Prednisone raw material characterization and formulation development

Abstract

Solid dosage forms for oral use, particularly tablets, are the most highly used dosage forms in therapy because they are easily administered, have high productivity and relatively low cost and provide a more stable drug to form a semi-solid net. Numerous parameters influence the quality of the final dosage form. In this study, the dissolution profile of 20-mg prednisone tablets bioequivalent to the reference product and three test formulations were evaluated using stability testing. During the study, prednisone tablets and the active pharmaceutical ingredient (API) prednisone from two different manufacturers were characterized with respect to their physical and physicochemical properties. The results showed that the dissolution profiles of the test batches and the reference product did not retain pharmaceutical equivalence throughout all the stability study. Notably, both samples of API prednisone were of the same crystal form, and any phase transition that occurred during the study could not be attributed to dissolution variation during stability.

Four modified sodium alginate/carboxymethylcellulose blends for prednisone delivery

“…To evaluate the diffusion of PRED from the developed blends, drug release tests were performed. PRED is a glucocorticoid drug used as an anti‐inflammatory and immunosuppressive agent 25,63 . The amount of drug embedded and the embedded efficiency (EE) for all the blends are presented in Table 1.…”