Original Article

Neoteric approach of fluoxetine laden orodispersible film for non-compliant paediatric patients of selective mutism and obsessive-compulsive disorder

10.4274/tjps.galenos.2021.23080

  • Haseeb Anwar Dad
  • Asra Shanzeh Shabbir
  • Saman Ali
  • Tariq Mahmood

Received Date: 21.12.2020 Accepted Date: 05.03.2021 Turk J Pharm Sci 0;0(0):0-0 [e-Pub]

The objective of present research work was the fabrication, characterization and optimization of fluoxetine laden orodispersible film (ODF), with intent to enhance dosage forms options for paediatric population suffering from incapacitating psychotic disorders of selective mutism and obsessive-compulsive disorder (OCD), which will be ultimately beneficial in enhancing compliance factor and the quality of pharmacotherapy. Solvent casting technique was used to formulate the fluoxetine laden orodispersible film (ODF) formed by natural hydrophilic polymers matrix of HPMC E15 and pullulan. Propylene glycol as plasticizing agent imparted satisfactory tenacity and flexibility to ODFs. FITR studies were done to investigate any potential compatibility and results revealed no potential interaction between fluoxetine and excipients. Developed ODFs were evaluated for physicochemical properties, content uniformity, in-vitro disintegration time and in-vitro dissolution time studies. The experimental data suggested that different polymer concentration had complex effect on content uniformity, in-vitro disintegration time and cumulative percentage drug release from the ODFs. TF7 was found out to be the most optimized formulation with disintegration time of 10.66 sec and 99.37 % drug release within 3 minutes. Further the most optimized fluoxetine ODF was submitted to universal testing machine for tensile strength and percentage elongation determination. It was also further evaluated by thermogravimetric analysis (TGA), scanning electron microscopy (SEM) and Xray diffraction (XRD). In conclusion, fluoxetine laden ODFs of good pharmaceutical quality can be prepared on small scale. Hereby opening the perspective of using ODFs for individualized pharmacotherapy to ameliorate the compliance issues in selective mutism and OCD paediatric patients.

Keywords: Orodispersible film, fluoxetine, selective mutism, obsessive-compulsive disorder, HPMC E15, Pullulan