Abstract
The objective of the current study was to formulate mucoadhesive controlled release matrix tablets of flurbiprofen and to optimize its drug release profile and bioadhesion using response surface methodology. Tablets were prepared via a direct compression technique and evaluated for in vitro dissolution parameters and bioadhesive strength. A central composite design for two factors at five levels each was employed for the study. Carbopol 934 and sodium carboxymethylcellulose were taken as independent variables. Fourier transform infrared (FTIR) spectroscopy studies were performed to observe the stability of the drug during direct compression and to check for a drug-polymer interaction. Various kinetic models were applied to evaluate drug release from the polymers. Contour and response surface plots were also drawn to portray the relationship between the independent and response variables. Mucoadhesive tablets of flurbiprofen exhibited non-Fickian drug release kinetics extending towards zero-order, with some formulations (F3, F8, and F9) reaching super case II transport, as the value of the release rate exponent (n) varied between 0.584 and 1.104. Polynomial mathematical models, generated for various response variables, were found to be statistically significant (P<0.05). The study also helped to find the drug's optimum formulation with excellent bioadhesive strength. Suitable combinations of two polymers provided adequate release profile, while carbopol 934 produced more bioadhesion.
Highlights
Oral controlled release systems continue to be the most popular of all the drug delivery systems available, despite the advancements made in other drug delivery systems (Ponchel, Irache, 1998)
The characteristic peaks of the drug at 1697 cm−1 and 2935 cm−1 were indicative of carbonyl and hydroxyl stretching, respectively. These Fourier transform infrared (FTIR) studies are found to be in line with previous studies, suggesting that there was drug stability during the direct compression technique (Shah et al, 2009)
Summary
Oral controlled release systems continue to be the most popular of all the drug delivery systems available, despite the advancements made in other drug delivery systems (Ponchel, Irache, 1998). Conventional oral dosage forms often produce fluctuations in drug plasma levels that either exceed safe therapeutic levels or quickly fall below the minimum effective levels; this effect is usually entirely dependent upon the particular agent’s biologic half-life, frequency of administration, and its release rate (Theeuwes et al, 1983). Flurbiprofen, when administered as conventional tablets, has been reported to exhibit fluctuations in plasma drug levels, which can result in either the manifestation of side effects or in the reduction of drug levels at the receptor site (Vaithiyalingam et al, 2001). A mucoadhesive controlled release tablet of flurbiprofen, which maintains plasma concentrations effectively over a 24-hour period, and which has the ability to avoid gastric-related adverse effects will heighten its area of application
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