Extended release compositions comprising tolterodine
Inventors
Jaiswal, Sunil Beharilal • Shah, Ankur Janak
Assignees
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Publication Number
US-8871275-B2
Publication Date
2014-10-28
Expiration Date
Abstract
The present invention deals with extended release pharmaceutical compositions comprising tolterodine, wherein the composition comprises: a) a drug layer comprising tolterodine tartrate, monosaccharide and/or disaccharide on an inert core; or a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide; and b) a polymer layer comprising extended release polymer(s). The invention also provides a process for the preparation of the above mentioned composition.
Core Innovation
The invention relates to an extended release pharmaceutical composition comprising tolterodine and an extended release polymer(s), where the composition includes a drug layer or a drug core containing tolterodine tartrate and monosaccharide and/or disaccharide on an inert core, and the drug layer or drug core is substantially free of the extended release polymer.
The composition further includes a polymer layer comprising extended release polymer(s). In the disclosed construction, tolterodine tartrate is combined with monosaccharide and/or disaccharide as a drug layer on an inert core, or as a drug core containing tolterodine tartrate and monosaccharide and/or disaccharide, while the drug layer or drug core remains substantially free of the extended release polymer(s).
The invention also provides processes for preparation of the extended release pharmaceutical composition by coating inert cores with a tolterodine tartrate drug layer including monosaccharide and/or disaccharide and then coating the drug layer with an extended release polymer layer to obtain extended release pellets. Alternatively, the processes include preparing a drug core by granulating tolterodine tartrate with monosaccharide and/or disaccharide, and then coating the drug core with extended release polymer(s) to obtain extended release pellets, where the drug core is substantially free of extended release polymer(s).
Claims Coverage
The partial content includes three independent claims. Each claim is directed to a distinct aspect: the composition structure, the pellet-coating process with an inert core, and the pellet preparation process starting from a drug core, with the drug layer or drug core being substantially free of extended release polymer.
Extended release tolterodine composition with substantially polymer-free drug layer/core
An extended release pharmaceutical composition comprising tolterodine and an extended release polymer(s), wherein the composition comprises a drug layer comprising tolterodine tartrate and monosaccharide and/or disaccharide on an inert core wherein the drug layer is substantially free of the extended release polymer; or a drug core comprising tolterodine tartrate and monosaccharide and/or disaccharide wherein the drug core is substantially free of the extended release polymer; and a polymer layer comprising extended release polymer(s).
Coating inert core with tolterodine tartrate sugar drug layer then extended release polymer layer
A process for the preparation of an extended release pharmaceutical composition comprising tolterodine, wherein the process comprises providing an inert core comprising a substantially water soluble material, a water swellable material, or mixtures thereof; coating the inert core with a drug layer comprising tolterodine tartrate, and monosaccharide and/or disaccharide; and coating the drug layer with a polymer layer comprising extended release polymer(s), optionally a plasticizer and optionally an anti-tack agent to obtain extended release pellets, wherein the drug layer is substantially free of the extended release polymer(s).
Preparing drug core then coating with extended release polymer to obtain extended release pellets
A process for the preparation of an extended release pharmaceutical composition comprising tolterodine, wherein the process comprises preparing a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide, and optionally an anti-tack agent; and coating said drug core with a polymer layer comprising extended release polymer(s), and optionally a plasticizer, an anti-tack agent or mixtures thereof, on the drug core to obtain extended release pellets, wherein the drug core is substantially free of the extended release polymer(s).
Across the independent claims, the coverage is centered on separating the tolterodine tartrate plus monosaccharide/disaccharide drug layer or drug core from a distinct polymer layer containing extended release polymer(s). The process claims further ground this separation in coating inert cores or coating granulated drug cores to obtain extended release pellets.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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