Fabrication and characterization of cocoa butter-based caffeine fast-melting tablets

<b>Aim:</b> The objective of this study was to develop and characterize the physical properties of fast-melting tablets (FMTs) using cocoa butter as the base and caffeine as the model drug. <b>Method:</b> The simple refrigerator freezing method was employed to prepare caffeine-loaded, FMTs from cocoa butter bases. <b>Results:</b> The F3 chosen formulation achieved a disintegration time of 1.20 min ± 0.035, which falls within the specified limit set by the European Pharmacopoeia. The cumulative drug release data of F3, was 88.52 and 94.08% within 60 and 75 min, respectively (NLT 85% as per US FDA requirement). All the other physical test standards for FMTs met the pharmacopeial specifications. <b>Conclusion:</b> Based on the findings, the simple refrigerator freezing method could be used to formulate FMTs. Patient-friendly natural caffeine-loaded cocoa butter-based fast-melting tablets with rapid disintegration, affordability, safety and biocompatibility are an efficient base for drug delivery. To the best of our knowledge, this is the first report on the caffeine-based fast-melting tablets (FMTs) concept using 100% natural ingredients by a simple freezing (refrigerator) method. The form V polymorph of cocoa butter, which was converted from its raw form using the tempering process, has been a suitable base for caffeine FMTs. The selected formulation (F3) loaded with caffeine showed better tablet appearance, acceptable hardness and rapid <i>in vitro</i> disintegration properties. Cocoa-based FMTs provide the greatest convenience to all age groups, especially for those who are afraid of swallowing the tablets. Drugs with palatability problems when administered orally can be resolved with the use of cocoa-based FMT formulations. All suitable natural and synthetic active ingredients can be incorporated into these cocoa-based FMTs. Cocoa butter is an eco-friendly and alternative ingredient for FMTs. In our study, the FMTs were stable for up to 6 months at room temperature and refrigerator storage conditions.