Accelerated stability studies are conducted to increase the rate of chemical degradation or physical change of a drug product by using exaggerated storage conditions. The Arrhenius equation describes the dependence of the reaction rate constant on temperature and can be used to extrapolate accelerated stability data to long-term storage conditions. Types of accelerated stability tests include those at elevated temperatures, high intensity light, high partial pressure of oxygen, and high relative humidity. However, accelerated stability testing has limitations when degradation is caused by factors other than temperature, such as microbial contamination or diffusion, or when a product loses physical integrity at higher temperatures. International guidelines provide recommendations for conducting stress tests and evaluating stability data.
Drug excipient incompatibilities are major concerns in formulation development.
Selection of the proper excipient during preformulation studies is of prime importance.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
Drug excipient incompatibilities are major concerns in formulation development.
Selection of the proper excipient during preformulation studies is of prime importance.
drug execipent compatibilty studies is of prime importance for the better formulation of the new drug and also for reducing cost by verfication of the data at the earlier atage.
this presentation will give the brief explanation of the goal, importance, dteps involve to studi the drug execient compatibility studies with different examples suitable accordiingly.
Superdisintegrants in Orally Administered Products of Pharmaceuticals A Reviewijtsrd
Superdisintegrants are developed to improve the palatability in orally administered products and to advancing the development of various formulations with increase performance and acceptability. Superdisintegrants are used to revise the potency of solid dosage form .This is accomplish by decreasing the disintegration time which in turn improvement the drug dissolution rate. Diverse categories of Superdisintegrants such as synthetic, semi synthetic, natural and cross processed blend etc. The present study comprises the various kinds of Superdisintegrants which are being used in formulations to provide the safer effective drug delivery with patient’s compliance. Snehal N. Dhoot | Sharda P. Shahane | Kiran. P. Gaikwad | Leena P. Joge | Jaya P. Ambhore "Superdisintegrants in Orally Administered Products of Pharmaceuticals: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50282.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50282/superdisintegrants-in-orally-administered-products-of-pharmaceuticals-a-review/snehal-n-dhoot
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
A co solvent system is one in which a water miscible or partially miscible organic solvent is mixed with water to form a modified aqueous solution. And the phenomenon called Cosolvency
cosolvents have some degree of hydrogen bond donating and or hydrogen bond accepting ability as well as small hydrocarbon regions.
The resulting solution will have physical properties that are intermediate to that of the pure organic solvent and water through the reduction of water–water interaction.
Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability testing is a routine procedure performed on drug substances and products and is employed at various stages of the product development.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
Presentation on-stability-study of pharmaceutical productMd Mohsin
this content takes important information about stability & stability study of pharmaceutical products including guidelines,climate zone,testing conditions,sampling plan,extension of shelf life,re test,current trends in stability study etc.
vendor validation is important now a days in pharmaceutical industries.
vendor is authorizes seller of raw material,equipment and packaging material to the pharmaceutical organization.
Superdisintegrants in Orally Administered Products of Pharmaceuticals A Reviewijtsrd
Superdisintegrants are developed to improve the palatability in orally administered products and to advancing the development of various formulations with increase performance and acceptability. Superdisintegrants are used to revise the potency of solid dosage form .This is accomplish by decreasing the disintegration time which in turn improvement the drug dissolution rate. Diverse categories of Superdisintegrants such as synthetic, semi synthetic, natural and cross processed blend etc. The present study comprises the various kinds of Superdisintegrants which are being used in formulations to provide the safer effective drug delivery with patient’s compliance. Snehal N. Dhoot | Sharda P. Shahane | Kiran. P. Gaikwad | Leena P. Joge | Jaya P. Ambhore "Superdisintegrants in Orally Administered Products of Pharmaceuticals: A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-4 , June 2022, URL: https://www.ijtsrd.com/papers/ijtsrd50282.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/50282/superdisintegrants-in-orally-administered-products-of-pharmaceuticals-a-review/snehal-n-dhoot
Dissolution, factors affecting drug dissolution, methods to evaluate dissolution, advantages and disadvantages, recent approaches--these are the topics covered in this presentation.
A co solvent system is one in which a water miscible or partially miscible organic solvent is mixed with water to form a modified aqueous solution. And the phenomenon called Cosolvency
cosolvents have some degree of hydrogen bond donating and or hydrogen bond accepting ability as well as small hydrocarbon regions.
The resulting solution will have physical properties that are intermediate to that of the pure organic solvent and water through the reduction of water–water interaction.
