Safety by design is fast becoming recognised as an integral part of tablet manufacture, where it can be used to improve medication adherence. In this feature, Jason Teckoe, technical director, EMEA at Colorcon, examines tablet design aspects in more detail, paying particular attention to swallowability.
tablet
In an environment where the senior population is on the rise and more people are taking multiple medications and dietary supplements (some of which are large tablets and capsules), swallowability is a growing concern. Regulatory agencies around the world provide guidance regarding the importance of tablet coating to not only address differentiation but to ease the swallowing of tablets and capsules to improve patient safety and compliance.
Safety by design to target patient adherence
Medication errors are reported to harm 1.5 million people every year, some of which result in sickness, injury and death. It is estimated that between two to 14% of patients are admitted to hospitals due to medication errors, and around one to two percent of those patients are harmed as a result.1
These numbers are alarming considering most, if not all medication errors could be prevented. Further, these statistics only include those medication errors that have actually been reported.
The World Health Organisation (WHO) also reports that poor patient compliance can lead to additional medical costs and adverse health outcomes, which is why regulators around the world have decided to step in.
Recent guidance from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) highlights the importance of ‘safety by design’, drawing attention to tablet dimension, coating and appearance.2,3
Tablets as preferred oral dosage forms
Tablets remain the most common solid oral dosage form for many reasons, including ease of manufacture, convenience for the patient, accurate dose administration and good stability.
Good tablet design can be used to provide product differentiation, avoid medication mix-ups and deter counterfeiting. The regulatory agencies consider ease of swallowing and patient compliance important issues for manufacturers to address, taking into consideration:
- Tablet size and shape
- Tablet coating and colour differentiation
The number and variety of medicines available increases and patients are now taking multiple medications and living longer. Administration of medicines may be carried out by several healthcare professionals and communication failures can lead to mistakes. By creating your dosage form with the patient in mind, you can make a tablet easier to swallow, both literally and figuratively.
From the patient’s perspective, coating makes the tablet appear easier to swallow and aids in visual differentiation, thus reducing the potential risk of medication errors. The coating also reduces tablet friability and overcomes any damage or dusting issues often associated with uncoated tablets.
The recent focus on medication errors has led regulatory bodies to consider tablet differentiation more prominently, encouraging manufacturers to think more about the patient’s perspective and whether they are likely to follow the recommended dosing regimen outlined in their prescription.
The FDA, for example, has released two industry guidance documents on this topic4,5 intended to champion the patient’s perspective, improve patient compliance and medication outcomes. Adding a coating to a previously uncoated tablet would improve patient compliance and bring the tablet in line with the FDA’s recent recommendations.
Size and finish matter
Now, more than ever, it’s increasingly important to create easily distinguished tablets. Similar looking tablets — especially plain white ones — can be readily confused by patients, pharmacists, caregivers and even manufacturers.
Smaller is also better. An FDA guidance on tablet design reports that complaints from patients about swallowing increase when tablets have diameters exceeding eight millimetres. And the agency states that the largest dimension of a tablet or capsule should never exceed 22 mm.5
In practice, formulators can address size by selecting ingredients and process to effectively minimise overall tablet weight and size. Even so, we know that dose strength, compressibility and other factors make it a challenge to keep tablet size down.
Choosing the path of least resistance
Coating makes tablets easier to swallow and improves tablet mobility; this is recognised as even more important for elderly people (recent EMA guidance).3 And as far as coating goes, the glossier the finish and more slip it can provide, the better.
Through extensive research and development, Colorcon has created a unique coating system to address this recognised and growing patient problem. This new Opadry EZ, Easy Swallow Film Coating has been found to provide increased motility during the swallowing process, satisfying both the perception and reality of easier swallowing, in a recent study.
The swallowability study, conducted by the University of Birmingham (2018, in preparation for submission), aimed to assess the potential for coatings to improve swallowability and to evaluate the mouthfeel of coated versus uncoated tablets. Participants evaluated the swallowability of tablets along with their mouthfeel, described as roughness, adhesiveness, slipperiness, and palatability. The study results confirmed that presence of coating improved the ease of swallowing and that uncoated tablets are clearly different to the coated tablets, being more difficult to swallow with poor mouthfeel. Tablets coated with Opadry EZ coatings were found to be most palatable from all the samples. Uncoated tablets rated as the least acceptable for the participants.
So, remember, when designing a tablet to ease swallowing, make it small, oval or a shape with more rounded edges, and don’t forget the coating.
References:
- United States Institute of Medicine, 2006.
- FDA Guidance: Safety Considerations for Product Design to Minimize Medication Errors. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf)
- EMA Guidance; Good practice guide on risk minimisation and prevention of medication errors. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196981.pdf)
- https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm331810.pdf
- https://www.fda.gov/downloads/drugs/guidances/ucm377938.pdf