Dosage Form Design and Development
Dosage Form Design and Development
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DOI：
10.1016/j.clinthera.2008.11.015
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发表时间：
2008-11-01
影响因子：
3.2
通讯作者：
Allen, Loyd V., Jr.
中科院分区：
文献类型：
--
作者：
Allen, Loyd V., Jr.
背景：药物必须适当配制，以供患者使用，无论年龄大小。儿科患者在依从性和治疗效果方面给配方设计者带来了一些额外的挑战。由于缺乏足够的药物产品的儿科人口，制药业和复方药店必须开发和提供适当的药物设计为children.Objective：本文的目的是审查的物理，化学和生物学特性的药物和药物成分，用于制备药物产品。此外，稳定性，外观，适口性，调味，甜味，着色，保存，包装和storage是discussed.Methods：信息为当前的文章是从文献综述收集，从专业和技术会议上的演讲，从讲座，书籍和出版物的作者，以及从他的专业经验。专业社会会议和标准制定机构也被用作resource.Results：适当的设计和制定的剂型需要考虑的物理，化学和生物学特性的所有药物和药物成分（辅料），用于制造产品。所用药物和药物材料必须相容，并生产稳定、有效、适口、易于给药和耐受性良好的药物产品。处方前因素包括物理性质，如粒度，晶体结构，熔点，溶解度，分配系数，溶解，膜渗透性，解离常数，和drug stability.Conclusions：成功的开发一个配方包括涉及药物，赋形剂，依从性，储存，包装，和稳定性，以及患者的口味，外观和适口性的考虑因素。(Clin Ther. 2008;30：2 1022111）（C）2008 Excerpta Medica Inc.
Background: Drugs Must be properly formulated for administration to patients, regardless of age. Pediatric patients provide some additional challenges to the formulator in terms of compliance and therapeutic efficacy. Due to the lack Of Sufficient drug products for the pediatric Population, the pharmaceutical industry and Compounding pharmacies must develop and provide appropriate medications designed for children.Objective: The purpose of this article was to review the physical, chemical, and biological characteristics of drug substances and pharmaceutical ingredients to be used in preparing a drug product. In addition, stability, appearance, palatability, flavoring, sweetening, coloring, preservation, packaging, and storage are discussed.Methods: Information for the current article was gathered from a literature review; from presentations at professional and technical meetings; and from lectures, books, and publications of the author, as well as from his professional experience. Professional society meetings and standards-setting bodies were also used as a resource.Results: The proper design and formulation of a dosage form requires consideration of the physical, chemical, and biological characteristics of all of the drug Substances and pharmaceutical ingredients (excipients) to be used in fabricating the product. The drug and pharmaceutical materials utilized must be compatible and produce a drug product that is stable, efficacious, palatable, easy to administer, and well tolerated. Preformulation factors Include physical properties Such as particle size, crystalline structure, melting point, solubility, partition coefficient, dissolution, membrane permeability, dissociation constants, and drug stability.Conclusions: Successful development of a formulation Includes multiple considerations involving the drug, excipients, compliance, storage, packaging, and stability, as well as patient considerations of taste, appearance, and palatability. (Clin Ther. 2008;30:2 1022111) (C) 2008 Excerpta Medica Inc.