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Polymers
Sep 23, 2022;14 (19):

The Development of Eletriptan Hydrobromide Immediate Release Buccal Films Using Central Composite Rotatable Design: An In Vivo and In Vitro Approach.

Waqar Siddique, Muhammad Zaman, Rai Muhammad Sarfraz, Muhammad Hammad Butt, Atta Ur Rehman, Noman Fassih, Ghadeer M Albadrani, Roula Bayram, Mohammad Y Alfaifi, Mohamed M Abdel-Daim
Author Information
  1. Waqar Siddique: College of Pharmacy, University of Sargodha, Sargodha 40100, Pakistan.
  2. Muhammad Zaman: Faculty of Pharmacy, University of Central Punjab, Lahore 54000, Pakistan. ORCID
  3. Rai Muhammad Sarfraz: College of Pharmacy, University of Sargodha, Sargodha 40100, Pakistan. ORCID
  4. Muhammad Hammad Butt: Department of Medicinal Chemistry, Faculty of Pharmacy, Uppsala University, 75123 Uppsala, Sweden. ORCID
  5. Atta Ur Rehman: Department of Pharmacy, Forman Christian College, Lahore 54000, Pakistan.
  6. Noman Fassih: Department of Medical Cell Biology, Faculty of Medicine, Uppsala University, 75123 Uppsala, Sweden.
  7. Ghadeer M Albadrani: Department of Biology, College of Science, Princess Nourah Bint Abdulrahman University, P.O. Box 84428, Riyadh 11671, Saudi Arabia. ORCID
  8. Roula Bayram: Pharmacy Program, Department of Pharmaceutical Sciences, Batterjee Medical College, Jeddah 21442, Saudi Arabia. ORCID
  9. Mohammad Y Alfaifi: Biology Department, Faculty of Science, King Khalid University, Abha 9004, Saudi Arabia.
  10. Mohamed M Abdel-Daim: Pharmacy Program, Department of Pharmaceutical Sciences, Batterjee Medical College, Jeddah 21442, Saudi Arabia. ORCID
PMID: 36235932 DOI: 10.3390/polym14193981

Abstract

The objective is to develop immediate release buccal films of Eletriptan Hydrobromide (EHBR) using hydroxypropyl methylcellulose (HPMC) E5. The buccal films have the ability to disintegrate rapidly and provide both systemic and local effects. The solvent casting method was employed to prepare the films and the central composite rotatable design (CCRD) model was used for film optimization. All the formulated films were characterized for physicochemical evaluation (Fourier transform infrared spectroscopy (FTIR), X-ray Diffraction (XRD), differential scanning calorimetry (DSC), and Scanning electron microscopy (SEM), in in-vitro, ex-vivo, and in-vivo drug release. The fabricated films were transparent, colorless, and evenly distributed. The FTIR spectra showed no chemical interaction between the drug and excipients. In in-vitro analysis, the film has the highest% drug release (102.61 ± 1.13), while a maximum of 92.87 ± 0.87% drug was diffused across the cellulose membrane having a pore size of 0.45 µm. In the ex-vivo study, drug diffusion across the goat mucosa was performed and 80.9% of the drug was released in 30 min. In-vivo results depict a mean half-life (t½) of 4.54 ± 0.18 h and a C of 128 ± 0.87 (ng/mL); T was achieved in 1 h. Furthermore, instability and histopathological studies buccal films were proven to be safe and act as an effective dosage form. In a nutshell, optimized and safe instant release EHBR buccal films were prepared that have the tendency to provide effect effectively.

Keywords

anti-migraine buccal films characterization oral cavity rapid onset

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Grants

  1. PNURSP2022R30/Princess Nourah bint Abdulrahman University
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