Contract development and manufacturing organisation (CDMO) Aptalis told a conference at CPHI Paris that doctors and nurses working in mental health want to prevent “cheeking”, when patients in involuntary care secrete tablets in their cheeks or under their tongues to avoid swallowing them.
Aptalis reformulates drugs with its partners to increase patient compliance, whether for those in mandatory care, or for the particular needs of paediatric, elderly, or CNS populations – who may have problems with bitter tastes or swallowing.
Quick-dissolve: other markets
Paolo Gatti, head of formulation and R&D, said orally disintegrating tablets (ODTs) are a good answer to the difficulties of all these groups because they make swallowing easier and faster.
“All the dosage forms that make swallowing easier could be applied here [for patients in mandatory treatment] because tablets that quickly dissolve under the tongue are more difficult not to be swallowed by the patient,” he said.
The company’s AdvaTabs dissolve in less than 30 seconds, with no need for water, according to Nadine Maalouf, Associate Director of Licensing.
The technology combines Diffucaps – Aptalis’s coating for delayed release – with micro-encapsulation – a polymer coating for individual liquid or solid API clusters to mask taste. Aptalis uses polymer coacervation (separation) to achieve micro-encapsulation.
“The most important part is we use a low compression force to help keep the integrity of the micro capsules. The standard method can break the capsules and cause grittiness and [release] a bitter taste,” said Maalouf.
AdvaTabs maintain their stability in normal blister packaging, she added.
Reformulating drugs to increase patient compliance helps life cycle management of existing drugs and can increase market share, Gatti said. Newer versions must show bioequivalence with the originals, with and without water.
Other technologies on the market for ease of swallowing include oral lyophilisates (melting tablets), oral mini-tablets, and orally dispersible films (ODFs).