Uji Dissolusi Terbanding Tablet Metilprednisolon Generik Bermerek dan Generik Berlogo Dibandingkan Dengan Tablet Metilprednisolon Paten

  • Hansen Nasif
  • Erizal Zaini
  • Agnes S

Abstract

Generic drugs are drugs that have expired patents and then can be produced by different industries from innovator companies. Controversy over the use of drugs Patents / original drugs and generic / copy drugs have been ongoing in society, including health practitioners, although research on the pharmaceutical and pharmacokinetic phases has been widely practiced. In biopharmaceutical studies, different formulations and drug production processes can affect the availability of drugs in the blood which in the later stages will affect the effects of the drug. This study aims to study the dissolution of methylprednisolone 4 mg branded generic tablets from drug manufacturers PT.B, generic “berlogo” from PT.I and patent product from PT.P. Dissolved content was measured using a UV-Vis spectrophotometer at a wavelength of 200-400nm. The dissolution profile showed no significant difference for patent / innovator, generic branded and generic “berlogo” with similarity factor (F2) patent product with branded generic is 86,9 and patent product with generic logo is 81,2, so it can be concluded that the dissolution profiles of these three drugs are the same.

References

Badan Pemeriksaan Obat dan Makanan Republik Indonesi. (2004). Pedoman uji bioekivalensi. Jakarta: Badan POM RI.

Davit, B., Braddy, A. C., Conner, D. P., & Lawrence, X. Y. (2013). International guidelines for bioequivalence of systemically available orally administered generik drug products: a survey of similarities and differences. The AAPS journal, 15(4), 974-990.

Duan, J. Z., Riviere, K., & Marroum, P. (2011). In vivo bioequivalence and in vitro similarity faktor (f2) for dissolution profile comparisons of extended release formulations: how and when do they match?. Pharmaceutical research, 28(5), 1144-1156.

FDA, U. (1997). Guidance for Industry: Dissolution testing of immediate-release solid oral dosage forms. Food and Drug Administration, Center for Drug Evaluation and Research (CDER).

Galia, E., Horton, J., & Dressman, J. B. (1999). Albendazole generiks—a comparative in vitro study. Pharmaceutical research, 16(12), 1871-1875.

Ghadiyali, Shahebaz, N. (2013). Study of processing parameters affecting dissolution profile of highly water soluble drug. Scholars Research Library, Der Pharmacia Letter, 5(3), 211-222.

Hime, S. A., Onunkwo, G. C., & Onyishi, I. I. (2013). Kinetics and mechanisms of drug release from swellable and non swellable matrices: a review. Res J Pharm Biol Chem Sci, 4(2), 97-103.

Kementrian Kesehatan Republik Indonesia. (2013). Keputusan Menteri Kesehatan Republik Indonesia Nomor 312/Menkes/SK/IX/2013 Tentang Daftar Obat Esensial Nasional.

Kementrian Kesehatan Republik Indonesia, (2014), Farmakope Indonesia edisi V. Kementrian Kesehatan RI. Jakarta.

Saranadasa, H., & Krishnamoorthy, K. (2005). A multivariate test for similarity of two dissolution profiles. Journal of biopharmaceutical statistics, 15(2), 265-278.

Shargel, L.,d an Yu, A.B.C. (2005). Biofarmasetika dan farmakokinetika Tearpan. Cetakan Kedua. Penerjemah: Fasich dan S. Sjamsiah. Surabaya: Airlangga University Press.

Shah, V. P., Tsong, Y., Sathe, P., & Liu, J. P. (1998). In vitro dissolution profile comparison—statistics and analysis of the similarity faktor, f2. Pharmaceutical research, 15(6), 889-896.

Sweeman, S.C. (2009). Martindale: The Extra Pharmacopoeia thirty-sixth edition. London: Pharmaceutical Press.

Toverud, E. L., Hartmann, K., & Håkonsen, H. (2015). A Systematic Review of Physicians’ and Pharmacists’ Perspectives on Generik Drug Use: What are the Global Challenges?. Applied health economics and health policy, 13(1), 35-45.

U.S. Pharmacopeia. The United States Pharmacopeia, USP 30/The National Formulary, NF 25. (2007) Rockville, MD: U.S. Pharmacopeial Convention, Inc., p.2635.
Published
2017-12-27
How to Cite
NASIF, Hansen; ZAINI, Erizal; S, Agnes. Uji Dissolusi Terbanding Tablet Metilprednisolon Generik Bermerek dan Generik Berlogo Dibandingkan Dengan Tablet Metilprednisolon Paten. Jurnal Sains dan Teknologi Farmasi, [S.l.], v. 19, n. Supl1, p. s46-s51, dec. 2017. ISSN 2580-5959. Available at: <http://jstf.ffarmasi.unand.ac.id/index.php/jstf/article/view/97>. Date accessed: 17 jan. 2018.

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