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									FORMULATION AND IN VITRO EVALUATION OF AN ANTIBIOTIC
           LOADED PERIODONTAL STRIPS.


           M. Pharm. Dissertation Protocol Submitted to




       Rajiv Gandhi University of Health Sciences, Karnataka
                       Bangalore – 560041

                                 By

                      Mr. PRAVEENA M B         B. Pharm


                      Under the Guidance of

                  Dr M.S.SRINATH      M. Pharm.PhD.




                  Department of Pharmaceutics
             SET’s College of Pharmacy, S. R. Nagar,
                      Dharwad, Karnataka – 580002.




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               RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
                           BANGALORE, KARNATAKA


                              ANNEXURE-II


       PROFORMA OF REGISTRATION OF SUBJECT OF DISSERTATION




1.   NAME OF THE CANDIDATE       PRAVEENA M B
     AND ADDRESS                 DEPARTMENT OF PHARMACEUTICS
                                 SET’s COLLEGE OF PHARMACY, S.R. NAGAR,
                                 DHARWAD-580002.




2.   NAME OF THE INSTITUTION     SET’s COLLEGE OF PHARMACY,
                                 S. R. NAGAR,
                                 DHARWAD-580002


3.   COURSE OF THE STUDY AND MASTER OF PHARMACY
     SUBJECT                     IN
                                 PHARMACEUTICS


4.   DATE OF ADMISSION TO        JUNE- 2011
     THE COURSE


5.   TITLE OF THE TOPIC:
     FORMULATION AND IN VITRO EVALUATION OF AN ANTIBIOTIC LOADED
     PERIODONTAL STRIPS.




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6.                          BRIEF RESUME OF THE STUDY:

     6.1 NEED FOR THE STUDY:
                  Periodontitis is a diseases associated with periodontium in which
     irreversible step Of loss of attachment of teeth occurs.1
                 Gingivitis and periodontitis are the two major inflammatory diseases
     affecting the periodontium. Gingivitis is inflammation of the gingiva that does
     not result in clinical attachment loss. Periodentitis is inflammation of the
     gingival and the adjacent attachment apparatus and is characterized by loss of
     connective tissue attachment and alveolar bone.2
                In conventional mode of drug administration many drugs do not reach
     target areas in the body in sufficient concentration because of premature
     inactivation and excretion. The systemic drug administration has been useful in
     treating periodontitis but the disadvantage is that, drug is diluted several
     thousand folds before it reaches the site and expose the rest of the body to
     potential side effects. The problem can be overcome by administering the drug
     directly to the intended site of action with lesser dose.3
               Sustained drug delivery systems are able to provide very precise
     control over drug release for prolonged period of time eliminating the need for
     frequent dosing and minimizing side effects, thereby increasing patient
     compliance and comfort.4 A site-specific system aims at delivering the
     therapeutic agent at sufficient levels inside the pocket and at the same time
     minimizing the side effects associated with the systemic drug administration.5
                   The aim of current periodontal therapy is to remove the bacterial
     deposits from the tooth surface. Therapeutic approaches include mechanical
     scaling and root planing and, in some cases, surgery. As a result of treatment,
     there is a decrease of gingival inflammation as well as clinical probing depth.6




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6.2 REVIEW OF LITERATURE:
            Pragati S. et al., Recent advance in Peridontal drug delivery systems.
Antibacterial agents have been used effectively in the management of
periodontal infection the effectiveness of mechanical debridment of plaque and
repeated topical and systemic administration of antibacterial agents or limited
due to      the lack of access ability to periodontopathic organisms in the
periodontal pocket. Systemic administration of drugs leads to therapeutics
concentrations at the site of infection, but short periods of time, forsing repeated
dosing for longer periods. Local delivery of antimicrobials has been investigated
for the possibility of overcoming the limitations of conventional therapy. The
use of sustain release formulation to deliver anti bacterial to the site of
infection(periodontal pocket) has recently gained interested.2
           Kumar M.et al., studied the Formulation and in vitro evaluation of
peridontal films containing metronidazole for local delivery, metronidazole films
were prepared by solvent casting techniques using ethyl cellulose,hydroxyl
propyl methylcellulose and eudragit RL-100 with dibutylphthalate and
polyethylene glycol 400 as plasticizers. Data of in –vitro relese from films were
fit to different equations and kinetic models to explain release kinetics. Hixon –
crowell, higuchi, and korsmeyer-peppas models were used to fit in-vitro release
data .6
          Prabhushankar GL. et al.,Formulated and evaluation of levofloxacin
dental films for treatments of peridontitis. A novel drug delivery system for the
treatment of periodontitis was developed for site –specific delivery of
levofloxacin wchich has excellent activity against anaerobic microorganisms.
The calibration curve for levofloxacin was developed for in pH 6.6 phosphate
buffer at 287.6 nm in the range of 2 to14 ug/ml. levofloxacin films were
prepared by solvent casting technique using ethylcellulose and other co-
polymers in chloroform: dichloromethane (1:1) solvent with dibutyl phthalate
and PEG 400 as plasticizers. Formulation F2 released 99.74% of drug at the end
of tenth day and was considered as best formulation. A short –tearm stability
study showas that drug content decreased in various films and was ranging from
0.9% to 3.14%.7




