The effect of recompression and concentration of polyvinylpyrrolidone (PVP) K-30 on the quality of paracetamol tablets

Authors

DOI:

https://doi.org/10.12928/pharmaciana.v14i2.28399

Keywords:

recompression, polyvinylpyrrolidone (PVP) K-30, paracetamol tablets, wet granulation

Abstract

Quality control during production is a critical process that ensures the quality of the tablets until it reaches the consumer. In the pharmaceutical industry, there is a possibility of reworking, including tablet recompression. Nevertheless, the recompression process may have affected the potential of PVP K-30 as a binder to reunite the particles of tablet ingredients. However, the difference of PVP K-30 concentration might be resulting in the differences of granule and tablet characteristics. This study aims to determine whether there is an effect of recompression and the difference of PVP K-30 on the quality of paracetamol tablets. The effect of recompression and the difference of PVP K-30 was seen based on whether there is a significant different on physical properties of the mixture of tablet ingredients (mixture’s flow rate and compressibility) and the tablets (compatibility and tablet’s hardness, friability, and disintegration time) from the formula with a concentration of 2% w/w and 4% w/w PVP K-30 after experiencing 2 times of recompression. Paracetamol tablets were made by wet granulation method through the stages of granulation, lubrication, physical properties testing of the mixture, tablet compression, physical properties testing of tablets, crushing, and recompression. Data analysis was performed statistically using the Shapiro-Wilk normality test, followed by two-way Analysis of Variance (ANOVA) or Kruskal-Wallis test and Post Hoc Mann Whitney test. The results showed there was an effect of recompression and different concentration of PVP K-30 on the potential of PVP K-30 as a binder as seen from significant differences in the physical properties of the mixture and tablets in each test group.

References

Al-zoubi, N., Gharaibeh, S., Aljaberi, A., & Nikolakakis, I. (2021). Spray Drying for Direct Compression of Pharmaceuticals. Processes, 9 (2), 267. https://doi.org/10.3390/pr9020267

Ardiansyah, Rahmawati, T. E., Nabila, N. A., Meliza, F. N., & Antoni, F. (2022). Optimasi Formula Tablet Parasetamol Dengan Metode Granulasi Basah (Wet Granulation). Jurnal Farmasi, 1(2), 28-31

Badan Pengawas Obat dan Makanan. (2018). Pedoman Cara Pembuatan Obat yang Baik (CPOB). Direktorat Pengawasan Produksi Obat, Narkotika, Psikotropika, dan Prekursor Badan Pengawas Obat dan Makanan.

Chen, K., Huo, B., Wu, H., Huang, X., Li, F., Xiao, Y., Li, J., Bao, Y., & Hao, H. (2019). Hollow and Solid Spherical Azithromycin Particles Prepared by Different Spherical Crystallization Technologies for Direct Tableting. Processes, 7(5), 276. https://doi.org/10.3390/pr7050276.

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

Elisabeth, V., Yamlean, P. V. Y., & Supriati, H. S. (2018). Formulasi Sediaan Granul Dengan Bahan Pengikat Pati Kulit Pisang Goroho (Musa Acuminafe L.) dan Pengaruhnya Pada Sifar Fisik Granul. Pharmacon, 7(4),1-11.

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), 26-31.

Fatmawati A., Emelda, & Elvana, A. (2020). Optimasi Formula Pada Granul Paracetamol Dengan Variasi Komposisi Bahan Pengisi Laktosa Dan Avicel Ph 101 Serta Evaluasi Parameter Kadar Lembab Moisture Content Dan Loss on Drying. INPHARNMED Journal, 4(1), 25-32. http://dx.doi.org/10.21927/inpharnmed.v4i1.1806.

Gamlen, M. J. D., Martini, L. G., & Al Obaidy, K. G. (2013). Effect of Repeated Compaction of Tablets on Tablet Properties and Work of Compaction Using an Instrumented Laboratory Tablet Press. Drug Development and Industrial Pharmacy, 41(1), 163-169. 10.3109/03639045.2013.850715.

