A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations

In the absence of commercially available, licensed, and age-specific dosage forms, extemporaneous compounding is a usual pharmacy practice. However, these preparations have significant risks compared to authorized drugs, with the primary concern being stability.

Belayneh A. and Tessema Z., in their recent work, studied the stability of pediatric extemporaneous formulations of commercially available conventional solid dosage forms by systematically reviewing the current literature.

They searched the databases of the Web of Science, PubMed, Scopus, EMBASE, Cochrane Library, and Google Scholar for the relevant articles and sorted 28 experimental studies reporting the stability of oral pediatric extemporaneous formulations. They considered oral extemporaneous formulations from commercially available dosage forms and pure drugs. 

According to the United States and British Pharmacopeia (USP and BP), most extemporaneous formulations are-

• Chemically stable: if they maintain ≥90% of the original drug amount, 
• Physically stable: if there is no apparent change in physical property, 
• Microbiologically stable: if there is no growth of microorganisms in prepared formulations. 

They found that most extemporaneous pediatric oral formulations were chemically, physically, and microbiologically stable, retaining >90% of the initial content. However, a minority of the studies refrain from considering either a physical or a microbiological stability test.

This systematic review demonstrated that the chemical and physical instabilities and microbial growth in pediatric oral extemporaneous formulations are rare in studies published in the literature. Most of them confirm extemporaneous preparations to be stable at the ICH recommended storage conditions and duration. Thus, extemporaneously prepared oral formulations can be a promising option for child medications.

Belayneh A, Tessema Z. A Systematic Review of the Stability of Extemporaneous Pediatric Oral Formulations. ScientificWorldJournal. 2021 Dec 15;2021:8523091. doi: 10.1155/2021/8523091. PMID: 34955693; PMCID: PMC8695031.