2020 Volume 12 Issue 2 Pages 84-94
Summary: A previous evaluation of the pharmaceutical stability of tablets of acetaminophen (AAP)-containing over-the-counter (OTC) drugs formulated with a combination of the excipients erythritol (ET) and crospovidone (CP) revealed that high-temperature and high-humidity storage conditions caused a delayed release of AAP. Reasons for the delay included decreases in micropore volume within tablets due to the deliquescence of ET under high-temperature and high-humidity storage conditions, and the subsequent formation of aggregates after the tablets were returned to room temperature. Erythritol has a pleasant taste, cooling feel, and is an inexpensive and useful flavoring agent. The optimal disintegrant to use with ET as a flavoring agent was studied. The disintegrants tested were CP, low-substituted hydroxypropylcellulose (L-HPC), and sodium starch glycolate (SSG). Results showed that the formulation with the combination of ET and L-HPC disintegrated within 30 min, indicating pharmaceutical stability. Delayed release occurred in Meloxicam, other active pharmaceutical ingredient (API) formulations containing ET and CP. This result suggested that other API formulations including ET and CP also delayed release. It has been confirmed that the use of L-HPC as a disintegrant in acetaminophen preparations could maintain the quality even under high-temperature and highhumidity storage conditions, but other APIs need to be further studied in detail in the future.
