title: Setting Ideal Lubricant Mixing Time for Manufacturing Tablets by Evaluating Powder Flowability.
abstract: We investigated the effectiveness of using Carr's flowability index (FI) and practical angle of internal friction (Φ) as indexes for setting the target Mg-St mixing time needed for preparing tablets with the target physical properties. We used FI as a measure of flowability under non-loaded conditions, and Φ as a measure of flowability under loaded conditions for pharmaceutical powders undergoing direct compression with varying concentrations of Mg-St and mixing times. We evaluated the relationship between Mg-St mixing conditions and pharmaceutical powder flowability, analyzed the correlation between the physical properties of the tablets (i.e., tablet weight variation, drug content uniformity, hardness, friability, and disintegration time of tablets prepared using the pharmaceutical powder), and studied the effect of Mg-St mixing conditions and pharmaceutical powder flowability on tablet properties. Mg-St mixing time highly correlated with pharmaceutical powder FI (R2= 0.883) while Mg-St concentration has low correlation with FI, and FI highly correlated with the physical properties of the tablet (R2values: weight variation 0.509, drug content variation 0.314, hardness 0.525, friability 0.477, and disintegration time 0.346). Therefore, using pharmaceutical powder FI as an index could enable prediction of the physical properties of a tablet without the need for tableting, and setting the Mg-St mixing time by using pharmaceutical powder FI could enable preparation of tablets with the target physical properties. Thus, the FI of the intermediate product (i.e., pharmaceutical powder) is an effective index for controlling the physical properties of the finished tablet.
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan. snakamur@g.matsuyama-u.ac.jp.
authors.forename: Shohei
authors.initials: S
authors.lastname: Nakamura
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan.
authors.forename: Saori
authors.initials: S
authors.lastname: Yamaguchi
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan.
authors.forename: Rikiha
authors.initials: R
authors.lastname: Hiraide
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan.
authors.forename: Kumi
authors.initials: K
authors.lastname: Iga
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan.
authors.forename: Takatoshi
authors.initials: T
authors.lastname: Sakamoto
authors.affiliation: Department of Pharmaceutical Technology, School of Clinical Pharmacy, College of Pharmaceutical Sciences, Matsuyama University, 4-2 Bunkyo-cho, Matsuyama, Ehime, 790-8578, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yuasa
mesh_terms: D006244:Hardness; D054327:Lubricants; D011208:Powders / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical; D013997:Time Factors
chemical_list: D054327:Lubricants; D011208:Powders; D013607:Tablets
keywords: Carr’s flowability index; angle of internal friction; lubricant; magnesium stearate; tablet property