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Question

Posted on: March 6 2013

A loco for Synalar Biotic.

Doctor prescribes to replace Synalar-biotic the following formula: Triamcinol. Acetonide 10mg, neomycin 35mg, polymyxin B sulfate 100000 E-10ml How is this best prepared?

Answer

The composition of the speciality reads: Fluocinolon. Acetonid. 0.25 mg (solution à 0.025%) — Neomycini Sulfas 3,500 IU — Polymyxini B Sulfas 10,000 IU — Propyleneglycol — Acid. Citric. Monohydr. — Aqua AD iniectabilia Q.S. ad ml un. — Natr. Hydroxyd. Q.S. AD pH 5.5-6.5.

We therefore note that as a solvent a mixture of water and propylene glycol (PG) is used. PG as solvent for the acetonide and water for the other products. The problem lies in finding the good relationship between these two solvents. That is why I propose weighing 5g propylene glycol and dissolving the triamcinolone acetonide. Then add slow water to 9g. Check if a precipitation arises. If no precipitate add the other medicines. These should then dissolve in the mixture water-PG. I hope this succeeds. If the water soluble does not dissolve the amount of PG will have to be reduced to 4 or 3g?

Given the limited operating time (Max 2 month and store in refrigerator) I would not consider optimal pH.

I suspect that small amounts of polymixin and neomycin should be weighed.

COMMENT (S)

Response (due to Apoth. D. Vannijlen) This preparation succeeds as you suggested except solving the neomycin. When adding neomycin to the solution propylene glycol/water, there is a clumping of the neomycin that no longer dissolves (even with magnetic stirrer). Solution: I first dissolved the neomycin and polymyxin in the water and then added to the propylene glycol, then everything remains in solution. Weighing polymycin and Triam. Acet.: First stronger solution made in the RESP. Liquid. pH of this solution is +/-6.