scholarly journals Evidence on the Stability of Nanoparticles of Comirnarty® in Syringes

Author(s):  
Francesca Selmin ◽  
Umberto M Musazzi ◽  
Silvia Franzè ◽  
Paola Minghetti

Abstract Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms limiting the storage and transport of Comirnaty® as diluted dose in 1mL-syringe. Here, the physical stability of lipid nanoparticles in “real-world” conditions was evaluated, comparing the effects of different syringe materials, temperature and mechanical stress on number and particle size distribution. the positive results of such proof-of-concept can support the preparation and transport of doses to hospitals or vaccination settings.

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1029
Author(s):  
Francesca Selmin ◽  
Umberto M. Musazzi ◽  
Silvia Franzè ◽  
Edoardo Scarpa ◽  
Loris Rizzello ◽  
...  

Moving towards a real mass vaccination in the context of COVID-19, healthcare professionals are required to face some criticisms due to limited data on the stability of a mRNA-based vaccine (Pfizer-BioNTech COVID-19 Vaccine in the US or Comirnaty in EU) as a dose in a 1 mL-syringe. The stability of the lipid nanoparticles and the encapsulated mRNA was evaluated in a “real-life” scenario. Specifically, we investigated the effects of different storing materials (e.g., syringes vs. glass vials), as well as of temperature and mechanical stress on nucleic acid integrity, number, and particle size distribution of lipid nanoparticles. After 5 h in the syringe, lipid nanoparticles maintained the regular round shape, and the hydrodynamic diameter ranged between 80 and 100 nm with a relatively narrow polydispersity (<0.2). Samples were stable independently of syringe materials and storage conditions. Only strong mechanical stress (e.g., shaking) caused massive aggregation of lipid nanoparticles and mRNA degradation. These proof-of-concept experiments support the hypothesis that vaccine doses can be safely prepared in a dedicated area using an aseptic technique and transferred without affecting their stability.


2019 ◽  
Vol 7 (5) ◽  
pp. 389-403 ◽  
Author(s):  
Ritika Kondel ◽  
Nusrat Shafiq ◽  
Indu P. Kaur ◽  
Mini P. Singh ◽  
Avaneesh K. Pandey ◽  
...  

Background: Acyclovir use is limited by a high frequency of administration of five times a day and low bioavailability. This leads to poor patient compliance. Objectives: To overcome the problem of frequent dosing, we used nanotechnology platform to evaluate the proof of concept of substituting multiple daily doses of acyclovir with a single dose. Methods: Acyclovir was formulated as solid lipid nanoparticles (SLN). The nanoparticles were characterized for particle size, surface charge and morphology and in vitro drug release. The pharmacokinetic and pharmacodynamic of SLN acyclovir were compared with conventional acyclovir in a mouse model. Results: SLN showed drug loading of 90.22% with 67.44% encapsulation efficiency. Particle size was found to be of 131 ± 41.41 nm. In vitro drug release showed 100% release in SIF in 7 days. AUC0-∞ (119.43 ± 28.74 μg/ml h), AUMC0-∞ (14469 ± 4261.16 μg/ml h) and MRT (120.10 ± 9.21 h) were significantly higher for ACV SLN as compared to ACV AUC0-∞ (12.22 ± 2.47 μg/ml h), AUMC0-∞ (28.78 ± 30.16 μg/ml h) and MRT (2.07 ± 1.77 h), respectively (p<0.05). In mouse model, a single dose of ACV SLN was found to be equivalent to ACV administered as 400mg TID for 5 days in respect to lesion score and time of healing. Conclusion: The proof of concept of sustained-release acyclovir enabling administration as a single dose was thus demonstrated.