Stability studies ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as pre-requisite for the acceptance and approval of any pharmaceutical product. Stability testing is a routine procedure performed on drug substances and products and is employed at various stages of the product development.
Preformulation Studies: Introduction to preformulation, goals and objectives, study of
physicochemical characteristics of drug substances.
a. Physical properties: Physical form (crystal & amorphous), particle size, shape, flow
properties, solubility profile (pKa, pH, partition coefficient), polymorphism.
b. Chemical Properties: Hydrolysis, oxidation, reduction, racemisation, polymerization
BCS classification of drugs & its significant
Application of preformulation considerations in the development of solid, liquid oral and
parenteral dosage forms and its impact on stability of dosage forms.
Presentation on-stability-study of pharmaceutical productMd Mohsin
this content takes important information about stability & stability study of pharmaceutical products including guidelines,climate zone,testing conditions,sampling plan,extension of shelf life,re test,current trends in stability study etc.
vendor validation is important now a days in pharmaceutical industries.
vendor is authorizes seller of raw material,equipment and packaging material to the pharmaceutical organization.
The system to deliver the drug to the body to produced desired therapeutic action and activity against diseases and disorders is known as Drug delivery system
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.
Quality Safety Efficacy Multidisciplinary (Q S E M)
ICH Q1 Stability
Case toxicity of ethylene glycol and diethylene glycol in cough syrup.
accelerated stability studies
constant interval method
Stability testing protocol for herbal products in a detailed review.It’s the ability of formulation to retain its physical, chemical, microbiological and toxicological parameter same as that time of manufacture .
Drug product remains within specifications established to ensure its identity, strength, quality and purity.
Stability – Chemical and Physical integrity of herbal medicinal products.
Over a given time period and under the influence of environmental factors including temperature, humidity and light.
To provide evidence on how the quality of active substance varies with time and environmental factors
To establish re- test period for active substance
To establish shelf life of finished products.
To recommend storage conditions.
To evaluate the efficacy of drug.
To develop suitable packing information for drug product
To submit stability information for regulatory agencies.
1.Physical stability study:-
The original physical properties namely appearance, uniformity, palatability, dissolution, and suspend ability are maintained.
Chemical stability study:-
Each and every active ingredient retains its chemical integrity as well as potency specified on label, within the specified limits.
It involves drug assay and determination of drug degradation.
Stability testing of natural products.docxKipaPape
Stability is defined as the capacity of drug to remain within established specification limits to maintain its identity, strength, quality and purity throughout the retest or expiration dating period.
It is the ability of formulations to retain its physical, chemical, microbiological and toxicological parameters same that time of manufacturer.
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
A marketed product stability program fulfills registration
commitments and ensures that marketed product is
stable until expiry date stamped on product
label....
Stability studies should be planned on the
basis of pharmaceutical R&D and regulatory
requirements...
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural Assembly meetings on 23 October 2015 establishing ICH as an international association, a legal entity under Swiss law.
This step built upon a 25-year track record of successful delivery of harmonised guidelines for global pharmaceutical development as well as their regulation, and a longer standing recognition of the need to harmonise.The guidance stated in the ICH harmonized tripartite guideline entitled “Stability Testing of New Drug Substances and Products” (issued by ICH on October 27, 1993) applies in general to biotechnological/biological products.
This is a presentation by Dada Robert in a Your Skill Boost masterclass organised by the Excellence Foundation for South Sudan (EFSS) on Saturday, the 25th and Sunday, the 26th of May 2024.
He discussed the concept of quality improvement, emphasizing its applicability to various aspects of life, including personal, project, and program improvements. He defined quality as doing the right thing at the right time in the right way to achieve the best possible results and discussed the concept of the "gap" between what we know and what we do, and how this gap represents the areas we need to improve. He explained the scientific approach to quality improvement, which involves systematic performance analysis, testing and learning, and implementing change ideas. He also highlighted the importance of client focus and a team approach to quality improvement.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
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.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Create Map Views in the Odoo 17 ERPCeline George
The map views are useful for providing a geographical representation of data. They allow users to visualize and analyze the data in a more intuitive manner.
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!
Ethnobotany and Ethnopharmacology:
Ethnobotany in herbal drug evaluation,
Impact of Ethnobotany in traditional medicine,
New development in herbals,
Bio-prospecting tools for drug discovery,
Role of Ethnopharmacology in drug evaluation,
Reverse Pharmacology.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
1. ACCELERATED STABILITY STUDY
Presented by:
PRATIKKUMAR
SATISHKUMAR HUDEKAR
(M.Pharm SEM-I )
Department of Quality Assurance
SCHOOL OF PHARMACY S.R.T.M.U.
