Abstract

When commercially accessible, licensed, and age-specific dosage forms are not available, pharmacists can create appropriate pharmacological compositions through a process known as "extemporaneous compounding." These preparations carry a lot more risk than using prescription medications. One of the main things to consider while preparing impromptu formulations is stability. The purpose of this work was to analyze all of the existing stability studies in order to investigate the stability of pediatric extemporaneous formulations of standard solid dosage forms that are sold in the market. Approach. The Web of Science, PubMed, Scopus, EMBASE, Cochrane Library, and Google Scholar databases were searched for articles. Based on the inclusion criteria, a total of 28 experimental trials documenting the stability of oral pediatric extemporaneous formulations were selected from all of the searched papers. Oral spontaneous formulations using pure pharmaceuticals and commercially accessible dose forms were taken into consideration. As per the United States and British Pharmacopeia (USP and BP), the majority of spontaneous formulations are deemed chemically stable if they preserve ≥90% of the initial drug quantity, physically stable if there is no discernible alteration in physical attributes, and microbiologically stable if the prepared formulations do not exhibit any microbial growth. Discovering. The majority of the study's impromptu oral formulations for children maintained over 90% of the original substance while also being chemically, physically, and microbiologically stable. There are very few studies that did not involve a microbiological or physical stability test. In conclusion. This comprehensive analysis indicates that there are relatively few published experimental experiments that show microbial growth, chemical instabilities, or physical instabilities on pediatric oral extemporaneous formulations. Extemporaneous preparations are stable at the ICH-recommended storage conditions and duration, according to the majority of investigations. In general, the most promising alternative for child drugs will be oral formulations that are spontaneously prepared.

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