Chemical kinetics provides the basis for predicting drug stability. The rate and order of reactions can be determined experimentally using graphic, substitution, and half-life methods. Factors like temperature, moisture, and light affect reaction rates. Accelerated stability testing under exaggerated conditions can predict shelf life using the Arrhenius equation. Appropriate storage conditions like containers, temperature, and protection from light and moisture maintain pharmaceutical product quality over the predicted shelf life.
Chapter of M pharm First semester, Which covers order and rate of reaction,first order and zero order kinetics , ICH guidelines for stability testing,Storage conditions,etc.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Stability Testing.pptx ,M.PHARM,1ST year ,1st semesterManshiRana2
Stability testing of dosage forms is an important aspect of pharmaceutical development and manufacturing. It involves evaluating the physical, chemical, and microbiological attributes of a dosage form over a specific period of time under various storage conditions.
The purpose of stability testing is to ensure the efficacy, quality and safety of the drug throughout its shelf life.
.
SCOPE OF STABILITY TESTING Provide evidence as to how the quality of drug product varies with time.
Determine recommended storage conditions.
Establish shelf life for the drug product.
Establish quality of a drug product or substance .
Determine container and closure system suitability .
The presentation concisely describes the different pharmacokinetic parameters and basics of compartment modelling. It will help undergraduate students to understand the basic concepts of Biopharmaceutics.
KINETICS OF STABILITY , ACCELERATED STABILITY STUDY, AND ICH STABILITY GUIDEL...Akhila Anil
CHEMICAL KINETICS
ORDER OF REACTION
DETERMINATION OF ORDER
SALIENT FEATURES OF ACCELERATED DRUG STABILITY
STABILITY METHOD
LIMITATIONS OF ACCELERATED DRUG STABILITY
ICH GUIDELINES ON STABILITY
9.2Physical Science SHS Measurement of Reaction Ra.pptxgoddesshera
It tells how fast or slow a certain chemical reaction occur.
There are two factors that can be used to determine reaction rates: concentration and rate constant.
It can simply be determined by measuring the changes in the concentrations of the reactants or products within a particular time frame.
Generally, a chemical reaction is represented in the following format.
As the chemical reaction takes place, the amount of reactants decrease as the amount of the products increase.
Δ[A], Δ[B], Δ[C], and Δ[D] are the measures of the change in respective concentrations over a period of time, Δt.
Reaction rates are always positive.
In terms of appearance of a product in a reaction, the expression is positive since the change in concentration is positive.
In term of disappearance of a reactant, the case is opposite; hence the expression is appended by a negative sign.
The rate law expresses the relationship of the rate of reaction to the rate constant and the concentration of the reactants raised to certain exponents.
The rate constant, k, is a constant of proportionality between the reaction rate and the concentration of the reactants.
Rate laws are always determined experimentally.
Chapter of M pharm First semester, Which covers order and rate of reaction,first order and zero order kinetics , ICH guidelines for stability testing,Storage conditions,etc.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Stability Testing.pptx ,M.PHARM,1ST year ,1st semesterManshiRana2
Stability testing of dosage forms is an important aspect of pharmaceutical development and manufacturing. It involves evaluating the physical, chemical, and microbiological attributes of a dosage form over a specific period of time under various storage conditions.
The purpose of stability testing is to ensure the efficacy, quality and safety of the drug throughout its shelf life.
.
SCOPE OF STABILITY TESTING Provide evidence as to how the quality of drug product varies with time.
Determine recommended storage conditions.
Establish shelf life for the drug product.
Establish quality of a drug product or substance .
Determine container and closure system suitability .
The presentation concisely describes the different pharmacokinetic parameters and basics of compartment modelling. It will help undergraduate students to understand the basic concepts of Biopharmaceutics.
KINETICS OF STABILITY , ACCELERATED STABILITY STUDY, AND ICH STABILITY GUIDEL...Akhila Anil
CHEMICAL KINETICS
ORDER OF REACTION
DETERMINATION OF ORDER
SALIENT FEATURES OF ACCELERATED DRUG STABILITY
STABILITY METHOD
LIMITATIONS OF ACCELERATED DRUG STABILITY
ICH GUIDELINES ON STABILITY
9.2Physical Science SHS Measurement of Reaction Ra.pptxgoddesshera
It tells how fast or slow a certain chemical reaction occur.
