Formulation and evaluation of dispersible isoniazid tablets for paediatric use: an extemporaneous model formulary application in a resource limited setting

Abstract

Background: Tuberculosis (TB) remains a global burden and public health concern. Isoniazid, a principal anti-tubercular drug (ATD) though effectively used in TB preventive chemotherapy is preferentially available in adult formulations. Its use therefore in paediatric population is challenged with issues of high probability of inaccurate dose administrations, low patient compliance and adherence. This burden may be higher in resource limited settings, thus development of simple child friendly formulations is needful.

Objectives: This study aimed to design, develop and evaluate an extemporaneous formulary model of a paediatric oral dispersible isoniazid tablet for use in a resource-limited setting.

Method: Paediatric oral dispersible isoniazid granulation batches with varying concentrations (0.5 - 5.5 % w/w) of sodium carboxyl methylcellulose as superdisintegrant were prepared by wet granulation method and compressed. Granulation batches were subjected to pre and post compression evaluations respectively in accordance with established standard methods. Results were statistically analysed using one-way analysis of variance (ANOVA) with significance set at p < 0.05.

Result: The outcome of the micromeritics variables for the granule batches were indicative of good flow properties. The tablet batches passed all the official tablet evaluation criteria, with no statistical significance between the batches. However, tablet batches that contained lower concentrations of carboxyl methylcellulose failed both the disintegration and dispersion tests. Optimal tablet formulation was obtained with 5.0 % w/w of the superdisintegrant.

Conclusion: An optimized formulation of an oral paediatric dispersible isoniazid tablet that could be applied as an extemporaneous compounding model in a resource limited setting has been developed.

Keywords: Paediatric Tuberculosis, Isoniazid, Dispersible Tablet, Extemporaneous Compounding