Assessment of the Compatibility of Famotidine with Selected Pharmaceutical Excipients
Keywords:
Famotidine, Drug-Excipient compatibility, FTIR, DSCAbstract
A drug–excipient compatibility study was performed to investigate the stability of Famotidine in combination with Polyvinylpyrrolidone (PVP K30), Polyethylene Glycol (PEG 6000), and Hydroxypropyl Methylcellulose (HPMC) under accelerated storage conditions. Physical mixtures of Famotidine and excipients were stored at 40°C/75% Relative Humidity (RH) and 50 ± 2°C for an appropriate duration (typically 30–90 days) and evaluated for possible physical and chemical interactions. The compatibility studies conducted under accelerated conditions of 40°C/75% RH and 50 ± 2°C demonstrated that Famotidine is compatible with PVP K30, PEG 6000, and HPMC. No significant physical changes, chemical degradation, or drug–excipient interactions were observed during storage. The characteristic thermal and spectroscopic properties of Famotidine were retained throughout the study period. Therefore, PVP K30, PEG 6000, and HPMC are considered suitable excipients for the formulation development of Famotidine, particularly in solid dispersions, tablets, and other solid dosage forms requiring enhanced solubility and stability.
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