There are two factors that can be used to determine reaction rates: concentration and rate constant.
It can simply be determined by measuring the changes in the concentrations of the reactants or products within a particular time frame.
Generally, a chemical reaction is represented in the following format.
As the chemical reaction takes place, the amount of reactants decrease as the amount of the products increase.
Δ[A], Δ[B], Δ[C], and Δ[D] are the measures of the change in respective concentrations over a period of time, Δt.
Reaction rates are always positive.
In terms of appearance of a product in a reaction, the expression is positive since the change in concentration is positive.
In term of disappearance of a reactant, the case is opposite; hence the expression is appended by a negative sign.
The rate law expresses the relationship of the rate of reaction to the rate constant and the concentration of the reactants raised to certain exponents.
The rate constant, k, is a constant of proportionality between the reaction rate and the concentration of the reactants.
Rate laws are always determined experimentally.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
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Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
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How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
2. CONTENTS
1. Introduction
2. rate and order of reaction
3. zero, 1st, 2nd,pseudo 1st.
4. Methods of determination or reaction order.
5. Factors affecting reaction rate.
6. Accelerated stability testing.
7. Kinetics of solid state and stability testing.
8. Prediction of Shelf-Life.
9. Storage of pharmaceutical products.
10. Kinetics and Thermodynamics.
11. References.
3. Drugs stability is defined as the pharmaceutical dosages form
to maintain the physical, chemical, therapeutic and microbial
properties during the time of storage and uses by the patient.
Stability is defined as the capacity of a drugs substance to
remain within the established specification to maintain its
identity, strength, quality and purity throughout the retest or
expiration during period.
Chemical kinetics is the study of rate of chemical changes
taking place during chemical reaction.
As applied to pharmaceutical formulation , this include a study of physical
and chemical changes in drugs and dosage form, factor influencing the
rate of these chemical reaction, accelerated stability testing and prediction
of shelf life.
4. RATES AND ORDER OF REACTION
The velocity with which a reaction or a process
occurs is called as its rate, concentration of drugs
influences the rate of reaction or process is called
as the order of reaction or order of process.
Considering the following chemical reaction
Drug A Drug B
5. Experimentally, the rate of reaction is determined
by measuring the decrease in concentration of
drugs A with time.
6. • If c is the concentration of drug A, the rate of decrease
in c of drug A as it is changed to B can be described by
expression as function of time t.
• dC/dt = -kc
• Where,
• k= rate constant n=order of reaction
If
n= 0 (zero order process)
n= 1 (first order p2r/7o/2c0e16ssv)
The order of a reaction determines the way in which
the concentration of a reactant or reactantsinfluences
the rate of a chemical reaction
7. • The molecularity of a reaction refers to the numbers of
molecules, atoms, or ions reacting in a elementary process to
give the reactants.
• If only one type of molecules undergoes a change in to yield the
product , the product is said to be unimolecular.
• If two molecules undergoes to change yield the product, the
reaction is said to be bimolecular.
• Reaction that involves more than one steps ( complex reaction)
may have different molecularity and order of reaction.
• The three commonly encountered rate process:
8. Introduction
(Zero, 1st, 2nd, Pseudo 1st)
• Chemical kinetics provide the basis to predict drug
stability.
• The extent of inactivation of drug due to various
environmental adverse conditions can be understood
from the drug stability studies.
• It is expressed as a rate process.
• These studies help to predict the expiry period (shelf
life) of a product.
9. • The rate, velocity or speed of a reaction is given by ±
(dc/dt). Here dc is the small change in the
concentration within a given time interval dt.
• Order of a reaction is defined as the number of
concentration terms on which the rate of a reaction
depends when determined experimentally.
Rate and order
(Zero, 1st, 2nd, Pseudo 1st)
10. • Zero order reaction is defined as a reaction in which
the rate does not depend on the concentration terms
of the reactants.
• This is mathematically expressed as:
• Where k0is the specific rate constant for a zero order
Zero Order Reaction
12. First Order Reaction
• First order reaction is defined as a reaction in which
the rate of reaction depends on the concentration of
one reactant.
