Formulation of Nanocrystal Loaded Racecadotril Immediate Release Tablets Using Quality by Design – QBD Approach
Keywords:
QBD, immediate release, Design of experiment & DissolutionAbstract
Racecadotril is primarily used to treat diarrhoea which acts as a peripherally acting enkephalinase inhibitor. Racecadotril gets rapidly converted to thiorphan which interacts specifically with active site of enkephalinase to produce potent blockade of enzyme, thereby preventing inactivation of endogenous opioid peptides, resulting in immediate release and enhanced drug release. Racecadotril is low solubility compound and most of the studies were performed to improve the solubility with traditional approach of product development. The present study was aimed to apply Design of Experiments (DoE) in the development and optimization of drug release from Racecadotril nanocrystal loaded immediate release tablets using three factor two level (23) full factorial designs with integrated Quality be Design (QbD) approach. Quality target product profile (QTPP) and Critical quality attributes (CQAs) were designed. Risk assessment was used to identify the Formulation variables impacting CQA dissolution. 23 factorial design in which three variables namely concentration of Pearlitol SD200, Crospovidone XL 10 & Microcrystalline cellulose PH 102 (AVICEL PH 102) were at two levels. The main interactive influences were tested using statistical model. The response surface plots were generated by software for analyzing effect of the independent variables on the response. All the batches were prepared by direct compression. The tablets were evaluated physiochemical parameters. Optimized formulation from DOE is analyse for physiochemical test.
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Deshpande KB, Ganesh NS. Orodispersible tablets: an overview of formulation and technology. Int J Pharm Bio Sci 2011;2(1):726–34.
Sandhya Mandadi, Vishwanadham Yerragunta, Umema Naaz Tarkash, Formulation and Evaluation of Atorvastatin Calcium Sustained Release Tablets 2016; 6(3): 124-130, ISSN 2249-1848
Kumar S, Ali J, Baboota S. Design Expert (®) supported optimization and predictive analysis of selegiline nanoemulsion via the olfactory region with enhanced behavioural performance in Parkinson’s disease. Nanotechnology. 2016;27(43):435101.
Peter CGV, Vijaya RC, Siddharth K, Siva SKM, Hari PR. Formulation, and optimization of coated PLGA–zidovudine nanoparticles using factorial design and in vitro in vivo evaluations to determine brain targeting efficiency. Saudi Pharm J. 2014;22(2):133-40.
Diaz, D. A., Colgan, S. T., Langer, C. S., Bandi, N. T., Likar, M. D., & Van Alstine, L. (2016). Dissolution similarity requirements: how similar or dissimilar are the global regulatory expectations? The AAPS journal, 18(1), 15-22.
Mishra, V., Thakur, S., Patil, A., & Shukla, A. (2018). Quality by design (QbD) approaches in current pharmaceutical set-up. Expert opinion on drug delivery, 15(8), 737-758.
T. Jiang, N. Han, B. Zhao, Y. Xie, and S. Wang, “Enhanced dissolution rate and oral bioavailability of simvastatin nanocrystal prepared by sonoprecipitation,” Drug Dev. Ind. Pharm., vol. 38, no. 10, pp. 1230–1239, 2012.
Leon L, Herbert AL, Joseph LK. The Theory and Practice of Industrial Pharmacy, 3rd edition, Varghese publishing house, Bombay.1987; 5.
Radosław K and Malgorzata S. Effect of Different Excipients on the Physical Characteristics of Granules and Tablets with Carbamazepine Prepared with Polyethylene Glycol 6000 by Fluidized Hot-Melt Granulation (FHMG).AAPS PharmSciTech. 2011; 12(4): 1241–1247.
Swamy PV, Gada S. N, Shirsand S.B, Kinagi MB and Shilpa H. Design and evaluation of cost effective orodispersible tablets of diethylcarbamazine citrate by effervescent method. International Journal of Pharma Sciences and Research (IJPSR). 2010; 1(6): 258-264
Dey P and Maiti, S. (2010) ‘. Orodispersible tablets: A new trend in drug delivery’, Journal of Natural Science, Biology and Medicin, 1(1), pp. 2-5
Setty MC, Prasad DVK, Gupta RM and Sa B. Development of fast dispersible Aceclofenac tablets: Effect of functionality of superdisintegrants. Indian J Pharm Sci. 2008; 70(2): 180-185
A. Vyas M, Lakshmi UA, Radha R E and P. Jyotsna. Formulation and Evaluation of Tramadol Hydrochloride oral thin films. IJPSR. 2018; 9(4): 1692-1698
Charoo NA, Shamsher AA, Zidan AS and Rahman Z. Quality by design approach for formulation development: a case study of dispersible tablets. International journal of pharmaceutics. 2012; 423(2):167-178.
Fahmy R, Kona R, Dandu R, Xie W, Claycamp G and Hoag SW. Quality by design I: application of failure mode effect analysis (FMEA) and Plackett–Burman design of experiments in the identification of “main factors” in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tabl.ets. AAPS PharmSciTech. 2012; 13(4):1243-54.
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