DRUG STABILITY & KINETICS General Outline 1) 2) 3) 4) 5) 6) 7) 8) 9) 10) 11) 12) Definition of drug stability and drug kinetics Importance of studying kinetics Basic

math principles Drug kinetics reaction orders Determination of reaction orders Shelf life and half life Overage Degradation pathways Influence of packaging on drug stability Influence of temperature on drug stability Influence of catalysts on drug stability Definition of drug stability and drug kinetics

Stability It is defined as the study of the extent to which the properties of a drug substance or drug product remain within specified limits at certain temperature. Properties may be physical, chemical, microbiological, toxicological or performance properties such as disintegration and dissolution. Drug Kinetics It is defined as how drug changes with time i.e., study of rate of change. Many drugs are not chemically stable and the principles of chemical kinetics are used to predict the time span for which a drug (pure or formulation) will maintain its therapeutic effectiveness or efficacy at a specified temperature.

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