《Pharmaceutics》课程教学大纲（三号黑体）
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
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.
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-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 diagnostic and/or therapeutic role(s) and delivery method(s) for the commonly used radiopharmaceuticals. In addition, the students can describe the concept and therapeutic utility of positron emission tomography (PET).
5．2 Products of Biotechnology
After learning this part, the student will be able to differentiate between the various techniques using living organisms in the production or modification of biotechnology drugs. After that, they can describe the classification of products of biotechnology used in clinical practice, provide examples of biotechnology drugs for each classification of biotechnology drug type. Thirdly, the students can summarize important concepts associated with biotechnology product handling, storage, and administration.
5. 3 Novel Dosage Forms and Drug Delivery Technologies
After learning this part, the student will be able to describe the benefits of new, innovative drug delivery systems, mechanisms utilized to develop new, novel dosage forms and list novel drug delivery systems for each topical, oral, vaginal, ophthalmic, and parenteral route. After that, the student is asked to list drugs which are typically administered by each of these drug delivery systems, explain the advantages each novel delivery system may or may not have over traditional oral administration. Thirdly, they can describe the principles of iontophoresis and phonophoresis, and their benefits in advancing topical drug administration. Furthermore, the student can differentiate between liposomes for parenteral administration, and standard parenteral solutions; describe a situation where liposomes for parenteral administration would be the preferred therapeutic dosage form over standard parenteral solutions.
（三）课程目标与毕业要求、课程内容的对应关系（小四号黑体）
表1：课程目标与课程内容、毕业要求的对应关系表 （五号宋体）
课程目标 | 课程子目标 | 对应课程内容 | 对应毕业要求 |
课程目标1 | 1.1 | Introduction to Drugs and Pharmacy | Learn the definition and role of pharmacopoeia, can describe the central features of a drug, preliminary know the regulations of drug administration and the contents of pharmaceutical care. |
1.2 | New Drug Development and Approval Process | Be able to distinguish the difference between IND and NDA as well as the main tasks, the classified phases in clinical test of new drugs, and understand the meaning of new drugs. | |
1.3 | Current Good Manufacturing Practices | Understand the definition, importance and related content of cGMP. | |
1.4 | Dosage form design: Pharmaceutical and Formulation Considerations | The necessity and properties of various dosage forms, the contents of preformulation studies, define drug stability and degradation mechanism, learn the drug stabilization methods,prediction and experimental methods. | |
1.5 | Dosage form design: Biopharmaceutical and Pharmacokinetic Considerations | The mechanism of drug transport, the main parameters of pharmacokinetics, distinguish bioavailability from bioequivalence, and understand the role of biopharmaceutics and pharmacokinetics in R&D of new drugs. | |
课程目标2 | 2.1 | Powders and Granules | The basic concept of micromeritics, the purpose and method of preparing granules. |
2.2 | Capsules | The concept, characteristics, preparation method and quality control of capsules. | |
2.3 | Tablets | Concept, characteristics, common excipients, preparation methods and quality control standards of tablets. | |
2.4 | Solid Oral Modified-release Dosage Forms and Drug Delivery Systems | Define various types of modified-release dosage forms and characteristics,and learn how to prepare and quality control. | |
课程目标3 | 3.1 | Ointments, Creams, and Gels | Differentiate between the various types of semisolid bases on the basis of physicochemical properties. |
3.2 | Transdermal Drug Delivery System | Definition and characteristics of transdermal drug delivery system, factors affecting transdermal drug absorption and methods of enhancing drug absorption. | |
3.3 | Suppositories | Definition and characteristics of rectal suppositories,routes of drug absorption, common bases, preparation methods and quality control criteria. | |
课程目标4 | 4.1 | Solutions | Definition and determination method of drug solubility, commonly used medicinal solvents, definition and characteristics of commonly used liquid preparations, including syrup, elixir, tincture;method of drug extraction. |
4.2 | Disperse Systems | Definition and characteristics of suspensions, emulsions, gels and magma, factors affecting the stability of suspensions, emulsion formation theory and existing stability problems, terms related to rheology. | |
4.3 | Parenterals | Definition, classification, characteristics and route of drug injection, concept of isotonic and osmolarity, sterilization method, preparation process of various injection. | |
4.4 | Special solutions and suspensions | Describe the meaning and specific properties of ophthalmic, nasal, and inhalation drug delivery. | |
课程目标5 | 5.1 | Radiopharmaceuticals | Preliminary understand the definition and classes of radiopharmaceuticals. |
5.2 | Products of Biotechnology | Understand the definition and research progress of the products of biotechnology. | |
5.3 | Novel Dosage Forms and Drug Delivery Technologies | Understand and list the definition and development of the new and innovative drug delivery systems. |
三、教学内容（四号黑体）
第一章 Introduction to Drugs and Pharmacy
1.教学目标 （五号宋体）
Define the pharmacy, pharmaceutics and pharmacopoeia, the contents of pharmaceutical care, the ethical code for pharmaceutical researchers,understand the regulations and laws related to drug administration.
