Introduction to Concepts of Similarity and Difference factors,
Importance of dissolution profile comparison,
Objective of dissolution profile comparison,
Method to compare dissolution profile , f1 & f2 Comparison
Presented By
N. Poojitha
Department of Pharmaceutics
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
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.
Physics of Tablet compression is very useful during study of the tablet. It contains the mechanism of tablet compression. It also contains the process of tablet compression.
Introduction to Concepts of Similarity and Difference factors,
Importance of dissolution profile comparison,
Objective of dissolution profile comparison,
Method to compare dissolution profile , f1 & f2 Comparison
Presented By
N. Poojitha
Department of Pharmaceutics
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
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.
Physics of Tablet compression is very useful during study of the tablet. It contains the mechanism of tablet compression. It also contains the process of tablet compression.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
This presentation includes the detail information about the physics of tablet compression and compaction, Compression, Effect of friction, distribution of forces, compaction profiles,solubility.
Introduction to Higuchi plots for tablet dissolution
Dissolution, Dissolution Models, Higuchi Plot
Presented by
Mohamed Omar Mahmoud
Department of Pharmaceutics
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
This presentation includes the detail information about the physics of tablet compression and compaction, Compression, Effect of friction, distribution of forces, compaction profiles,solubility.
Introduction to Higuchi plots for tablet dissolution
Dissolution, Dissolution Models, Higuchi Plot
Presented by
Mohamed Omar Mahmoud
Department of Pharmaceutics
Dissolution is pharmaceutically defined as the rate of mass transfer from a solid
surface into the dissolution medium or solvent under standardized conditions of
liquid/solid interface, temperature and solvent composition.
OFFICIAL DISSOLUTION APPARATUS
USP 30 classification
1. Rotating Basket (Ph.Eur./BP/JP)
2. Paddle (Ph.Eur./BP/JP)
3. Reciprocating Cylinder (Ph.Eur.)
4. Flow Through Cell (Ph.Eur./BP/JP)
5. Paddle Over Disk (Ph.Eur.)
6. Rotating Cylinder (Ph.Eur.)
7. Reciprocating Holder
The role of dissolution in the demonstration of bioequivalenceinemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
BIOPHARMACEUTIC CONSIDERATIONS IN DRUG PRODUCT DESIGNN Anusha
BIOPHARMACEUTICS studies the in vitro impact of physicochemical properties of drugs and drug products on delivery to body under normal or pathologic conditions.
Biopharmaceutics links the physical and chemical properties of drug and drug product to their performance, in vivo.
The aim of biopharmaceutics is to adjust the delivery of drug from drug products in such a manner as to provide: optimal therapeutic activity and safety for the patient.
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
BCS Guideline for solubility and Dissolution.pptxImdad H. Mukeri
Briefly explanation of The Biopharmaceutics Classification System (BCS) of drug substance
and its solubility in the pH range of 1–7.5, absorption or intestinal membrane permeability
DRUG DISSOLUTION, BIO-AVAILABILITY AND IVIVC DEVELOPMENTRoshan Sonkar
Dissolution and drug release tests are in-vitro tests that measure the rate and extent of dissolution or release of the drug substance from a drug product, usually in an aqueous medium under specified conditions.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Biological screening of herbal drugs: Introduction and Need for
Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
Antifertility, Toxicity studies as per OECD guidelines
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
7. IN-VITRO
In-vitro test for the active ingredient to release from
the dosage form is based on:-
Disintegration of product
Dissolution of active ingredient
8. IN VITRO DISSOLUTION OF
DRUG PRODUCT IS BASED ON
FACTORS LIKE:-
1. Drug substance related factors
2. Factors related to formulation
3. Factors related to manufacturing process
4. Factors related to dissolution test apparatus
9. DRUG SUBSTANCE RELATED FACTORS
Dissolution refers to the process of solubilization of the drug into the
dissolution medium.
Dissolution process is controlled by the affinity between the solid and
the dissolution medium.
Noyes and Whitney in 1897 proposed a fundamental equation for
dissolution:-
dm/dt = K X (Cs - Ct)
dm/dt = rate of dissolution
k = proportionality constant or dissolution constant
Cs = concentration at saturation
Ct = concentration at time t
Factors are:-
Drug solubility
Polymorphism
Salt factor
Surface area and particle size
10. DRUG SOLUBILITY
The drug substance solubility of a drug is related to the
dissolution rate of drug.
Higher dissolution rates are given by drugs which have high
solubility.
The solubility of compounds containing “ionizable groups” is a
function of the pH of the dissolution media and pKa of the
compound.
Solubility of a drug is determined using an equilibrium solubility
method and involves suspending an excess amount of solid drug in
selected aqueous medium.
