Post on 07-Apr-2022
transcript
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1827
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
OVERVIEW ON OROMUCOSAL FILM
1*Shameera V. V.,
2Dr. Vipin K. V.,
3Arathi Lakshmi R.,
4Dr. Ann Rose Augusthy
1,3M Pharm Student, College of Pharmaceutical Sciences, Government Medical College,
Kannur.
2,4Assistant Professor, College of Pharmaceutical Sciences, Government Medical College,
Kannur.
ABSTRACT
Oromucosal film is a novel approach which will increase consumer
acceptance by virtue of rapid dissolution, self administration without
water or chewing. The oromucosal film is an ideal intraoral mouth
dissolving drug delivery system, which satisfies the unmet needs of the
market, it is easy to handle and administer, maintains a simple and
convenient packaging, mask the unpleasant taste, and is straight
forward to manufacture. The advantages of oromucosal film are the
administration to pediatric and geriatric population so the difficulty of
swallowing larger oral dosage forms is get eliminated. This technology
has been used for local action, rapid release products and for
mucoadhesive systems. Oromucosal film offers an alternate platform for molecules that
undergo first pass metabolism and for delivery of peptides. The review article contains the
overview of an oromucosal film encompassing materials used in oromucosal film, critical
manufacturing aspects and applications.
INTRODUCTION
Oral route is the most preferred route for drug administration because it is most convenient,
cost effective and easy to intake which results high level of patient compliance. Despite of
this advantage some Generic and Paediatric patients are facing swallowing difficulty because
of fear of choking. Inorder to overcome this a new drug delivery system was developed. Fast
disintegrating drug delivery system has emerged as an advanced alternative to the traditional
system have started gaining popularity and acceptance because of rapid disintegration or
dissolution, self-administration even without the need of water or chewing. Fast dissolving
WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
SJIF Impact Factor 7.632
Volume 10, Issue 11, 1827-1843 Review Article ISSN 2278 – 4357
*Corresponding Author
Shameera V. V.
M Pharm Student, College of
Pharmaceutical Sciences,
Government Medical
College, Kannur.
Article Received on
17 September 2021,
Revised on 07 Oct. 2021,
Accepted on 27 Oct. 2021,
DOI: 10.20959/wjpps202111-20555
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1828
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
drug-delivery systems were first introduced in the late 1970s as an alternative to conventional
dosage forms to overcome the difficulties associated with traditional oral solid-dosage forms
for pediatric and geriatric patients(1)
. The permeability of oral mucosa is approximately 4-
4,000 times greater than that of the skin so It gives quick absorption and instant
bioavailability of drugs.[2]
Oromucosal film is a new delivery system which consist of a very thin oral film. This is
simply place on the tongue or oral mucosa which will instantly wet by saliva and cause rapid
disintegration and dissolution to release the drug.[3]
An oromucosal film delivery system
include substances like Active pharmaceutical ingredient, Film forming polymers, Plasticizer,
superdisintegrant, Sweetening agent, Saliva stimulating agent, Flavoring agent, Coloring
agent.[4]
Generally hydrophilic polymer is used for the preparation of fast dissolving film that
dissolve rapidly and deliver the drug.[5]
The oromucosal film dissolves rapidly in the oral cavity once in contact with the saliva,
resulting in quick drug release.[6]
Oromucosal absorption is mostly rapid in action, but also short acting. In terms of the
permeability mucosal area of the oral cavity is more permeable.
Fig. 1: Oral thin film.
Special features of oromucosal film[7]
Thin elegant.
Various sizes and shapes.
Fast disintegration.
Mucoadhesion.
Rapid release.
Quick dissolving.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1829
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Advantages and Disadvantages[8]
Table 1: Advantages and Disadvantages of oromucosal films.
Advantages Disadvantages
Convenient dosing.
Not need water.
Enhanced stability.
Ease of administration.
Bypass first pass metabolism.
Taste masking.
Site specific action.
Dose accuracy.
Improved patient compliances.
High dose cannot be incorporated.
