Application Of Factorial Design To Optimize Lubricant Concentration And Granule Mixing Time In The Formulation Of Sour Star Fruit (Averrhoa bilimbi L) Ethanolic Extract Tablet

Gunawan Setiyadi(1*), Yola Veranita Putri(2)

(1) Department of Pharmaceutics Universitas Muhammadiyah Surakarta, Sukoharjo, Jawa Tengah, Indonesia
(2) Department of Pharmaceutics Universitas Muhammadiyah Surakarta, Sukoharjo, Jawa Tengah, Indonesia
(*) Corresponding Author

Abstract

The use of lubricant in tablet compaction can reduce both intergranular and granule to die-wall friction that in turen improve granule flow properties and reduce adhesion of granule mass to the die wall. However, the concentration and method of adding lubricants into granule mass has also been known to influence the physical properties of tablets, such as hardness, friability, disintegration time and dissolution. This study aimed to apply 2-factor-2-level-factorial (22) design to determine the effect of lubricant concentration in granule mass (factor A) and the granule mixing time (factor B) on the physical properties of granules and tablets of starfruit leaves (Averrhoa bilimbi L.) ethanolic extract and to obtain the optimum setting of both factors that results in responses that satisfy most of the predefined criteria. The factorial design was set as follows: (l) = 2.5%, 5 minutes, a = 5%, 5 minutes, b = 2.5%, 15 minutes, and ab = 5%, 15 minutes. The lubricant used was a mixture of magnesium stearate and talc in a ratio of 1:9. Experimental design and optimization were carried out using Design Expert 13.0 software with granule flowability, angle of repose, and compressibility, as well as tablet weight uniformity (%RSD), hardness, friability, and disintegration time as responses. Optimum results were obtained with 2.5% lubricant and 5 minutes factor combination. The verification test to the optimum parameters showed that the granule flowability, angle of repose, tablet hardness and tablet friability are within the prediction interval range (PI 95%).

Keywords

Averrhoa bilimbi L; concentration; lubricant; factorial design; granule mixing time

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References

Abe, H., & Otsuka, M., 2012. Effects of lubricant-mixing time on prolongation of dissolution time and its prediction by measuring near infrared spectra from tablets. Drug Development and Industrial Pharmacy, 38(4), 412–419. https://doi.org/10.3109/03639045.2011.608679

Ajala, T. O., Odeku, O., Ajala, T. O., & Odeku, O. A., 2012. Lubricant Properties Of Some Local Talc Deposits In South Western Nigeria. West African Journal of Pharmacy, 23(1).

Alhassan, A., & Ahmed, Q., 2016. Averrhoa Bilimbi Linn.: A Review of Its Ethnomedicinal Uses, Phytochemistry, and Pharmacology. Journal of Pharmacy and Bioallied Sciences, 8(4), 265–271. https://doi.org/10.4103/0975-7406.199342

Apeji, Y. E., Ariko, N. A., Olayemi, O. J., Olowosulu, A. K., & Oyi, A. R., 2022. Optimization of the Extragranular Excipient Composition of Paracetamol Tablet formulation using the Quality by Design Approach. Brazilian Journal of Pharmaceutical Sciences, 58. https://doi.org/10.1590/s2175-97902022e20544

Badan Pengawas Obat dan Makanan Republik Indonesia, 2014. Persyaratan Mutu Obat Tradisional. Peraturan Kepala Badan Pengawas Obat dan Makanan Republik Indonesia.

Cahyani, A. N., Susanto, A., Dewi, I. R., & Nurhikmah, I., 2023. Formulasi Tablet Parasetamol Dengan Kombinasi PVP dan Amilum Umbi Porang (Amorphopallus onchopyllus) Sebagai Bahan Pengikat Terhadap Sifat Fisik Tablet. Jurnal Ilmiah Jophus, 4(02), 1–11.

de Backere, C., De Beer, T., Vervaet, C., & Vanhoorne, V., 2020. Evaluation of an external lubrication system implemented in a compaction simulator. International Journal of Pharmaceutics, 587(June), 119675. https://doi.org/10.1016/j.ijpharm.2020.119675

Desmariyenti, 2021. Efektifitas Rebusan Daun Belimbing Wuluh Terhadap Penurunan Tekanan Darah pada Lansia Hipertensi. Journal of Midwifery Sempena Negeri, 1(1), 23–29.

