Paracetamol bioavailability study by means of salivary samples

Area of Science:

• Pharmacology
• Pharmaceutical Sciences
• Clinical Pharmacy

Background:

• Paracetamol (acetaminophen) is a widely used analgesic and antipyretic.
• Assessing bioequivalence is crucial for generic drug approval and ensuring therapeutic interchangeability.
• Marketed paracetamol formulations require rigorous comparison against innovator products.

Purpose of the Study:

• To evaluate the bioequivalence of two generic paracetamol 500 mg tablets, Decamol and Otamol, compared to the innovator product, Dexamol.
• To confirm pharmaceutical equivalence through in vitro testing.
• To establish in vivo bioequivalence using saliva drug level measurements.

Main Methods:

• In vitro dissolution testing was performed on Decamol, Otamol, and Dexamol tablets.
• A crossover bioavailability study was conducted in healthy volunteers.
• Saliva paracetamol concentrations were measured over time to assess pharmacokinetic parameters.

Main Results:

• In vitro studies demonstrated pharmaceutical equivalence among all three paracetamol tablet brands.
• In vivo investigations showed no statistically significant differences in bioavailability between Decamol and Dexamol.
• Similarly, Otamol exhibited no statistically significant difference in bioavailability compared to Dexamol.

Conclusions:

• Decamol and Otamol are bioequivalent to the innovator product Dexamol.
• The in vitro pharmaceutical equivalence correlated well with in vivo bioavailability data.
• These findings support the therapeutic interchangeability of Decamol and Otamol with Dexamol for pain management.