INTRODUCTION:

For the delivery of drugs, oral route is the most suitable and preferred route to reach the systemic effect because of its ease of administration, non-invasiveness, adaptability, patient compliance, and acceptability^1,2. Most of the drugs are delivered orally in the form of tablet, because they are easily manufactured and higher patient compliance³. But in some cases the patients with geriatric, pediatric, nauseous, bed ridden and noncompliance disease experience difficulties in taking the conventional oral dosage forms as per prescription. The estimated rate of population is about 50 % was affected, and experienced by this problem during the use of conventional dosage forms. These problems will lead to develop more chance of noncompliance and ineffective therapy⁴. The conventional dosage forms including tablet have a very common complaint with tablet is size, and the fear of chocking. Geriatric and pediatric patients are not ready to swallow the tablet dosage form, and also the patients during travelling who may not carry or ready to access water^5,6. To defeat such type of problems, oral fast disintegrating/oro-dispersible drug delivery system was designed. Initially this system was designed in late 70’s as alternative methods for the development of tablet, capsules, syrup for pediatric, and geriatric patients who difficulties in swallowing the conventional/traditional oral solid dosage forms. The main property of these dosage forms is their fast dissolution, or disintegration normally within a 3 minute in mouth, without the need of water^7,8.

Figure 1: Example of Orodispersible Film

Orally fast-dissolving systems for medication delivery are popular nowadays. Oro-dispersible film was recently introduced for the delivery of pharmaceuticals through the oral route due to the demand for quick dissolving drug delivery methods. This system is based on a transdermal drug delivery device, such as a transdermal patch. The delivery method comprises of a very thin oral strip that is applied on the tongue or any other oral mucosal tissue by the patient. The main function of this film is to wet immediately by saliva, due to this phenomenon the film will hydrates and easily adhere at the site of administration. The medication that was inserted into the film disintegrates and dissolves quickly. This drug release phenomenon was effective in getting medication to the oromucosal and intragastric absorption sites quickly^9,10. Patients have praised oro-dispersible thin films for their simplicity of administration, mobility, and precise dosing at the delivery site¹¹. They also have a speedy beginning of action, taking only a few seconds, because oro-mucosal absorption of the medication occurs directly from the site of injection to the systemic circulation, bypassing first-pass metabolism^12,13,14,15. This review article's purpose is to give a brief overview of the orodispersible film delivery, manufacturing and evaluation technique.

· A range of medications can be created in the formulation of oro-dispersible films. Some of the unique items in oro-dispersible film may boost the therapeutic potential in the following indications^11,15.

· Pediatrics is the branch of medicine that deals with children (Expectorants, Anti-asthamatics, and Anti-tussives,)

· Geriatrics is a term that refers to a group of people who are (Antiepileptic, Expectorants)

· Gastrointestinal diseases

· Nausea (by Cytostatic therapy)

· Pain (Migraine)

· CNS (Anti-parkinsonism therapy)

Orodispersible films unique features^16,17:

· Thin elegant film

· Available in a variety of sizes and forms

· Unremarkable

· Excellent mucoadhesion

· Fast dissolution and disintegration

· Rapid release of drug

· Bypasses first pass outcome

Advantage of orodispersible films^18,21:

· Water is not required for administration.

· Suitable for children, the elderly and dysphasic individuals who have difficulties swallowing.

· Due to their huge surface area, medicines dissolve and disintegrate quickly.

· Because the hepatic first pass effect is bypassed, the drug has a faster onset of action and a higher bioavailability.

· Reduced dosage improves the drug's efficacy and safety profile while reducing negative effects.

· Because they are flexible and moveable, they are simple to handle, transport, and store.

· Ease of administration to mentally ill, severely disabled, uncooperative/unhelpful patients, and those who drink less water or are queasy.

· Helpful for individuals who have motion sickness, severe discomfort, an unexpected allergic reaction, an asthmatic attack, or coughing and require a fast beginning of action.

· Because the drug is in solid dosage form until it is consumed, it maintains its stability for a longer period of time.

