1. FORMULATION, OPTIMIZATIONAND
CHARACTERIZATIONOFETORICOXIB LOADED
POLYMERIC DENTALFILM
Presented by
Chakshu Walia
Reg. No.190740002
Supervisor
Dr. Amit Bhatia
Associate Professor
Department of Pharmaceutical Sciences and Technology,
Maharaja Ranjit Singh Punjab Technical University,
Bathinda, Punjab 151001
2. Introduction
Toothache is pain that you feel in or around your tooth. It is sign that there’s something
wrongs with your tooth or gums. It is sign of serious conditions which may require
immediate medical treatment. It leads swelling around teeth, fever or headache, bad odor
from the mouth. Dental film having the better flexibility and comfort.
Dental film is able to protect the wound surface, thus reduce pain and also treat oral
disease more comfortably. It should be flexible, elastic, soft film which protect from
certain problems in the mouth. These are the fast dissolving film with various properties
(rapid onset of action).
Fig 1: Toothache
3. It serves as the better alternatives for the delivering of several sensitives drugs which can easily
degrades in gastrointestinal tract. This leads to good adhesives properties which prolongs the
residence time of the dosage form at the site of absorption, hence increases the better
bioavailability.
There is rapid rate of absorption because of enormous blood flow and better flow rates. In, this
drug is protected from the degradation in the acidic environment.
As, Etoricoxib is a non- steroidal anti-inflammatory drug which helps to reduce the pain and
swelling (inflammation). Etoricoxib is known to be a selective inhibitor of the COX 2 enzyme.
• It approximately leads to form 106 folds selectively for COX 2 inhibition over COX 1. This
reduces the generation of progesterone from arachidonic acid
Fig 2: Pain in tooth
4. Rationality
The dental film preferred over buccal tablet in terms of flexibility and comfort
As they are easily placed in mouth which having no hepatic first pass metabolism of drug, less
side effects which are associated from the liver and have better therapeutic effect.
The film has direct access to the systemic circulation through the internal jugular vein, which
bypass the drug from the first pass metabolism leading to high bioavailability.
These dose forms are self-administrable, gained importance as efficacious and are cost effective
with good patient compliance
Oral mucosa provides a direct entry of the drug into the systemic circulation, avoiding
gastrointestinal degradation of the drug
There are several capsules, tablets, gel are present in marketed formulation and there are no such
formulation prepared i.e., dental film which prevent from toothache, pain which having the better
release of drug
5. AIM AND OBJECTIVES
AIM
Formulation, Optimization and Characterization of Etoricoxib Loaded PolymericDental Film.
OBJECTIVES
To develop and optimize the dental film
To characterize the optimized film
To determine In- vitro and Ex- vivo drug release and permeation profile, respectively
6. Plan of Work
Literature Survey
Preformulation Study
Identification of drug sample by FTIR
Melting Point
Finding the absorption maxima using UV-Spectroscopy
Formulation of Dental film
By Solvent Evaporation method
Optimization using Design of Experiment (DoE)
7. PLAN OF WORK
Characterization
Physical appearance
Thickness of film
Uniformity of weight
Folding endurance
Percentage moisture absorption and loss
Drug content determination
In-vitro release study
Ex-vivo permeation study
8. Results & Discussion
Organoleptic properties
Etoricoxib was a white crystalline powder which was bitter and odorless in taste.
• Melting point:-
Table 1: Melting point of Etoricoxib
Observed Melting Point Reported melting point
MP1 MP2 MP3 MEAN 134°C-135°C
(Etoricoxib _ C18H15ClN2O2S
PubChem, n.d.)
132°C 132°C 133°C 132.3±0.57 ºC
10. Identification of Drug Sample
Table 2: Interpretation of IR spectral data forEtoricoxib
Functional group Standard wavenumber(cm-1) Observed wave number
(cm-1)
C=N 1592.9cm-1 1596.17cm-1
S=O 1430.0cm-1, 1299.4cm-1, 1136.8cm-1,
1089.6cm-1
1430.39cm-1, 1293.36cm-1,
1138.87cm-1, 1083.49cm-1
C-Cl 834.0cm-1, 777.1cm-1, 639.22cm-1 838.05cm-1, 773.08cm-1,
634.93cm-1
11. Fig 4: U.V. spectrum and Calibration curve of Methanol (λmax 235)
12. Fig 5: U.V. spectrum and Calibration curve of Stimulated Salivary Fluid (λmax 6.8)
13. Table 3: Limit of detection and limit of Quantification
Table 4: Robustness of Dental film with Methanol
29. Conclusion
Etoricoxib was authenticated by using FT- IR spectroscopy, melting point and UV- spectroscopy, which confirmed
that the procured drug pure and free from significant amount of any impurities.
The developed UV method of etoricoxib was linear in range which having regression equation for SSF 6.8 was
y=0.0073x-0.0063 and coefficient of correlation value of 0.998 and for methanol was y=0.0975x+0.0046 &
coefficient of correlation value of 0.9981.
The analytical method developed for estimation of etoricoxib was found to be accurate and precise.
The initially formulated dental film of etoricoxib was found to having good physical characteristics indicating
suitability of excipients selected.
The dental film was prepared with the employing solvent evaporation method by using polymers and plasticizer.
In optimization studies, initially 20 formulations were takes places by the optimization using DOE. In which, F9
was found to be the best fit formulation over the all-other formulation. The formulation was evaluated such as
thickness (0.020±0.0002), weight uniformity (127.6± 0.57), % moisture absorption (74.42), %Moisture loss
(5.88±0.024), folding endurance (<145), drug content (97.301±0.004), in-vitro drug release studies (95.42%) and ex-
vivo permeation study (50.35%) which show satisfactory results. The dental film developed and optimized using
polymers and excipients were found to prolonged the drug release for more than 12 h.
30. It can be concluded that the designed formulations have potential to overcome the disadvantage of poor and
erratic bioavailability associated with presently marketed oral formulations. The process and method executed
for design of dental film was relatively simple and can easily be adopted in conventional manufacturing units on
a commercial scale. However, further studies need to be carried out to assess designed dental films in animals
and humans for acceptability and pharmacodynamic performances with good safety and efficiency.
31. PRSENTATION AND PARTICIPATION
Poster Presentation:
Chakshu Walia, Ritika, Shruti Chopra, Amit Bhatia. E-poster on “Bilayered nail lacquer of Itraconazole for
treatment of Onychomycosis” in 14th Chandigarh Science Congress CHASCON-2020, Panjab University,
Chandigarh on 17 to 19 December. Won 3rd Best Poster Presentation Award
Participation:
•3 days online National Conference on “Accustoming Pharmaceutical professionals with upcoming future
Challenges” organized by Guru Nanak College of Pharmacy, Nagpur on 29th – 31st May, 2020
•Webinar on Pharmacovigilance: Current and future prospects which was organized by Department of
Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University, Bathinda on 21st
– 23rd May, 2020
•Webinar on Self- Reliant India: Pharma Perspective which was organized by University Institute of
Pharmaceutical Sciences, Panjab University, Chandigarh on June 06, 2020
•Introductory Courses in pharmacokinetics – Modelling & Simulation a course of study organized by
Association of Pharmaceutical Teachers of India, conducted online by Prof. Chandramouli R on 7- 8 May, 2020
