Bioadhesive pharmaceutical carrier

• US 5,314,915 A
• Filed: 12/16/1992
• Issued: 05/24/1994
• Est. Priority Date: 09/25/1991
• Status: Expired due to Term

• Current Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Rencher, William F.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US07/991,696
• Time in Patent Office: 524 Days
• Field of Search: 514/535, 514/536, 514/779, 514/781, 514/902, 514/944, 514/966, 514/967, 514/969, 424/426, 424/433, 424/434, 424/435, 424/436, 424/488, 106/35, 433/215, 433/217.1, 433/226, 433/228.1, 523/115, 523/116, 523/118, 523/120
• US Class Current: 514/535
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/0063 Periodont
• CPC Class Codes: Y10S 424/14 Topical contraceptives and spermacides
• CPC Class Codes: Y10S 424/15 Suppositories

Abstract

Bioadhesive pharmaceutical carrier consisting essentially of a polymer blend of sodium carboxymethyl cellulose and xanthan gum or sodium alginate. The invention also provides for a method of control releasing a pharmaceutical active comprising incorporating an active into the bioadhesive pharmaceutical carrier. The invention is particularly adaptable for oral use and teething gels.

Claims

1. A bioadhesive pharmaceutical gel, consisting essentially of:

a therapeutically effective amount of at least one anesthetic other than benzocaine;

about 0.25 to about 25 percent by weight sodium carboxymethyl cellulose;

about 0.25 to about 25 percent by weight of xanthan gum or sodium alginate; and

diluent selected from the group consisting of glycerin, propylene glycol, dioxolanes, glycerol, glycofurol, dimethylacetamide, ethyl lactate, alcohols, glycols, sorbitols, USP oils, NF oils, lecithin, lanolin, ethyl oleate, isopropyl myristate, benzyl benzoate, petrolatum, cocoa butter and mixtures thereof.

2. The bioadhesive of claim 1 wherein the anesthetic is selected from the group consisting of pramoxine, dibucaine, diclonine, lidocaine, mepiracaine, prilocaine, tetracaine, procaine, pharmaceutically acceptable salts thereof and combinations thereof.

3. The bioadhesive of claim 2, further comprising pharmaceutically acceptable excipients selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants;

buffering agents, colorings, flavors, perfumes, sweeteners, and mixtures thereof.

4. The bioadhesive of claim 3 wherein the diluent is selected from the group consisting of glycerin, propylene glycol, dioxolanes, glycerol, glycofurol, dimethylacetamide, ethyl lactate, alcohols, glycols, sorbitols and mixtures thereof.

5. The bioadhesive of claim 4 wherein the diluent is a polyethylene glycol with a molecular weight of between 300 and 20,000 or mixtures thereof.

6. The bioadhesive of claim 1 comprising from about 10 to about 20 weight percent of sodium carboxymethyl cellulose and from about 10 to about 20 weight percent of xanthan gum or sodium alginate.

7. The bioadhesive of claim 6 comprising from about 15 to about 20 weight percent of sodium carboxymethyl cellulose and about 15 to about 20 weight percent of xanthan gum or about 10 to about 15 weight percent sodium alginate.

8. A method of orally administering the bioadhesive of claim 1 to a patient.

9. A method of orally administering the bioadhesive of claim 1 to the lips, mouth or gum area of a patient.

10. A method of orally administering the bioadhesive of claim 1 to the gums of a teething gel.