MODULE 1: Introduction to Pharmaceutics

Lesson 1: Basic Concepts of Biopharmaceutics and Pharmacokinetics

Biopharmaceutics

• study that deals with factors influencing the bioavailability of a drug

• provides the scientific basis for drug product design and drug product development

Bioavailability

• measure of systemic availability of a drug

• relative amount of drug administered that enters the systemic circulation and the rate at which the drug appears in the bloodstream

Biopharmaceutics Factors

• Physiological

  • pH

  • pKa of the drug

  • particle size

• Dosage form

• Route of administration

Biopharmaceutics Study

• In-Vitro Methods - employing test apparatus and equipment without involving laboratory animals or human

  • Disintegration

  • Dissolution

• In-Vivo Method - more complex studies involving humans subjects or laboratory animals

  • Determine the plasma blood concentration

Biopharmaceutics involves factors that influence

• Design

• Stability of drug product

• Manufacture of drug product

• Rate of release of drug at absorption site

• Delivery of drug to the site of action