This document discusses methods for comparing drug dissolution profiles, which provide information about how completely and quickly an active pharmaceutical ingredient is released from its dosage form. Graphical and statistical methods are described for directly comparing dissolution curves. Model-dependent approaches apply kinetic models like zero-order, first-order, and Higuchi models to the data. Model-independent methods calculate similarity factors f1 and f2 that provide single values for comparing profiles. Comparing dissolution profiles is important for evaluating drug release and bioequivalence of pharmaceutical formulations.
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
Biopharmaceutic considerations in drug product design and In Vitro Drug Produ...PRAJAKTASAWANT33
Introduction, biopharmaceutic factors affecting drug bioavailability, rate–limiting steps in drug absorption, physicochemical nature of the drug formulation factors affecting drug product performance
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
MEETING DISSOLUTION REQUIREMENTS PROBLEMS OF VARIABLE CONTROL IN DISSOLUTION ...MukeshKumarBhagat
The dissolution profile data from the pivotal clinical batches and primary (registration) stability batches should be used for the setting of the dissolution acceptance criteria of your product (ie, specification-sampling time point and specification value).
Computational modelling of drug disposition lalitajoshi9
computational modelling of drug disposition is the integral part of computer aided drug design. different kinds of tools being used in the prediction of drug disposition in human body. This topic in the CADD explains the details about the drug disposition, active transporters and tools.
Special concerns in bioavaliblity and bioeqvivalencePradnya Shirude
you will get here special concerns about bioavailability and bioequivalance. it will also give regulations and criteria for bioavalablity and bioeuivalance
MEETING DISSOLUTION REQUIREMENTS PROBLEMS OF VARIABLE CONTROL IN DISSOLUTION ...MukeshKumarBhagat
The dissolution profile data from the pivotal clinical batches and primary (registration) stability batches should be used for the setting of the dissolution acceptance criteria of your product (ie, specification-sampling time point and specification value).
Computational modelling of drug disposition lalitajoshi9
computational modelling of drug disposition is the integral part of computer aided drug design. different kinds of tools being used in the prediction of drug disposition in human body. This topic in the CADD explains the details about the drug disposition, active transporters and tools.
Special concerns in bioavaliblity and bioeqvivalencePradnya Shirude
you will get here special concerns about bioavailability and bioequivalance. it will also give regulations and criteria for bioavalablity and bioeuivalance
An in vitro – in vivo correlation (IVIVC) is defined by the U.S Food and Drug Administration (FDA) as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
IN-VITRO-IN VIVO CORRELATION (IVIVC).pptxRAHUL PAL
An in vitro – in vivo correlation (IVIVC) is defined by the U.S Food and Drug Administration (FDA) as a predictive mathematical model describing the relationship between the in vitro property of an oral dosage form and relevant in vivo response.
Modeling and comparison of dissolution profiles - Review by Paulo Costa*, Jos...MAHENDRA PRATAP SWAIN
Over recent years, drug release / dissolution from solid pharmaceutical dosage forms has been the subject of intense and profitable scientific developments. Whenever a new solid dosage form is developed or produced, it is necessary to ensure that drug dissolution occurs in an appropriate manner. The pharmaceutical industry and the registration authorities do focus, nowadays, on drug dissolution studies. The quantitative analysis of the values obtained in dissolution / release tests is easier when mathematical formulas that express the dissolution results as a function of some of the dosage forms characteristics are used. In some cases, these mathematics models are derived from the theoretical analysis of the occurring process. In most of the cases the theoretical concept does not exist and some empirical equations have proved to be more appropriate. Drug dissolution from solid dosage forms has been described by kinetic models in which the dissolved amount of drug is a function of the test time. Some analytical definitions of function are commonly used, such as zero order, first order, Hixson–Crowell,Weibull, Higuchi, Baker–Lonsdale, Korsmeyer–Peppas and Hopfenberg models. Other release parameters, such as dissolution time, assay time, dissolution efficacy, difference factor (f1), similarity factor (f2) and Rescigno index can be used to characterize drug dissolution / release profiles.
Model dependent approach for drug release testing of controlled drug deliveryNehaFernandes2
A controlled drug delivery system is the one which delivers the drug at a predetermined rate, locally or systemically, for a specified period of time. Drug release is an important property of a therapeutic system, constituting a pre-requisite to absorption of the therapeutic agent and one that contributes to the rate and extent of active availability to the body. Hence while formulating such dosage forms one important factor that has to be taken into consideration is the release kinetics.
To provide particular, predetermined release profiles, it is necessary to know the exact mass transport mechanisms involved in drug release, and to predict quantitatively the resulting drug release kinetics. This is when the mathematical equations come into picture.
Mathematical equations describe the dependence of release in function of time. The use of this tool is very beneficial to predict the release kinetics before the release systems are comprehended. This analytical solution comprises of several models that have been used to design a number of simple and complex drug delivery systems and devices and to predict the overall release behavior. By achieving such a goal, the development process can be accelerated and innovative products can be introduced more rapidly than if such predictions are unavailable.
