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In Vivo Predictive Dissolution (IPD) for Carbamazepine Formulations: Additional Evidence Regarding a Biopredictive
Marival Bermejo1, Jessica Meulman2, Marcelo Gomes Davanço3
1Department of Engineering, Pharmacy and Pharmaceutical Technology Area, Facultad de Farmacia, University Miguel Hernandez de Elche, San Juan de Alicante, 03550 Alicante, Spain.
Pharmaceutics
|June 21, 2020
Summary
A new dissolution medium with 1% sodium lauryl sulphate (SLS) effectively predicts carbamazepine (CBZ) in vivo performance. This biopredictive tool aids quality control for CBZ products, especially where bioequivalence studies are not mandated.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery and Formulation
- Biopharmaceutics
Background:
- Regulatory agencies require robust methods to ensure drug product quality.
- Predictive dissolution testing is crucial for assessing in vivo performance without extensive clinical trials.
- Carbamazepine (CBZ) quality control is vital, particularly in regions with less stringent bioequivalence (BE) study requirements.
Purpose of the Study:
- To provide further evidence for a 1% sodium lauryl sulphate (SLS) dissolution medium as a biopredictive tool for carbamazepine (CBZ) products.
- To establish and validate in vitro-in vivo correlations (IVIVC) for CBZ immediate-release (IR) formulations.
- To assess the utility of different IVIVC approaches, including one-step, two-step, and time-scaling methods.
Main Methods:
- Conducting a bioequivalence (BE) study with twelve healthy volunteers using test and reference CBZ immediate-release (IR) formulations.
- Performing dissolution profile analysis using a medium containing 1% SLS.
- Developing Level A in vitro-in vivo correlations (IVIVC) using one-step, two-step, and time-scaling approaches.
Main Results:
- The 1% SLS dissolution medium demonstrated effectiveness in predicting the in vivo behavior of CBZ products.
- Both one-step and two-step IVIVC approaches yielded good in vivo predictability.
- The study provided additional evidence supporting the 1% SLS medium as a universal biopredictive dissolution tool.
Conclusions:
- The 1% SLS dissolution medium is a reliable biopredictive tool for carbamazepine (CBZ) products.
- Established IVIVC methods (one-step and two-step) are effective for predicting in vivo performance.
- This biopredictive medium offers a valuable quality control solution for CBZ products in regions like Latin America.
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