The efficacy of any treatment depends on patients’ compliance with their regimen. Reducing the number of doses and offering medication in a form that is easy to take can positively affect patient behaviour.
The next generation of orally disintegrating tablets combines these benefits in one, simple product.
Many studies have suggested that patients’ compliance with medication instructions weakens as the number of daily doses required increases. The ease with which medication can be administered as well as the taste of the drug can also have a bearing on patient compliance.
John Taylor, director of business development for specialty pharmaceutical company Eurand, says: ‘There is an inverse correlation between the frequency of the dose regimen and patient compliance.
‘In response, pharmaceutical companies have developed controlled-release products, so that doses are less frequent. Our goal is to deliver these in oral disintegrating tablet (ODT) form.’
Improving compliance
ODTs are easy and discrete to administer, usually without the need for water, and improve patient compliance. Delivering controlled-release formulations in ODT form can have a dramatic impact on patient behaviour. The first controlled-release ODT product to do so could be Eurand’s AdvaTab, which will be launched in early 2008.
Taylor explains: ‘AdvaTab can be beneficial if patients have problems swallowing, which is often the case in paediatric and geriatric patients.
‘For central nervous system disorders or people with migraines, the reduced need for water is important. There could also be applications for acute treatment, pain and panic attacks, and there is a compelling argument that ADHD treatments could benefit from the ODT form.’
AdvaTab combines Eurand’s well-established, market-leading taste masking technology, Microcaps, with the company’s DiffuCaps controlled release technology.
DiffuCaps is a multiparticulate system that optimises release profiles by layering active drug onto a neutral core and then applying rate controlling, functional membranes.
MicroCaps, originally developed in the 1970s, coats drug granules in a polymer to isolate them from the taste buds. Over time, it has set the standard for taste masking, having been used with market leading drugs such as Advil and Tylenol.
Polymer coatings, especially if they are thick, used to retard dissolution, which posed a problem for controlled-release drugs. With AdvaTabs, Eurand has modified MicroCaps to combine perfect taste masking with rapid dissolution in the stomach.
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 Next-generation ODTs
ODT technology is not new, but AdvaTab and the next generation of products represent a significant step forward in terms of broadening the technology’s range of applications.
‘The first generation of ODTs was innovative,’ says Taylor. ‘It was in solid dosage form and was easy to take, even without water, but they had problems. We added the taste-masking technology so that we can use more bitter compounds and higher dosages. That is where we add value.’
The manufacturing process was another key focus of innovation for Eurand. ‘There were big challenges to address,’ says Taylor.
‘We were taking a coated product and compressing it, so there were some fractures in the polymer coating. We had to design particles to deal with that, which were not gritty when dissolved. We are now well up the learning curve on those issues.’
Early ODTs were expensive to manufacture and required special packaging, but the next generation promises to have manageable production costs. From a packaging perspective, AdvaTab is suitable for both bottles and blister packs. Furthermore, the equipment required for its manufacture is relatively standard, requiring a small modification to the familiar tablet press.
The potential benefits of ODTs for patients – their improved cost profiles and increasing applicability in controlled-release drug applications – has attracted great interest from major pharmaceutical companies, with the likes of Eurand’s collaboration partner GSK beginning a registration bioequivalence study for AdvaTab.
‘There is demand from major pharmaceutical companies for product differentiation, and AdvaTab meets that goal,’ says Taylor.
The future development of ODT technology will depend greatly on the success of products such as AdvaTab, which will be the first to set the standard. end
Company profile
Eurand Pharmaceuticals is a specialty pharmaceutical company that develops, manufactures and commercialises enhanced pharmaceutical and biopharmaceutical products using its proprietary drug formulation technologies. For more information, visit
Website: www.eurand.com
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