山东大学：《药剂学 Pharmaceutics》课程教学资源（PPT课件讲稿，双语）03 Dosage Form Design：Pharmaceutic and Formulation Considerations

3. Dosage Form Design: Pharmaceutic and Formulation Considerations

3. Dosage Form Design: Pharmaceutic and Formulation Considerations

Contents 1. The need for dosage forms 2. General considerations in dosage form design 3. Drug and drug product stability 4. Pharmaceuticalingredients

Contents 1. The need for dosage forms 2. General considerations in dosage form design 3. Drug and drug product stability 4. Pharmaceutical ingredients

0 nonmedical agents, referred to as pharmaceutic ingredients Drug substances are seldom administered alone

Drug substances are seldom administered alone nonmedical agents, referred to as pharmaceutic ingredients

The pharmaceutic ingredients ■ solubilize, suspend thicken ■ dilute emulsify ■ stabilize ■ preserve color ■ flavor

The pharmaceutic ingredients ◼ solubilize, ◼ suspend, ◼ thicken ◼ dilute ◼ emulsify ◼ stabilize ◼ preserve ◼ color ◼ flavor

The general area of study concerned with the ■ formulation Physical ■ manufacture Chemical Biological characteristics stability Compatible ■ effectiveness of pharmaceutical dosage forms

The general area of study concerned with the ◼ formulation ◼ manufacture ◼ stability ◼ effectiveness of pharmaceutical dosage forms. Physical Chemical Biological characteristics Compatible

a drug product ■ stable ■ efficacious ■ attractive ■ easy to administer safe a manufactured under appropriate measures of quality control

A drug product ◼ stable ◼ efficacious ◼ attractive ◼ easy to administer ◼ safe ◼ manufactured under appropriate measures of quality control

1. The need for dosage forms Besides providing the mechanism for the safe and convenient delivery of accurate dosage, dosage forms are needed for additional reasons. Protection from oxygen and humidity(coated tablets, sealed ampuls)

1. The need for dosage forms Besides providing the mechanism for the safe and convenient delivery of accurate dosage, dosage forms are needed for additional reasons: 1) Protection from oxygen and humidity (coated tablets, sealed ampuls)

2)Protection from gastric acid after oral administration(enteric- coated tablets) 3)To conceal the bitter salty, or offensive taste or odor of a arug substance(capsules? coated tablets, flavored syrups)

2) Protection from gastric acid after oral administration (enteric￾coated tablets) 3) To conceal the bitter, salty, or offensive taste or odor of a drug substance (capsules, coated tablets, flavored syrups)

insoluble Liquid unstable preparation in the desired vehicle Suspension

4) insoluble unstable in the desired vehicle Suspension Liquid preparation

Clear liquid dosage forms Syrups solutions

5) Clear liquid dosage forms Syrups solutions