Bioequivalence of different prednisolone tablet formulations

Area of Science:

• Pharmacokinetics and Drug Bioavailability
• Clinical Pharmacology
• Pharmaceutical Sciences

Background:

• Prednisolone (CAS 50-24-8) is a widely used corticosteroid.
• Assessing the bioavailability of different tablet formulations is crucial for ensuring therapeutic equivalence.
• Bioequivalence studies are essential for generic drug approval and therapeutic interchange.

Purpose of the Study:

• To evaluate the relative bioavailability of three Prednisolone Ferring tablet strengths (2 mg, 5 mg, and 20 mg).
• To compare these formulations against a reference prednisolone product.
• To determine bioequivalence based on established pharmacokinetic parameters.

Main Methods:

• A randomized, cross-over study design was employed in accordance with GCP/ICH guidelines.
• Thirteen healthy volunteers participated in the bioavailability investigation.
• Key pharmacokinetic parameters measured included Cmax, AUC0-12h, AUC0-infinity, t1/2, and tmax.

Main Results:

• All three Prednisolone Ferring tablet strengths (2 mg, 5 mg, 20 mg) met the bioequivalence criteria (90% confidence intervals within 0.80-1.25) compared to the reference.
• Pharmacokinetic parameters (Cmax, AUC, t1/2) for all test formulations were consistent with the reference.
• Time to maximum concentration (tmax) showed no significant differences, supporting bioequivalence.

Conclusions:

• The 2 mg, 5 mg, and 20 mg Prednisolone Ferring tablet formulations are bioequivalent to the reference product.
• These findings support the interchangeability of Prednisolone Ferring tablets with the reference formulation.
• The study confirms the consistent pharmacokinetic profile across different strengths of Prednisolone Ferring.