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Claims for Patent: 5,110,605

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Claims for Patent: 5,110,605

Title: Calcium polycarbophil-alginate controlled release composition and method
Abstract:A polymeric complex composition comprising a reaction complex formed by the interaction of a polycarbophil component with alginic acid or a salt thereof, said interaction being performed in the presence of a divalent cation and in the presence of an active agent selected from the group consisting of medicinal agents and cosmetic agents. There is also described a method of controlled release treatment comprising the steps of providing such a polymeric complex and an effective amount of an active agent selected from the group consisting of medicinal agents and cosmetic agents contained within said complex, and contacting an area of skin or mucous membrane to be treated with said composition for a sufficient period of time allow a therapeutically effective amount of said active agent to be released from the complex.
Inventor(s): Acharya; Ramesh N. (Lake Forest, IL)
Assignee: Oramed, Inc. (Mundelein, IL)
Application Number:07/570,340
Patent Claims: 1. A polymeric complex composition comprising a reaction complex formed by the interaction of (1) about 0.1% to about 90% calcium polycarbophil component which is a water-swellable, but water-insoluble, fibrous, cross-linked carboxy-functional polymer, said polymer containing (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 percent cross-linking agent substantially free from polyalkenyl polyether, said percentages being based upon the weights of unpolymerized repeating unit and cross-linking agent, respectively with (2) from about 0.1 to about 99. percent of alginic acid or a salt thereof, said interaction being performed in the presence of an active agent selected from the group consisting of medicinal agents and cosmetic agents, said interaction being at a pH from about 3 to about 10, the calcium polycarbophil being originally present, prior to said interaction, in the form of the calcium salt, having a calcium, and wherein the ratio of said reaction complex to said active agent is about 200,000:1 to about 1:100'.

2. The composition according to claim 1 wherein said polymeric complex composition is in the form of comminuted particles capable of passing through the screen of a sieve having a 100 mesh size, U.S. Standard Sieve Series, and said active agent is present as a saturated solute in a physiologically acceptable aqueous carrier.

3. The composition according to claim 1 wherein said active agent is contained in a medicinally inert matrix in the form of a three-dimensional structure having at least one surface portion, and said polymeric complex composition is disposed on at least said one surface portion.

4. The composition according to claim 1 wherein said active agent constitutes an agent for treating cardiovascular conditions.

5. The composition according to claim 1 wherein said active agent constitutes an agent for treating internal diseases and disorders.

6. The composition according to claim 1 wherein said active agent constitutes an anti-inflammatory agent.

7. The composition according to claim 1 wherein said active agent constitutes an anti-bacterial agent.

8. The composition according to claim 1 wherein at least about 90 percent of said polymer repeating units contain at least one carboxyl functionality.

9. The composition according to claim 1 wherein at least about 95 percent of said polymer repeating units contain at least one carboxyl functionality.

10. The composition according to claim 1 wherein said polymer contains about 0.1 to about 1 percent by weight of polymerized cross-linking agent.

11. The composition according to claim 1 wherein said carboxyl functionality is provided by polymerized acrylic acid.

12. A method of controlled release treatment comprising the steps of:

(a) providing a polymeric complex and an active agent selected from the group consisting of medicinal agents and cosmetic agents contained within said complex, said polymeric complex comprising a reaction complex formed by the reaction of (1) 0.1% to about 90% calcium polycarbophil which is a water-swellable, but water-insoluble, fibrous, cross-linked carboxy-functional polymer, said polymer containing (a) a plurality of repeating units of which at least about 80 percent contain at least one carboxyl functionality, and (b) about 0.05 to about 1.5 percent cross linking agent substantially free from polyalkenyl polyether, said percentages being based upon the weights of the unpolymerized repeating unit and cross-linking agent, respectively, or a salt thereof, with (2) from about 0.1 to about 99.9 percent of alginic acid or a salt thereof, said interaction being performed in the presence of said active agent, said interaction being at a pH from about 3 to about 10, and the calcium polycarbophil being originally present, prior to said interaction, in the form of the calcium salt, having a calcium content of from about 5 to about 25 percent, based on the weight of the polycarbophil, and wherein the ratio of said reaction complex to said active agent is about 200,000:1 to 1:100'; and

(b) contacting an area of skin or mucous membrane to be treated with said composition for a period of time to allow a therapeutically effective amount of said active agent to be released from the complex.

13. The method according to claim 12 wherein said composition comprises an intimate mixture of said reaction complex and said active agent.
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