· When opposed to liquid formulations, dosage accuracy is more important.

· There is no excess residue in the mouth following the administration of the film, leaving a pleasant feeling in the mouth.

Limitations of orodispersible films:

· High dose of drug can’t be given by film.

· Excessive bitter drugs are not feasible.

· A major technical challenge is to maintain the dose level.

· The drugs which cause irritation to the mucosal layer are not administered by orodispersible film.

· For the products' stability and safety, they require particular packaging.

Comparison between orodispersible films and orodispersible tablets^14,15,16:

The comparison between orodispersible film and orodispersible table should be described in Table 1:

Table 1: Comparison between Oral Films and Oral Disintegrating Tablets

S. No.	Orodispersible Films	Orodispersible Tablets
1.	With a bigger film surface area, there is more disintegration.	With less surface area than Orodispersible film, there is less dissolving.
2.	Flexible and long-lasting, oro-dispersible films	Flexible and long-lasting oro-dispersible films
3.	Low dose of drug is required to form ODF	High dose of drug can delivered
4.	The thickness of film is 50 to 500 µm	Thickness is equal to conventional tablet
5.	Patient compliance is more important than ever.	Patients respond is lower than FDOF^22,23,24.

Figure 1: Comparison of Orodispersible film over other dosage forms.

Benefits of fast dissolving oral film over fast disintegrating tablets^24,25:

· A large efficient surface area is helpful for the fast disintegration of drugs.

· Zero loss of friability

· Cheaper manufacturing and packaging materials is needed.

· Fear of choking is zero

· Less excipients are required

· Less time is required for manufacturing.

· More elegant

· More economical

Classification of orodispersible films:

The important classifications of Orodispersible film are enlisted in Table 2²⁴.

Formulation of orodispersible films:

Orodispersible films are made up of a variety of components including:

· Active medicinal compounds,

· Film forming polymers

· Plasticizers

· Flavoring agent

· Coloring agent

· Sweetening agent

· Saliva stimulating agent

· Surfactants

Pharmaceutical active ingredient²⁶:

The active pharmaceutical ingredient (API) in the Orodispersible film ranges from 1 to 30% by weight. Because high doses of medicine are difficult to combine into fast dissolving films, always use a lower dose of drug. Table 3 lists a vast range of medications that can be employed in the manufacture of Orodispersible film.²⁷

S. No.	Drug Candidate	Dose	Therapeutic Activity
1.	Azatidine Maleate	1 mg	Anti histaminic
2.	Nicotine	2 mg	Smoking cessation
3.	Loperamide	2 mg	Anti diarroheal
4.	Ondansetron	2.5 mg	Anti emetic
5.	Zolmitritpan	2.5 mg	Anti migraine
6.	Salbutamol	4 mg	Anti histaminic
7.	Chlorpheniramine Maleate	4 mg	Anti allergic
8.	Cetirizine	5-10 mg	Anti histaminic
9.	Acrivastine	8 mg	Anti histaminic
10.	Loratidine	10 mg	Anti histaminic
11.	Omiprazole	10-20 mg	Proton pump inhibitor
12.	Famotidine	10 mg	Antacid
13.	Ketoprofen	12.5 mg	Analgesic
14.	Dicyclomine hydrochloride	25 mg	Muscle relaxant
15.	Diphenhydramine hydrochloride	25 mg	Anti allergic
16.	Sumatriptan succinate	35-70 mg	Anti migraine
17.	Triplodine hydrochloride	2.5 mg	Anti histaminic

The selected drug's ideal characteristics:^{30,31,32,33,34}

· The medicine should have a pleasing taste.

· The drug's therapeutic dose should not exceed 40 milligram’s.

· The drug's molecular size and molecular weight should be reduced.

· The drug's solubility and stability in aqueous saliva should be lower.

· At the pH of the oral cavity, the drug is partially unionized.

· The medicine should be relatively unaffected by environmental factors.

· The drug's ability to enter the oral mucosal layer/tissue is important.

