E-DRUG: rectal formulation of chloralhydrate (cont)
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In the dutch pharmacists formulary (FNA) one can find formulas for
CHLORALHYDRATE supositories using PEG as basis (higher Bioavailability,
more consistent, reliable release of active ingredient) in plastic supp
moulds (incompatible with metal) and a solution in sesamoil (300mg)as a
rectiole.
Hope it will be helpful, we made this some time back , but there was no
great demand for it, probably because there are diazepam rectioles provided
in the essential drug kits. Eventually we discarded the Chloralhydrate raw
material.
greetings
Pascal Verhoeven/JMS
SUPP 500mg SUPP 1000mg
chloralhydrate 500mg chloralhydrate 1 g
polyethyleenglycol 1540 2 g PEG 1540 2.08 G
polyethyleenglycol 6000 170 mg peg 6000 520 mg
Calculate the quantity of ingredients for your particular batch size (plus
an excess) . Verify the quality of the raw material, Grind the
chloralhydrate to powder
warm the PEG mixture on the waterbath and mix.
Dissolve the powder in this mixture using a closed container (evaporation)
, pour the mass at 35-40 C in plastic moulds of 2,3 ml size (500mg) or 2,8
ml (1000mg)
Place the strips in a refrigeration for about one hour
store the supp is a closed container (hygroscopic)
verify the formula especially in relation to the real volume of the plastic
moulds used, by analysing samples before release of product
shelflife at least 6 months
RECTIOLE
chloralhydrate 330mg
sesamoil ad 3ml
verify quality of the chloralhydrate raw material
grind the chloralhydrate in a stone mortar to powder, dissolve the powder
in
a closed contianer in the oil (heat genlty).
Cool down to roomtemp and fill 3ml (nominal) rectioles
keep out of light, shelflife at least 6 months