INTRODUCTION:

Fast dissolving films for oral administration were a novel treatment option for individuals who had trouble swallowing pills or tablets. patients with dysphasia, children, and the elderly having trouble swallowing is a problem that many medical disorders have dose forms that are solid. According to one study, 26% of the 1576 patients found it challenging to swallow pills¹.

Technology advancements recently have made it possible for patients who are bedridden, nauseated, juvenile, elderly, or noncompliant to get dosages other than through the oral route. recently, buccal medication delivery become a significant drug delivery method. There are numerous bio adhesive mucosal dose formulations that produced, including gels and pills with adhesives patches, ointments, and most recently the usage of buccal delivery polymeric films, sometimes known as mouth-resolving movies². Fast dissolving buccal films provide drugs via a dissolving film by oral absorption (buccal or sublingually) or small intestine absorption (enteric ally). Hydrophilic polymers are used to create a film that quickly dispenses the medication by dissolving on the tongue or buccal cavity to moment a substance comes into touch with liquid, it dissolves and enters the bloodstream. Fast-fading buccal drug distribution through movies has become a cutting-edge substitute for conventional tablets and capsules and drinks are connected to prescription and over-the-counter drugs. comparable in size, usually made for oral use, thin film strips are similar in size and thickness to postage stamps. Administration, with the user positioning the strip along the inside of the mouth, under the tongue, or on the cheek. For conditions such as trigeminal neuralgia, diabetes, addiction, and Meniere's illness many buccal administration solutions have been commercialized or are being suggested³. As an alternative to traditional dosage forms for juvenile and geriatric patients who have trouble swallowing, in the late 1970s standard oral solid dose forms create the quick tablets are broken down using super disintegrants and components that are hydrophilic and have a higher bioavailability, prompt response, and greatest patience compliance. Numerous FDTs are created utilizing the costly lyophilization procedure, and occasionally fragile and difficult to handle (fragility and friability) fear of choking from quickly dissolving substances tablet⁴. When creating a fast-dissolving buccal film, aesthetic and functional factors such strip-forming polymers, plasticizers, active medicinal ingredients, sweeteners, saliva-stimulating agents, flavoring agents, and coloring agents are applied agents that thicken and stabilize. From a regulatory standpoint, each excipient utilized in the for usage in oral pharmaceutical dosage forms, the composition of oral medication strips should be approved. Recently, the use of fast-dissolving due to the development of buccal films that dissolve, babies in underdeveloped countries can now receive rotavirus immunizations.⁵. Up to 50–60% of all dosage forms, the traditional dosage forms (tablet and capsule) are widely accepted. The most common traditional dosage is still a tablet forms still exist now due to the convenience of self administration, a small nature, and simple manufacturing and it can be administered in precise doses. One crucial solid dosage forms' disadvantage is the difficulty in chewing or swallowing (dysphagia) in some cases notably those who are young and elderly. Because of their fear of choking, hand tremors, and dysphasia, geriatric patients frequently experience difficulty swallowing in young people because of their underdeveloped muscular and neural systems and in patients with schizophrenia, which causes a lack of patient cooperation⁶. The mouth-dissolving films are a cutting-edge drug delivery system for oral drug administration that is based on the transdermal patch technology. A very