The Opadry EZ Easy Swallow Film Coating System has been launched by formulations and drug delivery tech firm Colorcon to aid patients in swallowing oral medicines.
The product’s formulation contains a blend of film-former, plasticiser and pigments, spokesperson Deborah Taylor told this publication, and “works by the coating becoming extremely slippery on contact with water.”
She said “other polymers tend to become ‘sticky,’ so this is a significant innovation,” and added Opadry will help address the growing concern of swallowability.
“Colorcon wanted to create a product that satisfied both the perception and reality of ease of swallowing. Recent regulatory guidance, from the FDA and EMA, is focusing on patient compliance and directing pharmaceutical companies to improve efficacy through better tablet design.”
The US Food and Drug Administration (FDA) issued guidance in 2015 on the physical attributes of generic tablets and capsules describing how the presence and composition of a coating can potentially affect the ease of swallowing pills.
“The lack of a film coating can decrease or prevent tablet mobility compared with a coated tablet of the same size and shape,” the guidance states.
Similarly, 2016 guidance on the ‘Safety Considerations for Product Design to Minimize Medication Errors’ warns: “A drug product can become a choking hazard due to the size of the tablet or capsule. If the tablet or capsule coating is too sticky, it can become lodged in the patient’s throat or gastrointestinal tract.”
Taylor told us the coating – supplied as a ready-mix coating formulation by Colorcon to the manufacturer – will also act as a differentiator for drug companies.
“It’s now well recognized that not only elderly patients but many people taking medication on a regular basis,” she told us. “Mitigating adverse events such as pain, gagging, choking, and aspiration related to swallowing difficulties in the oropharyngeal phase of swallowing and increasingly occur at larger tablet and capsule size is important.
“Coating can potentially affect the ease of swallowing tablets. The lack of a film coating can decrease or prevent tablet mobility compared with a coated tablet of the same size and shape, which is important for patient compliance.”