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Current Drug Therapy

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ISSN (Print): 1574-8855
ISSN (Online): 2212-3903

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General Research Article

Optimization and Quality by Design Approach for Piroxicam Fast Dissolving Tablet Formulations Using Box-Behnken Design

Author(s): Harekrishna Roy*, Sisir Nandi, Ungarala Pavani, Uppuluri Lakshmi, Tamma Saicharan Reddy and Damarla Venkata Sri Gayatri

Volume 15, Issue 2, 2020

Page: [152 - 165] Pages: 14

DOI: 10.2174/1574885514666190409102614

Price: $65

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Abstract

Background: The present study deals with the formulation and optimization of piroxicam fast dissolving tablets and analyzes the impact of an independent variable while selecting the optimized formulation utilizing Quality by Design (QbD) and Box-Behnken Design (BBD).

Method: Seventeen formulations were prepared by direct compression technique by altering the proportion of cross carmellose sodium, spray dried lactose and hydro propyl methyl cellulose (HPMC K4M). The BBD statistical technique was used to optimize formulations and correlate the relationship among all the variables. Also, the powder mixture characteristics and tablet physiochemical properties such as hardness, friability, drug content, Disintegration Time (DT) and dissolution test were determined using 900 ml of 0.1N HCl (pH-1.2) at 37 ± 0.5°C.

Result: Significant quadratic model and second order polynomial equations were established using BBD. To find out the relationship between variables and responses, 3D response surface and 2D contour plot was plotted. A perturbation graph was also plotted to identify the deviation of the variables from the mean point. An optimized formula was prepared based on the predicted response and the resulting responses were observed to be close with the predicted value.

Conclusion: The optimized formulation with the desired parameter and formulation with variables and responses can be obtained by BBD and could be used in the large experiment with the involvement of a large number of variables and responses.

Keywords: Fast dissolving tablet, piroxicam, Box-Behnken design, direct compression technique, response surface, contour plot.

