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Controlled-release tablet formulation of isoniazid.
N K Jain1, K Kulkarni, N Talwar
1Department of Pharmaceutical Sciences, University of Saugor, Sagar, India.
Die Pharmazie
|April 1, 1992
Summary
Guar gum (GG) and Karaya gum (KG) show potential as controlled-release materials for isoniazid tablets. These natural polymers effectively extended drug release, achieving steady-state levels for 13 hours in human studies.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Isoniazid is a critical anti-tuberculosis drug requiring optimized delivery.
- Developing effective controlled-release formulations enhances therapeutic efficacy and patient compliance.
Purpose of the Study:
- To evaluate Guar Gum (GG) and Karaya Gum (KG) as release-retarding agents for isoniazid (1) controlled-release tablets.
- To assess the in vitro drug release profile and in vivo pharmacokinetic performance of these formulations.
Main Methods:
- Tablets of isoniazid were formulated using GG and KG, alone and with hydroxy-propylmethylcellulose (HPMC).
- In vitro drug release studies were conducted to determine release kinetics.
- Urinary excretion studies in normal subjects were performed to evaluate in vivo performance.
Main Results:
- Formulations exhibited a non-Fickian release profile with an initial rapid release of isoniazid.
- In vivo studies demonstrated sustained isoniazid levels in urine for 13 hours.
- A strong correlation (r = 0.9794) was observed between in vitro and in vivo data.
Conclusions:
- Guar gum and Karaya gum are effective release-retarding materials for isoniazid.
- These natural gums hold significant potential for developing controlled-release isoniazid formulations.