A REVIEW ON FAST DISSOLVING SUBLINGUAL FILMS FOR ...

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342

Varsha et al. World Journal of Pharmacy and Pharmaceutical Sciences

A REVIEW ON FAST DISSOLVING SUBLINGUAL FILMS FOR

SYSTEMIC DRUG DELIVERY

Varsha S. Nair1*,

R B. Saudagar2,

S. B. Gondkar3

1*

Department of Quality Assurance Techniques, R. G. Sapkal College of Pharmacy, Anjaneri,

Nashik-422213,Maharashtra, India.

2Department of Pharmaceutical chemistry. R. G. Sapkal College of Pharmacy, Anjaneri,

Nashik-422213, Maharashtra, India.

3Department of Pharmaceutics, R. G. Sapkal College of Pharmacy, Anjaneri,

Nashik-422213, Maharashtra, India.

ABSTRACT

Orally fast dissolving films are an emerging technology with fast onset

of activity and improved patient compliance. It enhances the viability

of API's and gives better medication use. These formulations are

suitable for cold, allergy rhinitis, asthma attacks, CNS issue where fast

onset of activity is needed for quicker help. The sublingual course of

medication organization is extremely compelling following the

medication retained through the sublingual veins by passes hepatic first

pass metabolic procedure and also gives a better bioavailability. The

present article outlines the definition viewpoints, manufacturing

methods like solvent casting method, evaluation parameters and

applications of fast dissolving films by sublingual route.

KEYWORDS: Sublingual delivery, Improved bioavailability, Solvent casting method.

INTRODUCTION

The Fast Dissolving Drug Delivery Systems was a headway that started to be in the early

1970's and combats over the utilization of the tablets, syrups, capsules which are the other

oral drug delivery system. Fast Dissolving Drug Delivery Systems serves as a real benefit

over the conventional dosage forms since the drugs gets quickly disintegrated & dissolves in

the salivation without the utilization of water.

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Article Received on

24 Dec 2014,

Revised on 19 Jan 2015,

Accepted on 12 Feb 2015

*Correspondence for

Author

Varsha S. Nair

Department of Quality

Assurance Techniques, R.

G. Sapkal College of

Pharmacy, Anjaneri,

Nashik-422213,

Maharashtra, India.


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The most well known oral solid dosage forms are tablets and containers. Numerous patients

find it hard to swallow tablets and hard gelatin capsules especially pediatric and geriatric

patients and do not take their medicines as prescribed.

Trouble in swallowing or dysphagia is seen to afflict almost 35% of the overall population.

At times, for example, motion sickness, sudden episode of unfavorably susceptible assault or

hacking, dread of gagging and an inaccessibility of water, the gulping of tablet alternately

containers may get to be troublesome. To overcome these troubles, a few fast dissolving

medication drug delivery system have been created. [1,2]

Orally fast-dissolving film is new drug delivery system for the oral delivery of the drugs. It

was developed on the basis of technology of the transdermal patch. The delivery system

consists of a very thin oral strip, which is simply placed on the patient’s tongue or any oral

mucosal tissue, instantly wet by saliva the film rapidly hydrates and adheres onto the site of

application. It then rapidly disintegrates and dissolves to release the medication for

oromucosal and intragastric absorption. Technology Catalysts forecasts the market for drug

products in oral thin film formulations was valued of $500 million in 2007 and could reach

$2 billion in 2012. Based on upward global growth trends of the past decade, the fast

dissolving dosage market could produce revenues of $13 billion by 2015.

Fast dissolving film is prepared using hydrophilic polymers that rapidly dissolves or

disintegrates in the mouth within few seconds and eliminates the fear of chocking as an

alternative to fast dissolving tablets. [3, 4]

Most fast dissolving films are accepting taste masked active ingredients which are swallowed

by the saliva of patients along with the soluble and insoluble ingredients.

This fast dissolving drug delivery system (FDDS) is fitted for the drugs which undergo high

first pass metabolism and is used for improving bioavailability with reducing dosing

frequency to mouth plasma peak levels, which in turn minimize adverse/side effects and

aswell accomplish it cost effective. [5]

Drug delivery by per-oral administering appear some problems such as hepatic first pass

metabolism and enzymatic degradation within the GI tract.[6]

For certain class of drugs, these

problems can be overcome by their administration through sublingual mucosa.


