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Oral Films: A Multifaceted Drug Delivery System

Aug. 19, 2021

Oral film for drug packaging has entered the limelight in recent years. It is made by oral film packaging machine. It is suitable for packaging film strips into pouches, such as oral dissolving film, mint strips, patches, etc. It has the advantages of safety in carrying drugs outside, easy application, handling and storage, moisture resistance, perfect sealing design, etc. Flexible pouch design in shape, size and color. Here we talk about the development of oral films in the pharmaceutical industry.

GF-300-P Oral Film Packing Machine Line

 

Introduction

In the late 1970s, fast-disintegrating drug delivery systems were developed as alternatives to capsules, tablets and syrups for patients with swallowing problems - a large estimated 30-40% of the population. Oral films represent a later advancement, using water-soluble polymers to release the drug into the oral cavity. One of the first pharmaceutical oral films on the market was Chloraseptic Relief Strips for sore throats. shortly after the introduction of chlorine sterilized oral films in early 2003, other oral films entered the market, but were plagued by stability and packaging issues. The science behind oral films has advanced significantly over the past decade, with the advent of oral film manufacturing and packaging machines improving film purity, efficacy and uniformity, resulting in greater investment and commercial viability.

 

The Benefits

In addition to providing an alternative for people with swallowing difficulties, oral film agents can impact the therapeutic index of a drug by improving effectiveness and reducing side effects. Depending on where the film is placed in the mouth - on or under the tongue or against the cheek - the release of the drug can vary.

When applied to the cheek or under the tongue, contact with saliva or oral mucosa initiates direct absorption of the drug into the vascular system, avoiding its degradation in the acidic environment of the stomach, elimination from the intestinal wall and elimination from the liver. Drugs that cause significant gastrointestinal side effects when administered orally may benefit from being made into oral film agents. Drugs that are pH sensitive may benefit from oral administration using oral films. Drug solubility is an important parameter affecting adsorption.

When placed on the tongue and swallowed, the oral film can rapidly disintegrate, releasing the drug already dissolved in the matrix. For prolonged and intestinal release, encapsulating the drug in the film will protect it from low gastric pH. Oral films offer significant advantages in delivering Biological Drug Classification System (BCS) Class II drugs - high permeability, low solubility.

 

Manufacturing

Scale-up of oral film production involves transitioning from discontinuous to continuous processes. The most common is solvent casting. With this method, the manufacturing process first dispenses the excipients, active ingredients, and solvents into temperature-controlled tanks in a defined order and then mixes them into a slurry, typically using a high-shear mixer to ensure a homogeneous slurry.

The slurry is then fed through the coating station into an oven, usually using a pump system. The slit die head or roller knife applicator is used to apply the slurry to the liner with a defined needle gauge. The choice of liner is an important consideration in the scale-up process as it affects the way the solvent (usually water) evaporates.
Some oral film fabricators enable operators to control the height and direction of the air nozzles and provide modular heating zones. Oven lengths can range from 10 feet to 24 feet or more. Typically, oral film products are stable at room temperature in an appropriate container containment system. Notably, there are no official methods or monographs in the U.S. Pharmacopeia to evaluate oral film properties such as disintegration, dissolution, or mucosal adhesion.

Oral Films: A Multifaceted Drug Delivery System

 

Packaging

The final step in production is the cutting of the master roll into sub rolls and further cutting into single doses that are placed into individual sachets or pouches via converting and packaging machines. The API dose of an oral film dosage product is directly determined by its weight. Therefore, it is critical to control the weight of each film product that is packaged.
Metallized polyester is a primary packaging material suitable for use in oral films. It is cost effective and protects the product from moisture and light. This pouch material can be child-proof and closure systems can be designed to ensure that the product passes child-proof testing while remaining user-friendly to the patient.
The manufacturing of oral films is a continuous but modular process that lends itself to automation. The manufacturing process has a low carbon footprint, with less water used for component preparation and sterilization than other dosage forms.

 

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