Polymers for film forming:

Polymer is the most important and important component of FDOFs^35,36. For the manufacture of Oro-dispersible film, a large number of polymers are available, and these are used at a concentration of about 40-45 percent w/w of total film weight, but can be increased up to 65 percent w/w of film weight without help or in arrangement to obtain desired oral film properties^37,38,39. The manufactured film must be hard sufficient, due to this quality there is no damage will found during transportation. The robustness of the Oro-dispersible film depends with the type of polymer used, and polymer quantity in the formulation. The physicochemical features of the polymer in the formulation of Oro-dispersible film play an important role to determine the desired dissolution, and disintegration time of Oro-dispersible film⁴⁰. Natural and synthetic film forming polymers are enlisted in Table 4⁴¹.

Ideal properties of the film forming polymers ^42,43:

· The polymer should be non-toxic in nature, nonirritant and devoid of any leachable impurities.

· It should have no taste.

· The wetting and spreading properties of oro-dispersible film are excellent.

· The peel, shear, and tensile strengths of the film polymer should be appropriate.

· Polymers are inexpensive and widely available.

· It should last for a long time.

· It should not result in any small infections in the oral mucosa or the dental area.

· Polymers have a good tongue feel to them.

· It would be nice to have a polymer that inhibited enzymes in the nearby area.

Table 4: List of some natural/synthetic film forming polymers⁴¹

S.No.	Natural Polymers	Synthetic Polymers
1.	Starch	Hydroxy propyl methyl cellulose Pectin
2.	Pectin	Polyvinyl alcohol (PVA)
3.	Gelatin	Poly vinyl pyrolidone (PVP)
4.	Sodium alginate	Poly ethylene oxide (PEO)
5.	Maltodextrin	Sodium Carboxy methyl cellulose
6.	Pullulan	Hydroxy propyl cellulose (HPC)
7.	Xanthan	Kollicoat IR
8.	Polymerized resin	Methyl cellulose (MC)
9.	Gum acacia	Hydroxy ethyl cellulose (HEC)

Plasticizers:

Film mechanical properties have been observed to be influenced by formulation considerations (Plasticizer, etc.). The qualities of ODF, such as tensile strength and elongation, have been improved by the addition of plasticizers. These properties may be affected by changes in their concentration. Plasticizers such as glycerol, dibutylpthallate, and polyethylene glycols are commonly utilized.

Sweetening agents^38,39:

Sweetening agents are used in formulation to improve the taste of film. They are important for the manufacturing of Orodispersible products. Sucrose, dextrose, fructose, glucose, liquid glucose, sorbitol, mannitol, iso-malt, polyhydric alcohols, Saccharin, cyclamate and aspartame are the major polymers used in the production of ODF.

Saliva stimulating agents⁴⁰:

Saliva stimulating chemicals are utilized to promote saliva production, and this phenomenon aids in the dissolving and disintegration of Orodispersible film formulations. Salivary stimulating chemicals are commonly employed in the food processing process. Citric acid, malic acid, lactic acid, ascorbic acid, and tartaric acid are some of the most common acids.

Surfactants:

Surfactants are agents which are used in the preparation of Orodispersible film. Due to the use of surfactants in formulation the film gets easily solubilize, wet, or dispersed within seconds, and the whole process will help to increase the release of drug frequently. The varieties of surfactants are used in the manufacturing of Orodispersible film which includes SLS (sodium lauryl sulfate), Benzolkonium chloride, tweens, and Bezthonium chloride etc. A commonly used surfactant is Polaxamer-407, which is used for their effective wetting, solubilizing, and disintegrating property.

Flavoring agents⁴¹:

To enhance the taste of film flavoring agents are used and the flavors are mostly obtained from the synthetic sources, eg; oils, and oleo resins. The extract was obtained from the several parts of plants which include leaves, fruits, and flowers. For the preparation of Orodispersible films the combination of flavors are used. Ideal different flavors as per the type and taste of the drugs are mentioned in Table 5⁴².

