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Question

Posted on: March 6 2013

Are 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 g
Sodium stearate 29.2 g for 100 to
now it appears that in Belgi ë sodium stearate is no longer available! Is there an alternative?

Answer

  1. 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.

  2. 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.

  3. composition without nastearate
    The FNA now describes the following composition
    R/Witepsol H15 143.4 g
    mgstearate 9.6 g
    glycerin 152.6 g
    for 100 suppositories of 3g
    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.

  4. composition with formation of nastearate in situ
    the DAC gives next composition
    R/stearic acid 9g
    Na2CO3 1 aq 3g
    glycerin 219g
    Water up to 300g
    for 100 suppositories of 3g
    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.

  5. 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.