INTRODUCTION:

Transmucosal drug delivery is one of the different drug delivery methods, and it has clear advantages over oral administration in terms of systemic impact. Buccal mucosa is one of the numerous transmucosal pathways.

When medications are administered to the buccal mucosa, which is found on the inside of the cheek inside the mouth, it can facilitate both local and systemic drug delivery. Thismethod prevents first-pass metabolism and enzymatic drug degradation while also offering effective therapy to patient groups that have trouble swallowing or are unable to swallow.

Buccal films circumvent the hepatic first pass metabolism, resulting in a high bioavailability, and have direct access to the systemic circulation through the internal jugular vein. Moreoral film, intraoral radiograph, bitewing, periapical radiograph, occlusal film, and panoramic radiographover, these dose forms are pharmacoeconomic, self-administerable, and have improved patient compliance. The film is an example of a dosage form that uses a water-dispersible polymer¹. When placed on the tongue or in the oral cavity, the dosage form quickly hydrates, adheres, and dissolves, resulting in systemic drug distribution.

Possible benefits of buccal films:

· Buccal films offer a significant surface area that causes the active medicinal ingredient to quickly disintegrate and dissolve in the oral cavity, hence promoting systemic absorption.

· There is no need to chew or swallow.

· No danger of choking.

· The movie skips around the hepatic first pass metabolism, increasing the medicines' systemic bioavailability.

· Gastrointestinal enzymes and an acidic environment can prevent drugs from degrading.

· A quick commencement of action with few adverse effects.

· Self-management is feasible.

· More precise dosing than liquid dosage formulations.

· Taste may be concealed.

· Increases bioavailability by extending the dosage form's time in residence at the absorption site.

· Simple administration to children, senior citizens, and other patients.

The most recent dose type for buccal administration is buccal films. These are semi-solid dosage forms that are dissolved after being applied to the buccal area. They immediately begin their methodical circulation after ingestion. Due to their quick acceptance as a new drug administration method accelerated onset of action and increased safety.

Fig.1: Reprsentation of Buccal Films

When compared to other buccal dosage forms like buccal tablets, lozenges, wafers, etc., buccal film is a beautiful and efficient dosage form with enhanced bioavailability since it skips the hepatic first-pass metabolism². They disintegrate in the buccal mucosa of the patient. Buccal and sublingual mucosa makes up the oral mucosa, the site of drug administration.

Buccal films should, among other things, be free of contaminants, all degradation products, and polymers that are not toxic, poisonous, or irritating. They should have strong viscoelastic characteristics, spreadability, swelling,wetting, solubility, biodegradability, and a biocompatible pH range. Itshould not decompose while being stored and have a suitable shelf life. It should have strong mechanical strength and adhere to the buccal mucosa fast. It should be well-accepted by the patient and not interfere with daily activities like talking, eating, or drinking. A dose with a low molecular weight should be less than 20mg.

Advantages:

Buccal films have a number of benefits, including the ability to be found in a variety of sizes and forms, convenience of transportation and handling, quick disintegration, precise dosage administration, improved stability and safety, and the avoidance of first-pass metabolism³.

Disadvantages:

In addition to their benefits, buccal films have several drawbacks, such as the oral mucosa's barrier qualities, restrictions on eating and drinking, the ability to deliver medications that require lower dose.

METHODOLOGY:

1. Solvent casting method:

Get the casting solution ready (API, polymer, distilled water). Deaerate this solution. Provide the proper transfer certain amount of solution into the mould⁴. The transferred casting solution is then dried. Cut the final dose form into shapes.

Fig. 2: Solvent casting method

2. Solid dispersion method:

Dispersing one or more active ingredients in an inert carrier in a solid state. (in presence of amorphous hydrophilic polymers) is known as solid dispersion. Drug is dissolved in a liquid solvent. Then incorporate this solution into a melt of polyethylene glycol below 70OC⁵. Obtained solid dispersions are shaped into films by means of dies.

Fig. 3: Solid Dispersion method

3. Hot melt extrusion method:

In hot melt extrusion method mixture of drug and other excipients is molten. Then forced through orifice to yield a more homogenous material in different shapes like granules, tablets, or films. It is used for transdermal drug delivery system⁶.

Fig. 4: Hot melt extrusion method

Evaluation⁷:

· Weight of the film:

Buccal film is weighed by calibrated weighing balance. Individual weight of each film is calculated. Average weight is calculated and compared with standard.

· Thickness:

Thickness of buccal film is evaluated by calibrated micrometer screw gauge. The thickness is measured at five different points of the film and means value is calculated. This is done to ensure the uniformity in the thickness of the film as it is directly correlated with accuracy of dose in the film and supports the reproducibility of the method used for the formulation.

· Tensile strength:

The tensile strength is the property of the film that requires a load to cause load deformation failure of film. Film strips in special dimension is held between two clamps positioned at a specific distance. Tensile strength is calculated by applying load at rupture and cross section area of fractured film from following equation.

Tensile strength (N/mm2):

Tensile strength = breaking force (N)/cross sectional area of sample (mm2)

· Surface pH of the film:

The films are allowed to swell by keeping them in contact with 1ml of distilled water for 2 hours at room temperature, and pH is noted down by bringing the electrode in contact with the surface of the film, allowing it to equilibrate for 1 min.

· Folding endurance:

Folding endurance is to be determined by repeatedly folding the film at the same place, until it breaks. The number of times, the film could be folded at the same place without breaking gives the value of folding endurance.

· Percentage moisture loss:

This is used to check integrity of films. Film is cut out and then takes weight. After it is kept in desiccator containing fuse anhydrous calcium chloride. After 72 hours it is removed and weighted. Average percentage moisture loss is calculated by below formula,

Percentage Moisture Loss = (Initial weight-final weight)/Initial weight ×100

· Drug Content uniformity:

Buccal film is dissolved in 100ml of pH 6.8 buffer separately and mixture is suitably diluted. The amount of drug in film is measured absorbance spectrophotometrically at 242nm. The average drug content is calculated.

· In-vitro disintegration:

It is determined visually in a petri plate containing 2 ml distilled water with swirling every 10seconds. The time at which film started to break or disintegrate is recorded as the in vitro disintegration time.

· In-vitro dissolution:

An in vitro dissolution study is carried out using USP type II apparatus (Basket type apparatus). pH 6.8 buffer (50ml) is used as a dissolution medium at 50rpm speed and 37^oC temperature. At specific time intervals, 1ml samples were withdrawn and replaced with the equal quantity of fresh dissolution medium. Buccal films are filtered through 0.45μm Whatman filter paper, and analyzed spectrophotometrically at λmax of active pharmaceutical ingredient.

· Swelling index:

The initial weight of the film is determined using a digital balance (W0). Then the films are allowed to swell on the surface of petri plate and kept in an incubator maintained at 37°C. Weight of the swollen film is determined (Wt) at predetermined time intervals for 5 min. The percentage of swelling (%S) is calculated using the following formula,

% S = (Wt-WO)/Wo x100

Where

Wt is the weight swollen patch after time t,

W0 is the initial weight.

CONCLUSION:

The conclusion from buccal films is that they are an effective and safe method of administering medication to patients. Buccal films offer a fast and easy method of delivering drugs, with minimal risk of side effects, making them a preferred method of drug delivery for many patients and healthcare professionals.

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Received on 26.03.2023 Modified on 01.01.2024

Asian J. Pharm. Tech. 2024; 14(3):225-228.

DOI: 10.52711/2231-5713.2024.00037