» SOLUBILITY
»
Figure 3. Patient Need Examples
taken into consideration in order to design for the best achievable outcome. It is crucial to understand these factors well at the outset of the drug development activity. In order to meet some very specifi c patient needs, design elements going beyond drug substance and drug product might need to be optimized, including packaging confi guration, devices, and handling process/instructions.
Examples of newer drugs addressing specifi c patient needs include easy-to-swallow products for patients with swallowing issues, such as the previously mentioned orodispersable fi lm strip Zuplenz® and the orodispersable tablet Zyprexa® Zydis.
Future Opportunities
Building on the signifi cant progress achieved in the four aforementioned domains, (absorption process understanding, developability of NCEs, formulation/drug delivery system design, and patient-centered drug design), there is still opportunity for additional advancement of the broader area of oral drug delivery, which can be achieved in particular by more seamlessly integrating development activities across the four domains (Figure 4).
In order to achieve this state, two main principles need to be applied. First, scientists from all domains involved will constantly have to evaluate how their activities infl uence the R&D space of their collaborators in adjacent domains. Second, everyone involved in the development process needs to direct his activities towards maximization of meeting the needs of his patients.
To achieve this, the overall development approach, which in the past was likened to a relay race where the team members pass on the baton, needs to be transformed to a collective approach, comparable to that of a rowing team where all the team members sit in one boat and pull jointly towards the common direction: improved patient outcomes.
Summary
Signifi cant progress has been made over the past 15 years in various domains vital to oral drug delivery including: absorption process understanding, developability of NCEs, formulation/drug delivery
34 | | September/October 2013 - 15TH ANNIVERSARY ISSUE
Figure 4. Integrated design of oral medications
system design, and patient-centered drug design. Patients have benefi tted from that progress via the availability of several novel and important medicines. Future innovations can be derived from a more overarching approach in drug development with signifi cant touch points between the aforementioned broader domains and gain better patient outcomes.
Author Biography
Ralph Lipp, Ph.D., is President and CEO of Lipp Life Sciences LLC. Before founding Lipp Life Sciences LLC, Ralph served as Vice President Pharmaceutical Sciences R&D at Eli Lilly and Company and Head Pharmaceutical Development at Schering AG. Ralph holds a degree in Pharmacy from Johannes Gutenberg University in Mainz, Germany, and obtained a Ph.D. in Medicinal Chemistry as well as a Habilitation for Pharmaceutical Technology from Free University Berlin, Germany. His scientifi c contributions comprise over 120 publications, including more than 20 patents, covering 5 marketed medicines.
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GBI Research. Oral Drug Delivery Market Report. Contract Pharma, June 2012.
R.T.Borchardt. Hidalgo, I. J., Raub, T. J., and Borchardt, R. T.: Characterization of the human colon carcinoma cell line (Caco-2) as a model system for intestinal epithelial permeability. Gastroenterology, 96, 736–749, 1989—The Backstory. AAPS Journal 13(3), 323-327 (2011).
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