FORMULATION AND EVALUATION OF MOUTH DISSOLVING FILM OF HALOPERIDOL FOR THE MANAGEMENT OF PSYCHOSIS: A QbD APPROACH Authors: Awati SS , DESAI AR, HIREMATH JN, HALAKATTI PK, GUDIGENNAVAR AS, SHIDRAMSHETTAR SL, MUDALAGI S AND KABATE PR
ABSTRACT
The study was aimed to formulate and evaluate the quick dissolving film of Haloperidol (HP)
using pullulan as a polymer and Secondary objective was to optimize the formulation by Box-
Benkhen design. Pullulan has been utilized as a polymer in the solvent casting method for
making the oral dispersible films. Poly ethylene glycol 400 was used as a plasticizer,
saccharine was used as a sweetening agent. Physical characteristics, thickness, folding
endurance, in vitro disintegration, surface pH, as well as drug content uniformity were among
the parameters that were assessed for the prepared films. In vitro dissolution test and stability
study. The optimized formulation of quick dissolving film of ?-Cyclodexrtin (?-CD) and HP
showed the improved solubility the folding endurance was found to be 129 folds, the
disintegration was found to be 24 seconds, the surface pH was found to be 6.5, the film burst
was found to be 0.045 Kg/cm2. The optimized formulation of quick dissolving film of ?-CD
and HP showed the improved solubility of HP which in term improves the bioavailability.
Key words: Haloperidol, Pullulan, Oral dispersible film, Box-Benkhen design, PEG 400 Publication date: 01/08/2025 https://ijbpas.com/pdf/2025/August/MS_IJBPAS_2025_9296.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2025/14.8.9296