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Mohd Sadakat
Dr. Dilip Agrawal
Dr. Mohit Khandelwal
Keywords:
Olanzapine; mouth-dissolving tablet; orally disintegrating tablet; crospovidone; croscarmellose sodium; sodium starch glycolate; direct compression; dissolution; similarity factor.
Abstract:
Mouth-dissolving tablets offer a practical alternative to conventional tablets for patients who find swallowing difficult. In the present work, olanzapine was selected as the model drug and formulated as a rapidly disintegrating oral tablet. The study focused on the role of commonly used superdisintegrants in achieving rapid tablet breakup and satisfactory drug release.
The objective was to develop and evaluate mouth-dissolving olanzapine tablets prepared with different superdisintegrants, either individually or in combination. Formulations showing the most promising disintegration and dissolution behavior were selected for further stability testing and for comparison with a marketed olanzapine tablet.
The tablets were prepared by direct compression using crospovidone, croscarmellose sodium and sodium starch glycolate. Preformulation studies and powder-flow measurements were carried out before compression. The prepared tablets were then evaluated for their physical characteristics, drug content, wetting time, disintegration and in-vitro dissolution. Dissolution testing was performed using USP Apparatus II in 500 mL of 0.1 N HCl at 37 ± 0.5 °C and 50 rpm, with drug estimation at 259.3 nm. Selected formulations were also stored under accelerated conditions of 40 ± 1 °C/75 ± 5% RH for 45 days.
All formulations showed satisfactory physical characteristics and acceptable drug content. In the A-series, disintegration time ranged from 37 to 220 s, while the B-series disintegrated within 36–67 s. A4 released 100.0% of the drug by 45 min, compared with 99.2% for B1 and 99.5% for B3. The dissolution data for A4, B1 and B3 showed the best fit with the first-order model, with r² values of 0.997, 0.981 and 0.950, respectively. Their similarity factors (f2) against the marketed product were 79.1, 76.7 and 77.7.
The study showed that mouth-dissolving olanzapine tablets could be successfully prepared by direct compression. Among the formulations studied, A4, B1 and B3 provided a useful balance of rapid disintegration and high drug release, with crospovidone-containing formulations showing particularly favorable performance. Their dissolution profiles were similar to that of the marketed product in the present in-vitro comparison. These findings are encouraging, although in-vivo studies and bioavailability assessment would be needed before drawing conclusions about in-vivo performance.
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International Journal of Recent Research and Review
ISSN: 2277-8322
Vol. XIX, Issue 3
September 2026
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PUBLISHED
September 2026
ISSUE
Vol. XIX, Issue 3
SECTION
Articles
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