INDICES> Sugar-free and alcohol-free paracetamol syrup (2)

["David Woods" <DavidWoods@healthotago.co.nz>]

INDICES> Sugar-free and alcohol-free paracetamol syrup (2)
----------------------------------------------------------

Dear Aica,

The following formulas appear in the Australian Pharmaceutical Formulary
14 Ed (APF 14) p 371
but contain some ethanol (see note below)


Paracetamol Elixir CF

Paracetamol       120 mg
Ethanol 90%         0.7 mL
Propylene Glycol    0.5 mL
Purified Water      0.5 mL
Glycerol        to    5 mL


Paracetamol Elixir Forte CF

Paracetamol        240 mg
Ethanol  90%         1 mL
Propylene glycol   0.5 mL
Purified water     0.5 mL
Glycerol   to        5 mL     


To put the alcohol issue into perspective, using the 120 mg per 5 mL
preparation,  a single dose of 15 mg per kg to a 10 kg child would give
rise to a Blood Ethanol Conc (BEC) of about 11 mg per 100 mL. If the 240
mg per 5 ml preparation is used the resultant BEC is about 8 mg per 100
mL. Both of these values are below the 25 mg per 100 mL threshold not to
be exceeded following a single dose of ethanol containing medicine, as
suggested by the American Academy of Pediatrics.
If chronic dosing is considered perhaps the ethanol content is more of a
concern.
Propylene glycol is usually considered non toxic in these amounts
Paracetamol suspensions are avialable in some countries and these are
usually alcohol and sugar free.
If ethanol is unacceptable I suggest the following, but only if
essential and if commercial products are not available.


Paracetamol               120  mg
Methylcellulose 1%         2.5 mL   (2.5 mL of a 1% dispersion of
methylcellulose)
Raspberry flavour          qs 
Parabens                   0.1 %    (preservative)
Glycerol             to    5   mL

The inclusion of 0.5 mL per 5 mL of propylene glycol would improve the
formulation by dissolving some of the paracetamol.
THe amount of methylcellulose may have to be varied as the different
grades available will produce different degrees of thickness.

I'd also recommend that such preparations are used within two weeks of
compounding.


Hope this is of some help.

Dave Woods
Lecturer and Drug Information Pharmacist
University of Otago
Dunedin
New Zealand
david.woods@stonebow.otago.ac.nz

[thanks, Dave! WB]

--
Send mail for the `INDICES' conference to `indices@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to:  `owner-indices@usa.healthnet.org'.