Oral Thin Films: A Promising Drug Delivery System

 

Oral Thin Films

Oral thin films, also known as oral soluble films or oral dissolvable films, are thin polymeric films manufactured using hydrocolloid polymers that rapidly disintegrate when placed on the tongue or buccal cavity. When compared to traditional oral dosage forms like tablets and capsules, oral soluble films have key advantages like rapid disintegration, easy swallowability without water, accurate dosing, and versatility in drug loading. These properties make oral soluble films a promising drug delivery system for a wide range of therapeutic molecules.

Composition and Manufacturing of Oral Thin Films

Oral Thin Films are typically composed of hydrophilic polymers that are film forming, flexible, and water soluble. Common polymers used include polyvinyl alcohol, pullulan, hydroxypropyl methylcellulose, sodium alginate, and carboxymethyl cellulose. Hydrophobic agents are sometimes added to modulate the mechanical and dissolution properties. Active pharmaceutical ingredients (APIs) along with polymers, plasticizers, sweetening agents and flavors are dissolved or dispersed to form a homogenous mixture. This mixture is cast onto a backing liner using manufacturing techniques like solvent casting/evaporation or hot-melt extrusion to produce oral soluble films of uniform thickness ranging from 20-50 μm. Quality testing ensures the films meet standards for physical properties, drug content and stability.

Advantages of Oral Thin Films Over Conventional Oral Dosage Forms

The major advantages of oral soluble films include:

1. Rapid disintegration - Oral thin films rapidly dissolve within seconds when exposed to saliva, leading to instant drug release. This property offers superior convenience compared to tablets.

2. Easy swallowability - Being thin and flexible, oral soluble films can be easily placed on the tongue and swallowed without water. This makes them very convenient for pediatric, geriatric patients and those unable to swallow tablets.

3. Accurate dosing - Oral soluble films allow for precise drug loading reproducibly across individual dosage units due to their uniform film geometry, providing greater dosing accuracy than capsules.

4. Versatility - Oral soluble films can be designed for a variety of APIs ranging from small molecules to biologics. Both immediate and controlled release profiles can be achieved by modulating the film composition and manufacturing process.

5. Patient compliance - The ease of consumption without water makes oral thin films a more patient-acceptable dosage form compared to tablets. This translates to better adherence to prescription regimens.

6. Tamper-resistant properties - Oral soluble films can integrate tamper-resistant technologies to prevent abuse and misuse of drugs. Drug extraction is also difficult compared to tablets.

Applications of Oral Thin Films in Drug Delivery

Owing to their numerous benefits, oral soluble films have emerged as an important drug delivery platform for various therapeutic applications:

Neurology
Oral thin films delivering drugs for acute conditions like migraine (rizatriptan), seizures (diazepam) and Parkinson's disease (levodopa/carbidopa) serve as effective alternatives to oral solid dosage forms. They ensure rapid onset of action essential for neurological therapies.

Pediatrics
Formulations of common pediatric drugs like paracetamol, ibuprofen and vitamins have been developed as oral soluble films. The ease of administration makes them ideal for pediatric populations.

Nausea/vomiting
Anti-emetics for chemotherapy-induced nausea like ondansetron are available as oral soluble films to enable quick onset of action.

Other applications include breath fresheners, nutraceuticals, nicotine replacement therapies and more. Oral soluble films have the potential to reformulate existing products for superior efficacy, safety and patient experience.

Commercialization of Oral Thin Films

Oral soluble films have emerged as a fast-growing segment in the pharmaceutical market owing to their widespread applications. According to estimates, the global oral thin film drug delivery market size was valued over $6 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) exceeding 10% from 2020 to 2027.

Major players offering oral soluble films include IntelGenx, ZIM Laboratories, Indivior, MonoSol Rx, Sumitomo Dainippon Pharma and Pfizer. Several blockbuster prescription drugs have also been reformulated as oral soluble films by these companies. Contract manufacturing organizations specialized in oral soluble films aid their production on a commercial scale. With continuous technological improvements and new product launches, oral soluble films are poised to revolutionize drug delivery in the years to come.

To conclude, oral thin films represent an innovative means of drug delivery, offering benefits like rapid dissolving, accurate dosing, easy administration without water and versatility for various molecules. Owing to these advantages, they have emerged as a fast-growing segment in drug delivery technology with diverse applications ranging from treatments of gastrointestinal, neurological and pediatric conditions. With continued innovation, further commercialization of existing and novel drugs as oral soluble films can positively impact patient outcomes worldwide.

 

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About Author:

Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc.

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