Hiremath P, Nuguru K, & Agrahari V. (2019). Material Attributes and Their Impact on Wet Granulation Process Performance. In Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm (pp. 264–296). essay, Elsevier Inc.

Hasper, E. S., Bethke, J., Vogler, N., & Goedecke, T. (2022). Flow Properties of Powdery or Granular Filling Substances of Dangerous Goods Packagings—Comparison of The Measurement of The Angle of Repose and The Determination of The Hausner Ratio. Packing Technology and Science, 35(10), 765-782. https://doi.org/10.1002/pts.2678

Huda, C., & Sari, T. A. (2019). Buku Ajar Teknologi Sediaan Solida. MNC Publishing.

Husni, P., Fadhiilah, M. L., & Hasanah, U. (2020). Formulasi dan Uji Stabilitas Fisik Granul Instan Serbuk Kering Tangkai Genjer (Limnocharis flava (L.) Buchenau.) Sebagai Suplemen Penambah Serat. Jurnal Ilmiah Farmasi Farmasyifa, 3(1), 1-8. https://doi.org/10.29313/jiff.v3i1.5163

Iqubal, M. K., Singh, P. K., Shuaib, M., Iqubal, A., & Singh, M. (2014). Recent Advances in Direct Compression Technique For Pharmaceutical Tablet Formulation. International Journal of Pharmaceutical Research and Development, 6(1), 49-57.

Janssen, P. H., Fathollahi, S., Bekaert, B., Vanderroost, D., Roelofs, T., Vanhoorne, V., Vervaet, C., & Dickhoff, B. H. (2023). Impact of material properties and process parameters on tablet quality in a continuous direct compression line. Powder Technology, 424, 118520. https://doi.org/10.1016/j.powtec.2023.118520.

Khaidir, S., Mimiek, M., & Kusuma, A. P. (2015). Formulasi Tablet Ekstrak Kangkung Air (Ipomoea aquatica F.) Dengan Variasi Kadar Amilum Manihot Sebagai Bahan Penghancur. Jurnal Ilmiah Farmasi, 11(1), 1-8. https://doi.org/10.20885/jif.vol11.iss1.art1

Mashabai. I., Ruspendi, & Syauqi, M. I. (2022). Analisa Permasalahan Sticking Pada Tablet XYZ Menggunakan Metode PDCA di PT. Sunthi Sepuri. Jurnal Pendidikan dan Aplikasi Industri, 9(1), 19-27. https://doi.org/10.33592/unistek.v9i1.2067

Puspita, O. E., Ebtavanny, T. G., & Fortunata, F. A. (2022). Studi Pengaruh Jenis Bahan Pengikat Sediaan Tablet Dispersi Solid Kunyit Terhadap Profil Disolusi Ekstrak Kunyit (Curcuma domestica). Pharmaceutical Journal of Indonesia, 8(1), 95-102. https://doi.org/10.21776/ub.pji.2022.008.01.10

Putra, D. J. S., Antari, N. W. Y., Putri, N. P. R. A., Arisanti, C. I. S., & Samirana, P. O. (2019). Penggunaan Polivinill Pirolidon (PVP) Sebagai Bahan Pengikat Pada Formulasi Tablet Ekstrak Daun Sirih (Piper betle L.). Jurnal Farmasi Udayana, 8(1), 14-21. https://doi.org/10.24843/JFU.2019.v08.i01.p03.

Rahayu, S., & Anisah, N. (2021). Pengaruh Variasi Konsentrasi Amprotab Sebagai Desintegrant Terhadap Sifat Fisik Tablet Ekstrak Buah Pare (Momordica charantia L.). Jurnal Ilmiah Ibnu Sina, 6(1), 39-48. https://doi.org/10.36387/jiis.v6i1.572.

Rashati, D., & Fauziah, A. (2017). Pengaruh Variasi Konsentrasi Amilum Zea mays (L) Sebagai Bahan Penghancur Secara Granulasi Basah Terhadap Sifat Fisik Tablet Parasetamol. Jurnal Ilmiah Farmasi AKFAR, 2(1), 1-6. https://doi.org/10.53864/jifakfar.v2i1.15.

