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Open AccessArticle

Development and Evaluation of a Reconstitutable Dry Suspension Containing Isoniazid for Flexible Pediatric Dosing

1
Division of Pharmaceutical Sciences, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria 0208, South Africa
2
Council for Scientific and Industrial Research, Pretoria 0001, South Africa
3
DST/NWU Preclinical Drug Development Platform, Faculty of Health Sciences, North-West University, Potchefstroom 2531, South Africa
4
Department of Physiology, Nelson Mandela University, Port Elizabeth 6031, South Africa
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(3), 286; https://doi.org/10.3390/pharmaceutics12030286
Received: 31 December 2019 / Revised: 14 March 2020 / Accepted: 15 March 2020 / Published: 23 March 2020
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. View Full-Text
Keywords: pediatric drug delivery; tuberculosis; reconstitutable dry suspension; isoniazid; polymer-lipid; microparticulate; direct emulsification pediatric drug delivery; tuberculosis; reconstitutable dry suspension; isoniazid; polymer-lipid; microparticulate; direct emulsification
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Adeleke, O.A.; Hayeshi, R.K.; Davids, H. Development and Evaluation of a Reconstitutable Dry Suspension Containing Isoniazid for Flexible Pediatric Dosing. Pharmaceutics 2020, 12, 286.

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