Orodispersible Tablets Containing Taste-Masked Lipid Pellets with Metformin Hydrochloride for Use by Elderly Patients
Abstract
Metformin HCl tablets encountered in the market show relatively inconvenient dimensions, decreasing the patient compliance during the treatment of type 2 diabetes mellitus. Furthermore, the crushing and dispersion of such a tablets in food or beverages exposes the unpleasant bitter taste of the API, which increases even more the nonadherence to treatment, especially by elderly patients. Therefore, this work focused on the development, manufacturing, and characterization of ODTs containing taste-masked lipid based micropellets of metformin HCl. To obtained pellets presenting taste-masked properties a recently extrusion/spheronization methodology using solid lipids excipients was employed: solid lipid cold extrusion followed by spheronization (SLCE). The manufacturing of small diameter extrudates based on different quantitative and qualitative solid lipid binders were investigated. Extrudates presenting different drug release kinetics, correlated with the amount of lipid binders, were obtained. As the taste-masking principle of the SLCE is to modify the drug release of the API, reducing its contact with the taste buds in the oral cavity after drug administration, all extrudate formulations, even those presenting sustained release profiles, were further spheronized. The material temperature during the spheronization of lipid based extrudates was reported the most critical factor in SLCE/spheronization method. Although this issue was recently investigated, there are no reports…
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