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Bioavailability of 17 ampicillin products

P L Whyatt, G W Slywka, A P Melikian

Journal of Pharmaceutical Sciences

|May 1, 1976

Summary

This study found no significant differences in the bioavailability of ampicillin capsules from 17 different manufacturers. All tested ampicillin products demonstrated comparable serum ampicillin levels and pharmacokinetic profiles.

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Area of Science:

Pharmacology
Pharmaceutical Sciences
Clinical Pharmacy

Background:

Ampicillin is a widely prescribed antibiotic.
Ensuring consistent bioavailability across different manufacturers is crucial for therapeutic efficacy.
Variability in drug products can impact patient outcomes.

Purpose of the Study:

To evaluate and compare the bioavailability of 250-mg ampicillin capsules from 17 different distributors/manufacturers.
To determine if significant pharmacokinetic differences exist between ampicillin products available on the market.

Main Methods:

Serum ampicillin levels were measured at multiple time points (1, 2, 3, 4, 6, and 8 hours) post-administration.
Key pharmacokinetic parameters including peak serum levels, time to peak, and area under the serum level-time curve (AUC) were analyzed.
Statistical analysis was performed to identify significant differences between products.

Main Results:

No statistically significant differences (p > 0.05) were observed between any of the 17 ampicillin capsule products tested.
All evaluated products exhibited similar serum ampicillin concentration-time profiles.
Pharmacokinetic parameters were consistent across all tested ampicillin lots.

Conclusions:

The bioavailability of 250-mg ampicillin capsules is comparable across the 17 evaluated brands.
This suggests consistent quality and therapeutic equivalence among these ampicillin products.
Patients can be assured of similar ampicillin drug performance regardless of the tested manufacturer.

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