药物制剂剂型设计高级教程(英)

INDUSTRIAL PHARMACY: PHARMACEUTICAL DOSAGE FORM DESIGN

GRADUATE COURSE IN PHARMACEUTICS

CREDIT: 3 Hours

1PHARMACEUTICAL DOSAGE FORM DESIGN (3)

1.1INTRODUCTION (3)

1.2AIMS AND OBJECTIVES OF THE COURSE (3)

1.3OBJECTIVES OF INDIVIDUAL STUDY UNITS (4)

1.3.1Review and study of the different phases of product development (4)

1.3.2Principles and factors of importance during development, production

and quality assurance of conventional dosage forms (6)

1.3.3Oral dosage forms (7)

1.3.4Parenteral dosage forms (10)

1.3.5Design of dosage forms for topical and local drug delivery systems (13)

1.3.6Pharmaceutical aerosol products (14)

1.3.7Rectal and vaginal suppositories (15)

1.3.8Novel dosage forms and biotechnology (16)

1.4ASSIGNMENTS (17)

1.5REFERENCES (18)

1.6Study Guide compiled by: (19)

1 PHARMACEUTICAL DOSAGE FORM DESIGN

1.1 INTRODUCTION

To manufacture a pharmaceutical dosage form, it is necessary to combine the unique properties of the drug with the unique properties of the specific dosage form as well as quality control requirements. The whole process starts with the development and clinical evaluation of the substance, proceeds via a preformulation phase for the drug and ends with the dosage form, which may be produced industrially after the necessary scale up procedures.

In this study guide the material that a student will have to manage to successfully complete the course Pharmaceutical Dosage Form Design as part of the Ph.D. in Pharmaceutics is outlined. It describes the aims and objectives of the course and gives information about the study material that the student will have to use.

1.2 AIMS AND OBJECTIVES OF THE COURSE

The aim of this course is to enable the successful student to recognise and understand the development process for pharmaceutical delivery systems that are therapeutically effective, bioavailable, safe and elegant. The objective is to study the different phases in the development of a dosage form. The different phases for conventional dosage forms include the stages in which the substance drug is clinically tested, formulated, manufactured and the quality control procedures related to each stage. Dosage form development using biotechnology and targeted dosage forms will also be studied.

On successful completion of the course, the student should have acquired the necessary background and understanding of the development process for pharmaceutical products so that he/she could, through innovative thoughts and scientific reasoning, design and evaluate new innovative pharmaceutical products.