Interplay of Aging and Lot-to-Lot Variability on the Physical and Chemical Properties of Excipients: A Case Study of Mono- and Diglycerides
| Autor: | Avik Sarkar, Amrit Paudel, Isha Saraf, Ioan Ardelean, Hansjoerg Weber, Peter Laggner, Trevor Vogel, Dattatray Modhave, Thean Yeoh, Varun Kushwah, Raymond Chen |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Relaxometry
Magnetic Resonance Spectroscopy Quantitative nmr Calorimetry Differential Scanning Chemistry Chemistry Pharmaceutical Solid-state Pharmaceutical Science 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Diglycerides Excipients 03 medical and health sciences 0302 clinical medicine Differential scanning calorimetry Physical structure Chemical engineering X-Ray Diffraction parasitic diseases Drug Discovery Spectroscopy Fourier Transform Infrared Molecular Medicine 0210 nano-technology Chemical composition |
| Zdroj: | Molecular pharmaceutics. 18(3) |
| ISSN: | 1543-8392 |
| Popis: | The present study investigates the chemical composition governing the physical properties of mono- and diglycerides (MDGs) at the microstructural level, as a function of aging and lot-to-lot variability. The physical structure of the MDG plays a vital role in ameliorating the emulsion stability and is widely explored in diverse research horizons related to the pharmaceutical, cosmetic, and food industries. In an effort to understand the mechanism of emulsion stabilization, physical properties were extensively evaluated in selective commercial lots to determine if there is a correlation between the chemical composition of MDG and physical properties. The solid state of the MDG samples with different aging profiles was characterized using X-ray scattering, differential scanning calorimetry, attenuated total reflection-Fourier transform infrared spectroscopy, and NMR relaxometry. Moreover, the kinetic aspect of solid-state transformation was also evaluated via treating MDG samples with a heat-cool cycle. The chemical composition of MDGs was quantified using a quantitative NMR (qNMR) method. Interestingly, the X-ray scattering results demonstrated a change in the MDG polymorphic form and an increase in the %β content as a function of aging. The increase in the %β content led to the formation of rigid crystal structures of MDG, as evident from the NMR relaxometry. Chemical quantification of isomeric composition revealed chemical composition change as a potentially critical factor responsible for the altered physical structures of MDG with respect to aging and lot-to-lot variability. The findings correlated the solid-state transformation with the change in the chemical composition of the MDG as a combined effect of aging and lot-to-lot variability. This work serves as a basis to better understand the interdependency of the physicochemical properties of MDG. Furthermore, the present work can also be used as guidance for setting up the specifications of MDG, as per the required polymorphic form for a multitude of applications. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|