Main author: Ellen K.G. Mhango
Institution or Company: Faculty of Pharmaceutical Science, University of Iceland
Co-Authors, Institution or Company:
Bergþóra S. Snorradóttir, Faculty of Pharmaceutical Science, University of Iceland. Benjamín R. Sveinbjörnsson, Faculty of Physical Sciences, University of Iceland. Svernbjörn Gizurarson, Faculty of Pharmaceutical Science, University of Iceland.
Introduction: Lack of appropriate dosage forms is a challenge in treating numerous diseases in children. Tablets are often either split or crushed to get the required dose for a child, which may result in incorrect measurements or may even give a stability problem. The problem is even worse in Africa, especially in rural tropical areas when children cannot swallow oral medications because of lack of consciousness, despite availability of other pediatric dosage forms such as oral liquids, dispersible and effervescent tablets, multiparticulates, films, orally disintegrating and chewable tablets.
Methods: In the present study, a formulation containing two lipophilic antimalarial drugs was designed and formulated. Design of experiments was used for preliminary experiments to screen the main factors and interaction effects of the formulation variables that included amount of each excipient and process conditions.
Results: The amount of a medium chain and long chain fatty acid as well as solubilization temperature were found to be important factors in maintaining both drugs dissolved in the formulation. Observational preliminary stability studies at room temperature also revealed that both drugs can remain in solubilized state depending on amount and types of fatty acids used in the formulation.
Conclusion: Results of this study revealed the possibility of formulating pediatric dosage forms by overcoming solubility and incompatibility problems associated with very lipophilic active pharmaceutical ingredients.
