INVESTIGATION OF QUALITY TARGET PROCESS PARAMETERS (QTPP) AND CRITICAL MATERIAL ATTRIBUTES (CMA) OF NANOCELLULOSE AS A POTENTIAL EXCIPIENT
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.
2. Ng HM, Sin LT, Tee TT, Bee ST, Hui D, Low CY, et al. Extraction of cellulose nanocrystals from plant sources for application as reinforcing agent in polymers. Composites Part B: Engineering 2015;75:176-200.
3. Karim M, Mohamed NB, Julien B. Nanofibrillated cellulose surface modification: a review. Materials 2013;6:1745-66.
4. Liu DY, Yuan XW, Bhattacharyya D, Easteal AJ. Characterisation of solution cast cellulose nanofibre reinforced poly (lactic acid). eXPRESS Polym Lett 2010;4:26–31.
5. Wang Z, Carlsson DO, Tammela P, Hua K, Zhang P, Nyholm L, et al. Surface modified nanocellulose fibers yield conducting polymer-based flexible supercapacitors with enhanced capacitances. ACS Nano 2015;9:7563-71.
6. Abdul K, Davoudpour Y, Chaturbhuj KS, Hossain Md, Adnan A, Dungani R, et al. A review on nanocellulosic fibres as new material for sustainable packaging: process and applications. Renewable Sustainable Energy Rev 2016;64:823-36.
7. Robert M, Ashlie M, John N, John S, Jeff Y. Cellulose nanomaterials review: structure, properties and nanocomposites. Chem Soc Rev 2011;40:3941-94.
8. Jiang G, Zhang J, Qiao J, Jiang Y, Zarrin H, Chen Z, Hong F. Bacterial nanocellulose/Nafion composite membranes for low temperature polymer electrolyte fuel cells. J Power Sources 2014;273:697-706.
9. Goczo H, Szabo Revesz P, Farkas B, Hasznos Nezdei M, Serwanis SF, Pintye Hodi K, et al. Development of spherical crystals of acetylsalicylic acid for direct tablet-making. Chem Pharm Bull 2000;48:1877-81.
10. Kaialy W, Larhrib H, Chikwanha B, Shojaee S, Nokhodchi A. An approach to engineer paracetamol crystals by antisolvent crystallization technique in presence of various additives for direct compression. Int J Pharm 2014;464:53-64.
11. Nokhodchi A, Maghsoodi M. Preparation of spherical crystal agglomerates of naproxen containing disintegrant for direct tablet making by spherical crystallization technique. AAPS PharmSciTech 2008;9:54-9.
12. US Food and Drug Administration. Guidance for Industry: Q8 (R2) Pharmaceutical Development; Center for Drug Evaluation and Research: Silver Spring, MD, USA; 2009.
13. US Food and Drug Administration. Guidance for Industry: Q9 Quality Risk Management; US Food and Drug Administration: Silver Spring, MD, USA; 2006.
14. Kovacs A, Berko S, Csanyi E, Csoka I. Development of nanostructured lipid carriers containing salicyclic acid for dermal use based on the quality by design method. Eur J Pharm Sci 2017;99:246-57.
15. Kirrstetter R. GMP aspects in practice: the new ICH guidelines concerning quality: ICH Q8, Q9 and Q10. Pharm Ind 2005;67:213-6.
16. Vanitha C, Satyanarayana SV, Bhaskar RK. Quality by design approach to stability-indicating reverse-phase high-performance liquid chromatography method development, optimization, and validation for the estimation of simeprevir in bulk drug. Asian J Pharm Clin Res 2019;12:93-100.
17. Hales D, Vlase L, Porav SA, Bodoki A, Barbu Tudoran L, Achim M. A quality by design (QBD) study on enoxaparin sodium loaded polymeric microspheres for colon-specific delivery. Eur J Pharm Sci 2017;100:249–61.
18. Iurian S, Bogdan C, Tomuta I, Szabo Revesz P, Chvatal A, Leucuta SE, et al. Development of oral lyophilisates containing meloxicam nanocrystals using QBD approach. Eur J Pharm Sci 2017;104:356-65.
19. Adam S, Suzzi D, Radeke C, Khinast JG. An integrated quality by design (QBD) approach towards design space definition of a blending unit operation by discrete element method (DEM) simulation. Eur J Pharm Sci 2011;42:106-15.
20. Wang JL, Kan SL, Chen T, Liu JP. Application of quality by design (QBD) to formulation and processing of naproxen pellets by extrusion-spheronization. Pharm Dev Technol 2015;20:246-56.
21. Pallagi E, Ambrus R, Szabo Revesz P, Csoka I. Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation. Int J Pharm 2015;491:384-92.
22. Karimi K, Pallagi E, Szabo Revesz P, Csoka I, Ambrus R. Development of a microparticle based dry powder inhalation formulation of ciprofloxacin hydrochloride applying the quality by design approach. Drug Des Dev Ther 2016;10:3331-43.
