SlideShare a Scribd company logo
1 of 18
Presented By
Nargis Ara
Ph. D Scholar (Pharmaceutics)
Integral University, Lucknow
SATBILITY CALCULATION
Contents
5/2/2021
PR04
2
 Introduction to Drug Stability Studies
 Drug Kinetics
 Prediction of Half-Life (t½)
 Prediction of Self-Life (t90)
 Zero-Order Rate Reaction
 First-Order Rate Reaction
 Second-Order rate Reaction
Introduction
 Drug stability refers to the capacity of a drug
substance or product to remain within
established specifications of identity, strength,
quality, and purity in a specified period of time.
 Purpose of Stability Studies:
Quality of a drug product
Self life of the drug product
Recommended storage condition
3 PR04 5/2/2021
Drug Kinetics
 It is defined as how drug changes with time
i.e., study of rate of change.
 The rate, velocity or speed of a reaction is
expressed as dc/dt where, dc is small
changes in the concentration within a given
time interval dt.
 Importance of Drug Kinetics
It helps to predict stability of drug (half-life).
It helps to predict the expiry period (shelf-
life) of product.
4 PR04 5/2/2021
Prediction of Half-Life
5/2/2021
PR04
5
 The half life (t½) is defined as the time
required for one-half of a reactant to
disappear, as [A] has decreased to ½[A].
 Because [A] at t½ is one-half of the original
[A],
[A]t = 0.5 [A]0
 The average ‘k’ value is calculated using the
data for appropriate order of reaction either by
substitution or graphical method and then the
t1/2 values for each time period in the kinetic
study is estimated.
Prediction of Self-Life
5/2/2021
PR04
6
 Shelf life (t90%) is defined as the time at which the
concentration of reactant [A], decreased to 90% of its
original concentration.
 As per definition the term equation becomes,
C =90a/100
or, t =t90
 The mathematical prediction of self-life is based
on Arrhenius equation.
 Substitution of ‘k’ value into the appropriate order
of reaction allows the amount of decomposition
after a given time to calculated.
Zero-Order Rate Reaction
5/2/2021
PR04
7
 Rate is constant and is independent of the concentration of
the reactant.
dc/dt=k0 k0= c0 – c /t
Where, c = drug concentration at time t
c0 = initial concentration of the drug
k0 = zero-order rate constant (concentration/time)
t = time
Calculation of t1/2
Let c = co /2 and t1/2 = t
substitute in equation;
c = co – k t
co /2= co - k t1/2
t1/2 = co / 2k
Calculation of t90
Let c = 0.9 co and t= t90
substitute in equation;
c = co –k t
0.9 co = co - k t90
t90 = 0.1 co / k
c
t
First-Order Rate Reaction
5/2/2021
PR04
8
 The reaction rate of change is proportional to drug
concentration.
dc/dt=-k.c c=c0.e-kt ln c =
ln c0-k.t
Where, c= drug concentration at time, t
c0= initial concentration of the drug
k =first-order rate constant (concentration/time)
t =time
Calculation of t1/2
let c = c0 /2 and t = t1/2
substitute in equation;
ln c = ln c0 – k.t
ln c0=ln c0-k.t1/2
t1/2 = ln 2/ k
t1/2 = 0.693 / k
Calculation of t0.9
Let c = 0.9 c0 and t = t0.9
substitute in equation;
ln c = ln c0 – k.t
t0.9 = 0.105 / k
lnc = lnco – kt
Slope = c1 – c2 / t1 – t2
Slope = -k
ln c
t
ln
c0
Second Order Rate Reaction
5/2/2021
PR04
9
 When two components reacting with each
other or one component reacting with itself.
Half life: t1/2 = 1 / kc0
Shelf life: t0.9 = 0.11 /
kc0
Graphical Determination of the
Reaction Order for the decomposition
of N2O5
5/2/2021
PR04
10
A Plot of [N2O5] Vs. Time for Three
Reaction Half-Life
5/2/2021
PR04
11
Examples
5/2/2021
PR04
12
 Example 1:
(k[A]=k0 )
• Example 2:
5/2/2021
PR04
13
(k=2.303/t . log c0/c)
5/2/2021
PR04
14
 Example 3:
5/2/2021
PR04
15
 Example 4:
An Overview of Rate, Half-life and
Self-life Equation
PR04
16
Reaction
Order
Rate equation Half –life
Equation ( t½ )
Self-life
Equation ( t90% )
Zero-order k0 = c0 – c /t c0 / 2k c0 / 10k
First-order k1= 2.303/t . ln .
c0/c
0.693/k 0.105/k
Second-order
(a=b=c0)
1/c – 1/c0 = kt 1/c0k 0.11/c0k
Here, c = concentration of the drug at time, t ; c0 = initial concentration ; k=
rate constant
5/2/2021
References
5/2/2021
PR04
17
 Patrick J. Sink. (2006). Martin’s Physical Pharmacy
and Pharmaceutical Sciences: Physical Chemical and
Biopharmaceutical Principles in the Pharmaceutical
Sciences. Lippincott William and Wilkins, 5, 400-432.
 Gilbert S. Banker and Christopher T. Rhodes. (2002).
Modern Pharmaceutics. Marcel Dekker, Inc., New
York, 4, 154-160.
 Tembhare E. et.al. (2019). An Approach to Drug
Stability Studies and Self-Life Determination. ACRI,
19(1), 1-20.
 https://mysite.science.uottawa.ca/sgambarotta/sites/d
efault/files/CHM%201311F/slide%20show/ch14-
kinetics/Ch14-kinetics-lecture.pdf 01/02/2021.
5/2/2021
PR04
18