Expensive packaging is required.
Dose uniformity is a technical challenge.
Require special package.
Drugs which cause irritation to oral mucosa cannot be
incorporated.
Ideal charecteristics of a oromucosal film(9)
Should have pleasant taste.
Low dose up to 40 mg should be incorporated.
Molecular weight of the drug should have smaller and moderate.
Should have good stability and solubility in water as well as saliva.
Should be partially unionized at the pH of oral cavity.
It should have ability to permeate the oral mucosal tissue.
Overview of oral mucosa
The oral mucosa consist of three layers. The first layer is the stratified squamous epithelium.
underneath this layer is the basement membrane and it overlies the lamina propria and
submucosa. On the surface of the epithelial layer of cells a layer of mucus is present which
plays a major role in cell-to-cell adhesion, oral lubrication, as well as mucoadhesion of
mucoadhesive drug delivery systems. The salivary glands present in the oral cavity produce
saliva, responsible for protecting the soft tissues from abrasion during the mastication of
food. Saliva plays an important role in facilitating the disintegration of fast disintegrating
drug delivery systems.[10]
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1830
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Fig. 2: Anatomy of oral cavity and different layers of oral mucosa.
Classification of oromucosal film[11]
There are three subtypes
Flash release – Rapid release formulation, fast onset of action, systemic or local effect.
Mucoadhesive melt-away film – Intermediate dissolution at application site, systemic or
local effect.
Mucoadhesive sustained release film - long acting release formulation, systemic effect.
Formulation[12]
Table 2: Ingredients used in oromucosal film.
INGREDIENT CONCENTRATION (%)
Drug 5-30
Polymer 40-50
Plasticizer 0-20
Sweetener 3-6
Flavor 2-10
Saliva stimulating agent 2-6
Colour 1
Stabilizing and Thickening Agents 5
Drug
Active pharmaceutical ingredient of oral thin film should posses.
No bitter taste.
Dose should low as possible.
Good stability.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1831
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Eg; Anti-histamine, anti-diarrheal, vasodilators, anti-asthmatic, antidepressants, and anti-
emetic etc.[13]
Film Forming Polymer
Different types of polymer available for the formulation of oromucosal films. It can be used
in combination or alone to get the desires properties of film. To get the desired properties
atleast 45% of polymer should be incorporated in the total weight of film. Hydrophilic
polymers are generally used for the preparation of the fast dissolving film.[14]
Table 3: Film forming polymer.
Natural polymer Synthetic polymer
Pullulan
Gelatin
Chitosan
Pectin
Sodium alginate
Maltodextrin
Lycoat NG 73
Polymerised rosin
Xanthan
HPMC
Hydroxy propyl cellulose
Carboxyl methyl cellulose
Polyvinyl pyrrolidone
Carboxy methyl cellulose
Polyvinyl alcohol
Kollicoat
Poly ethylene oxide
Plasticizers
Plasticizer is a important ingredient of the oromucosal film. It is used to improve the
flexibility and to reduce the brittleness of the oromucosal film.[15]
The glass transition
temperature of the polymer is reduced by plasticizer which is helps to improve the
oromucosal film properties. Generally plasticizers are used in the range of 0-20% of dry
polymer rate.
Eg; Polyethylene glycol, propylene glycol, glycerol, sorbitol etc.[16]
Sweetening agent
Sweeteners are used to reduce the bitter taste of the drug. In case of pediatric patient it is
important to maintain a sweet taste in the formulation. Sweeteners help to produce a good
mouth feel. Natural as well as artificial sweeteners are used to improve the palatability of the
formulation.
Eg; natural sweeteners- fructose, dextrose, sucrose etc.
Artificial sweeteners- saccharin sodium, aspartame, neotame, alitame etc(17)
.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1832
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Flavouring agent
Flavouring agents are used to mask the bitter taste of the formulation. The choice of flavour
is depent on the drug and population. Generally 10% flavours are used in the oromucosal
film.
Eg; artificial vanilla, cinnamon, and various fruit flavours etc.
