药品生产企业药学情报工作的新特点

在市场激烈竞争的今天,对信息的利用程度已经成为衡量企业竞争力的一个指标,医药企业药学情报工作已经被提到了议事日程。在美国,20世纪90年代初期就已经有90%的药学情报中心(DICs)采用计算机,功能包括检索药学情报数据库,储存和检索药学情报,编写药讯等情报资料。美国有的企业把情报检索能力作为考察药师业务能力的重要指标之一,要求所有药师都能利用企业现有的信息资源,回答药物情报提问,以证实他们能够称职地履行其药师职责。目前我国许多企业建立了药学情报部门,指派了专门从事药学情报工作的药师负责,药学情报工作正逐步得到应有的重…     

Classification of dermal sensitizers in pharmaceutical manufacturing

Workers in development and manufacturing of pharmaceuticals are at risk for occupational contact dermatitis (OCD) of irritative (ICD) or allergic (ACD) origin, due to contacts with reactive intermediates (IM) and drug substances (DS). We examined, if alternative methods could replace presently used animal tests for identification of ACD in pharmaceutical development and manufacturing, without apparent loss of worker health, in line with regulations. The status of alternative methods for regulatory toxicology for consumer products has recently been reviewed by the Organisation for Economic Co-operation and Development (OECD) and the European Commission’s Joint Research Center (JRC) for the European Chemicals Agency (ECHA). They concluded that prediction of skin sensitization potential, extent and quality by in vitro methods, for regulatory assessments, will depend on the regulatory purpose and level of confidence required. Some alternative methods are currently in validation. Current Globally Harmonized System (GHS) regulations on classification, labeling and packaging of substances and mixtures depend on human and animal data, whereas alternative methods may provide supportive evidence. Since the levels of workplace skin exposure to DS and IM in manufacturing of pharmaceuticals are usually not known, it is not possible to conduct quantitative risk assessments based on threshold calculations for contact sensitizers.     

Social aspects in additive manufacturing of pharmaceutical products

Introduction: Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels.

Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients’ health. The most recent activities in the field of printing technologies for fabrication of dosage forms and ‘polypills’ with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted.

Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.     

药品生产过程偏差处理程序

目的加强药品生产过程中偏差处理的管理。方法建立生产过程偏差处理程序,为生产过程偏差的处理提供规范的流程。结果使所有在生产过程发生的偏差得到有效的处理。结论保证药品的生产质量管理过程符合GMP要求。     

药品生产的偏差处理

偏差处理是GMP管理的关键要素,也是GMP执行过程中的难点之一。科学地进行偏差调查并合理制定相应的纠正和预防措施是药品生产、质量管理过程中能够严格执行GMP的保障之一。本文通过对药品生产过程中的偏差处理流程和偏差处理的要点及难点进行综述性的讨论,对药品生产、检验过程中的偏差处理方法提供建议,对GMP执行过程中的重要因素——偏差处理进行了详尽的解读和分析。     

浅谈我国药品委托生产的可行性及相关建议

委托生产(original equipment manufacture,OEM)起源于20世纪70年代的美国。它首先在电子信息行业和轻工业迅速发展,之后逐渐应用到医药行业,产生了药品委托生产。药品委托生产是指持有药品证明文件的委托方委托其他药品生产企业进行药品生产的行为。对于委托方,可以在不丧失对     