More Related Content

What's hot

Bracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisBracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisSarath Chandra
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...Pristyn Research Solutions
 
Ich guideline for stability testing
Ich guideline for stability testingIch guideline for stability testing
Ich guideline for stability testingShubham Gore
 
Chromarogaphy system suitability ppt
Chromarogaphy system suitability pptChromarogaphy system suitability ppt
Chromarogaphy system suitability pptkiranreddy munnangi
 
Ich guidelines for stability studies 1
Ich guidelines for stability studies 1Ich guidelines for stability studies 1
Ich guidelines for stability studies 1priyanka odela
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study pptpharmacy
 
Impurities in Drug Substance & in Drug Product
Impurities in Drug Substance & in Drug ProductImpurities in Drug Substance & in Drug Product
Impurities in Drug Substance & in Drug ProductKamal Ambalia
 
Hplc parameters, factors affecting resolution
Hplc parameters, factors affecting resolution  Hplc parameters, factors affecting resolution
Hplc parameters, factors affecting resolution DHINESHKUMAR V
 
Stability of Pharmaceuticals
Stability of PharmaceuticalsStability of Pharmaceuticals
Stability of PharmaceuticalsMalay Pandya
 
Solid state drug stability
Solid state drug stabilitySolid state drug stability
Solid state drug stabilityAnindya Jana
 
Kinetic principles in drug degradation
Kinetic principles in drug degradationKinetic principles in drug degradation
Kinetic principles in drug degradationTouheed Ovi
 
Stability study of Pharmaceutical Products and Regulatory Requirements
Stability study of Pharmaceutical Products and Regulatory Requirements Stability study of Pharmaceutical Products and Regulatory Requirements
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
 
Accelerated stability testing
Accelerated stability testingAccelerated stability testing
Accelerated stability testingGaurav Kr
 
Ph and solubility profile
Ph  and solubility profile Ph  and solubility profile
Ph and solubility profile Debashis Purohit
 
In-vitro in vivo dissolution correlation BCS classification
In-vitro in vivo dissolution correlation BCS classificationIn-vitro in vivo dissolution correlation BCS classification
In-vitro in vivo dissolution correlation BCS classificationRoshan Bodhe
 

What's hot (20)

Bracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysisBracketing and Matrixing Methods for Stability analysis
Bracketing and Matrixing Methods for Stability analysis
 
Drug stability
Drug stabilityDrug stability
Drug stability
 
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS ASKED IN QUALITY ASSURANCE AND QU...
 
