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Enteric Coating of Ibuprofen Crystals using Modified Methacrylate Copolymers

Simone Schmid, Martin A. Wahl, and Peter C. Schmidt

Department of Pharmaceutical Technology, Eberhard-Karls-University Tübingen, Tübingen (Germany)

Ibuprofen, a non-steroidal anti-inflammatory drug, shows a bitter, irritating taste and its use is often accompanied by gastrointestinal problems. To reduce these side effects, an enteric coating of each ibuprofen crystal is required. The objective of this study was to develop an optimized formulation for the coating of ibuprofen crystals with the new dispersion Eudragitâ FS 30 D. In addition, the influence of two different types of equipment on the coating of the microparticles was investigated. A Hüttlin Kugelcoater HKC 05-TJ and a Wurster bottom spray coater Glatt GPCG 5 were used for the experiments. The effect of different amounts of glyceryl monostearate and polysorbate 80 on the properties of Eudragit FS 30 D films was studied. Higher glyceryl monostearate quantities result in an increase in drug liberation, since the adhesion of the film to the surface of the core was reduced. In contrast, polysorbate 80 led to a significant tackiness. The microparticles were characterized by their dissolution profile, particle size, specific surface area and scanning electron micrographs. Using the Hüttlin Kugelcoater granulation obviously takes place instead of coating. In contrast, the Glatt-microparticles revealed only a marginal increase in particle size, resulting in a more uniform crystalline product and a faster drug release.

Key words Enteric coating · Glatt GPCG 5 · Hüttlin Kugelcoater HKC 05-TJ · Ibuprofen · Poly(meth)-acrylate dispersion