Download brief resume of the project study

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE
KARNATAKA
ANNEXURE-II
PROFORMA OF REGISTRATION OF SUBJECT OF DISSERTATION
SUMEER KUMAR B.Y
S/0 YESHWANTH NATH. M
NO-31, MUNISHAMAPPA LAYOUT,
KASHINAGAR, AMRUTHALLI,
BANGALORE - 560092
KARNATAKA.
1
NAME OF THE
CANDIDATE
AND ADDRESS
2
NAME OF THE INSTITUTION
VISVESWARAPURA INSTITUTE OF
PHARMACEUTICAL SCIENCES,
BANGALORE–560070.
3
COURSE OF THE STUDY AND
SUBJECT
MASTER OF PHARMACY
IN
PHARMACEUTICS
4
DATE OF ADMISSION TO THE
COURSE
30-01-2013
5
TITLE OF THE TOPIC:
DEVELOPMENT OF NOVEL HERBAL
DENTRIFICE
6
BRIEF RESUME OF THE PROJECT STUDY
6.1 NEED FOR THE STUDY:
India’s toothpaste tradition is based on its strong background of Ayurvedic
medicine. Special things were used for brushing which possess excellent medicinal properties.
Oral health is an integral component for health and is essential for well-being.1 Dental
problems include formation of dental plaques, dental caries and periodontal diseases.
In developing countries like India, very significant dental problems arises due to microbial
infections like Streptococcus mutans, Escheria coli and Candida albicans which infects oral
root canal. Poor oral hygiene is one of the reasons for accumulation of these microbes and
their harmful activities.2
Dental caries is a universal dental health problem affecting all ages. In India
prevalence of dental caries is reported to be about 50-60%. About 60-90% in children and vast
in adults1. Dental caries is a localized, transmissible infectious process that results in the
destruction of hard dental tissue via demineralization. It results from accumulation of plaque
on the surface of the teeth and biochemical activities of complex micro-communities.
Periodontal disease is a pathogenic process which affects supporting structure of teeth in
gingivitis, periodontal membrane, alveolar bone. Gingivitis is inflammation of gum which
occurs due to poor oral hygiene since bacteria around gum produce toxins & hydrolytic
enzymes irritate them, periodontal disease that affect the periodontal membrane and alveolar
bone may results in tooth loss. Streptococci, Spirochetes and Bacteroides are found to be the
possible pathogens responsible for the disease .2
Commercial toothpastes contain Triclosan, sodium lauryl sulphate and fluoride.
Drawbacks of using fluoride containing toothpaste are toxicity, damage to teeth by making
them hard and brittle. Excess fluoride is harmful to bones, joints, nervous system causing
fluorosis. Triclosan causes impaired heart and muscle function and is also carcinogenic.
Sodium lauryl sulphate causes swelling and bleeding of gums. Major side effects of toothpaste
are eliminated by using herbal and pharmaceutically acceptable excipients.
To overcome the above disadvantages, an attempt will be made in this study to
develop a herbal toothpaste containing a novel herbal isolate with no side effects.
6.2 REVIEW OF LITERATURE:
 Prashanth M et al., studied the antimicrobial efficacy of triclosan in different
toothpaste and mouthrinses against the oral pathogens. A total of five toothpastes (A to
E) and five mouthrinses (F to J) were tested for their antimicrobial activity against
three oral pathogens namely, Streptococcus mutans , Escherichia coli and Candida
albicans by agar diffusion assay. Statistical Analysis was performed using a statistical
package, SPSS windows version 15, by applying mean values using analysis of
variance with post-hoc least square differences method(α = 0.05). Resulted in
maximum zone of inhibition against the test organism, Escherichia coli showed in
toothpaste A compared to all other toothpastes formulations and other organism.
Mouthrinses formulation H showed maximum efficacy against the test organism,
Escherichia coli compared to all other mouthrinse formulations.2
 Shani S et al., formulated a local sustained release delivery system which extended the
time in the oral cavity while reducing the side effects. Amine fluorides an anticaries
agent have been discovered to possess antibacterial effect against periodontal pathogens
and caries associated with bacteria. The commensual flora like S.sobrinus, S.mutans
cause dental caries. In these formulations ethyl cellulose was used as a polymer
containing amine fluorides with local sustained release approach. The release kinetics
of the dosage form was measured. Local sustained release dosage forms containing
amine fluorides have the potential to serve as a medicament in prevention and treatment
of periodontal diseases and dental caries.3
 George J et al., performed clinical trials in parallel groups for study of efficacy of
herbal based toothpaste over other toothpaste in control of plaque and gingivitis. Thirty
subjects with gingivitis participated in the study. At baseline the clinical parameters
like gingival index, plaque index and salivary pH were estimated. Paired and unpaired
t-test were used to compare difference between groups at baseline and on the 30th day.
