《Pharmaceutics》课程教学大纲 一、课程基本信息 英文名称 Pharmaceutics 课程代码 PHAR1125 课程性质 专业必修课程 授课对象 医18药学全英文 学 分 4 学 时 72 主讲教师 崔京浩、陈华兵、邓益斌、丁大伟 修订日期 2021.6.19 指定教材 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems (10) 二、课程目标 (一)总体目标： Pharmaceutics is an applied science of drug formulation design and principles,preparation technology and quality control of various dosage forms.This is a specialized course for students majoring in Pharmacy. The task of this course is to ask student (1)to understand the concept of pharmaceutical dosage forms and the characteristics of each dosage form,(2)to master pharmaceutical excipients used in various dosage forms,(3)the basic preparation methods and technology of various dosage forms,(4)to understand unit operation and quality control method of preparation of each dosage form.It lays a foundation for the theoretical research,production and management of pharmaceutical preparations. （二)课程目标：
《Pharmaceutics》课程教学大纲 一、课程基本信息 英文名称 Pharmaceutics 课程代码 PHAR1125 课程性质 专业必修课程 授课对象 医 18 药学全英文 学 分 4 学 时 72 主讲教师 崔京浩、陈华兵、邓益斌、丁大伟 修订日期 2021.6.19 指定教材 Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems（10 版） 二、课程目标 （一）总体目标： Pharmaceutics is an applied science of drug formulation design and principles, preparation technology and quality control of various dosage forms. This is a specialized course for students majoring in Pharmacy. The task of this course is to ask student (1) to understand the concept of pharmaceutical dosage forms and the characteristics of each dosage form, (2) to master pharmaceutical excipients used in various dosage forms, (3) the basic preparation methods and technology of various dosage forms，(4) to understand unit operation and quality control method of preparation of each dosage form. It lays a foundation for the theoretical research, production and management of pharmaceutical preparations. （二）课程目标：
课程目标1： 1.1 Introduction to Drugs and Pharmacy Learn the development and purpose of the pharmacopoeia,able to describe the central features of a typical drug monograph,familiar with the concept of pharmaceutical care,understand significant drug regulation and control laws,summarize the Code of Ethics for Pharmacists and Pharmaceutical Scientists. 1.2 New Drug Development and Approval Process Compare and contrast an investigational new drug (IND)application from a new drug application (NDA), differentiate between phase I,phase II,phase III,and phase IV clinical trials,preliminary understand the sources of new drugs. 1.3 Current Good Manufacturing Practices Learn the definition and main contents of cGMP. 1.4 Dosage form design:Pharmaceutical and Formulation Considerations Learn the rationality and properties of preparing various dosage forms,familiar with the content of preformulation research in dosage form design,master the main mechanism of drug degradation and stabilization methods as well as the calculation of drug degradation kinetic parameters,study the pharmaceutical excipients. 1.5 Dosage form design:Biopharmaceutical and Pharmacokinetic Considerations Learn the mechanisms of drug absorption from pharmaceutical dosage forms,interpretation the relationship between drug dissolution and absorption,understand the physicochemical characteristics of a drug that affect its dissolution from various dosage forms. 课程目标2：Solid Dosage Forms and Solid Modified--Release Drug Delivery Systems 2.1 Powders and Granules Differentiate a powder from a granule,explain how a drug's powder particle size influences the pharmaceutical dosage forms which will be used to administer it,define micromeritics and related concepts. 2.2 Capsules
课程目标 1： 1．1 Introduction to Drugs and Pharmacy Learn the development and purpose of the pharmacopoeia, able to describe the central features of a typical drug monograph, familiar with the concept of pharmaceutical care, understand significant drug regulation and control laws, summarize the Code of Ethics for Pharmacists and Pharmaceutical Scientists. 1．2 New Drug Development and Approval Process Compare and contrast an investigational new drug (IND) application from a new drug application (NDA), differentiate between phase I, phase II, phase III, and phase IV clinical trials, preliminary understand the sources of new drugs. 1．3 Current Good Manufacturing Practices Learn the definition and main contents of cGMP. 1．4 Dosage form design: Pharmaceutical and Formulation Considerations Learn the rationality and properties of preparing various dosage forms, familiar with the content of preformulation research in dosage form design, master the main mechanism of drug degradation and stabilization methods as well as the calculation of drug degradation kinetic parameters, study the pharmaceutical excipients. 1．5 Dosage form design: Biopharmaceutical and Pharmacokinetic Considerations Learn the mechanisms of drug absorption from pharmaceutical dosage forms, interpretation the relationship between drug dissolution and absorption, understand the physicochemical characteristics of a drug that affect its dissolution from various dosage forms. 课程目标 2：Solid Dosage Forms and Solid Modified-Release Drug Delivery Systems 2．1 Powders and Granules Differentiate a powder from a granule, explain how a drug’s powder particle size influences the pharmaceutical dosage forms which will be used to administer it, define micromeritics and related concepts. 2．2 Capsules
