Storage stability of chocolate-based CDS formulations of midazolam and tramadol as whole tablets, quarter sized tablets and as reconstituted aqueous liquids

Edith K.Y. Tang, Minh N. Nguyen, Leah R. Benington, Okhee Yoo, Lee Yong Lim

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Introduction: Chewable chocolate-based (CDS) tablets provided palatable paediatric formulations of midazolam and tramadol with non-inferior bioavailability in clinical trials. This study aimed to demonstrate the stability of the CDS formulations on prolonged storage. Method: Midazolam HCl (5 mg) and tramadol HCl (11.3 mg) CDS tablets and liquids were stored at refrigerated, ambient and elevated temperatures. Tablets were monitored for drug content and drug release profiles, while liquids were monitored for texture, odour, pH and drug content. Results: Midazolam and tramadol CDS tablets at 18 months storage at ambient temperature retained drug contents at 90–110% of baseline, and released at least 80% of drug load by 20 min in 0.1 M HCl. Subdivided quarter midazolam and tramadol CDS tablets stored for 3 months at 40 °C showed residual drug content of 103% and 92%, respectively. Liquids prepared by reconstituting the CDS tablets in water had drug contents within 95–105% of baseline for at least 70 days when stored at 4–8 °C. Conclusion: Midazolam and tramadol CDS tablets are stable for at least 18 months at ambient temperature and at least 3 months at 40 °C. The CDS liquid formulations are stable for at least 70 days at refrigerated temperatures.

Original languageEnglish
Article number102574
JournalJournal of Drug Delivery Science and Technology
Volume64
DOIs
Publication statusPublished - Aug 2021

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