2.教学重难点
教学重点：Definition of pharmaceutics, pharmacopoeia, pharmaceutical care.
教学难点：The regulations and laws related to drug administration, pharmaceutical care.
3.教学内容
(1) The heritage of pharmacy, (2) Drug standards, (3) Drug regulation and control, (4) The pharmacist's contemporary role, (5) Code of ethics for pharmacists of the American Pharmacists Association, (6) Code of ethics of the American Association of Pharmaceutical Scientists.
4.教学方法
(1) Teaching method: Relevant concepts and theoretical framework.
(2) Discussion method: The use of heuristic teaching.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第二章 New Drug Development and Approval Process
1.教学目标 （五号宋体）
Define an investigational new drug (IND) application from a new drug application (NDA), understand the differences between phase I, phase II, phase III, and phase IV clinical trials，International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use.
2.教学重难点
教学重点：Drug research and development process, Early formulation studies, IND, NDA, ANDA, ICH
教学难点：How to know the research contents during the new drug application and development? Understanding and following normative technical guideline based on the pharmacodymics and physicochemical properties of a new chemical entity.
3.教学内容
(1) Drug discovery and drug design, (2) Biologic characterization, (3) Early formulation studies, (4) The investigational new drug application, (5) Clinical study registry, (6) The new drug application, (7) Supplemental, abbreviated, and other applications, (8)International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use.
4.教学方法
(1) Teaching method: Relevant concepts and theoretical framework, combined with typical drug examples.
(2) Discussion method: Flipped classroom was encouraged.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第三章 Current Good Manufacturing Practices and Current Good
Compounding Practices（小四号黑体）
1.教学目标 （五号宋体）
The significance of GMP and cGMP, familiar with the main contents of cGMP.
2.教学重难点
cGMP for finished pharmaceuticals.
3.教学内容
(1)Standards for current good manufacturing practice,(2) cGMP for finished pharmaceuticals,(3) Additional cGMP regulatory requirements.
4.教学方法
Combined with the content of cGMP in abroad, systematically introduce the composition of cGMP by reference and PPT.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第四章 Dosage Form Design: Pharmaceutical and Formulation Considerations（小四号黑体）
1.教学目标 （五号宋体）
Ask student understand the necessity of dosage form in clinical therapy, get familiar with the factors that need to be considered in the design of dosage form, and understand the often used pharmaceutical excipients.
2.教学重难点
The difference between drug and drug product, the necessity of drug preparation, various factors that need to be considered when designing dosage forms.
3.教学内容
(1) The need for dosage forms, (2) General considerations in dosage form design, (3) Pharmaceutical ingredients and excipients.
4.教学方法
Based on the introduction of case study, improve the student understanding factors including physicochemical and physiological characteristics that influence drug performance in vivo and in vitro
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第五章 Dosage Form Design: Biopharmaceutical and Pharmacokinetic
Considerations（小四号黑体）
1.教学目标 （五号宋体）
To understand the role of biopharmaceutics and pharmacokinetics in the process of new drug research and development, learn the mechanism of drug absorption, the relationship between drug dissolution and absorption, the definition of bioequivalence and the effect of administration route on drug fate in vivo.
