According to data from World Population Prospects: The 2017 Revision, the number of older persons, defined as those aged 60 years and over, is expected to more than double by 2050, to 2.1 billion.
As the world’s elderly population grows, so too do issues surrounding polypharmacy and the swallowability of small molecule drugs.
For formulations and drug delivery tech firm, Colorcon Inc., swallowability and medicine distinction, along with counterfeit tablets and pills, represent major concerns in the small molecule space.
in-PharmaTechnologist (IPT) asked Colorcon’s general manager of film coatings, Kelly Boyer (KB), how the firm is addressing these issues in oral solid dose drugs for older populations and paediatric patients, and in what other research areas is the firm focusing its attention.
IPT: The elderly are the fastest growing population segment. How can colours and shapes be used to target seniors?
KB: Colour for tablets helps recognition and differentiation, reducing the risk of medication error and supporting brand recognition.
The shape can help when designing tablets that are easier to pick up, hold and swallow. The ovoid shape is preferred to the traditional caplet shape for tablets, as these are smoother and more rounded, thus facilitating easier swallowing – along with the addition of a coating that provides good slip/lubrication.
There are some unique shapes in the market that address specific issues, such as dexterity. For example, patients with Parkinson’s disease can have trouble grasping their pills from flat surfaces. To address this, GSK designed a ‘tilt-tab’ comprising five sides and a pointed top surface to make its Parkinson's disease drug, Requip (ropinrole), easier for patients to pick up.
IPT: How can colours and shapes be used in other population groups, such as children?
KB: The challenge with children is for the medication to be palatable, while not looking or tasting like candy. Again, colour and shape can help to differentiate medications, while addressing swallowability issues: tablets can be designed to be smaller, more ovoid in shape, and/or specifically coated to aid swallowing while masking bad taste and odours.
Alternative dosage forms are also becoming popular, such as multiparticulates, which can be sprinkled into drinks and foods.
IPT: How does Colorcon distinguish itself from competition in this field?
KB: We have invested heavily in creating a unique coating system to address swallowability; a recognized and growing patient problem. Opadry EZ Easy Swallow Film Coating satisfies both the perception and reality of easier swallowing. It achieves this by using a high gloss finish that adds aesthetic appeal and increased mobility for the tablet during the swallowing process. In addition, Opadry EZ finished tablets are easy to handle when dry, while exhibiting exceptional slip upon contact with water, with no negative impact on release profile.
Colorcon also offers a BEST Unique Tablet Design Service to help clients choose the perfect colour and shape to distinguish their brand, designed with emphasis on attributes that help promote improved patient safety and medication compliance.
IPT: Which other patient populations could benefit from Colorcon’s ‘safety by design’ initiative?
KB: Regulatory agencies around the world provide guidance regarding the importance of tablet coating as a means of addressing differentiation, as well as facilitating the swallowing of tablets and capsules to improve patient safety and compliance.
This applies across all patient populations, and is especially important for those taking multiple medications - so-called ‘poly medication’. It it not just the elderly population that is susceptible to pill fatigue, but also those undergoing treatments that require a number of medicines.
If we consider current cancer treatments, for example, some require a cocktail of oncology drugs combined with anti-sickness and pain relief medication, which can create a real pill burden for the patient. In addition, it can be difficult for the patient to differentiate between the tablets to ensure a correct regime.
Being able to confidently differentiate between these pills, while at the same time easing swallowability, helps care givers and health workers as well as the patients themselves – either at home or in the hospital.
IPT: Counterfeiting remains an issue in small molecule pharma. What role does Colorcon play in ensuring against counterfeit drugs?
KB: To help counter the growing problem of counterfeit, diverted, and adulterated medicines around the world, Colorcon is working with Applied DNA Sciences to advance an anti-counterfeiting authentication technology that will be suitable for on-dose application.
The offering integrates Applied DNA’s SigNature molecular tags into Colorcon's film coating systems for pharma companies to apply to their tablets and capsules.
Applied DNA Molecular tags will provide traceability for audits and law enforcement and, perhaps most importantly, confirmation of the authenticity of the drug product to the patient and all those in the supply chain.
IPT: What should we expect from Colorcon over the next five years?
KB: Key research areas for Colorcon target innovations to support continuous processing, with excipients for direct compression and extending further the range of Opadry film coatings. We’re on track to bring on-tablet authentication technologies to market and further extend our BEST tablet design services, with 3D printed and coated tablets available for companies to market test their tablet designs.
Continued investment in film coating and excipient manufacturing plants, along with further expansion of our technical services labs around the world is also planned.
Kelly Boyer is general manager of film coatings at Colorcon Inc. A chemical engineer by training, Boyer has overseen a number of launches in the pharmaceutical space since joining the company in 2014.