Preparation and characterization of disintegrating film formulations containing bisoprolol fumarate for the treatment of hypertension

Abstract

Since oral administration is the most preferred route of drug administration, innovative and effective oral pharmaceutical dosage forms are being investigated. Among these new pharmaceutical forms, orally disintegrating films (ODFs) play an important role. This study aims to create optimum ODF formulations containing bisoprolol fumarate using solvent casting method. While pullulan and lycoat were used as polymers in the structure of the films, plasticizers such as polyethylene glycol 400 (PEG-400) and glycerin were used to provide flexibility. Characterization studies on the obtained films are determination of morphological characteristics, folding determination, thickness determination, determination of swelling behaviour, determination of disintegration time, in vitro release determination, mass uniformity determination, determination of content uniformity, tensile strength, elastic modulus and elongation percentage determinations. UV-Vis spectroscopy studies were performed to confirm bisoprolol fumarate. The complete disintegration time for the F-14 films with optimum characteristics was found to be 38 seconds on average in the petri dish method and 16 seconds on average using the dispersion time analyzer. These values revealed that pullulan polymer exhibited better film-forming capacity when used in close amounts with lycoate polymer. ODFs containing bisoprolol fumarate have provided an effective, safe, innovative and easy to use treatment for hypertension.

Keywords

• orally disintegration films
• bisoprolol fumarate
• pullulan
• lycoat

Supporting Institution

Marmara University Health Sciences Institute

Thanks

The authors are thankful to Prof. Dr. Timuçin Uğurlu for supplying Bisoprolol fumarate and other excipients. Authors are also thankful to Ali Raif Pharmaceutical Industry Co., Ltd. for supplying pullulan and lycoat.

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