Ich guideline for stability testing
Ich guideline for stability testingIch guideline for stability testing
Ich guideline for stability testing
 
Chromarogaphy system suitability ppt
Chromarogaphy system suitability pptChromarogaphy system suitability ppt
Chromarogaphy system suitability ppt
 
Ich guidelines for stability studies 1
Ich guidelines for stability studies 1Ich guidelines for stability studies 1
Ich guidelines for stability studies 1
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study ppt
 
Impurities in Drug Substance & in Drug Product
Impurities in Drug Substance & in Drug ProductImpurities in Drug Substance & in Drug Product
Impurities in Drug Substance & in Drug Product
 
Hplc parameters, factors affecting resolution
Hplc parameters, factors affecting resolution  Hplc parameters, factors affecting resolution
Hplc parameters, factors affecting resolution
 
Stability of Pharmaceuticals
Stability of PharmaceuticalsStability of Pharmaceuticals
Stability of Pharmaceuticals
 
Solid state drug stability
Solid state drug stabilitySolid state drug stability
Solid state drug stability
 
ICH Stability testing of new drug substances and products QA (R2) - 2015
ICH Stability testing of new drug substances and products QA (R2) - 2015ICH Stability testing of new drug substances and products QA (R2) - 2015
ICH Stability testing of new drug substances and products QA (R2) - 2015
 
Kinetic principles in drug degradation
Kinetic principles in drug degradationKinetic principles in drug degradation
Kinetic principles in drug degradation
 
Stability study of Pharmaceutical Products and Regulatory Requirements
Stability study of Pharmaceutical Products and Regulatory Requirements Stability study of Pharmaceutical Products and Regulatory Requirements
Stability study of Pharmaceutical Products and Regulatory Requirements
 
ICH- Q3 Impurity
ICH- Q3 ImpurityICH- Q3 Impurity
ICH- Q3 Impurity
 
Accelerated stability testing
Accelerated stability testingAccelerated stability testing
Accelerated stability testing
 
Ph and solubility profile
Ph  and solubility profile Ph  and solubility profile
Ph and solubility profile
 
Residual solvents
Residual solventsResidual solvents
Residual solvents
 
In-vitro in vivo dissolution correlation BCS classification
In-vitro in vivo dissolution correlation BCS classificationIn-vitro in vivo dissolution correlation BCS classification
In-vitro in vivo dissolution correlation BCS classification
 
PHOTOSTABILITY TESTING SEM I SEMINAR
PHOTOSTABILITY TESTING SEM I SEMINARPHOTOSTABILITY TESTING SEM I SEMINAR
PHOTOSTABILITY TESTING SEM I SEMINAR
 

Similar to Satbility calculation

kinetics of stability Molecular pharmaceutics
kinetics of stability Molecular pharmaceuticskinetics of stability Molecular pharmaceutics
kinetics of stability Molecular pharmaceuticsMittalGandhi
 
Kinetics and drug stability ed
Kinetics and drug stability edKinetics and drug stability ed
Kinetics and drug stability edDereje Kebebe
 
Stability studies presentation
Stability studies presentationStability studies presentation
Stability studies presentationMedical Knowledge
 
Stability Studies-----(Pharmaceutics)
Stability Studies-----(Pharmaceutics)Stability Studies-----(Pharmaceutics)
Stability Studies-----(Pharmaceutics)Soft-Learners
 
12 chemistry impq_ch04_chemical_kinetics_02
12 chemistry impq_ch04_chemical_kinetics_0212 chemistry impq_ch04_chemical_kinetics_02
12 chemistry impq_ch04_chemical_kinetics_02B Bhuvanesh
 
Reaction Kinetics
Reaction KineticsReaction Kinetics
Reaction Kineticsmiss j
 
Lect w2 152 - rate laws_alg
Lect w2 152 - rate laws_algLect w2 152 - rate laws_alg
Lect w2 152 - rate laws_algchelss
 
Estabilidad y inestabilidad de los medicamentos
Estabilidad y inestabilidad de los medicamentosEstabilidad y inestabilidad de los medicamentos
Estabilidad y inestabilidad de los medicamentosC Alberto Caballero A
 
Order reaction , s.j.shah
Order reaction , s.j.shahOrder reaction , s.j.shah
Order reaction , s.j.shahsahilhusen
 
