ArticlePharmaceutical research2016
The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers.
Article in Pharmaceutical research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
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Who cites it
16 citing papers in PubMed.
- Enhancing Therapeutic Efficacy Through Tailored Pharmacokinetics: A Review of Mesoporous Silica Nanoparticle-Based Delivery Systems.International journal of nanomedicine · 2026Review
- Exploring Experimental and Statistical Approaches to Control Oversensitivity of In Vitro Permeability to Excipient Effects.Pharmaceutics · 2025Article
- Biowaiver based on biopharmaceutics classification system: Considerations and requirements.Pharmaceutical science advances · 2024Review
- Challenges in Permeability Assessment for Oral Drug Product Development.Pharmaceutics · 2023Review
- Article
- Application of co-precipitated glutinous rice starch as a multifunctional excipient in direct compression tablets.Heliyon · 2023Article
- Regulatory utility of physiologically-based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report.CPT: pharmacometrics & systems pharmacology · 2023Review
- Preclinical Pharmacokinetic Studies of a Novel Diuretic Inhibiting Urea Transporters.Molecules (Basel, Switzerland) · 2022Article
- Evaluation of Excipient Risk in BCS Class I and III Biowaivers.The AAPS journal · 2022Review
- The involvement of extracellular vesicles in the transcytosis of nanoliposomes through brain endothelial cells, and the impact of liposomal pH-sensitivity.Materials today. Bio · 2022Article
- Acyclovir-Loaded Solid Lipid Nanoparticles: Optimization, Characterization and Evaluation of Its Pharmacokinetic Profile.Nanomaterials (Basel, Switzerland) · 2020Article
- The Effect of Anesthetic Regimens on Intestinal Absorption of Passively Absorbed Drugs in Rats.Pharmaceutical research · 2020Article
- Employing a PLGA-TPGS based nanoparticle to improve the ocular delivery of Acyclovir.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2019Article
- Simultaneous Semi-Mechanistic Population Pharmacokinetic Modeling Analysis of Enalapril and Enalaprilat Serum and Urine Concentrations From Child Appropriate Orodispersible Minitablets.Frontiers in pediatrics · 2019Article
- Anti-Rift Valley fever virus activity in vitro, pre-clinical pharmacokinetics and oral bioavailability of benzavir-2, a broad-acting antiviral compound.Scientific reports · 2018Article
- A Mixed Micelle Formulation for Oral Delivery of Vitamin K.Pharmaceutical research · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeCurrently, the FDA allows biowaivers for Class I (high solubility and high permeability) and Class III (high solubility and low permeability) compounds of the Biopharmaceutics Classification System (BCS). Scientific evidence should be provided to support biowaivers for BCS Class I and Class III (high solubility and low permeability) compounds.
methodsData on the effects of excipients on drug permeability are needed to demonstrate that commonly used excipients do not affect the permeability of BCS Class III compounds, which would support the application of biowaivers to Class III compounds. This study was designed to generate such data by assessing the permeability of four BCS Class III compounds and one Class I compound in the presence and absence of five commonly used excipients.
resultsThe permeability of each of the compounds was assessed, at three to five concentrations, with each excipient in two different models: Caco-2 cell monolayers, and in situ rat intestinal perfusion. No substantial increases in the permeability of any of the compounds were observed in the presence of any of the tested excipients in either of the models, with the exception of disruption of Caco-2 cell monolayer integrity by sodium lauryl sulfate at 0.1 mg/ml and higher.
conclusionThe results suggest that the absorption of these four BCS Class III compounds would not be greatly affected by the tested excipients. This may have implications in supporting biowaivers for BCS Class III compounds in general.
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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.