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OVERVIEW OF THE ORAL CAVITY [7]

The oral mucosa is made out of a outermost layer of stratified squamous epithelium. Beneath

this lies a basement membrane, a lamina propria followed by the submucosa as the innermost

layer. The oral mucosa in general is intermediate between that of the epidermis and intestinal

mucosa in terms of permeability. It is assessed that the permeability of the buccal mucosa is

4-4000 times greater than that of the skin. There are extensive differences in permeability

between different regions of the oral cavity because of the various structures and functions of

the different oral cavity.

Fig. 1: Figure of sublingual gland

Sublingual glands [8]

Salivary glands are available in the floor of the mouth underneath the tongue. They are also

known as sublingual glands. They produce mucin in turn produces saliva. The inner area of

the mouth stays lubricated due to production of the saliva by the glands, which is necessary

Fig. 1: Diagram of the sublingual gland

Fig. 2: Figure of Oral Mucosa


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for chewing and food swallowing. The fluid which is produced by the glands gets blend with

the food, so the food gets easily chewed. Due to low secretion of the saliva it can create

problem in swallowing the food and potential for food lodge in the throat increases. The

absorption is transfer of the drug from its site of administration into systemic circulation, so it

can be said that absorption is directly proportional layer thickness. The absorption of the drug

is like Sublingual > Buccal > Gingival >Palatal. Due to high permeability and rich blood

supply, the sublingual route can deliver fast onset of action so the drug with short delivery

period can be delivered and dose regimen is regulars. The drug gets diluted in the saliva and

from there the drug is adsorbed across the oral cavity.

Sublingual absorption

The absorption capability of the buccal mucosa is impacted by the lipid solubility and

therefore the permeability of the solution (osmosis), the ionization (pH), and the molecular

weight of the substances. For example, absorption of few drugs via the buccal mucosa is

shown to increase when carrier pH is lowering (more acidic) and decrease with a lowering of

pH (more alkaline) 7.9.[9,10]

The cells of the oral epithelium and epidermis are additionally fit for retaining by endocytosis

(the uptake of particles by a cell as though by hollowly wrapping itself around it. These

inundated particles are generally excessively vast to diffuse through its divider).It is

impossible that this mechanism is utililized over the whole stratified epithelium. It is also

unlikely that active transport processes operate within the oral mucosa. However, it is

accepted that acidic stimulation and uptake into the circulatory system. [11]

Special Features [12, 13]

Thin elegant film

Various sizes and shapes

Unobstructive

Mucoadhesion

Fast disintegration

Quick dissolving

Rapid release


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FACTORS AFFECTING THE SUBLINGUAL ABSORPTION [14]

Solubility in Salivary Secretion

In addition to high lipid solubility, the drug should be soluble in aqueous buccal fluids i.e.

biphasic solubility of drug is all-important for absorption.

Binding to Oral Mucosa

Systemic availability of drugs that bind to oral mucosa is poor.

pH and pKa of The Saliva

As the mean pH of the saliva is 6.0, this pH favors the absorption of drugs which remain

unionized. Also, the absorption of the drugs through the oral mucosa occurs if the pKa is

greater than 2 for an acid and less than 10 for a base.

Lipophilicity of Drug

For a drug to be absorbed absolutely through sublingual route, the drug must have slightly

higher lipid solubility than that required for GI absorption is all-important for passive

permeation.

Thickness of Oral Epithelium

As the thickness of sublingual epithelium is 100‐200 μm which is less as compared to buccal

thickness. So the absorption of drugs is faster due to thinner epithelium and aswell the

immersion of drug in smaller volume of saliva.

CHARACTERISTICS OF AN IDEAL ORALLY SOLUBLE FILM DRUG DELIVERY

SYSTEM

1. Do not require water to swallow and should dissolve or disintegrate in the mouth within a

few seconds.

