Formulation and In-Vitro Evaluation of Bromocriptine Mesylate Polymeric Nanoparticle loaded in Fast Dissolving Oral Film

نویسندگان

1 Department of Pharmaceutics, Alrasheed University College of Pharmacy, Iraq

2 Department of Pharmaceutics, Alrasheed University College of Pharmacy, Iraq

3 Department of Pharmaceutics, Alrasheed University College of Pharmacy, Iraq

4 Department of Pharmaceutics, Alrasheed University College of Pharmacy, Iraq

5 Department of Pharmaceutics, Al-Esraa University College of Pharmacy, Iraq

doi
10.22052/JNS.2026.03.029
چکیده

Polymer-based nanoparticles are colloidal systems composed of either natural or synthetic polymers. Bromocriptine, a semi-synthetic ergot alkaloid, binds to D2 dopamine receptors, decreasing prolactin secretion. It is prescribed for conditions like neuroleptic malignant syndrome, acromegaly, infertility, and hyperprolactinemia. Bromocriptine mesylate has limited water solubility, with gastrointestinal absorption between 28% and 37%. Nevertheless, its oral bioavailability is reduced to about 6% due to first-pass metabolism in the liver. This study aimed to develop and assess a polymeric nanoparticle system containing bromocriptine mesylate to improve its solubility, wettability, dissolution rate, and stability. This would facilitate more efficient delivery of bromocriptine mesylate through a fast-dissolving oral film. The method involved polymeric nanoparticle emulsification and solvent evaporation. Initially, the polymer solution was emulsified in an aqueous nanomaterial phase, then solvent evaporation was performed. PEG400 and poloxamer 188 served as the internal polymers, while Tween 80 functioned as the surfactant to produce the polymeric nanoparticles. The nanoparticle formulated with PEG400 as the internal polymer had a size range of 154 nm to 537 nm. The entrapment efficiency (EE) was tested on the selected formula (F4), which had the smallest particle size, resulting in 92%. Drug release reached 96% within 60 minutes. FTIR analysis showed no changes in the fingerprint region of bromocriptine