OVERVIEW ON OROMUCOSAL FILM

www.wjpps.com │ Vol 10, Issue 11, 2021. │ ISO 9001:2015 Certified Journal

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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


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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.


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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]


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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.


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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)

.


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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.


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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.


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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.


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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]


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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:


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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]


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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


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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


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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]

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OVERVIEW ON OROMUCOSAL FILM