Formulation development and evaluation of gastroretentive floating tablets of ambroxol hydrochloride
The present study is focused on the development of gastroretentive floating drug delivery system of ambroxol hydrochloride, which acts as a mucolytic agent that is reported to be useful in gastric neoplasms which are designed to increase the gastric residence time, thus prolonging the drug release in the stomach. Gastro retentive floating tablets of ambroxol hydrochloride were prepared by direct compression method using altered concentrations of HPMC K4, HPMC K15 and PVP K30 as polymers. Sodium bicarbonate and citric acid was used as gas releasing agent. The prepared tablets of ambroxol hydrochloride were evaluated for hardness, thickness, friability, weight variation, drug content uniformity, buoyancy lag time, total floating time, in-vitro dissolution study, etc. All the compositions were resulted in adequate Pharmacopoeial limits. Compatibility studies was execution during FTIR shown that there was absence of probable chemical interaction between pure drug and excipients. The varying concentration of gas generating agent and polymers was found to affect on in-vitro drug release and floating lag time. In vitro drug release of floating gastro retentive tablet of ambroxol hydrochloride shown that the formulation F6 was found to be the best formulation as it releases 99.87% in a controlled manner for an extended period of time (up to 12 hrs). The release data was fitted to various mathematical models such as Higuchi, Korsmeyer-Peppas, First order and Zero order to evaluate the kinetics and mechanism of the drug release. The optimized formulation (F6) showed no significant change in physical parameters such as, hardness, friability, weight variation and %drug content for accelerated stability condition at 40±2oC temperature and 75±5% relative humidity for a period 3 months. Prepared floating tablets of ambroxol hydrochloride may prove to be a potential candidate for safe and effective controlled drug delivery over an extended period of time for gastro retentive drug delivery system.
Keywords: Ambroxol hydrochloride, Gastro retentive floating tablets, Mucolytic agent, Total floating time.
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