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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 involves 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 films 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 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.
Depending on the site of administration, two kinds of Oral Thin Films are available-
Oromucosal – the one that adheres to the mucosal regions of the oral cavity and slowly releases the drug.
Orodispersible – the one when placed on the tongue disintegrates quickly upon contact with saliva. You will find two subtypes in orodispersible films – orally disintegrating and orally dissolving.
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 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 Ingredient (APIs) up to 30 mg.
Some of the components that are required in manufacturing OTFs include:
Avoid the discomfort of swallowing large tablets and capsules and carrying bulky syrup bottles. Choose Fast Dissolving Oral Thin Films for convenience, better taste and hassel free admistration of medicines. ZIM Laboratories, an EU-GMP Certified Company, is one of the best and leading manufacturers and suppliers of quick-dissolving oral thin films. All the OTFs are tried and tested as per guidance from medical professionals. We, at ZIM Laboratories, are ready to serve you.
ZIM Labs is an innovative drug delivery solution provider focusing on improving patient convenience and adherence to drug intake. We offer a range of technology-based drug delivery solutions and non-infringing proprietary manufacturing processes for the production and supply of innovative and differentiated generic pharmaceutical products to our customers globally. At ZIM Labs we provide our customers a comprehensive range of value-added solid dosage differentiated generic products in semi-finished and finished categories/formulations. These include granules, pellets (sustained, modified, extended-release), taste-masked powders, suspensions, tablets, capsules, and recently developed Oral Thin Films (OTF).
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