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Oral dissolving films are advanced forms of oral medication designed to adhere to the buccal mucosa, offering both local and systemic effects. When compared to other oral drug delivery systems, these dosage forms are preferred due to their flexibility and comfort. These films make use of certain polymers with bio-adhesive properties, which, upon hydration, target a specific region of the body for a prolonged period, thus bypassing first-pass metabolism and enhancing bioavailability. This review aims to give an overview of fast-dissolving oral film. Recent advancements in technology have introduced viable dosage options for pediatric, geriatric, bedridden, nauseous, or noncompliant patients, offering alternatives to the oral route. The fast-dissolving oral thin film is a solid form of medication that breaks down or dissolves within 1 minute when placed in the mouth without the need for water or chewing.
Oral administration is a widely used method for giving medications because it is cost-effective, convenient, and easy for patients to take, which improves their adherence to treatment. However, the oral route can be challenging for older and pediatric patients who have difficulty swallowing and fear choking [1]. Fast dissolving oral thin films are extremely thin films that use a water-loving polymer that quickly hydrates or sticks when placed on the tongue or in the buccal cavity [2]. As the mucosa is exceedingly enhanced with blood supply, it give fast assimilation and moment bioavailability of drugs. A oral film is effortlessly set on the patient's tongue or mucosal tissue, where it instantly gets damp by spit and breaks up rapidly[3]. Oral dispersed film have advanced from confection and oral care. Companies that have created polymer coatings containing dynamic pharmaceutical fixings (APIs) for transdermal medicate organization have bounced at the opportunity to change over their innovation to ODF designs. ODFs are approved and affirmed procedure for systemic conveyance of APIs in over-the counter (OTC) pharmaceuticals and they are still within the early stages of advancement for medicine drugs[4].
Classification Of Oral Films: Oral films can be divided into three categories
1. Flash release films
2. Mucoadhesive melt-away films
3. Mucoadhesive sustained-release films
Ideal properties of the film forming polymers
• The polymer utilized ought to be non-toxic, non-irritant and void of leachable debasements.
• It ought to have great wetting and spreadability property.
• The polymer ought to show adequate peel, shear and malleable qualities.
• The polymer ought to be promptly accessible and ought to not be exceptionally costly.
• It would be perfect to have a polymer that would have nearby chemical restraint activity in conjunction with entrance improving property.
Advantages
• Avoiding the chance of choking
• Avoid to begin with pass digestion system and give speedier onset of activity at lower measurements.
• No necessity of water
• Large surface region gives fast deterioration and disintegration within the verbal depth
• Ease of organization of film to the patients enduring from dysphagia, rehashed emesis, movement affliction, and mental disarranges as well as crisis condition
Disadvantages
• Drugs with tall measurements cannot be joined into the film.
• Drugs which causes bothering to the mucosa cannot be managed.
• As it is delicate and must be ensured from water, it requires extraordinary bundling.
Formulation Considerations For Oral Dispersed Film
Oral dispersed film having a surface region of 1-3 cm2 are most worthy. The entire sum of drug that can be conveyed over the buccal mucosa in one day from a 2cm2 gadget is assessed to be around 10-20mg. The shape of the conveyance framework can moreover change, while an ellipsoid shape shows up to be the foremost fitting for buccal drug administration. The conveyance device's thickness is regularly restricted to a couple of millimeters[5]. Since nourishment and/or refreshment utilization may request evacuation of the conveyance gadget, the most extreme length of buccal medicine retention and absorption is around 4-6 hour.[6]
Composition Of The Formulation
A typical composition contains the following:
1. Drug: 5% to30%w/w
2. Water soluble polymer: 45%w/w
3. Plasticizers: 0-20%w/w
4. Surfactants: q.s.
5. Sweetening agent: 3 to 6%w/w
6. Saliva stimulating agent: 2 to 6%w/w
7. Fillers, colors, flavors etc.: q.s
1.Choice of Drug candidate:
Less bitter, strong and profoundly lipophilic medicate ought to be favored for OTF as in case of quick dissolving tablets.
Anti-ulcers (e.g. omeprazole), anti-asthmatics (salbutamol sulfate), antitussives, antiemetics, expectorants and NSAIDs [7].
2. Active pharmaceutical ingredient:
A normal film contains 1-30% w/w of the dynamic pharmaceutical fixing. it is basic to consolidate micronized API since it upgrade the surface of film and give fast disintegration and consistency within the quick dissolving film [8]
3.Water Soluble Polymers:
As the film forming polymer (which serves as the oral Film's stage) is the foremost imperative and significant component, at slightest 45 % w/w of polymer ought to be show based on the overall weight of dry oral Film[9].
e.g. hydroxypropyl cellulose (HPC), pullulan, carboxymethyl cellulose (CMC), pectin, starch, polyvinyl acetic acid derivation (PVA) and sodium alginate are among the film-forming polymers contained in these ODFs [10].