• Mathematically, the first order rate equation can be
written as:
• Where c is the concentration of the reactant and k1is
the specific rate constant for first order
14. • Second order reaction is defined as a reaction in which the rate depends on
the concentration terms of two reactants each raised to the power one.
Consider the following reaction
•
• The rate equation can be written as
• Where [A] and [B] are the concentration of A and B, respectively, and k2 is
the specific rate constant for second order. In other words, the rate of
reaction is first order with respect to A, and again first order with respect to
B. So the overall order of this reaction is second order.
Second Order Reaction
16. • Pseudo first order reaction is defined as a reaction which is
originally a second order, but is made to behave like a first
order reaction.
In second order reaction, the rate depends on the concentration
terms of two reactants. Therefore the rate equation would be
•
Pseudo First Order Reaction
17. Methods of determination or
reaction order
• There is no straight forward method to theoretically
know the order of a reaction.
• The exact order can be determined experimentally.
The following methods are employed to decide the
order of a reaction.
1. Graphic Method
2. Substitution Method
3. Half Life Method
18. 1.Graphic Method
• This pictorial method may be more reliable because
deviations from the best fit line can be easily
observed. Conduct the kinetic experiment and collect
the data on the time course of changes in the
concentration of the reactants. Plot the data on a
graph paper as per the general principles of each
order.
• Decide which graph gives a better fit for a straight
line. The reaction is considered to be of that order.
20. 2. Substitution Method
• Conduct a kinetic experiment and collect the data on
the time course of changes in the concentration of
reactants. Substitute the data in the integral equation
of zero, first, and second order reactions to get k
values.
21. • Select the order in which k values at different time
periods remain constant within the experimental
errors. The reaction is considered to be of that order.
2. Substitution Method
22. 3. Half Life Method
• Calculate the average k value using the data for zero,
first, and second orders as given in substitution
method or graphic method. Then, estimate the
values for each time period in the kinetic study.
• Equations are as follows.
t1/2
25. Factors affecting reaction rate
• It is the time course of changes in the concentration
of the reactants in a reaction.
1. Drug stability
2. Dissolution
3. Drug release
4. Pharmacokinetics
5. Drug action
26. Types of stability studies
1. Long term stability studies
2. Accelerated stability studies
3. Testing frequency
4. Packaging and container
28. Accelerated stability analysis
• Accelerated stability analysis is design to predict stability
and hence shelf life of formulation under normal and
recommended storage condition by carrying out the study
under accelerated condition of temperature, moisture and
light.
Prediction of shelf life
• Shelf life is the time period during which the dosages
form is supposed to retain its original quantity.
• The prediction is based on the arrhenius equation.
29.
30. Kinetics of solid state and
stability testing
• In all solid dose formulations there will be some free
moisture (contributed by excipients as well as the
drug), and certainly in tablets a significant
percentage, typically 2% w/w, is required to facilitate
good compression.
• The ionic equilibria are quite different and
comparison is meaningless.
• They should not be extrapolated glibly to the solid
state.
31. Prediction of Shelf-Life
• The mathematical prediction of shelf-life is based on
the application of the Arrhenius equation.
• If the slope of this line is determined from the results
of accelerated tests at high temperatures.
• Substitution of this value of k into the appropriate
order of reaction allows the amount of decomposition
after a given time to be calculated.
• This approach involves, and preliminary experiments
are therefore necessary to determine this order.
33. Storage of pharmaceutical
products
• Appropriate storage of raw materials which includes
drugs, excipients and finished products is necessary.
• Storage of medicinal products maintains the physical,
chemical and biological properties.
• Major areas which demand careful consideration of
storage are hospitals, marketplace of retailers and
wholesalers.
• All medicinal products should be stored in such a
way as to avoid contamination.
34. • Some of the methods are discussed in the following
sections.
1. Storing of products in well-closed containers
2. Storing the products by protection from light
3. Storing the products in a cool place
4. Storing the products by the addition of other
substances
Methods for Storage of
pharmaceutical products
35. Kinetics and Thermodynamics
• Kinetics: Chemical kinetics involve the study of the
rate of a chemical process. The rate of a reaction can
be understood by studing the time course of changes
in the concentration.
• Thermodynamics: Thermodynamics deals with the
quantitative relationships of interconversion of the
various forms of energy, including mechanical,
chemical, electric, and radiant energy.