Basis to Aid Crisis: Favipiravir Oral Solution for Hospital Compounding During COVID-19 Drug Shortage

The COVID-19 pandemic outbreak has been overwhelming the healthcare system worldwide. A rapidly growing number of younger pediatric patients in Thailand necessitated the formulation of favipiravir, the most locally accessible antiviral agent against COVID-19, into a child-friendly dosage form as a safer alternative to a dispersion of crushed tablets in simple syrup. While striving to quickly develop a liquid formulation that is feasible for any local hospital production units, an oral solution was chosen due to its simplicity. Despite the large dose and poor aqueous solubility of favipiravir, a combination of pH control and use of poloxamer as a solubilizing agent has enabled us to streamline the manufacturing process of a 200 mg/15 mL oral solution for hospital compounding. To ensure its efficacy and safety, a specification for quality control was also established in accordance with the ICH quality guidelines and USP. The finished product stability was subsequently demonstrated under the conditions of 5 degrees C +/- 3 degrees C, 25 degrees C +/- 2 degrees C/75% RH +/- 5% RH, 30 degrees C +/- 2 degrees C/ 75% RH +/- 5% RH, and 40 degrees C +/- 2 degrees C/75% RH +/- 5% RH. The results indicated that our formulation can be stored at 30 degrees C +/- 2 degrees C/75% RH for 30 days, which will very well serve the need to allow drug distribution and patient use during the crisis, while the shelf-life can be extended to 60 days when stored at 5 degrees C +/- 3 degrees C. Thus, accessibility to an essential medical treatment has been successfully enhanced for pediatric patients in Thailand and neighboring countries during the COVID-19 outbreak. (c) 2022 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.

Automated summary

The formulation of favipiravir as a child-friendly dosage form has improved convenience and safety for pediatric patients in Thailand. With the use of pH control and poloxamer as a solubilizing agent, a 200 mg/15 mL oral solution was successfully manufactured and demonstrated stability at 30 degrees C for 30 days and at 5 degrees C for 60 days.