tiny oral strip serves as the delivery method simply applied to the patient's tongue or other oral cavity mucosal tissue, immediately wet by saliva, rapidly wetting the film hydrates and sticks to the application place. It quickly melts and disintegrates to release the formula or drug for Oro mucosal absorption changes won't affect the quickly dissolving factors make it possible for gastric absorption to accomplished when ingested. As opposed to other presently available, rapidly disintegrating dosage formulations, which include the quick films can be created using a mixture of lyophilizates a manufacturing procedure that rivals the production expenses for a method that is cost-effective compared to how traditional tablets are made⁷. A new drug delivery technology for oral drug administration is fast-dissolving film. It was created using the transdermal patch's technology. The distribution system is made up of a thin oral strip that is only applied on the tongue or any other oral mucosal tissue of the patient, the film is instantaneously moistened by saliva and quickly moisturizes and adheres to the application site then quickly liquefies and disintegrates to release the drug for both intragastric and Oro mucosal absorption. According to Technology Catalysts, the market for pharmaceuticals in oral thin film formulations was worth $500 million in 2007 and may do so by the year 2012. in light of upward the quick worldwide growth tendencies of the previous ten years the market for dissolving dose might generate $13 in sales per year by 2015^8,9. Oral Dissolving Films are thin, quickly dissolving films with a zone that measures 5 to 20 cm2 in size what is the solidified form of the active pharmaceutical ingredient (API) a hydrophilic polymer matrix. The present ingredients used in medicine are commonly combined to 15 mg in relation to various excipients, such as plasticizers, sweeteners, flavor enhancers, colorants, etc. The stacking of prescription drugs in buccal adhesive films legitimately absorbed through a layer of buccal tissue that passes it on to the fundamental flow to demonstrate its effect¹⁰. Many lyophilized dosage forms of fast-dissolving tablets are soft, friable, or brittle and typically require specialized and expensive packaging and processing. These tablets were either compressed at very low pressure, have naturally soft matrixes, or are exceptionally porous. It's time to dissolve or disintegrate. Placing the delivery device directly on the tongue or another oral mucous membrane of the patient is sufficient¹¹. The water soluble and/or water swell able film manufacturing techniques are used to create the oral disintegrating films polymer that causes the film to disintegrate quickly being inserted in the oral cavity on the tongue. The first oral strips were created by Pfizer dubbed it Listerine® and used it as a mouthwash freshening¹². By creating an easy-to-use dosage form, Novel Pharmacological Delivery System (NDDS), a recent advancement, promises to improve the safety and effectiveness of currently used drug molecules improved patient compliance and better administration. To create a chemical entity, it takes a lot of money, effort, and time are necessary. Therefore, the development is being given more attention of innovative drug delivery techniques for already available medications, combining increased effectiveness and bioavailability, resulting in a dose reduction appropriate dosage intervals to lessen the negative effects¹³. Cross-linked carboxymethyl cellulose is one of the primary super disintegrants used in the creation of FDT (Croscarmeliose), Glycol sodium starch (Primogel, Explotab). Polyvinyl pyrrolidone (Polyplasdone), among other materials, which immediate pill dissolution following placement on the tongue making the medication available in the saliva. The methods employed for Spray drying and freeze-drying are used to make fast-dissolving tablets^14,15.

