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Optimization and evaluation of instant release buccal films of eletriptan: a quality-by-design approach

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Abstract

Oral bioavailability is the main decisive factor in achieving the desired systemic drug concentration, and it can be increased by developing novel dosage forms that can avoid first-pass metabolism. The current study aimed to employ the quality-by-design (QbD) approach to develop and optimize the therapeutically efficient instant release buccal films (IRBFs) of eletriptan, which should not only be able to avoid the first-pass metabolism, but also circumvent the condition of gastric stasis which is associated with migraine. The solvent casting method was employed to fabricate IRBFs, including hydroxypropyl methylcellulose E-5 (HPMC E5) as a polymer, glycerin as a plasticizer and permeation enhancer, and tween-80 (T80) as a surfactant. The prepared films were subjected to different physicochemical characterizations using Fourier transform infrared spectroscopy (FTIR), surface morphology, disintegration time (DT), in vitro, and ex vivo permeation studies. The findings have shown that prepared films were rapidly disintegrating (DT < 30 s), immediately dissolving (TDT < 120 s), and instantly releasing and allowing rapid permeation of the drug. The outcomes of the study have assisted to develop the optimized formulation, followed by its characterization, which showed that the findings were quite similar to those, predicted by the statistical tool for the optimized formulation. The similarity of predicted and obtained results have confirmed the reproducibility of the prepared IRBFs.

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Acknowledgements

The authors are grateful to Wilshire Labs (Pvt) Ltd., Lahore, for providing the drug eletriptan. The authors extend their appreciation to the Deanship of Scientific Research at King Saud University for funding this work through research group no. RG-1441-340.

Funding

The authors extend their appreciation to the Deanship of Scientific Research at King Saud University for funding this work through research group no. RG-1441–340.

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Authors and Affiliations

  1. Faculty of Pharmacy, University of Central Punjab, Lahore, Pakistan

    Qurat ul Ain, Muhammad Zaman, Muhammad Jamshaid, Tehseen Riaz & Muhammad Hammad Butt

  2. College of Pharmacy, University of Sargodha, Sargodha, Pakistan

    Waqar Siddique

  3. Quaid-e-Azam Medical College, Bahawalpur, Pakistan

    Asad Shabbir

  4. Department of Pharmacy, Forman Christian College (A Chartered University), Lahore, Pakistan

    Omer Salman Qureshi

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  1. Qurat ul Ain
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  2. Muhammad Zaman
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  4. Tehseen Riaz
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  7. Muhammad Hammad Butt
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  8. Omer Salman Qureshi
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Contributions

Conceptualization was carried out by Q.A., M.Z., T.R., and M.J.; methodology by M.Z., Q.A, T.R.; formal analysis and investigation by Q.A., M.Z., and W.S.; writing by Q.A. and W.S.; writing review and editing by M.Z., M.J., and T.R.; funding acquisition and supervision by M.Z.; all authors have read and agreed to the published version of the manuscript.

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Correspondence to Muhammad Zaman.

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Ain, Q.u., Zaman, M., Jamshaid, M. et al. Optimization and evaluation of instant release buccal films of eletriptan: a quality-by-design approach. Polym. Bull. 80, 10429–10455 (2023). https://doi.org/10.1007/s00289-022-04547-x

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  • DOI: https://doi.org/10.1007/s00289-022-04547-x

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