Ch15 130105195439-phpapp01
Ch15 130105195439-phpapp01Ch15 130105195439-phpapp01
Ch15 130105195439-phpapp01Cleophas Rwemera
 
Accelerated stability studies
Accelerated stability studiesAccelerated stability studies
Accelerated stability studiesRamyaP53
 
Order of a reaction 2302
Order of a reaction 2302Order of a reaction 2302
Order of a reaction 2302Prawin Ddy
 

Similar to Satbility calculation (20)

kinetics of stability Molecular pharmaceutics
kinetics of stability Molecular pharmaceuticskinetics of stability Molecular pharmaceutics
kinetics of stability Molecular pharmaceutics
 
Kinetics and drug stability ed
Kinetics and drug stability edKinetics and drug stability ed
Kinetics and drug stability ed
 
4
44
4
 
Stability studies presentation
Stability studies presentationStability studies presentation
Stability studies presentation
 
Leo...
Leo...Leo...
Leo...
 
Stability Studies-----(Pharmaceutics)
Stability Studies-----(Pharmaceutics)Stability Studies-----(Pharmaceutics)
Stability Studies-----(Pharmaceutics)
 
Stability studies
Stability studies Stability studies
Stability studies
 
12 chemistry impq_ch04_chemical_kinetics_02
12 chemistry impq_ch04_chemical_kinetics_0212 chemistry impq_ch04_chemical_kinetics_02
12 chemistry impq_ch04_chemical_kinetics_02
 
Lds kinetics 3
Lds kinetics 3Lds kinetics 3
Lds kinetics 3
 
Lds kinetics 3
Lds kinetics 3Lds kinetics 3
Lds kinetics 3
 
Reaction Kinetics
Reaction KineticsReaction Kinetics
Reaction Kinetics
 
Lect w2 152 - rate laws_alg
Lect w2 152 - rate laws_algLect w2 152 - rate laws_alg
Lect w2 152 - rate laws_alg
 
Estabilidad y inestabilidad de los medicamentos
Estabilidad y inestabilidad de los medicamentosEstabilidad y inestabilidad de los medicamentos
Estabilidad y inestabilidad de los medicamentos
 
Ch 15 Web
Ch 15 WebCh 15 Web
Ch 15 Web
 
Order reaction , s.j.shah
Order reaction , s.j.shahOrder reaction , s.j.shah
Order reaction , s.j.shah
 
Order of Reaction.pdf
Order of Reaction.pdfOrder of Reaction.pdf
Order of Reaction.pdf
 
Ch15 130105195439-phpapp01
Ch15 130105195439-phpapp01Ch15 130105195439-phpapp01
Ch15 130105195439-phpapp01
 
Accelerated stability studies
Accelerated stability studiesAccelerated stability studies
Accelerated stability studies
 
Order of a reaction 2302
Order of a reaction 2302Order of a reaction 2302
Order of a reaction 2302
 
Kinetics pp
Kinetics ppKinetics pp
Kinetics pp
 

Recently uploaded

Midocean dropshipping via API with DroFx
Midocean dropshipping via API with DroFxMidocean dropshipping via API with DroFx
Midocean dropshipping via API with DroFxolyaivanovalion
 
Customer Service Analytics - Make Sense of All Your Data.pptx
Customer Service Analytics - Make Sense of All Your Data.pptxCustomer Service Analytics - Make Sense of All Your Data.pptx
Customer Service Analytics - Make Sense of All Your Data.pptxEmmanuel Dauda
 
Call Girls In Mahipalpur O9654467111 Escorts Service
Call Girls In Mahipalpur O9654467111  Escorts ServiceCall Girls In Mahipalpur O9654467111  Escorts Service
Call Girls In Mahipalpur O9654467111 Escorts ServiceSapana Sha
 
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service Amravati
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service AmravatiVIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service Amravati
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service AmravatiSuhani Kapoor
 
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdf
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdfMarket Analysis in the 5 Largest Economic Countries in Southeast Asia.pdf
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdfRachmat Ramadhan H
 
Brighton SEO | April 2024 | Data Storytelling
Brighton SEO | April 2024 | Data StorytellingBrighton SEO | April 2024 | Data Storytelling
Brighton SEO | April 2024 | Data StorytellingNeil Barnes
 
