Method of treating dysglycemia and glucose excursions
Inventors
Assignees
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Publication Number
US-9061061-B2
Publication Date
2015-06-23
Expiration Date
Abstract
The present application relates to pharmaceutical compositions for reducing glucose excursions in a normal subject or a subject having an insulin-related disorder or dysglycemia. The pharmaceutical composition contains one or more active agent-containing layers, which each contain a dry blended mixture including a therapeutically effective amount of a polar ionizable insulin-sensitizing oral hypoglycemic agent or a pharmaceutically acceptable salt thereof, and an amphipathic compound in monomelic form consisting of an amphipathic ionic compound in monomelic form. Each dry blended mixture contains a sufficient amount of the amphipathic ionic compound such that upon contact with an aqueous fluid, the amphipathic ionic compound forms a reverse micelle comprising the polar ionizable insulin-sensitizing oral hypoglycemic agent. The present invention also relates to a use of a modified release pharmaceutical composition comprising a therapeutically effective amount of an insulin-sensitizing oral hypoglycemic agent for sensitizing pre-prandial (basal) insulin levels and/or reducing postprandial glucose excursions in a normal patient or a patient having an insulin-related disorder.
Core Innovation
The invention relates to a multi-layer, controlled-release pharmaceutical tablet comprising a first layer and a second layer. The first layer contains an effective amount of metformin with an ionic surfactant as an intimately mixed and granulated dose, and cetyl alcohol has been added hot and rapidly cooled during high-shear granulation.
The second layer is formed by coating granules of agglomerated mucoadhesive polymer with an enteric polymer and forming the coated granules into the second layer on only one side of the first layer. The enteric polymer is selected from hydroxypropyl methyl cellulose phthalate (HPMCP), cellulose acetate phthalate (CAP), or methacrylic acid-methyl methacrylate copolymer variants (1:1) and (1:2). The ionic surfactant is selected from sodium or potassium dodecyl sulfate, sodium octadecylsulfate, sodium bis(2-ethylhexyl)sulfosuccinate (AOT), or combinations thereof.
Claims Coverage
The document shows one independent claim. The inventive features concern a two-layer tablet architecture, preparation of a metformin/ionic surfactant first layer, and an enteric-coated mucoadhesive polymer granule second layer located on only one side of the first layer.
Two-layer controlled-release tablet with one-sided enteric mucoadhesive layer
A multi-layer, controlled-release pharmaceutical tablet comprising a first layer and a second layer, wherein the second layer is formed by completely coating granules of agglomerated mucoadhesive polymer with an enteric polymer and forming the granules into the second layer on only one side of the first layer.
Intimately mixed and granulated metformin with ionic surfactant and hot-added, rapidly cooled cetyl alcohol
A first layer containing an effective amount of an intimately mixed and granulated dose of metformin and an ionic surfactant, wherein cetyl alcohol has been added hot and rapidly cooled during high-shear granulation.
The independent claim coverage centers on the defined multi-layer tablet architecture combining a first layer of granulated metformin with an ionic surfactant and a second layer made from enteric-coated mucoadhesive polymer granules placed on only one side of the first layer.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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