2. Compatible with taste masking and added excipients.[15]

3. They possess pleasant mouth feel.[16]

4. Leave minimal or no residue in the mouth after oral administration.

5. They can bears the rigors of the manufacturing process and post manufacturing

handling.[17]

6. Resistant to environmental conditions such as humidity and temperature.[17]

7. They are adustable and amenable to the absolute processing and packaging machinery.

8. Processing and packaging of strips/ films can be done at low amount prices.[17]


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ADVANTAGES OF THIN FILMS [18]

1. Thin film is more stable, durable and quick dissolving than other conventional dosage

form.

2. Thin film enables to improve dosage accuracy relative to liquid formulations, since every

strip is manufactured in such a way that it contains a absolute amount of the drug.

3. Buccal films not only ensure more accurate administration of drug, but also can improve

compliance due to the intuitive nature of the dosage form and its inherent ease of

administration.

4. Buccal films has the ability to dissolve rapidly without the need for water, which provides

an alternate way to the patients to swallow and to patients suffering from nausea, such as

those patients receiving chemotherapy.

5. Permits continuous drug administration and the use of drugs with a short biological half-

life.

6. Accessibility of larger surface area that leads to quickly disintegrate and dissolution in

the oral cavity within seconds.

7. The large surface area available in the film dosage form allows rapid wetting by saliva

then quickly disintegrates and dissolve and absorbed directly and can enter the systemic

circulation without undergoing first-pass hepatic metabolism and on increase the

bioavailability.

8. The first pass effect can be avoided, so a reduction in the dose which can prompt to

decrease in side effects associated with the molecule.

9. It also avoids the risk and inconveniences of intravenous therapy.

10. Sublingual film delivers a convenient, quick-dissolving therapeutic dose contained within

an abuse-deterrent film matrix that cannot be crushed or injected by patients, and rapidly

absorbs under the tongue to ensure compliance.

DISADVANTAGES OF THIN FILMS

1. High doses cannot be incorporated.

2. Dose uniformity is a technical challenge.

3. These films are moisture sensitive and expensive packing of oral film is required.

4. Limitations: Most bitter drugs should be avoided or taste masking is required.

Proteinaceous drugs should be avoided if used then co-administration of enzyme

inhibitors such as aprotinin bestatin, puromicin and bile salts required for the inhibition of

proteolytic enzymes present in saliva.


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FORMULATION DEVELOPMENT

Table 1: General Composition of Fast dissolving films

Sr. No. Category Concentration (%)

1. Drug 1-25%

2. Hydrophilic Polymer 40-50%

3. Plasticizer 0-20%

4. Colors, Flavors, Fillers 0-40%

(A) CHOICE OF DRUG CANDIDATE

No bitter taste or if it is then it should be masked.

Good stability in water and saliva.

Dose should be low as possible up to 40 mg.

It should be partially unionised at the pH of oral cavity.

It should have the ability to permeate the oral mucosal tissue

Examples of some drugs that can be incorporated in Oral Fast dissolving films are listed in

Table 2.

Fig. 2: Drug Candidate


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Table 2: Drugs that can be incorporated in fast dissolving films

API Category Therapeutic Category Dose

Nicotine Smoking cessation 1-15mg

Nitroglycerin derivatives Vasodilator 0.3-0.6mg

Zolmitriptan Anti migraine 2.5mg

Loratidine Anti histaminic 5-10 mg

Omeprazole Proton pump inhibitor 10-20mg

Ketoprofen Anti inflammatory 12.5-25mg

Oxycodone Opoid Anagesic 2.5-10mg

Chlorpheniramine maleate Anti allergic 4mg

Loperamide Antidiarroheal 2mg

Triplolidine hydrochloride Antihistaminic 1.0mg

Famotidine Antacid 10mg

Azatidine maleate Antihistaminic 1.0mg

Sumatriptan succinate Antimigraine 35mg

Ketoprofen Analgesic 12.5mg

Cetrizine Antihistaminic 5-10mg

(B) SELECTION OF POLYMER [20, 21]

A variety of polymers are available for preparation of oral dissolving films. The polymers

can be ustilized alone or in combination to enhance hydrophilicity, flexibility, mouth feel

and solubility qualities of oral films.

The stiffness of the film relies on the type of polymer and the amount of polymer in the

formulation.

The different polymers which can be utilized for making mouth dissolving films must be

water soluble with low molecular weight and incredible film forming capacity, since the

primary use of all thin film oral dosage forms relies on their disintegration in the saliva of

the oral cavity.

