Particle size control and the interactions between drug and stabilizers in an amorphous nanosuspension system

Bi, Yanping; Liu, Jingjing; Wang, Jianzhu; Hao, Jifu; Li, Fēi; Wang, Teng; Sun, Hongwei; Guo, Fang

doi:10.1016/j.jddst.2015.07.012

Cited by 24 publications

(7 citation statements)

References 25 publications

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“…Particle properties of nanosuspensions depend on the technology and conditions of the manufacturing process, where crystalline nanoparticles are mainly produced through top-down technology, whereas amorphous nanoparticles are mainly produced using the bottom-up technology (McClements & McClements, 2016;Peltonen & Strachan, 2015). In general, amorphous particles obtained through the latter method show high solubility (Bi et al, 2015;Junyaprasert & Morakul, 2015;Peltonen & Strachan, 2015), but in practice, the top-down technique is preferred over the bottom-up technique because the latter uses toxic solvents during the manufacturing process and provides insufficient storage stability (Keck & Müller, 2006).…”

Section: Introductionmentioning

confidence: 99%

Stability properties and antioxidant activity of curcumin nanosuspensions in emulsion systems

Kim

Lee

et al. 2021

CyTA - Journal of Food

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Section: Introductionmentioning

confidence: 99%

Stability properties and antioxidant activity of curcumin nanosuspensions in emulsion systems

Kim

Lee

et al. 2021

CyTA - Journal of Food

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“…Pharmaceutical nanosuspension is defined as colloidal, biphasic systems, in which solid drug particles are very finely dispersed in an aqueous vehicle, without any matrix material, stabilized by surfactants and/or polymers [14,15]. The particle size of the solid particles in nanosuspensions is usually less than 1 μm with a mean particle size ranging between 200 and 600 nm [16].…”

Section: Introductionmentioning

confidence: 99%

Study on Optimization of Wet Milling Process for the Development of Albendazole Containing Nanosuspension with Improved Dissolution

Fülöp

Jakab

Tóth

et al. 2020

Period. Polytech. Chem. Eng.

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The main objective of this work was to show the potential of the optimization of top-down wet planetary bead milling process parameters (milling speed, process time and size of the milling medium) by Design Of Experiments (DOE) approach for the development of albendazole (ABZ) containing nanosuspension with improved dissolution. In addition, the influence of process parameters (capacity of milling container, applied volume of milling beads, size of the milling medium, milling speed, milling time) on ABZ polymorphic transition has also been investigated. The optimized, milled formula yielded ~ 145.39 times reduction in mean particle size (182.200 ± 1.3130 nm) compared to unmilled dispersion, which demonstrated 13.50 times gain in mean dissolution rate value compared to the unmilled dispersion in medium at pH = 1.2. No lag time values were observed in the dissolution kinetics of the nanosuspension in comparison with the unmilled samples. Moreover, maximal mean solubility value was also improved by 1.45 times compared to the unmilled suspension, in medium at pH = 6.8, supporting the significance of the Ostwald-Freundlich equation. Diffraction pattern comparisons have indicated a polymorphic transition of albendazole to Form II, which was more pronounced in smaller container at high milling speed values and prolonged operations.

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“…Polymers such as hydroxypropyl methylcellulose (HPMC), polyvinyl pyrrolidone (PVP), and hydroxypropyl cellulose (HPC) and surfactants such as dodecyl β-Dmaltoside (DM), sodium dodecyl sulfate (SDS), and polyethylene glycol (PEG) are frequently used in nanosuspension formulations intended for oral or parenteral drug administration as means to enhance the physical stability of nanosuspensions (1)(2)(3)(4)(5). It is well known that a significant number of new chemical entities exhibit poor water solubility, resulting in poor oral absorption and the need for bioavailability enhancement (6)(7)(8).…”

Section: Introductionmentioning

confidence: 99%

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

Patel

Bummer

2015

AAPS PharmSciTech

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Abstract. This report describes the development of a chromatographic method for the simultaneous quantification of a polymer, hydroxypropyl methylcellulose (HPMC), and a surfactant, dodecyl β-Dmaltoside (DM), that are commonly used in the physical stabilization of pharmaceutical formulations such as nanosuspensions and solid dispersions. These excipients are often challenging to quantify due to the lack of chromophores. A reverse phase size exclusion chromatography (SEC) with evaporative light scattering detector (ELSD) technique was utilized to develop an accurate and robust assay for the simultaneous quantification of HPMC and DM in a nanosuspension formulation. The statistical design of experiments was used to determine the influence of critical ELSD variables including temperature, pressure, and gain on accuracy, precision, and sensitivity of the assay. A robust design space was identified where it was determined that an increase in the temperature of the drift tube and gain of the instrument increased the accuracy and precision of the assay and a decrease in the nebulizer pressure value increased the sensitivity of the assay. In the optimized design space, response data showed that the assay could quantify HPMC and DM simultaneously with good accuracy, precision, and reproducibility. Overall, SEC-ELSD proved to be a powerful technique for the simultaneous quantification of HPMC and DM. This technique can be used to quantify the amount of HPMC and DM in nanosuspensions, which is critical to understanding their effects on the physical stability of nanosuspensions.KEY WORDS: design of experiments; dodecyl β-D-maltoside; evaporative light scattering detector; HPMC; nanosuspensions.

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Particle size control and the interactions between drug and stabilizers in an amorphous nanosuspension system

Cited by 24 publications

References 25 publications

Stability properties and antioxidant activity of curcumin nanosuspensions in emulsion systems

Stability properties and antioxidant activity of curcumin nanosuspensions in emulsion systems

Study on Optimization of Wet Milling Process for the Development of Albendazole Containing Nanosuspension with Improved Dissolution

Development of a Robust Method for Simultaneous Quantification of Polymer (HPMC) and Surfactant (Dodecyl β-D-Maltoside) in Nanosuspensions

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