[e-drug] Paediatric formulations for malaria drugs (5)

["Magnus Ajong" <magnusajong@yahoo.com>]

E-DRUG: Paediatric formulations for malaria drugs (5)
---------------------------------------------------------------

Dear E-druggers,

While appreciating the improved recommendations outlined in the recent WHO Expert Committee on the list of Essential Medicines for children, I noticed with dismay that for oral liquid dosage forms (syrups and powders for reconstitution), members did not address the important issue of the presence of a safe and efficacious preservative in such a preparation. Preservation of the reconstituted dry powder from contamination by microbes should be considered as important as the dosaging of the drug itself, since available clean and potable drinking water is a major problem in resource-poor settings. Most of the artemisinin-derived dry powders on the market suggest a treatment period of 5-7 days, a sufficient time for bacterial and fungal growth, which can cause co-infection especially in a vulnerable age group like young children. In a study published recently in Malarial Journal on `Assessment of content and efficacy of preservatives in artemisinin-derived antimalarial dry suspensions (www.malariajournal.com/content/pdf/1475-2875-6-12.pdf), we found that many drug companies did not mention the type of preservative(s) used on their product label, and for those that did have this agent, there was incomplete dissolution after adding water. As expected, after challenging the suspensions with a number of micro-organisms the products failed the preservative efficacy test requirments of the Ph. Eur.

I suggest to health workers prescribing any paediatric oral formulations requiring addition of an aqueous medium to advice patients to:
1) use properly boiled and cooled drinking water for reconstitution
2) do a visual check on the powder: if powder particles stick together or cake, there will be a problem with under- or overdosaging
3) after adding water and mixing, check for sedimentation over the days as undissolved excipients (including poorly soluble actives) may settle if a suitable suspending agent was not used in the formulation
   
Magnus A. Atemnkeng PhD
Montreal, Canada
E-mail: magnusajong@yahoo.com