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Physical Pharmacy Experiment 6

This document summarizes an experiment on determining the shelf life of a drug product. It discusses reaction kinetics, factors that affect reaction rates such as concentration, temperature, and catalysts. It also describes different orders of reactions and methods for determining reaction order. The document outlines types of drug instability including physical and chemical degradation. Specific degradation pathways are discussed for aspirin where hydrolysis produces salicylic acid and acetic acid. The effect of temperature on reaction rate and calculations for half-life and shelf life based on a given degradation rate are also summarized.

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Krsna Navera
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0% found this document useful (0 votes)
101 views5 pages

Physical Pharmacy Experiment 6

This document summarizes an experiment on determining the shelf life of a drug product. It discusses reaction kinetics, factors that affect reaction rates such as concentration, temperature, and catalysts. It also describes different orders of reactions and methods for determining reaction order. The document outlines types of drug instability including physical and chemical degradation. Specific degradation pathways are discussed for aspirin where hydrolysis produces salicylic acid and acetic acid. The effect of temperature on reaction rate and calculations for half-life and shelf life based on a given degradation rate are also summarized.

Uploaded by

Krsna Navera
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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EXPERIMENT 6: SHELF LIFE

DETERMINATION

Reaction
Kinetics
• The study of rate at which a reaction
occurs or proceeds ​Rate of Reaction
• Measures the amount of reactant that appears or disappears in a chemical
reaction per unit time ​Shelf-Life
• Determine how stable the product
is
• The time required for 10% of the drug to degrade with 90% of the intact
drug remaining ​Half-Life
• Time necessary for the original concentration to be reduced by one
half

Types of
Reaction:
1. Zero
Reaction
▪ The rate of reaction is independent of the concentration of the reactants; hence it is the fastest
order of reaction to decompose
▪ ​Half-Life
♥ or the time required for one-half of the material to disappear is: ♥ T1/2 =
0.5A​0​/k​0 ​2. First Order Reaction
▪ The reaction rate is proportional to the first power concentration of the substance remaining in the
reaction mixture
▪ The half-life in the first order reaction
is:
♥ T1/2 =
0.693/k ​3. Second Order
Reaction
▪ Characterized by the property that their rate is proportional to the product of two reactant concentrations
4. Third Order Reaction
▪ A reaction is said to be of third order if the rate is determined by the variation of three
concentration terms. The minimum number of molecules necessary for the reaction to take place is
three.
▪ There may be three different cases in third order reaction. ♥
All the three species have equal concentrations ♥ Two species
have equal concentrations and one different ♥ All three species
have unequal concentrations

Determination of the Order of


Reaction
1. Substitution
Method
▪ The data accumulated in a kinetic study maybe substituted in the integrated form of the equations
that describe the various orders
▪ When the equation is found in the calculated k, values remain constant within limits, the reaction is
considered to be of that order ​2. Graphic Method
▪ A plot of the data in the form of a graph is used to ascertain the
order
▪ If a straight line results when concentration is plotted against the time, the reaction is zero
order
▪ The reaction is first order if log (a-x) versus time gives a straight
line
3. Half-Life
Method
▪ Will be used if the following
applies:
▪ In a zero order reaction, the half-life is proportional to the initial concentration and the half-life of a
first order reaction is independent of the concentration

Factors Affecting the Rate of


Reaction:
1.
Concentration
▪ The concentration of reactants plays an important role in chemical kinetics. It is true that by increasing
the amount of reactants, the rate of reaction is increased. According to collision theory, the greater the
number of molecules the higher is the collision ratio, consequently faster is the rate of reaction.
2. Temperature
▪ Increasing the temperature of a system increases the average kinetic energy of its constituent particles.
As the average kinetic energy increases, the particles move faster and collide more frequently per unit time
and possess greater energy when they collide. Hence the reaction rate of all reactions increases with
increasing temperature. ​3. Catalyst
▪ A catalyst is a substance, which controls the rate of reaction without itself undergoing a
permanent chemical change.
▪ Catalysts are of two types: ​POSITIVE
CATALYST
♥ A positive catalyst increases the rate of reaction by lowering the energy of activation.
Thus in the presence of a positive catalyst, the greater fraction of the total molecule will
posses lower energy of activation and collided successfully in a short period of time, there
by increasing the rate of reaction
▪ ​NEGATIVE CATALYST OR
INHIBITOR:
♥ A negative catalyst retards the rate of reaction. Negative catalyst do not lower the energy of activation
rather they are combined with reactant molecule thus decreasing the number of colliding reactant
molecules. This ​decreases the effective collisions, hence rate of reaction. 4. Surface Area
▪ In heterogeneous reactions, the rate of reaction depends upon the surface area of solid reactant.
Greater the surface area, higher is the rate of reaction.
▪ In other words, by increasing the surface area of reactant, rate of reaction increases due to greater contact
between individual particles and also due to the fact that the surface molecules reacts more quickly. ​Drug
Stability
• The incapacity or incapability of a particular formulation in a specific container to remain within a
particular chemical, microbiological, therapeutic, physical & toxicological specification.
• ​FACTORS EFFECTING DRUG STABILITY: ​Factors effecting the drug stability
are as under
1) PH 2)
Temperature 3)
Moisture 4)
Light 5)
Radiations

Types of Drug
Instability
• ​Physical
Degradation
1) Loss of volatile
components
2) Loss of H2O 3)
Absorption of H2O 4)
Crystal growth 5)
Polymorphic changes
6) Color changes
• ​Chemical Degradation ​1)
Hydrolysis 2) Oxidation 3)
Decarboxilation 4)
Isomerization 5)
Polymerization ​Aspirin
• Aspirin is used to treat pain, and reduce fever or inflammation. It is sometimes used to treat or prevent
heart attacks, strokes, and chest pain (angina)

POSTLA
B:
• Degradation product ofAspirin:
▪ Salicylic acid & Acetic
acid

• Effect of temperature on the rate of


reaction:
▪ As the temperature increases, the rate of reaction increases (direct
proportion)
• Based on the computed degradation rate ay 25°C, determine the half-life and
shelf-life

▪ ​Given: ​♥ k1= 3.6737745 x 10


-4
▪ ​Answers:
♥ T90 = 285.81 min
♥ T1/2 = 1886.34
min

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