Abstract
Tuberculosis (TB) is a major cause of childhood death. Despite the startling statistics, it is neglected globally as evidenced by treatment and clinical care schemes, mostly extrapolated from studies in adults. The objective of this study was to formulate and evaluate a reconstitutable dry suspension (RDS) containing isoniazid, a first-line anti-tubercular agent used in the treatment and prevention of TB infection in both children and adults. The RDS formulation was prepared by direct dispersion emulsification of an aqueous-lipid particulate interphase coupled with lyophilization and dry milling. The RDS appeared as a cream-white free-flowing powder with a semi-crystalline and microparticulate nature. Isoniazid release was characterized with an initial burst up to 5 minutes followed by a cumulative release of 67.88% ± 1.88% (pH 1.2), 60.18% ± 3.33% (pH 6.8), and 49.36% ± 2.83% (pH 7.4) over 2 h. An extended release at pH 7.4 and 100% drug liberation was achieved within 300 min. The generated release profile best fitted the zero order kinetics (R2 = 0.976). RDS was re-dispersible and remained stable in the dried and reconstituted states over 4 months and 11 days respectively, under common storage conditions.
Highlights
Tuberculosis (TB) remains a major global health problem present in every country in the world, regardless of the availability of standard treatment guidelines [1,2]
Latent TB infection is known as a state of persistent immune responses to stimulation by Mycobacterium tuberculosis (Mtb) antigens with no evidence of clinical manifestations associated with active infection or symptoms of illness
The isoniazid-loaded reconstitutable dry suspension (RDS) formulation was developed using a combination of the direct dispersion emulsification technique, lyophilization, and dry milling
Summary
Tuberculosis (TB) remains a major global health problem present in every country in the world, regardless of the availability of standard treatment guidelines [1,2]. It is the leading cause of death from a single infectious agent, ranking above the Human Immunodeficiency Virus (HIV) with about 10 million new active infections and 1.5–2 million fatalities annually [1,3,4,5]. TB is an airborne, highly contagious disease often spread by coughing and sneezing It is caused by strains of bacteria known as Mycobacterium tuberculosis (Mtb), which primarily infects the lungs (pulmonary TB) and, occasionally, other body parts (extra-pulmonary TB) [1,5,6,7]. Latent TB can develop into full-blown, active infection later [1]
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