Formulation, evaluation and 3(2) full factorial design-based optimization of ondansetron hydrochloride incorporated taste masked microspheres.
BACKGROUND
Masking the bitter taste of Ondansetron hydrochloride (ONS) may improve palatability, acceptance and compliance of ONS products.


OBJECTIVE
ONS-loaded, taste-masked microspheres were prepared with a polycationic pH-sensitive polymer and 3(2) full factorial design (FFD) was applied to optimize microsphere batches.


METHODS
Solvent evaporation, in acetone--methanol/liquid paraffin system, was used to prepare taste-masked ONS microspheres. The effect of varying drug/polymer (D/P) ratios on microspheres characteristics were studied by 3(2) FFD. Desirability function was used to search the optimum formulation. Microspheres were evaluated by FTIR, XRD and DSC to examine interaction and effect of microencapsulation process. In vitro taste assessment approach based on bitterness threshold and drug release was used to assess bitterness scores.


RESULTS
Prepared ONS microspheres were spherical and surface was wrinkled. ONS was molecularly dispersed in microspheres without any incompatibility with EE100. In hydrochloric acid buffer pH 1.2, ONS released completely from microsphere in just 10 min. Contrary to this, ONS release at initial 5 min from taste-masked microspheres was less than the bitterness threshold.


CONCLUSIONS
Full factorial design and in vitro taste assessment approach, coupled together, was successfully applied to develop and optimize batches of ONS incorporated taste-masked microspheres.
Faculty of Pharmaceutical Sciences, Jodhpur National University, Boranada, Jodhpur , Rajasthan , India .
Vandana
V
Kharb
Vikas Anand
VA
Saharan
Kapil
K
Dev
Hemant
H
Jadhav
Suresh
S
Purohit
D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage* / Q000378:metabolism; D004339:Drug Compounding; D006801:Humans; D008863:Microspheres; D017294:Ondansetron / Q000008:administration & dosage* / Q000378:metabolism; D010316:Particle Size; D011108:Polymers / Q000737:chemistry / Q000494:pharmacology; D013649:Taste / Q000187:drug effects*; D055815:Young Adult
D014151:Anti-Anxiety Agents; D011108:Polymers; D017294:Ondansetron