Cannabidiol (CBD) is a natural product isolated from the Cannabis sativa plant that was approved by the United States Food and Drug Administration (US FDA) for the treatment of resistant epilepsy. Despite its therapeutic potential, CBD’s clinical application is limited by its poor aqueous solubility and low oral bioavailability. The primary aim of this research was to enhance the aqueous solubility and oral bioavailability of CBD by developing nanostructured lipid carriers (NLCs) using conventional hot homogenization method (CHH). In the current study, nine CBD NLC formulations were developed through CHH, of which, NLC5 emerged as the most promising formulation, exhibiting high CBD entrapment efficiency (99.23%), particle size of 207 nm, a polydispersity index of 0.19, and a zeta potential of -26 mV. Additionally, drug release testing for NLC5 showed a high CBD release rate of more than 90% within 15 min, indicating an enhancement of CBD dissolving rate compared to pure CBD. The in vivo pharmacokinetic study of NLC5 formulation showed 27% CBD oral bioavailability. Furthermore, Stability studies conducted at 4 °C and 25 °C on this formulation over three months, revealed consistent parameters, underscoring the robustness of the formulation. In conclusion, the successful formulation of CBD-loaded NLCs resulted in improved CBD release rate, enhanced oral bioavailability of CBD, and maintained stability, making it a promising approach for the effective delivery of CBD. Graphical Abstract

The objective of this work was to use hot-melt extrusion (HME) technology to improve the physiochemical properties of lansoprazole (LNS) to prepare stable enteric coated LNS tablets. For the extrusion process, we chose Kollidon^® 12 PF (K12) polymeric matrix. Lutrol^® F 68 was selected as the plasticizer and magnesium oxide (MgO) as the alkalizer. With or without the alkalizer, LNS at 10% drug load was extruded with K12 and F68. LNS changed to the amorphous phase and showed better release compared to that of the pure crystalline drug. Inclusion of MgO improved LNS extrudability and release and resulted in over 80% drug release in the buffer stage. Hot-melt extruded LNS was physically and chemically stable after 12 months of storage. Both formulations were studied for compatibility with Eudragit^® L100-55. The optimized formulation was compressed into a tablet followed by coating process utilizing a pan coater using L100-55 as an enteric coating polymer. In a two-step dissolution study, the release profile of the enteric coated LNS tablets in the acidic stage was less than 10% of the LNS, while that in the buffer stage was more than 80%. Drug content analysis revealed the LNS content to be 97%, indicating the chemical stability of the enteric coated tablet after storage for six months. HME, which has not been previously used for LNS, is a valuable technique to reduce processing time in the manufacture of enteric coated formulations of an acid-sensitive active pharmaceutical ingredient as compared to the existing methods.