Special features of Fast Dissolving Films¹⁶:

· Thin elegant film.

· Available in various sizes and shapes.

· Unobstructive.

· Excellent mucoadhesion.

· Fast disintegration.

· Rapid release.

ADVANTAGES OF FAST DISSOLVING FILMS^17,18,19:

· Ease of administration for patients who are mentally ill, physically disabled, or unwilling.

· The dose form dissolves and degrades quickly.

· Overcomes the medications' unpleasant taste.

· Permits heavy drug loading.

· Ability to offer liquid medicine benefits in the form of a solid preparation (Adaptable and compatible with current processing and packaging equipment).

· Cost-effective.

· Beneficial in situations where an extra quick onset of action is necessary, such as motion sickness, severe discomfort, allergic reactions, or coughing.

· In comparison to liquid formulations, each strip of the film ensures accuracy in the delivered dose.

DISADVANTAGES OF FAST DISSOLVING FILMS²⁰:-

· Due to its hygroscopic nature, it needs to be stored in dry areas.

· Additionally, it exhibits the effervescent, fragile granule feature.

· For the stability and safety of the items, they need particular packaging.

INGREDIENTS USED IN FAST DISSOLVING FILMS:

1. Active Pharmaceutical Ingredient.

2. Polymers

3. Plasticizers

4. Surfactants

5. Sweetening agents

6. Saliva Stimulating agents

7. Flavoring agents

8. Coloring agents

I. Active Pharmaceutical Ingredient:

The active ingredient may be any class of pharmaceutically active substances that can be administered orally or through the buccal mucosa. According to published research, API can be added to polymers in amounts ranging from 5% to 25% by weight. The dosage of the formulation's efficient (Less than 20 mg/day) Drug should be in mgs. The powerful medicines have high first pass levels. The greatest candidates for fast-dissolving buccal films are those with low metabolism and uncooperative patients. Researchers are interested in creating fast-dissolving films for medications like: Geriatrics, pediatrics, and pediatric expectorants and anti-asthmatics (antiepileptic, expectorants), disorders of the digestive system Nausea (e.g.:- due to cytostatic treatment) (e.g. due to cytostatic therapy), Pain (such as migraines), CNS (such as treatment for anti-parkinsonism).

II. Polymers:

There are numerous polymers that can be used to create buccal films that dissolve quickly. To achieve the desired film qualities, either one polymer or a mixture of polymers can be utilized. The acquired film must be durable enough to prevent damage during handling or use transportation. The kind of polymer and its concentration in the strip determine its durability formulation. The most widely used polymers for the creation of fast-dissolving films are cellulose or cellulose derivatives, pullulan, gelatin, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose and polyvinyl alcohol. Other polymer include sodium alginate, xanthine gum, tragacanth gum, guar gum, acacia for preparation, modified starches are also employed.

Example:-HPEC E15, HPMC K4M, HPMC E5, PVP, PVA, Gelatin²¹.

Polymers used in Fast Dissolving Films^22,23,24,25:

Sr. No.	Polymer	Examples
1.	Natural Polymers	Pullulan, Starch, Gelatine, Pectin, Sodium alginate, Maltodextrins, Polymerized Rosin.
2.	Synthetic Polymers	Hydroxypropyl methylcellulose, Sodium Carboxy methyl cellulose, Polyethylene oxide, Hydroxypropyl cellulose, Polyvinyl pyrrolidone, Polyvinyl alcohol.

III.Plasticizers:

The inclusion of the plasticizer can enhance the films' mechanical characteristics, such as tensile strength and elongation. Additionally, it enhances the strip's flexibility and lessens the fragility of the strip. By lowering the glass transition, they also enhance the strip's characteristics. The polymer's temperature The inclusion of the improves the flow of polymer and plasticizer. These characteristics are impacted by variations in their concentration. The choice of the plasticizer's compatibility with the polymer and the type of solvent will both be factors used in the casting of it.

Example:

Glycerine, sorbitol, propylene glycol, polyethylene glycol, triacetin, di-butylpthalate, triethyl citrate, acetyl triethyl citrate and other citrate esters²⁶.

IV. Surfacants:

Surfactants are employed as solubilizing, wetting, or dispersion agents to breakdown the film quickly and release the active ingredient. Surfactants also increase the solubility of poorly soluble medications in buccal films that dissolve quickly.

Example:- Sodium lauryl sulphate, benzalkonium chloride, benzthonium chloride, tweens and spans²⁷.

V. Sweetening Agents:

Sweeteners now play a crucial role in medicinal medicines that are meant to dissolve or disintegrate in the mouth. Sucrose, dextrose, fructose, glucose, liquid glucose, and iso-maltose are the traditional sources of sweetness. One can taste fructose's sweetness enters the mouth more quickly than sucrose and dextrose. Compared to sorbitol, fructose is sweeter, and Mannitol is a common sweetener because of this. Alcohols that are polyhydric, such as sorbitol, mannitol, and iso-malt can be combined because they both add to the nice mouth feel and cooling effect. Polyhydric alcohols don't have a harsh aftertaste and are less carcinogenic. This is an important consideration when creating oral medications. Artificial sweeteners have gained popularity greater acceptance in pharmaceutical formulations.

Example:-Sucrose, fructose, glucose, iso-maltose²⁸.

