Question
Posted on: March 6 2013Are water free glycerin suppositories yet to prepare? In The Netherlands apparently no more.
I received a composition from a Dutch physician. The reason why one cannot prepare the suppositories in the Netherlands is unknown to me. We wonder if there is no certain amount of water in the composition.
R/glycerol 312.2 gnow it appears that in Belgi ë sodium stearate is no longer available! Is there an alternative?
Sodium stearate 29.2 g for 100 to
Answer
- Water or no water in the original composition?
indeed in the original composition of 1987, 16ml of water occurs. This quantity is added after Nastearate was dissolved in glycerin at 115 ° C. - The problem nastearate
In the submitted formula both Nastearate and glycerin have a laxative effect. Now it is no longer available as a registered raw material or as a raw material with a certificate of analysis, we need to look for possible solutions. - composition without nastearate
The FNA now describes the following compositionR/Witepsol H15 143.4 g
Witepsol Melted on hot water bath below 40 ° C after which mgstearate is rubbed into a dish with a double quantity of melted white epsol. Then the remaining molten mass is added and mixed to homogenous. Then the glycerin is added and very well blended. Possibly slightly when heating and mixing to homogenous. This mixture is poured into the suppository form under continuous stirring. The suppositories are hygroscopic and require a customized packaging.
mgstearate 9.6 g
glycerin 152.6 g
for 100 suppositories of 3g - composition with formation of nastearate in situ
the DAC gives next compositionR/stearic acid 9g
stearic acid and Sodium carbonate is mixed with a glass rod with 20g of water in a tarred beaker. This mixture is heated and mixed for 15 minutes on a boiling water bath. Then glycerin is added and reheated on the boiling water bath and mixed for 10 min. The temperature of the mixture must exceed 90 ° C. The mixture should be almost clear but not yellow or brownish colored. Eventually, water is put on weight. Let it cool down to 70 ° C after which it can be poured under stirring. Preferably, they are used in plastic, where the surface is taped off after filling.
Na2CO3 1 aq 3g
glycerin 219g
Water up to 300g
for 100 suppositories of 3g - A third possibility is the use of sodium docusate instead of sodium stearate.
but it is not clear to me whether this product is available in accordance with the legislation on raw materials.