2.教学重难点
Principles of drug absorption depending on administration route, the difference between bioavailability and bioequivalence, why generic drugs should perform bioequivalence study,etc.
3.教学内容
(1)Principles of drug absorption, (2) Dissolution and drug absorption, (3) Bioavailability and bioequivalence, (4) Bioequivalence of drug products, (5) Routes of drug administration, (6) Fate of drug after absorption, (7)Pharmacokinetic principles.
4.教学方法
Firstly, ask student could combine theory and knowledge frame between pharmaceutics and biopharmaceutics & pharmacokinetics, through typical case introduction. Secondly, enhance the understanding of new drug development process, thereafter to construct the pharmaceutical knowledge system.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第六章 Powders and Granules（小四号黑体）
1.教学目标 （五号宋体）
To understand the knowledge micromeritics and concepts especially related to pharmaceutical preparations,to differentiate the properties of powders and granules. To familiar with the purpose and methods for preparation of granules, and quality control in the field of pharmaceutical products.
2.教学重难点
Demonstrate the concepts of micromeritics, the purpose to prepare granules and quality control method, how to overcome the disadvantages of powder and granules.
3.教学内容
(1) Historical use, (2) Applications, (3) Powders, (4) Medicated powders, (5) Granules, (6) Quality control, (7) Packaging/dispensing.
4.教学方法
Teaching theory and case presentation.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第七章 Capsules（小四号黑体）
1.教学目标 （五号宋体）
Make students familiar with the definition and characteristics of capsule, the difference between hard capsule and soft capsule, capsule preparation method and quality control, etc.
2.教学重难点
Advantages and disadvantages of capsules compared with other oral delivery preparations, preparation methods and quality control of capsules.
3.教学内容
(1) Overview of capsules, (2) Hard gelatin capsules, (3) Cleaning and polishing capsules, (4) Soft gelatin capsules, (5) Compendial requirements for capsules, (6) Official and commercially available capsules, (7) Inspecting, counting, packaging, and storing capsules, (8) Oral administration of solid dosage forms.
4.教学方法
Teaching theory and case presentation.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第八章 Tablets（小四号黑体）
1.教学目标 （五号宋体）
To understand the definition, characteristics, commonly used excipients, various preparation methods and quality control criteria of tablets; to familiar with the characteristics and preparation methods of other different types of tablets.
2.教学重难点
The various commonly excipients, composition of formulation, preparation method and quality control of tablets, the advantages and disadvantages of different types of tablets.
3.教学内容
(1) Types of tablets, (2) Compressed tablets, (3) Chewable tablets, (4) Tablet coating, (5) Impact of manufacturing changes on solid dosage forms, (6) Official and commercially available tablets, (7) Packaging and storing tablets, (5) Other solid dosage forms for oral administration.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第九章 Solid Oral Modified-Release Dosage Forms and Drug Delivery Systems （小四号黑体）
1.教学目标 （五号宋体）
To enable students to understand the classification, characteristics, the novel preparation technologies and application of Solid Oral Modified-Release Dosage Forms and Drug Delivery Systems.
2.教学重难点
Formulation and preparation process of extended-release pharmaceuticals, terminology, technical guidelines for detailed evaluation.
3.教学内容
(1) The rationale for extended-release pharmaceuticals, (2) Terminology, (3) Extended-release oral dosage forms, (4) Delayed-release oral dosage forms, (5) USP requirements and FDA guidance for modified-release dosage forms.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十章 Ointments, Creams, and Gels（小四号黑体）
1.教学目标 （五号宋体）
To understand the commonly used bases and vehicles, the main principle of bases selection, preparation and evaluation method for various semi-solid dosage forms.
2.教学重难点
Define topical administration semisolid such as ointments, creams, gels and pastes; the advantages and disadvantages of various semisolid dosage forms, how to select appropriate bases and vehicles also will be introduced.
