Investigation of quality target process parameters (qtpp) and critical material attributes (cma) of nanocellulose as a potential excipient

Abstract

Objective: The current work highlights the use of the Quality by Design (QbD) for optimization of Nanocellulose (NC) production from corn husk by two techniques, namely, Acid hydrolysis (AH) and High pressure homogenization (HPH). Methods: Characterization of NC involved Fourier transform infrared spectroscopy (FTIR), thermo gravimetric analysis (TGA), X-ray diffraction (XRD), transmission electron microscopy (TEM). For the risk assessment, QbD Software was used. According to this results 32 factorial design was applied in which two independent variables (acid concentration and time for AH whereas pressure and no of passes for HPH) and two dependent variables (particle size and yield) were selected. Results: FTIR showed similarity in the peaks which indicates there is no change in parent molecular structure of cellulose. TGA confirmed that the NC extracted by both the methods showed improved thermal property at onset temperature of 290 °C as compared to Avicel PH101, 270 °C. XRD results showed that the crystallinity index of the extracted nano cellulose from both the method was 83.15% which indicates transition and reorientation of corn husk into compact crystalline cellulosic structure after removal of non-cellulosic materials. TEM images indicated that the fibers were well dispersed and the treatment had reduced the size of fibers with average dimensions of 100 to 1000 nm in length. Product assay revealed that as the acid concentration and time is increased, narrow particle size is observed whereas lower number of passes and pressure resulted in a broader particle size. Studies on the variables and the experiment of NC preparation contributed a maximum yield of 77% in case of AH and 83 % in case of HPH. Conclusion: Evident from the results, NC prepared by QbD approach had better flow property and compatibility. Hence it is suitable for usage as an excipient in product design for variety of tailor made customized oral dosage forms in pharmaceutical industry.