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While carrier-free powder agglomerates break up into smaller fragments and/or primary drug particles, drug particles in carrier-based systems have to detach from the carrier surfaces via sliding and/or rolling (14). Due to the intrinsic difference in the dispersion mechanisms, predicting the effect of throat-induced de-agglomeration for carrier-based systems on the basis of the carrier-free counterparts may not be valid. The present study extends our previous work (10) to investigate the de-agglomeration effects of the USP and Alberta throats on carrier-based powder systems using commonly available commercial products containing lactose carriers. A straight tube is included to serve as a negative control for throat impaction as it has identical dimensions to the USP throat, except for the 90° bend. Zhou et al. (5) highlighted the importance of grease coating the Alberta throat to obtain comparable throat deposition with the in vivo data, especially for large agglomerates (>10 μm), as particle bounce/re-entrainment is not expected to occur in vivo. While a non-coated Alberta throat allows direct comparison with the pharmacopeia-approved non-coated USP induction port, the use of a coated Alberta throat minimizes particle bounce within the geometry and mimics the in vivo condition better. Therefore, the Alberta throat is used with and without a grease coating to directly assess the effects of powder impaction on further de-agglomeration inside the throat.
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As with other pharmacopoeias, the document is revised periodically. The 18th edition (JP18) came into effect on June 7, 2021. The text is originally prepared in Japanese and translated to English after the publication of the Japanese version. This usually is done within one year. According to the publication schedule, Supplement I to JP18 is to be published in December 2022 and Supplement II in 2024. It is planned that the 19th edition will be published in 2026.
Medical air (MA) is widely used in hospitals, often manufactured onsite by compressing external ambient air and supplied through a local network piping system. Onsite production gives rise to a risk of impurities that are governed by the same pharmacopoeia purity standards applicable to commercially produced MA. The question to be addressed in this paper is how to assess if a lack of purity poses a medical problem?