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Thin Film Drug Delivery

Thin film drug delivery, also referred to as orally dissolving thin film, has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with prescription and OTC medications. Similar in size, shape and thickness to a postage stamp, thin film strips are typically designed for oral administration, with the person placing the strip on his/her tongue, along the inside of his/her cheek or under the tongue. As the thin film dissolves, the technology enables the drug to be delivered to the blood stream either intragastrically, buccally or sublingually.

The first commercial non-drug product to use thin film for cosmetic purposes was the Listerine PocketPak breath strip. Since then, thin film products for other breath fresheners, as well as a number of cold, cough, flu and anti-snoring medications, have entered the marketplace. There are currently several projects in development that will deliver prescription drugs utilizing the thin film dosage form.

Advantages
The design of thin film, often referred to as PharmFilm, as a drug delivery technology and its oral administration offer several advantages over other modes of drug delivery, such as ingestible tablets, chewable tablets, orally dissolving tablets, softgels, liquids or inhalants :


 * The sublingual and buccal delivery of a drug via thin film has the potential to improve the onset of action, lower the dosing, and enhance the efficacy and safety profile of the medicament.


 * All tablet dosage forms, softgels and liquid formulations primarily enter the blood stream via the gastrointestinal tract, which subjects the drug to degradation from stomach acid, bile, digestive enzymes and other first pass effects. As a result, such formulations often require higher doses and generally have a delayed onset of action.


 * Conversely, buccal and sublingual thin film drug delivery can avoid these issues and yield quicker onsets of action at lower doses.


 * Thin film is more stable, durable and quicker dissolving than other conventional dosage forms.


 * Thin film enables improved dosing accuracy relative to liquid formulations since every strip is manufactured to contain a precise amount of the drug.


 * Thin film not only ensures more accurate administration of drugs but also can improve compliance due to the intuitive nature of the dosage form and its inherent ease of administration. These properties are especially beneficial for pediatric, geriatric and neurodegenerative disease patients where proper and complete dosing can be difficult.


 * Thin film’s ability to dissolve rapidly without the need for water provides an alternative to patients with swallowing disorders and to patients suffering from nausea, such as those patients receiving chemotherapy.


 * Thin film drug delivery has the potential to allow the development of sensitive drug targets that may otherwise not be possible in tablet or liquid formulations.


 * From a commercial perspective thin film drug delivery technology offers an opportunity to extend revenue lifecycles for pharmaceutical companies whose drug patent is expiring and will soon be vulnerable to generic competition.

Taste masking
An important aspect of thin film drug delivery technology is the masking of the often bitter and poor taste of drug formulations. One method of taste-masking is encapsulation, the coating of drug particles with a polymeric covering sufficient to mask the taste of the drug particle while maintaining the ability to release the drug for absorption.

Encapsulation is an efficient method for combining a high ratio of drug-to-non-drug elements in the taste-masked particle. Another method is the use of an ion exchange resin to bind the drug, forming a resinate that is less bitter than the drug alone.

Drug content uniformity
Drug content uniformity is a requirement for all dosage forms, particularly those containing low dose highly potent drugs. To uniquely meet this requirement, thin film formulations contain uniform dispersions of drug throughout the whole manufacturing process.

Avoiding drug degradation
Sensitive drugs may degrade over time in an aqueous environment. Thin film formulations must ensure that the integrity of the drug remains constant over time.

To overcome these challenges, developers of thin film have created highly specialized unique and often proprietary processes to deliver drugs on thin film.