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Question

Posted on: March 6 2013

Which preservative to add to a loco for Mucoclear ampoules in order to insure a 1 month usage mine?

Next preparation is a cheaper alternative to Mucoclear amp.
R/NaCl 6%
water up to 500ml

S/2x/day 4 ml in aerosol

I could find that benzalkonium chloride (present in Ventolin inhalation fluid) is discouraged as it sometimes gives rise to bronchospasm. In addition, here the volume to be submitted is larger than the usual dose of Ventolin!
as a safe alternative is in Br. J. Clin. Pharmac. 1991, 31, 204-206 suggested: 0.05% chlorbutol in comb. With 0.05% Chlorocresol.
problem: Chlorocresol and other non-ionogenic preservatives are no longer available.
In Bisolvon Inhalation fluid is used made of methylparahydroxybenzoate. Is This a good alternative? Concentration? Or can we better simply use Aqua Conservans? Is that safe enough for inhalation?

Answer

You did an extensive research to find a solution. Personally, I could put the hand on:
Clinical Investigations

Drug-Induced Bronchospasm: Analysis of 187 Spontaneously Reported Cases

J ö RG D. Leuppi, Pia Schnyder, Katharina Hartmann, Walter H. Reinhart, Max Kuhn, in Respiration 2001 ; 68:345-351

Drug formulation Agents (excipients)
Bronchoconstriction due to drug formulation agents was reported in 17 cases with 41% (7/17) classified as serious. Although in only 8 cases the reaction was induced by the excipient itself, in 9 cases the drug as well as the excipient could have been the inducing agent. Figure 4 lists the involved agents. Cases involving preservatives (Benzalkonium chloride, parabens, benzyl alcohol, thiomersal), colorants, emulsifiers (Cremophor), antioxidants (sulfites) and pharmaceutical agents in inhaled asthma preparations were reported. In 5 of the 10 nonserious cases, Asthma (3), atopy (1) or a drug allergy (1) was indicated to be a predisposing factor. In 4 of the 7 assessed serious cases asthma (2) or a drug allergy (2) was reported.

so that we can decide that the parabens are not without danger either. Allergy to Parabens is a pretty well known phenomenon. Therefore, it is better not to add a preservative to your solution and therefore to deliver a smaller quantity such as e.g. 100 ml. This is a quantity for a small 14 days. Ideally true an episode of a unit dose packed in ampoules or Flapullen!

In addition, I would sterilize the solution of 100 ml together with the bottle either in the autoclave or according to the method of Deussen. As a last precaution, I would advise the CLI ë NT to store the bottle in the refrigerator and to use it in a clean manner.