NANDED
1
3. INTRODUCTION
Stability:
Stability of pharmaceutical product may be defined as
the capability of a particular formulation in a specific
container/closure system to remain within its physical,
chemical, therapeutic and toxicological specification.
3
4. Need for stability testing:
1. Provide evidence as to how the quality of the drug
product varies with time.
2. Establish shelf life for the drug product.
3. Determine recommended storage conditions.
4. Determine container closure system suitability.
5. Safety point of view of patient.
6. Prevention of expenses.
7. Essential quality attribute.
8. To save time and money.
4
5. Types of Stability
Type Condition to be
maintained
1.Chemical : Chemical integrity &
lebelled potency
2.Physical: Appearance,
uniformality.
3.Microbiological Sterility
4.Therapeutic: Drug action remains
unchanged
5.Toxicological: No increase in toxicity
5
6. ACTIVATION ENERGY:
It is defined as the energy that must be overcome in order for a
chemical reaction to occur. Activation energy may also be defined as
the minimum energy required to start a chemical reaction.
The activation energy of a reaction is usually denoted by Ea
6
7. ARRHENIUS EQUATION :
Arrhenius equation gives "the dependence of the rate constant k
of chemical reaction on the temperature T and activation energy
Ea", as shown below:
Where k=specific rate constant
A=frequency factor
Ea= activation energy
R=ideal gas constant
T=absolute temperature
7
Take log on both sides,
ln k = ln A –Ea/RT ln e (2)
Converting eq. 2 to log 10
log k = log A – Ea/2.303RT
(1)
8. TYPES OF STABILITY TESTS:
Long term stability tests
Accelerated stability tests
Stress study
Accelerated stability studies:
Studies designed to increase the rate of chemical
degradation or physical change of an active substance or
drug product by using exaggerated storage conditions as
part of the formal, definitive storage programme.
8
9. Tests at elevated temperature:
Drug liquid preparation stored at 50, 60, 70,85,100 and
121˚c.
Also study performed at R.T. and or refrigerator temp.
Sampling:
First year- 3 month interval
Second year- 6 month interval
Four climatic zones:
Temperate zone 21˚c/45%RH
Mediterranean zone 25˚c/60%RH
Tropical zone 30˚c/70%RH
Desert zone 30˚c/35%RH
9
10. Tests at high intensity of light:
Drug substances darken on exposing to light, can be controlled by
using amber glass or opaque container.
By exposing drug substance to 100& 121(fc)4 & 2 weeks to light and
another sample examined protected from light .
Results found on appearance and chemical loss may be recorded.
Comparing color or using spectroscopy for examination.
e.g. cycloprofen becomes very yellow after five days exposing to light.
10
11. Tests at high partial pressure of oxygen:
Here, high oxygen tension plays important role to
investigate stability Usually ,40% of oxygen atmosphere
allows for rapid evaluation.
Results were correlated with inert & without inert
condition .
11
12. Tests at high relative humidity:
Presence of moisture may cause hydrolysis and oxidation.
These reactions may accelerated by exposing the drug to
different relative humidities.
Control humidity by Lab desiccators
Closed dessicator are placed in an oven to provide constant
temperature.
12
13. LIMITATIONS OF ACCELERATED STABILITY TESTING
Valid only when the break down depends on temperature.
The energy of activation obtained in the study should be
between 10 to 30 kcal/mole.
It is not useful when degradation is due to:
• Microbial contamination
• Diffusion
• Excessive agitation
When the product looses its physical integrity at higher
temperatures.
When the order changes at elevated temperatures.
13
14. ICH GUIDELINES ON STRESS TESTING:
Standard Title and reference
ICH Q1A(R2) Stability Testing of New Drug Substances and
Products (the parent guideline)
ICH Q1B Photostability Testing of New Drug
Substances and Products
ICH Q C Stability testing of new dosage forms
ICH D Bracketing and matrixing designs
ICH Q E Evaluation of stability data
ICH Q F Stability data package for registration
applications in climatic zone I and IV
14
15. REFERENCES
Martin’s Physical Pharmacy and Pharmaceutical Sciences.
Patrick J.Sinko ,
Theory and practice of Industrial Pharmacy – Lachman
International Stability Testing Drug stability- Cartensen
Textbook of Physical Pharmaceutics C V S Subrahmanyam
Vallabh Prakashan
15