The polymer employed should be non-toxic, non-irritant with good wetting and

spreadability property.

The polymer should not be very expensive and should be readily available.

Water dissolvable polymer that may be used include natural gums such as xanthan, guar,

acacia, tragacanth other available polymers include cellulose or cellulose derivatives,

hydroxypropylmethyl cellulose with different grades like HPMC E15, HPMC E5, HPMC

K4M, HPMC K100, hydroxyethylcellulose, hydroxypropylcelluose,

carboxymethylcellulose, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, gelatin.


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The physicochemical characteristic of the polymer or polymers selected for film

formulation play a vital role in determining the resultant disintegration time of the cast

thin film oral dosage form.

Presently, both natural and synthetic polymers are used for preparation of fast dissolving

oral film. Table 3 represents different natural & synthetic polymers which are nowadays

used in Oral Fast preparation.

Table: 3 Polymers Available Preparation of Oral Film [22]

Sr. No. Polymer Examples

1. Natural Polymer Pullulan, Starch, Gelatin, Pectin,Sodium

alginate,Maltodextrins,Polymerized Rosin

2. Synthetic Polymer Hydroxy propyl methyl cellulose, Sodium

Carboxy methyl cellulose, ethylene oxide,

Hydroxy propyl cellulose, Poly vinyl pyrrolidone,

Polyvinyl alcohol

(C)PLASTICIZER [23, 24]

Plasticizer is a key ingredient of the quick dissolving films.

Plasticizer serves to enhance the flexibility of the strip and reduces the brittleness of the

films.

It significantly enhances the film forming properties by diminishing the glass transition

temperature of the polymer.

The chemical structure and concentration of plasticizers play an important role in

alleviating the glass transition temperature of the polymers.

The selection of plasticizer will rely on its compatibility with the polymer and also the

type of solvent employed in the casting of the film.

The flow of polymer will get better with the use of plasticizer and improves the strength

of the polymer. Glycerol, Propylene glycol, low molecular weight polyethylene glycols,

phthalate derivatives like dimethyl, diethyl and dibutyl phthalate, citrate derivatives such

as tributyl, triethyl, acetyl citrate, triacetin and castor oil are some of the regularly utilized

plasticizer excipients.

Typically the plasticizers are used in the concentration of 0–20 percent; w/w of dry

polymer weight. However, inappropriate use of plasticizer may prompt to film breaking,

splitting and peeling of the strip.

It is also reported that the use of certain plasticizers may also affect the absorption rate of

the drug.


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(D)SWEETENING AGENT [25]

Sweeteners have become the important part of pharmaceutical products intended to be

disintegrated or dissolved in the oral cavity.

The classical source of sweetener is sucrose, dextrose, fructose, glucose, liquid glucose

and isomaltose.

Polyhydric alcohols such as sorbitol, mannitol and isomalt can be utilized as a part of mix

as they mouth feel and cooling sensation.

The artificial sweeteners like Saccharin, cyclamate and aspartame are the first generation

of the artificial sweeteners followed by acesulfame-k, sucralose, alitame and neotame

which fall under the second generation artificial sweeteners.

Generally sweeteners are used in the concentration of 3 to 6 %w/w either alone or in

combination

(E)FLAVOURING AGENT [26]

Ideally up to 10%w/w flavors are added in the Fast dissolving film formulations.

The acceptance of the oral disintegrating or dissolving formulation by an individual is

largely.

Depends on the initial flavor quality which is seen in first few seconds after the product

has been consumed and the after taste of the formulation which lasts for at least about 10

min.

The geriatric population like mint or orange flavors while younger generation like flavors

like fruit punch, raspberry etc.

Flavoring agents can be selected from the synthetic flavor oils, oleo resins, extracts

derived from various parts of plants like leaves, fruits and flowers. Any flavor can be

added such as essential oils or water soluble extracts of menthol, intense mints such as

peppermint, sweet mint, spearmint, wintergreen, cinnamon, clove, sour fruit flavor such

as lemon, orange or sweet confectionary.

Flavors such as vanillin, chocolate or fruit essence like apple, raspberry, cherry,

pineapple.