Mints -peppermint, menthol.
Essential oils -thymol, eucalyptol and methyl salicylate(18)
.
Colouring agent
Pigments are commonly used as colouring agent. A small amount of colours are used in the
formulation. Usually not more than 1% is used.
Eg; titanium dioxide
Full range of colors are available including FD and C, natural and custom pantone-matched
colors.[19]
Saliva Stimulating Agent
Saliva Stimulating Agent helps to provide faster disintegration by increasing the rate of
production of saliva. About 2-6% of agent are commonly used.
Eg; citric acid, malic acid, tartaric acid, ascorbic acid and lactic acid etc[20]
Manufacturing Process.[21]
1) Casting and drying method
a) Solvent casting method
It is the commonly used method for the preparation of oromucosal film. The water soluble
excipients, polymer, and drug are dissolved in the deionsed water to get a clear viscous
solution. The selection of the solvent depend on the physio chemical property of the API.
During the formulation there is a chance for entrapment of air which will effect the
uniformity of mixture and it is removed by vacuum. The mixture is then poured into a
petridish and allowed to dry. Then peel the strip.
b) Semisolid casting method
In this method a water soluble polymer solution prepared and added to a solution of acid
insoluble polymer which is prepared by sodium or ammonium hydroxide. Then plasticizer
added to the solution to get a gel mass. The gel mass is then casted to a film.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1833
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Fig. 2: Casting and drying method (a) Solvent casting (b) Semisolid casting.[22]
2) Extrusion method
a) Hot melt Extrusion method
It is the process of shaping the mixture of ingredients into a film by melting. The mixture is
melted by the extruder and the melts is then charged through the die to get homogeneous
matrixes. This is a solvent free process.
b) Solid dispersion extrusion
In this method involve the dispersion of drug solution in to melted polymer along with
immiscible component. Then cut the solid dispersion into film.
Fig. 3: Extrusion method (a) Hot melt extrusion (b) Solid dispersion extrusion.[23]
3) Rolling method
The prepared suspension of drug and polymer in alcohol or water subjected to rollers. The
solvent get evaporated and film is formed. Then the film is cut into pieces.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1834
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Fig. 4: Rolling method.[24]
4) Printing technique
a) Inkjet printing
i) Continuous inkjet printing
In this the liquid is directed through an orifice of 50-80 µm diameter creating a continuous
ink flow. The liquid is caused to flow and break into drops at a specified speed and size at
regular intervals using a piezoelectric crystal. These parameters are controlled by creating an
electrostatic field. The electrostatic field created directs the charged droplets to the substrate.
ii) Drop-on-demand (DOD) printing
The drop-on-demand technique contains multiple heads (100–1000) and can use two types of
translators, a thermal head or a piezoelectric crystal. The thermal head use volatile liquids.
The piezoelectric covers a wide range of liquid. The ability to operate at room temperature,
with less volatile and more biocompatible liquids, makes piezoelectric printing technology
more suitable for the development of drug delivery devices.
b) Flexographic printing technology
It is a rotary printing process. The ink containing the drug substance solution and suspension
is measured by an anilox roller. It is then transferred to a printing cylinder that prints the film
after unwinding the daughter roll.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1835
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Fig. 5: Printing technique (a) Inkjet printing (b) Flexographic printing.[25]
Quality Control Tests
1) Mechanical property
Thickness test
The thickness of film is directly proportional to the dose accuracy of film so, it is important to
maintain a uniform thickness. The thickness of film is determined by using digital
micrometer. Generally, thickness of three film from all batches is detrmined and average is
calculated. The thickness is evaluated at five different location of a film. The thickness
should be in the range of 5-200µm.[26]
Weight variation test
Weight variation of film is determined by cutting the film into square. The individual weight
of three film were recorded. The average weight and standard deviation were calculated. The
variation test is performed to ensure the homogeneity of the film.[27]
Dryness test
There is almost eight stages of film drying process which are identified viz dry-to touch, dry-
to-recoat, dry hard, set-to-touch, dust-free, tack-free and dry print-free. These tests are used to
evaluate dryness of films in paint industry but are also adoptable for assessing oromucosal
films. This test is performed to check out the ability of a film to adheres to a piece of paper
that pressed between strips.[28]
Tensile strength
Tensile strength is the maximum stress applied to a point at which the oromucosal film
specimen breaks. It is calculated by the applied load at rupture divided by the cross-sectional
area of the oromucosal film.[29]
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1836
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Percent elongation
On the application of stress the film get stretched it is called as strain. Strain is the change in
length of film divided by initial length of the film. Percentage elongation is related to the
amount of plasticizer used. Increase in the amount of plasticizer results in enhanced
elongation.
