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Abstract

FORMULATION AND EVALUATION OF CHRONOTHERAPEUTIC TIMED RELEASE TABLETS OF TERBUTALINE FOR NOCTURNAL ASTHMA

Priyanka M.* and Grace Rathnam

Abstract

The study was carried out to develop and assess press-coated tablets for chronotherapeutic (pulsatile) delivery of terbutaline sulfate for the therapy of nocturnal asthma. The event of asthma is most elevated in the early morning hours and is alluded to as "morning dip”. A formulation that can deliver the drug in a specific concentration just before the asthmatic attack could effectively control the disease. The dosage form consisted of a tablet inside a tablet which was prepared by direct compression method. The core tablet contained 5 mg terbutaline sulfate for immediate release. The core tablets were press coated with various grades of a swellable polymer HPMC (HPMC K100M, HPMC K4M, and HPMC 15 cps) to achieve a lag time of 6.5 hours. Precompression and post-compression studies for the formulations were carried out. Using Box-Behnken design from Design Expert® 12; Stat-Ease Inc the optimized formulation was obtained. The results of the preformulation studies were satisfactory. No interaction was observed between terbutaline and polymers by Fourier transform infrared spectroscopy. Tablets formulated using the optimized formulas were evaluated for lag time, swelling index, and in-vitro dissolution. The developed formulation successfully released the initial dose after 6.5 hours. Due to optimization by Box-Behnken Design, there was no notable change observed between the predicted and the observed actual responses of the optimized formula. Rather than the morning dose, the evening dose could be more effective for the treatment of nocturnal asthma by chronotherapy with terbutaline sulfate. This dosage form can adequately control nocturnal asthma.

Keywords: Box-Behnken design, chronotherapy, nocturnal asthma, press coated tablet, terbutaline sulfate, pulsatile drug delivery system.


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