Eklavya College of Pharmacy, Tasgaon, India.
Since mouth dissolving films are more convenient and user-friendly than other dosage forms like buccal tablets, sublingual tablets, and orally disintegrating tablets, they represent a novel approach to oral drug delivery systems. As a result, many pharmaceutical industries are becoming interested in mouth dissolving films. Due to the strong vascularization of the oral buccal mucosa, medications can be absorbed straight and enter the bloodstream without first-pass hepatic processing. Adequate flexibility, elasticity, softness, resistance to breaking, minimal disintegration time, and flavor compliance are all characteristics of the perfect MDF.
The most popular and patient-friendly method of administering medication is orally. Almost all patients, including adults, children, and elderly patients, take the majority of the medications in pills and capsules. When it comes to medication distribution, the oral cavity (intraoral route) is superior to the traditional gastrointestinal route, parenteral, and other mucosal routes. It offers easy administration, the option to stop delivery when necessary, and immediate entrance into the systemic circulation, eliminating the hepatic first pass impact. Technological advancements have led to the introduction of bioadhesive mucosal dosage forms, such as adhesive tablets, gels, and patches. When put on the tongue, oral disintegrating films (ODFs) instantly hydrate by absorbing saliva after dissolving and/or disintegrating, releasing the active medicinal ingredient from the dosage form. These systems, such as fast-dissolving tablets and capsules for children and the elderly, were created in late 1970 as an alternative to traditional dosage forms.
When applied on the tongue or in the oral cavity, a film or strip is a dosage form that uses a water-dissolving polymer (usually a hydrocolloid, although it can also be a bioadhesive polymer) that enables the dosage form to rapidly hydrate, adhere, and dissolve to release the medicine.
SPECIAL FEATURES OF MOUTH DISSOLVING FILMS:
1. Thin elegant film.
2. Unconstructive.
3. Available in various size and shapes.
4. Fast disintegration.
5. Rapid release.
6. Give a pleasant mouth feel.
7. Have an acceptable taste
Restrictions
1. Uniformity of dose is a technological problem.
2. They are hygroscopic.
3. It is not possible to incorporate high doses (less than 40 mg/cm2 piece).
4. Demand unique packaging to ensure the stability and security of the goods.
MATERIAL
Active medicinal Agent
Fast-dissolving films can be used to deliver a range of active medicinal components.
Micronised active pharmaceutical components are usually beneficial since they enhance the film's texture and promote improved dissolution and homogeneity in oral fast-dissolving films. 1-25% w/w of the medication is present in a typical film formulation. Fast-dissolving films can be used to deliver a range of active medicinal components.
Polymer
The polymers employed in the oral film preparation should be:
1. Non-Toxic and Non-Irritant.
2. Devoid of leachable impurities.
3. Should not retard disintegration time of film.
4. Tasteless.
5. Should have good wetting and spread ability property.
Table. List of some ploymers
|
Sr. |
Polymer |
Example |
|
1. |
Natural Polymer |
Pollulan, Starch, Gelatin, Pectin, Sodium Alginate |
|
2. |
Synthetic Polymer |
Hydroxy Propyl methyl cellulose, Sodim carboxy methyl cellulose, polyethylene oxide, Hydroxy propyl cellulose |
Plasticizers:
One of the primary components of oral thin films is plasticisers. The plasticisers aid in improving the film's mechanical qualities, including its elongation and tensile strength. Additionally, it lessens the film's brittleness. It might improve the polymer's strength and flow. Making the right plasticiser choices is crucial. Glycerol, propylene glycol, polyethylene glycol, castor oil, n-tri-butyl, triethyl, acetyl citrate, dimethyl, dibutyl, diethyl phthalate, and triacetin are examples of plasticisers that are frequently used.
Sweetening Agent:
For convenience of administration, mouth-dissolving films are made to disintegrate rapidly in the mouth. A sweetening ingredient is crucial for enhancing flavour. Sweeteners are now a common ingredient in pharmaceutical and culinary items that are meant to dissolve or disintegrate in the mouth. Both artificial and natural sweeteners are utilised to increase the mouth-dissolving formulations' palatability.
Disintegrating agent
Because they speed up the film's breakdown when it comes into touch with moisture (like saliva), disintegrating agents are essential to Mouth Dissolving Films (MDFs).
Without the patient having to swallow the film or take it with water, the aim is to make sure that it dissolves rapidly and is released for the body to absorb. The following disintegration agents are frequently used:
talc, sodium bicarbonate, polyvinyl alcohol (PVA), crospovidone, and sodium starch glycolate.