Fadhilah, I. N., & Saryanti, D., 2019. formulasi dan Uji Stabilitas Fisik Sediaan Tablet Ekstrak Buah Pare (Momordica charantia L.) Secara Granulasi Basah. Smart Medical Journal, 2(1), 25. https://doi.org/10.13057/smj.v2i1.29676

Hernani, Winarti, C., & Mawarti, T., 2009. Pengaruh Pemberian ekstrak Daun Belimbing Wuluh Terhadap Penurunan Tekanan Darah Pada Hewan Uji. Jurnal Pascapanen, 6(1), 54–61.

Kementerian Kesehatan Republik Indonesia, 2020. Farmakope Indonesia Edisi VI (VI). Direktorat Jenderal Kefarmasian dan Alat Kesehatan, Kementerian Kesehatan Republik Indonesia.

Nakamura, S., Yamaguchi, S., Hiraide, R., Iga, K., Sakamoto, T., & Yuasa, H., 2017. Setting Ideal Lubricant Mixing Time for Manufacturing Tablets by Evaluating Powder Flowability. AAPS PharmSciTech, 18(7), 2832–2840. https://doi.org/10.1208/s12249-017-0765-6

Paul, S., & Sun, C. C., 2018. Systematic evaluation of common lubricants for optimal use in tablet formulation. In European Journal of Pharmaceutical Sciences (Vol. 117, Issue 2017). Elsevier B.V. https://doi.org/10.1016/j.ejps.2018.02.013

Puspadina, V., Legowo, D. B., Fitriany, E., Priyoherianto, A., & Damayanti, W., 2021. Effect Of Variation Of Lubricant Cncentration (Magnesium Stearate) On The Physical Quality Of Metocloramid HCl Tablets With Direct Printing Method. Indonesian Journal of Pharmaceutical Education, 1(2), 67–75. https://doi.org/10.37311/ijpe.v1i2.10567

Rori, W. M., Yamlean, P. V. Y., & Sudewi, S., 2020. Formulasi dan Evaluasi Sediaan Tablet Ekstrak Daun gedi Hijau (Abelmochus manihot) dengan metode Granulasi Basah. Pharmacon, 5(2), 47–72. https://doi.org/10.4324/9780429281532-5

Syukri, Y., 2018. Teknologi Sediaan Obat Dalam Bentuk Solid. Universitas Islam Indonesia.

Uchimoto, T., Iwao, Y., Hattori, H., Noguchi, S., & Itai, S., 2013. Determination of Useful Ranges of Mixing Conditions for Glycerin Fatty Acid Ester by Multiple Regression Analysis. In Chem. Pharm. Bull (Vol. 61, Issue 11).

Uchimoto, T., Iwao, Y., Ikegami, Y., Murata, T., Sonobe, T., Miyagishima, A., & Itai, S., 2010. Lubrication properties of potential alternative lubricants, glycerin fatty acid esters, to magnesium stearate. International Journal of Pharmaceutics, 386(1–2), 91–98. https://doi.org/10.1016/j.ijpharm.2009.11.001

Wang, J., Wen, H., & Desai, D., 2010. Lubrication in tablet formulations. European Journal of Pharmaceutics and Biopharmaceutics, 75(1), 1–15. https://doi.org/10.1016/j.ejpb.2010.01.007

Zarmpi, P., Flanagan, T., Meehan, E., Mann, J., & Fotaki, N., 2020. Impact of Magnesium Stearate Presence and Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. AAPS Journal, 22(4). https://doi.org/10.1208/s12248-020-00449-w

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