Pharmaceutical formulation

Abstract

A pharmaceutical formulation for topical dental administration or medical (e.g., implant) treatment, including effective amounts of: at least one antimicrobial compound; at least one peroxide source compound; and at least one gel agent. Also disclosed are methods of oral anatomy treatment. The pharmaceutical formulation and treatment methods provide the patient with oral anatomy benefits including, for example, decreased or arrested gum recession; decreased or arrested bone recession; decreased or arrested bone mass loss; decreased or eliminated pain; decreased or eliminated bleeding; decreased or eliminated swelling; enhanced regeneration of bone; enhanced soft tissue repair; or a combination thereof.

What is claimed is: 
     
         1 . A pharmaceutical formulation for topical dental administration, comprising:
 at least one antimicrobial compound in an effective amount from 5 to 90 weight % of the total weight of the formulation;   at least one peroxide source compound in an effective amount from 1.5 to 44 weight % of the total weight of the formulation; and   at least one gel agent in an effective amount from 1.0 to 90 weight % of the total weight of the formulation.   
     
     
         2 . The pharmaceutical formulation of  claim 1 , further comprising at least one carrier present in from 1 to 10 weight % in superaddition to the total weight of the formulation. 
     
     
         3 . The pharmaceutical formulation of  claim 1 , further comprising at least one additive in from 1 to 10 weight % in superaddition to the total weight of the formulation selected from: a sweetner, a flavorant, a colorant, a fragrance, a preservative, a stabilizer, an acid, a base, a buffer, a surfactant, a diluent, or combinations thereof. 
     
     
         4 . The pharmaceutical formulation of  claim 1 , wherein the at least one peroxide source compound is carbamide peroxide. 
     
     
         5 . The pharmaceutical formulation of  claim 1 , wherein the at least one antimicrobial compound is selected from tetracycline, doxycycline, chlortetracycline, clomocycline, demeclocycline lymecycline meclocycline metacycline, omadacycline, oxytetracycline, penimepicycline, rolitetracycline, sarecycline, minocycline, clindamycin, azithromycin, amoxicillin, clavulanate, metronidazole, ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, metronidazole, cephalexin, clarithromycin, cefazolin, cefaclor, cefdinir, cefuroxime, cefadroxil, cefepime, ceftriaxone, or a combination of minocycline, metronidazole, and ciprofloxacin, a salt thereof, a prodrug thereof, or combinations thereof. 
     
     
         6 . The pharmaceutical formulation of  claim 1 , wherein the at least one antimicrobial compound is a tetracycline, a salt thereof, a prodrug thereof, in from 10 to 40 weight % of the total weight of the formulation. 
     
     
         7 . The pharmaceutical formulation of  claim 1 , wherein the at least one antimicrobial compound is a tetracycline, a salt thereof, a prodrug thereof, in from 25 to 30 weight % of the total weight of the formulation. 
     
     
         8 . The pharmaceutical formulation of  claim 1 , wherein the formulation is formulated as a gel, a paste, a tooth mousse, a mouthwash, a rinse, a dental floss coating, a chewing gum, an oral care strip or film for direct application or attachment to an oral surface, a lozenge, or a combination thereof, and free of any Schedule I-V analgesic narcotics. 
     
     
         9 . A method of treating or preventing at least one of:
 bleeding;   swelling;   pain;   receding gums;   receding tooth-support bone;   loosing tooth-support bone mass; or a combination thereof, in an oral cavity of a subject, comprising: applying the topical dental pharmaceutical formulation of  claim 1 .   
     
     
         10 . A method of oral anatomy treatment, comprising:
 administering to a patient in need of such administration an effective amount of a topical dental pharmaceutical formulation comprising:
 at least one antimicrobial compound in an effective amount from 5 to 90 weight % of the total weight of the formulation; 
 at least one peroxide source compound in an effective amount from 1.5 to 44 weight % of the total weight of the formulation; and 
 at least one gel agent in an effective amount from 1.0 to 90 weight % of the total weight of the formulation, 
   
       wherein at least one condition is minimized or eliminated and the condition is selected from:
 bleeding of the patient's gums; 
 swelling of the patient's gums; 
 experiencing a pain sensation in the patient's gums or teeth; 
 receding of the patient's gums; 
 receding of the patient's tooth-support bone; 
 loss of the patient's tooth-support bone mass; or a combination thereof, compared to the patient without the administration of the topical dental pharmaceutical formulation. 
 
     
     
         11 . The method of  claim 10 , further comprising applying an anesthetic to at least one root of the patient's teeth before, during, after, or a combination thereof, the administration of the topical dental pharmaceutical formulation. 
     
     
         12 . The method of  claim 10 , further comprising topically administering to the patient in an effective amount of at least one growth-factor enhanced matrix material comprising a human growth factor and an osteoconductive matrix, wherein the topical administration of the matrix material is accomplished before, during, after, or a combination thereof, the administration of the topical dental pharmaceutical formulation. 
     
     
         13 . The method of  claim 10 , further comprising systemically administering to the patient an effective amount of at least one antimicrobial compound in an effective amount, wherein the systemic administration of at least one antimicrobial compound is accomplished before, during, after, or a combination thereof, the administration of the topical dental pharmaceutical formulation. 
     
     
         14 . The method of  claim 10 , wherein the receding of the patient's gums, the receding of the patient's tooth-support bone, loss of the patient's tooth-support bone mass, or a combination thereof are eliminated. 
     
     
         15 . The method of  claim 10 , wherein the administering to a patient an effective amount of the topical dental pharmaceutical formulation comprises at least one of:
 the amount of the formulation administered to the patient in a treatment session;   the duration of contact of the formulation with the patient's oral anatomy having at least one condition;   the frequency the formulation is administered to the patient's affected oral areas, or combinations thereof.   
     
     
         16 . The method of  claim 10 , wherein administering to a patient an effective amount of a topical dental pharmaceutical formulation is accomplished free of one or more of: general anesthesia; local anesthetics; or analgesics. 
     
     
         17 . The method of  claim 10 , further comprising flushing the patient's mouth with one or more washes to accomplish at least one of: remove excess or residual topical dental pharmaceutical formulation; avoid patient swallowing the topical dental pharmaceutical formulation, or both. 
     
     
         18 . The method of  claim 10 , wherein administering to a patient an effective amount of the topical dental pharmaceutical formulation provides superior wound healing to the patient who has had oral surgery compared to the patient without the administration of the topical dental pharmaceutical formulation. 
     
     
         19 . The method of  claim 10 , wherein administering the topical dental pharmaceutical formulation to a patient in need of such administration provides synergistic results, including:
 decreased or arrested gum recession;   decreased or arrested tooth support bone recession;   decreased or arrested tooth support bone mass loss;   decreased or eliminated bleeding of the oral anatomy;   decreased or eliminated swelling of the oral anatomy;   decreased or eliminated pain sensation of the oral anatomy;   enhanced regeneration of bone;   enhanced soft tissue repair; or a combination thereof.   
     
     
         20 . The method of  claim 10 , wherein administering to a patient an effective amount of the topical dental pharmaceutical formulation provides oral prophylaxis to the patient.