In the present study, we explored a new miniaturized disk intrinsic dissolution rate (IDR) method applied to 14 model drug compounds, using as little as 5 mg to make compacted disks of 0.071 cm2 exposed surface area, rotated in buffer media of as little as 10 mL volume. Drug concentration was measured by an in situ fiber optic UV method. All of the low-soluble and many of the high-soluble model drugs considered by Yu et al.1 along with some other compounds with available IDR data obtained by traditional means were included in the comparison. The main objective of the study was to demonstrate that the miniaturized disk IDR apparatus and method can produce results of comparable reliability as those obtained by traditional Wood’s apparatus methods, without the need for any scaling adjustments, and that the miniaturized apparatus can be potentially useful in BCS classification of solubility, applied at a much earlier time in the development cycle.
下载此内容仅限于登录用户。
登录