Methylcobalamin

Neuropathic pain is intense in nature and difficult to maintain. The main aim of this study is to provide maximum relief from pain.  The objective was to prepare bilayer tablet comprising  of pregabalin and methylcobalamin for effective treatment of neuropathic pain. Methylcobalamin was formulated as immediate release (IR) layer using super-disintegrant sodium starch glycolate (SSG) whereas pregabalin was formulated as sustained release (SR) layer using polymers hydroxypropyl methyl cellulose (HPMCK4M, K100M)  to deliver the drug at sustained manner effective for the treatment of neuropathic pain. The SR layer of pregabalin is prepared by wet granulation method and IR layer of methylcobalamin is prepared by direct compression method. Tablet blends were evaluated through various pre-compression and post-compression tests. Super disintegrant, SSG at 20% concentration produced excellent results for immediate release of methylcobalamin to exert its action and other additional beneficial effects. The K100M and K4M grade of HPMC produced excellent SR efficiency. Optimum formulation released methylcobalamin and pregabalin at 98.92%  in 45 min and 97.81% in 12 h from respective layers. Pre-compression and post-compression parameters of optimized IR layer comprising Methylcobalamin and SR layer comprising pregabalin exhibit satisfactory results. Bilayer tablet of Methylcobalamin and pregabalin prove to be effective as a combination therapy for the treatment of neuropathic pain by sequential release of the drug.

To method develop and validate simple, rapid, cost effective, linear, accurate, precise and economical for the simultaneous estimation of Pregabalin and Methylcobalamin in bulk and tablet dosage form by using UV-Spectrophotometry. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV-Spectroscopic method was developed for estimation of Pregabalin and Methylcobalamin in bulk and tablet dosage form and also validated as per ICH guidelines. The method based on measurement of absorbance at two wavelengths 222 nm (λmax of Pregabalin) and 219 nm (λmax of Methylcobalamin) in Ethanol and distilled water. Linearity graph of Pregabalin and Methylcobalamin were found to be linear in the concentration ranges of 30-150 μg/ml and 0.6-3 μg/ml, respectively, with their correlation coefficient values (R2) 0.999. The low %RSD values indicate method to be accurate and precise. The % recovery of tablets found to be in range of 97-102% and other validation parameter were found to be within the limits as per ICH guidelines.