|Numbering Code||U-PHA00 2C310 LJ86||Year/Term||2021 ・ Second semester|
|Number of Credits||2||Course Type||Lecture|
|Target Year||2nd & 3rd year students||Target Student|
|Instructor name||TAKAHASHI YUUKI (Graduate School of Pharmaceutical Sciences Associate Professor)|
|Outline and Purpose of the Course||In order to use a physiologically active substance as a pharmaceutical product, it is necessary to formulate it (shape it into a suitable dosage form) while considering efficacy, safety, stability, usability, and other qualities. In these lectures, you will learn about the therapeutic significance, method of formulating designs, and methods of manufacturing and evaluating various formulations from a comprehensive perspective, moving from basic to clinical levels.|
1. Explain the significance of formulation design and its role in drug development.
2. Explain the therapeutic significance and characteristics of various pharmaceutical preparations, prescription designs, manufacturing methods, and test methods.
3. Explain physicochemical theories related to the manufacture of various pharmaceutical preparations.
4. Explain problems and solutions related to manufacturing various pharmaceutical preparations.
|Schedule and Contents||
1. Significance of formulation design in drug development
2. Therapeutic significance and classification of injection drugs
3. Basic theory of injection-drug design (solubility)
4. Basic theory of injection-drug design (stability)
5. Various general test methods related to injection drugs, including injection-drug manufacturing and the Japanese Pharmacopoeia formulation test method
6. Characteristics and methods of manufacturing dispersion-based preparations
7. Types, applications, and methods of preparing other liquid preparations, including eye drops, spray preparations, and crude drug preparations
8. Types of typical solid preparations listed in the Japanese Pharmacopoeia
9. Basic theory of the design of oral solid preparations (powder engineering)
10. Formulation design, manufacturing methods, and methods of evaluating powders, granules, and tablets
11. Capsule- and suppository-formulation design, manufacturing methods, and evaluation methods
12. Methods of evaluating solid preparations, including the Japanese Pharmacopoeia preparation-test method and the rheological characteristics of preparations
13. Formulation design, manufacturing methods, and methods of evaluating external preparations, such as ointments and patches
14. Significance of the drug-delivery system (DDS) and typical DDS preparations
15. Bioequivalence and generic-drug development
|Evaluation Methods and Policy||Evaluation will be based on the following: attendance and small tests 10%; regular tests 90%.|
|Study outside of Class (preparation and review)||Lecture printouts will be distributed in advance, so please read them and resolve any doubts you have about the content. In addition, small tests related to the content studied in the previous lecture may be administered, so be sure to review the material in order to retain the knowledge you have acquired|
|Textbooks||Textbooks/References||Other, printed handout|
|References, etc.||『薬剤学第５版』 (Hirokawa Shoten), 『図解で学ぶDDS第２版』 (Jibou)|