Company insight Get the right dose
Improving drug adherence is not only a financial opportunity for drug companies, but also an opportunity to meet a social need of patients. This is something SPI Pharma knows well as it examines the trends driving orally dispersible dose development and technologies to meet emerging needs.
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n the US, studies estimate non- adherence costs over $0.5trn annually and also reduces the quality of life for many individuals. Adherence is addressed through behavioural methods and financial policy, but the drug dose form itself can be a useful tool for drug developers to address non-adherence. The convergence of several trends, as well as global regulatory requirements have created an incentive to address adherence much earlier in the drug development process.
Patient-centred drug development, outcome-based reimbursement and regulatory requirements for paediatric investigations plans are trends that drive drug developers to use alternate dose forms. The US FDA patient-focused drug development programme encourages a systematic approach to capture and incorporate experiences, perspectives, needs and priorities into drug development. Increasingly, reimbursement is based on patient outcomes. Companies’ reimbursement rate can be based on the efficacy as measured in actual patients. Focus on patient experience and convenience, leading to adherence and increased safety and efficacy in the outcome, is becoming germane to the reimbursement model.
There is also a need for more paediatric drug development. A paediatric investigation plan, or PIP, is required both in Europe and the US. This is especially true because regulators worldwide tend to adopt models similar to the US and Europe where incentives are given following a “carrot and stick approach”.
Companies not developing paediatric drugs will fall behind the competition. On the other hand, companies that develop doses for paediatrics, will not only make it to the market first, but will gain an advantage over the competition. Convenient dose forms can address these trends and lead to higher adherence. This is a dynamic environment that calls for new mindsets and technologies for drug development.
A view of the OTC market This portion of the drug market has consistently had to address patient preferences and incorporate consumer perspectives, needs and priorities into development. One of the advances that the market has developed is convenient dose forms – chewable, dissolvable tablets and gummies. In this segment of the drug industry, companies have a portfolio with a wide variety of dosage forms. They are increasingly developing forms that can be easily administered to children in the correct
dose, but also address emerging consumer presence for convenient administration. More convenient and patient-centric dose forms could be utilised in new drug development to address patient preferences, boost adherence and address regulatory trends. Unfortunately, drug companies often do not possess the expertise to effectively formulate these dose forms. As a result, development slows and productivity suffers. Orally dispersible dose forms not only provide an interesting way to help improve patient adherence, but also improve the speed of development programmes for drug companies. Creating orally dispersible tablets (ODT) or chewable tablets deliver advantages such as convenient administration, no liquids needed, child- friendly dose forms, and higher stability versus liquids. However, formulating these dose forms includes the additional complexity of taste and palatability, release profiles, and the correct structural integrity of the tablet. Pre-formulated platforms can help bridge this knowledge gap and speed up development.
A leading expert
SPI Pharma is a leader in providing preformulated platforms for ODT and chewable tablets. SPI has significant experience formulating ODTs, helping to bring over 60 products to market using its technologies. The company provides preformulated products to create ODTs, Flash ODTs, chewable tablets and powder sachets. These products incorporate our application knowledge and allow drug developers to increase development productivity by increasing development speed and project success rate, while also addressing the regulatory and business challenges that are emerging in the drug industry. ●
References available on request. ODTs are chewable tablets that deliver advantages, including child-friendly applications. World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
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