Differentiate the definition and properties between hard gelatin and soft gelatin capsules,learn the preparation method and quality control of hard capsules. 2.3 Tablets Study the definition and properties of various types of tablet dosage forms,familiar with diverse excipients employed in the tablets,masters the common preparation methods for tablets. Describe quality control standards for tablets,understand the common occurred problems in the preparation of tablets and how to solve them. 2.4 Solid Oral Modified-release Dosage Forms and Drug Delivery Systems Differentiate between the various types of modified-release dosage forms,compare and contrast advantages and disadvantages of them.List physicochemical characteristics of drugs that used as candidates for an extended-release dosage form.Learn some technologies to prepare modified-release dosage forms,such as microencapsulation,ion exchange,and osmotic pump,etc.Understand the significance of the in vitro and in vivo drug release from an extended-release/delayed-release oral dosage form will differ from an oral, film-coated tablet. 课程目标3：Semisolid Dosage Forms,Transdermal Drug Delivery System and Suppositories 3.1 Ointments,Creams,and Gels After learning,the student could differentiate between the various types of ointment bases on the basis of physicochemical properties,list the criteria for the selection of an ointment base to treat a topical affliction.After that,they describe the methods to incorporate (an)active ingredient(s)into an ointment base,explain the difference between an ointment,a cream,and a gel.In addition,the student could compare and contrast an ophthalmic ointment base and a topical ointment base for application to the skin. Furthermore,they could list advantages and disadvantages of administering drugs rectally and vaginally. 3.2 Transdermal Drug Delivery System After learning this part,the student can explain the physicochemical properties of drugs which determine their ability to be incorporated into a transdermal dosage form.After that,they can describe
Differentiate the definition and properties between hard gelatin and soft gelatin capsules, learn the preparation method and quality control of hard capsules. 2．3 Tablets Study the definition and properties of various types of tablet dosage forms, familiar with diverse excipients employed in the tablets, masters the common preparation methods for tablets. Describe quality control standards for tablets, understand the common occurred problems in the preparation of tablets and how to solve them. 2. 4 Solid Oral Modified-release Dosage Forms and Drug Delivery Systems Differentiate between the various types of modified-release dosage forms, compare and contrast advantages and disadvantages of them. List physicochemical characteristics of drugs that used as candidates for an extended-release dosage form. Learn some technologies to prepare modified-release dosage forms, such as microencapsulation, ion exchange, and osmotic pump, etc. Understand the significance of the in vitro and in vivo drug release from an extended-release/delayed-release oral dosage form will differ from an oral, film-coated tablet. 课程目标 3：Semisolid Dosage Forms, Transdermal Drug Delivery System and Suppositories 3．1 Ointments, Creams, and Gels After learning, the student could differentiate between the various types of ointment bases on the basis of physicochemical properties, list the criteria for the selection of an ointment base to treat a topical affliction. After that, they describe the methods to incorporate (an) active ingredient(s) into an ointment base, explain the difference between an ointment, a cream, and a gel. In addition, the student could compare and contrast an ophthalmic ointment base and a topical ointment base for application to the skin. Furthermore, they could list advantages and disadvantages of administering drugs rectally and vaginally. 3．2 Transdermal Drug Delivery System After learning this part, the student can explain the physicochemical properties of drugs which determine their ability to be incorporated into a transdermal dosage form. After that, they can describe
physiological factors of the skin which influence percutaneous absorption.In addition,the student can understand various permeation enhancement strategies for drugs,including chemical and physical methods. Furthermore,they can list the advantages and the disadvantages of transdermal delivery of drugs compared to other forms of drug delivery. 3.3 Suppositories After learning this part,the student can compare and contrast various suppositories dosage forms in terms of physical appearance,size and shape.Understand the advantages and disadvantages of suppository drug deliveryversus oral drug delivery,identify and explain physiologic factors which influence the drug absorption from rectal suppository administration.In addition,they can identify and explain the physicochemical factors of the drug and suppository base as this influence rectal absorption,compare and contrast the various classes of suppository bases.Furthermore,the student is able to describe the three methods of suppository preparation. 课程目标4：Liquid Dosage Forms and Sterile Dosage Forms and Delivery Systems 4.1 Solutions After learning this part,the student can define the various types of oral and topical liquid dosage forms and the advantages and disadvantages of using liquid dosage forms in extemporaneous compounded prescriptions and in patient therapy.After that,they can compare and contrast liquid dosage forms to traditional oral dosage forms,define solubility and describe how different factors increase or decrease solute solubility in a given solvent.Furthermore,the student could evaluate and select a proper solvent and delivery system for a given solute,purpose,and/or patient population. 4.2 Disperse Systems After learning this part,the student can differentiate between a suspension,an emulsion,a gel,and a magma,compare and contrast various disperse systems and list advantages and disadvantages of each system. After that,they can compare and contrast the following emulsification theories:surface tension,oriented-