Tear resistance
Tear resistance is the resistance to repture. The maximum stress required to tear the film is
measured as tear resistance value. The area of the plot in a stress strain curve measures the
tear resistance. If the area of the plot is higher it indicate that the toughness of film is
higher.[30]
Young’s modulus
Young’s modulus indicates the elasticity of the films. It is the resistance to deformation of the
film. The slope of the plot in a stress strain curve measures Young’s modulus. Hardness and
brittleness s of the films related with Young’s modulus and tensile strength. A hard and brittle
film reflects higher value of tensile strength and Young’s modulus with smaller elongation.
Folding endurance
It is determined by repeatedly folding a film at the same point till it breaks. The number of
times the film is folded without breaking is the measure of folding endurance. Higher folding
endurance value indicates the more mechanical strength of a film.[31]
2) Moisture loss
Percent moisture loss is a parameter used to determines the hygroscopicity of a film. This is
determined by first finding the initial weight of the film, afterwards, putting this film in a
dessicator containing calcium carbonate for three days.. After three days, films are taken out
and reweighed. Moisture loss is determined by:
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1837
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
3) Swelling property
Swelling studies of films is check by using simulated saliva solution Initial weight of film is
determined and it is placed in pre-weighed wire mesh. The mesh containing film is then
dipped into simulated saliva solution. Increase in the weight of film is noted at predetermined
time intervals till no more increase in the weight.[32]
4) Content uniformity
The content uniformity of the film was detrmined by measuring the drug content in each of
of the film. The film was dissolved in 100 ml phosphate buffer of pH 6.8. The solution was
filtered and diluted with phosphate buffer before determining the drug content
spectrophotometrically. The drug contents of three films was measured then average is
calculated. The film is considered to be acceptable if the drug content was in the range of 85-
115%.[33]
5) Contact angle
Contact angle measurement helps to predicts the wetting behavior, disintegration time, and
dissolution of oromucosal thin film. These measurements are performed with help of
goniometer and the measurements must be done at room temperature. Double distilled water
should be used to determine contact angle. A drop of double distilled water is placed on the
dry film surface. Images of water droplet are recorded within 10 s by means of digital
camera. Digital pictures can be analyzed by image J 1.28v software (NIH, USA) for the
determination of angle.
6) Surface pH
The pH value of a film is determined by using pH meter. The prepared film was put in a petri
dish and film is made wet by using distilled water and note the pH by touching the film
surface with a pH meter electrode. The pH of the film should be close to neutral.[34]
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1838
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
7) In vitro disintegration time
Actually there are no official guidelines available for determining disintegration time of
orally fast disintegrating films. There are six methods:
a) Slide frame method
A drop of distilled water is poured onto the film clamped into slide frames placed on the petri
dish. Time taken by the film to disintegrate is noted.
b) Petri dish method
A film is placed in a petridish containing 2 ml distilled water. Time taken by the film to start
disintegrate is considered as the disintegrating time.
c) Pharma test
The disintegration time also determined using a disintegration taster with distilled water at
37°C and stirring. The time for ODF to disintegrate into tiny fragments was considered as
disintegration time.
d) Slide frame and ball method
The film is fixed on a perforated plate (exposed area of 6cm2).
distilled water (900μL) is deposite on the surface of the film at 37°C and a stainless steel
ball (d ¼ 10mmand mass 4g) is deposited on the surface of the film (to simulate the force of
the tongue). The time required for the ball to pierce the film and fall into the lower part of the
system is the disintegration time.
