좌약 시험기 (SDT-1000)
(Suppository Tester)
◆ 개요(Description)
▶ 좌약 시험기 (Suppository Tester)
▶ 좌약 미국 및 유럽 약전 규격 제품
• The rate of drug release (dissolution) for hydrophilic suppositories can be measured
using the standard basket, paddle or flow through methods described in
USP Chapter <711> and Ph. Eur. 2.9.3. methods for lipophilic suppositories include:
• a modified basket method
• a paddle method
• a modified flow method
In addition to this, the European Pharmacopeia references two other technical procedures
relating to disintegration and softening time of suppositories:
2.9.2 Disintegration of suppositories and pessaries
2.9.22 Softening time determination of lipophilic suppositories
▶ Suppositories, which advantageously avoid the risk of digestion of the active drug
in the gastrointestinal tract, are classified as either
Hydrophilic: made from a water-soluble base such as polyethylene glycol, which dissolves in rectal or vaginal fluids.
Lipophilic: made from a greasy base such as cocoa butter, which melts at body temperature.
There is no single method of drug release testing suitable for all types of suppository formulations.
▶ Straightforward suppository testing:
Designed in accordance with the specifications laid down in Ph. Eur. 2.9.2, the SDT 1000 is a single unit tester optimised for assessing the disintegration properties of suppositories and pessaries and with the appropriate attachment, for measuring the softening time of lipophilic suppositories (as per Ph. Eur.2.9.22.-2).
The SDT 1000 has a simple design, which uses manual inversion controlled via a water-resistant pulley system. Test parameters including water bath temperature and stirrer speed are easily set using the touch key interfaces.
▶ Softening Time Attachment
A special attachment is used in place of the disintegration test station, in combination with a 4-litre beaker containing three glass rods (C1) for measuring the softening time of lipophilic suppositories, in accordance with Ph. Eur. 2.9.22.-2.
◆ 제품사양(Specifications)
Pharmacopoeial Compliance | Ph. Eur. Test 2.9.2 Ph. Eur 2.9.22.-2 (with suitable attachments) |
User Interface | Touchpad buttons, LED display |
Test Stations | Disintegration: 1 Softening Time: Up to 3 |
Temperature Range | Ambient - 50 °C |
Sample Inversion | Manual |
Stirrer Speed | 80 - 2000 rpm (in 10 rpm intervals) |