physiological factors of the skin which influence percutaneous absorption. In addition, the student can understand various permeation enhancement strategies for drugs, including chemical and physical methods. Furthermore, they can list the advantages and the disadvantages of transdermal delivery of drugs compared to other forms of drug delivery. 3. 3 Suppositories After learning this part, the student can compare and contrast various suppositories dosage forms in terms of physical appearance, size and shape. Understand the advantages and disadvantages of suppository drug deliveryversus oral drug delivery, identify and explain physiologic factors which influence the drug absorption from rectal suppository administration. In addition, they can identify and explain the physicochemical factors of the drug and suppository base as this influence rectal absorption, compare and contrast the various classes of suppository bases. Furthermore, the student is able to describe the three methods of suppository preparation. 课程目标 4：Liquid Dosage Forms and Sterile Dosage Forms and Delivery Systems 4．1 Solutions After learning this part, the student can define the various types of oral and topical liquid dosage forms and the advantages and disadvantages of using liquid dosage forms in extemporaneous compounded prescriptions and in patient therapy. After that, they can compare and contrast liquid dosage forms to traditional oral dosage forms, define solubility and describe how different factors increase or decrease solute solubility in a given solvent. Furthermore, the student could evaluate and select a proper solvent and delivery system for a given solute, purpose, and/or patient population. 4．2 Disperse Systems After learning this part, the student can differentiate between a suspension, an emulsion, a gel, and a magma, compare and contrast various disperse systems and list advantages and disadvantages of each system. After that, they can compare and contrast the following emulsification theories: surface tension, oriented-
wedge,and interfacial film.In addition,the students can define and differentiate the following terms from one another:Lyophobic,Lyophilic,Hydrophobic,Hydrophilic,Amphiphilic,Imbibition,Swelling,Syneresis, Thixotropy,and Xerogel. 4.3 Parenterals After learning this part,the student can list the advantages and disadvantages of parenteral administration,define parenteral administration and list the different parenteral methods of administration.After that,they are able to compare and contrast the risks and benefits of the various parenteral routes,identify the challenges of using nonaqueous vehicles in parenteral products.In addition, the students are asked to define osmolality and osmolarity and explain their relationship with the tonicity of a substance,compare and contrast a small-volume and a large-volume parenteral.Furthermore,they can outline the different methods of sterilization for parenteral products,differentiate between single-and multiple-dose packaging requirements. 4.4 Special solutions and suspensions After learning this part,the student will be able to describe ophthalmic,nasal,and inhalation drug delivery,list drugs which are typically administered by each of these drug delivery systems.Secondly,they can explain the advantages/disadvantages of using one of these drug delivery systems over oral administration.Thirdly,the students are asked to describe the use of the various pharmaceutical ad juvants which are employed in the creation of these dosage forms.Fourthly,they can explain the proper administration of each of these drug delivery systems. 课程目标5：Novel and Advanced Dosage Forms,.Delivery Systems,and Devices 5.1 Radiopharmaceuticals After learning this part,the student can Compare and contrast the three principal types of radioactive decay (i.e.. alpha,beta,gamma),compare and contrast the use of radiopharmaceuticals in diagnostics and therapeutics.After that,they can identify the
wedge, and interfacial film. In addition, the students can define and differentiate the following terms from one another: Lyophobic, Lyophilic, Hydrophobic, Hydrophilic, Amphiphilic, Imbibition, Swelling, Syneresis, Thixotropy, and Xerogel. 4．3 Parenterals After learning this part, the student can list the advantages and disadvantages of parenteral administration, define parenteral administration and list the different parenteral methods of administration. After that, they are able to compare and contrast the risks and benefits of the various parenteral routes, identify the challenges of using nonaqueous vehicles in parenteral products. In addition, the students are asked to define osmolality and osmolarity and explain their relationship with the tonicity of a substance, compare and contrast a small-volume and a large-volume parenteral. Furthermore, they can outline the different methods of sterilization for parenteral products, differentiate between single- and multiple-dose packaging requirements. 4．4 Special solutions and suspensions After learning this part, the student will be able to describe ophthalmic, nasal, and inhalation drug delivery, list drugs which are typically administered by each of these drug delivery systems. Secondly, they can explain the advantages/disadvantages of using one of these drug delivery systems over oral administration. Thirdly, the students are asked to describe the use of the various pharmaceutical adjuvants which are employed in the creation of these dosage forms. Fourthly, they can explain the proper administration of each of these drug delivery systems. 课程目标 5：Novel and Advanced Dosage Forms, Delivery Systems, and Devices 5．1 Radiopharmaceuticals After learning this part, the student can compare and contrast the three principal types of radioactive decay (i.e., alpha, beta, gamma), compare and contrast the use of radiopharmaceuticals in diagnostics and therapeutics. After that, they can identify the