Results revealed that herbal based toothpaste showed significant reductions in plaque
and gingival index scores in test groups compared to conventionally formulated
dentrifice.4
 Mohire NC et al., developed polyherbal toothpaste using chitosan and evaluated its
plaque reducing potential and destruction of dental pathogens using disk diffusion
method as per US Government tooth paste specifications. Clinical studies were carried
out for 4 weeks with oro dental problems in patients. Total microbial count was carried
out to determine percentage decrease in oral bacterial count. Studies revealed that
chitosan polyherbal toothpaste reduces plaque index by 70.47% and bacterial count by
85.29% and proves as a novel oral hygiene product against chlorhexidine
gluconate(0.2%w/v) mouthwash.5
 Ribeiro LG et al., carried out a study to assess the duration of action of different
formulations (solutions, gels and varnishes) of chlorhexidine in reducing the oral
S.mutans species. Chlorhexidine 1% concentration gels and varnishes were used in
extensive treatment by applying 3-4 times application over 2 days which showed
significant reduction in bacterial population. The treatment using 1% chlorhexidine
varnish displays large variations in the level and length to decrease S.mutans levels.
Treatment with chlorhexidine was monitored, given sharp individual variability in
response to this treatment.6
 Chentouf N.C et al., assessed antimicrobial activities of methanolic extracts of
Algerian hoggar salvadora persica L, mouthwash against microbial strains from
children’s oral cavity by agar disc diffusion and microdilution methods and dental
plaques samples were tested over a week. Four bacterial genera (Staphylococcus,
Streptococcus, Escherichia and Lactobacillus) were identified in all subjects at
different colonization levels. Hoggar extract more significantly inhibited the growth of
Gram negative bacteria from the dental plaque than Gram positive ones. Hoggar
salvadora persica L. mouthwash was stable at 4°C and 25°C over a week while a
temperature of 40°C induced variations in the physicochemical parameters and
considered not suitable for preservation. This studies revealed that Hoggar mouthwash
showed a significant reduction in bacteria of the oral cavity and helps in prevention of
tooth decay compared to placebo.7
 Joiner A et al., investigated a new silica based blue covarine toothpaste for the stain
removal ability, abrasivity towards enamel and dentine and fluoride efficacy by
brushing artificially to bovine specimens and measured wear via changes in geometry
of Knoop indents and surface profilometry. Fluoride efficacy was assessed using
remineralisation, demineralisation and fluoride-uptake methods. This study revealed
that silica based blue covarine toothpaste removed significantly more stain than the
non-whitening toothpaste and does not have an undue degree of abrasivity to enamel
or dentine compared to other relevant commercially available products, and is an
efficacious source of fluoride.8
 Tiwari G et al., studied controlled delivery of Metronidazole-Doxicycline drugs to
periodontal pocket by formulating mucoadhesive gel using carboxy methyl cellulose,
methyl cellulose, hydroxylethylcellulose, polyvinylpirrolidine polycarbophil and
poloxamer. Hexagonal phase formation is seen when addition of CMC and PVP to the
gel. The gelation temperature was decreased linearly and melting temperature was
increased with an increasing concentration of drug. Increasing concentration of each
polymeric component significantly increased formulation hardness, compressibility,
adhesiveness, mucoadhesion and syringeability but decreased cohesiveness. Increased
time of contact between formulation and mucin increased force of detachment. As
concentration of polymer increased drug release from all formulation decreased, due to
increased viscosity of formulation and swelling kinetics of polycarbophil when contact
with dissolution fluid. A gel with 30% hydroxylethylcellulose had zone of inhibition
on agar resulted in antibacterial action for periodontal pocket.9
 Houshmand B et al., assesed in vitro study for antibacterial effect of garlic extract of
different concentration against human on dental plaque microbiota. By disk diffusion
method four different concentration of garlic extracts (5%,10%,20%,100%) for
antibacterial effect were evaluated against Streptococcus mutans, S.Sangius,
S.Salivarius, Pseudomonas aeruginosa and lactobacillus by paper soaked in 0.2%
concentration chlorhexidine gluconate and saline were used as positive and negative
controls. This data were subjected to ANOVA and tukey multiple comparisions test at
5% results showed all bacterial strains were inhibited. A 5%,10%,20%,100%
concentration of garlic extract had similar effect, so by using optimum concentration of
garlic extract in toothpaste or mouth wash is useful in management of dental caries.10
 Vyas YK et al., studied antibacterial activity of a herbal dentrifice v/s other brands
