DISOLUSI TERBANDING TABLET DEKSAMETASON MERK DAGANG DAN GENERIK YANG BEREDAR DIPASARAN

Bimantoko, Fajar (2014) DISOLUSI TERBANDING TABLET DEKSAMETASON MERK DAGANG DAN GENERIK YANG BEREDAR DIPASARAN. Skripsi thesis, Universitas Setia Budi Surakarta.

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Abstract

Dexamethasone is used for asthma, colitis, acute gout, leukemia and other cancers with sitostatica. Dexamethasone tablet product of generic and brand name, both are different in formulation and method of fabrication. Dexamethasone was included in the Biopharmaceutical Classification System (BCS) class II, so it is necessary to conduct compared dissolution test to ensure product quality by comparing the similarity of physical quality and similarity of dissolution profiles (F2). This study used three types of dexamethasone tablets brand name produk (ODA, ODB, ODC) and two types of generic products (OGD, OGE). Physical quality test was performed including weight uniformity, hardness, friability and disintegration time. Dissolution test was performed according to standard FI IV using dissolution apparatus type 1 (basket), the rotation speed 100 rpm in 500 ml of HCl (1 : 100), at 37 ± 0.5 ° C. Determination of dissolved dexamethasone tablets used UV spectrophotometer at 242 nm wave length. Parameters measured were amount value of dissolved substances (Q45), Dissolution Efficiency (DE60) and similarity factor (F2). The result of OGD dexamethasone tablets physical quality test had disintegration time 0.3 minutes, hardness 6.73 kg and friability 0.33 %. The results of the study for the parameters Q45 and DE60 showed all drug product meets dissolution test requirements. All products have similar drug dissolution profile seen from the similarity factor. Value of similarity factor (F2) was the greatest of all the products contained in the OGD with OGE i.e. 85.925. Keywords: Dexamethasone, dissolution, BCS II, similarity factor (F2)

Item Type:	Thesis (Skripsi)
Uncontrolled Keywords:	Dexamethasone, dissolution, BCS II, similarity factor (F2)
Subjects:	R Medicine > RS Pharmacy and materia medica
Divisions:	Fakultas Farmasi > Prodi S1 Farmasi
Depositing User:	Tifany Nur Arfiana
Date Deposited:	18 Feb 2020 06:41
Last Modified:	18 Feb 2020 06:41
URI:	http://repo.setiabudi.ac.id/id/eprint/2344

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