Determination of bioequivalence between generic and reference drugs using laser-induced breakdown spectroscopy

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Current in vitro bioequivalence studies solely compare dissolution, neglecting chemical formulation similarities.
• Existing methods lack consideration for chemical composition differences between generic and reference drugs.
• A novel approach is needed to assess chemical similarity for in vitro bioequivalence.

Purpose of the Study:

• To develop and validate a Laser-Induced Breakdown Spectroscopy (LIBS) method for in vitro bioequivalence determination.
• To establish LIBS as an alternative to in vivo studies for generic immediate-release solid oral dosage forms.
• To assess formulation similarity between generic and reference drugs using LIBS.

Main Methods:

• Utilized Laser-Induced Breakdown Spectroscopy (LIBS) for direct analysis of drug samples.
• Employed chemometric analysis of LIBS spectra to determine differentiation (f1) and similarity (f2) factors.
• Applied established pharmaceutical industry criteria (f1 < 15, f2 > 50) for bioequivalence assessment.

Main Results:

• The LIBS method provides fast, simple, and cost-effective in vitro bioequivalence determination.
• Spectrochemical similarity was confirmed for generic drugs compared to reference standards using LIBS.
• All tested generic drugs demonstrated in vitro bioequivalence, meeting regulatory standards (f1 < 15, f2 > 50).
• The method proved effective even for low-concentration active ingredients in Biopharmaceutics Classification System Class III and IV drugs.

Conclusions:

• Laser-Induced Breakdown Spectroscopy (LIBS) is successfully applied for the first time in advanced pharmaceutical analysis.
• The LIBS method offers a reliable and specialized approach to establish formulation similarity without component identification.
• This technique presents a novel and potential tool for determining in vitro bioequivalence in generic immediate-release solid oral dosage forms.