Bioadhesive pharmaceutical carrier

• US 5,192,802 A
• Filed: 09/25/1991
• Issued: 03/09/1993
• 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:
  US07/766,493
• Time in Patent Office: 531 Days
• Field of Search: 514/900-902, 514/535, 514/536, 424/49-58, 106/35, 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 teething gel consisting essentially from about 5 to 10% benzocaine;

5 to 20% NaCMC;

an agent selected from the group consisting of 5 to 20% xanthan gum and 10 to 20% sodium alginate and a diluent selected from the group consisting of polyethylene glycol and polyethylene glycol with glycerine wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings, flavors, sweetener and mixtures thereof.

8. The teething gel of claim 1 wherein the benzocaine is present in an amount of about 7.5% by weight.

2. A teething gel consisting essentially of from about 5 to 10% benzocaine;

5 to 15% glycerine;

5 to 20% NaCMC;

5 to 20% xanthan gum; and

35 to 75% polyethylene glycol wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings, flavors, sweeteners and mixtures thereof.

9. The teething gel of claim 2 wherein the glycerine is present in an amount of about 10% by weight.

10. The teething gel of claim 2 wherein additionally present are pharmaceutically acceptable flavorings and antimicrobial preservatives.

11. The teething gel of claim 2 wherein the polyethylene glycol is a mixture of about 30 to 60% polyethylene glycol with an average molecular weight of 600 and about 5 to 15% polyethylene glycol with an average molecular weight of 3350.

3. A teething gel consisting essentially from about 5 to 10% benzocaine;

5 to 20% NaCMC;

10 to 20% sodium alginate; and

a diluent selected from the group consisting of polyethylene glycol and polyethylene glycol with glycerine wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings flavors, sweetener and mixtures thereof.

4. The teething gel of claim 3 wherein the benzocaine is present in an amount of about 7.5% by weight.

5. The teething gel of claim 3 wherein the glycerine is present in an amount of about 10% by weight.

6. The teething gel of claim 3 wherein additional present are pharmaceutically acceptable flavorings and antimicrobial preservatives.

7. The teething gel of claim 3 wherein the polyethylene glycol is a mixture of about 30% to 60% polyethylene glycol with an average molecular weight of 600 and about 5 to 15% polyethylene glycol with an average molecular weight of 3350.

12. A method for adhering a local anesthetic to the moist membranes of the lips and mouth area or gums of a teething child for affording a continued release of anesthetic for over 180 minutes at the moist site of application consisting essentially of:

(a) applying to the moist membranes a teething gel containing from about 5 to 10% benzocaine;

5 to 20% NaCMC; and

agent selected from the group consisting of 5 to 20% xanthan gum and 10 to 20% sodium alginate and a diluent selected from the group consisting of polyethylene glycol and polyethylene glycol with glycerine wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected form the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings, flavors, sweeteners and mixtures thereof.

13. A method for adhering a local anesthetic to the moist membranes of the lips and mouth area or gums of a teething child for affording a continued release of anesthetic for over 180 minutes at the moist site of application consisting essentially of:

(a) applying to the moist membranes a teething gel containing from about 5 to 10% benzocaine;

5 to 15% glycerine;

5 to 20% NaCMC;

5 to 20% xanthan gum; and

35 to 75% polyethylene glycol wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings, flavors, sweeteners and mixtures thereof.

14. A method for adhering a local anesthetic to the moist membranes of the lips and mouth area or gums of a teething child for affording a continued release of anesthetic for over 180 minutes at the moist site of application consisting essentially of:

(a) applying to the moist membranes a teething gel containing from about 5 to 10% benzocaine;

5 to 20% NaCMC;

10 to 20% sodium alginate; and

a diluent selected from the group consisting of polyethylene glycol and polyethylene glycol with glycerine wherein the percentages are by percent weight of the teething gel and optionally there may be added to said teething gel an effective amount of a pharmaceutically acceptable excipient selected from the group consisting of acidifying agents, antimicrobial preservatives, antioxidants, buffering agents, colorings, flavors, sweeteners and mixtures thereof.