Presented by Neha Srivastava Pharmacy Punjab College of Technical Education Ludhiana Stability Kinetics
Introduction Shelf Life Long term Stability studies Accelerated Stability Studies
Theoratical Consideration Order of Reaction Zero order reaction Independent of concentration When solid in solution
Theoratical Consideration
Theoratical Consideration Pseudo zero order Reaction Drug react with moisture and behave as suspension Excess of drug is available so, first order behave as pseudo zero order K = K’
Theoratical Consideration First Order Reaction Reaction rate depend on concentration of only one reactant
Theoratical Consideration
Theoratical Consideration
Theoratical Consideration When time is t Half Life
Theoratical Consideration Pseudo First order Reaction Basically second order but behave as first order When concentration of one drug is in excess
Influence of pH H + ions catalyzes in Acidic pH OH - ions catalyzes in basic pH
Influence of temperature
Influence of temperature
Influence of temperature Limitation to Arrhenius Theory
Stability Prediction
Stability Prediction
General acid base catalysis of reaction Buffer salts catalyzes the reaction
Influence of ionic strength Drug is positively charge undergoing H + catalysis, in rate of reaction Drug is positively charge undergoing OH - catalysis, in rate of reaction
Degradative pathways Hydrolysis Ester Hydrolysis Rapture of covalent linkage between C and O Supported by catalyst Alkaline catalyzed reaction is irreversible Acid catalyzed reaction is reversible
Degradative pathways Hydrolysis Ester Hydrolysis Rapture of covalent linkage between C and O Supported by catalyst Alkaline catalyzed reaction is irreversible Acid catalyzed reaction is reversible
Degradative pathways Hydrolysis Ester Hydrolysis Rapture of covalent linkage between C and O Supported by catalyst Alkaline catalyzed reaction is irreversible Acid catalyzed reaction is reversible
Degradative pathways Factor affecting ester hydrolysis pH Type of solvents Complexation Surfactants Modification of chemical structures Salt and esters
Degradative pathways Amide hydrohylsis
Degradative pathways Amide hydrohylsis
Degradative pathways Ring alteration
Degradative pathways Ring alteration
Degradative pathways Oxidation Reduction Removal of electrons Addition of oxygen and removal of Hydrogen Autoxidation – Reaction with molecular oxygen
Degradative pathways
Degradative pathways Heavy metal act as catalyst To overcome: Antioxidants Chelating agents pH Solvent system