DESIGN, DEVELOPMENT, AND CHARACTERIZATION OF LORATADINE SUSTAINED RELEASED BUCCAL FILM: IN VITRO AND IN VIVO STUDY IN BEAGLE DOGS

SIHAM A. ABDOUN; AMLAK S. ALTUWAYJIRI; BUSHRA A. ALFURAYDI; KHAWLAH A. ALBURAYH; GAMAL O. ELHASSAN; DALIA A. GABER

doi:10.22159/ijap.2024v16i2.50119

Authors

SIHAM A. ABDOUN Department of Pharmaceutics, College of Pharmacy, Qassim University, Buraidah, KSA
AMLAK S. ALTUWAYJIRI College of Pharmacy, AL-Qassim University, Buraidah, KSA
BUSHRA A. ALFURAYDI College of Pharmacy, AL-Qassim University, Buraidah, KSA
KHAWLAH A. ALBURAYH College of Pharmacy, AL-Qassim University, Buraidah, KSA
GAMAL O. ELHASSAN Department of Pharmaceutics, Unaizah College of Pharmacy, Qassim University, Unaizah, KSA
DALIA A. GABER Department of Pharmaceutics, College of Pharmacy, Qassim University, Buraidah, KSA. Department of Quality Control and Quality Assurance, Holding Company for Biological Products and Vaccines, Cairo, Egypt

DOI:

https://doi.org/10.22159/ijap.2024v16i2.50119

Keywords:

Buccal drug delivery, Mucoadhesive polymers, Loratadine, Films, Bioavailability

Abstract

Objective: The aim of this work was to develop and evaluate bucco-adhesive films of Loratadine (LTD) for sustained release use.

Methods: Design of twelve different sustained released buccal film formulas using Carbopol, pectin, sodium alginate, glycerol, carboxymethyl cellulose (CMC), hydroxypropyl cellulose (HPC), Gelatin, Hydroxyethyl cellulose (HEC), and Hydroxypropyl methylcellulose (HPMC) as mucoadhesive polymers. Films were evaluated for physicochemical properties, thickness, swelling, moisture content, drug content, in vitro dissolution. The pharmacokinetic parameters of optimal formula were evaluated in beagle dogs.

Results: The selected film formula (F6) showed accepted content and muco-adhesion properties. The in vitro release study showed prolonged release of drug from films over 10 h in optimal formulation. The bioavailability studies performed using beagle dogs model showed that there was 113.45% increase in the AUC_0-24of selected film compared with oral market tablets.

Conclusion: Bucco-adhesive films is a promising dosage form for improving the bioavailability of loratadine.

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