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Review
. 2015 Nov;17(6):1327-40.
doi: 10.1208/s12248-015-9814-9. Epub 2015 Aug 15.

Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

Hong Wen  1 , Huijeong Jung  2 , Xuhong Li  3
Affiliations
Review

Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

Hong Wen et al. AAPS J. 2015 Nov.

Abstract

Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with poor water solubility or low permeability, techniques such as amorphous solid dispersion, liposomes, and complexations have been used to improve their oral bioavailability. Modified release (MR) formulations have been widely used to improve patient compliance, as well as to reduce side effects, especially for those drugs with short half-lives or narrow therapeutic windows. More than ten drugs using sterile long-acting release (LAR) formulations with clear clinical benefit have been successfully marketed. Furthermore, drug delivery systems have been used in delaying drug clearance processes. Additionally, modifying the in vivo drug distribution using targeted delivery systems has significantly improved oncology treatments. All the drug delivery approaches have their advantages and limitations. For both brand and generic drugs, the achievement of consistent quality and therapeutic performance using drug delivery systems can also pose serious challenges in developing a drug for the market, which requires close collaboration among industry, academia, and regulatory agencies. With the advent of personalized medicines, there will be great opportunities and challenges in utilizing drug delivery systems to provide better products and services for patients.

Keywords: absorption, distribution, metabolism, and elimination (ADME); adverse effects; bioequivalence; clinical pharmacology; drug delivery; formulation design; local delivery; long-acting release; modified release; personalized medicine; pharmacokinetic profiles; prodrug; quality; regulatory; targeted delivery; therapeutic performance.

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Figures

Fig. 1
Fig. 1
The relationship between drug aqueous solubility and pH values: a monoprotic acid, b monoprotic base
Fig. 2
Fig. 2
Scheme of a micelle formed by phospholipids in an aqueous solution
See this image and copyright information in PMC

References

    1. Drug delivery. Available from: http://en.wikipedia.org/wiki/Drug_delivery.
    1. Anselmo AC, Mitragotri S. An overview of clinical and commercial impact of drug delivery systems. J Control Release. 2014;190:15–28. doi: 10.1016/j.jconrel.2014.03.053. - DOI - PMC - PubMed
    1. Dawidczyk CM, et al. State-of-the-art in design rules for drug delivery platforms: Lessons learned from FDA-approved nanomedicines. J Control Release. 2014;187:133–44. doi: 10.1016/j.jconrel.2014.05.036. - DOI - PMC - PubMed
    1. Guidance for industry and review staff: target product profile—a strategic development process tool. 2007; Available from: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati....
    1. Advanced delivery devices - wearable bolus injectors - a new class of patient-friendly drug delivery systems 2014; Available from: http://www.drug-dev.com/Main/Back-Issues/ADVANCED-DELIVERY-DEVICES-Weara....

MeSH terms