. 2019; 16(2): 0-0

Screening of Sacrificial Excipients for Arresting Devitrification of Itraconazole from Solid Dispersion

Bhargavi M. Patel, Mukesh C. Gohel, Vaishali T. Thakkar, Lalji H. Baldaniya, Ruby R. Christian, Tejal R. Gandhi
Anand Pharmacy College, Gujarat Technological University, Anand, Gujarat, India.

INTRODUCTION: Present investigation was aimed at developing the solid dispersion of itraconazole (ITR) using sacrificial excipients like pregelatinized starch, spray dried lactose alongside HPMC E5 and Poloxamer 188, thereby arresting the conversion of amorphous form of ITR to crystalline form and to assess the dissolution stability of an amorphous form of the drug on short-term storage.
METHODS: Itraconazole loaded solid dispersions were prepared by kneading method. Formulation optimization was achieved by using 24 full factorial design on the basis of cumulative percent drug released at t30, t60 and t120 min. Artificial neural network (ANN) was also applied as a statistical tool for obtaining better predictive ability and the outcomes of ANN were compared with that of design expert software.
RESULTS: The spectral data revealed no drug-carrier interactions. The P-XRD study of optimized batch showed decrease in crystallinity of drug as compared to the untreated drug. The in vitro dissolution studies of the optimized batch showed highest dissolution (92% at 120 min.) in comparison to the other formulations. Dissolution stability study of was performed at 40ºC and 75% RH for 90 days for the optimized formulation. Results of optimized batch showed insignificant changes in cumulative percentage drug release on storage.
DISCUSSION AND CONCLUSION: Dissolution stability could be attributed to the presence of sacrificial excipients as they tend to absorb the moisture on storage and possibly itself get converted into crystalline form thereby minimizing the recrystallization of ITR.

Keywords: Solid dispersion, Itraconazole, ANN, Sacrificial Excipients, Devitrification


Bhargavi M. Patel, Mukesh C. Gohel, Vaishali T. Thakkar, Lalji H. Baldaniya, Ruby R. Christian, Tejal R. Gandhi. Screening of Sacrificial Excipients for Arresting Devitrification of Itraconazole from Solid Dispersion. . 2019; 16(2): 0-0

Corresponding Author: Vaishali T. Thakkar, India


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