Abstract:
These studies were directed to development of practical, reliable methods for characterizing drug release from petrolatum ointments. The apparatus was a modification of the standard USP dissolution apparatus. Release slopes and diffusion coefficients were the same whether a membrane was present or not, confirming that the membrane did not limit transport. Standard deviations were lower with a membrane present. The method detected changes in drug concentration, formulation and manufacturing procedure. Table 1 shows the effect of cooling rate and mixing speed on the diffusion coefficient of phenol. All of the ointments had the same composition in this experiment.
| Manufacture | Mean Diffusion Coefficient (cm2/h x 10000) |
| Slow cool, slow mix | 2.53 |
| Slow cool, fast mix | 2.93 |
| Fast cool, slow mix | 3.89 |
| Fast cool, fast mix | 4.73 |