Coated tablet formulation and method

A - Human Necessities – 61 – K

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Details

A61K 9/24 (2006.01) A61K 31/403 (2006.01)

Patent

CA 2568391

A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin, formula (I), or its HCl salt, which is subject to intra-molecular cyclization, which formulation includes a tablet core containing one or more fillers, and other conventional excipients, which tablet core includes a coating thereon which may include two or more layers, at least one layer of which is an inner seal coat layer which is formed of one or more coating polymers, a second layer of which is formed of medicament which is the DPP4-inhibitor and one or more coating polymers, and an optional, but preferable third outer protective layer which is formed of one or more coating polymers. A method for forming the coated tablet is also provided.

Il est prévu une formulation de comprimé revêtu comprenant un médicament comme un inhibiteur DPP4, une saxaglipitine, de formule (I), ou bien son sel HCl, objet d~une cyclisation intramoléculaire, laquelle formulation comporte un noyau de comprimé contenant un ou plusieurs produits de remplissage et d~autres excipients conventionnels, lequel noyau de comprimé comporte un revêtement sur celui-ci, pouvant comprendre deux ou plusieurs couches, dont au moins une couche est une couche de revêtement et de scellement interne, constituée d~un ou de plusieurs polymères de revêtement, dont une seconde couche est constituée d~un médicament de type inhibiteur DPP4 et d~un ou de plusieurs polymères de revêtement, et une troisième couche de protection externe en option, mais préférablement, constituée d~un ou de plusieurs polymères de revêtement. Il est également prévu un procédé de formation du comprimé revêtu.

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