In Vitro Release Evaluation of Gastroretentive Amoxicillin Floating Tablets Employing a Specific Design of the Flow-Through Cell

Abstract

Floating amoxicillin trihydrate (AmoxT) tablets, used for eradication of Helicobacter pylori (H. pylori), were prepared according to a gas-generating technique to extend the drug residence time in the stomach. The drug release rate from the floating tablets in acidic dissolution medium, in which AmoxT is known to be unstable, was studied using two dissolution techniques: openloop system of the flow-through cell (FTC) and the beaker method. Analysis of AmoxT in the dissolution medium was carried out by UV spectrophotometric and HPLC methods. The comparison indicates that the open-loop system of the FTC, which is based on non-cumulative (fresh) dissolution samples, is the preferred dissolution technique, and in this case, the drug could be analyzed by UV spectrophotometric and HPLC methods. However, in the case of a large number of QC samples, UV spectrophotometry is preferred to the HPLC method, which requires relatively longer time for analysis thereby increasing drug degradation. On the other hand, in the case of the beaker method, which is based on cumulative dissolution samples, the drug must be analyzed by HPLC. Generally, the beaker method is not recommended due to the problems associated with the accumulation of AmoxT degradation product in the dissolution medium. This study describes a simple dissolution method capable of discriminating between different AmoxT gastroretentive formulations without any additional experimental or calculational steps.

Comparative in Vitro Dissolution Study on Metformin Market Products Using Different Dissolution Apparatuses

“…Although the Flow through the cell (FTC) became an official USP method since 1995 (USP Apparatus IV) [8], in vitro dissolution studies using this apparatus under different operational conditions and/or features are few in literature [5,[9][10][11][12][13][14][15][16][17]. Our previous studies using the FTC proved that we should optimize the in vitro dissolution conditions for the finished product or during the preparation of different formulations to achieve accurate and reproducible results and to detect the effect of minor formulation changes upon storage [18].…”

Development and validation of RP-HPLC method for determination of amoxicillin residues and application to NICOMAC coating machine

“…2 AMO is official in British Pharmacopeia (BP), 1 European Pharmacopeia (EP) 3 and United States Pharmacopeia (USP) 4 , they include HPLC method for its determination. It is still a limited number of analytical methods that are reported for the determination of AMO including kinetics degradation, [5][6][7] spectrophotometric, [8][9][10][11][12][13] UHPLC UPLC and mass spectrometry, [14][15][16][17][18][19] thin layer chromatography (TLC), [20][21][22] capillary electrophoresis, [23][24][25][26] high performance liquid chromatography (HPLC), [27][28][29][30][31] in vitro dissolution studies, [32][33][34][35][36] amoxicillin residues in animal tissues using SPE-LC, 37 SPE-cation exchange, 38 in eggs using HPLC-FLD, 39 or HPLC-MS 40 and in commercial meat and milk samples 41 using HPLC-FLD. According to the best of our knowledge there is no validated method for the determination of amoxicillin residues and application to cleaning machine in pharmaceutical industries.…”

Formulation and Evaluation of Famotidine Gastroretentive Floating Tablet by Using Biopolymer

“…Zero order release would be predicted by the following equation: At = Ao-Kot At-Drug release at time 't' Ao-Initial drug concentration Ko-Zero-order rate constant (hr -1 ) When the data plotted as cumulative % drug release Vs time and the plot is linear, then the data obeys zero-order equal to Ko [20].…”