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Biowaiver monographs for immediate release solid oral dosage forms: furosemide
G E Granero1, M R Longhi, M J Mora
1Chemical Sciences Faculty, Pharmacy Department, National University of Córdoba, Córdoba, Argentina.
Journal of Pharmaceutical Sciences
|December 5, 2009
Summary
Furosemide, a diuretic, is classified as Biopharmaceutics Classification System (BCS) Class IV. This classification indicates that a waiver of in vivo bioequivalence (BE) testing is not justified for immediate-release dosage forms.
Area of Science:
- Pharmaceutical Sciences
- Drug Development
- Regulatory Science
Background:
- Furosemide is a widely used diuretic.
- The Biopharmaceutics Classification System (BCS) aids in determining bioequivalence (BE) waiver eligibility.
- Immediate-release (IR) solid oral dosage forms require assessment for BE.
Purpose of the Study:
- To review literature and experimental data for furosemide's suitability for a biowaiver.
- To evaluate furosemide's classification within the BCS.
- To determine if a waiver of in vivo BE testing is appropriate for furosemide IR products.
Main Methods:
- Literature review of furosemide's solubility, absorption, and permeability.
- Classification of furosemide based on Biopharmaceutics Classification System (BCS) criteria.
- Assessment of therapeutic use, index, pharmacokinetics, excipient interactions, and reported BE/bioavailability (BA) issues.
Main Results:
- Furosemide is classified as BCS Class IV based on its properties.
- Data on solubility, oral absorption, and permeability support this classification.
- Consideration of therapeutic index and potential for excipient interactions was performed.
Conclusions:
- The biowaiver procedure is not justified for furosemide IR products.
- This applies to both new multisource drug products and major postapproval changes.
- Regulatory approval pathways for furosemide require in vivo bioequivalence testing.
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