PREPARATION AND CHARACTERIZATION OF ATROPINE SULFATE ORODISPERSIBLE TABLETS

Ibrahim, Mohamed F; Emam, Mohamed H; Mowafy, Hammam A; Afouna, Mohsen M

doi:10.21608/ajps.2023.332166

PREPARATION AND CHARACTERIZATION OF ATROPINE SULFATE ORODISPERSIBLE TABLETS

Authors

¹ Department of Pharmaceutics and Pharmaceutical Technology, College of Pharmacy (Boys), Al-Azhar University, 1 El-Mokhayam El-Daem St., Nasr City, P.O. Box 11884, Cairo, Egypt.

² Captain Pharmacist at Egyptian Armed Forces

10.21608/ajps.2023.332166

Abstract

The oral route of administration is considered as the most widely accepted route. The unique environment of the oral cavity offers its potential as a site for drug delivery. The objective of the current study was to formulate and evaluate an atropine sulfate (AS) orodispersible tablet (ODT) as an alternative non-invasive and portable dosage form for treatment of various emergency health conditions as treatment of organophosphate (OP) toxicity. Atropine sulfate auto injector, AtroPen®, is the only self-administered dosage form available as an antidote for out-of-hospital emergency use, but it is associated with several limitations and drawbacks. Nine formulations of atropine sulfate orodispersible tablets (F1 to F9) were prepared using different superdisintegrants, namely sodium starch glycolate, crosspovidone, crosscarmellose sodium with different concentrations (3, 5, and 8 (%. The compatibility studies of drug and excipients were performed by Fourier transform infrared spectroscopy (FTIR) and differential scanning colorimetry (DSC). The final blend of the drug and excipients were evaluated for powder flow properties such as bulk density, tapped density, compressibility index, Hausner’s ratio, and angle of repose. All nine formulations were evaluated for post-compression parameters such as thickness, weight variation, hardness, friability, drug content, disintegration time, wetting time, and in vitro dissolution studies. It was found that F9 had the best results as it had short disintegration time (11 sec) and wetting time (24.8 sec) with 102.22% drug release after 2 minutes. F9 was subjected to an accelerated stability study for 3 months, which showed no significant changes in all physicochemical parameters.

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