Abstract
Ibuprofen is a propionic acid derivative that belongs to the class NSAIDs. Major adverse reactions associated with Ibuprofen are related to GIT and include peptic and mucosal ulcers, dyspepsia, severe gastric pain and bleeding, that results in excessive treatment failure. The goal of this study was to develop enteric coated ibuprofen tablets in order to avoid gastric mucosal irritation, diffusion of drug across mucosal lining and to let active ingredient be absorbed easily in small intestine. The formulation was developed and manufactured through the direct compression process, the simplest, easiest and most economical method of manufacturing. Enteric coating was done using an Opadry white subcoating and an aqueous coating dispersion of Acryl-Eze. Enteric coated formulation was subjected to disintegration and dissolution tests by placing in 0.1 M hydrochloric acid for 2 h and then 1 h in phosphate buffer with a pH of 6.8. About 0.04% of drug was released in the acidic phase and 99.05% in the basic medium. These results reflect that ibuprofen can be successfully enteric coated in order to prevent its release in the stomach and facilitate rapid release of the drug in the duodenum, due to the presence of superdisintegrant. Formulating this enteric coated tablets could increase patient compliance by decreasing adverse drug reactions (ADR S) associated with Ibuprofen therapy.
Highlights
The application of coatings to the surface of pharmaceutical solid-dosage forms, especially tablets, has been practiced for over 150 years (Porter, Bruno, 1990)
Film coating is a technique widely used in the pharmaceutical field to improve and modify technological and release characteristics of capsules, tablets and granules due to the capability of depositing a variety of coating materials onto solid cores (Bonacucina et al, 2006; Fitzgerald, Cole, Taday, 2005, Nastruzzi et al, 2000; Cole et al, 2002; Bobmeir, 1997)
Controlled and localized release of drugs in the intestine can be achieved by enteric coating
Summary
The application of coatings to the surface of pharmaceutical solid-dosage forms, especially tablets, has been practiced for over 150 years (Porter, Bruno, 1990). Enteric polymers have been shown to be safe, and widely accepted for use in drug products (Biju et al, 2004; Nykanen, 2003). Hydroxypropyl methylcellulose (HPMC) was selected as a base polymer to develop novel enteric coating agents for acid protection, in contrast to ethyl cellulose (EC), it is water soluble and might leach out of the film coating, creating water filled pores through which drug diffuses more rapidly than EC (Kokubo et al, 1997; Gunder, Lippold, Lippold, 1995). Aqueous-based coating systems are advantageous over organic solvents because they overcome the drawbacks of the latter, namely pollution, explosion hazards and solvent toxicity, especially for operators. Stability of coated tablets was determined at room and under accelerated conditions
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