Taking medication can be a hard pill to swallow—but it doesn’t have to be! Orally disintegrating tablets (ODTs) have become increasingly popular due to their superior bioavailability, faster pregastric absorption and higher rates of patient compliance. But while pharmaceutical companies attempt to keep up with the growing ODT demand, many have found that they can pose difficult manufacturing and packaging challenges.

Why Are Orally Disintegrating Tablets an Effective Dosage Form?

• High rates of patient compliance.
  One of the major advantages of orally disintegrating tablets is their higher rate of patient compliance. Dissolving tablets are easier than swallowing a pill for many patient populations, especially for geriatric and pediatric populations as well as those who suffer from dysphagia. A decade ago, one study found that “patient nonadherence to medication results in an annual revenue loss of approximately $564 billion for the global pharmaceutical industry.”
  Across the board, choking or gagging sensations and unpleasant tastes are among the most common complaints about pills. A study from The European Journal of Clinical Pharmacology found that 30% of adults had difficulty swallowing pills. Around 10% of them stopped taking the medications because of these frustrations. Orally disintegrating tablets avoid this issue, making them an alternative with much higher patient compliance rates.
• Increased portability and hygiene.
  One critical factor impacting compliance is that patients do not need a glass of liquid to ingest orally disintegrating tablets. ODTs are valuable for patients who travel frequently or need to take the medication in situations where they may not always have water on hand. Increased hygiene is another advantage of ODTs – and a timely one. In our post-pandemic world, healthcare workers and patients are more aware of hygiene than ever. Patients don’t need to worry whether a glass was washed correctly or if their nurse thoroughly washed their hands before handing them a pill from an already-open jar. The individual blister packaging common to orally disintegrating tablets keeps the medication sterile until the patient is ready to take it.

• Increased bioavailability and faster absorption.
  When medication is absorbed through oromucusal tissues and other pregastric areas, patients experience increased bioavailability and faster absorption of the medication. The medication absorbed in the mouth enters the bloodstream more quickly, making orally disintegrating tablets ideal for indications such as:
  • Neurological disorders
  • Epilepsy
  • Sleep disorders
  • Psychosis
  • Cardiovascular conditions
  • Pain relief

ODTs can also increase the bioavailability of the medication. Protein- or peptide-based therapies degrade quickly in stomach acid, so they are more effective when taken via ODT.

ODT Manufacturing Challenges

While ODTs are an easy dosage form to take and have multiple advantages, there are some challenges when it comes to manufacturing.

• Lack of mechanical strength.
  During the manufacturing process, medications must often survive a drop of several inches. They must also stay intact during the packaging and shipping process. These stress tests are a challenge for orally disintegrating tablets because they don’t possess the same durability as pills.According to FDA guidance, ODTs must dissolve completely in 30 seconds or less. Most pills contain cellulose to keep their rigidity, but cellulose does not dissolve fast enough for ODTs, forcing manufacturers to find less-sturdy alternatives. The harder the tablet, the more difficult the disintegration process.

• Cost-prohibitive packaging.
  High friability and a lack of mechanical strength mean ODTs often need to be packaged in individual blisters instead of bottles. Blister packaging, however, is more expensive since it requires more material. Also, pharmacies charge higher dispensing fees for blister packs. When manufacturing blister packaging, companies can opt for hot-blister or cold-blister processes.With a hot-blister process, the heat can be a complication for an intentionally-fragile tablet, and many active pharmaceutical ingredients (APIs) are heat sensitive. That’s why most ODT producers choose cold-blister packaging. This process is more expensive and is slower – which may be an issue for manufacturers at higher volumes.

• ODTs and Reliance on Sugar
  Mechanical strength plays a big role in taste. Since orally disintegrating tablets dissolve on or near the tongue, taste is a key factor for patient compliance. To help with taste, most manufacturers add sugar to the medication. But sugar is very sensitive to humidity, and even slight amounts of moisture can immediately start degrading the product and its mechanical strength.

• No controlled or extended-release option.
  The fast disintegration of ODTs is just as much an advantage as it is a disadvantage. Since the medication is absorbed so quickly in the oral cavity, ODTs cannot support controlled or extended-release medication.

The form of your medication matters

Companies choosing a pharmaceutical dosage form must first consider the patient population. If the medication is targeted toward pediatric or geriatric patients, or patients who struggle with compliance, then an orally disintegrating tablet might be the best option. Manufacturing and supply chain issues, however, may pose challenges, and the friability of the tablet formulation – or the expense of the packaging – might also be deterrents. On the other hand – and depending on the indications for use – an ODTs’ speed of absorption and bioavailability may be deciding factors.

The Future of ODTs

While ODTs have tremendous potential, they also have their challenges, such as packaging, which companies like LGM are working to solve. For example, we have developed an ODT tablet formulation in which 100 tablets can be packaged in standard pill bottles.

Setting aside the difficult formulation and packaging considerations, the potential for ODTs to increase patient adherence makes the dosage form particularly attractive to companies looking to repurpose an existing drug.

If you’re considering orally disintegrating tablets, it’s important to evaluate an entire range of factors — patient population, cost, supply chain, capabilities and capacities. There are also additional factors that will determine whether an ODT project is successful – namely, the teams performing formulation and regulatory support. Having experienced formulation and regulatory support teams has often proved to be the key decision in ODT projects.

A thorough review of these considerations with a seasoned CDMO like LGM Pharma can help determine if ODTs are an optimal solid dose format for your product. Give us a call today!