3.教学内容
(1) Ointments, (2) Compendial requirements for ointments, (3) Creams, (4) Gels, (5) Transdermal preparations, (6) Miscellaneous semisolid preparations: Pastes, plasters, and glycerogelatins, (7) Features and use of dermatologic preparations, (8) Features and use of ophthalmic ointments and gels, (9) Features and use of nasal ointments and gels, (10) Features and use of rectal preparations, (11) Features and use of vaginal preparations, (12) Drug release from semisolid dosage forms.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十一章 Transdermal Drug Delivery Systems（小四号黑体）
1.教学目标 （五号宋体）
Explain the physicochemical properties of drugs that determine their ability to be incorporated into a transdermal dosage form, describe physiological factors of the skin that influence percutaneous absorption, define a chemical permeation enhancer and describe physical methods used to facilitate the percutaneous absorption of drugs.
compared to other forms of drug delivery
2.教学重难点
The pathway of transdermal drug delivery, the problems will be occurred in percutaneous absorption, advantages and disadvantages of transdermal delivery system, chemical and physical enhancing permeation strategies.
3.教学内容
(1) Factors affecting percutaneous absorption, (2) Percutaneous absorption enhancers, (3) Percutaneous absorption models, (4) Design features of transdermal drug delivery systems, (5) Advantages and disadvantages of TDDSs, (6) Examples of transdermal drug delivery systems, (7) General clinical considerations in the use of TDDSs.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十二章 Suppositories, Inserts, and Sticks（小四号黑体）
1.教学目标 （五号宋体）
To understand the definition, characteristics, preparation and quality evaluation methods of rectal suppositories, as well as the characteristics of drug absorption after rectal administration.
2.教学重难点
Compare and contrast various suppository in terms of physical appearance, size, and shape, the advantages and disadvantages of suppository versus oral drug delivery, identify and explain physiologic and physicochemical factors that influence the drug absorption from rectal suppository administration，learn to select appropriate suppository bases, the preparation and evaluation methods of suppository.
3.教学内容
(1) Suppositories, (2) Uses and applications, (3) Some factors of drug absorption from rectal suppositories, (4) Suppository bases, (5) Formulation variables, (6) Preparation of suppositories, (7) Manufacturing suppositories, (8) Quality control, (9) Packaging and storage, (10) Stability, (11) Rectal suppositories, (12) Vaginal inserts, (13) Special types of suppositories.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十三章 Solutions （小四号黑体）
1.教学目标 （五号宋体）
Definition, characteristics, preparation methods and quality control standards of commonly used liquid preparations.
2.教学重难点
Definition of drug solubility, types and characteristics of solvents, methods of water purification; definitions, characteristics and preparation methods of various liquid preparations; methods of extraction of medicinal ingredients from plants.
3.教学内容
(1) Solubility, (2) Some solvents for liquid preparations, (3) Preparation of solutions, (4) Oral solutions and preparations for oral solution, (5) Syrups, (6) Elixirs, (7) Tinctures, (8) Proper administration and use of liquid peroral dosage forms, (9) Topical solutions and tinctures, (10) Vaginal and rectal solutions, (11) Topical tinctures, (12) Topical oral (dental) solutions, (13) Miscellaneous solutions, (14) Nonaqueous solutions, (15) Extraction methods for preparing solutions.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十四章 Disperse Systems （小四号黑体）
1.教学目标 （五号宋体）
The student will be able to: (1) Differentiate between a suspension, an emulsion, a gel, and a magma;(2) List advantages and disadvantages of each system, (3) Compare and contrast the following emulsification theories: surface tension, oriented-wedge, and interfacial film, (4) Understand some rheology terms use in disperse systems.
2.教学重难点
Stabilization of suspension, the problems might be occurred in emulsion systems, how to design disperse system depending upon drug physicochemical properties and indications. The application of rheology theory in disperses system.
3.教学内容
(1) Suspensions, (2) Emulsions, (3) Gels and magmas, (4) Proper administration and use of disperse systems, (5) Aerosols, (6) Types of aerosols, (7) Foams, (8) Preparation of foams.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十五章 Parenterals （小四号黑体）
1.教学目标 （五号宋体）
Understand the definition, classification, characteristics and quality control criteria of injections; solvents and additives commonly used in injections; the general preparation process of injection; concept, types, preparation technology and quality control method of large volume injection and sterilized powders for injection. Learn the treatment method of injection container. Technical theories related to sterilization and sterile preparations. Understand the knowledge related to aseptic assurance process of injection and aseptic production process verification.
