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.
Highlights
Cellulose is highly known for its excellent properties such as renewability, biodegradability, biocompatibility, high specific surface areas, low density, low thermal expansion, good optical property, excellent mechanical property and high chemical reactivity [1,2,3,4,5], as a result of which it has drawn attention from various researchers across the globe [6]
After the identification of the quality target product profile (QTPP) and the critical quality attributes (CQAs), the following step was to determine the critical material attributes and process parameters (CMAs and critical process parameters (CPPs)) by risk estimation matrix (REM), which represents the potential risks associated with each material attribute and process parameter that has a profound effect on CQAs
This study demonstrates the applicability of Quality by Design” (QbD) for production of Nanocellulose by processing cellulose obtained from recycling corn husk
Summary
Cellulose is highly known for its excellent properties such as renewability, biodegradability, biocompatibility, high specific surface areas, low density, low thermal expansion, good optical property, excellent mechanical property and high chemical reactivity [1,2,3,4,5], as a result of which it has drawn attention from various researchers across the globe [6]. QbD concept is a fairly new approach in the development phase of pharmaceutical products [12,13,14,15,16] as stated in International Conference on Harmonization (ICH) Q8 and Q9 guidelines of technical requirements for registration of pharmaceuticals for human use. It is a systematic process for the assessment, control, communication, and review of risks to the quality of the APIs through the product lifecycle. To ensure dependent variables can be measured, the critical parameters of both the techniques involved in production of NC based on the results of risk assessment were determined post which 3^2 factorial design was applied for the current study [24,25,26]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
