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Development of coated multiparticulate solid dosage forms for gastric and enteric release of papain-cyclodextrin complex


The use of enzymes in pharmaceutics has boomed due to its broad therapeutical action. Papain is a proteolytic enzyme isolated from the latex of green papaya fruit and leaf, Carica papaya Linné, as a cutaneous absorption enhancer and for debridement of wounds and burns. Despite its therapeutic potential, such biomolecules are not commonly used for oral administration. The purpose of this project is to develop coated multiparticulate formulations, pellets and minitablets, containing papain and papain:²-cyclodextrin complex, for gastric and enteric release, suitable for the treatment of gastrointestinal ulcers. Papain:cyclodextrin complexes will be produced and characterized in order to be mixed with excipient for the formulation development. The formulations will be characterized according to the quality parameters accepted for pellets and minitablets manufacture and coated using polymeric films. Release and biological activity of the enzyme will be also assayed. The expectations of the development of solid, coated multiparticulate pharmaceutical dosage forms for protein-like biomolecules vehiculation, such as papain, correspond to the contribution in terms of knowledge and experience for the vehiculation of other protein biomolecules of pharmaceutical and therapeutical relevance. The obtained results shall lead to the development of scientific articles and/or patents of the formulations, which will be presented to pharmaceutical companies interested in the work. (AU)

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