2.教学重难点
Classification of injections, preparation of water for injection, preparation of different injections, the mechanism and method of sterilization, the definition aseptic operation, characteristics and removal methods of pyrogen, formulation design of injections, method and calculation of osmotic pressure adjustment.
3.教学内容
(1) Injections, (2) Small-volume parenterals, (3) Insulins, (4) Large-volume parenterals, (5) Special considerations associated with parenteral therapy, (6) Irrigation and dialysis solutions.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十六章 Special Solutions and Suspensions （小四号黑体）
1.教学目标 （五号宋体）
The student will be able to: (1) Describe ophthalmic, nasal, and inhalation drug delivery, (2) List drugs that are typically administered by each of these drug delivery methods, (3) Explain the advantages/disadvantages of using one of these drug delivery methods over oral administration, (4) Describe the use of the various pharmaceutical adjuvants, which are employed in the formulation of these dosage forms, (5) Explain the proper administration of each of these drug delivery systems.
2.教学重难点
Differentiate the definition and properties of ophthalmic, nasal, and inhalation drug delivery systems; the quality control standards of these dosage forms.
3.教学内容
(1) Ophthalmic drug delivery, (2) Pharmacologic categories of ophthalmic drugs, (3) Pharmaceutical requirements, (4) Packaging ophthalmic solutions and suspensions, (5) Proper administration of ophthalmic solutions and suspensions, (6) Contact lenses and care and use solutions, (7) Nasal preparations, (8) Otic preparations
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十七章 Radiopharmaceuticals （小四号黑体）
1.教学目标 （五号宋体）
A preliminary understanding of the definition, types and characteristics of radiopharmaceuticals
2.教学重难点
Definition, types, and handling precautions of radiopharmaceuticals.
3.教学内容
(1) Background information, (2) Diagnostic imaging, (3) Therapeutic use of radiopharmaceuticals, (4) Radiopharmaceuticals, (5) Positron emission tomography, (6) Drug antidote for radiation exposure, (7) Nonradioactive pharmaceutical use in nuclear medicine, (8) Practice of nuclear pharmacy.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十八章 Products of Biotechnology
1.教学目标 （五号宋体）
To understand the research progress of products of biotechnology, learn some novel high technologies.
2.教学重难点
Application of various biotechnologies in pharmaceutical preparations and medicines.
3.教学内容
(1) Techniques used to produce biotechnologic products, (2) Products of biotechnology, (3) Tissue plasminogen activators, (4) The future of biotechnology products, (5) The FDA office of biotechnology products, (6) Patient information from the pharmacist, (5) Pharmacist self-help with biotechnology drugs.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
第十九章 Novel Dosage Forms and Drug Delivery Technologies
1.教学目标 （五号宋体）
After learning this chapter, the student will be able to:(1) Describe the benefits of new, innovative drug delivery systems, (2) Describe the mechanisms utilized to develop new, novel dosage forms, (3) List novel drug delivery systems for each topical, oral, vaginal, ophthalmic, and parenteral route, (4) Explain the advantages each novel delivery system may or may not have over traditional oral administration.
2.教学重难点
The definition of innovative drug delivery systems, the mechanisms utilized to develop new and novel dosage forms, various marketed novel drug delivery systems, the advantages each novel delivery system.
3.教学内容
(1) Composition, (2) Topical administration, (3) Oral administration, (4) Vaginal administration, (5) Ophthalmics, (6) Parenteral administration, (7) PEGylated dosage forms, (8) Fusion protein: Special handling, (9) Implants, (10) Other novel delivery systems.
4.教学方法
Teaching theory and case presentation, flipped classroom will be conducted.
5.教学评价
Quick summary test and discuss selected frequently asked questions.
