title: Characterization of tableting properties measured with a multi-functional compaction instrument for several pharmaceutical excipients and actual tablet formulations.
abstract: Before designing tablet formulations, it is important to understand the "Tableting Properties" of excipients and API (active pharmaceutical ingredient) powders. Those properties refer to "Compressibility", "Compactability" and "Manufacturability", which are difficult to evaluate quantitatively. In this study, we aimed to evaluate the "Tableting Properties" by using a benchtop single-punch tablet press, developed recently to measure these parameters using a single device. In order to facilitate understanding of the results visually, we proposed a new plot, where the X-axis showed the tensile fracture stress and the Y-axis showed the ejection stress. This plot, which is composed of four regions, shows the combination of "Compactability" and "Manufacturability". We confirmed the ability of this device to evaluate the characteristics of typical pharmaceutical additives as a value of "Tableting Properties". Losartan potassium was used as an API, and Dilactose R and MCC as an excipient with good "Tableting Properties". The ejection stresses of losartan potassium and Dilactose R were very high. An increase in magnesium stearate shifted the point along the Y-axis in this plot, and it meant an improvement in "Manufacturability". It was confirmed that the device and plot are useful in designing formulations efficiently using a small amount of sample powders.
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan; Pharmaceutical Technology Department, Sawai Pharmaceutical Co. Ltd, 12-34, Hiroshibacho, Suita-Shi, Osaka 564-0052, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Osamura
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Takeuchi
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan.
authors.forename: Risako
authors.initials: R
authors.lastname: Onodera
authors.affiliation: Pharmaceutical Technology Department, Sawai Pharmaceutical Co. Ltd, 12-34, Hiroshibacho, Suita-Shi, Osaka 564-0052, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kitamura
authors.affiliation: Pharmaceutical Technology Department, Sawai Pharmaceutical Co. Ltd, 12-34, Hiroshibacho, Suita-Shi, Osaka 564-0052, Japan.
authors.forename: Yoshiteru
authors.initials: Y
authors.lastname: Takahashi
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Tahara
authors.affiliation: Laboratory of Pharmaceutical Engineering, Gifu Pharmaceutical University, 1-25-4 Daigaku-Nishi, Gifu 501-1196, Japan. Electronic address: takeuchi@gifu-pu.ac.jp.
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Takeuchi
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D019245:Compressive Strength; D005079:Excipients / Q000737:chemistry*; D013607:Tablets / Q000737:chemistry*
chemical_list: D005079:Excipients; D013607:Tablets
keywords: Compactability; Compressibility; Formulation design; Manufacturability; Plot way; Tableting properties