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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...

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Related Experiment Video

Updated: Jul 14, 2026

A Reference Broth Microdilution Method for Dalbavancin In Vitro Susceptibility Testing of Bacteria that Grow Aerobically

A Reference Broth Microdilution Method for Dalbavancin In Vitro Susceptibility Testing of Bacteria that Grow Aerobically

Published on: September 9, 2015

Bioequivalence study of sultamicillin suspensions.

Reinhard Sailer¹, Peter Arnold, Aydin Erenmemişoğlu

¹Pharmakin GmbH, Gesellschaft für Pharmakokinetik, Ulm, Germany. reinhard.sailer@pharmakin.de

Arzneimittel-Forschung

|May 23, 2007

Summary

This study found that the Devasid sultamicillin suspension is bioequivalent to the originator product. Pharmacokinetic parameters for ampicillin and sulbactam confirm comparable bioavailability between the two sultamicillin formulations.

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Last Updated: Jul 14, 2026

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Published on: September 9, 2015

Area of Science:

Pharmacology
Clinical Pharmacy
Drug Development

Background:

Sultamicillin is a prodrug combining ampicillin and sulbactam.
It functions as an antibiotic with a beta-lactamase inhibitor.

Purpose of the Study:

To evaluate the relative bioavailability of Devasid sultamicillin suspension.
To assess the bioequivalence of Devasid compared to the originator sultamicillin product.

Main Methods:

A randomized, two-period crossover study in 24 healthy male volunteers.
Pharmacokinetic analysis of ampicillin and sulbactam plasma concentrations using LC-MS/MS.
Bioequivalence assessment based on AUC(0-infinity) and C(max) with 90% confidence intervals.

Main Results:

Maximum plasma concentrations (Cmax) and Area Under the Curve (AUC) for ampicillin and sulbactam were comparable between test and reference products.
90% confidence intervals for the T/R-ratios of AUC and Cmax fell within the 80%-125% range.
Plasma elimination half-lives (t1/2) and time to maximum concentration (tmax) were similar for both preparations.

Conclusions:

Devasid sultamicillin suspension demonstrated bioequivalence to the originator product.
The study supports the interchangeability of the two sultamicillin formulations.
Pharmacokinetic profiles confirm comparable drug absorption and disposition.