Login Register Cart 0
Generic placeholder image

Drug Delivery Letters

Editor-in-Chief

ISSN (Print): 2210-3031
ISSN (Online): 2210-304X

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

The Application of the Box-Behnken Design Response Surface Methodology to Study Optimized Formulation Variables on the Drug Release Pattern of Benidipine Hydrochloride Extended-release Matrix Tablet

Author(s): Amaresh Prusty*, Bijon K. Gupta and Amiyakanta Mishra

Volume 12, Issue 1, 2022

Published on: 29 April, 2022

Page: [62 - 73] Pages: 12

DOI: 10.2174/2210303112666220329154050

Price: $65

Abstract

Background: In this research study, an attempt has been made using Box-Behnken design (BBD) Response Surface Methodology to find optimized formulation variables at 3 levels (low, medium, and high) to affect the dependent response, which is the % drug release pattern at different time intervals in extending drug release of Benidipine Hydrochloride(BH) matrix tablets. BH extended-release tablets reduce the side effects of multiple dosing used during conventional tablets.

Methods: As in the preliminary work, we have found the most profound formulation factors for extending drug release of BH matrix tablets are Eudragit RS 100 amount (X1), HPMC K 100 M (X2),

chitosan amount (X3), which we selected as independent factors at their low and high levels for this study considering % drug release at three different time intervals i.e., R1 (% of drug release in 2 hours), R2 (% of drug release in 15 hours) and R3 (% of drug release in 18 hours) as dependent variables using a dissolution media of phosphate buffer pH of 6.8 with 75rpm.

Results: From the experimental runs of prepared tablets as predicted by the Design-Expert software, the model shows a quadratic equation due to less p-value, and a very less difference was observed between adjusted R2 and predicted values R2 in all selected responses, which we considered as the % drug release.

Conclusion: Therefore, by using the graphical response surface plot of BBD software, the optimized formulation of BH extended-release tablet of Eudragit RS 100, HPMC K 100 M, and Chitosan containing an amount of 45mg, 105 mg, and 45.71 mg, respectively shows an extended drug release of more than 18 hours. To construct a satisfying fit of the model for the optimized formulation, a result analysis was carried out for the internally studentized residuals versus the experimental runs indicating all data points were placed within limits, and the values of the predicted and actual response of each run were normally distributed near a straight line.

Keywords: Box Behnken Design (BBD), Benidipine Hydrochloride (BH), Matrix Tablet, ANOVA, QbD, Eudragit.