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       Ahmed MG. et al., studied the Preparation and evaluation of periodontal
strips of gatifloxacin for periodontal diseases. Gatifloxacin is a broad-spectrum
anti microbial agent, which is active against a number of aerobic, anaerobic
,Gram +ve Gram –ve        periodontal pathogens. In the present investigation
,chitosan strips containing gatifloxacin (10%,20% and 30% to the weight of
polymer ) were prepared by solution casting method using 1% v/v acetic acid in
water .further strips containing 30% gatofloxacin were crossed –linked by
exposing to the vapours of 2%v/v glutaraldehyde in water intended to extened
the release. Macroscopical features revealed the drug was dissolved in the
polymer matrix rather than dispersing. The prepared films were evaluated for
their thickness,content uniformity,weight variation, tensil strength, hardness and
in-vitro dissolution.8
        Suresh PK. et al.,studied on the            Devolpment and in vitro
characterization of metronidazole loaded chitosan microsphere for delivery to
periodontal pocket. In the present work, metronidazole loaded chitosan
microspheres were prepared by external gelatin technique using tirpolyphosphate
as the cross-linker. The drug to polymer ratio was chosen at the three levels:
1:4,1:5 and 1:6 (by weight) and tripolyphosphate concentration also at three
levels : 6,12 and 18(%). The microsphears were characterized for surface
morphology, partical size, drug entrapment efficiency, swelling, erosion,
bioadhesion and drug release profile. Nearly spherical, rough and porous
particals(size-800 um) were obtained. The drug entrapment efficiency was found
to be in the range of 60-75%. Percentage swelling, erosion and bioadhesion
ranged from 10-25%, 5-15% and 43-59% respectively.9
          Marssafy LE et al ., studied on the concept of immediate loading by
using titanium one-piece implant can be preferred to the two stage technique due
to the ability of the immediate loading to eliminate the need for the healing
period to restore the implant. The aim of the present study was to evaluate the
effect of adding platelet-rich plasma with immediately loaded self-tapping dental
implant (OsteoCare™ Maxi-Z one piece) placed in healed bony sites (posterior
maxillary area) on accelerating the rate of osseointegration or reducing the
crestal bone resorption around these implants through the first three months


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follow-up period.Complete soft tissue healing had occurred in all patients and all
the implants were successfully osseointegrated over the twelve months follow-
up period with a success rate of 100%. The results of the present study showed
that there was no statistical difference between the two sides (test+control)
regarding PD, MBI, MPI, implant mobility, crestal bone resorption and bone
density through the twelve Months. The Osteocare’s Maxi Z one-piece, self-
tapping self-drilling implant has shown high success rate regarding initial
stability and successful osseointegration. However, within the limitations of the
present study,local application of autologous platelet-rich plasma into the
prepared drill holes immediately before implant placement didn’t accelerate the
rate of osseointegration or decrease the crestal bone resorption “through first
three months period” in immediately loaded dental implant placed in posterior
maxillary area.12


6.3 OBJECTIVE OF THE STUDY:

     The objectives of the study are to prepare polymeric strips containing the
antimicrobial agent for periodontal pockets.


     Specific objectives of the present investigation are as follows:

     1) To develop Drug loaded polymeric strips containing an antibiotic.

     2) To study dissolution profile of the films.
     3) To study the Drug and excipient interaction by using FTIR method.
     4) To carry out physico-chemical evaluation studies:
             a) Drug content
             b) Tensile strength
             c) Thickness
             d) Folding endurance




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7.   MATERIALS AND METHODS:
     7.1 SOURCE & COLLECTION OF DATA:
           Standards Reference books.
           www.Helinet.in
           Indian journal of pharmaceutical sciences.
           AAPS Pharma Sci Tech.
           International journal of Pharmaceutics, etc.


     7.2 METHOD OF COLLECTION OF DATA:
     MATERIALS:
                  Antibiotic drug.
                  HPMC K15M & HPMC K100M.
                  Carbopol 934
                  Sodium bicarbonate & Citric acid.


