Method to stabilize a dietary supplement to facilitate joint health in humans
Inventors
Poxon, Scott William • Walters, Denise Lowe
Assignees
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Publication Number
US-9592202-B2
Publication Date
2017-03-14
Expiration Date
Abstract
The present invention provides for compositions comprising glucosamine wherein the glucosamine has improved and/or enhanced stability. Additionally, the present invention provides for methods of stabilizing compositions for use in preparing an oral dosage form comprising glucosamine.
Core Innovation
The invention relates to manufacturing a composition comprising therapeutically effective amounts of glucosamine and therapeutically effective amounts of calcium by separately granulating glucosamine and calcium, and then mixing the separately granulated components. The glucosamine is granulated separately apart from the calcium, and the calcium is granulated separately apart from the glucosamine, in order to obtain a composition with improved and/or enhanced shelf stability.
The glucosamine granulation is formed using less than 3% w/w granulation fluid and, in a wet-granulation embodiment, at a pH no greater than 7. A separate calcium granulation is prepared that includes calcium and, in an embodiment, at least one vitamin, mineral or active ingredient, and then the first and second granulations are mixed.
In example formulations described in the provided content, moisture-sensitive degradation issues are addressed by essentially dry glucosamine granulation using a granulation fluid amount below 3% w/w and by controlling the glucosamine slurry pH to ≤ 7, so that glucosamine potency is retained and degradant formation is reduced. Comparative stability observations are described showing substantially improved glucosamine retention after storage at 40°C/75% RH when glucosamine and calcium are separately granulated and mixed, relative to conditions in which glucosamine and calcium carbonate are granulated together.
Claims Coverage
The claim set includes three independent manufacturing methods for glucosamine/calcium compositions with separate granulation to improve and/or enhanced shelf stability. Across the independent claims, there are three inventive features: separate granulation of glucosamine and calcium with defined disintegrant and binder components, specific calcium source selection, and constraints on glucosamine granulation using granulation fluid amount and pH, including an embodiment with inclusion of at least one vitamin, mineral or active ingredient in the calcium granulation.
Separately granulating glucosamine and calcium then mixing for improved shelf stability
A method for manufacturing a composition comprising therapeutically effective amounts of glucosamine and therapeutically effective amounts of calcium wherein the glucosamine is granulated separately apart from the calcium and the calcium is granulated separately apart from the glucosamine by providing a first granulation composition comprising glucosamine, a first disintegrant and a first binder, providing a second granulation composition comprising calcium, a second disintegrant and a second binder, and mixing the first granulation and the second granulation, wherein the composition has improved and/or enhanced shelf stability.
Glucosamine granulation formed with less than 3% w/w granulation fluid
The separate-granulation method wherein the first granulation is formed in less than 3% w/w granulation fluid, with calcium selected from calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium gluconate, calcium lactate, calcium citrate, and combinations thereof, and the therapeutically effective amounts are administered in a single dose or multiple doses.
Wet granulating at pH no greater than 7 with calcium granulation including vitamin, mineral or active ingredient
A method wherein wet granulating a first granulation composition comprising glucosamine, a first disintegrant and a first binder using less than 3% by weight of granulation fluid at a pH no greater than 7; wet granulating a second granulation composition comprising calcium, a second disintegrant, a second binder and at least one vitamin, mineral or active ingredient; and mixing the first granulation and the second granulation, wherein the composition has improved and/or enhanced shelf stability, with the calcium selected from calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, calcium gluconate, calcium lactate, calcium citrate, and combinations thereof, and wherein the therapeutically effective amounts are administered in a single dose or multiple doses.
All independent claims center on manufacturing a glucosamine-calcium composition by separately granulating glucosamine and calcium and mixing the granulations to achieve improved and/or enhanced shelf stability. The independent claim set further narrows the glucosamine granulation by specifying granulation fluid amount constraints and, in one independent claim, a pH no greater than 7, while specifying a defined selection of calcium sources and, in one independent claim, inclusion of at least one vitamin, mineral or active ingredient in the calcium granulation.
Stated Advantages
Improved and/or enhanced shelf stability.
Documented Applications
Administration of the manufactured composition comprising therapeutically effective amounts of glucosamine and therapeutically effective amounts of calcium in a single dose or multiple doses.
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