Developing a compact dosage system for the management of helicobacter pylori peptic ulcers

Non-adherence to medication therapy is a significant cause of treatment failures and antimicrobial resistance worldwide. This study aims to design a less bulky, single oral multicomponent dosage unit to improve access and adherence to combination therapies for Helicobacter pylori-indicated peptic ulcers, reducing pill burden, cost, side effects, and overall patient adherence. The study investigates the use of supercritical carbon dioxide and extrusion-spheronisation formulation techniques to create a single-unit solid oral dosage system with improved solubility using various optimization strategies. It utilized DSC, FTIR, XRD, and dissolution techniques to conduct baseline studies on commercially purchased oral dosage forms of clarithromycin, omeprazole, and amoxicillin. Solid dispersions and pellets were generated from the three model drugs and characterised. Solid dispersions of CLR-SOL showed markedly high dissolution rates >85% compared to commercial CLR formulations, with the lowest crystallinity of 8% recorded in the SD with the lowest drug-to-polymer ratio of 1:4. In contrast, OMP-SOL SDs showed lower dissolution rates of ≤48% compared to commercial OMP formulations, AMX-SOL SDs gave release rates of >51%, lower than commercial AMX formulations used in this study. The study found that a 60-minute processing time at 50°C was sufficient for generating amorphous solid dispersions using scCO2. Pellets of CLR and AMX at 10% and 50%w/w drug loading showed improved release rates of >88% and >92%, respectively, compared to the commercial formulations. OMP pellets at 10%w/w drug loading gave a>85% release rate, while 50% w/w drug load showed a 33% release rate. The study developed cost-efficient, simple techniques to generate binary drug-SOL solid dispersions and pellets of model drugs, addressing the lack of access to medication and patient non-adherence.