Evaluasi Fisik Sediaan Tablet Amlodipine (Besilat) sebagai Obat Antihipertensi: Perbandingan antara Tablet Generik dan Generik Bermerek
DOI:
https://doi.org/10.55606/klinik.v4i2.4060Keywords:
Physical Evaluation, Amlodipine (Besylate), Generic, Branded GenericAbstract
Popular antihypertensive drugs used are amlodipine (besylate) in generic and branded generic tablets. To ensure that a drug is of good quality and efficacy, evaluation of the physical quality of the tablet is very important. This study aims to determine the results of the physical evaluation of generic and branded amlodipine (besylate) tablets that are currently available for purchase. This type of experimental study involves random sample selection. Testing was carried out on three samples of generic amlodipine (besylate) tablets and one sample of branded generic tablets. The physical evaluation of the tablets carried out was uniformity of weight, uniformity of size, hardness, friability, and disintegration time as part of the physical examination. The test results showed that generic tablets 3 and branded generics met the requirements of the Indonesian Pharmacopoeia.
References
Bulsara, K. G., & Cassagnol, M. (2021). Amlodipine. StatPearls Publishing.
Caren, G. J. (2023). Review artikel: Critical quality attributes dan critical process parameter dari tablet kempa langsung. Farmaka, 21(2).
Collier, D. J., Taylor, M., Godec, T., Shiel, J., James, R., Chowdury, Y., ... Caulfield, M. J. (2024). Personalized antihypertensive treatment optimization with smartphone-enabled remote precision dosing of amlodipine during the COVID-19 pandemic (PERSONAL-CovidBP Trial). Journal of the American Heart Association, 13(4). https://doi.org/10.1161/JAHA.123.030749
Depkes RI. (1979). Farmakope Indonesia (Edisi III). Departemen Kesehatan Republik Indonesia.
Depkes RI. (1995). Farmakope Indonesia (Edisi IV). Departemen Kesehatan Republik Indonesia.
Depkes RI. (2014). Farmakope Indonesia (Edisi V). Departemen Kesehatan Republik Indonesia.
Depkes RI. (2020). Farmakope Indonesia (Edisi VI). Departemen Kesehatan Republik Indonesia.
Ferrari, R., Camici, P. G., Crea, F., Danchin, N., Fox, K., Maggioni, A. P., ... Lopez-Sendon, J. L. (2018). Expert consensus document: A “diamond” approach to personalized treatment of angina. Nature Reviews Cardiology, 15(2), 120–132. https://doi.org/10.1038/nrcardio.2017.131
Hadisoewignyo, L., & Fudholi, A. (2016). Sediaan solid. Pustaka Pelajar.
Hidayatullah, M. H., Ibrahim, S., & Permana, B. (2022). Pengembangan dan validasi metode analisis amlodipin besilat dan identifikasi cemarannya dalam sediaan tablet. Pharmacon: Jurnal Farmasi Indonesia, 19(2).
Iskandar, B., & Susanti, I. (2019). Uji sifat fisik tablet salut enterik kalium diklofenak generik dan generik bermerek yang beredar di apotek Kecamatan Siak Hulu. Jurnal Penelitian Farmasi Indonesia, 8(1).
Kuncoro, B., Zaky, M., & Lestari, I. (2015). Formulasi dan evaluasi fisik sediaan fast dissolving tablet amlodipine besylate menggunakan sodium starch glycolate sebagai bahan penghancur. Ida Lestari, 2(2).
Kusuma, D., & Apriliani, E. D. (2018). Evaluasi fisik tablet parasetamol generik dan tablet parasetamol bermerek dagang. AKFARINDO, 3(1), 1–7.
Parrot, E. (1970). Pharmaceutical technology: Fundamental pharmaceutics. Burgess Publishing Company.
Saleem, M., Shahin, M., Srinivas, B., & Begum, A. (2016). Evaluation of tablets by friability apparatus. International Journal of Research in Pharmacy and Chemistry, 4(4), 837–840. www.ijrpc.com
Sha, A., Elz, S., & Hoag, S. (2017). NIR spectroscopy analysis. European Journal of Chemistry, 8(3), 265–272. https://doi.org/10.5155/eu
Sugiyanto, K. C., Palupi, D. A., & Kuncoro, B. (2017). Evaluasi hasil pengukuran keseragaman ukuran, keregasan, dan waktu hancur tablet salut film Neuralgad produksi Lafi Ditkesad Bandung. Cendekia: Journal of Pharmacy.
Syukri, Y. (2018). Teknologi sediaan obat dalam bentuk solid. Universitas Islam Indonesia.
Tang, L., El-Din, T. M. G., Swanson, T. M., Pryde, D. C., Scheuer, T., Zheng, N., & Catterall, W. A. (2016). Structural basis for inhibition of a voltage-gated Ca2+ channel by Ca2+ antagonist drugs. Nature, 537(7618), 117–121.
Tiwari, R. N., Shah, N., Bhalani, V., & Mahajan, A. (2015). LC-MS/MS studies for the characterization of degradation products of amlodipine. Journal of Pharmaceutical Analysis, 5, 33–42.
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