Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions

Cefdinir (CEF) is classified as a third-generation cephalosporin within class IV of the Biopharmaceutical Classification System (BCS). Cefdinir has low solubility and permeability, which may reduce oral bioavailability.   The aim of this research was the preparation of cefdinir ternary solid dispersion in order to enhance its solubility. Then, after evaluating this ternary SD, investigate its stability under harsh conditions. In addition, formulation and evaluation of CEF ternary SD as capsule dosage form. The ternary SD is prepared by the solvent evaporation method using CEF, curcumin, and polyvinylpyrrolidone k30 in a weight ratio of 1:1:1. The ternary SD is subject to evaluation using Differential Scanning Calorimetry (DSC), Powder X-ray Diffractometry (PXRD), and Fourier Transform Infrared Spectroscopy (FTIR), saturated solubility, release, antibacterial activity, and a two months stability study under conditions of 40 ºC and 75% relative humidity. Then, six different capsule formulas were prepared using different excipients; each formula contained 300 mg of CEF. The capsule formulas were subjected to pre-formulation and capsule evaluation tests, which included weight variation, drug content, disintegration time, and In-vitro dissolution tests. The selected optimum capsule formula was subjected to further antibacterial activity test. Evaluation of ternary SD showed that, the system is totally amorphous with enhanced dissolution, saturated solubility, and antibacterial activity compared to pure CEF. Stability studies showed that, ternary SD remains amorphous after two months. Compared to commercial capsules (Sefarin® 300 mg) and other formulas, the F6 formula released 90% of CEF in 30 min. Antibacterial activity test results showed that the F6 formula was active against Staphylococcus aureus and Proteus vulgaris bacterial isolate. This research concludes that CEF solubility, antibacterial activity enhancement, and stability insurance could be obtained by preparing CEF ternary SD. All the ternary SD prepared capsule formulas showed enhancements in release compared to commercial capsules.