VI. Saliva Stimulating Agents:

In order to hasten the breakdown of the formulations for the rapid dissolving strips, saliva stimulating chemicals are used to boost saliva production. Generally speaking, salivary stimulants can be made from acids that are used in meal preparation.

Example:-Citric acid, malic acid, lactic acid, ascorbic acid, tartaric acid²⁹.

VII. Flavouring Agents:

You can choose flavouring agents from artificial flavour oils, oleo resins, and extracts made from different plant components like leaves, fruits, and flowers. You can use flavours individually or in combination. Any flavour can be added, including menthol water soluble extracts or essential oils. Sour fruit, cinnamon, clove, and strong mints including peppermint, sweet mint, spearmint, wintergreen, and sweet mint lemon, orange, or sweet confectionery flavours are a few examples of flavour.

Example:-Peppermint, sweet mint, spearmint, wintergreen³⁰.

VIII. Coloring Agents:

FD&C colours, EU colours, natural colouring ingredients, natural juice concentrates, pigments including titanium oxide, silicon dioxide, and zinc dioxide, and bespoke pantone-matched colours are also available. These colouring agents should not total more than when portion of the formulation is used, these substances are included at concentration levels of 1% w/w. Insoluble or suspension forms of chemicals or medications are present.

Example:-Titanium oxide, silicon dioxide and zinc dioxide.

METHODS OF MANUFACTURE OF FAST DISSOLVING FILMS:-

· Solvent casting

· Hot-melt extrusion

· Semisolid casting

· Solid dispersion extrusion

· Rolling.

1. Solvent Casting:

Fast-dissolving buccal films are often made using the solvent casting method, which involves dissolving the water-soluble components to create a clear, viscous solution and dissolving the medication and other excipients in an appropriate solvent before combining and stirring the two solutions and dried after being cast into the Petri plate. Hydroxypropyl methylcellulose, hydroxypropyl cellulose, pullulan, sodium alginate, pectin, and carboxymethyl cellulose are water-soluble hydrocolloids used to create films³¹.

API and other agents are dissolved in a suitable solvent, along with water-soluble components, to create a clear viscous solution.

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Both solutions have been combined.

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The finished product is cast into a film and allowed to dry.

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Film is collected.

Fig. 1 :- Diagram of Solvent-Casting Film System³².

2. Hot-melt Extrusion:-

Granules, sustained release tablets, transdermal, and transmucosal medication delivery systems are frequently made via hot metal extrusion. We employed melt extrusion as a pharmaceutical industry manufacturing tool as early as 1971³³.

The medicine and carriers are combined in solid form.

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The mixture is melted by an extruder with heating.

↓

Finally, the dies from the melt into films.

3. Semisolid Casting:-

A water soluble film-forming polymer solution is created.

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The resulting solution is mixed with an acid-insoluble polymer solution (e.g. cellulose acetate phthalate, cellulose acetate butyrate).

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A sufficient amount of plasticizer is applied to produce a mass of gels.

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Finally, using heat-controlled drums, the gel mass is cast into the films or ribbons. The film should be between 0.015 and 0.05 inches thick. The ratio of film-forming polymer to acid-insoluble polymer should be 1:4³⁴.

4. Solid Disperssion Extrusion:

When one or more active chemicals are dispersed in an inert carrier in a solid form while amorphous hydrophilic polymers are present, this is referred to as a solid dispersion. a drug in a suitable liquid solvent, dissolved. So the answer is a component of the available polyethylene glycol melt below 70°C. The solid dispersions are finally formed into the movies through deaths³⁵.

5. Rolling:

According to this technique, a pre-mix is prepared, an active is added, and then a film is created.

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Create a pre-mix using a polar solvent, film-forming polymer, and additional ingredients other than a medication.

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Fill the master batch feed tank with premix.

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

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Add the necessary dosage of the medicine to the chosen mixer.

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To create a consistent matrix, combine the medicine with the master batch premix.

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Through second metering pumps, a predetermined volume of uniform matrix is subsequently supplied to the pan.

