Delivering drug‐polymer complex via quick dissolving film: A step towards the development of an appropriate pediatric formulation

Abstract

Lack of suitable prednisolone formulations for treatment of asthma could limit treatment compliance in pediatric population and hence the aim of this study was to develop prednisoloneâ€polymer complexes with enhanced solubility
and to incorporate this complex into orally disintegrating films to enable rapid drug delivery. The prednisoloneâ€polymeric complexes were prepared using solvent evaporation and freeze drying techniques with a drugâ€polymer ratio of 1:1 using
hydroxypropyl βâ€cyclodextrin (HP βâ€CD), hydroxypropyl methylcellulose 4 cps, and polyvinylpyrrolidone K-30 as polymeric carriers and the parameters such as an aqueous solubility, dissolution profile, and solidâ€state characterization
using differential scanning calorimetry (DSC) of the complexes determined.The optimized complex was then incorporated into films prepared using solvent casting technique and the weight variation, thickness, solidâ€state characterization,
in vitro disintegration and dissolution profiles of the films were then determined. The highest prednisolone solubility was seen with the prednisoloneâ€HP βâ€CD complex prepared by freeze drying (1.82 mg/mL) followed by the same complex
prepared by solvent evaporation (1.70 mg/mL). The solubility’s were significantly higher compared to prednisolone powder (0.2 mg/mL) (P < 0.05). DSC analysis of complexes revealed a reduction in area of the endothermic peak indicating
the presence of amorphous drug while in comparison, the DSC analysis of films did not show endothermic peak showing complete absence of crystalline drug. The film was thin, uniform in weight and thickness, showing rapid disintegration of
55 s with almost complete drug release within 3 min. The study revealed the incorporated drugâ€polymer complex have maintained the amorphous state and enabled rapid drug release.