PERNDINGABAN PROFIL DISOLUSI TABLET ATORVASTATIN GENERIK DAN MEREK DAGANG TERHADAP INOVATOR DALAM MEDIUM DAPAR FOSFAT PH 6,8

Bagus, Bambang (2016) PERNDINGABAN PROFIL DISOLUSI TABLET ATORVASTATIN GENERIK DAN MEREK DAGANG TERHADAP INOVATOR DALAM MEDIUM DAPAR FOSFAT PH 6,8. Other thesis, Universitas Sebelas Maret.

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    Abstract

    DISSOLUTION PROFILE COMPARISON OF GENERIC AND BRANDED ATORVASTATIN TABLETS ON INNOVATOR TABLET IN PHOSPHATE BUFFER pH 6,8 AS MEDIUM Bambang Bagus Suryadi Department of Pharmacy, Faculty of Mathematic and Natural Sciences Sebelas Maret University ABSTRACT Difference in formulation and manufacturing process and method affect difference and variation in dissolution profile especially for drugs with limited solubility. Atorvastatin has low solubility and high permeability that includes in BCS class II. Patent of atorvastatin tablet innovator has expired thus have produced several copy drugs that need equivalence in drug release profile. This research aimed at conducting in vitro equivalency test that has been used to demonstrate similarity between copy and innovator drugs. Dissolution testing of atorvastatin tablets was carried out on generic, branded, and innovator drug using apparatus type II USP model with phosphate buffer pH 6.8 as medium at 37 ± 0,5oC. Dissolution profile was statistically compared to DE45min by using Student t-test with confidence level of 95%, and difference factor (f1) and similarity factor (f2) were then determined from dissolution profiles. The results showed that DE45min between generic and branded to innovator products was statistically significant (p>0.025). Generic tablet showed unsimilarity in dissolution profile that was shown by f1 and f2 values of 19.03 and 35.19, respectively. Branded tablet showed similarity in dissolution profile that was shown by f1 and f2 values of 1.73 and 87.89, respectively. Keywords : Atorvastatin, Dissolution profile, Phosphate buffer pH 6,8, BCS class 2

    Item Type: Thesis (Other)
    Subjects: Q Science > Q Science (General)
    Divisions: Fakultas Matematika dan Ilmu Pengetahuan Alam > D3 - Farmasi
    Depositing User: Gun Gun Gunawan
    Date Deposited: 21 Nov 2016 11:50
    Last Modified: 21 Nov 2016 11:50
    URI: https://eprints.uns.ac.id/id/eprint/29419

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