Pharma firms must provide imaginative solid dosage alternatives to tablets and capsules, says research claiming more than half of patients have problems swallowing traditional pills.
Tablets and capsules are undeniably the cheapest solid dosage form to manufacture and so have gathered widespread use. But 55% of users have difficulty swallowing them – a problem not limited to the elderly – according to research by Hermes Pharma, a German formulation services firm, and independent pollster Spiegel Institut.
Perhaps surprisingly, a survey of US and German consumers found younger people reported this issue more frequently, with 70% of 16-34 year-olds and 44% of those aged over 65 saying they find it hard to swallow pills.
Problems included drugs being too large to swallow, becoming stuck in the throat, and having an unpleasant taste.
Patients’ responses to these difficulties led in some cases to poorer treatment: 32% resorted to breaking up tablets before swallowing, and 17% crushed the pills and dissolved them in water. Both methods can speed up API (active pharmaceutical ingredient) release time and affect bioavailability. Eight per cent resorted to not taking their medication at all.
Fizzy solutions… the solution?
Hermes said effervescent and chewable tablets, lozenges, orally disintegrating granules and instant drinks are all alternatives drugmakers can consider to make their drugs more user-friendly. Patients scored these forms as easier to swallow, easier to open, and giving a better sensation in the mouth.
A consumer culture means today’s patients are used to freedom of choice and the benefits of convenience, said the company:
“They also enjoy instant access to a wealth of information, leading them to request specific products and treatments. To deliver medical and commercial success, pharmaceutical products will need to appeal to a wider range of preferences, from treatment needs through to lifestyle requirements.”
Innovation: a bitter pill?
But developing solid-dose alternatives has its challenges, said Hermes’ Director of Business Development and Regulatory Affairs, Thomas Hein, as drugmakers must overcome the bitter taste of most APIs, and the complex regulation governing innovative delivery forms.
“The bitter taste of most APIs can be a problem, as our dosage forms spend a longer time in the mouth and are actively tasted rather than simply being swallowed, as is the case for conventional tablets and capsules.
“Effective taste-masking without compromising on mouth feel, stability or API release profile requires the use of specific technologies and processes, such as hot melt coating (HMC) and TOPO granulation.”
Hein said achieving regulatory approval for innovative user-friendly products can also be difficult. “The current regulatory environment has been established principally with conventional dosage forms in mind, and the introduction of novel dosage forms can require the establishment of new guidelines and procedures.”
Hermes works with regulators to push forward boundaries and develop new recommendations, he said.