Application of a wide-range bioavailability model facilitates screening of potential drug candidates for controlled release, optimizing formulation design, and interpreting bioavailability data.
INTRODUCTION
DRUG DISSOLUTION PROCESS
DISSOLUTION PROFILES COMPARISON
DISSOLUTION MODELS/METHODS TO COMPARE DISSOLUTION PROFILE WITH PROPER CLASSIFICATION & EXPLANATIONS
CONCLUSION
It is a graphical represents in terms of (Concentration Vs Time) of complete release of API from a dosages form in a appropriate selected dissolution medium, i.e., in short it is the measure of the release of API form a dosage from with respect to time
Similar to Comparision of dissolution profile (20)
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
Follow us on: Pinterest
Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stockrebeccabio
Factory Supply Best Quality Pmk Oil CAS 28578–16–7 PMK Powder in Stock
Telegram: bmksupplier
signal: +85264872720
threema: TUD4A6YC
You can contact me on Telegram or Threema
Communicate promptly and reply
Free of customs clearance, Double Clearance 100% pass delivery to USA, Canada, Spain, Germany, Netherland, Poland, Italy, Sweden, UK, Czech Republic, Australia, Mexico, Russia, Ukraine, Kazakhstan.Door to door service
Hot Selling Organic intermediates
2. CONTENTS:
INTRODUCTION
IMPORTANCE OF DISSOLUTION PROFILE COMPARISON
OBJECTIVE OF DISSOLUTION PROFILE COMPARISON
METHODS USED TO COMPARE DISSOLUTION PROFILE
GRAPHICAL METHOD
STASTITICAL METHOD
MODEL DEPENDENT METHODS
MODEL INDEPENDENT METHODS
CONCLUSION
REFERENCES
2
3. Definition :
It is graphical representation [in terms of
concentration vs. time] of complete release of drug from a dosage form in an
appropriate selected dissolution medium.
i.e. in short it is the measure of the release of A.P.I from a dosage form
with respect to time.
3
4. Importance of dissolution profile Comparison :
Dissolution profile of an A.P.I. reflects its release pattern under the selected
condition sets. i.e. either sustained release or immediate release of the
formulated formulas.
For optimizing the dosage formula by comparing the dissolution profiles of
various formulas of the same A.P.I
FDA has placed more emphasis on dissolution profile comparison in the
field of post approval changes.
The most important application of the dissolution profile is that by knowing
the dissolution profile of particular product of the BRAND LEADER, we
can make appropriate necessary change in our formulation to achieve the
same profile of the BRAND LEADER.
4
5.
Objective of dissolution profile Comparison :
To Develop in-vitro in-vivo correlation which can help to reduce
costs, speed-up product development and reduce the need to perform
costly bioavailability human volunteer studies.
Establish the similarity of pharmaceutical dosage forms, for
which composition, manufacture site, scale of manufacture,
manufacture process and/or equipment may have changed within
defined limits.
5
6. METHODS TO COMPARE DISSOLUTION PROFILE
Graphical
method
Statistical
method
t- Test
Model independent method
(Pair Wise Procedure)
ANOVA
f1 and f2 comparison
Model dependent methods
Zero order
First order
Hixsoncrowell law
Higuchi
model
Korsemeyar and
peppas model
6
7. Graphical method:
In this method we plot graph of Time V/S concentration of solute
(drug) in the dissolution medium or biological fluid.
The shape of two curves is compared for comparison of dissolution
pattern and the concentration of drug at each point is compared for
extent of dissolution.
If two or more curves are overlapping then the dissolution profile is
comparable.
If difference is small then it is acceptable but higher differences
indicate that the dissolution profile is not comparable.
7
8. Statistical Analysis:
Calculated ‘t’ value is compared with tabulated value of ‘t’ if the
calculated value exceeds the tabulated value , then the null hypothesis
should be rejected and vice versa.
8
9. 2. ANOVA method (ANALYSIS OF VARIENCE)
This test is generally applied to different groups of data. Here we
compare the variance of different groups of data and predict whether
the data are comparable or not.
Minimum three sets of data are required. Here first we have to find the
variance within each individual group and then compare them with
each other.
9
10. ANOVA table.
Source of
variance
Between columns
Between rows
Within group/
error
Total
S2
df
M2
F value
No. of
columns-1
No. of rows -1
dfbetween
columns×
dfbetween rows
(No. of columns
×No. of rows)-1
Compare the calculated F- value with the tabulated value at particular degrees
of freedom and level of significance. If the calculated value is less than the
tabulated value, then degrees of variance is insignificant.
