Formulation and stability study of hydroxychloroquine sulfate oral suspensions

Hydroxychloroquine is an antimalarial drug indicated in the treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also used for the treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and more recently proposed in COVID-19 therapy. Hydroxychloroquine is only available in tablets which are not easy to administer for pediatric and geriatric patients, and patients unable to swallow such as patients found in intensive care units. The aim of this work was to develop and optimize a ready to use liquid hydroxychloroquine formulation and to carry out the corresponding chemical and microbiological stability studies. The formulation was evaluated for ease of preparation, physical properties, and palatability. Its stability was performed at ambient temperature and under refrigeration. After 6 months of stability testing, the results showed no pH change, no drug loss, no microbial development, and no visual change. The formulation, employing excipients in a range that EMA has recommended, showed chemical and microbiological stability for at least 6 months even in the worst storage conditions.

Read the full article: : Sarah El Mershati , Agathe Thouvenin , Philippe-Henri Secretan , Pascale De Lonlay , Caroline Tuchmann-Durand , Salvatore Cisternino & Joël Schlatter (2021): Formulation and stability study of  ydroxychloroquine sulfate oral suspensions, Pharmaceutical Development and Technology

Conclusion
This HCQ sulfate oral suspension at 25 mg/mL and 50 mg/mL was physically, chemically, and microbiologically stable for 150 days when stored at room or refrigerated temperature in plastic bottles. The suspensions were optimized to ensure a satisfactory palatability for adult and pediatric patients.

Materials and methods
HCQ sulfate, sodium methyl paraben, hydroxypropylcellulose (Klucel®), xanthan gum, strawberry aroma, raspberry aroma, banana aroma, Sodium chloride powder, caramel liquid, Orange aroma, Maltitol syrup