Investigating Intestinal Permeability of Bortezomib Using a Validated HPLC-UV Method
Mohammad Mahmoudian1,2, Parvin Zakeri-Milani3, Hadi Valizadeh4
1Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.
Drug Research
|November 20, 2018
Summary
Bortezomib (BTZ) oral delivery was evaluated using intestinal perfusion. The study determined BTZ
Area of Science:
- Pharmacokinetics and Drug Delivery
- Gastrointestinal Physiology
- Analytical Chemistry
Background:
- Bortezomib (BTZ) is a proteasome inhibitor used for multiple myeloma and mantle cell lymphoma.
- Current administration routes for BTZ include intravenous injection and subcutaneous injection.
- Evaluating oral delivery potential is crucial for improving patient compliance and treatment accessibility.
Purpose of the Study:
- To assess the intestinal permeability of Bortezomib (BTZ) for oral delivery evaluation.
- To develop and validate an analytical method for quantifying BTZ in perfusion studies.
- To predict the biopharmaceutical class of BTZ based on its permeability characteristics.
Main Methods:
- In situ single-pass intestinal perfusion (SPIP) technique was employed to measure BTZ intestinal permeability.
- A validated High-Performance Liquid Chromatography with Ultraviolet detection (HPLC-UV) method was used for analysis.
- Chromatographic separation utilized a C18 column with a methanol/deionized water mobile phase.
Main Results:
- The HPLC-UV method demonstrated linearity (r² > 0.99), acceptable quantitation limits, and high recovery rates for BTZ.
- Stability studies confirmed the working standard solution of BTZ remained stable for 48 hours.
- An effective permeability (Peff) value of (3.36±0.5)×10⁻⁵ cm/sec was determined for BTZ.
Conclusions:
- Bortezomib exhibits moderate intestinal permeability, suggesting potential for oral formulation development.
- The validated HPLC-UV method is suitable for quantifying BTZ in pharmacokinetic studies.
- BTZ is predicted to belong to the Biopharmaceutical Classification System (BCS) Class III.
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