Table 5: Ideal flavouring agents according to the type and taste of drug candidate

S. No.	Drug Candidate	Ideal Flavoring Agent
1.	Antibiotics	Cherry, pineapple, maple, orange, banana-vanilla, raspberry, butterscotch, fruit-cinnamon, coconut-custard, strawberry, vanilla
2.	Barbiturates	Banana-pineapple, banana-vanilla, cinnamon-peppermint, orange, peach-orange, grenadine-strawberry.
3.	Antihistamines	Apricot, cinnamon, cherry, grape, lime, honey, peach-orange, raspberry, peach-rum, wild cherry
4.	Electrolyte solutions geriatrics	Cherry, lemon-lime, grape, wild cherry syrup, raspberry, grenadine-strawberry, port-wine, lime, cherry-wine, wild strawberry. Drug with salty taste Butterscotch, drug with bitter taste wild cherry, chocolate-mint, walnut, Drug with sweet taste berry, vanilla.
5.	Decongestants and Expectorants	Anise, apricot, butterscotch, cherry, coconut-custard, custard mint- strawberry, grenadine-peach, strawberry-lemon, gooseberry, orange-lemon, coriander, pineapple, raspberry.

Coloring agents:

A wide variety of hues are available, including FD&C, EU, Natural, and Pantone-matched bespoke colours. The drug/Colouring agent must be comfortable for integrating in Orodispersible film once the incorporated drug in the film was available in the form of suspended or insoluble particles. Colorants such as titanium dioxide or FD&C certified coloring compounds are commonly used (concentrations of less than 1% w/w)^{43,44,45,46,47,48}.

Table 6: Criteria for selection of excipients along with their concentration

S. No.	Category	Concentration (%)
1.	Drug	1-25
2.	Polymer	4.-50
3.	Plasticizer	25-35
4.	Sweetener	2-10
5.	Flavor	2-5

Manufacturing techniques:

· Solvent casting

· Semisolid casting

· Hot melt extrusion

· Solid dispersion extrusion

· Rolling

Solvent casting⁴⁹

The majority of Orodispersible films are made using solvent casting processes. Ingredients that are soluble in water and easily dissolve into a clear viscous solution are employed in this procedure. A suitable solvent is required to dissolve the drug with other excipients. After that, both the solutions are mixed together, and by continuous stirring them finally ready to casted in to the dried Petri plate.

Figure 3: Solvent Casting.

Semisolid casting³³:

In semi-solid casting methods a solution is prepared which contain water soluble polymer to form an Orodispersible film. Then the solution was added to a solution which contains acid insoluble polymer commonly include cellulose acetate phthalate, and cellulose acetate butyrate. A required quantity of plasticizer was used to get the gel mass. Now, add the gel mass in the film by using heat controlled drums. Film thickness was maintained around 0.015-0.05 inches, and the ratio should be maintained about 1:4.

Hot melt extrusion⁵⁰:

This approach can be used to make granules, sustained-release pills, as well as transdermal and transmucosal drug delivery devices. This method was used from since 1971 in pharmaceutical industries. Also this method was helpful to prepare the fast dissolving films.

Figure 4: Hot Melt Extraction.

Solid dispersion extrusion:

In solid dispersion extrusion method a combination of one of more active ingredients was used as an inert carrier by solid state. The material was used in the occurrence with amorphous polymers which are hydrophilic in nature. The dissolution of drug should be occurred at suitable solvent which is liquid in nature. After that the solution was administered at 70°C by melting polyethylene glycol. Inlast the prepared solid dispersions were made in the form of films.

Figure 5: Solid Dispersion Extrusion Method.

Rolling method⁵¹:

In the rolling approach, the film was made first, then an active ingredient was added, which was pre-mixed with the film forming polymer. The polar solvent, as well as additional chemicals were utilized. Fill a master batch feed tank with the pre-mixed solution. Another mechanism for managing a control valve is used to balance the two mixers, which is fed with the help of the first metering pump. Then, add the needed amount of medicine to the desired mixer on a regular basis. After that, mix the medication with the master batch to create a homogenous matrix. The 2nd metering pump is used to add the desired amount of uniform matrix to the pan. Finally, the Orodispersible film will be prepared with the aid of a roller, and the film will be allowed to dry using a control bottom.

