Thin film drug delivery is a process of
deliveringDrug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies are patent protected formulation technologies that modify drug release profile, absorption, distribution and elimination for the benefit...
drugs to the
systemic circulationSystemic circulation is the portion of the cardiovascular system which carries oxygenated blood away from the heart, to the body, and returns deoxygenated blood back to the heart. The term is contrasted with pulmonary circulation.-Course:...
via a
thin filmThin films are thin material layers ranging from fractions of a nanometre to several micrometres in thickness. Electronic semiconductor devices and optical coatings are the main applications benefiting from thin film construction....
that
dissolvesDissolution is the process by which a solid or liquid forms a homogeneous mixture with a solvent . This can be explained as a breakdown of the crystal lattice into individual ions, atoms or molecules and their transport into the solvent....
when in contact with
liquidLiquid is one of the principal states of matter. A liquid is a fluid that has the particles loose and can freely form a distinct surface at the boundaries of its bulk material. The surface is a free surface where the liquid is not constrained by a container....
, often referred to as a
dissolving film or
strip. Thin film drug delivery has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with
prescriptionA prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
and
OTCOver-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription...
medications. Similar in size, shape and thickness to a
postage stampA postage stamp is adhesive paper evidence of a fee paid for postal services. Usually a small rectangle attached to an envelope, the stamp signifies the person sending it has fully or partly paid for delivery...
, thin film strips are typically designed for oral administration, with the user placing the strip on or under the tongue or along the inside of the cheek.
Thin film drug delivery is a process of
deliveringDrug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals. Drug delivery technologies are patent protected formulation technologies that modify drug release profile, absorption, distribution and elimination for the benefit...
drugs to the
systemic circulationSystemic circulation is the portion of the cardiovascular system which carries oxygenated blood away from the heart, to the body, and returns deoxygenated blood back to the heart. The term is contrasted with pulmonary circulation.-Course:...
via a
thin filmThin films are thin material layers ranging from fractions of a nanometre to several micrometres in thickness. Electronic semiconductor devices and optical coatings are the main applications benefiting from thin film construction....
that
dissolvesDissolution is the process by which a solid or liquid forms a homogeneous mixture with a solvent . This can be explained as a breakdown of the crystal lattice into individual ions, atoms or molecules and their transport into the solvent....
when in contact with
liquidLiquid is one of the principal states of matter. A liquid is a fluid that has the particles loose and can freely form a distinct surface at the boundaries of its bulk material. The surface is a free surface where the liquid is not constrained by a container....
, often referred to as a
dissolving film or
strip. Thin film drug delivery has emerged as an advanced alternative to the traditional tablets, capsules and liquids often associated with
prescriptionA prescription drug is a licensed medicine that is regulated by legislation to require a prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
and
OTCOver-the-counter drugs are medicines that may be sold to a customer without a prescription from a health care professional, as compared to prescription drugs, which may only be sold to customers possessing a valid prescription...
medications. Similar in size, shape and thickness to a
postage stampA postage stamp is adhesive paper evidence of a fee paid for postal services. Usually a small rectangle attached to an envelope, the stamp signifies the person sending it has fully or partly paid for delivery...
, thin film strips are typically designed for oral administration, with the user placing the strip on or under the tongue or along the inside of the cheek. As the strip dissolves, the drug can enter the blood stream
entericEnteric can refer to:* A general term for the intestines** Microorganisms that inhabit the intestines are commonly known as enteric bacteria* Enteric nervous system* Enteric coating that is often applied to pills and supplements...
ally, buccally or
sublingualSublingual, literally 'under the tongue', from Latin, refers to the pharmacological route of administration by which drugs diffuse into the blood through tissues under the tongue...
ly.
The first commercial non-drug product to use thin films was the Listerine PocketPaks breath freshening strips. 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 formA dosage form is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption...
.
Advantages
The design of thin film, often referred to as PharmFilm, as an oral drug delivery technology offers several advantages over other modes of drug delivery, such as ingestible tablets, chewable tablets, orally dissolving tablets, softgels, liquids or inhalants:
- The sublingual
Sublingual, literally 'under the tongue', from Latin, refers to the pharmacological route of administration by which drugs diffuse into the blood through tissues under the tongue...
and buccalBuccal can refer to:* The adjective form of cheek* The buccal index* The buccal smear in Genetic testing* The "buccal artery", also known as the Buccinator artery* Buccal nerve* The 'outer' surface of a tooth Dental caries...
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. Since this criteria is essential for the quality of the thin film and final pharmaceutical dosage form, the use of Laser Scanning Confocal Microscopy (LSCM) was recommended to follow the 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.
Availability
There are not yet many medications available in a thin film
formA dosage form is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption...
on the market. Those that are include:
- Benadryl
Benadryl is a brand name allergy medicine manufactured by McNeil Healthcare Limited. Benadryl is used as an antihistamine for the temporary relief of seasonal and perennial allergy symptoms. It will also help with normal symptoms of insect stings even if there is no allergic reaction...
- Gas-X
- Melatonin PM
Leiner Health Products is a company based in Carson, California, and is one of America's largest manufacturers of vitamins, minerals, herbal nutritional supplements, and generic medications...
- Orajel Kids
- Sudafed
Sudafed is a brand name and registered trademark for a family of over-the-counter decongestants manufactured by Johnson & Johnson for sale in Australia, Canada, the United Kingdom and the United States. It is used to treat symptoms of the common cold...
- Supress
- TheraFlu
TheraFlu is a brand of over-the-counter cold and flu medicines, from Novartis that contain different groupings of various cold and flu symptom medications. The original version of TheraFlu contained Acetaminophen , Chlorpheniramine maleate , Dextromethorphan hydrobromide , and Pseudoephedrine...
- Triaminic
An application to the Food and Drug Administration (United States) for a thin-film formulation of
ondansetronOndansetron or GlaxoSmithKline's Zofran is a serotonin 5-HT
3 receptor antagonist used mainly as an antiemetic to treat nausea and vomiting following chemotherapy. Its effects are thought to be on both peripheral and central nerves...
has been accepted and is currently under review.
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