Abstract
Child-appropriate dosage forms are critical in promoting adherence and effective pharmacotherapy in pediatric patients, especially those undergoing long-term treatment in low-resource settings. The present study aimed to develop orodispersible films (ODFs) for isoniazid administration to children exposed to tuberculosis. The ODFs were produced from the aqueous solutions of natural and semi-synthetic polymer blends using electrospinning. The spinning solutions and the resulting fibers were physicochemically characterized, and the disintegration time and isoniazid release from the ODFs were assessed in simulated salivary fluid. The ODFs comprised of nanofibers with adequate thermal stability and possible drug amorphization. Film disintegration occurred instantly upon contact with simulated salivary fluid within less than 15 s, and isoniazid release from the ODFs in the same medium followed after the disintegration profiles, achieving rapid and total drug release within less than 60 s. The ease of administration and favorable drug loading and release properties of the ODFs may provide a dosage form able to facilitate proper adherence to treatment within the pediatric patient population.
Highlights
Tuberculosis (TB) is an infectious disease ranked among the top ten causes of death worldwide
Children exposed to Mycobacterium tuberculosis infections are at increased risk of developing TB, especially in settings with high prevalence of the disease, and are a primary target group in immediate need of preventive treatment
Shorter treatment regimens containing rifampicin have been applied with similar efficacy, yet the highly prevalent adverse effects related to rifampicin treatment commonly result in treatment discontinuation [5]
Summary
Tuberculosis (TB) is an infectious disease ranked among the top ten causes of death worldwide. 6% of the annual global TB burden, resulting in the deaths of up to 80,000 HIV-uninfected children every year in many TB endemic countries [1]. Children exposed to Mycobacterium tuberculosis infections are at increased risk of developing TB, especially in settings with high prevalence of the disease, and are a primary target group in immediate need of preventive treatment. Chemoprophylaxis with isoniazid (ISO) has proven highly effective in mitigating the risk of developing active TB [2]. According to the World Health Organization’s (WHO) recommendations, isoniazid preventive therapy (IPT) should involve a daily dose of 5 mg/kg (maximum 300 mg) for young children (
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