Background and importance Multiple food allergy (MFA), in its severe stage, is a pathology with nutritional and pharmacotherapeutic restrictions. Drug intolerance to available medicines and lack of alternatives can lead to magistral formulations.
Aim and objectives To compound oral liquid formulations of iron, zinc and sirolimus by eliminating all preservatives, antioxidants, colourings and flavourings, and evaluate their use in a paediatric patient with MFA.
Material and methods We made a literature review including physicochemical characteristics of the active principles studied and the compounding magistral formulations described. We also compared the composition between these commercialised drugs and simple syrups.
We accomplished all of the controls described in the pharmacopeia for oral liquid forms on days 1 and 30.
Efficacy was evaluated by clinical monitoring from the patient’s birth in 2017.
Results According to our bibliographic review, three active principles were formulated with an adjuvant free vehicle: 64% preservative free simple syrup (PFSS).
The final composition was:
Sirolimus 0.5 mg/mL oral suspension: sirolimus in 1% preservative free carboxymethylcellulose and PFSS. It was compounded using as a pattern the formulation of a tacrolimus suspension, based on molecular similarities.
Zinc 5 mg/mL oral solution: zinc acetate dihydrate in sterile water 20% and diluted PFSS, based on existing formulations. We used the best tolerated salt.
Iron 30 mg/mL oral solution: ferrous sulfate heptahydrate in sterile water 20% and diluted PFSS. We chose the salt with the highest absorption and solubility.
Quality controls: the solutions showed clarity and absence of precipitates and the suspension, re- dispersibility and homogeneity after stirring. The organoleptic characteristics were not optimal for the taste. The results for microbiological controls were negative.
Due to the physicochemical and microbiological characteristics, a period of validity of 30 days in refrigerated amber glass was considered.
Zinc and iron deficiency were corrected and blood levels of sirolimus were within the adequate range. Currently the patient continues with treatment and an exhaustive follow-up is being carried out.
Conclusion and relevance Our oral liquid formulation was appropriate for the pathology of our patient and contributed to his growth and health. The comprehensive pharmaceutical care and an individualised compounding for the MFA was essential.
References and/or acknowledgements No conflict of interest.
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