 833-839.
Taylor, M. K., J. Ginsburg, A. Hickey and F. Gheyas. 2000. Composite method to quantify powder flow as a screening method in early tablet or capsule formulation development. AAPS. PharmSciTech. 1: 18.
Velmurugan, S., B. Deepika, K. Nagaraju and S. Vinushitha. 2010. Formulation and in vitro evaluation of buccal tablets of piroxicam. Int. J. PharmTech. Res. 2: 1958-1968.
Wolfgang, H. J. and D. Angersbach. 2005. Ropinirole, a non-ergoline dopamine agonist. CNS Drug Rev. 11: 253-272.
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