USP Apparatus A Case Study

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Drug dissolution testing is important so that we can be able to understand the trend followed by the drug in the biological system. USP Apparatuses are used for dissolution testing but the shortcoming of some of these apparatuses is not being able to mimic the conditions in the biological system. USP Apparatus 3 have recently been developed and has shown to have superiority over the other USP Apparatuses 1 and 2 based on the mentioned disadvantage, and others. USP Apparatus 1 is called the Basket and USP Apparatus 2 the Paddle. USP Apparatus 3 is called the Bio-Dis and is a reciprocating cylinder, it is versatile and is essential for assessing the release characteristics of solid oral dosage forms invitro (Bianca, 2015). The advantage is this …show more content…
It is this agitation that will cause disintegration and erosion of the matrix of the dosage form, followed by dissolution of the drug particles (Bianca). The development of this apparatus was made in a way that it will be able to simulate the environment to which the dosage forms are exposed to in the biological system, which is when they pass through the gastrointestinal tract (Bianca). This is achieved by having dissolution media of different pH, different buffer in the different rows in which the vessels are placed (Erika). Also, the different buffer solutions can be used with or without surfactants (Bianca). Surfactants are particularly important in a case where the product used is poorly water soluble (Khamanga & Walker). However, in a case where surfactants are used the movement of the reciprocating cylinders may generate foam and may therefore need antifoaming agents to be added to stop the foam (Bianca). At low agitation speeds, the use of antifoaming agent such as simethicone is excluded (Chiluba). This apparatus has also been manipulated to simulate the fasted and fed state environments of the biological system to assess the behaviour of these drugs in those conditions (Bianca). This is achieved by changing the medium properties. It also allows for volume change of dissolution medium. It is important to maintain sink conditions when selecting the media, sink conditions are defined as a volume of medium greater than at least three times of that required to form a saturated solution of the drug (Cynthia). The apparatus must possess good discriminatory power of the dissolution method which is the method’s ability to detect changes in the drug product

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