Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate - Pharmaceutical Technology

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Lubrication of Direct-Compressible Blends with Magnesium Stearate Monohydrate and Dihydrate
The influence of magnesium stearate (MgSt) on powder lubrication and finished solid-dose properties presents big challenges to drug manufacturers.

Pharmaceutical Technology

Table VI: Physical and chemical results for tablets.
Table VII shows the regression analysis for the ejection force. Based on the tablet physical results, the diluent ratio had the greatest influence on ejection force (p <0.005). The data also showed that the % API and % MgSt in the formulation had second- and third-highest influence on tablet ejection based on the coefficient at p <0.005 Overall, R 2 (indicating the linearity of the regression) was 0.9250, suggesting that the selected model design was appropriate.

Table VII: Regression analysis for ejection force.
In addition, the regression model for the total forces (precompression and main-compression forces) as depicted in Table VIII shows that the diluent ratio also had the highest influence on combined compression forces (p <0.005). The second and third highest–ranking responses, based on the coefficient at p <0.005, were the percentage of MgSt and the type of MCC, respectively. The model shows a linearity, R 2= 0.9110. These regression models show that the influence of the diluent ratio, percentage of MgSt, percentage of API, and type of MCC, if held constant, could offer some insights into the subtle characteristics of other factors such as the type of MgSt and the duration of lubrication. As such, an optimized design was constructed to keep these factors the same and minimize their influence to fully elucidate the presence (or absence) of influence of differing MgSt hydrates.

Table VIII: Regression analysis for total force (precompression and main).
Influence of MgSt type and duration of lubrication on blend uniformity assay. Two experiments were conducted using a binary diluent system of MCC (Avicel PH 101) and LAC at the ratio of 75:25, with APAP as the active ingredient at 1.25% w/w concentration. With the level of MgSt at 1.0% w/w, the influence of lubrication on blend uniformity assay was monitored at 2-, 4-, 8-, 12-, and 16-min time points. Results show that Batch 13 lubricated with MgSt-M gave failing %RSD on blend uniformity assay at 2-min (36.0%) and 4-min (8.1%) time points (see Table IX). Results at the 8-, 12-, and 16-min time points, however, were acceptable. For Batch 15 lubricated with MgSt-D, the results at all the time points were acceptable. Although no reason was found for the failed results for Batch 13, the influence of the MgSt type on a uniformity blend could not be ruled out.


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