against Streptococcus mutans and Lactobacillus acidophilus found in oral cavity by
cup-well method. Branded toothpaste produced 5.83 mm and 10.17 mm zone of
inhibition while herbal dentrifice produced 5.5 mm and 10 mm zone of inhibition
against Streptococcus mutans and Lactobacillus acidophilus under microaerophilic
condition.11
 Ikinci G et al., carried out study to determine the antimicrobial activity of chitosan
either in gel or film form against oral porphyromonas gingivitis. Local antimicrobial
agents are preferred in treating periodontal diseases due to disadvantages with systemic
administration of antimicrobial agents. The incorporation of chlorhexidine had not
affected bioadhesion property of gels and films when examined ex vivo. Chitosan was
found to have antimicrobial activity against P.gingivalis. The unwanted side effects of
chlorhexidine can be avoided by combined use of chitosan and chlorhexidine. The gel
and films of chitosan seemed to be promising delivery systems for localized therapy of
periodontal diseases with antimicrobial and bioadhesion properties.12
 Gangwar.A investigated influence of calcium hydroxide formulation prepared with
vehicles like metapex, saline, glycerine, camphorated paramonochlorphenol on root
canal flora for antimicrobial effectiveness in endodontic infections. The samples were
collected in petridish prepared for calcium hydroxide combination for bacterium and
incubated. At 24 hrs maximum zone of inhibition and inhibitory effect were seen ,
most susceptible bacteria was S.aureus and least was E.faecalis in formulation of
calcium hydroxide with camphorated paramonochlorphenol.13
 Patel TK et al., developed medicated dental gels using Ofloxacin for extended period
of time and studied the effect of various mucoadhesive in different concentrations of
propylene glycol. The formulations were subjected for various physicochemical studies
like pH, spreadability, extrudability, viscosity, drug content, in vitro drug release,
rheological and stability studies. In vitro drug release studies were carried out in
diffusion cell using pH 7.2 phosphate buffer as receptor medium. During rheological
studies plots of shear rate versus viscosity showed that all the gels were nonNewtonian and exhibit pseudoplastic behavior. Optimal formulations were selected for
stability studies. Stability studies were carried out for 3 months at different temperature
conditions 25 ± 20C, 37 ± 2oC, and 4oC. Different parameters like pH, spreadability,
extrudability, viscosity and drug content, did not show any significant variation during
stability studies.14
 Prashanth GM et al., evaluated antimicrobial activity of mango and neem extract on
Streptococcus species causing dental caries. Mango and neem sticks were sun dried,
crushed into a coarse powder and weighed into 5 gm, 10 gm, 50 gm amounts, added to
100 ml of deionized distilled water soaked for 48 hrs at 4°C, water is filtered. Filterate
was inoculated onto blood agar plates containing Streptococcus species and incubated
at 37°C for 48 hrs. Results revealed that Mango extract, at 50% concentration, showed
maximum zone of inhibition on Streptococccus mitis. Neem extract at 50%
concentration, showed maximum zone of inhibition on Streptococccus mutans.15
6.3 OBJECTIVES OF THE STUDY:
The objectives of present study are as follows:
1. To develop herbal toothpaste.
2. To check feasibility of incorporating a carotenoid isolated from an exotic flower.
3. To evaluate formulation for various quality control parameters.
4. To carry out stability studies.
7
MATERIALS AND METHODS:
7.1 SOURCE OF DATA
1. Helinet, Pubmed.
2. Web resources and experimental work.
3. Journals : Indian Journal of Pharmaceutical Science, American Association of
Pharmaceutical Science, Dental Research Journal, Indian Pharma Science Technology,
Indian Journal of Dental Research, Herbal Pharmacopoeia.
7.2 METHOD OF COLLECTION OF DATA:
The data will be collected from developed formulation evaluation and stability
studies using various standard books, journals & other sources like research literature data
bases such as Science direct, Pubmed, Elsevier and laboratory experiments.
7.3 MATERIALS:
 Liquid base, abrasive, thickener, humectant, surfactant, herbal active, flavour,
sweetener and preservative.
7.4 METHOD OF PREPARATION:
 Solid components of the formulation like abrasives, gelling and thickening agent would
be mixed. To above mixture, all liquid components will be added to form a smooth
gel/paste, Finally the active agent will be incorporated and homogenized to get a
uniform paste.
7.5 FORMULATION EVALUATION PARAMETERS :
1. Appearance
2. Spreadability
3. pH
4. Foaming power
5. Abrasiveness
6. Viscosity
7. Antimicrobial efficacy
8. Stability
7.6 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS
OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
-NO-
7.7 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTE?
