Polymeric behavior evaluation of PVP K30-poloxamer binary carrier for solid dispersed nisoldipine by experimental design

Abstract

Context: High melting point polymeric carrier without plasticizer is unacceptable for solid dispersion (SD) by melting method. Combined polymer–plasticizer carrier significantly affects drug solubility and tableting property of SD.

Objective: To evaluate and optimize the combined effect of a binary carrier consisting PVP K30 and poloxamer 188, on nisoldipine solubility and tensile strength of amorphous SD compact (SD_compact) by experimental design.

Materials and methods: SD of nisoldpine (SD_nisol) was prepared by melt mixing with different PVP K30 and poloxamer amount. A 3² factorial design was employed using nisoldipine solubility and tensile strength of SD_compact as response variables. Statistical optimization by design expert software, and SD_nisol characterization using ATR FTIR, DSC and microscopy were done.

Results: PVP K30:poloxamer, at a ratio of 3.73:6.63, was selected as the optimized combination of binary polymeric carrier resulting nisoldipine solubility of 115 μg/mL and tensile strength of 1.19 N/m².

Discussion: PVP K30 had significant positive effect on both responses. Increase in poloxamer concentration after a certain level decreased nisoldipine solubility and tensile strength of SD_compact.

Conclusion: An optimized PVP K30–poloxamer binary composition for SD carrier was developed. Tensile strength of SD_compact can be considered as a response for experimental design to optimize SD.

• Factorial design
• nisoldipine
• solid dispersion
• solubility

Declaration of interest

The authors report no declaration of interest on the manuscript and related matter. The authors are thankful to the RMC, International Islamic University Malaysia (IIUM) for supporting the research through “Endowment grant” (EDW B 14–097-0982).