Abstract:
Objective: The present research aims at formulating a mouth dissolving sublingual film of fixed dose combination of doxylamine succinate (DS) and
pyridoxine hydrochloride (PH) that would provide faster onset of action and hence relief from the condition of nausea and vomiting in pregnancy.
Methods: Mouth dissolving films were prepared using a solvent casting technique. A 23
full-factorial design of eight formulations was set up with three
independent variables: X1 - polymer 1 HPMC E15 concentration, X2 - polymer 2 HPMC E5 concentration, and X3 - plasticizer PEG 400 concentration.
The responses, i.e., dependent variables measured for the study were Y1 disintegration time in seconds, Y2 tensile strength in kg/cm2
, Y3 drug release
in the percentage of DS, and Y4 drug release in the percentage of PH. All the formulations were evaluated for physicochemical parameters such as
clarity, weight, thickness, folding endurance, surface pH, and content. The design expert software 11.0 trial version was used for statistical analysis
of the responses.
Results and Conclusion: All the film formulations were found to be transparent, non-tacky, and easily peelable having the satisfactory tensile strength
and folding endurance. The concentration of polymer 1 and 2 was found to have a significant effect on disintegration time and drug release of mouth
dissolving films. The best film formulation DP1 was found to have a disintegration time of 77.66 s and found to release 96.22% of DS and 95.43% of
pyridoxine HCl in 21 min.
Description:
The authors would like to thank Dr. S. N. Mamle Desai, Principal of P.E.S’s
Rajaram and Tarabai Bandekar College of Pharmacy for providing
research facility and for his support whenever required and our guide
Dr. H. M Tank for his guidance and support
