Process variable studies for preparation of optimized system for bupropion hydrochloride using CCD
Aim of present work is to develop optimized sustained release dosage form of Bupropion hydrochloride using Formulation by Design (FbD) approach. Development and optimization of formulation batches was done by design experiment using Central Composite Design (CCD). Tablets were formulated by direct compression technique and evaluated. The impact of independent variables like concentration of Hydroxypropyl Methyl Cellulose (HPMC K4M) and Carbopol (CP 934P) were observed on dependent variable like hardness of tablet, drug release in 12 h (Q12h) and the time for fifty percent release of drug (T50%). Polynomial equations were generated using multiple linear regression analysis (MLRA), response surface plots and contour plots were drawn, optimum formulations were selected by brute force method. The hardness and Q12h was found in the range of 4.4- 4.7 Kg/cm2 and 88.19- 96.7% respectively, while T50% was found in the range of 3.5- 5.5h. Validation of optimization study performed using four confirmatory experimental runs which indicated very high degree of prognostic ability of FbD methodology with percentage error varied between -0.024% and 0.024 %. The overlaying of all these plots provided an overlay plot, which signified the region of optimization. Thus, central composite design (CCD) is a useful tool in the development of optimized dosage form along with the significance of independent variable as well as least investment of money, manpower and time.
Keywords: Formulation by Design, Central Composite Design, Bupropion Hydrochloride.
2. Jiloha, R.C. Pharmacotherapy of smoking cessation. Indian J of Psychiatr. 2014; 56:87-95.
3. Fava, M., Rush, A.J., Thase, M.E., Clayton, A., Stahl, M.S., Pradko, J.F. and Johnston, J.A. 15 Years of clinical experience with bupropion Hydrochloride: From bupropion to bupropion SR to bupropion XL. Prim Care Companion J Clin Psychiatry. 2005; 7:106–113.
4. Grover, S., Dutt, A. and Avasthi A. An overview of Indian research in depression. Indian J of Psychiatr. 2010; 5(Suppl 1):178-188.
5. Fouladi, F. and Mortazavi, S.A. Preparation and in-vitro evaluation of gastroretentive bupropion hydrochloride tablets. TJPR. 2012; 11:351-359.
Garg, R.K. and Singhavi. I. 2015. Optimization techniques: an overview for formulation development. AJPR. 5, 217-221.
6. Chodankar, R.S. and Dev A. Optimisaton techniques: a futuristic approach for formulating and processing of pharmaceuticals. IJPBR. 2016; 4:32-40.
7. Dalavi, V.V. and Patil, J.S. Optimization techniques: An introductory overview.JPR. 2009; 2:144-147.
8. Kumar, S. and Baldi, A. Formulation by Design Approach for Fizzy Granules Using Statistical Optimization Methodologies. AJP. 2015; 9:S59-S67.
9. Debnath, S., Aishwarya M.N.L. and Babu M.N. Formulation by Design: An approach to designing better Drug Delivery Systems. Pharma Times. 2018; 50:9-14.
10. Jadhav, B.K., Khandelwal, K.R., Ketkar, A.R., Pisal, S.S. Formulation and evaluation of mucoadhesive tablet containing eugenol for the treatment of periodontal diseases. Drug Developmental and Industrial Pharmacy. 2004; 30:195-203.
11. Singh, L., Nanda, A., Sharma, S. and Sharma V. Design optimization and evaluation of gastric floating matrix tablet of glipizide. TJPR. 2013; 12:869-876.
12. Togaru, V., Venisetty R. K., Bakshi V. and Jadi, R. K. Formulation Development and In Vitro Evaluation of Propranolol Hydrochloride Extended Release Matrix Tablets. Emergent Life Sciences Research; 2017; 3:38-47.
13. Quinten, T., Andrews, G. P., Beer, T. De., Saerens, L., Bouquet, W., Jones, D.S., Hornsby P., Remon J.P. and Vervaet C.. Preparation and Evaluation of Sustained-Release Matrix Tablets Based on Metoprolol and an Acrylic Carrier Using Injection Moulding. AAPS. 2012; 13:1197-1211.
14. Rathore, B.H.S., Sharma, A., Garg, A. and Sisodiya, D.S..Formulation and evaluation of enteric coated tablet of Ilaprazole. International Current Pharmaceutical Journal. 2013; 2:126-130.
15. Al-Hashemi, H.M.B. and Al-Amoudi, O.S.B. A review on the angle of repose of granular materials. Powder Technology. 2018; 330:397-417.
16. Kumar, K.V. and Ajaykumar, B. Formulation and evaluation of rapid disintegration tablets of moxifloxacin HCl. Scholars Research Library. 2013; 5238-250.
17. Sharma, H.S.C., Kumar, Y.K. and Reddy, K.R. Effect of drug release on Albendazole chewable tablets by using different formulation techniques. IJPSR. 2014; 5:4543-4547.
18. Ganesh, G.N.K., Sureshkumar, R., Jawahar, N., Senthil, V., Nagasamy, V.D. and Shanmukha, S.M. Preparation and evaluation of sustained release matrix tablet of diclofenac sodium using natural polymer. JPSR. 2, 360-368.
19. Ige, P.P., Mahajan, D.R.and Sonawane, R.O. Development of muoadhesive sustained release matrix tablets of methimazole for oral delivery. IJPER. 2015; 49:259-267.
20. http://www.pharmacopeia.cn/v29240/usp29nf24s0_m10524.html. Retrieved on June 20, 2018.
21. Higuchi, T. Mechanism of sustained-action medication: theoretical analysis of rate of release of solid drugs dispersed in solid matrices. Journal of Pharmaceutical Sciences. 1963; 52:1145-1149.
22. Korsemeyer, R.W., Gurny, R., Doelker, E., Buri, P. and Peppas, N. Mechanism of solute release from porous hydrophillic polymers. IJP. 1983; 15:25-35
23. Stetsko, G. Statistical Experimental Design and its Application to Pharmaceutical Development Problems. Drug Development and Industrial Pharmacy. 1986; 12:1109-1123.
24. Madgulkar, A.R., Bhalekar, M.R., Kolhe, V.J. and Kenjale, Y.D. Formulation and optimization of sustained release tablets of venlafaxine resinates using response surface methodology. IJPS. 2009; 7:387-394. .
25. Mandal, U., Gowda, V., Ghosh, A., Selvan, S., Solomon, S. and Pal, T.K.. Formulation and Optimization of Sustained Release Matrix Tablet of Metformin HCl 500 mg Using Response Surface Methodology. PSJ. 127,1281-1290.
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