Factors Affecting Dissolution : Factors Affecting Dissolution Presented by: Sameer I. Patel (M.Pharm SEM-I ) Department of Pharmaceutics Supervised by : Dr . J. I. Disouza (Principal) Department of Pharmaceutics Guided by : Mr. S. A. Payghan (H.O.D ) Department of Pharmaceutics Tatyasaheb Kore College of Pharmacy, Warananagar CONTENT:: Definition Factors affecting rate of dissolution CONTENT: Slide 3: Definition: The process by which solid substance enter into solvent to form a solution is called as dissolution. It is affinity between solid substance and solvent. FACTORS AFFECTING RATE OF DISSOLUTION:: Factors related to physiological properties of drugs. Factors related to drug product formulation Effect of processing factor on dissolution rate. Factors related dissolution test parameter. Miscellaneous factor. FACTORS AFFECTING RATE OF DISSOLUTION: Factors related to physicochemical properties of drug :: Effect of solubility on dissolution: According to Noyes and Whitney equation aqueous solubility of drug is the major factor. Effect of particle size: Dissolution rate is directly proportional to surface area. Effect of solid phase characteristic of drug on dissolution: Amorphicity and Crystallinity. Factors related to physicochemical properties of drug : Factors related to physicochemical properties of drug :: Polymorphism Polymorphism and state of hydration ,salvation ,and complexation , markedly influence dissolution characteristic of drug by change in solubility characteristic of drug .Ex- Tolbutamide and Chloramphenicol. Factors related to physicochemical properties of drug : Factors related to drug product formulation: Effect of granulating agent and binder Hydrophilic binder show better dissolution profile with hydrophobic drug like Phenacetin by implanting hydrophilic properties to granule surface. As the binder quantity is increased hardness of tablet is increased and dissolution is decreased. Factors related to drug product formulation Slide 8: Effect Of Lubricant : Nature, quality, quantity of lubricant can affect dissolution rate. Effect of Magnesium Stearate on dissolution of salicylic acid tablet. Effect of processing factor on dissolution rate: Effect of processing factor on dissolution rate If the product is developed from the wet granulation it increases the rate of dissolution by giving hydrophilic properties. Effect Of Compression Forces on Dissolution: It affect Density ,Porosity, Hardness, Disintegration time, Dissolution rate It decreases solvent penetrability. Effect Of Compression Forces on Dissolution Factors Related to Dissolution Test Parameter: 1- Vibration: Excessive vibration increases dissolution rate. 2-Vessel design and construction: Minor changes alter the dissolution rate and it determined by paddle method. Factors Related to Dissolution Test Parameter Temperature Control: Drug solubility is depend upon the temperature. so careful temperature control during dissolution process is very important. Dissolution fluid is maintained at 37 ±0.5⁰c slit changes in this give significant change in the result. Temperature Control Dissolution Medium: Surface Tension pH of dissolution medium Viscosity of dissolution medium Deaeration of dissolution medium Dissolution Medium Miscellaneous Factors: Adsorption: Adsorption has influence on dissolution rate slightly soluble solid. Sorption: Sorption from atmosphere into tablet containing microcrystalline cellulose is very rapid. Humidity: Moisture shows to influence the dissolution rate of many drugs from solid dosage form. Miscellaneous Factors Slide 15: Thank You for your patience during seminar……. Slide 16: Questions?