10
11. Model dependent methods:
Zero order kinetics:
Qt = Q0 + K0t
Where,
Qt is the amount of drug dissolved in time t
Q0 is the initial amount of drug in the solution
K0 is the zero order release constant expressed in units of concentration/time.
Plot: Cumulative amount of drug released versus time.
Applications: Transdermal systems, as well as matrix tablets with low
solubility drugs in coated forms, osmotic systems, etc.
11
12. Zero order Plot:
100
cumulative percent of drug released
90
80
70
60
50
TEST
R² = 0.959
REFERENCE
40
R² = 0.965
30
20
10
0
0
5
10
Time (h)
15
20
25
12
13. First order model:
log C = log C0 - Kt / 2.303
Where
C0 is the initial concentration of drug,
K is the first order rate constant, and
t is the time.
Plot: log cumulative percentage of drug remaining vs. time which would
yield a straight line with a slope of -K/2.303.
Application: This relationship can be used to describe the drug dissolution
in pharmaceutical dosage forms such as those containing water soluble drugs
in porous matrices.
13
18. Korsmeyer - Peppas model:
• The KORSEMEYER AND PEPPAS described this method..
It is given by the equation :
Mt/Ma = Ktn
where Mt / Ma is fraction of drug released
t = time
K=constant includes structural and geometrical characteristics
of the dosage form
n= release component which is indicative of drug release
mechanism
where , n is diffusion exponent.
If n= 1 , the release is zero order .
n = 0.5 the release is best described by the Fickian diffusion
0.5 < n < 1 then release is through anomalous diffusion or case
two diffusion. In this model a plot of percent drug release versus time
is linear.
18
19. Some models with linear equation for graphical presentation:
Model
Zero order
First order
Linear equation
Hixon crowell
Mt/Ma = Ktn
On Y-axis
Time
Cumulative
amount
of drug released
Time
log cumulative
percentage
of drug
cumulative
percentage
drug release
Time
log C = log C0 - Kt / 2.303
On X-axis
Square root of
Time
Qt = Q0 + K0t
Higuchi model
KorsmeyerPeppas model
Plot
cube root of
drug percentage
remaining
Log Time
log cumulative
percentage drug
release
19
20.
Model Independent Approach Using a Similarity Factor:
• The difference factor (f1 ) calculates the percent (%) difference
between the two curves at each time point and is a measurement of
the relative error between the two curves:
f1= {[Σ t=1n |R-T|] / [Σ t=1n R]} ×100
where n is the number of time points, R is the dissolution value of
the reference (prechange) batch at time t, and T is the dissolution value
of the test (postchange) batch at time t.
20
21. The similarity factor (f2 ) is a logarithmic reciprocal square root
transformation of the sum of squared error and is a measurement of the
similarity in the percent (%) dissolution between the two curves.
f2= 50×log {[1+ (1/n) Σ t=1n (R-T) 2]-0.5 ×100
Limits for similarity and difference factors
Difference
factorf1
0
Similarity
factor f2
100
Inference
Dissolution profiles are similar
Similarity or equivalence of
two
≤15
≥50
profiles.
21
22. Advantages:
(1) They are easy to compute
(2) They provide a single number to describe the comparison of
dissolution profile data.
Disadvantages
(1) The values of f1 and f2 are sensitive to the number of dissolution
time point used.
(2) If the test and reference formulation are inter changed , f2 is
unchanged but f1 Is not yet differences between the two mean profile
remain the same.
(3) The basis of the criteria for deciding the difference or similarity
between dissolution profile is unclear.
22
23. conclusion:
Graphical method is first step in comparing dissolution profile and it
is easy to implement but it is difficult to make definitive conclusions
from the it.
Various model dependent methods can be used to compare the
dissolution profile but selecting the model, interpretation of model
parameters and setting similarity limit is difficult.
f1 and f2 comparison is easy and this is most widely used method to
compare dissolution profiles. This is also recommended by FDA.
by using all the above given models we can compare dissolution
profiles of drugs.
23
24. References:
1. Hussain L,Ashwini D,Sirish D. Kinetic modeling and dissolution
profiles comparison: an overview.Int J Pharm Bio Sci 2013; 4(1): 728
- 737.
2. Thomas O’H, Adrian D, Jackie B and John D. A review of methods
used to compare dissolution profile data. PSTT 1998; 1(5): 214-223.
24
25. 3.
Jignesh A,Maulik P,Sachi P . Comparison of dissolution profile by
Model
independent
&
Model
dependent
methods.
http://pharmaquest.weebly.com/uploads/9/9/4/2/9942916/comparison_
of_dissolution_profile.pdf (accessed 15 November 2013).
4.
U.S. Department of Health and Human Services Food and Drug
Administration
Center
for
Drug
Evaluation
and
Research
(CDER). Guidance for Industry Dissolution Testing of Immediate
Release
Solid
Oral
Dosage
Forms.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory
Information/Guidances/ucm070237.pdf (accessed 15 November 2013).
25