Suppository Tester  

Introduction to Suppository Testing  

The suppository is a more common and accepted dosage form in Europe than in the USA. This probably explains why pharmacopoeial references to specific test methods relating to suppositories and associated dosage forms are in the main confined to the European Pharmacopoeia.

Hydrophilic suppositories are made from a water soluble base such as polyethylene glycol which dissolves in the rectal or vaginal fluids. The rate of drug release (dissolution) of such suppositories can be measured using the standard paddle, basket or flow through methods described in USP Chapter <711> and Ph. Eur. 2.9.3.

Lipophilic suppositories, on the other hand, are made from a greasy base, such as cocoa butter, which melts at body temperature. Various methods have been described to measure the rate of drug release (dissolution) from lipophilic suppositories including a modified basket method, a paddle method using a sinker and a modified flow through cell with dual chambers described in Ph. Eur. 2.9.42.

In addition, the European Pharmacopoeia 7th Edition makes reference to two other technical procedures relating to the disintegration and softening times of suppositories, namely:

2.9.2 Disintegration of suppositories and pessaries
2.9.22 Softening time determination of lipophilic
suppositories

For comprehensive product details, specifications and part numbers, please request a copy of our brochure “Quality Solutions for the Testing of Pharmaceuticals”.

Suppository Tester  

The Suppository Tester Model SDT 1000 s a single stage unit which has been designed in accordance with the specifications as laid down in the European Pharmacopoeia Test 2.9.2 for the disintegration of suppositories, pessaries and vaginal tablets and with suitable attachments 2.9.22.-2 Apparatus 2 for measuring the softening time of lipophilic suppositories.

The disintegration test station is made up of a 60 mm long acrylic cylinder having an internal diameter of 52 mm into which is inserted the sample holder containing the sample under test.

Consistent heating of the media is achieved by immersing the test station into a 4 litre glass vessel contained within a plexiglass water bath controlled at 36-37 degrees C. Every 10 minutes during operation, the sample holder and hence the sample is inverted through 180 degrees. All of the samples should disintegrate within the stated time.

A special attachment is available for measuring the softening time of lipophilic suppositories.

For comprehensive product details, specifications and part numbers, please request a copy of our brochure “Quality Solutions for the Testing of Pharmaceuticals”.