Polysorbate 80 UV/vis spectral and chromatographic characteristics – defining boundary conditions for use of the surfactant in dissolution analysis

Wuelfing, W. Peter; Kosuda, Kathryn M.; Templeton, Allen C.; Harman, Amy; Mowery, Mark D.; Reed, Robert A.

doi:10.1016/j.jpba.2006.01.020

Cited by 61 publications

(36 citation statements)

References 13 publications

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“…The latter, apart from contributing to the resemblance with the surfactant present in the lung lining fluid, is essential to enable the dissolution of RFB, which is not soluble in PBS. The presence of Tween 80 ® at the used concentration was reported not to affect spectrophotometric measurements at the considered wavelength [36].…”

Section: In Vitro Drug Releasementioning

confidence: 86%

Inhalable Antitubercular Therapy Mediated by Locust Bean Gum Microparticles

et al. 2016

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Tuberculosis remains a major global health problem and alternative therapeutic approaches are needed. Considering the high prevalence of lung tuberculosis (80% of cases), the pulmonary delivery of antitubercular drugs in a carrier system capable of reaching the alveoli, being recognised and phagocytosed by alveolar macrophages (mycobacterium hosts), would be a significant improvement to current oral drug regimens. Locust bean gum (LBG) is a polysaccharide composed of galactose and mannose residues, which may favour specific recognition by macrophages and potentiate phagocytosis. LBG microparticles produced by spray-drying are reported herein for the first time, incorporating either isoniazid or rifabutin, first-line antitubercular drugs (association efficiencies >82%). Microparticles have adequate theoretical properties for deep lung delivery (aerodynamic diameters between 1.15 and 1.67 µm). The cytotoxic evaluation in lung epithelial cells (A549 cells) and macrophages (THP-1 cells) revealed a toxic effect from rifabutin-loaded microparticles at the highest concentrations, but we may consider that these were very high comparing with in vivo conditions. LBG microparticles further evidenced strong ability to be captured by macrophages (percentage of phagocytosis >94%). Overall, the obtained data indicated the potential of the proposed system for tuberculosis therapy.

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Section: In Vitro Drug Releasementioning

confidence: 86%

Inhalable Antitubercular Therapy Mediated by Locust Bean Gum Microparticles

et al. 2016

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“…Handling, storage conditions, and compounding of the mAbs may therefore be responsible for the formation of aggregates [13,31]. In addition, excipients from the compounded mAbs may absorb at a wavelength above 210 nm [32], leading thereby to another source of variability.…”

Section: Resultsmentioning

confidence: 99%

High-throughput identification of monoclonal antibodies after compounding by UV spectroscopy coupled to chemometrics analysis

et al. 2016

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Monoclonal antibodies (mAbs) compounded into the hospital pharmacy are widely used nowadays. Their fast identification after compounding and just before administration to the patient is of paramount importance for quality control at the hospital. This remains challenging due to the high similarity of the structure between mAbs. Analysis of the ultraviolet spectral data of four monoclonal antibodies (cetuximab, rituximab, bevacizumab, and trastuzumab) using unsupervised principal component analysis led us to focus exclusively on the second-derivative spectra. Partial least squares-discriminant analysis (PLS-DA) applied to these data allowed us to build models for predicting which monoclonal antibody was present in a given infusion bag. The calibration of the models was obtained from a k-fold validation. A prediction set from another batch was used to demonstrate the ability of the models to predict well. PLS-DA models performed on the spectra of the region of aromatic amino acid residues presented high ability to predict mAb identity. The region corresponding to the tyrosine residue reached the highest score of good classification with 89 %. To improve the score, standard normal variate (SNV) preprocessing was applied to the spectral data. The quality of the optimized PLS-DA models was enhanced and the region from the tyrosine/tryptophan residues allowed us excellent classification (100 %) of the four mAbs according to the matrix of confusion. The sensitivity and specificity performance parameters assessed this excellent classification. The usefulness of the combination of UV second-derivative spectroscopy to multivariate analysis with SNV preprocessing demonstrated the unambiguous identification of commercially available monoclonal antibodies. Graphical abstract PLS-DA models on the spectra of the region of aromatic amino acid residues allows mAb identification with high prediction.

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“…However, since polysorbate 80 also interferes on these measurements (e.g. it adsorbs in a wide range of UV/visible spectra) [22], spectroscopic techniques cannot either be used for the studies of BSA adsorption. Other authors studied the BSA adsorption by means of measuring changes on the nanoparticle size [8], but this method does not enable results with accuracy and adsorption isotherms cannot be plotted, because only a single concentration can be tested.…”

Section: Discussionmentioning

confidence: 99%