The objective of present investigation was to develop sustained release matrix tablet of ambroxol hydrochloride and salbutamol sulphate combination for the treatment of nocturnal asthma. In the present study the effect of various formulation factors such as polymer proportion, polymer viscosity and compression force on the in vitro release of drugs was studied. To analyze the concentration value of ambroxol hydrochloride and salbutamol sulphate simultaneous equations were formed. Infrared spectroscopy study confirms that drugs and other excipients are compatible with each other. The powder mixtures were evaluated for there micromeritic properties showed satisfactory compressibility and flow properties. Formulations were developed by using polymer HPMC (K4M, K15M, and K100M) in varying concentrations by direct compression method. The developed drug delivery system were evaluated for there pharmacotechnical properties which comply with official specifications. Invitro dissolution study were carried out in 0.1 N HCL for first 2 hrs and in phosphate buffer pH 6.8 up to 12 hrs using USP Type II dissolution apparatus revealed that the release rate decreases with increase in polymer concentration, viscosity grade and compression force. In vitro dissolution study also revealed that HPMC K100M at a concentration of 20% of the dosage form weight was found to be significant to control simultaneous releases of both drugs for 12 hrs, exhibit non-Fickian diffusion with heguchi release kinetics. Swelling and erosion study of formulation indicates that swelling followed by erosion could be the mechanism of drugs release. The batch reproducibility study and accelerated stability study was also performed for optimized formulation (FH-15) indicated that formulation was reproducible and stable. It may conclude that developed sustained release matrix tablet of ambroxol hydrochloride and salbutamol sulphate combination could perform therapeutically better than conventional dosage forms, leading to improve efficacy, feasibility and better patient compliance.
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