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Oral Thin Films (OTFs) are one of the most preferred methods of drug administration as they are easy to consume and involve low manufacturing cost. Notably, Fast-Dissolving Drug Delivery Systems (FDDDS) were created as an alternative to capsules and tablets that are difficult to swallow, and syrups that provide a feel of medication taste in the mouth.
During the late 1970s, rapid disintegrating drug delivery systems were developed as an alternative to capsules, tablets, and syrups for improving patients’ medication adherence.
As an advanced technology, oral thin films are now being made using easy to dissolve hydrophilic polymers that instantly release the drug into the oral cavity. Currently, there are only 11 Fast Dissolving Oral Thin Film products in the market that are known to treat different medical conditions, such as schizophrenia, migraines, etc.
When placed in the oral cavity, the oral film quickly disintegrates and immediately releases the drug to get solubilized with the saliva. Thus, the drug is ready for absorption and uptake by the body to provide rapid onset of action and relief to the patients. The light weight, ultra-thin and flexible structure of OTFs makes them easy to administer without causing discomfort of swallowing/choking. The large surface area of the OTFs quickly hydrates the polymeric film with saliva to achieve disintegration within seconds, thus eliminating the requirement of water for ingestion.
When applied onto the mucosal area (enriched with a network of blood supply) of the oral cavity, the drug released from the oral thin films gets absorbed quickly through mucosa and enters directly into the bloodstream. It bypasses the first-pass metabolism and thus increases bioavailability of the drug molecules susceptible to degradation in gastro-intestinal tract.
Oromucosal OTFs adhere to the mucosal regions of the oral cavity and slowly release the drug. This type of film provides prolonged drug release, making it an ideal choice for drugs that need to be released slowly over a long period of time. For example, oromucosal OTFs can be used for pain management, hormone replacement therapy, and to treat diseases like Parkinson's.
Orodispersible OTFs, on the other hand, disintegrate quickly upon contact with saliva when placed on the tongue. There are two subtypes of Orodispersible OTFs: orally disintegrating and orally dissolving. Orally disintegrating strips dissolve rapidly in the mouth, making them an ideal choice for drugs that need to be absorbed quickly into the bloodstream. Orally dissolving films, on the other hand, take slightly longer to dissolve but are more robust and can handle larger drug loads.
One of the key advantages of OTFs is that it is a patient-friendly dosage form. As compared to tablets or capsules, the larger surface makes it easy for faster wetting, quick breakdown, and dissolving of the drugs. This gives quicker and direct results. Patients do not have to chew, swallow, or take the medication with water to ingest the medicine. Moreover, the films have a good flavor and color that makes them acceptable to children and adults.
The second advantage of OTF is its precise dosage and flexibility. They can be molded into different sizes and thickness to provide a variable range of doses according to the need of therapy, especially in case of children (and even adults) who may need limited doses. Oral Thin Films can be developed using powderless and water-based formulas without use of harmful solvents, which makes it simpler than tablets and capsules.
Recent research shows that OTFs can incorporate a broad range of drugs with variable therapeutic efficacy. There is a common misconception that development of Oral Thin Films is restricted to only water soluble drugs. However, research shows that BCS Class II/IV drugs can also be included in OTFs.
Applications of Oral Thin Films can also be extended to patent-expiring drugs. On receiving the FDA approval, the drug can be re-developed into fast-dissolving film dosage form with three years of market exclusivity based on relevant clinical data.
Many factors are taken into account while manufacturing OTFs to provide solution to increased patient compliance and adherence to therapy. Different attributes such as masking the taste, quick-dissolving, maintenance of medicinal properties, physical appearance, acceptable mouth feel are considered to produce oral thin film products with good acceptability amongst consumers. However, the compact size of the dosage form restricts the loading of Active Pharmaceutical Ingredients (APIs) up to 30 mg.
Avoid the discomfort of swallowing large tablets and capsules or carrying bulky syrup bottles, choose Fast Dissolving Oral Thin Films for convenience, better taste and hassle free administration of medicines.
ZIM Labs, a European Union Good Manufacturing Practices (EU-GMP) certified company, is a distinguished manufacturer and supplier of fast-dissolving oral thin films. Our OTFs have been meticulously developed and tested in accordance with the guidance of medical experts. We are committed to providing exceptional service, and look forward to the opportunity to serve you.
