Relevance of Spectral Acquisition Conditions in the Analysis of Gummies using NIR Spectrophotometry

BIDEGAIN M.; PEREYRA R.; GONZALEZ VIDAL N.; RAZUC M.

Congreso; 7ª Reunión Internacional de Ciencias Farmacéuticas; 2023

Gummies represent an alternative to tablets and other oral pharmaceutical forms, particularly for children and individuals who struggle with swallowing pills. In the context of ensuring critical quality properties, rapid and non-destructive analysis of gummies utilizing Near-Infrared (NIR) spectroscopy, coupled with chemometric techniques, serves as a valuable approach. This methodology swiftly assesses several properties essential for quality control, offering insights into ingredient uniformity, concentration of active pharmaceutical ingredients (APIs), and texture. However, it is noteworthy that this technique is sensitive to the conditions of spectra acquisition, potentially introducing variability in the results. Therefore, the focus of this study was to evaluate and standardize the spectrum acquisition process for gummies containing diverse APIs. Gummies, both without APIs (Control) and containing Amiodarone (100 mg), Ganoderma lucidum extract (750 mg) and Praziquantel (75 mg) were utilized for analysis. The primary constituents, in descending order of concentration, included water, sorbitol, glycerin, and gelatin. These gummies underwent analysis after a stabilization period, during which a significant proportion of water content is lost. The analyses were performed using a Thermo Scientific Nicolet iS50 FTIR-NIR spectrophotometer. Measurements were conducted within the range of 4,000 to 10,000 cm-1. Each spectrum was generated as an average of 64 scans, utilizing a resolution of 4 cm-1. Determinations were directly carried out on the gummies without any preprocessing. The effect of pressing the gummy against the platen prior to sample collection, the positioning of the gummy in relation to the incident beam, and the placement of a cover (opaque or reflective gold or aluminum) over the gummy were taken into consideration during the experimentation. The collected data were subjected to analysis through Principal Component Analysis (PCA). Various types of data pretreatments, including Standard Normal Variate (SNV), Multiplicative Scatter Correction (MSC), and derivative methods, were applied to the data before performing PCA.The placement of the gummies, in relation to the incident beam, exhibited effects on the baseline characteristics and slight changes in the spectra shape that were discernible by PCA analysis. Moreover, the introduction of different covers, including opaque and reflective options, induced noticeable alterations in the baseline behavior, as well as in the intensity of certain bands. This phenomenon strongly suggests that the incident beam effectively traverses the entirety of the gummy during analysis. Intriguingly, the act of pressing the gummy onto the analysis platen prior to spectral collection emerged as a factor influencing the resolution of the resulting spectra. Notably, the impact of these experimental variables was observed to be contingent on the specific API present. Among the tested substances, Praziquantel demonstrated the least susceptibility to these acquisition-related effects. In terms of chemometric analysis, the application of PCA enabled successful differentiation among gummies containing distinct APIs. This differentiation underscores the technique´s capability to discern subtle compositional variations.In conclusion, the combination of NIR spectroscopy and chemometric techniques offers a promising avenue for rapid analysis of some quality properties of gummies. However, the standardization of spectra acquisition process emerges as a critical consideration to minimize potential result discrepancies. It becomes essential that factors such as gummy placement and applied force are considered for ensuring the reproducibility and reliability of analytical outcomes.