2009 ◽  
Vol 1213 ◽  
Author(s):  
Iliana Medina-Ramirez ◽  
Xu-Bin Pan ◽  
Sajid Bashir ◽  
Jingbo Louise Liu

AbstractPlatinum (Pt) is the most efficient and highly utilized electrocatalsyt; however its high cost hinders its widespread use as a stand-alone catalyst. To remedy this problem, a nickel (Ni) encapsulated by Pt (NiⓔPt) nanocatalyst was fabricated using a cost-effective green colloidal method. The NiⓔPt nanoparticles (NPs) were then characterized using transmission electron microscope (TEM) equipped with X-ray energy dispersive spectroscopy (EDS), and X-ray powder diffraction (XRD) to determine the particle size distribution, morphology, elemental composition, and crystalline phase structure. The surface energetic was also measured using ZetaPALS™ to identify the stability of the colloidal suspension.


2017 ◽  
Vol 866 ◽  
pp. 3-7 ◽  
Author(s):  
Orrawan Poonsri ◽  
Wiyada Kwanhian ◽  
Apakorn Poltien ◽  
Piyatida Tangteerawatana ◽  
Jitbanjong Tangpong

Nanoemulsions are well characterized in a promising drug delivery system with applications for drug and cosmetic. Traditionally and cosmetic industries use Rice bran oil and Hesperethusa crenulata or Thanakha bark aqueous extract in sunscreen formulations, anti ageing products and in treatments for skin diseases. The aim of this study was to produce the nanoemulsion and to evaluate their physical stability, irritation potential. In vitro study, the total phenolic contents and total antioxidant capacity of SangYod Rice bran oil (SRBO) were 1130.44 ± 53.55 mg GAE/mg and 25.94±4.69 mmol TEAC/mg and Thanakha were 3.85±0.23 mg GAE/gdw and 19.87 ± 2.59 mmol TEAC/gdw, respectively. The nanoemulsion containing SRBO and Thanakha, oil in water, was produced using low-pressure homogenizer and ultrasonicator techniques and the particle size was 167.03±1.75 nm. The stability of nanoemulsion represented no significant change on pH and particle size after day 0, 5, 11, 14 and over 12 month at temperature 4, 25 and 40 °C. Moreover, it’s also showed no irritation on HET–CAM test, a basic test for embryotoxicity, systemic toxicity and immunopathology. Conclusion, these results suggested that the nanoemulsion containing SRBO and Thanakha may serve as potential vehicles for improved transdermal delivery antioxidant compound and no irritation.


2018 ◽  
Vol 789 ◽  
pp. 26-30
Author(s):  
Dan Shi Zhu ◽  
Li Wei Wei ◽  
Xiao Jun Ren ◽  
Xue Hui Cao ◽  
He Liu ◽  
...  

Acidity is an important influence factor for juice stability. In this study, the effects of acidityon stability of cloudy apple juice were investigated. The stability indexes, such as, turbidity, cloudvalue, cloud stability, and particle size distribution (PSD) were measured at pH 2.0, 2.5, 3.0 and 3.5,along with the untreated juice (pH 3.8) as control group. The results showed that, pH has significanteffects on turbidity, chrome (C*), cloud value, and D50, D90 in PSD of cloudy apple juice. The juicehad a better stabilization at pH 2.5. At this pH condition, the turbidity, cloud value, cloud stability ofjuice was the best. In addition, at pH 2.5, the color of the juice was better, the particles were smaller,and the particle sizes were more uniform. By this study, a theoretical reference could be provided forimproving stability of cloudy apple juice and extending juice shelf life.


2009 ◽  
Vol 1193 ◽  
Author(s):  
Pirkko Holtta ◽  
Mari Lahtinen ◽  
Martti Hakanen ◽  
Jukka Lehto ◽  
Piia Juhola