Mature dropshipping via API with DroFx.pptx
Mature dropshipping via API with DroFx.pptxMature dropshipping via API with DroFx.pptx
Mature dropshipping via API with DroFx.pptxolyaivanovalion
 
RA-11058_IRR-COMPRESS Do 198 series of 1998
RA-11058_IRR-COMPRESS Do 198 series of 1998RA-11058_IRR-COMPRESS Do 198 series of 1998
RA-11058_IRR-COMPRESS Do 198 series of 1998YohFuh
 
Dubai Call Girls Wifey O52&786472 Call Girls Dubai
Dubai Call Girls Wifey O52&786472 Call Girls DubaiDubai Call Girls Wifey O52&786472 Call Girls Dubai
Dubai Call Girls Wifey O52&786472 Call Girls Dubaihf8803863
 
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Callshivangimorya083
 
100-Concepts-of-AI by Anupama Kate .pptx
100-Concepts-of-AI by Anupama Kate .pptx100-Concepts-of-AI by Anupama Kate .pptx
100-Concepts-of-AI by Anupama Kate .pptxAnupama Kate
 
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdf
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdfKantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdf
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdfSocial Samosa
 
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...Suhani Kapoor
 
04242024_CCC TUG_Joins and Relationships
04242024_CCC TUG_Joins and Relationships04242024_CCC TUG_Joins and Relationships
04242024_CCC TUG_Joins and Relationshipsccctableauusergroup
 
Unveiling Insights: The Role of a Data Analyst
Unveiling Insights: The Role of a Data AnalystUnveiling Insights: The Role of a Data Analyst
Unveiling Insights: The Role of a Data AnalystSamantha Rae Coolbeth
 
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al Barsha
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al BarshaAl Barsha Escorts $#$ O565212860 $#$ Escort Service In Al Barsha
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al BarshaAroojKhan71
 
Beautiful Sapna Vip Call Girls Hauz Khas 9711199012 Call /Whatsapps
Beautiful Sapna Vip  Call Girls Hauz Khas 9711199012 Call /WhatsappsBeautiful Sapna Vip  Call Girls Hauz Khas 9711199012 Call /Whatsapps
Beautiful Sapna Vip Call Girls Hauz Khas 9711199012 Call /Whatsappssapnasaifi408
 

Recently uploaded (20)

Midocean dropshipping via API with DroFx
Midocean dropshipping via API with DroFxMidocean dropshipping via API with DroFx
Midocean dropshipping via API with DroFx
 
Customer Service Analytics - Make Sense of All Your Data.pptx
Customer Service Analytics - Make Sense of All Your Data.pptxCustomer Service Analytics - Make Sense of All Your Data.pptx
Customer Service Analytics - Make Sense of All Your Data.pptx
 
Call Girls In Mahipalpur O9654467111 Escorts Service
Call Girls In Mahipalpur O9654467111  Escorts ServiceCall Girls In Mahipalpur O9654467111  Escorts Service
Call Girls In Mahipalpur O9654467111 Escorts Service
 
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service Amravati
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service AmravatiVIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service Amravati
VIP Call Girls in Amravati Aarohi 8250192130 Independent Escort Service Amravati
 
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdf
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdfMarket Analysis in the 5 Largest Economic Countries in Southeast Asia.pdf
Market Analysis in the 5 Largest Economic Countries in Southeast Asia.pdf
 
Brighton SEO | April 2024 | Data Storytelling
Brighton SEO | April 2024 | Data StorytellingBrighton SEO | April 2024 | Data Storytelling
Brighton SEO | April 2024 | Data Storytelling
 
Mature dropshipping via API with DroFx.pptx
Mature dropshipping via API with DroFx.pptxMature dropshipping via API with DroFx.pptx
Mature dropshipping via API with DroFx.pptx
 
RA-11058_IRR-COMPRESS Do 198 series of 1998
RA-11058_IRR-COMPRESS Do 198 series of 1998RA-11058_IRR-COMPRESS Do 198 series of 1998
RA-11058_IRR-COMPRESS Do 198 series of 1998
 