« Previous Next »
Graphical Abstract

[1]
Juran, J.M. Juran on quality by design: The new steps for planning quality into goods and services; Free Press: New York, 1992.
[2]
Schwartz, J.B.; O’Connor, R.E.; Schnaare, R.L. Modern pharmaceutics: Optimization techniques in pharmaceutical formulation and processing, 4th ed; Banker, G.S.; Rhodes, C.T., Eds.; Marcel Dekker, Inc.: New York, USA, 2002, pp. 607-626.
[3]
Box, G.E.P.; Behnken, D.W. Some new three level designs for the study of quantitative variables. Technometrics, 1960, 2(4), 455-475.
[http://dx.doi.org/10.1080/00401706.1960.10489912]
[4]
Palamakula, A.; Nutan, M.T.H.; Khan, M.A. Response surface methodology for optimization and characterization of limonene-based coenzyme Q10 self-nanoemulsified capsule dosage form. AAPS PharmSciTech, 2004, 5(4), e66.
[http://dx.doi.org/10.1208/pt050466] [PMID: 15760063]
[5]
Ragonese, R.; Macka, M.; Hughes, J.; Petocz, P. The use of the Box-Behnken experimental design in the optimisation and robustness testing of a capillary electrophoresis method for the analysis of ethambutol hydrochloride in a pharmaceutical formulation. J. Pharm. Biomed. Anal., 2002, 27(6), 995-1007.
[http://dx.doi.org/10.1016/S0731-7085(01)00659-8] [PMID: 11836062]
[6]
Govender, S.; Pillay, V.; Chetty, D.J.; Essack, S.Y.; Dangor, C.M.; Govender, T. Optimisation and characterisation of bioadhesive controlled release tetracycline microspheres. Int. J. Pharm., 2005, 306(1-2), 24-40.
[http://dx.doi.org/10.1016/j.ijpharm.2005.07.026] [PMID: 16246512]
[7]
Prabaharan, M.; Mano, J.F. Chitosan-based particles as controlled drug delivery systems. Drug Deliv., 2005, 12(1), 41-57.
[http://dx.doi.org/10.1080/10717540590889781] [PMID: 15801720]
[8]
Vakkalanka, S.; Brazel, C.S.; Peppas, N.A. Temperature and pH sensitive hydrogels for controlled release of antithrombotic agents. MRS Proceedings, 1993, 331, 211.
[9]
Kydonieus, A.; Dekker, M. Treatise on controlled drug delivery - fundamentals, optimisation - applications; New York, NY, 1991.
[10]
Khan, G.M. Controlled release oral dosage forms: Some recent advances in matrix type drug delivery systems. Science, 2001, 1(5), 350-354.
[11]
Prusty, A.; Gupta, B.K. Effect of polymer in release profile of extended release matrix tablet of anti-hypertensive drug and to study impact of agglomerative phase of comminution (Apoc)method on drug release. Int. J. Pharm. Sci. Res., 2018, 9(10), 1000-1008.
[12]
Kumari, P.V.K.; Yarraguntla, S.R.; Sharmila, M.; Gulibindala, E. Application of box-behnken design for formulation parameters of eslicarbazepine tablets. Indian J. Pharm. Sci., 2021, 83(3), 575-583.
[13]
Cochran, W.G.; Cox, G.M. Experimental designs, 2nd ed; Wiley: New York, 1992, pp. 335-339.
[14]
Schwartz, J.B.; O’Connor, R.E.; Schnaare, R.L. Modern pharmaceutics: Optimization techniques in pharmaceutical formulation and processing, 4th ed; Banker, G.S.; Rhodes, C.T., Eds.; Marcel Dekker, Inc.: New York, USA, 2002, pp. 607-626.
[15]
Rath, S.; Gupta, B.K.; Bala, N.N.; Dhal, H.C. Formulation and optimization of immediate release telmisartan tablets using full factorial design. Int. J. Appl. Pharm., 2011, 3(3), 587-610.
[16]
Kumari, K.P.; Shankar, G.G.; Prabhakar, T. Optimisation of L-asparaginase production by Streptomyces griseoluteus WS3/1 using experimental methods. J. Pharm. Biomed. Sci., 2011, 10(11), 1-6.
[17]
Ibrahim, T.M.; El-Megrab, N.A.; El-Nahas, H.M. Optimization of injectable PLGA in-situ forming implants of anti-psychotic risperidone via Box-Behnken design. J. Drug Deliv. Sci. Technol., 2020, 58, 58.
[http://dx.doi.org/10.1016/j.jddst.2020.101803]
[18]
Elbary, A.A.; Aboelwafa, A.A.; Al Sharabi, I.M. Once daily, high-dose mesalazine controlled-release tablet for colonic delivery: Optimization of formulation variables using Box-Behnken design. AAPS PharmSciTech, 2011, 12(4), 1454-1464.
[http://dx.doi.org/10.1208/s12249-011-9708-9] [PMID: 22038474]
[19]
Yu, L.X.; Amidon, G.; Khan, M.A.; Hoag, S.W.; Polli, J.; Raju, G.K.; Woodcock, J. Understanding pharmaceutical quality by design. AAPS J., 2014, 16(4), 771-783.
[http://dx.doi.org/10.1208/s12248-014-9598-3] [PMID: 24854893]
[20]
Prusty, A.; Mishra, A.K.; Gupta, B.K. Development and evaluation of matrix tablet by taking new chemicals combination of chitosan and eudragit-l 100. J. Young Pharm., 2016, 8(3), 168-176.
[http://dx.doi.org/10.5530/jyp.2016.3.2]
[21]
Myers, R.H.; Montgomery, D.C. Response Surface Methodology: Product and Process Optimization Using Designed Experiments, 2nd ed; John Wiley & Sons: New York, 2002.

Rights & Permissions Print Cite
Article Metrics
20
1
© 2025 Bentham Science Publishers | Privacy Policy