A combined microhydrodynamics–polymer adsorption analysis for elucidation of the roles of stabilizers in wet stirred media milling

Bilgili, Ecevit; Afolabi, Afolawemi

doi:10.1016/j.ijpharm.2012.09.040

Cited by 104 publications

(103 citation statements)

References 48 publications

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“…G F i s a Biopharmaceutics Classification System (BCS) Class II drug with an aqueous solubility of 7.7 μg/ml (20). It was selected here as a model BCS Class II drug because it was used in various wet stirred media milling studies (8,9,45), which helps to select the stabilizer formulation rationally and allows for comparative assessment. Hydroxypropyl cellulose (HPC, SL grade), which is commonly used as a neutral polymeric stabilizer, was donated by Nisso America Inc. (New York, NY, USA).…”

Section: Methodsmentioning

confidence: 99%

“…Table I presents the process parameters as well as amounts of drug suspension and slurry (drug suspension with beads) used in the milling experiments. In all suspensions, GF, HPC, and SDS concentrations were kept at 10, 2.5, and 0.05%, respectively, based on the excellent physical stability of the GF nanosuspensions prepared with HPC-SDS combination via wet media milling (45). Here, all percentages in formulations are w/w with respect to deionized water.…”

Section: Methodsmentioning

confidence: 99%

“…Both the milling chamber and the holding tank are equipped with a chiller unit (model number M1-.25A-11HFX, Advantage Engineering, Greenwood, IN, USA) that kept the suspension temperature in the holding tank below 35°C. Details of the equipment and milling procedure can be found elsewhere (24,45). The suspensions at several milling time points were collected from the outlet of milling chamber for particle size analysis.…”

Section: Preparation Of Suspensions Via Wet Stirred Media Millingmentioning

confidence: 99%

“…Figure 1 presents the temporal evolution of the characteristic particle sizes D 50 and D 90 during the milling with different bead sizes. Since it is well-established that the combined use of HPC-SDS imparts excellent stability to nanosuspensions of GF (24,45) and multiple BCS Class II drugs (46), a shallower slope of the D 50 vs. time curves or greater D 50 at select milling times indicates slower particle breakage and lower breakage rate. As seen from Fig.…”

Section: Impact Of Bead Size At Low Power Densitymentioning

confidence: 99%

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An Intensified Vibratory Milling Process for Enhancing the Breakage Kinetics during the Preparation of Drug Nanosuspensions

Zhang

Davé

et al. 2015

AAPS PharmSciTech

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Abstract. As a drug-sparing approach in early development, vibratory milling has been used for the preparation of nanosuspensions of poorly water-soluble drugs. The aim of this study was to intensify this process through a systematic increase in vibration intensity and bead loading with the optimal bead size for faster production. Griseofulvin, a poorly water-soluble drug, was wet-milled using yttrium-stabilized zirconia beads with sizes ranging from 50 to 1500 μm at low power density (0.87 W/g). Then, this process was intensified with the optimal bead size by sequentially increasing vibration intensity and bead loading. Additional experiments with several bead sizes were performed at high power density (16 W/g), and the results were compared to those from wet stirred media milling. Laser diffraction, scanning electron microscopy, X-ray diffraction, differential scanning calorimetry, and dissolution tests were used for characterization. Results for the low power density indicated 800 μm as the optimal bead size which led to a median size of 545 nm with more than 10% of the drug particles greater than 1.8 μm albeit the fastest breakage. An increase in either vibration intensity or bead loading resulted in faster breakage. The most intensified process led to 90% of the particles being smaller than 300 nm. At the high power intensity, 400 μm beads were optimal, which enhanced griseofulvin dissolution significantly and signified the importance of bead size in view of the power density. Only the optimally intensified vibratory milling led to a comparable nanosuspension to that prepared by the stirred media milling.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Preparation Of Suspensions Via Wet Stirred Media Millingmentioning

confidence: 99%

Section: Impact Of Bead Size At Low Power Densitymentioning

confidence: 99%

See 2 more Smart Citations

An Intensified Vibratory Milling Process for Enhancing the Breakage Kinetics during the Preparation of Drug Nanosuspensions

Zhang

Davé

et al. 2015

AAPS PharmSciTech

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“…Micro-and nanoparticles with high SSA and high free E are controlled by surface forces and, if the particles are not stabilized, they may coagulate because of the high particle mobility (Friedrich et al, 2006). Stabilizers are added to compensate the extra free E of the newly created surfaces, thereby preventing the aggregation of milled drug particles and inhibiting particle growth (ripening) during milling/storage (Bilgili and Afolabi, 2012). The degree of compensation required is related to the interactions between the drugs and stabilizers.…”

Section: The Role Of Additives In Wet Millingmentioning

confidence: 99%

Application of wet milling techniques to produce micronized and nanonized drug pre-dispersions for the development of intranasal formulations

Bartos¹

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Process Analytical Chemistry and Nondestructive Analytical Methods: The Green Chemistry Approach for Reaction Monitoring, Control, and Analysis

Gómez

Restrepo

Stelzer

et al. 2019

Handbook of Green Chemistry

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This chapter is focused on nondestructive analytical methods based on vibrational spectroscopy. Following the tenets of process analytical chemistry, these analytical methods may monitor a manufacturing process as it occurs providing information on critical product quality attributes that is then used to control the process and achieve the expected product quality. The application of these principles to the improvement of pharmaceutical manufacturing has been termed process analytical technology, and is currently transforming the manner in which pharmaceutical processes are evaluated by regulatory agencies.Nondestructive methods may also be developed for use in a laboratory setting providing information after the product is manufactured. In both settings, the use of hazardous substances and consumption of materials is avoided in the analyses performed. These nondestructive methods present several advantages in comparison to the current laboratory‐based methods that require the use of reagents and transformation to clear solutions. The use of nondestructive testing often permits the simultaneous determination of chemical and physical properties in the materials analyzed. In some cases spectral changes may also be correlated with sensorial evaluation of product properties. These advantages have become a reality in industrial settings. Examples from the biodiesel, dairy, pharmaceutical, and polymer industries are discussed.

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A combined microhydrodynamics–polymer adsorption analysis for elucidation of the roles of stabilizers in wet stirred media milling

Cited by 104 publications

References 48 publications

An Intensified Vibratory Milling Process for Enhancing the Breakage Kinetics during the Preparation of Drug Nanosuspensions

An Intensified Vibratory Milling Process for Enhancing the Breakage Kinetics during the Preparation of Drug Nanosuspensions

Application of wet milling techniques to produce micronized and nanonized drug pre-dispersions for the development of intranasal formulations

Process Analytical Chemistry and Nondestructive Analytical Methods: The Green Chemistry Approach for Reaction Monitoring, Control, and Analysis

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