AbstractNon-cementitious grouts have been tested in Olkiluoto for the sealing of fractures with the small hydraulic apertures. A promising non-cementitious inorganic grout material for sealing the fractures with the apertures less than 0.05 mm is commercial colloidal silica called silica sol. The potential relevance of colloid-mediated radionuclide transport is highly dependent on their stability in different geochemical environments. The objective of this work was to follow stability of silica sol colloids in low salinity Allard and saline OLSO reference groundwater (pH 7–11) and in deionized milliQ water. Stability of silica sol colloids was followed by measuring particle size distribution, zeta potential, colloidal and reactive silica concentrations. The particle size distributions were determined applying the dynamic light scattering (DLS) method and zeta potential based on dynamic electrophoretic mobility. The colloidal silica concentration was calculated from DLS measurements applying a calibration using a standard series of silica sol. Dissolved reactive silica concentration was determined using the molybdate blue (MoO4) method.These results confirmed that the stability of silica colloids dependent significantly on groundwater salinity. In deionized water, particle size distribution and zeta potential was rather stable except the most diluted solution. In low salinity Allard, particle size distribution was rather constant and the mean particle diameter remained less than 100 nm. High negative zeta potential values indicated the existence of stable silica colloids. In saline OLSO, particle size distribution was wide from a nanometer scale to thousands of nanometers. The disappearance of large particles, decrease in colloidal particle concentration and zeta potential near zero suggest flocculation or coagulation. Under prevailing saline groundwater conditions in Olkiluoto silica colloids released from silica sol are expected to be instable but the possible influence of low salinity glacial melt water has to be considered.


Author(s):  
ASHWINI JADHAV ◽  
BINOY VARGHESE CHERIYAN

Objective: The main aim of this study to formulate a nifedipine-loaded nanocarrier for improving solubility and bioavailability. Methods: To improve the solubility of drug, nifedipine-loaded nanocarrier (lipotomes) were prepared by using the film lipid hydration technique. lipotomes were prepared by using tween 80, which is used for increasing solubility and cetyl alcohol for lipophilic environment. Drug excipients interaction determined by FTIR. lipotomes were characterized for particle size, Entrapment efficiency and zeta potential. lipotomes were optimized by using Design-Expert 12 software. Optimized formula further lyophilized by using different cyroproyectant to improve the stability and oral administration of the drug. Results: FTIR shows there was no interaction between formulation ingredients. Mean particle size, entrapment efficiency, zeta potential was determined and found to be 308.1 nm, 96.7%, 20.1mV, respectively. Surface morphology of lipotomes was observed by a scanning electron microscope (SEM). Optimized lipotomes was lyophilized with Mannitol (8% w/v) was the ideal cryoprotectant to retain the physicochemical characteristics of the OLT formulation after lyophilization. Conclusion: Nifedipine loaded nanocarrier was successfully prepared, using film hydration method. Which have good particle size, EE% and zeta potential. After lyophilization no significant changes was observed in particle size with good physical stability, so it could be a good choice for conventional drug delivery system by doing further investigation as in vitro and in vivo study


Author(s):  
SUTRIYO SUTRIYO ◽  
RADITYA ISWANDANA ◽  
MARINA DWI HAFSHARI

Objective: Gold nanoparticles (AuNPs) have been developed as a promising effective site-specific drug to increase drug efficacy and reduce potentialside effects. However, AuNPs are unstable because they easily aggregate. This study aims to produce stable resveratrol (RSV)-conjugated AuNPs usingpolyvinyl alcohol (PVA).Methods: AuNPs were synthesized using the Turkevich method, which involves the reduction of chloroauric acid with sodium citrate as a reductor.AuNPs were then modified with PVA as a stabilizing agent and conjugated with RSV as a drug model in the carrier system. The formed conjugates werecharacterized using ultraviolet–visible spectrophotometry, Fourier transform infrared spectroscopy, particle size analysis, and high-performanceliquid chromatography. Furthermore, stability tests were performed in various media (2% bovine serum albumin [BSA], 1% cysteine, phosphatebufferedsaline [PBS] pH 4, PBS pH 7.4, and 0.9% NaCl) for 28 days.Results: RSV–AuNPs–PVA had a particle size of 78.75 nm, with polydispersity index (PDI) of 0.356, zeta potential of −36.1 mV, and highest entrapmentefficiency of 78.1%±0.7. RSV–AuNPs without PVA stabilization had a particle size of 51.97 nm, with PDI of 0.694 and zeta potential of −24.6 mV. Theresults of the stability tests demonstrated that RSV–AuNPs–PVA was stable in 2% BSA, PBS pH 7.4, PBS pH 4, and NaCl 0.9% and were unstable in 1%cysteine. RSV–AuNPs without PVA were stable in 2% BSA and PBS pH 7.4 and unstable in 1% cysteine, PBS pH 4, and 0.9% NaCl.Conclusion: PVA can improve the physical stability of RSV-AuNPs conjugates.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 437
Author(s):  
Paola Mura ◽  
Francesca Maestrelli ◽  
Mario D’Ambrosio ◽  
Cristina Luceri ◽  
Marzia Cirri