     A.   METHOD OF PREPRATION:
          By solvent casting method.


     B. CHARACTERIZATION :
          1. Particle size.
          2. Surface Morphology.
          3. Drug entrapment Efficiency


     C. EVALUATION OF DENTAL STRIPS FOR :

             Drug content

             Tensile strength

             Thickness

             Folding endurance

             Stability studies


     D.   IN VITRO DRUG RELEASE:
          By dissolution studies.

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7.3   DOES     THIS      STUDY   REQUIRE   ANY    INVESTIGATIONS   OR
      INTERVENTIONS        TO    BE   CONDUCTED    ON   PATIENTS   OR
      ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY.

      - No.


7.4 ETHICAL CLEARANCE :
      -Not Applicable.




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8.   LIST OF REFERENCES:


     1. Mastiholimath VS, Dandagi PM, Gadad AP, Patil MB, Manvi FV, Cahndur
        VK. Formulation and evaluation of ornidazole dental implants for
        periodontitis Ind J Pharma Sci 2006;68(1):68-71.
     2. Pragati S, Ashok S, Kuldeep S. Recent advances in periodontal drug delivery
        systems. Int J Drug Delivery 2009;1:1-14.
     3. Rahman S, Ahuja A, Ali J, Khar RK. Site specific delivery system for the
        treatment of periodontitis. Ind J Pharma Sci 2003;65(2):106-12.
     4. Kenneth S, Kornman. Controlled release local delivery of antimicrobial in
        periodontitcs; prospect for the future. J Periodontol 1993;64:782-91.
     5. Pandit JK. Targeted devices for periodontal disease, Edited by Jain NK.
        Controlled and novel drug delivery. New Delhi: CBS publisher and
        distributors; 2004.
     6. Kumar M, Prabhushankar GL, Santheshbabu PR. Formulation and in vitro
        evaluation of peridontal films containing metronidazole.Int J Pharm Tech
        Res 2010 Oct-Dec;2(4):2188-93.
     7. Prabhushankar GL, Gopalkrishna B, Manjunath KM, Girisha CH.
        Formulation and evaluation of levofloxacin dental films for peridontitis. Int J
        Pharm Pharm Sci 2010;2(1):162-68.
     8. Ahmed MG, Narayan CR, Kanthraj K, Harish NM, Prabhu P. Preparation
        and evaluation of periodontal strips of gatifloxacin for periodontal diseases.
        Int J Pharm Bio Sci 2010 July-Sep;1(3):1-8.
     9. Suresh PK, Dewangan MK. Devolpment and in vitro characterization of
        metronidazole loaded chitosan microsphere for delivery to periodontal
        pocket J Applied Pharm Sci 2011;01(08):165-69.
     10. Sweetman SC. Martindale The Complete Drug Reference. Great Britain:
        Pharmaceutical press; 2002.
     11. Marssafy LE, Dahab OA, Zahran A, Shoib M. Evaluation of Immediate
        loaded dental implant placed in healed bony sites with or without addition of
        autolouge platelet rich plasma. J American Sci 2011;7(3):633-43.




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9.   SIGNATURE OF THE STUDENT


10. REMARK OF THE GUIDE
    The above mentioned information and literature has been extensively investigated,
     verified and was found to be correct. The present study will be carried out under my
     supervision and guidance.
11. 11.1 NAME AND DESIGNATION               Dr. M.S SRINATH M. Pharm. PhD.
         OF THE GUIDE                       PROFESSOR,
                                            DEPT. OF PHARMACEUTICS
                                            SET’s COLLEGE OF PHARMACY,
                                            S.R.NAGAR, DHARWAD- 580002.

     11.2 SIGNATURE


     11.3 NAME AND DESIGNATION
          OF CO-GUIDE

                                                             ----------

     11.4 SIGNATURE


     11.5 HEAD OF THE                       Prof. S.P. THAKKER M. Pharm.
          DEPARTMENT                        PROFESSOR AND HEAD,
                                            DEPT. OF PHARMACEUTICS
                                            SET’s COLLEGE OF PHARMACY,
                                            S.R.NAGAR, DHARWAD- 580002.

     11.6 SIGNATURE



12. 12.1 REMARK OF THE                      The above mentioned information is correct and
         PRINCIPAL
                                            I recommend the same for approval.

                                            Dr. V. H. KULKARNI M. Pharm, Ph.D.
                                            PROFESSOR & PRINCIPAL,
                                            SET’s COLLEGE OF PHARMACY,
                                            S.R.NAGAR, DHARWAD- 580002.


     12.2 SIGNATURE




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