The role of blood-brain barrier studies in the pharmaceutical industry

The blood-brain barrier (BBB) remains one of the greatest challenges for the discovery and development of treatments for CNS disorders, which to this day remains one of the riskiest disease areas in terms of clinical success rates. Although the BBB is currently seen predominantly as a permeability obstacle for CNS drug delivery, it is becoming increasingly clear that the BBB has many more implications for the pharmaceutical industry impacting on CNS pharmacology and pathology, CNS pharmacokinetics and pharmacodynamics, and adverse CNS effects, to name but a few areas. The present review does not intend to summarize the activities in the field of BBB research per se, which has been accomplished by a number of excellent recent reviews, but instead to provide an overview of the role of BBB studies from a pharmaceutical industry perspective. This review will elaborate on the specific needs in terms of BBB-related issues across the different drug discovery and development phases, i.e. target identification and validation, lead generation and optimization, candidate selection and profiling, preclinical development and clinical studies. The specific approaches taken will be discussed in terms of specific requirements, questions to be asked, feasibility, interpretability, and impact. It becomes clear that few of the existing BBB models fully meet the requirements of the industrialized drug discovery process, highlighting the need for an array of new or modified tools and approaches that are more effective in helping make decisions which are more specifically tailored to the various stages of the lengthy process from target to the clinic. In looking at the numerous ongoing activities in the area of BBB research from the drug discovery and development point of view, an attempt has been made to place a stronger emphasis on the applicability of particular techniques and approaches, to identify gaps and areas for future activities. In order to materialize the considerable knowledge gained in recent years, the review is intended to foster an increased awareness of the need to better integrate basic academic research with the specific requirements of the pharmaceutical industry for the search of effective and safe new CNS medicines.     

A comprehensive approach to compliance training in a pharmaceutical manufacturing facility

A healthcare manufacturer seeking to ensure that dollars invested in training return value in performance improvements will want to consider each of these elements and develop a written training plan. Companies who have created a training plan to meet their business objectives are already reaping benefits of reduced turnover and increased productivity.     

流变学在热熔挤出制剂加工中的应用

热熔挤出作为一种新型的药物制备技术,在制药领域展现出诸多优势。本文就热熔挤出的技术原理、流变学基础、流变学在热熔挤出制剂加工中的应用以及挤出过程中常见问题进行综述。     

我国医药制造业知识存量与R&D投入的关系研究

目的探讨我国医药制造业中知识存量对研究与开发(research and development,R&D)投入的影响关系,并从知识产出角度提出增加R&D投入的建议。方法分别以拥有发明专利数、专利申请数计算知识存量,以R&D经费内部支出衡量R&D投入,通过协整检验、动态最小二乘法估计、基于向量误差修正模型的格兰杰因果检验,探究其关系。结果拥有发明专利数和专利申请数存量对R&D投入的影响系数分别为0.70和0.87,且两者均为R&D投入的格兰杰原因,滞后期分别为4年和3年。结论知识存量对R&D投入具有显著的正向促进作用;拥有发明专利数和专利申请数的增加可分别引起R&D投入4年和3年后的增长;专利申请数对于R&D投入的影响效果优于拥有发明专利数。因此保持知识产出持续稳定的增长是提升R&D投入的有效手段。     

Production and characterization of carbamazepine nanocrystals by electrospraying for continuous pharmaceutical manufacturing

In this paper, an electrospray technique followed by annealing at high temperatures was developed to produce nanocrystals of carbamazepine (CBZ), a poorly water-soluble drug, for continuous pharmaceutical manufacturing process. Electrospraying solutions of CBZ in methanol obeys the expected scaling law of current, which is I ～ Q(1/2) (I, electrical current; Q, flow rate), for liquids with sufficiently high conductivity and viscosity. Lower flow rates during electrospraying were preferred to produce smaller diameters of monodisperse, dense CBZ nanoparticles. CBZ nanoparticles were predominantly amorphous immediately after electrospraying. Crystallization of CBZ nanoparticles was accelerated by annealing at high temperatures. CBZ nanocrystals with the most stable polymorph, form III, were obtained by annealing at 90°C, which is above the transition temperature, 78°C, for the enantiotropic CBZ form III and form I. The solubility and dissolution rates of CBZ nanocrystals increased significantly as compared with those of CBZ bulk particles. Therefore, electrospray technology has the potential to produce pharmaceutical dosage forms with enhanced bioavailability and can readily be integrated in a continuous pharmaceutical manufacturing process.     

调脂药物的药学特点及生产现场检查的常见问题讨论

调脂药物是当前一致性评价及仿制药注册申报热点,其活性成分多数具有对光、湿、热敏感,存在多个手性中心与多晶型,部分溶解度较差,原料药合成及制剂工艺易产生遗传毒性杂质等特点.本文总结了调脂药物的药学特点,结合一致性评价及注册生产现场检查中主要关注点及常见问题,对调脂药物的处方工艺及质量控制进行了分析和探讨.