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- W3191008090 abstract "This study aimed to develop a reliable stability-indicating method (SIM) for amoxicillin 500 mg capsules (DP-drug product). A literature review addressing amoxicillin (AMX; DS-drug substance) forced degradation studies and the existing SIMs was conducted to verify the most significant outcomes. Subsequently, the forced degradation of DP and DS was carried out following the Brazilian Health Surveillance Agency (ANVISA) guidelines, including thermal degradation (dry and wet heat), acidic and alkaline hydrolyses, hydrogen peroxide oxidation, reaction with copper, and photodegradation. Both DS and DP were more susceptible to 0.015 M NaOH, resulting in approximately 50% degradation. AMX DS and DP were not significantly photodegraded, but some degradation products (PDegs) showed susceptibility to light exposure. Thermodegraded samples showing ≥ 10% degradation exhibited modified profiles in thermogravimetric (TG) and differential scanning calorimetric (DSC) analyses. The X-ray powder diffraction patterns (XRPD) of DS samples exposed to dry and wet heat displayed complete amorphization of AMX, attesting to the occurrence of physical degradation concomitantly with chemical degradation, which can alter the drug’s bioavailability. In contrast, the thermodegraded DP samples exhibited intact AMX crystals interspersed with the amorphous form, perhaps partly protected by the excipient. The validated SIM was able to detect and quantify about 80 PDegs." @default.
- W3191008090 created "2021-08-16" @default.
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- W3191008090 date "2021-01-01" @default.
- W3191008090 modified "2023-09-27" @default.
- W3191008090 title "Forced Degradation Study and Development of a Stability-Indicating Method for Amoxicillin Capsules According to ANVISA Guidelines" @default.
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- W3191008090 doi "https://doi.org/10.21577/0103-5053.20210111" @default.
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