MODULE 1: Introduction to Pharmaceutics

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

In-Vitro Methods

• employing test apparatus and equipment without involving laboratory animals or human

In-Vivo Methods

• more complex studies involving humans subjects or laboratory animals

Drug

substance intended for use in the diagnosis, cure, mitigation, treatment, prevention of disease/

Drug Product Performance

release of the drug substance from the drug product either for local drug action

Bioequavalance

comparison of bioavailabilities of different formulations, drug products, or batches of the same drug product

Pharmacokinetics

• science of the kinetics of drug adme

• body does to the drug

Drug Input/Disposition

• loss of drug from the central compartment due to transfer into other peripheral compartments

• _ is an important prerequisite for the determination or modification of dosing regimens for individuals and groups of patients/