4.Plasticizers:
It is an important ingredient of oral thin film. The plasticizers improve progress the mechanical properties of film such as pliable quality and prolongation to the film. It too diminishes the brittleness of the film [11]. e.g. glycerol, propylene glycol, polyethylene glycol, dimethyl, dibutyl, diethyl phthalate, tributyl, triethyl, actyl citrate, triacetin and castor oil [12].
5. Surfactants:
Surfactants are utilized in details as a solubilizing, wetting or dispersed agent, permitting the film to break up in seconds and the active substance to be released quickly [13]. e.g. Sodium lauryl sulfate, Poloxamer 407, benzalkonium chloride and tweens are some of the mostly use [14].
6.Saliva stimulating agent:
The reason of utilizing saliva stimulating agent is to extend the rate of production of saliva so that the oral film disintegrate and break up speedier within the oral cavity. e.g. citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid. Among this, citric acid is the mostly used [15].
7.Sweetening agent:
Enhancing agent sweeteners are used to mask the bitter taste of certain medicines. Both natural and artificial sweeteners can be used alone or in combination( 16). Sweeteners that are generally employed include isomaltose, polyhydric alcohols( sorbitol, mannitol), fructose, glucose, sucrose, and dextrose. also, artificial sweeteners similar as cyclamate, aspartame, saccharin, acesulfame K, sucralose, alitame, and neotame( alternate generation) can be employed( 17).
8.Flavouring agent:
Any flavor that championed by the US Food and Sedate Organization( FDA) can be included, similar as solid mints, acrid natural product flavors or sweet confectionery flavors( 18). The sum of flavor needed to cover the taste is decided by the kind and quality of the flavor They confer enhance to the description Fruity flavors( vanilla, cocoa, coffee, chocolate, and citrus) and flavor canvases ( peppermint, cinnamon, and nutmeg) are as frequently as possible employed( 19).
9. Colouring agents:
colors like silicon dioxide, titanium oxide or FD&C approved coloring agents are most generally used. Their attention position should n't exceed 1% [20]
Methodologies For Preparation Of Oral Dispersed Films:
o Solvent casting method
o Semisolid casting method
o Hot melt extrusion method
o Solid dispersion extrusion method
o Rolling method
Evaluation Parameters
Consistence indicates the measures fineness of rehabilitate within the film. It's measured by a micrometer screw guarantee or calibrated motorized Vernier calipers. The consistence of the film ought to be within the extend of 5- 200 µm( 21).
Weight variation is calculated by importing any five flicks from the expression collectively on a digital balance and also calculating the average weight( 22).
It's the outside stress applied to a point of film at which the strip illustration breaks. tensile strength is calculated by the applied cargo at rupture divided by the cross-sectional area of the strip.
Tensile Strength= Load at failure ×100/strip thickness ×strip width
Tear resistance It's the maximum resistance needed to tear the film. A veritably low rate of cargo of 51 mm/ min is applied. Its unit is Newton or pounds force.
The stiffness of the strip is determined by it. In the region of elastic distortion, it's the rate of applied stress to strain. High tensile strength and youthful's modulus are set up in flicks which are hard and brittle( 23)
Young’s modulus=Slope×100/strip thickness cross × head speed
Capacity In arrange to control the oral physical integrity and stability, this test is conducted in an environment with hoisted humidity. Taking after that, the film are measured, and the taking after equation is utilized to decide their rate dampness assimilation capacity [24].
?pabilities for absorbing moisture = (Starting Weight – Ending Weight) Starting Mass × 100
When a stress is applied to the film, it begins to stretch and is called strain. The film's deformation is divided by its original dimensions. It depends on the plasticizer added [25].
% elongation=Increase in length of film×100/Initial length of film
A film's mechanical qualities can be determined by folding endurance. Folding the film repeatedly at the same spot determines it. The endurance of the oral dissolving films is determined by the number of times they can be folded without tearing [26].
Drug Content:
A solvent-filled volumetric flask is used to place the film, which has been cut to 2 cm2. To gain a homogenous result, this is shaken for two hours in a mechanical shaker. A UV spectrophotometer is used to identify the medicine content after the proper dilution( 27).
To determine the transparency of the film, a simple UV spectrophotometer is used. Film is taken and placed on the internal side of the spectrophotometer cell and also analysed at 600 nm. You can calculate transparency using the following formula( 28).
Transparency = (log T600)/B = -€c
In the humidity chamber, an accelerated environment with 65% relative humidity and 35°C temperature is used to conduct the stability investigation. After three months, the drug content, disintegration time, and physical appearance of flicks are estimated.
CONCLUSION
The formulators need to bring novelty and provide consumer satisfaction simultaneously in the current scenario. Oral dissolving films have been found to be one of the promising and novel approaches for maximizing the therapeutic action of drug and enhancing the patient compliance as well. They're capable of delivering the active ingredient both locally and systemically. For patients with swallowing difficulties, as well as for the elderly and pediatric populations.
REFERENCES
Ayesha patil*, Sanika Bhosale, Rutuja Gadade, Oral Dispersed Film, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 11, 377-382. https://doi.org/10.5281/zenodo.14051150
10.5281/zenodo.14051150