Figure 6: Rolling Method.

Characterization of fast dissolving films:^{52,53,54,55,56,57,58}

Thickness

The thickness of the film is important to get their ideal size, the term thickness is frankly linked with uniformity of drug content. So, this parameter is useful to identify the thickness of the film. The thickness of the film can be measured by two methods one is known as micrometer screw gauze, and another one is known as calibrated digital Vernier Caliper.

Dryness test or tack tests

Tack test is used to identify the tenacity of prepared film in which the strip will adhere with a paper piece, and then gently pressed the strip. To check these properties there are many instruments available.

Tensile strength

A maximum stress is applied to the film strip, and note down at which point the film will break. This phenomenon is called as tensile strength of film. The formula for the calculations of tensile strength of Orodispersible film will given in the equation given below:

Tensile Strength = (Load of Failure × 100)/(Strip Thickness × Strip Width)

Percent elongation:

A stress is useful to place on a film strip in the Percent elongation parameter. The film will stretch as a result of the force, resulting in a strain. The stretching of the film is essentially the bending of the film strip, followed by the division of the film's initial dimension. When the amount of plasticizers in a film strip is increased, the elongation of the film strip usually increases.

Percent Elongation = (Increase in Length × 100)/ (Original Length)

Young's modulus:

Young's modulus is a measure of strip stiffness. In the zone of elastic deformation, it is expressed as the ratio of applied stress to strain:

Young's Modulus = (Force of Corresponding Strain)/ (Cross Sectional Area) ×1/(Corresponding Strain)

Resistance to tears:

Tear resistance is a multidimensional function of prepared plastics film or sheeting's ultimate resistance to rupture. To determine the ripping resistance of film strip, a very slow rate of 51mm or 2inch/min is used. The highest stress or applied force is what causes the tearing to begin. The needed tearing sample was calculated using the Newton's (pounds) force value.

Variation in weight:

The weight variation of the film was investigated independently by weighing and calculating the average weight of ten randomly selected films.

Folding endurance:

Folding endurance of the film was calculated by recurring the folding of the strip, the same place were noted down till the breaking of film strip. The number of times the film is folded without breaking was justified as the folding endurance value.

pH of the film's surface:

The pH of the surface of the Orodispersible film was tested in-vivo to see if there were any negative effects. This was accomplished with the help of a combination pH electrode. The pH was determined by placing the electrode on the wetted surface of the oral film.

Swelling index:

Film swelling tests are carried out with a simulated saliva solution. Each film sample was first weighed and then placed in a stainless steel container that had been pre-weighed (wire mesh). Then pour it into a 15ml medium plastic jar. The weight of the film was measured at predetermined intervals until it reached a constant weight. The following equation was used to compute the film's swelling behaviour:

∝ = (Wt-Wo)/Wo

Wt-weight of film at time t,

Wo-weight of film at time zero

Transparency:

The UV Spectrophometer was used to verify the film transparency. The film was then cut into rectangles and placed under the spectrophotometer's cell. At 600 nm, determine the transmittance of films. The films transparency was determined as follows:

Transparency=logT600/b=-€c

T600- Transmittance at 600 nm,

b- Film thickness (mm),

c- Concentration.

Assay and content uniformity:

Assay and content uniformity of any drug substance was calculated according to standard pharmacopoeia. The Content uniformity of active pharmaceutical ingredients was calculated to identify the individual film. The content uniformity limit of API’s is about 85–115%.

Disintegration time:

Orally fast dissolving films require disintegration equipment made in the United States. CDER (Center for Drug Evaluation and Research) set a 30-second time limit for Orodispersible tablets and a shorter time limit for Orodispersible films. The pace of disintegration of formulations varies depending on their type, although the typical range for film disintegration is 5 to 30 seconds. Furthermore, there is no allowed disintegration direction available for Orodispersible strips.

