Paddle and basket type are the types of dissolution, both used for the same purpose, although they have some differences. The major difference between paddle and basket dissolution is that the paddle type apparatus is used for a broad range of dosage forms, whereas the basket type apparatus is particularly used for capsules, suppositories, and those dosage forms that float on dissolution media or disintegrate slowly.
The dissolution test is used by pharmacopeias as an official test for evaluating drug release of various solid dosage forms such as tablets, capsules, or, caplets, etc. It calculates adequate bioavailability and provides essential information in the development of solid dosage forms for any pharmaceutical preparation following official pharmacopeias (USP/ BP/IP/EP). The samples of dissolution may be tablets, capsules, caplets that are immediate-release, delayed-release, controlled-release extended-release, chewable tablets, transdermal patches, and film formulations, etc.
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Overview of dissolution technique:
The most common method or route of drug administration is still oral solid dosage forms. The rate at which the active pharmaceutical ingredient (API) is released into the body after the medication is swallowed being a key characteristic of drug development. To begin functioning pharmacologically on the patient after swallowing a solid dosage, such as tablets or capsules, it must first disintegrate and dissolved in the stomach before being absorbed into the bloodstream, and this could be a challenging task for drug development. Therefore the dissolution testing is significant for delivering important information on drug release in-vitro and predicting their behavior in-vivo.
To create a model of the circumstances within a human stomach, the rotational operating speed of the shaft (up to 100) and the temperature (37oC) of the liquid in the vessel are accurately controlled. Then the time taken to completely dissolve the dosage is recorded for analysis purposes.
Dissolution testing is the most essential analytical method used to check for quality control, uniformity, and batch-to-batch consistency of pharmaceutical products. There are different types of dissolution apparatus as per the USP such as basket, paddle, reciprocating cylinder, flow-through cell, paddle over the disk, cylinder type, and reciprocating disk type apparatus, etc. Of these, the paddle dissolution tester and the basket dissolution tester are the most widely accepted methods for performing such tests for a variety of dosage forms. Both of these techniques involve immersing a revolving shaft in a transparent dissolving vessel to agitate the sample and dissolve it with the liquid (dissolution media) inside the vessel.
Paddle dissolution method:
It is a widely used method for disengagement that consists of specially coated paddles that reduce disturbance due to stirring. In the paddle apparatus, the rotating shaft is attached to a blade attached vertically at the end. This blade works as a stirrer, mixing the dissolution media (buffer) which is presently added to the vessel containing the sample to be analyzed. The water (bath/tank) temperature (usually it is 370C) is maintained by the controller using a pump. The sample is usually placed in the vessel; it is allowed to sink to the bottom of the vessel before the paddle starts rotating.
Basket dissolution method:
In this technique, instead of the paddle, a separate apparatus is placed at the end of the rotating shaft, called the basket which is cylindrical and made with non-reactive mesh. The sample being tested is first placed inside a basket that is firmly attached to the end of the rotating shaft. After that, the motor is turned on and the shaft rotates the basket inside the vessel. The mesh pores allow the dissolving dosage form to pass from the basket to the holding vessel, resulting in a uniform solution.
The equipment and procedure except for the sampling process for the paddle method are similar to the rotating basket method. As per the dissolution profile, once the sample solution is withdrawn needs to be maintaining its volumes by adding dissolution medium. The samples are taken at a depth of 1 cm from the wall of the vessel, halfway between the top of the paddle (or basket) and the top of the medium. Once a sample has been filtered and needs to be analyzed, this is usually determined through UV-Vis spectroscopy or HPLC analysis.
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