Formulation and Invitro Evaluation of floating Microspheres for the treatment of Helicobacter Pylori

Abstract

Helicobacter pylori infection is a major cause of peptic ulcers and gastric complications Current treatment regimens involve multiple drugs which can lead to poor patient compliance and inconsistent therapeutic outcomes A novel approach integrating triple therapy into a single dosage form may enhance efficacy and patient adherence The study aimed to develop and evaluate a single hard gelatin capsule containing Metronidazole MNZ floating microspheres Clarithromycin CMN floating microspheres and Pantoprazole sodium PZS enteric coated tablets for the effective treatment of H pylori MNZ microspheres were formulated using Plantago ovata seed mucilage POSM while CMN microspheres were prepared using Abelmoschus esculentus fruit mucilage AEFM due to their gastroprotective properties Pantoprazole sodium tablets were enteric coated with Eudragit L 100 and cellulose acetate phthalate A central composite design using Design Expert 11 software was employed to optimize polymer concentrations for drug entrapment efficiency and floating time DSC and FTIR studies were performed for drug excipient compatibility The formulations were assessed for flow properties particle size yield floating behaviour drug release and uniformity Additionally in vivo trials in rabbits were conducted to evaluate systemic drug availability The microspheres and tablets exhibited good flow properties uniformity and extended drug release DSC and FTIR analysis confirmed no significant drug excipient interactions The optimized hard gelatin capsule demonstrated uniform weight proper disintegration and enhanced systemic drug absorption In vivo studies further validated effective systemic drug availability highlighting the potential of this novel formulation for improved H pylori treatment The developed triple therapy capsule containing MNZ floating microspheres CMN floating microspheres and PZS enteric coated tablets offers an effective strategy for H pylori treatment The inclusion of POSM and AEFM enhanced the formulations gastro protective properties making