Dissolution test:

According to the pharmacopoeia a standard basket and paddle apparatus was used for dissolution testing. In the process of dissolution the medium was selected according to the sink condition and increasing dose of active pharmaceutical ingredients. When the film strip is floating in the dissolution solvent, the paddle mechanism can cause problems.

Studies on stability:

In the humidity chamber, stability investigations must be performed under accelerated conditions (65% relative humidity and 35°C temperature).

Applications of orodispersible films:

Orodispersible films are favored for local action, and they can also use to control pain, allergies, difficulty in sleeping, and disorders of CNS⁵⁹.

Topical applications:

For wound care and other uses, orodispersible films are used to apply active chemicals such as analgesics or antibacterial compounds.

Gastro retentive dosage systems:

Gastro Retentive Dosage Systems are a type of gastrointestinal retentive dosing system. Poorly soluble or water soluble molecules are considered for the application of oral film for gastro retentive dose forms, and diverse molecular weights of pharmaceuticals are used in film format. The pH or enzyme secretions in the gastrointestinal tract affect the disintegration of oral films. As a result, these films are employed to treat GIT diseases.

Diagnostic devices:

Orodispersible films were used with reagents that are sensitive in nature, and they can allow the film to release drug in a controlled manner. When the film will meet to the biological fluid, then it will create an isolating obstruction to separate the numerous reagents by enabling the reaction in proper time with a diagnostic device.

Vaccines:

Orodispersible films are delivered through vaccine, in accordance with their stability at room temperature. This process may lead to dissolve the film quickly in our mouth or saliva. An Orodispersible Buccal film was prepared by United States for the treatment of Rotavirus. These films are made with the purpose of enhancing bioavailability of poorly bioavailable drugs.

CONCLUSION:

FDF has recently acquired favour as a dosage form since it is the most palatable and precise oral dose form that bypasses the hepatic system and exhibits a greater therapeutic response. Pharmaceutical firms choose this dose form because of patient compliance (particularly in children and the elderly) and industrial acceptance. They combine the increased stability of a solid dosage form with the ease of use of a liquid dosage form. Due to decreased costs and customer choice, oral films may be able to replace over-the-counter drugs, generics, and brand names on the market. This technique may be used to extend the patent life of current items as part of product life cycle management. OFDFs offer a lot of promise for delivering the medicinal agent both systemically and locally, and they have a lot of benefits over many other dosage forms, including fast dissolving tablets. This explains why so much study is being done on this technology. As a result, this technology is rapidly evolving, posing a challenge to most pharmaceutical firms in developing oral films for a variety of active pharmaceutical components.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

ACKNOWLEDGMENTS:

The authors would like to thank Dr. Shammy Jindal, Associate Professor, Department of Pharmaceutics, Laureate Institute of Pharmacy, Jawalamukhi, Kathog (H.P) and Sweta, Regulatory Affair Officer, Scott-Edil Pharmacia Ltd., Plot No. 28/6, Industrial Area, Phase II, Chandigarh, India for their kind support during the completion of this review article.

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Received on 17.07.2023 Modified on 06.09.2023

Res. J. Pharma. Dosage Forms and Tech.2024; 16(1):98-106.

DOI: 10.52711/0975-4377.2024.00016

S. No.	Property and Sub Type	Flash release wafer	Mucoadhesive melt- away wafer	Mucoadhesive sustained release wafer Area
1.	Area (cm²)	2-8	2-7	2-4
2.	Thickness (mm)	20-70	50-500	50-250
3.	Structure	Single layer	Single and multilayer arrangement	Multi-layer arrangement
4.	Excipients	Soluble with hydrophilic polymers	Soluble with hydrophilic polymers	Low soluble, and some time non soluble with polymers
5.	Phase of drug	Solid form of solution	Solid solution and the suspended particles of drug	Suspension and solid solution