11. POLYMORPHISM OF DRUG
When a drug substance :-
existing in two or more crystalline phases that have different
arrangement/conformation of the molecule in the crystal lattice
having different hydrate forms
Having amorphous phases which do not possess a distinguishable
crystal lattice
Dissolution rates of drugs having various polymorphic form are
effected due to different lattice energies of the polymorphs which
have different solubility.
Crystalline form has less solubility than the amorphous form due to
fixed and compact lattice structure
Example :- Two polymorphic forms of Chloramphenicol palmitate
exist which are A and B, form B is better orally absorbed than form A
due to greater solubility.
12. Unionizable molecules are less water soluble as
compared to the organic salts which offers a criterion for
improving the rate of dissolution.
So,during the development of drug salts of
weak bases and weak acids are chosen .
Example :- The non-steroidal anti-inflammatory drug
‘Naproxen’ was originally marketed as a free acid for the
treatment of rheumatoid or osteo- arthritis.
13. FACTORS RELATED TO FORMULATION
Drug product dissolution is greatly affected by the excepients which are used in
the
formulation.
For dosage forms which are for immediate release, those excepients are are
used which help in enhancing the dissolution rate.
Disintegrants like sodium starch glycolate and croscarmellose facilitate the
deaggregation and promote the breakup of tablets into granules.
The disintegrants effect is to provide an increased surface area of the drug
particle and hence
promoting dissolution.
Surfactants can also be included to increase the dissolution rates e.g. sodium
lauryl sulphate.
14. Several manufacturing variables can affect the drug product
dissolution characteristics so here, manufacturing strategies may
be employed to enhance dissolution rates.
For example, spray drying of the active ingredient with excipients
such as polyvinyl pyrrolidine (PVP) can be used to generate
stabilized amorphous dispersions, which have greatly accelerated
dissolution rates.
Improved wetting of hydrophobic drug surfaces and enhanced
dissolution rates are sometimes achieved by employing wet
granulation vs. dry granulation processes, during product
manufacture.
15. DISSOLUTION TEST FACTORS
The dissolution test parameters such as:-
Apparatus type
Rotation speed
Dissolution medium pH
Volume
16. IN VITRO DRUG
PRODUCT
PERFORMANCE
EVALUATION
Disintegration test :-
It is a qualitative test.
An official disintegration apparatus, the USP basket rack assembly, is used to
perform the test, which is generally applicable only to immediate-release products.
When product dissolution is rapid (defined by ICH as dissolution NLT 80% in 15min
at pH 1.2, 4.0, and 6.8) and the dosage form contains drugs that are highly soluble
throughout the physiological range, disintegration testing may be meaningful.
The ICH Guidance considers a drug substance to be highly soluble when the
highest dose strength is soluble in 250mL or less of aqueous media over the pH
range of 1.2-6.8.
18. The test quantitatively measures the amount of active drug that dissolves from
the dosage form in a liquid dissolution medium using standard dissolution
apparatus and procedures.
Apparatus
Apparatus 1 (basket) and 2 (paddle), the apparatus most commonly used for
studying the dissolution of solid oral dosage form. The basket at 100 rpm is
commonly used for testing capsules, and the paddle at 50 rpm for tablets.
Media
The selection of a dissolution test medium is based on the physico-chemical
properties of the drug substance and characteristics of the dosage form.
Media with pH ranging from 1.2 (gastric pH) to 6.8(intestinal pH) are generally
preferred.
The most common media used in dissolution testing are water, 0.1N
hydrochloric acid, pH 4.5 acetate buffer, and pH 6.8 phosphate buffer.
The temperature of the dissolution bath is usually maintained at 37 0.5C to
reflect human body
temperature
19. .
Tolerance
The dissolution test acceptance criterion, or tolerance, is specified in terms
of the quantity (‘‘Q’’)
that is dissolved within a specified time interval.
for most oral dosage forms, 75% or 80% (‘‘Q’’) of the labelled amount of
the active drug ingredient is specified to be dissolved within a set time
duration (test times between 15 and 60min are most common).
21. APPLICATIONS OF IN VITRO
DISSOLUTION
Product Development
In vitro dissolution is an important and useful tool during
the development of a dosage form. In vitro dissolution often
aids in guiding the selection of prototype formulations and
for determining optimum levels of ingredients to achieve drug
release profiles.
Product Stability
In vitro dissolution is also used to assess drug product
quality with respect to stability and shelf life.
As products age, physicochemical changes to the dosage
form may alter the dissolution characteristics of the drug
product over time.
For example, as the moisture level increases or decreases over
time, this can result in altered tablet hardness and subsequent
possible changes in dissolution characteristics.