Study-Unit Description

Study-Unit Description


CODE PHR2036

 
TITLE Pharmaceutical Kinetics and Stability Testing

 
UM LEVEL 02 - Years 2, 3 in Modular Undergraduate Course

 
MQF LEVEL Not Applicable

 
ECTS CREDITS 4

 
DEPARTMENT Pharmacy

 
DESCRIPTION - Pharmaceutical kinetics

- Aims and applications of kinetics studies

- Order of kinetic processes, rates and order of reactions, definition of law of mass action, order, molecularity, complex reactions, specific rate constant.

- Order of reactions and units of the basic rate constants for zero, first and second order, pseudo order. Determination of order, description of substitution method, graphic method and half-life method

- Complex reactions: reversible reactions, parallel or side reactions, series or consecutive reactions, rate determining step

- Influence of temperature on reaction rates: Arrhenius equation, determination of A and E using graphic methods

- Classic collision theory of reaction rates: Boltzmann distribution law, comparison between the collision rate theory and the Arrhenius equation, transitional state theory, comparison of the transitional state theory with the collision rate theory and the Arrhenius Equation

- Effects of solvent on reaction rates: rate equations in terms of the activity of species in their transition state and in terms of activity coefficients, influence of the polarity of solvents on reaction rates

- Influence of ionic strength on reaction rates: definition of ionic strength, activity coefficient in terms of ionic strength using the Debye-Huckle equation for a bimolecular reaction, graphic relationship between reaction rates and ionic strength

- Effect of dielectric constant on reaction rates: definition of dielectric constant, relationship between reaction rates and dielectric constant, influence of the nature of solvents, solutions and ionic strength on dielectric constant and reaction rates, pharmaceutical significance of dielectric constant

- Catalysis: definition and types of catalysts, operation of catalysts, specific acid-base catalysis and their rate-pH profiles, general acid-base catalysis and their rate-pH profiles, enzymes as biological catalysts, co-operativity and hysteresis

- Colloids: properties, types of detergents, micelle formation, critical micelle concentration

- Suspensions and Emulsions: zeta potential

- Stability testing

- Application of kinetic principles of pharmacy: shelf-life and the Q10 method

- Stability concerns in dosage forms: physical, chemical, therapeutical and microbiological changes in a dosage form, hydrolysis and oxidation as the major reactions providing stability concerns

- Methods for determining the stability of a dosage form: isothermal and nonisothermal accelerated stability studies, handling and plotting of data from an isothermal accelerated stability study to extract the shelf-life of a product.

Study unit aims:

o to introduce the student to the concept of kinetics as representing a time-dependent change in a parameter. The student will become familiar with the basic concepts of kinetic processes, and the various factors that can affect the kinetics of a particular process.
o to demonstrate the applications of kinetics in pharmaceutics, particularly the concept ofstability of dosage forms and the methods used to monitor stability.

Learning Outcomes:

1. Knowledge & Understanding
By the end of this study unit, the student will be able to:
o acquire a clear understanding of those factor that influence the kinetics of a reaction
o comprehend the influence these factors have when formulating a drug delivery system with that particular format.

2. Skills
By the end of this study unit, the student will be able to:
o identify the characteristics of those factors which influence the kinetics of drug delivery systems,
o acquire mathematical skills needed in calculating the kinetic factors being sought.

Main texts:

o The British Pharmacopoeia Vols I & II. The Stationery Office.
o Ansel, H., Allen, L., Popovich, N. Pharmaceutical Dosage Forms and Drug Delivery Systems. 1999. Williams & Wilkins. (7th edition).
o Sinko PJ. Martin's physical pharmacy and pharmaceutical sciences. USA: Lippincott Williams and Wilkins. 2006 ISBN 978 0 7817 5027

 
STUDY-UNIT TYPE Lecture and Tutorial

 
METHOD OF ASSESSMENT
Assessment Component/s Sept. Asst Session Weighting
Examination (2 Hours) Yes 100%

 
LECTURER/S Edwina V. Brejza
Claire Shoemake

 

 
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It should be noted that all the information in the description above applies to study-units available during the academic year 2023/4. It may be subject to change in subsequent years.

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