Dubai Call Girls Wifey O52&786472 Call Girls Dubai
Dubai Call Girls Wifey O52&786472 Call Girls DubaiDubai Call Girls Wifey O52&786472 Call Girls Dubai
Dubai Call Girls Wifey O52&786472 Call Girls Dubai
 
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call
꧁❤ Greater Noida Call Girls Delhi ❤꧂ 9711199171 ☎️ Hard And Sexy Vip Call
 
100-Concepts-of-AI by Anupama Kate .pptx
100-Concepts-of-AI by Anupama Kate .pptx100-Concepts-of-AI by Anupama Kate .pptx
100-Concepts-of-AI by Anupama Kate .pptx
 
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdf
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdfKantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdf
Kantar AI Summit- Under Embargo till Wednesday, 24th April 2024, 4 PM, IST.pdf
 
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...
VIP High Profile Call Girls Amravati Aarushi 8250192130 Independent Escort Se...
 
04242024_CCC TUG_Joins and Relationships
04242024_CCC TUG_Joins and Relationships04242024_CCC TUG_Joins and Relationships
04242024_CCC TUG_Joins and Relationships
 
Unveiling Insights: The Role of a Data Analyst
Unveiling Insights: The Role of a Data AnalystUnveiling Insights: The Role of a Data Analyst
Unveiling Insights: The Role of a Data Analyst
 
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al Barsha
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al BarshaAl Barsha Escorts $#$ O565212860 $#$ Escort Service In Al Barsha
Al Barsha Escorts $#$ O565212860 $#$ Escort Service In Al Barsha
 
E-Commerce Order PredictionShraddha Kamble.pptx
E-Commerce Order PredictionShraddha Kamble.pptxE-Commerce Order PredictionShraddha Kamble.pptx
E-Commerce Order PredictionShraddha Kamble.pptx
 
꧁❤ Aerocity Call Girls Service Aerocity Delhi ❤꧂ 9999965857 ☎️ Hard And Sexy ...
꧁❤ Aerocity Call Girls Service Aerocity Delhi ❤꧂ 9999965857 ☎️ Hard And Sexy ...꧁❤ Aerocity Call Girls Service Aerocity Delhi ❤꧂ 9999965857 ☎️ Hard And Sexy ...
꧁❤ Aerocity Call Girls Service Aerocity Delhi ❤꧂ 9999965857 ☎️ Hard And Sexy ...
 
VIP Call Girls Service Charbagh { Lucknow Call Girls Service 9548273370 } Boo...
VIP Call Girls Service Charbagh { Lucknow Call Girls Service 9548273370 } Boo...VIP Call Girls Service Charbagh { Lucknow Call Girls Service 9548273370 } Boo...
VIP Call Girls Service Charbagh { Lucknow Call Girls Service 9548273370 } Boo...
 
Beautiful Sapna Vip Call Girls Hauz Khas 9711199012 Call /Whatsapps
Beautiful Sapna Vip  Call Girls Hauz Khas 9711199012 Call /WhatsappsBeautiful Sapna Vip  Call Girls Hauz Khas 9711199012 Call /Whatsapps
Beautiful Sapna Vip Call Girls Hauz Khas 9711199012 Call /Whatsapps
 

