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Re-evaluation of in vitro dissolution techniques for supersaturating drug delivery systems.
Saumitra Bagchi1, Tusharmouli Mukherjee, Fotios Plakogiannis
1Division of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy and Allied Health Sciences, Long Island University, Brooklyn, NY 11201, USA. saumitra_ju@yahoo.com
Pharmaceutical Development and Technology
|February 3, 2011
Summary
Fiber optic dissolution testing accurately measures drug release from supersaturable self-microemulsifying (SME) formulations, unlike HPLC which can overestimate release due to formulation components. This highlights the fiber optic method
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Analytical Chemistry
Background:
- Supersaturable drug delivery systems aim to enhance drug solubility and bioavailability.
- Accurate dissolution testing is critical for characterizing complex formulations like self-microemulsifying (SME) systems.
- Albendazole (ABZ) exhibits pH-dependent solubility, complicating dissolution studies.
Purpose of the Study:
- To compare conventional high-performance liquid chromatography (HPLC) analysis with a fiber optic dissolution method.
- To evaluate the suitability of these methods for studying supersaturable drug delivery systems, specifically SME formulations of albendazole.
- To identify potential errors in dissolution testing of complex formulations.
Main Methods:
- Two albendazole (ABZ) SME formulations (15 mg and 5 mg/capsule) were prepared.
- Dissolution studies were conducted in media of varying pH (1.2, 4.5, 6.8, 7.4).
- Samples were analyzed concurrently using HPLC and an online fiber optic dissolution system.
Main Results:
- For the 15 mg/capsule formulation, HPLC showed 80-100% release at pH 4.5-7.4, while fiber optic showed <40% release.
- Precipitation due to ABZ's pH-dependent solubility and supersaturation were observed.
- The discrepancy arose because HPLC quantified total drug, including that in oil/water phases, while fiber optic measured dissolved drug.
Conclusions:
- Conventional HPLC analysis can lead to significant errors in developing complex SME formulations.
- The fiber optic dissolution method provides a more accurate assessment of drug release from SME systems.
- Method selection is crucial for reliable characterization of supersaturable drug delivery systems.
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