四、学时分配（四号黑体）
表2：各章节的具体内容和学时分配表（五号宋体）
章节 | 章节内容 | 学时分配 |
第一章 | 1.Introduction to Drugs and Pharmacy | 4 |
第二章 | 2.New Drug Development and Approval Process | 2 |
第三章 | 3. Current Good Manufacturing Practices and Current Good Compounding Practices | 2 |
第四章 | 4. Pharmaceutical and Formulation Considerations | 4 |
第五章 | 5. Biopharmaceutical and Pharmacokinetic Considerations | 4 |
第六章 | 6. Powders and Granules | 4 |
第七章 | 7. Capsules | 2 |
第八章 | 8. Tablets | 4 |
第九章 | 9. Solid Oral Modified-release Dosage Forms and Drug Delivery Systems | 4 |
第十章 | 10. Ointments, Creams, and Gels | 2 |
第十一章 | 11. Transdermal Drug Delivery System | 2 |
第十二章 | 12. Suppositories,Inserts, and Sticks | 4 |
第十三章 | 13. Solutions | 8 |
第十四章 | 14. Disperse Systems | 4 |
第十五章 | 15. Parenterals | 8 |
第十七章 | 17. Special solutions and Suspensions | 4 |
第十八章 | 18. Radiopharmaceuticals | 2 |
第十九章 | 19. Products of Biotechnology | 2 |
第二十章 | 20. Novel Dosage Forms and Drug Delivery Technologies | 2 |
五、教学进度（四号黑体）
表3：教学进度表（五号宋体）
周次 | 日期 | 章节名称 | 内容提要 | 授课时数 | 作业及要求 | 备注 |
1 | 1.Introduction to Drugs and Pharmacy (1) | 2 | Selected physical pharmacy capsules cases,group and individual activities. Asked to write clearly , answer the question complete, the content is accurate. | |||
1 | 1.Introduction to Drugs and Pharmacy (2) | 2 | ||||
2 | 2.New Drug Development and Approval Process | 2 | ||||
2 | 3. Current Good Manufacturing Practices and Current Good Compounding Practices | 2 | ||||
3 | 4. Pharmaceutical and Formulation Considerations (1) | 2 | ||||
3 | 4. Pharmaceutical and Formulation Considerations (2) | 2 | ||||
4 | 5. Biopharmaceutical and Pharmacokinetic Considerations (1) | 2 | ||||
4 | 5. Biopharmaceutical and Pharmacokinetic Considerations (2) | 2 | ||||
5 | 5. Biopharmaceutical and Pharmacokinetic Considerations (3) | 2 | ||||
5 | 13. Solutions (1) | 2 | ||||
6 | 13. Solutions (2) | 2 | ||||
6 | 13. Solutions (3) | 2 | ||||
7 | 13. Solutions (4) | 2 | ||||
7 | 12. Suppositories,Inserts, and Sticks (1) | 2 | ||||
8 | 12. Suppositories,Inserts, and Sticks (2) | 2 | ||||
8 | 8. Tablets (1) | 2 | ||||
9 | 8. Tablets (2) | 2 | ||||
9 | 9. Solid Oral Modified-release Dosage Forms and Drug Delivery Systems (1) | 2 | ||||
10 | 9. Solid Oral Modified-release Dosage Forms and Drug Delivery Systems (2) | 2 | ||||
