Profil Disolusi Tablet Amlodipin dan Perbandingan Kadar Dua Produk Generik dengan Produk Inovator

  • Sukmayati Alegantina Pusat Biomedis dan Teknologi Dasar Kesehatan, Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan
  • Ani Isnawati Pusat Biomedis dan Teknologi Dasar Kesehatan, Badan Penelitian dan Pengembangan Kesehatan, Kementerian Kesehatan
Keywords: Amlodipine tablets, Dissolution, Generic Drugs, Drug innovator, Levels of amlodipine

Abstract

Amlodipine is an antihypertensive and antianginal drug belonging to the class of dihydropyridine calcium antagonist (calcium ion antagonist). Amlodipine patent term expired in 2007, thus nowadays some national pharmaceutical manufacturers produce amlodipine as generics and branded generics medicine. In order to determine the quality of generic amlodipine, dissolution profile and contents of two generic amlodipine were studied by comparing them with their innovator product. The dissolution test was carried out using a type 2 (paddle) and the dissolved content was determined by using UV spectrophotometer, whereas amlodipine content tablet was determined by using HPLC (High Performance Liquid Chromatography). The results showed that all of the three tablets met the FDA requirements of dissolution, i.e.within 30 minutes they should be dissolved not less than 85%. All of the three tablets had the same dissolution profile p=0,521 (CI=95%), whereas both the generic and branded generic tablet compared to the innovator product had similar or comparables profile , (f2>50). The content of all three tablets are not significantly different with p=0,08 (CI = 95%). The highest content of amlodipine was found in amlodipine a tablet with an average content of 102,69%.

References

1. National High Blood Pressure Education Program. The seventh report of the join national committee on: Prevention detection, evolution and treatment of high blood pressure. NIH Publication; 2003 Dec.
2. Kementerian Kesehatan RI. Laporan hasil riset kesehatan dasar Indonesia Tahun 2013. Jakarta: Badan Penelitian dan Pengembangan Kesehatan. Kementerian Kesehatan RI; Desember 2013.
3. Laurent L, Bruno, Keith L, Parker, (alih bahasa:Yulinah E, Adnyana IK, Sigit JI, Sasongko LDN, Anggadiredja K), Manual farmakologi dan terapi (Goodman dan Gilman), Cetakan 2011, Penerbit Buku Kedokteran; 2011.
4. Indonesia. Undang-undang Republik Indonesia Nomor 14 Tahun 2001 tentang Paten. Jakarta: Sekretariat Negara Republik Indonesia; 2001.
5. Sepuluh obat ini paling banyak diresepkan [diunduh 23 Maret 2014] dari http: //health.kompas.com/read/2011/04/21/103 9593/10.
6. Lucida H, Erizal, Rahmi SA. Comparative dissolution test between generic and branded name of furosemide tablets. Jurnal Sains dan Teknologi Farmasi. 2006;11(2):58-62.
7. Informasi spesialite obat Indonesia. Penerbit Ikatan Apoteker Indonesia. 2011-2012;46:326
8. Siregar CJP, Wikarsa S. Teknologi farmasi sediaan tablet: dasar-dasar praktis. Jakarta: EGC; 2010.
9. Ansel HC. Pengantar bentuk sediaan farmasi. UI-Press. 1989.4;245-59.
10. Indonesia. Keputusan Menteri Kesehatan No.HK.0301/Menkes/146/I/2010 tentang Harga Obat Generik. Jakarta: Kementerian Kesehatan Republik Indonesia; 2010.
11. Syukri Y, Yuwono T, Hakim L. Preformulasi sediaan furosemid mudah larut, Majalah Farmasi Indonesia. 2002;13(1): 50-4.
12. US Pharmacopoeia. Revisi bulletin official, Dissolution testing of Immediate Release Solid oral dosage form, February1;2011 [diunduh l8 Januari 2015] dari http: //www.usp.org/sites/ default/files/usp_pdf/EN/USPNF/amlodipineBesylateTabletsm3575.pdf.
13. Departemen of Industry and Human Services FDA, Guidance for Industry: Waiver of in vivo bovailability and bioequivalence studies for immediaterelease solid oral dosage form bassed on biopharmaceutics classification system. Center for Drug Evaluation and Research (CDER), August 2000 [Diunduh 5 Januari 2015] dari http://webcache.googleusercontent.com/search?q=cache:MelD728ap mMJ:www.fda.gov/download/Drugs/Gui dances/ucm070246.pdf+&cd=1&hl=id&c t=clnk.
14. Feroz M, Razvi N, Ghayas S, Anjum F, Ghazal L, Siddiqui SA, Assessment of parmaceutical quality control and equivalence of various brands of amlodipine besylate (5 mg) tablets available in the Pakistani market under biowaiver conditions. Int J Pharm Sci. 2014;6(2):909-13. Jurnal Kefarmasian Indonesia. 2015;5(1):11-18 18
15. Olusola AM, Olubukola OO, Emeka OH, Liliane AE. Equivalence of two generic brands of amlodipine besylate under biowaiver conditions, Int J Pharm. 2012; 4(2):265-8.
16. Shohin E, Ramenskaya GV, Vasilenko GF, Malashenko EA. In vitro dissolution of amlodipine tablets marketed in Russia under biowaiver conditions. Dissolution Technologies; 2010 August; 20-2.
Published
2015-02-17
How to Cite
1.
Alegantina S, Isnawati A. Profil Disolusi Tablet Amlodipin dan Perbandingan Kadar Dua Produk Generik dengan Produk Inovator. jki [Internet]. 17Feb.2015 [cited 26May2022];5(1):11-8. Available from: https://ejournal2.litbang.kemkes.go.id/index.php/jki/article/view/3029
Section
Articles