e) Sponge surface
First the surface of a sponge about 7-10 cm is moistened with phosphate buffer, pH 6.4
(250mL). Films are deposited on the surface of the sponge. The complete disappearance of
the film will be considered as the disintegration time.
f) Sensor testing
They developed an optical pass-through confirmation sensor to automatically evaluate the
disintegration time of the film. For the evaluation distilled water or artificial saliva solution
was used which is kept at 37°C in different volumes and times. The disintegration time is the
time at which the disintegration film and the test medium passed through the opening of the
apparatus.[35]
8) In-vitro dissolution test
Dissolution studies on films was conducted by using standard official basket or paddle
apparatus. During dissolution sink conditions should be maintained. Sometimes while
performing this process, film floats over the medium making it difficult to perform the test
properly so it is better to choose basket apparatus. Media used for dissolution are 6.8 pH
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1839
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
phosphate buffer (300ml) or 0.1 N HCl (900ml). Temperature should be maintained at 37±0.5
0C and rotation speed of 50 rpm is usually adjusted. Samples of drug are collected at pre-
determined time intervals and analyzed by using UV-spectrophotometer[36]
9) Permeation studies
Modified Franz diffusion cell can be used along with porcine buccal mucosa to study the
permeability. The modified Franz diffusion cell consists of a donor compartment and a
receptor compartment. In between the two compartments is the buccal mucosa mounted and
size of the mucosa should be same as that of the head of receptor compartment. Buffer is
filled in the receptor compartment and maintained at a temperature of 37 ± 0.2°C and to
maintain thermodynamics a magnetic bead stirring at 50 rpm speed is also used. A film
specimen is moistened with few drops of simulated saliva should be kept in contact with the
mucosal surface. The donor compartment must consist of 1 ml simulated saliva of pH 6.8.
Samples are withdrawn at particular interval and replaced with same amount of fresh
medium. Percentage of drug permeated can be determined by suitable analytical method.[37]
10) Visual inspection and surface morphology
Visual inspection of the film gives information about colour, homogeneity and transparency
of the film. For surface morphology, scanning electron microscopy is used. Absence of pores
and surface uniformity reflects good quality of films.
11) Stability Testing
The oromucosal films were stored under controlled conditions of 25 °C / 60 % RH as well as
40°C/75% over a period of 12 months according to the ICH guideline . During storage the
film should be inspected for their morphological properties, mass, thickness and reduction of
film thickness, tensile properties, water content and dissolution behavior(38)
.
Commercial oral thin film[40]
Table 4: List of some commercial oral thin films.
Product API Use
Listerine®
Benadryl
Suppress®
Klonopin
wafers
Theraflu
Orajel
Gas-X
Chloraseptic
Sudafed PE
Cool mint
Diphenyhydramine HCL Menthol
Clonazepam
Dextormethorphan Menthol/pectin
Simethicone Benzocain/menthol Phenylepinephrine
Diphenhydramine
Fentanyl
Ondansetron
Buprenorphine, Naloxone
Sennosides
Mouth ulcer
Antiallergic
Cough suppressant
Antianxiety
Antiallergic
Mouth freshner
Antiflatuating
Sore throat
Congestion
Antiallergic
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1840
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
Triaminic
onsolisTM
setofilm®
Suboxone®
Pedia-LaxTM
opioid analgesic
antiemetic
Treat narcotic
addiction
Laxative
API: Active pharmaceutical ingredient, PE: Polyethylene
Packaging
Packing considerations are censorious for storage, protection and stability of dosage form.
Packaging.
for oromucosal films includes foil paper or plastic pouches, single pouch, aluminium pouch,
blister packaging with multiple track sealing units are employed to get air tight sealing.
Barrier films are most commonly used for those drugs which are extremely moisture
sensitive. In the primary package, the strips are placed into individual lower packaging. The
pack should provide adequate moisture barrier and mechanical protection to the strip.
