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Question

Posted on: March 6 2013

After phenobarbital 3 grams, Aq Purif ad 300 cc, FSA sol. Stability problems?

Answer

Because of its poor taste and instability, an aqueous solution of after phenobarbital is not so suitable. Discussion has arisen about administering alcohol and propylene glycol. We do not have reliable data on the complete harmfulness of these substances mainly in children. We must therefore ask ourselves the different formulations of elixirs with phenobarbital, which contain these solvents sometimes in quite high concentration depending on the concentration of phenobarbital. Therefore we are referred to the preparation of a suspension.

Following wording is appropriate for this purpose:

phenobarbital 3 G Citric acid 0.15 g Veegum 3 G After CMC middle viscosity 3 G Raspberry Essence 6 Dr Tween 80 0.3 g Sugar syrup 100 g Conc. NIPA Solution 2.1 G Aqua AD 300 ml (320 g)

Preparation: Tarreer a beaker of 500 ml and disperse with a mixer the Veegum in about 180 ml of freshly boiled water until no more lumps are visible. Add CMC and disperse again. Add the Conc. NIPA solution and the citric acid and mix. Allow to cool. Rub 3.3 g phenobarbital finely and sieve. Apply 3 G in a mortar and rub with the Tween 80. Weigh in a tarred beaker 110 g sugar syrup. Add a small amount of syrup to the phenobarbital and rub to a homogeneous paste. Add the raspberry essence and dilute the mixture with sugar syrup under good blending. Make sure that 100 g of sugar syrup is taken from the tarred beaker. Apply the contents of the mortar as quantitatively as possible (use Panlikker!) under well mix gradually into the beaker with the CMC-Veegum gel in the mortar. Write down the weight and measure the missing amount of water. Rinse the mortar with this water and bring the rinse water into the beaker. Disperse with the mixer. Apply everything in a bottle and label indicating the use and text "Shake before use".

Comment:

  1. the pH should be between 5.5 and 6 (in Process Control)
  2. shelf life is three months
  3. The phenobarbital should be very fine if not, it creates a precipitate of larger crystals. Get out of the powdered form.
  4. Tween 80 is required for humidification