Ensuring Homogeneity in Powder Mixtures for Pharmaceuticals and Dietary Supplements: Evaluation of a 3-Axis Mixing Equipment.

Bruna Marianni,Marcone A.L Oliveira,Hudson Polonini

doi:10.3390/pharmaceutics13040563

Bruna Marianni, Marcone A.L Oliveira + Show 1 more

Open Access

https://doi.org/10.3390/pharmaceutics13040563

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Journal: Pharmaceutics	Publication Date: Apr 16, 2021
Citations: 5	License type: CC BY 4.0

Affiliation: Universidade Federal de Juiz de Fora

Abstract

The mixing process plays a pivotal role in the quality of pharmaceuticals and food/dietary supplements, as it can impact the homogeneity of the substances in their dosage form and affect characteristics such as dissolution and stability. Thus, the choice of the right mixing device is paramount for compounding pharmacies. In this paper, we evaluated the mixing efficacy of a new 3-axis mixer device and determined its optimal working conditions. Three different formulations were compounded with the device and a total of 540 individual assays were performed by HPLC or ICP-MS to validate its use, in addition to a direct comparison among it and two alternative mixing methods. The 3-axis mixer device was able to provide homogeneous mixtures and finished capsules with adequate content uniformity with a broad range of conditions of use (mixing times from 2 to 8 min, and speed of rotation from 10 to 100 rpm). In addition, the device was superior to classical mixing methods (such as the use of manually shaken plastic bags) and at least equivalent to well-established ones (Y-shaped mixer). Finally, we proposed a cleaning procedure that was also adequate to prevent cross-contamination among products compounded with the same device.

Highlights

The mixing process plays a fundamental role in the quality of pharmaceuticals and food/dietary supplements, as tit can impact the homogeneity of the substances in their dosage form and affect characteristics such as dissolution and stability [1,2].One can say that the main, directly objective goal of the different mixing processes available in the market is to provide homogeneity to a given product, to ideally consume a minimum quantity of energy and time, and to have good productivity with the lowest possible cost [3,4]
Results for the 90 assays performed for each active pharmaceutical ingredient (API) are described in Table 2, as well as their acceptance value (AV)
Defining and ensuring homogeneity in powder mixtures is crucial, as in the vast majority of the solid oral pharmaceuticals and dietary supplements, the APIs are only a small proportion of the entire mass of the dosage form, the rest being composed of excipients [10]

Summary

Introduction

One can say that the main, directly objective goal of the different mixing processes available in the market is to provide homogeneity to a given product, to ideally consume a minimum quantity of energy and time, and to have good productivity with the lowest possible cost [3,4]. In this sense, a mixture can be considered homogeneous when any fraction of it contains all components in the same proportion as the total preparation [5]. A new device for powder mixing entered the market—a 3-axis mixer device (FagronLab InvoMatic, Scheßlitz, Germany) (Figure 1)

Methods

Results

Conclusion