Study of paracetamol 1-g oral solution bioavailability.

Area of Science:

• Pharmacology
• Pharmacokinetics

Background:

• Paracetamol is a widely used analgesic and antipyretic.
• Assessing the bioavailability of different paracetamol formulations is crucial for ensuring therapeutic efficacy.

Purpose of the Study:

• To evaluate the bioavailability of paracetamol following administration of a 1 g oral solution (Gelocatil Oral Solution).
• To characterize the pharmacokinetic profile, including absorption speed and maximum plasma concentration, of the 1 g paracetamol oral solution.

Main Methods:

• An open-label study involving 18 healthy volunteers.
• Administration of 15.4 ml (1 g paracetamol) of Gelocatil Oral Solution to fasting subjects.
• Serial blood sampling over 12 hours with paracetamol plasma concentrations determined by reverse-phase high-performance liquid chromatography (HPLC).

Main Results:

• Fast absorption was observed, with a median time to maximum concentration (tmax) of 20 minutes.
• Mean maximum plasma concentration (Cmax) was 24.3 mg/l, and area under the curve (AUC(0-t)) was 64.0 mg h/l.
• Pharmacokinetic parameters were comparable to lower doses and immediate-release tablet formulations of paracetamol.

Conclusions:

• The 1 g Gelocatil Oral Solution demonstrates suitable bioavailability and rapid absorption.
• The fast absorption profile suggests an immediate onset of action for pain and fever relief.
• Results support the efficacy of the 1 g oral solution for therapeutic use.