Injectables

D’Souza, Susan

doi:10.1002/9781118675748.ch3

Cited by 6 publications

(2 citation statements)

References 108 publications

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“…tissues has been proposed to resemble transport processes occurring in chromatography . In pharmaceutical research and drug development, there is an unmet need for characterization technologies with biopredictive capabilities for injectable formulations. − Various in vitro release testing approaches seeking to emulate selected features of the human body have been pursued attempting to improve our understanding of the complex processes occurring upon injection and until the drug substance reaches the circulation. − With few exceptions, chromatographic methods have exclusively been used for drug quantification upon sample removal from the in vitro release testing system. Imaging techniques are warranted for their ability to visualize physical changes and link these alterations to changes in chemical composition and are universally useful for elucidating processes and mechanisms.…”

Section: Introductionmentioning

confidence: 99%

Development of UV–Vis Imaging Compatible Chromatographic Matrix with Application for Injectable Formulation Characterization

Bock,

Hu,

Cicale

et al. 2023

Anal. Chem.

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Transport within human tissue matrices, e.g., the subcutaneous tissue, exhibits some resemblance to chromatographic processes. Here, a porous matrix comprising agarose beads compatible with UV–vis imaging was developed for a parallel piped rectangular flow cell (4 mm light path). Introduction of high-molecular weight dextrans (M r ∼ 200000 and ∼500000) at 10% (w/v) rendered imaging possible by providing optical clearing of the turbid porous matrix, resulting in improved transmittance as well as resolution (from 400 to 180 μm) at 280 nm, as well as 520 nm. The interplay between diffusive and convective transport at 0 < Pe ≤ 28 was visualized at 280 nm upon injection of dexamethasone suspensions. Real-time UV–vis imaging showed in-flow cell the effect of incorporating ion-exchange resins on the retention of infliximab, lysozyme, and α-lactalbumin. The ion-exchange matrix may serve as a surrogate for polyelectrolytes in the subcutaneous tissue, assessing the potential role of electrostatic interactions of biotherapeutics upon injection. UV–vis imaging of size-exclusion chromatographic matrixes may be of interest in its own right and potentially develop into a characterization tool for injectables.

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Section: Introductionmentioning

confidence: 99%

Development of UV–Vis Imaging Compatible Chromatographic Matrix with Application for Injectable Formulation Characterization

Bock,

Hu,

Cicale

et al. 2023

Anal. Chem.

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“…With the growing interest in parenteral sustained-release formulations, in vitro methods, which accurately model the conditions at the injection site, are needed. As of today, there are no compendial in vitro release methods for conventional- or controlled-release parenteral formulations [ 24 , 25 , 26 ].…”

Section: Introductionmentioning

confidence: 99%

Methodological Considerations in Development of UV Imaging for Characterization of Intra-Tumoral Injectables Using cAMP as a Model Substance

Bock

Boetker

Larsen

et al. 2022

IJMS

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A UV imaging release-testing setup comprising an agarose gel as a model for tumorous tissue was developed. The setup was optimized with respect to agarose concentration (0.5% (w/v)), injection procedure, and temperature control. A repeatable injection protocol was established allowing injection into cavities with well-defined geometries. The effective resolution of the SDi2 UV imaging system is 30–80 µm. The linear range of the imaging system is less than that of typical spectrophotometers. Consequently, non-linear cAMP calibration curves were applied for quantification at 280 nm. The degree of deviation from Beer’s law was affected by the background absorbance of the gel matrix. MATLAB scripts provided hitherto missing flexibility with respect to definition and utilization of quantification zones, contour lines facilitating visualization, and automated, continuous data analysis. Various release patterns were observed for an aqueous solution and in situ forming Pluronic F127 hydrogel and PLGA implants containing cAMP as a model for STING ligands. The UV imaging and MATLAB data analysis setup constituted a significant technical development in terms of visualizing behavior for injectable formulations intended for intra-tumoral delivery, and, thereby, a step toward establishment of a bio-predictive in vitro release-testing method.

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Recent advances in lipid-based long-acting injectable depot formulations

Sharma

Yadav

et al. 2023

Advanced Drug Delivery Reviews

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Injectables

Cited by 6 publications

References 108 publications

Development of UV–Vis Imaging Compatible Chromatographic Matrix with Application for Injectable Formulation Characterization

Development of UV–Vis Imaging Compatible Chromatographic Matrix with Application for Injectable Formulation Characterization

Methodological Considerations in Development of UV Imaging for Characterization of Intra-Tumoral Injectables Using cAMP as a Model Substance

Recent advances in lipid-based long-acting injectable depot formulations

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