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Development of minitablets loading papain free and complexed with cyclodextrins and sodium alginate for delivery in small intestine and colon


The production of medicines containing enzymes has been undergoing a constant expansion due to its broad therapeutic potential. Papain is a proteolytic enzyme isolated from the latex of the green fruit and leaves of adult papaya, Carica papaya Linné. It is used like a debridement of wounds and sores, as well an enhancer skin absorption agent.Despite the therapeutic potential that these biomolecules have, they are little explored for administration orally. In this regard, the goal of this project is to develop coated minitablets, a multiparticulate dosage form, containing free papain and complexed with cyclodextrins and sodium alginate, for both enteric and colonic release for the treatment of ulcerative processes onto these locations and also to evaluate papain as an enhancer permeability agent. Thus, complexes between papain and cyclodextrins or alginate will be produced, characterized and subsequently mixed with inert excipients for the production of formulations. The produced formulations will be evaluated for quality parameters for minitablets and subsequently subjected to the coating with polymer film. Afterwards, the formulations will be evaluated for release profile of papain and maintenance of its biological activity. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
LOSITO, DANILO W.; LOPES, PATRICIA S.; UEOKA, ANDREZA R.; FANTINI, MARCIA C. A.; OSELIERO FILHO, PEDRO LEONIDAS; ANDREO-FILHO, NEWTON; MARTINS, TEREZA S.. Biocomposites based on SBA-15 and papain: Characterization, enzymatic activity and cytotoxicity evaluation. Microporous and Mesoporous Materials, v. 325, . (19/12301-1, 17/26618-1, 17/17844-8, 16/22916-5, 20/13204-7, 19/08582-5)
CORAZZA, FULVIO G.; ERNESTO, V, JULIA; NAMBU, FELIPE A. N.; DE CARVALHO, LUMA R.; LEITE-SILVA, VANIA R.; VARCA, GUSTAVO H. C.; CALIXTO, LEANDRO A.; VIEIRA, DANIEL P.; ANDREO-FILHO, NEWTON; LOPES, PATRICIA S.. Papain-cyclodextrin complexes as an intestinal permeation enhancer: Permeability and in vitro safety evaluation. JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, v. 55, . (15/19212-3, 10/10935-9, 16/22916-5, 15/19213-0)
CORAZZA, FULVIO G.; ERNESTO, JULIA V.; NAMBU, FELIPE A. N.; CALIXTO, LEANDRO A.; VARCA, GUSTAVO H. C.; VIEIRA, DANIEL P.; LEITE-SILVA, VANIA R.; ANDREO-FILHO, NEWTON; LOPES, PATRICIA S.. Enhancing the Furosemide Permeability by Papain Minitablets Through a Triple Co-culture In Vitro Intestinal Cell Model. AAPS PHARMSCITECH, v. 21, n. 7, p. 10-pg., . (10/10935-9, 16/22916-5, 15/19213-0, 15/19212-3)

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