Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

Kang-Min Kim; Geun-Tae Kim; Jae-Seon Kang

doi:10.14233/ajchem.2016.20115

Issue

Vol. 28 No. 12 (2016): Vol 28 Issue 12

Issue Published : September 1, 2016

This work is licensed under a Creative Commons Attribution 4.0 International License.

Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

https://doi.org/10.14233/ajchem.2016.20115

Kang-Min Kim

CMC R&D center, LG Life Sciences, Ltd., Daejeon 305-380, Republic of Korea

Geun-Tae Kim

CMC R&D center, LG Life Sciences, Ltd., Daejeon 305-380, Republic of Korea

Jae-Seon Kang

College of Pharmacy, Kyungsung University, Busan 608-736, Republic of Korea

Corresponding Author(s) : Kang-Min Kim

kkij79@hanmail.net

Asian Journal of Chemistry, Vol. 28 No. 12 (2016): Vol 28 Issue 12
Article Published : September 2, 2016

Abstract

Design of experiment provides a quality risk management to the manufacturing process of a product. This study was performed to select the water amount and identify the critical process parameters for wet granulation. Design of experiment, one of the quality by design approaches, was used in the study. The manufacturing process of valsartan and paravastatin fixed-dose combination tablets involves wet granulation, drying, sieving, blending and tableting. For wet granulation, a 3-factorial (granulating time, agitator speed and the amount of granulating water), 2-level (granule density and dissolution), 1-center (n = 3) point was used in the design of experiment batches and analyzed using Design Expert Software. Previously, this formulation was found to show good assay and content uniformity. Thus, only physical properties, bulk density and dissolution were evaluated for the design of experiment study. The amount of granulating water was identified as an important factor affecting the mean dissolution (p < 0.05) in contrast to the granulating time and agitator speed. Present results indicated that granulating time (6 to 10 min), amount of granulating water (40 to 60 g) and agitator speed (150 to 250 rpm) were optimal for wet granulation of valsartan and pravastatin fixed-dose combination tablets.

Keywords

Valsartan Pravastatin Quality by design Design of experiment Wet granulation

Kim, K.-M., Kim, G.-T., & Kang, J.-S. (2016). Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet. Asian Journal of Chemistry, 28(12), 2759–2763. https://doi.org/10.14233/ajchem.2016.20115

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A.N. Zaid, S. Natur, A. Qaddomi, M. Abualhasan, R. Al-Ramahi, N. Shraim, S. Khammash and N. Jaradat, Pak. J. Pharm. Sci., 27, 755 (2014).

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. Hirano, F. Komuro, S. Furukawa, S. Nagano and T. Takahashi, Metabolism, 39, 605 (1990); doi:10.1016/0026-0495(90)90026-9.

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.

V.K. Rai, N. Pathak, R. Bhaskar, B.C. Nandi, S. Dey and L.K. Tyagi, Int. J. Pharm. Sci. Drug Res., 1, 51 (2009).

International Conference on Harmonisation (ICH) Guideline, Q8 Pharmaceutical Development (2008).

Product Quality Research Institute (PQRI), Process Robustness-A PQRI White Paper, Pharm. Engine. 26, 1 (2006).

D.C. Montgomery, Design and Analysis of Experiments, J. Wiley & Sons Inc., Hoboken New Jersey, edn 6 (2005).

B.J. Ennis, in ed.: D.M. Parikh, Theory of Granulation: An Engineering Perspective, Handbook of Pharmaceutical Granulation Technology, Taylor and Francis group, New York, pp. 140-144 (2006).

A.J. Rogers, A. Hashemi and M.G. Ierapetritou, Processes, 1, 67 (2013); doi:10.3390/pr1020067.

S. Bajaj, D. Singla and N. Sakhuja, J. Appl. Pharm. Sci., 2, 129 (2012).

M. Benali, V. Gerbaud and M. Hemati, Powder Technol., 190, 160 (2009); doi:10.1016/j.powtec.2008.04.082.

G. Levy, J.M. Antkowiak, J.A. Procknal and D.C. White, J. Pharm. Sci., 52, 1047 (1963); doi:10.1002/jps.2600521106.

N.C. Ngwuluka, B.A. Idiakhoa, E.I. Nep, I. Ogaji and I.S. Okafor, Res. Pharm. Biotechnol., 2, 25 (2010).

N. Tavakoli, N.G. Dehkordi, R. Teimouri and H. Hamishehkar, Jundishapur J. Nat. Pharm. Prod., 3, 33 (2008).

L.X. Yu, Pharmaceut. Res., 25, 781 (2008); doi:10.1007/s11095-007-9511-1.

M. Litviæ, K. Smic, V. Vinkovic and M. Filipan-Litvic, J. Photochem. Photobiol. Chem., 252, 84 (2013); doi:10.1016/j.jphotochem.2012.11.008.

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., 53, 1684 (2008); doi:10.4067/S0717-97072008000400010.

A. Mishra, S. Kumar and S. Kumar, J. Sci. Ind. Res., 67, 1098 (2008).

O.C. Nkuzinna, M.C. Menkiti, O.D. Onukwuli, G.O. Mbah, B.I. Okolo, M.C. Egbujor and R.M. Government, Nat. Resour., 5, 299 (2014); doi:10.4236/nr.2014.57028.

E.O. Akala, S. Adesina and O. Ogunwuyi, Int. J. Environ. Res. Public Health, 13, 47 (2016); doi:10.3390/ijerph13010047.

Issue

Vol. 28 No. 12 (2016): Vol 28 Issue 12

Design of Experiments for Wet Granulation of Valsartan and Pravastatin Fixed-Dose Combination Tablet

Corresponding Author(s) : Kang-Min Kim

Abstract

Keywords

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