(F) COLOURING AGENT

A full range of colors is available including FD&C colors, EU colors, natural coloring agents

and natural juice concentrates, pigments such as titanium dioxide, silicon dioxide and zinc

oxide and custom pantone matched colors.


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MANUFACTURING METHODS [27, 28]

There are five methods for manufacturing purpose:

Solvent casting method

Semisolid casting method

Hot melt extrusion method

Solid dispersion extrusion method

Rolling method

But the most commonly used industrial methods are Solvent-casting method and Hot melt

extrusion.

1. Solvent casting method

Fast dissolving films are ideally formulated using the solvent casting method, whereby the

water soluble ingredients are dissolved to form a clear viscous solution and the drug along

with different excipients is dissolved in a suitable solvent then both the solutions are mixed

and stirred and lastly casted into the Petri plate and dried.

Water soluble ingredients are dissolved in water

API and other agents are dissolved in suitable solvent to form a clear viscous solution

Both the solutions are mixed

Degassed under vacuum

Resulting solution is cast as a film

Film is dried in drying oven and collected


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Fig. 3: Solvent casting method

2. Hot melt extrusion

Hot melt extrusion method has various benefits; those are fewer operation units, minimum

product wastage, better content uniformity, an anhydrous process, absence of organic

solvents.

In hot melt extrusion method-

Drug is mixed with carriers in solid form.

The extruder having heaters melts the mixture

Finally the melt is shaped in films by the dies

Fig. 4: Hot melt extrusion process


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3. Semisolid casting method

This technique is ideally embraced when acid insoluble polymers are to be used in the

preparation of the films. Acid-insoluble polymers used to prepare films include: cellulose

acetate phthalate, cellulose acetate butyrate. Acid insoluble polymer and film forming

polymer should be used in the ratio of 1:4.

Solution of water soluble film forming polymer is prepared.

Resulting solution is added to a solution of acid insoluble polymer

Appropriate amount of plasticizer is added so that gels mass is obtained.

Finally the gel mass is casted into the films or ribbons using heat controlled drums.

4. Solid dispersion extrusion method

The term solid dispersions refer to the dispersion of one or more active ingredients in an inert

carrier in a solid state in the presence of amorphous hydrophilic polymers.

Drug is dissolved in a suitable liquid solvent.

Then solution is incorporated into melt of polyethylene glycol, obtainable below 700C.

Finally the solid dispersions are shaped into the films by means of dies.

Precautions while preparing solid dispersions

The selected solvent or dissolved drug may not be miscible with the melt of polyethylene

glycol and polymeric form of drug precipitated in the solid dispersions may get affected by

the liquid solvent used.

5. Rolling method

In this method the film is prepared by preparation of a pre-mix, the addition of an active and

subsequent formation of a film.


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Prepare pre-mix with film forming polymer, polar solvent and other additives except a drug.

Add pre mix to master batch feed tank.

Fed it via a 1st metering pump and control valve to either or both of the 1st and 2nd mixer.

Add required amount of drug to the desired mixer.

Blend the drug with master batch pre mix to give a uniform matrix.

Then a specific amount of uniform matrix is then fed to the pan through 2nd metering pumps.

The film is finally formed on the substrate and carried away via the support roller.

The wet film is then dried using controlled bottom drying

PACKAGING [29]

In the pharmaceutical industry, it is vital that the package selected adequately should preserve

the integrity of the product. Expensive packaging, specific processing and special care are

required during manufacturing and storage to protect the dosage of other fast dissolving

dosage forms. A variety of packaging options are available for fast dissolving films. Single

packaging is mandatory for films. An aluminum pouch is the most commonly used packaging

format.

1. Foil, paper or plastic pouches

The flexible pouch is a packaging concept capable of providing not only a package that is

temper-resistance, but also by the proper selection of material, a package with a high degree

of environmental protection. A flexible pouch is usually formed during the product filling

operation by either vertical or horizontal forming, filling or sealing equipment. The pouches

can be single pouches or aluminum pouches.

2. Single pouch and Aluminum pouch

Soluble film drug delivery pouch is a able pouch for “quick dissolve” soluble films with high

barrier properties. The pouch is transparent for product display. Using a 2 structure


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combination allows for one side to be clear and the other to use a cost effective foil

lamination. The foil lamination has essentially zero transmission of both gas and moisture.