Aluminium foils are most preferred for packing of strips. By applying suitable lidding foil
tamper proof packaging is achieved. Next the laser printed upper packaging placed on it and
is subjected to sealing process.[39]
REFERENCE
1. Bala R, Pawar P, Khanna S, Arora S. Orally dissolving strips: A new approach to oral
drug delivery system. Int J Pharm Investig, 2013; 3(2): 67-76.
2. Galey WR, Lonsdale HK, Nacht S. The in vitro permeability of skin and buccal mucosa
to selected drugs and tritiated water. J Invest Dermatol, 1976; 67: 713–717.
3. Arya A, Chandra A, Sharma V, Pathak K. Fast dissolving oral films: An innovative drug
delivery system and dosage form. Int J Chem Tech Res., 2010; 2: 576–583.
4. Bhyan B, Jangra S, Kaur M, Singh H. Orally fast dissolving films: Innovations in
formulation and technology. Int J Pharm Sci Rev Res., 2011; 9: 50–56.
5. Mahajan A, Chabra N, Aggarwal G. Formulation and characterization of fast dissolving
buccal films: A review. Sch Res Libr Der Pharm Lett., 2011; 3: 152–65.
6. Vibhooti P, Preeti K. Wafers technology–a newer approach to smart drug delivery
system. Indian Journal of Research in Pharmacy and Biotechnology, 2013; 1(3): 428-439.
7. Kalyan S, Bansal M. Recent Trends In The Development of Oral Dissolving Film. Int J of
Pharm tech Res., 2012; 4(2): 725-733.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1841
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
8. Banarjee T, Ansari VA, Singh S, Mahmood T and Akhtar J. A review on fast dissolving
films for buccal delivery of low dose drugs. Int J Life Sci & Rev., 2015; 1(4): 117-123.
9. Gavaskar B, Vijayakumar S, Sharma G and Rao YM. Overview of fast dissolving films.
Int J Pharm and Pharm Sci. 2010; 2(3): 29-33.
10. El-Setouhy DA, El-Malak NSA. Formulation of a novel tianeptine sodium orodispersible
film. AAPS PharmSciTech, 2010; 11(3): 1018–1025.
11. Danckwerts M.P. Intraoral drug delivery: A comparative review. Amer. J. Drug Del,
2003; 1: 149-224.
12. Jaiswal, H. Oral Strip Technology. Ind J Pharmaceut Bio Res, 2014; 2(2): 130-114.
13. T. Nagaraju R. Gowthami M. Rajasheka S. Sandeep, M. Mallesham, D. Sathish and Y.
Shravan Kumar. Comprehensive Review On Oral Disintegrating Films. Current Drug
Delivery, 2013; 1(10): 96-108.
14. Dixit RP.& Puthli SP. Oral strip technology: Overview and future potential. Journal of
Controlled Release, 2009; 139(2): 94–107.
15. Saurabh R, Malviya R, Sharma PK. Trends in buccal film: Formulation characteristics,
recent studies and patents. Eur J Appl Sci., 2011; 3(3): 93‑101.
16. Rowe FC, Forse SF. The effect of polymer molecular weight on the incidence of film
cracking and splitting on film coated tablets. J. Pharm. Pharmacol, 1980; 32(8): 583-584.
17. Rowe RC, Forse SF. The effect of plasticizer type and concentration on the incidence of
bridging of intagliations on film-coated tablets. J. Pharm. Pharmacol. 1981; 33(3): 174-
175.
18. Mennella JA, Beauchamp GK. Optimizing oral medications for children. Clin Ther, 2008;
30(11): 2120- 2132.
19. Alpesh R, Dharmendra S, Jignyasha, A. Fast dissolving films as a newer venture in fast
dissolving dosage forms. Int J Drug Develop Res., 2010; 2(2): 232-246.
20. Patel NK and Pancholi SS. An Overview on: Sublingual Route for Systemic Drug
Delivery. Int j Res Pharm and Bio Sci., 2012; 3(2): 913- 923.
