Evaluating superdisintegrants for their performance in orally disintegrating tablets containing lysozyme enzyme

Orally disintegrating tablets (ODTs) are gaining importance and popularity due to their numerous advantages. Lysozyme, an enzyme with antibacterial properties, is currently only available as a conventional tablet and syrup. The main aims of this study were to formulate ODTs containing lysozyme using a variety of excipients and evaluate how formulation technology and excipient selection affected enzyme activity. Three different superdisintegrants in two concentrations, two different types of fillers, and three types of modern, ready-to-use co-processed excipients were investigated. The effect of the quality of the materials and the applied compression force were also studied. The investigated Critical Quality Attributes were disintegration time, dissolution profile and activity of lysozyme enzyme. A higher enzyme activity was found for ODTs with a higher hardness and density, containing the stabilizing agent in a smaller particle size. The structure of the superdisintegrant crystals had a greater impact on the disintegration time and dissolution profile of ODTs than the amount of superdisintegrants used. The results also revealed that despite the general advantages and effectiveness of ready-to-use excipients, the use of tailored formulations is more advantageous for sensitive drugs like enzymes.

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