The package provides a flexible thin film alternative for nutraceutical and pharmaceutical

application. The single dose pouch provides both product and dosage protection. Aluminum

pouch is the most commonly used pouch.

3. Blister card with multiple units

The blister container consists of two components : the blister, which is the formed cavity that

holds the product, and the lid stock, which is the material that seals to the blister. The blister

package is formed by heat-softening a sheet of thermoplastic resin and vacuum- drawing the

softened sheet of plastic into a contoured mold. After cooling the sheet is released from the

mold and proceeds to the filling station of the packaging machine. The semi rigid blister

previously formed is filled with the product and lidded with the heat sealable backing

material. The film selection should be based upon the degree of protection required.

Generally the lid stock is made of aluminum foil. The material used to form the cavity is

typically a plastic, which can be designed to protect the dosage form from moisture.

EVALUATION TESTS [32, 33, 34, 35, 36, 37, 38, 39]

1. Thickness

As the thickness of film is directly concern with drug content uniformity so it is necessary to

ascertain uniformity in the thickness of the film. It can be measured by micrometer screw

gauge or calibrated digital Vernier Calipers at different strategic locations.

2. Weight Variation

Weight variation is studied by individually weighing 10 randomly selected films and by

calculating the average weight.

3. Folding endurance [30,31]

Folding endurance is determined by repeated folding of the strip at the same place till the

strip breaks. The number of times the film is folded without breaking is computed as the

folding endurance value.

4. Dryness test/tack tests

Tack is the tenacity with which the strip adheres to an accessory (a piece of paper) that has

been pressed into contact with the strip. Instruments are also available for this study.


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5. Tensile strength

Tensile strength is the maximum stress applied to a point at which the strip specimen breaks.

It is calculated by the applied load at rupture divided by the cross‐sectional area of the strip as

given in the equation below.

Tensile strength = Load at Failure × 100

Strip thickness × Strip Width

6. Percent elongation

When stress is applied, a strip sample stretches and this is referred to as strain. Strain is

basically the deformation of strip divided by original dimension of the sample. Generally

elongation of strip increases as the plasticizer content increases.

% Elongation = Increase in length × 100

Original length

7. Surface pH

The film to be tested was placed in a petri dish and was moistened with 0.5ml of distilled

water and kept for 30sec.The pH was noted after bringing the electrode of the pH meter in

contact with the surface of the formulation and allowing equlibriation for 1min. The average

of three determinations for each formulation was done

8. Uniformity of drug content

This parameter was determined by dissolving one film of dimension 2 x 2cm by

homogenization in 100 ml of stimulated saliva of pH 6.8 for 30 min with continuous shaking.

From this, 10 ml was diluted to 50 ml with simulated salivary fluid. The absorbance was

measured using an UV spectrophotometer. The experiments were carried out in triplicate for

the films of all formulations and average values were recorded.

9. In vitro dissolution studies

Dissolution profile of fast dissolving films was carried out using USP type II (paddle

apparatus) with 300 mL of simulated salivary fluid (pH 6.8) as dissolution medium

maintained at 37 ± 0.50C. Medium was stirred at 100 rpm. Samples were withdrawn at every

30 sec interval, replacing the same amount with the fresh medium. Amount of drug in the

withdrawn samples was determined by UV spectrophotometer. The percent drug released was

plotted against time.


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10. Disintegration time

Disintegration of orally fast dissolving films requires US disintegration apparatus. The

disintegration time limit of 30 seconds or less for orally disintegrating tablet described in

Centre for Drug Evaluation and Research (CDER) guidance can be applied to fast dissolving

oral strips. Disintegration time will vary depending on the formulation but typically the

disintegration range from 5 to 30 seconds.

CONCLUSION

Sublingual absorption is efficient since the percent of drug absorbed by this route is generally

higher than that achieved by oral route. Sublingual film have gained popularity because of

better patient compliance, rapid onset action, the drug is directly absorbed into systemic

circulation. Films have several advantages over the conventional dosage forms. So, they are

of great importance during the emergency condition like allergy. Short term spasm and

asthma a whenever immediate onset of action is desired. Therefore oral thin films are an

accepted technology for systemic delivery of API’s.

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