Patient centric drug product design in modern drug delivery as an opportunity to increase safety and effectiveness

ABSTRACT

Introduction: The advances in drug delivery technologies have enabled pharmaceutical scientists to deliver a drug through various administration routes and optimize the drug release and absorption. The wide range of drug delivery systems and dosage forms represent a toolbox of technology for the development of pharmaceutical drug products but might also be a source of medication errors and nonadherence. Patient centric drug product development is being suggested as an important factor to increase therapeutic outcomes.

Areas covered: Patients have impaired health and potentially disabilities and they are not medical or pharmaceutical experts but are requested to manage complex therapeutic regimens. As such the application of technology should also serve to reduce complexity, build on patients’ intuition and ease of use. Patients form distinct populations based on the targeted disease, disease cluster or age group with specific characteristics or therapeutic contexts.

Expert opinion: Establishing a target product and patient profile is essential to guide drug product design development. Including the targeted patient populations in the process is a prerequisite to achieve patient-centric pharmaceutical drug product design. Addressing the needs early on in the product design process, will create more universal design, avoiding the necessity for multiple product presentations to cover the different patient populations.

KEYWORDS:

• Patient centric
• drug product design
• medication errors
• adherence
• medication management
• target product profile
• target patient profile
• multimorbidity
• polypharmacy

Article highlights

• The patient factor in drug therapy is achieving increasing attention in the scientific community as well as the regulatory authorities

• There is growing evidence that medication errors and non-adherence are preventable to a certain extend by pharmaceutical drug product design

• There is an increasing number of patients with multimorbidity, polypharmacy, and high age whose needs are not sufficiently addressed with the standard drug product design.

• Patient-centric drug product design starts with a target product as well as patient profile taking into account the patients context, including their own expectations and learnings.

• The different patient factors have to be considered and prioritized during the development of the drug product to achieve a more universal design, suitable for the broadest patient population.

• A process to develop patient-centric drug product design that has recently be proposed is being summarized.

• This box summarizes key points contained in the article.

Acknowledgments

The author would like to thank Mrs. Maria Bradler from Graz University of Technology for her linguistic support and reviewing the publication

Declaration of Interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded