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Question

Posted on: March 6 2013

How do I prepare chloral hydrate 500 mg, f Suppo child 1 g dt two pieces?

Peg 4000 does not give a fixed result. Witepsol also no result. Always too liquid. I read that PEG basis is appropriate. What kind of PEG is recommended? I thought to make suppos of 2 grams (child is three years).

Answer

The suppositories should also be related to the following composition per 50 suppositories:

Suppositories of 2 G 27,500 g Chloralhydrate + 55.1 g Novata B and 35.7 g Novata D

COMMENT (S)

Not a good proposal because Novata D is no longer on the market. Only Novata B is on the market. As for the Macrogols, only Macrogol 400, 4000 and 1500/300 are on the market. In What proportion can these be used for Chloralhydraatsuppos?

reply For a number of problem preparations, for which there was a good solution, we are going backwards due to the lack of suitable resources. This is valid for the suppositories you cited. A first possibility exists in the use of yellow or white wax to increase the lowered melting point back. Camphor, Guaiacol, eucalyptol and analogue compounds in a concentration of 1% give a smeltpoint reduction of 0.3 °C while for chloral hydrate the value = to 0.1 °C. The finished suppository is best a melting point of +/-35 °C. If the melting point reduction BV is 3 °C, we need to use a mass with melting points 38 °C. The percentage of yellow wax can be read from the graph below.

Would you like to make the suppositories with Macrogolen, which is said to give a better resorption, then best can be worked with mixtures of Macrogol 400, 4000 or possibly 6000. Let me give you an example: Chloral hydrate 0.5 g; PEG 400 1g; PEG 4000 1.2 G for 1 suppository of 2g.

The interrelationships 400 to 4000 are naturally dependent on the concentration of chloral hydrate.

Response due to Apoth. Broecks I have tried suppositories (R/Folcodine 8mg-Papaverine 20mg-Eucalyptol 80mg-camphor 80mg-for 1 suppo Child DT 10) to prepare using adeps solidus and white wax (quantity read off the chart above). The melting point is in order. The graph can therefore also be used for ADEPs solidus (Witepsol).

question: Is there anything known about stability and release of Chloral Hydrate Suppo?

Answer: I can only tell you that studies have shown that a PEG base is preferable.

Presuppositories wrapped in plastic shapes in a glass jar and suppositories loose in a glass jar, both retained at 21 °C, were not differences in these properties compared to the time of preparation after 1 year of preservation. After 3 years at 21 °C, the percentage of unresolved remainder had become 25-30% (compared with about 15% at the time of preparation); The amount of acid reacting substances was increased to 500 mg and 1000 mg respectively to 0.05 meq and 0.2 meq lye per suppository. The content has barely decreased. On the basis of these results, the retention period shall be limited to 1 year for prudence.