Comparison Of Tablet Glimepiride Dissolution Profile Stocks Of Raw Materials For Modified Polymorph
Abstract
GMP is an oral anti diabetes medicine which included the third generation of sulfonilurea . GMP classified as class II Bio-pharmaceutical Classification System
which has low solubility and high permeability. Based on these, there should be effort to increase the solubility and dissolution rate. Poly-morph modification is
one of methods to modify physicochemical properties, especially solubility and
dissolution, by changing the shape or crystal system of drug molecules from stable form into metastable because of the effect of temperature and pressure. This research compares the profile of the tablet dosage GMP raw materials (RM with GMP modified poly-morph (MP) in order to see a real difference, especially on the dissolution profile. The formulation of the tablet by the method of direct felts made in the two formulas: GMP formula raw materials (RM) and formula tablet GMP modification poly-morphs (MP). Ingredients GMP modification poly-morphs using the results of the previous research (Alfajri, 2015). The test is conducted an evaluation of the mass of the felts (the flow properties, density and moisture content) and evaluation of tablet (organoleptik, uniformity of weight, uniformity size, friksibility and friability, tablet hardness,
disintegration time and dissolution test). The results of the research on the formulation and evaluation of the tablet GMP RM and GMP MP show that modification the poly-morphs on GMP is the best method to improve GMP's solubility and dissolution. Poly-morphs modification method increases dissolution percentage in
the 60th minutes of the GMP from 56,36% to 98,90%.
Keywords
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Agoes, Goeswin. 2012. Sediaan Farmasi Padat, Bandung : ITB
Ansel, Howard C. (1989). Pengantar Bentuk Sediaan Farmasi , Edisi IV , Universitas
Indonesia Press, Jakarta, Hal 118-122,153 .
Ansel, Howard C,. (1989). Pengantar Bentuk Sediaan Farmasi, Edisi IV. Terjemahan:
F. Ibrahim. Universitas Indonesia Press : Jakarta.
Bonfilio, R., Pires, A. S., Ferreira, L., Almeida, E. A. andDoriguetto, C. A. (2012).A
discriminating dissolution method for glimepiride polymorphs.Journal of
Pharmaceutical Sciences, 101(2), 794-804.
Bonfilio, R., Pires S. A., Ferreira L. M., de Almeida A. E., Doriguetto A.C., de Araújo
M. B., Salgado H. R. (2011). A Discriminating Dissolution Method for
Glimepiride Polymorphs, US National Library of Medicine National Institute of
Health. J. Pharm Sci, 101 (2): 794-804.
Darusman, Fitrianti. (2014). Peningkatan Kelarutan dan Disolusi Glimepirid dengan
Metode Kokristal [tesis], Sekolah Farmasi, Institut Teknologi Bandung,
Bandung.
Departemen Kesehatan Republik Indonesia. (1979). Farmakope indonesia (edisi III).
Jakarta: Dirjen POM Departemen Kesehatan Republik Indonesia.
Departemen Kesehatan RI. (1995). Farmakope Indonesia, Edisi IV, Direktorat Jenderal
Pengawasan Obat Dan Makanan, Jakarta.
Draeger, KE; Wernicke-Panten, K .; Lomp, HJ; Schüler, E .; Roßkamp, R .; Horm.
Metab. Res. 1996, 28, 419.
Eropa Farmakope, 6 th ed, Dewan Eropa:. Strasbourg, Prancis, 2008.
Goeswin, Agoes. (2008). Pengembangan Sediaan Farmasi, Edisi Revisi dan Perluasan,
Penerbit ITB, Bandung.
Parrot, EL., 1971, Pharmaceutical Technology Fundamental Pharmaceutics, 3rd Ed,
Burgers Publishing Company, Minneapolis, USA, 73-84; 158-171
Inukai, K., Watanabe M, Nakashima Y,Takana N,Isoyama A ,Sawa T, Kurihara S,
Awata T, katayama S. (2005) . Glimepride Enhances Intrinsic Peroxisome
Proliferator-Activated Receptor-Gama Activity in 3T3-L1 Adipocytes,
Biochem Biophys Res Commun: 11;328(2):484-90.
Lachman, L., H. A. Lieberman dan J. L. Kanig,.(1989). Teori dan Praktek Farmasi
Industri, Edisi Ketiga., UI Press, Jakarta
Lachman, L., H. A. Lieberman dan J. L. Kanig,.(1994). Teori dan Praktek Farmasi
Industri, Edisi Ketiga (Siti Nuryatmi,Penerjemah)., UI Press, Jakarta
Langtry HD, Balfour JA (1998) Glimepiride: A review of its use in the management of
type 2 diabetics. Drugs 55:563–84
Lieberman, H. A., L. Lachman., J. B.Schwartz. (1989). Pharmaceutical Dosage Form :
Tablets Volume 1.2nd edition. The United States of American: Marcel Dekker,
Inc
Martin , A.,J Swarbrick, & A Cammarata . (1990). Farmasi Fisika dan Ilmu
Farmasetika, Edisi V, terjemahan Joshita Djajadisastra dan Amalia H .
Hadinata ,Penerbit Buku Kedokteran EGC ,Jakarta,Hal. 55-57, 425-427,438
Puspitasari .Efi .(2013) . Laporan praktek kerja profesi apoteker ,fakultas farmasi
program profesi apoteker ,universitas Indonesia . Jakarta.
Ramadhan, M Arif. (2013). Pengaruh Penambahan Aerosil sebagai Glidan terhadap
Karakteristik Tablet yang Mengandung Ekstrak Jintan Hitam dan Lada Hitam
[Skripsi], Jurusan Farmasi Universitas Islam Bandung : Bandung.
Rowe, R.C., Sheskey, P.J., and Quinn, M.E., 2009, Handbook of Pharmaceutical
Excipients, 6th edition, 580-584, Pharmaceutical Press and American
Pharmacists Association 2009, Washington D.C.
Roßkamp, R .; Wernicke-Panten, K .; Draeger, E .; Diabetes Res. Clin. Pract. 1.996, 31,
S33.
Syamsuni. (2006). Ilmu Resep, Penerbit Buku Kedokteran EGC, Jakarta.
Soegondo S. Diagnosis dan Klasifikasi Diabetes Mellitus Terkini. Dalam Soegondo
S,Soewondo P dan Subekti I (eds). Penatalaksanaan
Diabetes Mellitus Terpadu, Pusat Diabetes dan Lipid RSUP Nasional Cipto
Mangunkusumo-FKUI, Jakarta, 2004.
Sweetman,Sean C.(2009).Martindale the Complete Drug Reference 36th
Ed,Pharmaceutical Press, USA,Hal.532.
United States Pharmacopeia. (2007). The United States Pharmacopeia 30th Ed , US
Pharmacopeia Convention Inc., Rockville, Hal. 2226-2227
Voigt, Rudolf. (1995). Buku Pelajaran Teknologi Farmasi, Yogyakarta, UGM Press
DOI: http://dx.doi.org/10.29313/.v0i0.2919