Rijal, M., Buang, A., & Prayitno, S. (2022). Pengaruh Konsentrasi PVP K-30 Sebagai Bahan Pengikat Terhadap Mutu Fisik Tablet Ekstrak Daun Tekelan (Chromolaena Odorata. L.). Jurnal Kesehatan Yamasi Makassar, 6(1), 98-111.

Rojas, J., Zuluaga, C., & Cadavid, A. (2015). Effect of Reprocessing and Excipient Characteristics on Ibuprofen Tablet Properties. Tropical Journal of Pharmaceutical Research, 14(7), 1145-1152. http://dx.doi.org/10.4314/tjpr.v14i7.4.

Rori, W. M., Yamlean, P. V., & Sudewi, S. (2016). Formulasi dan Evaluasi Sediaan Tablet Ekstrak Daun Gedi Hijau (Abelmoschus manihot) Dengan Metode Granulasi Basah. Pharmacon, 5(2), 243-250. https://doi.org/10.35799/pha.5.2016.12212.

Saputri, F. E., & Saryanti, D. (2022). Formulasi Tablet Ekstrak Daun Kelengkeng (Euphoria Longana Lam) Dengan Variasi Polivinil Pirolidone (Pvp K-30) Sebagai Bahan Pengikat. Jurnal Kesehatan Pharmasi, 4(1), 17-23. https://doi.org/10.36086/jpharm.v4i1.1231.

Sheskey, P. J., Cook, W. G., & Cable, C. G. (2017). Handbook of Pharmaceutical Excipients, Eight edition. Pharmaceutical Press.

Sholikhati, A., Rahmawati, R. P., & Kurnia, S. D. (2022). Analisis Mutu Fisik Granul Ekstrak Kulit Manggis Dengan Metode Granulasi Basah. Indoneisa Jurnal Farmasi, 7(1), 1-9. 751/ijf.v7i1.1421.

Siregar, C. J. P., & Wikarsa, S. (2015). Teknologi Farmasi Sediaan Tablet : Dasar-Dasar Praktis. Penerbit Buku Kedokteran EGC.

Sugiyono, Komariyatun, S., & Hidayati, D. N. (2017), Formulasi Tablet Parasetamol Menggunakan Tepung Bonggol Pisang Kepok (Musa paradisiaca cv. Kepok) Sebagai Bahan Pengikat. Media Farmasi Indonesia, 12(1), 1156-1166.

Suhery, W. N., Fernando, A., & Giovanni, B. (2016). Perbandingan Metode Granulasi Basah dan Kempa Langsung Terhadap Sifat Fisik dan Waktu Hancur Orally Disintegrating Tablets (ODTs) Piroksikam. Jurnal Sains Farmasi & Klinis, 2(2), 138-144. 10.29208/jsfk.2016.2.2.65.

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

Ulusoy, U. (2022). A Review of Particle Shape Effects on Material Properties for Various Engineering Applications: From Macro to Nanoscale. Minerals, 13(1), 91. https://doi.org/10.3390/min13010091.

Wahyuni, (2016). Pemanfaatan Pati Umbi Tire (Amorphophallus onchopillus) Sebagai Bahan Pengikat Tablet Parasetamol Dengan Metode Granulasi Basah. Fakultas Kedokteran dan Ilmu Kesehatan, Universitas Islam Negeri Alauddin.

Wulandari, A., & Sugiyono. (2017). Formulasi Tablet Hisap Ekstrak Etanol Daun Pare (Momordica charantia L) Dengan Pemanis Sukrosa- Laktosa-Aspartam. Jurnal Ilmiah Cendekia Eksakta, 2(1), 9-16. http://dx.doi.org/10.3194/ce.v2i1.1792.

Zaini, A. N., & Gozali, D. (2016). Pengaruh Suhu Terhadap Stabilitas Obat Sediaan Suspensi. Farmaka, 14(2), 140-150. https://doi.org/10.24198/jf.v14i2.10820.

Downloads

Published

2024-07-24

Issue

Section

Pharmaceutics and Pharmaceutical Technology