In pharmaceutical laboratories, an increasingly important role is being played by release studies. These determine the amount of active substance in a pharmaceutical dosage form dissolved in a defined medium within a defined period of time. Of late, the Mumbai-based Electrolab has introduced a new version of Dissolution Test Apparatus ((TDT - 08L)) which includes a Tablet Dispenser and a Motorized Sampling Manifold which fulfills the requirements laid down in USP, IP, BP, EUR Pharmacopoeia. Integrating this unit with Sampling Pump and Fraction Collector or UV Spectrophotometer automates the task of sampling.
As different pharmacopoeia have suggested precisely standardized conditions for dissolution testing apparatus, the aim is to achieve optimum reproducibility of results. The following are some of the requirements laid down:
n dimension tolerances of the test vessel
n geometry of Paddles and Baskets
n specifications for centering and
the tolerances permitted
n absence of any vibration that could influence the test
n revolution speed and temperature
All components coming in the contact with the dissolution media must be chemically inert.
The TDT - 08L with 8 stirring stations is ergonomically designed to eliminate numerous routine manual operations.
Since all the 8 stirring station is equipped with the stirrer, the user can use one test vessel for the replenish media, one can be used to test a placebo or an empty capsule shell simultaneously with the 6 samples under the same test conditions.
The bayonet type Snap- Fit locking mechanism for paddles, basket and other shafts ensures a quick changeover between them. The height of the stirrer to the vessel is automatically adjusted precisely as per the method selected (1, 2, 5, 6 and intrinsic dissolution test) without additional equipment and device.
The test vessels are provided on the periphery for ease of the sampling. The critical centering of vessels is precisely aligned in the center with respect to the paddle by self centering ring and can be interchanged without disturbing the centering thus eliminating routine validation.
Adjustable legs are provided at the base of the instrument for the leveling of the instrument.
The user is guided through a series of prompts on 20 X 4 characters LCD Display. The online menus and prompts make the operation of the instrument very easy and user friendly.
The water bath is attached to an isolated water-circulating pump with a temperature controller to ensure a uniform set temperature in the bath. The pump is isolated from the water bath to eliminate vibration. The water bath is moulded to prevent leakage and shaped for easy cleaning to comply with GLP. It is provided with quick release coupling for ease of operation.
The advance microcontroller along with PT100 sensor and water circulating pump controls the temperature in the water bath in range of 30.0°C to 40.0°C and can be controlled within ± 0.1°C. Individual temperature probes to each vessel for validating temperature during sampling and generating a print out during the test can be provided. A standard mobile external probe is provided to monitor and validate the temperature in the individual test vessel or in the bath.
The microcontroller based stepper motor drive ensures a precise speed control in range of 25 to 200 RPM with accuracy better than ± 0.5 RPM. The built in tachometer monitors, validates and generates RPM data, which can be printed during test.
Twenty individual protocols can be programmed, stored, recalled for each test. Sixteen programmable sampling intervals can be set.
The TDT - 08L supports a simple and effective automatic online and offline sampling using a multi - channel peristaltic pump and a manifold.
The latest version is provided with dispenser plate, which is integrated with self-managing vessel lids for low evaporation and condensation recovery of media and tablet dispensing for simultaneous dispensing of tablet at a push of button.