The aim of this study was the optimization of solid lipid nanoparticles (SLN) and nanostructured lipid carriers (NLC) in terms of physicochemical and biopharmaceutical properties, to develop effective and stable aqueous liquid formulations of hydrochlorothiazide, suitable for paediatric therapy, overcoming its low-solubility and poor-stability problems. Based on solubility studies, Precirol® ATO5 and Transcutol® HP were used as solid and liquid lipids, respectively. The effect of different surfactants, also in different combinations and at different amounts, on particle size, homogeneity and surface-charge of nanoparticles was carefully investigated. The best formulations were selected for drug loading, and evaluated also for entrapment efficiency and release behaviour. For both SLN and NLC series, the use of Gelucire® 44/14 as surfactant rather than PluronicF68 or Tween® 80 yielded a marked particle size reduction (95–75 nm compared to around 600–400 nm), and an improvement in entrapment efficiency and drug release rate. NLC showed a better performance than SLN, reaching about 90% entrapped drug (vs. 80%) and more than 90% drug released after 300 min (vs. about 65%). All selected formulations showed good physical stability during 6-month storage at 4 °C, but a higher loss of encapsulated drug was found for SLNs (15%) than for NLCs (<5%). Moreover, all selected formulations revealed the absence of any cytotoxic effect, as assessed by a cell-viability test on Caco-2 cells and are able to pass the intestinal epithelium as suggested by Caco-2 uptake experiments.


Molecules ◽  
2018 ◽  
Vol 23 (10) ◽  
pp. 2591 ◽  
Author(s):  
Pusen Chen ◽  
Wenxue Chen ◽  
Shan Jiang ◽  
Qiuping Zhong ◽  
Haiming Chen ◽  
...  

Concentrated coconut milk (CCM), a raw material from coconut products, is extremely unstable because of its high oil content (>30%). In this study, three model emulsions—primary emulsions stabilized by coconut proteins only, secondary emulsions stabilized by the conjugation of sugar beet pectin (SBP) and coconut protein, and laccase-treated secondary emulsions—were prepared to investigate the effects of different factors (coconut proteins, coconut proteins + SBP, laccase-treated emulsions) on the stability of model emulsions and the application of this method to real CCM. The stability of the emulsions was evaluated based on their interfacial tension, zeta potential, particle size distribution, rheological properties, and the assembly formation of SBP and coconut protein at the oil–water interface. Results showed that addition of SBP or laccase can increase the viscosity and reduce the interfacial tension of the emulsion, and the effect was concentration dependent. Zeta potential of the emulsion decreased with the increase of protein (from −16 to −32 mV) and addition of SBP (from −32 to −46 mV), and it was reduced when laccase was added (from −9.5 to −6.0 mV). The secondary emulsion exhibited the narrowest particle size distribution (from 0.1 to 20 μm); however, laccase-catalyzed secondary emulsions showed the best storage stability and no layering when the laccase content reached 10 U/100 g. Confocal laser scanning microscopy (CLSM) revealed that protein was adsorbed on the oil–water interface and SBP distributed in the continuous phase could undergo oxidative crosslinking by laccase. These results show that the stability of the concentrated emulsion can be effectively improved by adding SBP and laccase.


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