Formulation of mebeverine hydrochloride MR pellets in capsules and comparative characterization against colofac MR capsules
Journal Title: International Journal of Pharmacy and Analytical Research - Year 2014, Vol 3, Issue 4
Abstract
The aim and objective of the present study is to develop Mebeverine Hydrochloride MR pellets in the form of capsule. Pellets with coating for Modified Release have a lower risk of dose dumping than coated tablets. Modified Release capsules of Mebeverine HCl were formulated by using the solid drug layering (SDL) process by dusting the Drug Excipients mixture on inert MCC pellets by using Povidone K-30 + IPA solution as binder. The drug layered pellets were coated by using the Eudragit S-100, PEG 6000 and Talc dispersed in purified water in order to modify the drug release. The coated pellets are filled in capsules and these capsules were evaluated for assay, weight variation, content uniformity, lock length, moisture content and in-vitro dissolution tests and all within the specification limit. There is no physicochemical interaction between drug and excipient which was proven by compatibility study results which was carried out for 4 weeks at Accelerated stability (AS) condition. The optimized batch F7 is kept under AS conditions (40°C/75%RH) and the product is monitored and analyzed for assay, moisture content, content uniformity, in-vitro dissolution study and all the parameters were well within the specification limit. The release rate was compared with the Reference product “Colofac MR” (Abbot Pharmaceuticals Ltd) and F1 & F2 values were within the limit. And it is pharmaceutically equivalent to that of the reference
Authors and Affiliations
Petchimuthu S
Keywords
Related Articles
- EP ID EP656217
- DOI -
- Views 49
- Downloads 0
RP-HPLC Method Development and Validation for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Tablet Dosage Form
A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Rosuvastatin and Ezetimibe in pharmaceutical tablet dosage form. Chromat...
Formulation and evaluation of combination porous tablet containing naproxen sodium as immediate release and sumatriptan succinate as sustained release
Migraine is a chronic disorder and characterized by splitting headaches. A combination of sumatriptan succinate and naproxen sodium was found to be effective. Time to reach Cmax and biological half-life of both drugs are...
Development and Validation of Uv-Spectrophotometric Method for Estimation of Abacavir Sulfate Nanoparticles.
A simple, precise and accurate spectrophotometric method has been developed for the determination of Abacavir Sulfate nanoparticles. Standard Stock solution was prepared in pH 7.4 phosphate buffer and further dilution we...
Consumer’s Perception Regarding Pharmaceutical Product Packaging: A Survey of Pakistan
The packaging of the pharmaceutical product plays an important role to maintain the product stability and an increase in sales which ultimately increase in profit margin of any organization. The packaging continuously pr...
Analytical Method Development and Validation for Simultaneous Estimation of Lamivudine and Zidovudine in Tablet Dosage form by RP-HPLC
A new, precise, rapid, accurate RP-HPLC method was developed for the Simultaneous Estimation of Lamivudine and Zidovudine in pharmaceutical dosage forms. Chromatographic separation was achieved with mobile phase consisti...