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Finally, the film is created on the substrate and removed using the support roller.

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Then, controlled bottom drying is used to dry the wet film³⁶.

EVALUATION:

1. Hardness:

The FDT's maximum allowable hardness is typically kept in the lower range to encourage early disintegration in the mouth. It is possible to gauge the tablet's hardness. Employing standard hardness testers (Monsanto tablet a hardness gauge). It is stated in kilogram’s or pounds³⁷.

2. Friability:

It is difficult for a formulator to keep an FDT's % friability within acceptable ranges (0.1-0.9c/o) because all FDT manufacturing processes are accountable for raising the percentage friability values. the brittleness of each batch in "Electro lab friabilator" was measured. The ten pre-weighed 100 tablets were rotated at a rate of 25 rpm for 4 minutes. The tablets were then weighed again and the following methods were used to calculate the percentage of weight loss³⁸.

3. Mechanical Strength:

Tablets should have sufficient mechanical strength to withstand handling shocks throughout production, packing, and shipment. Crushing power Friability and are two crucial criteria for the mechanical strength measurement³⁹.

4. Folding Endurance:

Folding durability is assessed by repeatedly folding sheets with constant thickness and cross sectional area⁴⁰.

5. Swelling Property:

Utilizing simulated saliva solution, studies on film swelling are carried out. Each film sample is weighed before being put into a stainless steel wire mesh that has been preweighed. A 15ml container is placed over mesh containing a film sample. A plastic jar of medium. an increase in weight was established at predetermined intervals until we saw a steady weight⁴¹.

6. In vitro disintegration time:

In a glass dish filled with 25ml of distilled water and swirled every 10 seconds, the in vitro disintegration time is measured visually. When the disintegration time occurs, the film begins to crack or fall apart⁴².

7. In vitro dissolution studies:

The in vitro dissolving investigation is conducted at 37°C with a USP paddle device in simulated saliva solution with a pH of 6.4 phosphate buffer examples are withdrawn at periodic intervals of time, and by a UV-Visible spectrophotometer analysis⁴³.

8. Dissolution test:

If taste masking is not used, the dissolution procedures for FDT are almost exact replicas of those for regular tablets. The medications frequently have similar to the USP monograph’s dissolving conditions pH and 0.1N HCl Evaluation of should be performed using pH 4.5 and pH 6.8 buffers. FDT works the same as their standard tablet counterparts. The best paddle device is USP 2 as well as a popular option for FDT tablets' dissolving test, due to special differences from USP1 (basket) equipment Tablets' physical attributes. The typical paddle speed for paddle equipment is 25–75 rpm. Given that FDTs dissolve quickly when used with USP decreased paddle speeds may result from certain circumstances use to produce a comparative profile hefty tablets there could be a mound in the dissolution vessel from (1gram). This is avoidable by employing faster paddle speeds⁴⁴.

CONCLUSION:

Oral thin films are intended for application in the oral cavity and promising dosage form specially use in pediatrics and geriatrics. Fast dissolving buccal films have gained popularity because of better patient compliance, rapid drug delivery system, drug is directly absorbed into systemic circulation, first pass metabolism and degradation in gastrointestinal tract can be avoided. The present review conclude that fast dissolving oral film is most acceptable and accurate oral dosage form which bypass the hepatic system and show more therapeutic response. The pharmaceutical companies prefer this dosage form due to both patient compliance as well as industrial acceptability. Oral films can replace the over the counter (OTC) drugs, generic and name brand from market due to lower cost and consumer’s preference. This technology is a good tool for product life cycle management for increasing the patient life of existing products. Oral Fast Dissolving Films are also having great potential of delivering the medicinal agent systemically as well locally and have several advantages over many dosage forms even over the fast disintegrating tablets. This explains the extensive research actively going on this technology.

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Received on 15.12.2022 Modified on 28.03.2023

Asian J. Res. Pharm. Sci. 2023; 13(3):211-217.

DOI: 10.52711/2231-5659.2023.00037