Abstract

FORMULATION AND IN VITRO EVALUATION OF PANTOPRAZOLE SODIUM TABLET IN TABLET USING COMPRESSION COATING TECHNOLOGY

Gunjan A. Satpute*, Pankaj Pimpalshende

ABSTRACT

The current study explains the formation of a Tablet-in-Tablet (TiT) dosage form of Pantoprazole Sodium in which compression coating is used to attain the effects of co-administration of chronotherapeutic drugs with a given lag time. This will be aimed at ensuring that nocturnal conditions that are associated with acid, including GERD and duodenal ulcers, are prevented. Wet granulation was performed with each concentration of sodium starch glycolate (0.96-1.80 mg) superdisintegrant, to produce three formulations (F1-F3): core tablets containing 40 mg Pantoprazole Sodium. These cores were then compression-coated with ethyl cellulose as a rate controlling polymer and microcrystalline cellulose as a dilution. FTIR preformulation tests revealed the compatibility of the medicine with excipients. Micromeritic analysis of the granules revealed that they have good flow characteristics, Carr Index 9.93, Hausner 1.11 with an angle of repose less than 20. Core tablets were of pharmacopeial hardness (6.5-8.5 kg), friability (<0.6%), weight change and disintegration time (2-4 minutes). Cumulative drug release (CDR) in vitro was 81.12% in 210 minutes. F2 with more ethyl cellulose (174 mg) had a good lag time (around 3 hours) released 1percent drug during the first hour and 80.51percent CDR at 240 minutes among coated players. This design assists administration at 10 PM, allowing the release of the drug in the early morning hours, thus enhancing its therapeutic efficacy, compliance, and decreasing the dosing rate, among other factors.

Keywords: Tablet in Tablet, Compression Coating, Pantoprazole Sodium, Chronotherapeutic Drug Delivery, Controlled Release, Lag Time.