Evaluation of the physicochemical stability of hard gelatin capsules containing lycopene microencapsulates
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Abstract
Three batches of hard gelatin capsules containing lycopene microencapsulates were evaluated for their physicochemical stability during storage at a temperature of 20 ± 5°C in amber glass bottles. The tests conducted included lycopene concentration, visual inspection, weight, and disintegration time, with a sampling frequency of 0, 3, 6, 9, and 12 months, according to the ICH Q1A guidelines. Based on the results of lycopene concentration over time, the stability period was determined. The antioxidant activity of the capsules was confirmed at the end of the study using the DPPH method. The capsules maintained their physical integrity, showing no adhesion, cracks, swelling, or color changes. The weight variation remained within the acceptable range of 90 to 110%, and the disintegration time remained under 45 minutes. The stability period varied from 12,53 to 14,24 months in the analyzed batches. The results obtained indicate that the capsules maintain their physical and chemical characteristics for 12 months, meeting the acceptance criteria established for solid oral dosage forms
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