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Design of Experiments for Tablet Compression of Valsartan and Pravastatin Fixed-Dose Combination Tablet
Corresponding Author(s) : Kang-Min Kim
Asian Journal of Chemistry,
Vol. 28 No. 11 (2016): Vol 28 Issue 11
Abstract
Design of experiment is important to set-up of new manufacturing processes with the impact of the variables. The object of this study was to select the ranges of critical process parameters in the compression process of valsartan and pravastatin fixed-dose combination tablets by using design of experiment (23 full factorial design with three center points). 3-Factorial (compression force, press speed and feeder speed), 4-level (hardness, disintegration, content uniformity and dissolution) and 1-center (n = 3) points as critical quality attributes were applied for the design of experiment batch using Design Expert Software. Compression force was an important factor in the hardness, disintegration and dissolution results (p < 0.05), more so than press and feeder speeds. The results indicated that compression force (from 8 to 12 kN), press speed (from 15 to 25 rpm) and feeder speed (from 10 to 30 rpm) for tablet compression were ideal ranges of operation for the critical process parameters.
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- I. Muszalska, A. Sobczak, A. Dolhañ and A. Jeliñska, J. Pharm. Sci., 103, 2 (2014); doi:10.1002/jps.23760.
- K.M. Kim, W.S. Hwang, J.H. Jung, B.G. Kim and G.T. Kim, J. Pharm. Investig, 45, 399 (2015); doi:10.1007/s40005-015-0185-0.
- D. Srinivas and T.R.S. Subal Debnath, , J. Chem. Pharm. Res., 2, 534 (2010).
- Q.-R. Cao, Y. Liu, W.-J. Xu, B.-J. Lee, M. Yang and J.-H. Cui, Int. J. Pharm., 434, 325 (2012); doi:10.1016/j.ijpharm.2012.05.076.
- T. Hatanaka, Clin. Pharmacokinet., 39, 397 (2000); doi:10.2165/00003088-200039060-00002.
- K.K. Koh, S.H. Han, P.C. Oh, E.K. Shin and M.J. Quon, Atherosclerosis, 209, 307 (2010); doi:10.1016/j.atherosclerosis.2009.09.007.
- S. Almeida, A. Filipe, A. Almeida, I. Gich, R. Antonijoan, M. Puntes, M. Barbanoj and M.C. Caturla, Arzneimittelforschung, 56, 70 (2006); doi:10.1055/s-0031-1296704.
- International Conference on Harmonisation (ICH) guideline. Pharmaceutical development Q8 (R2). Step 5 versions (2009).
- Product Quality Research Institute (PQRI), Pharm. Eng., 26, 1 (2006).
- K. Joshi, A. Asthana, G.S. Asthana and S. Pande, World J. Pharm. Res., 4, 1379 (2015).
- S. Bajaj, D. Singla and N. Sakhuja, J. Appl. Pharm. Sci., 2, 129 (2012).
- G.S. Sonar and S. Rawat, J. Appl. Pharm. Sci., 5, 91 (2015); doi:10.7324/JAPS.2015.501016.
- L.X. Yu, Pharm. Res., 25, 781 (2008); doi:10.1007/s11095-007-9511-1.
- A. Kocijana, R. Graheka and L. Zupancic-Kraljb, Acta Chim. Slov., 53, 464 (2006).
- S. Brain-Isasi, C. Requena and A. Alvarez-Lueje, J. Chil. Chem. Soc., 52, 1684 (2008); doi:10.4067/S0717-97072008000400010.
- E.O. Akala, S. Adesina and O. Ogunwuyi, Int. J. Environ. Res. Public Health, 13, 47 (2016).
- L.A. Corá, P.R. Fonseca, M.F. Américo, R.B. Oliveira, O. Baffa and J.R.A. Miranda, Eur. J. Pharm. Biopharm., 69, 372 (2008); doi:10.1016/j.ejpb.2007.11.005.
- O.C. Nkuzinna, M.C. Menkiti, O.D. Onukwuli, G.O. Mbah, B.I. Okolo, M.C. Egbujor and R.M. Government, Nat. Resour., 4, 299 (2014).
- B. Guebitz, H. Schnedl and J.G. Khinast, Expert Syst. Appl., 39, 7291 (2012); doi:10.1016/j.eswa.2012.01.089.
- International Conference on Harmonisation (ICH) Guideline, Pharmaceutical Quality System Q10, Step 5 versions (2015).
References
I. Muszalska, A. Sobczak, A. Dolhañ and A. Jeliñska, J. Pharm. Sci., 103, 2 (2014); doi:10.1002/jps.23760.
K.M. Kim, W.S. Hwang, J.H. Jung, B.G. Kim and G.T. Kim, J. Pharm. Investig, 45, 399 (2015); doi:10.1007/s40005-015-0185-0.
D. Srinivas and T.R.S. Subal Debnath, , J. Chem. Pharm. Res., 2, 534 (2010).
Q.-R. Cao, Y. Liu, W.-J. Xu, B.-J. Lee, M. Yang and J.-H. Cui, Int. J. Pharm., 434, 325 (2012); doi:10.1016/j.ijpharm.2012.05.076.
T. Hatanaka, Clin. Pharmacokinet., 39, 397 (2000); doi:10.2165/00003088-200039060-00002.
K.K. Koh, S.H. Han, P.C. Oh, E.K. Shin and M.J. Quon, Atherosclerosis, 209, 307 (2010); doi:10.1016/j.atherosclerosis.2009.09.007.
S. Almeida, A. Filipe, A. Almeida, I. Gich, R. Antonijoan, M. Puntes, M. Barbanoj and M.C. Caturla, Arzneimittelforschung, 56, 70 (2006); doi:10.1055/s-0031-1296704.
International Conference on Harmonisation (ICH) guideline. Pharmaceutical development Q8 (R2). Step 5 versions (2009).
Product Quality Research Institute (PQRI), Pharm. Eng., 26, 1 (2006).
K. Joshi, A. Asthana, G.S. Asthana and S. Pande, World J. Pharm. Res., 4, 1379 (2015).
S. Bajaj, D. Singla and N. Sakhuja, J. Appl. Pharm. Sci., 2, 129 (2012).
G.S. Sonar and S. Rawat, J. Appl. Pharm. Sci., 5, 91 (2015); doi:10.7324/JAPS.2015.501016.
L.X. Yu, Pharm. Res., 25, 781 (2008); doi:10.1007/s11095-007-9511-1.
A. Kocijana, R. Graheka and L. Zupancic-Kraljb, Acta Chim. Slov., 53, 464 (2006).
S. Brain-Isasi, C. Requena and A. Alvarez-Lueje, J. Chil. Chem. Soc., 52, 1684 (2008); doi:10.4067/S0717-97072008000400010.
E.O. Akala, S. Adesina and O. Ogunwuyi, Int. J. Environ. Res. Public Health, 13, 47 (2016).
L.A. Corá, P.R. Fonseca, M.F. Américo, R.B. Oliveira, O. Baffa and J.R.A. Miranda, Eur. J. Pharm. Biopharm., 69, 372 (2008); doi:10.1016/j.ejpb.2007.11.005.
O.C. Nkuzinna, M.C. Menkiti, O.D. Onukwuli, G.O. Mbah, B.I. Okolo, M.C. Egbujor and R.M. Government, Nat. Resour., 4, 299 (2014).
B. Guebitz, H. Schnedl and J.G. Khinast, Expert Syst. Appl., 39, 7291 (2012); doi:10.1016/j.eswa.2012.01.089.
International Conference on Harmonisation (ICH) Guideline, Pharmaceutical Quality System Q10, Step 5 versions (2015).