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Polyoxyethylene Lauryl Ether (Brij-35) and Poloxamer 407–Based Non-ionic Surfactant Vesicles for Dissolution Enhancement of Tacrolimus

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Abstract

Purpose

This study aimed to develop niosomes using polyoxyethylene lauryl ether (Brij-35) and poloxamer 407 surfactants for dissolution enhancement of tacrolimus, a poorly water-soluble drug for improving oral bioavailability.

Methods

Niosomes were prepared using surfactants polyoxyethylene lauryl ether (Brij-35) (Group I), poloxamer 407 (Group II), and hybrid niosomes including both Brij-35 and poloxamer 407 (Group III). A thin film hydration technique was employed for the development of niosomes. Drug-surfactant interactions were examined using FTIR. The entrapment efficiency of niosomes was determined using ultra-centrifugation technique. Vesicle size, PDI, and zeta potential were measured by DLS experiments. Morphological evaluation of vesicles was carried out using SEM microscopy. DSC technique was used to evaluate the thermal behavior of niosomes. In vitro dissolution study of optimized niosomes (F1-Br35, F1-PL407, and F1-BrPL) was performed by dialysis bag method.

Results

FTIR studies revealed the compatibility of tacrolimus with used surfactants. Percent entrapment efficiency values were in the range of 88.65 ± 3.13 to 93.67 ± 1.57% for Brij-35-based formulations, 87.83 ± 6.24 to 89.01 ± 5.83% for poloxamer 407, and 90.08 ± 1.12 to 92.81 ± 0.31% for hybrid niosomes. The vesicle size of niosomes was in the range of 282.5 to 622.5 nm. SEM analysis showed an almost spherical shape of optimized formulations (F1-Br35, F1-PL407, and F1-BrPL). DSC analysis demonstrated amorphous form of tacrolimus indicating improved dissolution of tacrolimus. In vitro dissolution of optimized formulations F1-Br35, F1-PL407, and F1-BrPL at pH 7.4 indicated an improved dissolution profile of tacrolimus compared to pure drug aqueous dispersion.

Conclusion

Overall, the results of the study concluded that newly developed niosomes could act as a promising approach for enhancing the dissolution profile of tacrolimus and can act as alternate oral carriers.

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Data Availability

Authors declare that all the data supporting the findings of this study are included in the article.

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Acknowledgements

The authors extend their gratitude to Allmed Pharmaceuticals Pvt. Ltd. Lahore, Pakistan; Riphah International University, Lahore, Pakistan; LCW University, Lahore, Pakistan; and Lahore University of Management Sciences, Lahore, Pakistan, for the facilitation of the research process.

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Authors and Affiliations

  1. Riphah Institute of Pharmaceutical Sciences, Riphah International University, Lahore, 54000, Pakistan

    Razia Hanif, Muhammad Imran Khan, Muhammad Furqan Akhtar, Muhammad Farhan Sohail, Sufyan Junaid Usmani, Aslam Khan & Athar Masood

  2. Department of Pharmaceutics, Faculty of Pharmacy, The Islamia University of Bahawalpur, Bahawalpur, 63100, Pakistan

    Asadullah Madni

  3. Department of Pharmacology, Faculty of Pharmacy, G.C. University Faisalabad, Faisalabad, Pakistan

    Ammara Saleem

  4. Department of Pharmacy, Faculty of Biological Sciences, Quaid-I-Azam University, Islamabad, 45320, Pakistan

    Mubashar Rehman

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  1. Razia Hanif
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Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by Razia Hanif, Muhammad Imran Khan, Asadullah Madni, Muhammad Furqan Akhtar, Muhammad Farhan Sohail, Ammara Saleem, Mubashar Rehman, and Sufyan Junaid Usmani. The first draft of the manuscript was written by Muhammad Imran Khan, and all authors commented on previous versions of the manuscript. Review, editing, and statistical analysis were carried out by Aslam Khan and Athar Masood. All authors read and approved the final manuscript.

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Correspondence to Muhammad Imran Khan.

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Hanif, R., Khan, M.I., Madni, A. et al. Polyoxyethylene Lauryl Ether (Brij-35) and Poloxamer 407–Based Non-ionic Surfactant Vesicles for Dissolution Enhancement of Tacrolimus. J Pharm Innov 18, 1487–1499 (2023). https://doi.org/10.1007/s12247-023-09737-2

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