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. Author manuscript; available in PMC: 2022 Mar 11.
Published in final edited form as: AAPS J. 2021 Mar 11;23(2):42. doi: 10.1208/s12248-021-00566-0

Table 5.

Summary of the physicochemical properties of the raw API and the final suspensions.

Formulations API size (μm) API crystallinity Residual(w/w) Solubility (μg/mL) Morphology PEG3350 source* Release rate
F-A 15 weak 0.20%, unclear** 7.19±0.11 Irregular, round edge 1 Medium
F-B 20 weak 0.16%, Acetone 10.79±0.04 Plate like, sharp edge 1 Slowest
F-C 15 weak 0.20%, unclear** 7.53±0.03 Irregular, round edge 2 Fastest
F-D 15 strong 0.16%, THF 10.04±0.04 Plate like, sharp edge 1 Fastest
RLD 20 weak unknown 10.01±0.26 Irregular, spherical Unknown Fastest
*

1 and 2 represent Spectrum and BASF, respectively.

**

Based on the certificate of the analysis of the raw API, several different residual solvents are listed: N,N-dimethylformamide, methanol, methylene chloride, THF, pyridine, acetic acid and ethanol. However, the specific amount of each is unclear.