Satbility calculation

  • 1. Presented By Nargis Ara Ph. D Scholar (Pharmaceutics) Integral University, Lucknow SATBILITY CALCULATION
  • 2. Contents 5/2/2021 PR04 2  Introduction to Drug Stability Studies  Drug Kinetics  Prediction of Half-Life (t½)  Prediction of Self-Life (t90)  Zero-Order Rate Reaction  First-Order Rate Reaction  Second-Order rate Reaction
  • 3. Introduction  Drug stability refers to the capacity of a drug substance or product to remain within established specifications of identity, strength, quality, and purity in a specified period of time.  Purpose of Stability Studies: Quality of a drug product Self life of the drug product Recommended storage condition 3 PR04 5/2/2021
  • 4. Drug Kinetics  It is defined as how drug changes with time i.e., study of rate of change.  The rate, velocity or speed of a reaction is expressed as dc/dt where, dc is small changes in the concentration within a given time interval dt.  Importance of Drug Kinetics It helps to predict stability of drug (half-life). It helps to predict the expiry period (shelf- life) of product. 4 PR04 5/2/2021
  • 5. Prediction of Half-Life 5/2/2021 PR04 5  The half life (t½) is defined as the time required for one-half of a reactant to disappear, as [A] has decreased to ½[A].  Because [A] at t½ is one-half of the original [A], [A]t = 0.5 [A]0  The average ‘k’ value is calculated using the data for appropriate order of reaction either by substitution or graphical method and then the t1/2 values for each time period in the kinetic study is estimated.
  • 6. Prediction of Self-Life 5/2/2021 PR04 6  Shelf life (t90%) is defined as the time at which the concentration of reactant [A], decreased to 90% of its original concentration.  As per definition the term equation becomes, C =90a/100 or, t =t90  The mathematical prediction of self-life is based on Arrhenius equation.  Substitution of ‘k’ value into the appropriate order of reaction allows the amount of decomposition after a given time to calculated.
  • 7. Zero-Order Rate Reaction 5/2/2021 PR04 7  Rate is constant and is independent of the concentration of the reactant. dc/dt=k0 k0= c0 – c /t Where, c = drug concentration at time t c0 = initial concentration of the drug k0 = zero-order rate constant (concentration/time) t = time Calculation of t1/2 Let c = co /2 and t1/2 = t substitute in equation; c = co – k t co /2= co - k t1/2 t1/2 = co / 2k Calculation of t90 Let c = 0.9 co and t= t90 substitute in equation; c = co –k t 0.9 co = co - k t90 t90 = 0.1 co / k c t
  • 8. First-Order Rate Reaction 5/2/2021 PR04 8  The reaction rate of change is proportional to drug concentration. dc/dt=-k.c c=c0.e-kt ln c = ln c0-k.t Where, c= drug concentration at time, t c0= initial concentration of the drug k =first-order rate constant (concentration/time) t =time Calculation of t1/2 let c = c0 /2 and t = t1/2 substitute in equation; ln c = ln c0 – k.t ln c0=ln c0-k.t1/2 t1/2 = ln 2/ k t1/2 = 0.693 / k Calculation of t0.9 Let c = 0.9 c0 and t = t0.9 substitute in equation; ln c = ln c0 – k.t t0.9 = 0.105 / k lnc = lnco – kt Slope = c1 – c2 / t1 – t2 Slope = -k ln c t ln c0
  • 9. Second Order Rate Reaction 5/2/2021 PR04 9  When two components reacting with each other or one component reacting with itself. Half life: t1/2 = 1 / kc0 Shelf life: t0.9 = 0.11 / kc0
  • 10. Graphical Determination of the Reaction Order for the decomposition of N2O5 5/2/2021 PR04 10
  • 11. A Plot of [N2O5] Vs. Time for Three Reaction Half-Life 5/2/2021 PR04 11
  • 16. An Overview of Rate, Half-life and Self-life Equation PR04 16 Reaction Order Rate equation Half –life Equation ( t½ ) Self-life Equation ( t90% ) Zero-order k0 = c0 – c /t c0 / 2k c0 / 10k First-order k1= 2.303/t . ln . c0/c 0.693/k 0.105/k Second-order (a=b=c0) 1/c – 1/c0 = kt 1/c0k 0.11/c0k Here, c = concentration of the drug at time, t ; c0 = initial concentration ; k= rate constant 5/2/2021
  • 17. References 5/2/2021 PR04 17  Patrick J. Sink. (2006). Martin’s Physical Pharmacy and Pharmaceutical Sciences: Physical Chemical and Biopharmaceutical Principles in the Pharmaceutical Sciences. Lippincott William and Wilkins, 5, 400-432.  Gilbert S. Banker and Christopher T. Rhodes. (2002). Modern Pharmaceutics. Marcel Dekker, Inc., New York, 4, 154-160.  Tembhare E. et.al. (2019). An Approach to Drug Stability Studies and Self-Life Determination. ACRI, 19(1), 1-20.  https://mysite.science.uottawa.ca/sgambarotta/sites/d efault/files/CHM%201311F/slide%20show/ch14- kinetics/Ch14-kinetics-lecture.pdf 01/02/2021.