Formulation and In-Vitro Evaluation of Enteric Coated Tablet Incorporating Rabeprazole

The objective of the work is to try and assess the applicability and manufacturing possibilities to optimize an enteric coated tablet formulation containing Rabeprazole sodium as the drug aiming at the anti-acidity activity with desired drug release properties. Enteric coated tablet was chosen as dosage form being a cost-effective technology for pharmaceutical industry requiring fewer procedures. Before the implementation of the pharmaceutical technological aims, analysis of critical factors influencing the manufacture was carried out. Reproducible manufacturing processes are required to achieve suitability and tablets uniformity to achieve the uniform properties of tablets, which could influence experimental parameters. Rabeprazole in core content of tablet is blended with HPMC (different grades), xanthan gum, PVPK30, mannitol, crosspovidone, Sodium starch glycolate, Colloidal silicon dioxide to formulate the product. Prepared formulation was tested for weight and content uniformity, physical characteristics, in vitro dissolution behaviour, acid resistance and accelerated stability studies. All studies performed resulted and revealed for assurance of such enteric coated tablet formulation for drug Rabeprazole with optimum characteristics, concluding it as a promising approach to enhance drug release characteristics. Keywords: Rabeprazole, HPMC, enteric coated tablets, In Vitro evaluation.

PREPARATION AND CHARACTERIZATION OF CHITOSAN SUCCINATE AS COATING POLYMER FOR ENTERIC-COATED TABLET

Objective: This present study was aimed to evaluate the potential of chitosan succinate as a coating polymer.Methods: In this study, chemical modification of chitosan was performed by substituting a succinate group into chitosan’s amine group. This reactionused a water-solvent method to obtain chitosan succinate. Chitosan succinate was characterized and used as a coating agent in enteric-coated tabletdosage forms containing sodium diclofenac as the drug model at concentrations of 3% and 4% and combined it with hydroxypropyl methylcellulosephthalate (HPMCP) in ratios of 3:1 and 2:1 (3%). The obtained tablets were evaluated based on their physical appearance, uniformity of weight andsize, thickness film, disintegration time for an hour in acid, and dissolution profile.Results: Although the enteric-coated tablets with 3% and 4% chitosan succinate dissolved after 1 h in acid, they could not hold drug release in theacid medium under 10%. The enteric-coated tablet combined with chitosan succinate and HPMCP (3:1 and 2:1) at 3% did not dissolve after 1 h in theacid medium and could hold drug release up to 8.53% in acid.Conclusion: A combination of chitosan succinate and HPMCP (3:1 and 2:1) at 3% has a better ability to hold drug release in acid medium and met therequirement as a coating in enteric-coated tablet dosage forms.