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Asahi Kasei
Effect of the molecular mobility of water adsorbed by disintegrants on storage-induced hydrolytic…
The purpose of this study was to investigate the effect of molecular mobility of water adsorbed by disintegrants on the hydrolytic degradation of active pharmaceutical ingredients (APIs). Fourteen different disintegrants were tested. First, powdered disintegrants were stored at conditions of 40…
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A Precise Prediction Method for the Properties of API-Containing Tablets Based on Data from Placebo…
We previously reported a novel method for the precise prediction of tablet properties (e.g., tensile strength (TS)) using a small number of experimental data. The key technique of this method is to compensate for the lack of experimental data by using data of placebo tablets collected in a database.…
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Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review
The ICH quality vision introduced the concept of quality by design (QbD), which requires a greater understanding of the raw material attributes, of process parameters, of their variability and their interactions. Microcrystalline cellulose (MCC) is one of the most important tableting excipients…
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