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医药载体系统评论综述
影响因子: 2.9 5年影响因子: 3.72 SJR: 0.736 SNIP: 0.551 CiteScore™: 2.43

ISSN 打印: 0743-4863
ISSN 在线: 2162-660X

医药载体系统评论综述

DOI: 10.1615/CritRevTherDrugCarrierSyst.v16.i1.10
83 pages

Formulation, Stability, and Delivery of Live Attenuated Vaccines for Human Use

Carl J. Burke
Department of Vaccine Pharmaceutical Research, Merck Research Laboratories, WP78-302, West Point, PA 19486 USA
Tsu-An Hsu
National Health Research Institutes, Taipei, Taiwan
David B. Volkin
Department of Vaccine Pharmaceutical Research, Merck Research Laboratories, WP78-302, West Point, PA 19486 USA

ABSTRACT

The successful use of live attenuated viral and bacterial vaccines depends not only on the proper choice and delivery of the microorganisms, but also on maintaining the sufficient potency required for an immune response. The inherent lability of live organisms presents a particular formulation challenge in terms of stabilizing and preserving vaccine viability during manufacturing, storage, and administration. This review examines pharmaceutical approaches to the stabilization, formulation, and lyophilization of biological macromolecules in general, as well as the specific applicability of these principles to live attenuated viral and bacterial vaccines. Several formulation development case studies with live vaccines are presented. In addition, comparative stability data are summarized for many other live viral and bacterial preparations. Various pharmaceutical issues with conventional and novel delivery systems for administration of parenteral and oral live vaccines are also discussed.


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