Chettupalli A K, Padmanabha Rao A, Kuchukuntla M, Bakshi V.
Chettupalli A K*, Padmanabha Rao A, Kuchukuntla M, Bakshi V.
Centre for Nanomedicine Anurag Group of Institutions, Venkatapur, Ghatkesar, Medchal, Hyderabad-500088, India.
Volume - 13,
Issue - 12,
Year - 2020
The main objective of the study is to develop and optimize the potential variables which influence aripiprazole oral disintegration tablets (ODTs) formulation. Aripiprazole ODTs were prepared by using a direct compression method. Three factors with three levels of Box- Behnken design were used to optimize and develop the aripiprazole ODT formulation. The design recommended 20 formulations of different independent variables such as Microcrystalline cellulose (MCC) (X1), Crospovidone (CP) (X2), and Cascarmellose sodium (CCS) (X3) and their effect was monitored on dependent variables such as tablet weight (Y1), Thickness (Y2), Hardness (Y3), Dissolution (Y4), Disintegration (Y5). Agreeable flow properties which are ranged from good to excellent were demonstrated by all powder blends. The disintegration time (Y5) was directly related to the lubricant concentration and mixing of time which intern had a direct effect on tablet thickness, hardness and compression force these interns had a direct impact on friability. The Box-Behnken design recommended an optimized formula of 20mg (X1), 3mg (X2) and 3mg (X3) of the selected independent variables. Finally, the prediction error percentage responses of dependent variables Y1, Y2, Y3, Y4, and Y5 were found to be 0.38, 0.59, 2.43, 4.06, and 3.67% respectively. The 2, 4, and 10 formulas achieved more than 90% of drug release within the seven min of dissolution test time. The optimized formulation of aripiprazole ODT was successfully developed using box Behnken design and the same was prepared efficiently by using the direct compression method.
Cite this article:
Chettupalli A K, Padmanabha Rao A, Kuchukuntla M, Bakshi V. Development and Optimization of Aripiprazole ODT by using box-Behnken Design. Research J. Pharm. and Tech. 2020; 13(12):6195-6201. doi: 10.5958/0974-360X.2020.01080.X
Chettupalli A K, Padmanabha Rao A, Kuchukuntla M, Bakshi V. Development and Optimization of Aripiprazole ODT by using box-Behnken Design. Research J. Pharm. and Tech. 2020; 13(12):6195-6201. doi: 10.5958/0974-360X.2020.01080.X Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-12-95
1. Eslick GD, and Talley NJ. Dysphagia: epidemiology, risk factors, and impact on quality of life--a population-based study. Aliment Pharmacol Ther. (2008) 27: 971–979.
2. Chen PH, Golub JS, Hapner ER, and Johns MM. Prevalence of perceived dysphagia and quality-of-life impairment in the geriatric population. Dysphagia. (2009) 2: 1–6.
3. Fu Y, Yang S, Jeong SH, Kimura S and Park K Orally fast disintegrating tablets: developments, technologies, taste-masking, and clinical studies. Crit Rev Ther Drug Carrier Syst. (2004) 21: 433–475.
4. Mostafa HF, Ibrahim MA, and Sakr A. Development and optimization of dextromethorphan hydrobromide oral disintegrating tablets: effect of formulation and process variables. Pharm Dev Technol. (2013) 18: 454–463.
5. Late SG, Yu YY and Banga AK. Effects of the disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets. Int J Pharm. (2009) 365: 4–11.
6. Miller TA. and York P. Pharmaceutical tablet lubrication. Int J Pharm. (1998) 41: 1–19.
7. Perrault M, Bertrand F and Chaouki J. An investigation of magnesium stearate mixing in a v-blender through gamma-ray detection. Powder Technol. (2010) 200: 234–245.
8. Fassihi RA, Mcphillips AM, Uraizee SA, and Sakar AM. Potential use of magnesium stearate and talc as dissolution retardants in the development of controlled drug delivery systems. Pharm Ind. (1994) 56: 579–583.
9. Morin G and Briens L. The effect of lubricants on powder flowability for pharmaceutical application. AAPS Pharm Sci. Tech. (2013) 14: 1158–1168.
10. Kuno Y, Kojima M, Nakagami H, Yonemochi E and Terada K. Effect of the type of lubricant on the characteristics of orally disintegrating tablets manufactured using the phase transition of sugar alcohol. Eur. J Pharm Biopharm. (2008) 77: 986–992.
11. Indurwade NH, Rajyaguru TH and Nakhat PD Noval approach-fast dissolving tablets. Indian Drug (2002) 38:405-9.
12. The United States Pharmacopoeia 29, National Formulary 24,
13. Asian Edition. Rockville, MD: USPC, Inc; 2006. p. 1890.
14. Jacob S, Shirwaikar A, Joseph A, and Srinivasan KK. Novel co-processed excipient of mannitol and microcrystalline callous for preparing fast dissolving tablets of Glipizide. Ind J Pharm Sci. (2007) 69:633-9.
15. Hiremath JG, Shastry CS and Srinath MS. Pharmaceutical approach of taste masking in oral dosage forms. Ind Drug. (2004) 41:253-7.
16. Abdelbary A, Elshafeey AH and Zidan G. Comparative effects of different cellulosic-based directly compressed or dispersible tablets on oral bioavailability of famotidine. Car Poly (2009).77:799-806.
17. Sanjeevani S, Deshkar, Arvind Pawara S and Satish Shirolkar V. Formulation and optimization of floating tablets of clopidogrel bisulfate using design of experiments. Int J App Pharm. (2018)10: 94-102.
18. Yin L, Qin C, Chen K, Zhu C, Cao H, Zhou J, He W and Zhang Q. Gastro-floating tablets of cephalexin: preparation and in vitro/in vivo evaluation. Int J Pharm. (2013) 452:241-8.
19. Albany AA, Ali WK and Al-Saady FA. Formulation and evaluation of prochlorperazine maleate sustained floating release tablet. Int J Pharm Pharm Sci. (2017) 9:89-98.
20. Mali AD, and Bathe RS. Development and evaluation of the gastroretentive floating tablet of a quinapril HCl by direct compression technique. Int J Pharm Pharm. Sci. (2017) 9:35-46.