Cyclodextrin-Based Inclusion Complexes Improve the In Vitro Solubility and Pharmacokinetics of Ivacaftor Following Oral Administration in Mice Article Swipe
David S. Nakhla
,
Youssef W. Naguib
,
Sanjib Saha
,
Dylan Gao
,
Nikesh Gupta
,
Walla Malkawi
,
Timothy M. Acri
,
Aliasger K. Salem
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1208/s12249-025-03131-6
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1208/s12249-025-03131-6
Cystic fibrosis is a serious life-threatening hereditary disease that occurs due to a mutation in the cystic fibrosis transmembrane conductance regulator gene ( CFTR ). Ivacaftor (IVA) is a drug that targets the mutated CFTR protein. IVA is highly hydrophobic (log P = 5.6) with poor aqueous solubility (0.05 µg/mL) and is formulated as an amorphous solid dispersion tablet under the brand name Kalydeco ® . The recommended daily dose of Kalydeco ® is twice per day with a high fat meal to aid in IVA’s absorption. In this research, we studied the application of cyclodextrins (CDs) to improve the dissolution of IVA. Phase solubility studies between IVA and four different CDs (α-, β-, γ-, and hydroxypropyl-β-CD [HP-β-CD]) were conducted and a significant improvement in IVA’s aqueous solubility with HP-β-CD was observed. Solid state characterizations confirmed the formation of IVA/HP-β-CD inclusion complexes. In vitro dissolution studies were conducted at pH = 6.8 and showed improvement in IVA’s rate and extent of dissolution with IVA/HP-β-CD (1:2) complexes in comparison to uncomplexed IVA. In vivo pharmacokinetics in mice showed a 2-fold increase in area under the curve (AUC) after the oral administration of the IVA/HP-β-CD complex in comparison to Kalydeco tablets. In addition, HP-β-CD extended the release of IVA from the IVA/HP-β-CD complexes with a longer T max of 7.05 h compared to 2.96 h with Kalydeco ® tablets. These results demonstrate that CD inclusion complexes of IVA using HP-β-CD can be a successful alternative approach to improving the solubility of IVA while extending its release. Graphical Abstract
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1208/s12249-025-03131-6
- https://link.springer.com/content/pdf/10.1208/s12249-025-03131-6.pdf
- OA Status
- hybrid
- References
- 47
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4410424715
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4410424715Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1208/s12249-025-03131-6Digital Object Identifier
- Title
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Cyclodextrin-Based Inclusion Complexes Improve the In Vitro Solubility and Pharmacokinetics of Ivacaftor Following Oral Administration in MiceWork title
- Type
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articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-05-16Full publication date if available
- Authors
-
David S. Nakhla, Youssef W. Naguib, Sanjib Saha, Dylan Gao, Nikesh Gupta, Walla Malkawi, Timothy M. Acri, Aliasger K. SalemList of authors in order
- Landing page
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https://doi.org/10.1208/s12249-025-03131-6Publisher landing page
- PDF URL
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https://link.springer.com/content/pdf/10.1208/s12249-025-03131-6.pdfDirect link to full text PDF
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YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
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https://link.springer.com/content/pdf/10.1208/s12249-025-03131-6.pdfDirect OA link when available
- Concepts
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Pharmacokinetics, Ivacaftor, Solubility, Pharmacology, Chemistry, Bioavailability, Cyclodextrin, Oral administration, In vitro, Chromatography, Medicine, Biochemistry, Organic chemistry, Gene, Cystic fibrosis transmembrane conductance regulatorTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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47Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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