Microbiological control of adapted liquid dosage forms in a pediatric hospital from Manaus

Abstract

Background and Objectives: Ideal dosage forms for pediatric use are liquid because this population has difficulty swallowing. However, the pharmaceutical market does not have a large arsenal. To solve this situation, it is necessary to adapt drugs intended for the adult public in the form of oral solutions that allow the use of pediatric patients. Such practice changes the physicochemical and microbiological properties of these drugs. Most studies on pharmaceutical adaptations are directed to the physicochemical stability. Therefore, this study aimed to perform microbiological control of liquid pharmaceutical forms adapted in a pediatric hospital. Methods: Microbiological analysis was performed according to the specifications of the Brazilian Pharmacopoeia for non-sterile products. The total number of mesophilic microorganisms and the presence of pathogenic microorganisms were counted. Results: During the study period, 36 pharmaceutical adaptations were prepared in the hospital and then, after applying exclusion criteria, 16 samples were selected for microbiological analysis. The most common classes were diuretics, antihypertensives and psycholeptics. No preservatives were used in the preparation of the analyzed pharmaceutical adaptations. Half of the adaptations had a total number of mesophilic microorganisms above the allowed limit on the day of manipulation, 43.75% in the middle of the shelf life and 62.5% in the end of the shelf life. Conclusion: Only 03 (18.75%) adaptations were within the acceptable microbial limits established throughout the study. Regarding the presence of pathogens, all were free from the pathogens Escherichia coli, Salmonella sp., Pseudomonas aeruginosa and Staphylococcus aureus during the study period.