Fernando J. Muzzio

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Computational analysis is used to examine the hydrodynamic environment within the USP Apparatus II at common operating conditions. Experimental validation of the computational model shows that the simulations of fluid motion match the dispersion of dye observed in experiments. The computations are then used to obtain data that cannot be easily measured with(More)
The hydrodynamics within the United States Pharmacopeia Apparatus 2 have been shown to be highly non-uniform with a potential to yield substantial variability in dissolution rate measurements. Through the use of readily available engineering tools, several geometric modifications to the device were evaluated in this study. Specifically, we examined the(More)
In this article, three well-established engineering tools are used to examine hydrodynamics in dissolution testing apparatuses. The application of these tools would provide detailed information about the flow, shear, and homogeneity in dissolution tests. Particle image velocimetry successfully measures two-dimensional cross-sections of the velocity field in(More)
The USP tablet dissolution test is an analytical tool used for the verification of drug release processes and formulation selection within the pharmaceutical industry. Given the strong impact of this test, it is surprising that operating conditions and testing devices have been selected empirically. In fact, the flow phenomena in the USP test have received(More)
A combination of analytical and statistical methods is used to improve a tablet coating process guided by quality by design (QbD) principles. A solid dosage form product was found to intermittently exhibit bad taste. A suspected cause was the variability in coating thickness which could lead to the subject tasting the active ingredient in some tablets. A(More)
It is desirable for a pharmaceutical final dosage form to be manufactured through a quality by design (QbD)-based approach rather than a quality by testing (QbT) approach. An automatic feedback control system coupled with PAT tools that is part of the QbD paradigm shift, has the potential to ensure that the pre-defined end product quality attributes are met(More)
In this article the gravitational displacement rheometer (GDR) is used to characterize the effects of formulation composition and environmental conditions (moisture) on flow properties of cohesive pharmaceutical powders under unconfined conditions. The amount of moisture in the sample often has important effects on the physical and chemical properties of(More)
A method was developed for studying mixing of cohesive pharmaceutical mixtures. A combination of accurate sampling and NIR spectroscopic analysis was developed as a suitable method to determine homogenization of magnesium stearate as a function of blending variables. A typical pharmaceutical blend containing a ratio 35:64:1 lactose, avicel, and magnesium(More)
We use a variety of experimental results to illustrate issues and challenges involved in the sampling and characterization of pharmaceutical mixtures. Accurate and reliable characterization of granular mixtures is hindered by both the complexity of granular systems and the lack of validated and reliable sampling technology and techniques. Both sampling(More)