ReviewJournal of pharmaceutical sciences2026
Biowaiver monograph for immediate-release solid oral dosage forms: Amlodipine besylate.
Review in Journal of pharmaceutical sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
Amlodipine besylate is a calcium channel blocker widely used for treating hypertension and coronary artery disease. This biowaiver monograph evaluates the suitability of BCS-based biowaivers for immediate-release (IR) oral dosage forms containing amlodipine besylate. A comprehensive review of available data was conducted to assess solubility, permeability, bioavailability, dissolution, pharmacokinetics, safety, and excipient interactions. Amlodipine besylate is a highly soluble base across the pH range 1.2-6.8. Although mass balance in humans showed a fraction absorbed of ≥96%, inconclusive in vitro permeability data revealed a risk associated with a BCS class I classification. Nonetheless, several IR formulations, including fixed-dose combinations (FDC), have demonstrated bioequivalence (BE). This has been related to very rapid in vitro dissolution profiles at 75 rpm for the reference product, as recommended by guidelines. Taken together, the risk of BE failure due to formulation or manufacturing differences is low, provided a very rapid dissolution and the use of standard excipients. With a favorable safety profile and a wide therapeutic index, the overall evidence leads to a conservative classification of amlodipine besylate to BCS III. Thus, IR products containing this drug can be candidates for the BCS-based biowaiver, thereby enabling substitution of surrogate in vitro methods for in vivo BE approval of multisource products.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.