Orodispersible Films for Drug Delivery: An Overview
The oral route of drug administration is widely held as the most accepted and effective route due to the convenience of self-administration, easy manufacturing, and compactness. However, the most evident issue in the common oral dosage drug forms, such as capsules and tablets, is the difficulty in swallowing.
It makes many patients non-compliant with the dosage, especially geriatric and pediatric patients. At the same time, it is applicable to all patients who are bedridden and the ones who are actively working and remain busy.
This is where the Orodispersible Films (ODFs) come into the picture as an efficient method for drug delivery.
What are Orodispersible Films?
As mentioned before, the oral route happens to be the most preferred way to administer drugs as it ensures higher patient compliance. A common issue in all age groups is dysphagia (difficulty in swallowing). In fact, fifty percent of the population suffers from this problem. This difficulty can be attributed to the surface, size, and taste of the tablet in the case of Orodispersible. While traveling, water isn’t accessible easily and that adds to the difficulty.
Recently, the US Pharmacopoeia, the British Pharmacopoeia, and the Centre for Drug Evaluation and Research (CDER) have approved the ODF terminology. As per the US FDA, ODFs are referred to as a type of solid dosage that contains medicinal substances that rapidly disintegrate and takes a few seconds to dissolve when placed over the tongue.
According to European Pharmacopoeia, the term OD tablet refers to any kind of tablet that is put in the mouth to rapidly disperse without the need to swallow anything.
Ideal Characteristics of Orodispersible Films
Ideally, an ODF should have the following properties:
- needs no water
- easy to transport and portable
- have a pleasant taste
- easily disperse or dissolve in the saliva within seconds
- leaves no or negligible residue in the mouth after administration
- ability to make in a conventional and simple manner without the additional cost burden
- permit the manufacturing through conventional processing
- remain less sensitive to the environmental changes like humidity, temperature, and so on
Benefits of Orodispersible Films
- Ease of administering to patients who can’t swallow (stroke victims, geriatric and bedridden patients), patients who shouldn’t swallow (patients of renal failure), and patients who refuse to swallow (pediatrics, psychiatric, and geriatric patients)
- Better compliance
- Easier to use for disabled patients and the ones busy and traveling without ready access to proper drinking water
- No chewing required
- No water required
- Improved taste
- Better stability
- Suitable for sustained/controlled release actives
- Suitable for precise drug loading
- Leaves minimum residue
- Capacity to offer the benefits of liquid medication in the form of a solid preparation
- Rapid intervention drug therapy
- Have a pleasant mouthfeel with an acceptable taste
- Suitability for patients with esophageal issues who cannot swallow tablets or capsules readily
Limitations of ODFs
- Higher drug loading is not possible for Orodiserpersible technology.
- Usually, higher drug-loaded films contain insufficient mechanical strength, which means careful handling is needed.
- The orodispersible film might leave an unpleasant taste in the mouth when not formulated in the right way.
Essential Properties of ODFs
- The performance of the ODFs are dependent on the technology utilized at the time of manufacturing.
- An important property of these platform technologies is that they can disintegrate fast and dissolve or disperse in saliva, which obviates the requirement for water.
- Different technologies are coming up to improve the solubility of the Orodispersible Films and Tablets.
Keeping all the factors in mind, an ideal ODF needs to meet the given criteria:
- Contain enough strength to go through the rigorous manufacturing process and post-manufacturing movements
- Should have a pleasant mouthfeel and no strong after taste
- Remain insensitive to environmental changes related to temperature and humidity
- Remain amenable and adaptable to the present packaging and processing machinery
The ODFs have come a long way since their initial form, but they still have a lot of development left. The current focus is on making the ODFs more cost-effective and faster to dissolve in the mouth.
About ZIM Laboratories
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).