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所在平台: Udemy |
课程主页: https://www.udemy.com/course/preformulation-studies-for-pharmaceutical-industry/
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**课程名称：** 药物工业制剂前研究 **课程概述：** 本课程深入探讨了药物工业制剂前研究的重要性，强调了理解药物活性成分基本化学和物理特性对于成功开发药物剂型至关重要。课程将引导学习者掌握制剂前研究的方法论，并涵盖一系列关键的理化性质，这是设计和制造安全有效的药物产品的基础。 **核心内容：** 课程重点研究以下药物活性成分的关键理化性质： * **溶解度：** 影响药物吸收和生物利用度的关键因素。 * **渗透性：** 药物穿过生物膜的能力。 * **电离常数（pKa）：** 影响药物溶解度、渗透性和在不同pH环境下的稳定性。 * **结晶度：** 药物以晶体形式存在的性质，影响其稳定性和溶解度。 * **多晶型：** 同一化合物不同晶体结构的存在，可能影响溶解度和生物利用度。 * **无定形：** 药物缺乏有序晶体结构的性质，通常具有更高的溶解度。 * **粒径：** 药物颗粒的大小，影响溶解速率、过滤性和制剂的均匀性。 * **粒径形态：** 药物颗粒的形状，可能影响流动性、压片性和体外溶出度。 * **比表面积：** 药物颗粒的总表面积，影响溶解速率。 * **堆密度与流动性：** 评估粉末在储存和加工过程中的行为，对制剂生产至关重要。 **课程目标：** 通过本课程的学习，学员将能够： * 理解制剂前研究在药物开发中的核心作用。 * 掌握药物活性成分关键理化性质的测量和解释。 * 将制剂前研究的发现应用于药物剂型设计。 * 考虑剂量、剂型和给药途径对前研究需求的影响。 * 认识到制剂学在药物设计、配制和生产中的科学技术基础。
Preformulation studies are very important for the development of a pharmaceutical dosage forms in the pharmaceutical industry. This course will help you to understand preformulation development approach with basic concepts of preformulation studies of the Pharma Industry. Each drug substance has intrinsic chemical and physical characteristics that must be considered before the development of a pharmaceutical formulation. Drug product is formulated using the information gained during the preformulation studies and with the consideration of the dose or doses, dosage form, and route of administration desired for the clinical studies and for the proposed marketed product. Pharmaceutics includes the scientific and technological aspects of the design, compounding, and manufacture of dosage forms. In the scope of this course, most important physicochemical properties of the drug substance such as solubility, permeability, ionization constant, crystality, polymorphism, amorphous, particle size, particle shape, particle surface area and bulk tapped density & flow evaluation have been discussed.These aspects in the design of dosage forms are discussed in the scope of this course.COURSE CONTENTPhysicochemical Properties of the Drug SubstanceTopic 1: SolubilityTopic 2: PermeabilityTopic 3: Ionization ConstantTopic 4: CrystalityTopic 5: PolymorphismTopic 6: AmorphousTopic 7: Particle SizeTopic 8: Particle ShapeTopic 9: Particle Surface AreaTopic 10: Bulked Tapped Density & Flow Evaluation
