NIR Spectroscopy Analysis of Ganoderma Lucidum Extract in Gummies

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

Congreso; 7ª Reunión Internacional de Ciencias Farmacéuticas; 2023

Ganoderma lucidum (Gl) is a medicinal mushroom renowned for its myriad therapeutic properties. Pharmaceutical gummies emerge as a compelling choice for dispensing Gl extract, with advantages like ease of administration and dose flexibility.Near Infrared (NIR) spectroscopy has been previously employed for polysaccharide determination in powdered Gl extracts [1]. However, this technique is missing in the literature concerning analytical methods applied for quality control of pharmaceutical formulations containing such extracts. Due to the significant water content in gummies, along with its well-known absorption profile in the NIR spectrum, determining Gl content within this pharmaceutical form presents a substantial challenge. Hence, the primary objective of this study is to conduct an exploratory analysis to assess the feasibility of employing NIR spectroscopy to determine Gl extract content in gummies, as well as to predict other quality properties of this pharmaceutical formulation.Gummies, both without (control) and containing Gl extract, at three varying concentrations (250, 500, and 750 mg), were utilized for analysis. The primary constituents, in descending order of concentration, included water, sorbitol, glycerin, and gelatin. The gummies underwent analysis prior and after a stabilization process, during which a considerable proportion of water content is lost. The analysis was performed using a Thermo Scientific Nicolet iS50 FTIR-NIR spectrophotometer. Measurements were conducted in absorbance mode within the range of 4,000 to 10,000 cm1. Each spectrum was generated as an average of 64 scans, utilizing a resolution of 4 cm1. Determinations were directly carried out on the gummies without any preprocessing. Subsequently, the collected data were subjected to analysis through the chemometric technique known as Principal Component Analysis (PCA). Several 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 optimal outcome was achieved by employing SNV with 3 primary components. The attained explained variance stood at 99.96%. PCA effectively distinguished the samples based on Gl content and time after manufacturing (degree of stabilization process). The initial findings gathered thus far lead to the conclusion that NIR spectroscopy is a suitable technique to predict Gl content in pharmaceutical gummies, even considering potential interference from their high-water content. Additionally, the results indicate the feasibility of applying this spectroscopy to the determination of the stabilization degree, accounting the drying period the gummies undergo.