The present investigation concerns the development of Sustained release matrix tablets of Zaleplon, which after oral administration are designed to prolong the duration up to 8 hrs and thereby increase patient compliance, reduced frequency of administration and increase therapeutic efficacy.so as to provide the advantages of improving sleep quality, Prevent Middle-of-the-Night Awakening with No Adverse Effects on Next Day Performance. A 32 full factorial design was used in present study for optimization. Nine batches of tablets were fabricated containing Zaleplon, polymers HPMC K4M, Microcrystalline cellulose, Lactose and other excipients. All the batches were formulated by direct compression. After evaluation of physical properties of tablet, In‐vitro dissolution study was performed by using USP Type II Apparatus (Paddle type) at 75rpm. Deionized water, 900ml was used as dissolution medium which maintained at 37±0.5°C. here deionized water is used because zaleplon has pH independent solubility over the pH range 1.0 to 9.0. The results obtained were satisfactory and complies with the Pharmacopoeial specifications. The formulation containing HPMC K4M (15%) and Microcrystalline cellulose (20%) (F6) showed slower release with required loading dose as compare to other formulations. F6 batch was optimized based on satisfactory retarding release of Zaleplon from matrix to 8 hrs and maximum similarity factor (73.89). The mechanism of drug release of optimized batch was found to be non-Fickian diffusion followed zero order kinetics. Drug excipient compatibility study showed no interaction between drug and excipient. Stability study of optimized formulation showed that tablets were stable at accelerated environment condition.
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