10 | 10. Ointments, Creams, and Gels（2） | 2 | ||||
11 | 11. Transdermal Drug Delivery System | 2 | ||||
11 | 6. Powders and Granules (1) | 2 | ||||
12 | 6. Powders and Granules (2) | 2 | ||||
13 | 7. Capsules | 2 | ||||
13 | 14. Disperse Systems(1) | 2 | ||||
14 | 14. Disperse Systems (2) | 2 | ||||
14 | 15. Parenterals (1) | 2 | ||||
15 | 15. Parenterals (2) | 2 | ||||
15 | 15. Parenterals (3) | 2 | ||||
16 | 15. Parenterals (4) | 2 | ||||
17 | 17. Special solutions and Suspensions（1） | 2 | ||||
17 | 17. Special solutions and Suspensions（2） | 2 | ||||
18. Radiopharmaceuticals | 2 | |||||
19. Products of Biotechnology | 2 | |||||
20. Novel Dosage Forms and Drug Delivery Techonologies(1) | ||||||
20. Novel Dosage Forms and Drug Delivery Techonologies(2) |
六、教材及参考书目（四号黑体）
1. 方亮主编，药剂学，人民卫生出版社，2016年
2. 刘建平主编，生物药剂学与药物动力学，人民卫生出版社，2016年
3. Patrick J. Sinko，Martin’s Physical Pharmacy and Pharmaceutical Sciences，Wolters Kluwer，2011年.
4. Alexander T Florence, Physicochemical Principles of Pharmacy，Pharmaceutical Press，2006年.
5. Leon Shargel, Susanna Wu-Pong, Andrew B.C. Yu, Applied Biopharmaceutics & Pharmacokinetics, McGraw-Hill’s Access PHARMACY (2016)
七、教学方法 （四号黑体）
1. Teaching method: Teaching the basic concepts and principles of this course by PPT and video, etc.,promote the students can understand the relevant professional knowledge of pharmaceutical science.
2.Discussing method: The heuristic teaching method will be employed in the class, and flipping classroom will be used at regular intervals to encourage the active studying and learning presentation techniques, too.
八、考核方式及评定方法（四号黑体）
（一）课程考核与课程目标的对应关系 （小四号黑体）
表4：课程考核与课程目标的对应关系表（五号宋体）
课程目标 | 考核要点 | 考核方式 |
课程目标1 | Pharmacopoeia, central features of a drug, regulations of drug administration and the contents of pharmaceutical care. IND and NDA, the classified phases in clinical test of new drugs, cGMP, properties of various dosage forms, preformulation studies, drug stability and degradation mechanism, stabilization methods, prediction and experimental methods.The mechanism of drug transport, parameters of pharmacokinetics, bioavailability and bioequivalence, the role of biopharmaceutics and pharmacokinetics in R&D of new drugs. | 平时作业、期中考试、期末考试 |
课程目标2 | The basic concept of micromeritics, the purpose and method of preparing granules.The concept, characteristics, preparation method and quality control of capsules.Concept, characteristics, common excipients, preparation methods and quality control standards of tablets.Define various types of modified-release dosage forms and characteristics,and learn how to prepare and quality control. | 平时作业、期中考试、期末考试 |
课程目标3 | Differentiate between the various types of semisolid bases on the basis of physicochemical properties.Definition and characteristics of transdermal drug delivery system, factors affecting transdermal drug absorption and methods of enhancing drug absorption.Definition and characteristics of rectal suppositories,routes of drug absorption, common bases, preparation methods and quality control criteria. | 平时作业、期中考试、期末考试 |
课程目标 4 | Definition and determination method of drug solubility, commonly used medicinal solvents, definition and characteristics of commonly used liquid preparations, including syrup, elixir, tincture;method of drug extraction.Definition and characteristics of suspensions, emulsions, gels and magma, factors affecting the stability of suspensions, emulsion formation theory and existing stability problems, terms related to rheology.Definition, classification, characteristics and route of drug injection, concept of isotonic and osmolarity, sterilization method, preparation process of various injection.Describe the meaning and specific properties of ophthalmic, nasal, and inhalation drug delivery. | 平时作业、期中考试、期末考试 |
课程目标 5 | The definition and classes of radiopharmaceuticals.The definition and research progress of the products of biotechnology. The definition and development of the new and innovative drug delivery systems. | 平时作业、期中考试、期末考试 |
（二）评定方法 （小四号黑体）
1．评定方法 （五号宋体）
平时成绩：20%（考勤、提问、作业）；
期中考试：30%（闭卷）；
2．课程目标的考核占比与达成度分析 （五号宋体）
表5：课程目标的考核占比与达成度分析表（五号宋体）
考核占比 课程目标 | 平时 | 期中 | 期末 | 总评达成度 |
课程目标1 | 2% | 6% | 5% | 分目标达成度=（0.1ｘ平时分目标成绩+0.3ｘ期中分目标成绩+0.6ｘ期末分目标成绩）/分目标总分。 |
课程目标2 | 3% | 6% | 10% | |
课程目标3 | 6% | 6% | 15% | |
课程目标4 | 6% | 6% | 15% | |
课程目标 5 | 3% | 6% | 5% |
（三）评分标准 （小四号黑体）
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