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[1]
Lal M, Lai M, Estrada M, Zhu C. Developing a flexible pediatric dosage form for antiretroviral therapy: a fast-dissolving tablet. J Pharm Sci 2017; 106(8): 2173-7.
[http://dx.doi.org/10.1016/j.xphs.2017.05.004 ] [PMID: 28499879]
[2]
Thipparaboina R, Thumuri D, Chavan R, Naidu VGM, Shastri NR. Fast dissolving drug-drug eutectics with improved compressibility and synergistic effects. Eur J Pharm Sci 2017; 104: 82-9.
[http://dx.doi.org/10.1016/j.ejps.2017.03.042] [PMID: 28366649]
[3]
Abd El Rasoul S, Shazly GA. Propafenone HCl fast dissolving tablets containing subliming agent prepared by direct compression method. Saudi Pharm J 2017; 25(7): 1086-92.
[http://dx.doi.org/10.1016/j.jsps.2017.05.003] [PMID: 29158720]
[4]
Maestrelli F, Mura P, Cirri M, Mennini N, Ghelardini C, Di Cesare Mannelli L. Development and characterization of fast dissolving tablets of oxaprozin based on hybrid systems of the drug with cyclodextrins and nanoclays. Int J Pharm 2017; 531(2): 640-9.
[http://dx.doi.org/10.1016/j.ijpharm.2017.05.033] [PMID: 28522425]
[5]
Lee AR, Kwon SY, Choi DH, Park ES. Quality by Design (QbD) approach to optimize the formulation of a bilayer combination tablet (Telmiduo®) manufactured via high shear wet granulation. Int J Pharm 2017; 534(1-2): 144-58.
[http://dx.doi.org/10.1016/j.ijpharm.2017.10.004] [PMID: 29031980]
[6]
Oh GH, Park JH, Shin HW, Kim JE, Park YJ. Quality-by-design approach for the development of telmisartan potassium tablets. Drug Dev Ind Pharm 2018; 44(5): 837-48.
[http://dx.doi.org/10.1080/03639045.2017.1414233] [PMID: 29252038]
[7]
Huang J, Goolcharran C, Ghosh K. A Quality by design approach to investigate tablet dissolution shift upon accelerated stability by multivariate methods. Eur J Pharm Biopharm 2011; 78(1): 141-50.
[http://dx.doi.org/10.1016/j.ejpb.2010.12.012] [PMID: 21168490]
[8]
Charoo NA, Shamsher AA, Zidan AS, Rahman Z. Quality by design approach for formulation development: a case study of dispersible tablets. Int J Pharm 2012; 423(2): 167-78.
[http://dx.doi.org/10.1016/j.ijpharm.2011.12.024] [PMID: 22209997]
[9]
Abdallah MH. Box-Behnken design for development and optimization of acetazolamide microspheres. Int J Pharm Sci Res 2014; 5: 1228-39.
[10]
Roy H. Box-Behnken design for optimization of formulation variables for fast dissolving tablet of urapidil. Asian J Pharm 2018; 12(03): S946-54.
[11]
Prajapati ST, Patel LD, Patel DM. Gastric floating matrix tablets: design and optimization using combination of polymers. Acta Pharm 2008; 58(2): 221-9.
[http://dx.doi.org/10.2478/v10007-008-0006-3] [PMID: 18515232]
[12]
Mohammadi-Samani S, Zojaji S, Entezar-Almahdi E. Piroxicam loaded solid lipid nanoparticles for topical delivery: Preparation, characterization and in vitro permeation assessment. J Drug Deliv Sci Technol 2018; 47: 427-33.
[http://dx.doi.org/10.1016/j.jddst.2018.07.015]
[13]
Merah A, Abidi A, Chaffai N, Bataille B, Gherraf N. Role of hydroxypropylmethylcellulose (HPMC 4000) in the protection of the polymorphs of Piroxicam extended release tablets. Arab J Chem 2017; 10: S1243-53.
[http://dx.doi.org/10.1016/j.arabjc.2013.03.005]
[14]
Nor SB, Woi PM, Ng SH. Characterisation of ionic liquids nanoemulsion loaded with piroxicam for drug delivery system. J Mol Liq 2017; 234: 30-9.
[http://dx.doi.org/10.1016/j.molliq.2017.03.042]
[15]
Karnachi AA, Khan MA. Box-behnken design for the optimization of formulation variables of indomethacin coprecipitates with polymer mixtures. Int J Pharm 1996; 131: 9-17.
[http://dx.doi.org/10.1016/0378-5173(95)04216-4]
[16]
Patel DM, Patel SP, Patel CN. Formulation and evaluation of fast dissolving tablet containing domperidone ternary solid dispersion. Int J Pharm Investig 2014; 4(4): 174-82.
[http://dx.doi.org/10.4103/2230-973X.143116] [PMID: 25426438]
[17]
Kumar MU, Babu MK. Design and evaluation of fast dissolving tablets containing diclofenac sodium using fenugreek gum as a natural superdisintegrant. Asian Pac J Trop Biomed 2014; 4(Suppl. 1): S329-34.
[http://dx.doi.org/10.12980/APJTB.4.2014B672] [PMID: 25183106]
[18]
Wlodarski K, Tajber L, Sawicki W. Physicochemical properties of direct compression tablets with spray dried and ball milled solid dispersions of tadalafil in PVP-VA. Eur J Pharm Biopharm 2016; 109: 14-23.
[http://dx.doi.org/10.1016/j.ejpb.2016.09.011] [PMID: 27658987]
[19]
Sheshala R, Khan N, Chitneni M, Darwis Y. Formulation and in vivo evaluation of ondansetron orally disintegrating tablets using different superdisintegrants. Arch Pharm Res 2011; 34(11): 1945-56.
[http://dx.doi.org/10.1007/s12272-011-1115-y] [PMID: 22139694]
[20]
Esim O, Savaser A, Ozkan CK, Bayrak Z, Tas C, Ozkan Y. Effect of polymer type on characteristics of buccal tablets using factorial design. Saudi Pharm J 2018; 26(1): 53-63.
[http://dx.doi.org/10.1016/j.jsps.2017.10.013] [PMID: 29379333]
[21]
Ferrero C, Munoz N, Velasco MV, Muñoz-Ruiz A, Jiménez-Castellanos R. Disintegrating efficiency of croscarmellose sodium in a direct compression formulation. Int J Pharm 1997; 147: 11-21.
[http://dx.doi.org/10.1016/S0378-5173(96)04784-9]
[22]
Shahzad Y, Shah SN, Ansari MT, et al. Effects of drug-polymer dispersions on solubility and in vitro diffusion of artemisinin across a polydimethylsiloxane membrane. Chin Sci Bull 2012; 57: 1685-92.
[http://dx.doi.org/10.1007/s11434-012-5094-2]
[23]
Patadia R, Vora C, Mittal K, Mashru R. Investigating effects of hydroxypropyl methylcellulose (HPMC) molecular weight grades on lag time of press-coated ethylcellulose tablets. Pharm Dev Technol 2016; 21(7): 794-802.
[PMID: 26100758]
[24]
Srinivas P, Jahnavi Reddy A. Formulation and evaluation of isoniazid loaded nanosponges for topical delivery. Pharm Nanotechnol 2015; 3: 68-76.
[http://dx.doi.org/10.2174/2211738503666150501003906]

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