Studies on Novel Pantoprazole and Cefuroxime Axetil Tablets for Site Specific Delivery.

Abstract

In this study core in coat tablets containing enteric coated Pantaprazole (PP) core and Cefuroxime axetil (CA) floating type coat formulation as single unit prepared by compression coating method. The tablets were evaluated for their various pre-compression, compression characteristics, in vitro drug release kinetics and stability studies. The analytical estimation of drugs was found to be accurate and precise. The results of rheological characteristics indicated that, the powder beds of both core formulations of PP are freely flowable and easily compressible. Acryl EZE coating over the core tablets protects PP from GI fluids and helps in release of drug in intestinal pH. These studies on coat granules indicated that, the granule beds of all the coat formulations of CA are easily compressible and that flow increases with the addition of glidants. The release rate of CA from HPMC K4M formulations is majorly by burst effect, since HPMCK4M (p<0.05) is relatively more hydrophilic and when swells it forms weaker gel. Also, the release of CA from guar gum and xanthan gum formulations follows zero order release (p<0.05). The guar gum when it swells forms thicker gels hence the release rate ‘k’ is small of the three diluents. Stability studies at 40°C / 75% RH indicated that there is no significant change in CA content for a period of 3 months. Therefore it could be concluded that the combination of PP and CA would be useful for improved ulcer therapy associated with symptomatic relief to the patient.

KEYWORDS: Pantoprazole, Acryl EZE, Cefuroxime axetil, In vitro dissolution, Stability studies