- Not applicable-
7.8 PLACE OF STUDY:
Visveswarapura Institute of Pharmaceutical Sciences, Bangalore-70.
8
REFERENCES:
1. Patro BK, Ravi KB, Goswani A, Mathur VP, Nongkynrih B. Prevalence of dental
caries among adults and elderly in urban resettlement colony of New delhi. Indian J
Dent Res 2008;19(2):95-98.
2. Prashanth M. Antimicrobial Efficacy of Different Toothpastes and Mouthrinses: An In
Vitro Study. Dent Res J 2011; 8(2):85-94.
3. Shani S, Friedman M, Steinberg D. In vitro assessment of antimicrobial activity of a
local sustained release device containing amine fluoride for the treatment of oral
infectious diseases. Diagn Microbial Infect Dis 1998;30(2):93-97.
4. George J, Hegde S, Rajesh KS, Kumar A. The efficacy of a herbal-based toothpaste in
the control of plaque and gingivitis: A clinico biochemical study. Indian J Dent Res
2009;20(4):480-482.
5. Mohire NC, Yadav Av. Chitosan based polyherbal tooth paste as novel oral hygiene
product. Indian J Dent Res 2010;21:380-384.
6. Ribeiro LGM, Hashizume LN, Maltz M. The effect of different formulation of
chlorhexidine in reducing levels of mutans Streptococci in the oral cavity. J Dent 2007;
35:359-370.
7. Chentouf NC, Meddah ATT, Mullie C, Aoues A, Meddah B. In vitro and in vivo
antimicrobial activity of Algerian Hoggar Salvadora persica L. extracts against
microbial strains from children’s oral cavity. J Ethnopharmacology 2012;144:57-66.
8. Joiner A, Philpotts C, Ashcroft AT, Laucello M, Salvaderi A. In vitro cleaning,
abrasion and fluoride efficacy of a new silica based whitening toothpaste containing
blue covarine. J Dent 2008;36S:S32-S37.
9. Tiwari G, Tiwari R, Awani KR . Studies on development of controlled delivery of
combination drug(s) to periodontal pocket. Ind J Den Res 2010;21(1):72-83.
10. Houshmand B, Mahjour F, Dianat O. Antibacterial effect of different concentrations of
garlic (Allium sativum) extract on dental plaque bacteria. Ind J Res 2013;24:71-75.
11. Vyas YK, Bhatnagar M, Sharma K. In vitro evaluation of antibacterial activity of an
herbal dentifrice against Streptococcus mutans and Lactobacillus acidophilus. Ind J
Dent Res 2008; 19(1):26-28.
12. Ikinci G, Senel S, Akincibay H, Kas S, Ercis S, Wilson C.G, Hincal A.A. Effect of
chitosan on a periodontal pathogen Porphyromonas gingivalis. Int J Pharm 2002;
121:121-127.
13. Gangwar A. Antimicrobial effectiveness of different preparations of calcium
hydroxide. Indian J Den Res 2011;22:66-70.
14. Patel TK, Patel VM. Formulation and evaluation of medicated dental gels for
periodontal infection. Int J Phr Inn.2013;3(2):1-10.
15. Prashant GM, Chandru GN, Murulikrishna KS, Shafiulla MD. The effect of mango and
neem extract on four organisms causing dental caries: Streptococcus mutans,
Streptococcus salivavius, Streptococcus mitis, and Streptococcus sangius: An in vitro
study. Ind J Den Res 2007;18:148-151.
9
SIGNATURE OF THE
CANDIDATE
10
REG NO.
11
REMARKS
OF THE GUIDE
12
(SUMEER KUMAR B.Y)
The assigned work is feasible
and recommended.
NAME AND DESIGNATION OF
12.1
GUIDE
12.2
SIGNATURE
12.3 CO -GUIDE
Dr. NAMITA NAIKKHANVTE
M.Pharm, Ph.D.
Asst. Professor
Department of Pharmaceutics,
VIPS, Bangalore-560070
Dr. RAJARAJESHWARI. N
M.Pharm, Ph.D.
Asst. Professor
Department of Pharmacognosy
VIPS, Bangalore-560070
12.4 SIGNATURE
12.5 HEAD OF THE
DEPARTMENT
Dr. G.Y. NARMADA M.Pharm, Ph.D.
Professor & HOD
Dept. of Pharmaceutics, VIPS, Banglore-560070.
12.6 SIGNATURE
13
13.1 PRINCIPAL
13.2 SIGNATURE
Dr. D. H. HARISH KUMAR
M.Pharm, Ph.D.
VIPS, Bangalore- 560070.