Bioadhesive progressive hydration tablets
First Claim
1. A bioadhesive controlled, sustained release progressive hydration pharmaceutical composition for delivering an active ingredient to a mucosal surface of a mammal, comprising:
- an effective amount of an active ingredient, and a sustained release active ingredient delivery system comprising a water insoluble, water-swellable cross-linked polycarboxylic polymer, and a water soluble polymer, wherein the polymers are present in an amount in combination which enable the composition to become progressively hydrated to provide an extended release of the active ingredient over time;
wherein the delivery system includes amounts of the polymers which, in combination, are effective to allow the composition to progressively hydrate when contacting a mucosal surface of a mammal to provide an extended release of the active ingredient to the mammal.
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Accused Products
Abstract
A bioadhesive controlled, extended release progressive hydration composition wherein the active ingredient may be protected from water or the surrounding environment, thereby protecting it from metabolism or from other degradation caused by moisture, enzymes, or pH effects, and making it bioavailable only at a controlled rate. The active ingredient may be protected from moisture during the manufacturing process, as necessary or desired, and more importantly may be protected from moisture and the immediate septic environment until well after the patient has applied the composition, and then only at a slow and controlled rate. It is by this process of progressive hydration that the active ingredient remains protected for many hours after administration. It is also by the process of progressive hydration that controlled and sustained release is achieved because only that part of the active ingredient that is the hydrated (aqueous) fraction of the composition is available for absorption (bioavailable).
153 Citations
29 Claims
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1. A bioadhesive controlled, sustained release progressive hydration pharmaceutical composition for delivering an active ingredient to a mucosal surface of a mammal, comprising:
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an effective amount of an active ingredient, and a sustained release active ingredient delivery system comprising a water insoluble, water-swellable cross-linked polycarboxylic polymer, and a water soluble polymer, wherein the polymers are present in an amount in combination which enable the composition to become progressively hydrated to provide an extended release of the active ingredient over time;
wherein the delivery system includes amounts of the polymers which, in combination, are effective to allow the composition to progressively hydrate when contacting a mucosal surface of a mammal to provide an extended release of the active ingredient to the mammal. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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- 11. A method for sustained release delivery of an active ingredient to the bloodstream of a mammal through a mucosal surface which comprises administering to a mucosal surface of a mammal in need of receiving the active ingredient a composition that includes effective amounts of the active ingredient and a sustained release active ingredient delivery system comprising a water insoluble, water-swellable cross-linked polycarboxylic polymer, and a water soluble polymer, wherein the delivery system includes amounts of the polymers which, in combination, are effective to allow the composition to progressively hydrate when contacting the mucosal surface of a mammal to provide an extended release of the active ingredient to the mammal.
- 21. A method of treating a health condition in a human which comprises administering a tablet to a mucosal surface of the human, wherein the tablet progressively hydrates to release an active ingredient over an extended period of time, the tablet comprising effective amounts of the active ingredient and a sustained release active ingredient delivery system comprising a water insoluble, water-swellable cross-linked polycarboxylic polymer, and a water soluble polymer, wherein the delivery system includes amounts of the polymers which, in combination, are effective to allow the composition to progressively hydrate when contacting a mucosal surface of a mammal to provide an extended release of the active ingredient to the mammal.
Specification