21. Vaidya MM and Khutle NM, Gide PS. Oral fast dissolving drug delivery system: A
modern approach for patient compliance. World J Pharm Res, 2013; 2(3): 558-577.
22. Kumar RK and Mercy SM. Fast Dissolving Film: A Unique Strategy for Drug Delivery
Asian J. Pharm. Res., 2014; 4(1): 47-55.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1842
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
23. Prabhu SC, Parsekar HD, Shetty A, Monteiro SS, Azharuddin M and Shabaraya AR. A
Review on Fast Dissolving Sublingual Films for Systemic Drug Delivery. Int J Pharm
&Chem Sci., 2014; 3(2): 482-496.
24. Nagar P, Chauhan Iti, Yasir M. Insights into Polymers:Film Formers in Mouth Dissolving
Films. Drug invention today, 2013; 3(12): 280-289.
25. Preis M, Woertz C, Kleinebudde P, Breitkreutz J. Oromucosal film preparations:
classification and characterization methods. Expert Opin Drug Deliv, 2013; 10: 1303–
1317.
26. Preis M, Breitkreutz J, Sandler N. Perspective: concepts of printing technologies for oral
film formulations. Int J Pharm, 494: 578–584.
27. Bhura N, Sanghvi K, Patel U, Parmar B and Patel D. A review on fast dissolving film.Int
J Pharm Res & Bio-Sci, 2012; 1(3): 66-89.
28. Jurulu NS. Fast dissolving oral films: A review. Int J Advances Pharmacy Bio & Chem,
2013; 12(1): 108-112.
29. Kumar SV, Gavaskar B, Sharan G, Rao YM. Overview on fast dissolving films. Int J
Pharm Pharm Sci, 2010; 2(3): 29‑33.
30. Sharma PK, Sharma PK, Darwhekar GN, and Shrivastava B. an overview about novel
fast dissolving oral films. International Journal of Drug Regulatory Affairs, 2018; 6(1):
1-7.
31. Ali S, Quadir A. High molecular weight povidone polymer‑based films for
fast‑dissolving drug delivery applications. Drug Deliv Technol, 2007; 7(6): 36‑43.
32. Mashru RC, Sutariya VB, Sankalia MG, Parikh PP. Development and evaluation of fast
dissolving films of salbutamol sulphate. Drug Dev Ind Pharm, 2005; 31(1): 25-34.
33. Yellanki SK, Jagtap S, Masareddy R. Dissofilm: a novel approach for delivery of
phenobarbital; design and characterization. J. Young Pharm, 2011; 3(3): 181-188.
34. Elagamy HI, Essa EA, Nouh A, & El Maghraby GM. Development and evaluation of
rapidly dissolving buccal films of naftopidil: in vitro and in vivo evaluation. Drug
Development and Industrial Pharmacy,2019; 1–32.
35. Meathrel B, Moritz C. Dissolvable films and their potential in IVDs. IVD Technol, 2007;
13(9): 53‑8.
36. Garcia VA dos S, Borges JG, Vanin FM, Carvalho RA de. Orally disintegrating films of
biopolymers for drug delivery. Biopolymer Membranes and Films, 2020; 12: 289–307.
www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal
1843
Shameera et al. World Journal of Pharmacy and Pharmaceutical Sciences
37. Mahajan A. Formulation and evaluation of fast dissolving buccal films of sertraline. Int J
Drug Dev Res., 2012; 4(1): 220‑226.
38. Patel AR, Prajapati DS, Raval JA. Fast dissolving films (FDFs) as a newer venture in fast
dissolving dosage forms. Int J Drug Dev Res., 2010; 2(2): 232‑246.
39. Rathi V, Senthil V, Kammili L, Hans R. A Brief Review on Oral Film Technology. Int J
Res Ayurveda Pharm, 2011; 2(4): 1138-47.
40. Karki S, Kim H, Na S-J, Shin D, Jo K, Lee J. Thin films as an emerging platform for drug
delivery. Asian J Pharm Sci., 2016; 11: 559-574.