23. Jornil J, Jensen KG, Larsen F, Linnet K. Risk assessment of accidental nortriptyline poisoning: the importance of cytochrome p450 for nortriptyline elimination investigated using a population-based pharmacokinetic simulator. Eur J Pharm Sci 2011;44:265-72.
24. Beirao-da-Costa S, Duarte C, Moldao Martins M, Beirao-da-Costa ML. Physical characterization of rice starch spherical aggregates produced by spray-drying. J Food Eng 2011;104:36-42.
25. Paradkar AR, Pawar AP, Chordiya JK, Patil VB, Ketkar AR. Spherical crystallization of celecoxib. Drug Dev Ind Pharm 2002;28:1213-20.
26. Box GE, Hunter JS, Hunter WG. Statistics for experimenters: design, innovation, and discovery. 2nd ed. John Wiley and Sons, Inc.: Hoboken, NJ, USA; 2005.
27. Nelson ML, O'Connor RT. Relation of certain infrared bands to cellulose crystallinity and crystal lattice type II. A new infrared ratio for estimation of crystallinity in cellulose I and II. J Appl Polym Sci 1964;8:1325-41.
28. Segal L, Creely JJ, Martin AE Jr, Conrad CM. An empirical method for estimating the degree of crystallinity of native cellulose using the x-ray diffractometer. Text Res J 1959;29:786-94.
29. Xue Y, Fuyi H, Chunxia Xu, Shuai J, Liqian H, Lifang L, et al. Effects of preparation methods on the morphology and properties of nanocellulose (NC) extracted from corn husk. Industrial Crops Products 2017;109:241-7.
30. Carr RL. Evaluating flow properties of solids. Chem Eng 1965;72:163-8.
31. Amrita S, Vaibhav R, Varsha K. Formulation development and evaluation of fast dissolving tablet of ramipril. Int J Pharm Pharm Sci 2015;7:127-31.
32. Kannissery P, Jomon NB, Elambilan NB. Effect of non-volatile solvent and excipient ratio on flow and consolidation properties of powder blend for liquisolid compacts. Int J Pharm Pharm Sci 2015;7:150-5.
33. Haafiz MKM, Hassan A, Zakaria Z, Inuwa IM. Isolation and characterization of cellulose nanowhiskers from oil palm biomass microcrystalline cellulose. Carbohydrate Polymers 2014;103:119-25.
34. Liu Z, Li X, Xie W. Carrageenan as a dry strength additive for papermaking. Plos One 2017;12:13-26.
35. Xie W, Song Z, Liu Z, Qian X. Surface modification of PCC with guar gum using organic titanium ionic crosslinking agent and its application as papermaking filler. Carbohydrate Polymers 2016;150:114-20.
36. Rosa SML, Rehman N, Miranda MIG, Nachtigall SMB, Bica CID. Chlorine-free extraction of cellulose from rice husk and whisker isolation. Carbohydrate Polymers 2012;87:1131-8.
37. Jiang F, Hsieh YL. Cellulose nanocrystal isolation from tomato peels and assembled nanofibers. Carbohydrate Polymers 2015;122:60-8.
38. Sain M, Panthapulakkal S. Bioprocess preparation of wheat straw fibres and their characterisation. Ind Crops Products 2006;23:1-8.
39. Isogai I. Allomorphs of cellulose and other polysaccharides. Gilbert RD. ed (Cincinnati) Cellulosic polymers, blends and composites. Hanser/Gardner Publications; 1994.
40. Ryshkewitch E. Compression strength of porous sintered alumina and zirconia. J Am Ceramic Soc 1953;36:65-8.
41. Wang L, Han G, Zhang Y. Comparative study of composition, structure and properties of Apocynum venetum fibers under different pretreatments. Carbohydrate Polymers 2007;69:391-7.
42. El-Sakhawy M, Hassan ML. Physical and mechanical properties of microcrystalline cellulose prepared from agricutural residues. Carbohydr Polym 2007;67:1-10.
43. Suesat J, Suwanruji P. Preparation and properties of microcrystalline cellulose from corn residues. Adv Mater Res 2011;1781-4.
44. Johar N, Ahmad I, Dufresne A. Extraction, preparation and characterization of cellulose fibres and nanocrystals from rice husk. Industrial Crops Products 2012;37:93-9.
45. Espino E, Cakir M, Domenek S, Roman Gutierrez AD, Belgacem N, Bras J. Isolation and characterization of cellulose nanocrystals from industrial by-products of agave tequilana and barley. Industrial Crops Products 2014;62:552-9.
46. Kallel F, Bettaieb F, Khiari R, Garcia A, Bras J, Chaabouni SE. Isolation and structural characterization of cellulose nanocrystals extracted from garlic straw residues. Industrial Crops Products 2016;87:287-96.
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