The system for determining the solubility of tablets and other medicinal forms

The system for determining the solubility of tablets and other medicinal forms

Manufacturer: ERWEKA (Germany)

The system consists of the following components:

1. Tester for determining the solubility of tablets with an autosampler

Model: DT 800 LH

Technological description.

The tester is designed in accordance with all the requirements of the current pharmacopoeias ÃÔ XIII (SPh XIII)/USP/EP/JP and the requirements of DIN EN 61010.

The device is designed to determine the solubility degree of capsules, tablets and pellets with and without coating. The tester is equipped with 8 testing stations, fitted out with a mixer rotation speed controller and an automatic sampling station with 8 samplers with fixed height. Sampling is made in accordance with the program entered into the device memory. The device memory is intended for 60 programs where it is possible to store the information on the characteristics of the test products and testing conditions. The device is controlled with a touchpad.

The configuration includes a flow-type thermostat (DH 2000), an external temperature probe Pt100 and an inbuilt device check system which allows to perform tester validation independently.

The mixer rotation speed can be varied in the range of 20 – 220 rpm.

The water bath temperature is 20 – 50 °Ñ ±0.2 °Ñ.

2.  Dissolution Tester for determination of active ingredient release parameters

Model: RRT-10

Technological description.

The devices meets all the requirements of method No. 3 of current pharmacopoeia USP.

The device is equipped with 6 testing stations making reciprocating motions in the media placed into the test vessels (up to 300 ml volume) immersed into the water bath which allows to carry out up to 6 automatic media changes (each vessel row can be filled with different media).

The system is fitted out with a continuous-flow heater DH1500 which guarantees a constant heating of the water bath and the absence of vibrations as well as with an external thermal sensor Pt 100.

The test conditions (the testing stations vibration mode, the test temperature, the media in all the rows, holding time when switching media etc.) can be preset individually for each row.

3. System for preparation of the media for solubility test

Model: MediPrep 820

Technological description.

The compact tabletop device allows to carry out mixing, vacuum degassing, heating and gravimetric dispensing of the prepared media (up to 8 l) into the tester vessels in a single stage (less than 15 minutes) in order to determine tablet solubility with the use of a remote dispensing device.

Basic features of the device for preparation of the media:

• Rapid preparation and filling of up to 8 liters of the media for solubility test in accordance with the USA Pharmacopoeia (USP), European Pharmacopoeia (EP) and Russian Pharmacopoeia;
• The use of up to 6 liters of lathering media with surface-active substances;
• The use of mixing ratios of media concentrates from 1:9 to 1:1 to a precision of ≤ 1%;
• Gravimetric filling of vessels taking into account the media density;
• Full documenting of preparation and dispensing volume including an identification by batch ID according to Good Laboratory Practice/Good Manufacturing Practice (GLP/GMP);
• Easy adjustment and calibration of the temperature, pressure and volume of prepared sample;
• The inbuilt automatic cleaning procedure for the container and pipeline;
• Color touch panel and User Manual via menu and icons;
• Memory for 100 methods of media preparation;
• Dispensing volume and accuracy: 250 - 1000 ml (max. 8 l), max. 1%;
• Heating temperature, accuracy: max. 50 ºÑ ± 0.5 ºÑ

• Degassing pressure, accuracy: ≤ 200 mbar ± 2 mbar

All Equipment