Surfactants:
Surfactants are utilised as a dispersing, wetting, or solubilising agent to dissolve the film in a matter of seconds and release the active ingredient right away. Benzethonium chloride, sodium lauryl sulphate, tweens, benzalkonium chloride, and poloxamer 407 are frequently used.
Saliva stimulating agents:
Saliva stimulating chemicals are used to speed up the production of beneficial saliva. in the quicker breakdown of formulations for rapid dissolving strips. Citric acid, malic acid, lactic acid, ascorbic acid, and tartaric acid are a few examples of salivary stimulants.
Methods Of Manufacture Of Fast Dissolving Films:
Solvent casting method:
The solvent casting process involves dissolving water-soluble polymers in water and the medicine and additional excipients in an appropriate solvent. The two solutions are then combined, swirled, and eventually cast onto a Petri plate to dry.
Hot-melt extrusion Method
The mass is first manufactured using the current approach, which controls steering speed and temperature. Once more, the temperature, air circulation, and line speed are regulated as the film is coated and dried in a drying tunnel. The films are then punched, pouched, and sealed in the last phase after a slitting.
Solid dispersion extrusion Method
"Dispersion of one or more active ingredients in an inert carrier or matrix (hydrophilic) at solid state prepared by fusion, solvent, or melting solvent method" was the original definition of solid dispersion given by Chiou and Reigelman. Using this technique, one or more active substances are distributed in a suspended carrier in a solid form while amorphous hydrophilic polymers are present. To create a solution, the active pharmaceutical ingredient is dissolved in an appropriate solvent. Without eliminating the liquid solvent, solution is added to the melt of an appropriate polymer (PEG) below 70 °C. Ultimately, solid dispersions are formed into films using dies.
Rolling method:
The rolling method is a process for creating oral thin films in which a drug-containing solution or suspension is rolled onto a carrier. The film is then dried on the rollers and cut into the appropriate shapes and sizes using the solvent, which is often water or a mixture of water and alcohol.
Evaluation:
Thickness test-
In the film, thickness indicates the drug's dose perfection. The final thickness of the film is determined by calculating the mean value, which is measured at five different crucial places using a Micrometre screw gauge or calibrated digital Vernier callipers. The film's width need to fall between 5 and 200 µm.
Tensile strength-
The maximum stress applied to a strip specimen's breaking point is known as its tensile strength.
It is computed using the following equation, which divides the applied load at break by the strip's cross sectional area:
Tensile Strength = load of breakage/ strip thickness × strip width
Appearance –
Every created film can be examined to see if it appears to be opaque or clear. Although visual inspection is typically done, surface characteristics can also be determined with tools like a microscope.
Weight variation-
It is necessary to weigh each film separately and compute the average weights. The unique weight of each film is then deducted from the average weight of the films. A wide range in weight suggests that the procedure used was ineffective and that the medication content was probably not consistent.
Disintegration time –
U.S.P. disintegration equipment is needed to break down oral fast-dissolving films. Fast dissolving oral strips can be subject to the same disintegration time constraint of 30 seconds or less for orally disintegrating tablets as specified in C.D.E.R. guidelines. Although the disintegration period will vary based on the formulation, it usually ranges between 5 and 30 seconds.
CONCLUSION
Due to its low cost and ease of usage, which improve patient compliance, the oral route is the most widely used method for administering therapeutic drugs by mouth-dissolving film. Though little discussed or studied in the literature, mouth dissolving films appear to be a perfect dosage form for young children, particularly in paediatric and elderly patients.As a result, patients no longer require mouth dissolving films, which combine the improved stability of solid dosage forms with the excellent application of liquids. For MDF to be more stable and effective, the right materials are needed. More significantly, mouth dissolving films are convenient dosage forms for patients who may not be able to carry water with them. As a result, mouth dissolving film becomes a special, sophisticated, useful, and selective dosage form. The preparation process creates challenges that can be overcome by employing various film creation techniques. The evaluations must be examined for their stability.
REFERENCES
Rahim Mulani*, Tushar Kore, Shrirang Kharmate, Saurabh Joshi, Dipak Phalle, Mrudula More, Mrunal Mali, Pratibha Shingade, Mouth Dissolving Films: A Novel Approach to Oral Drug Delivery and Patient Compliance, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3, 128-132. https://doi.org/10.5281/zenodo.14960719
10.5281/zenodo.14960719
