INTRODUCTION
FACTORS EFFECTING STABILITY
OBJECTIVE
TYPES OF STABILITY
TYPES OF STABILITY THAT MUST BE CONSIDERED FOR ANY DRUG
REGULATORY REQUIREMENTS
STABILITY STUDIES FOR PHARMACEUTICAL PRODUCTS
DEGRADATIVE PATHWAYS
Stability studies are performed in life sciences, chemical, and food and beverage industries to determine the effects of environmental conditions on product quality. Environmental conditions can impact product shelf life, and the viability of product formulation.
DEFINATION
The capacity of a drug or product to remain within established specifications of identity, quality, purity in a specific period of time.
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The capacity or the capability of a particular formulation in a specific container to remain with in particular chemical, microbiological, therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a product retains with in specified limits and throughout its period of storage and use (i.e. shelf life).
The primary factors effecting stability:
PH, Temperature, Moisture, humidity, light, Storage closure and containers Oxygen.
The major factors effecting drug stability are:
Particle size (suspension and emulsion), PH, additives and molecular binding and diffusion of drugs and excipients.
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.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
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.
Objectives of CGMP
Layout of buildings, services, equipments & maintenance
Production organization
material management
handling and transportation
inventory management &control
Production and planning control
Sales forcasting
Budget and cost control
Industrial and personnel relationship
Total quality management
ICH stands for “International Conference For Harmonization Of Technical Requirements For Pharmaceutical For Human Use” brings together the medicines regulatory authorities and pharmaceutical industry around the world.
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.
It is a graded seminar presentation of Mohammad Abuzar Shaikh Umer on the topic of quality by design (QbD) with case study on naproxen enteric coated pallets model for QbD study.by using plackette burman boxe behnken design and statistical analysis by using ANOVA.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
ICH stands for “International Conference For Harmonization Of Technical Requirements For Pharmaceutical For Human Use” brings together the medicines regulatory authorities and pharmaceutical industry around the world.
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light.
It is a graded seminar presentation of Mohammad Abuzar Shaikh Umer on the topic of quality by design (QbD) with case study on naproxen enteric coated pallets model for QbD study.by using plackette burman boxe behnken design and statistical analysis by using ANOVA.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
stability The ability of a pharmaceutical product to retain its chemical, physical, microbiological and biopharmaceutical properties within specified limits throughout its shelf-life.Why is stability of a drug important?
Drug stability affects the safety and efficacy of the drug product; degradation impurities may cause a loss of efficacy and generate possible adverse effects. Therefore, achieving the chemical and physical stability of drugs is essential to ensure their quality and safety.Common factors that affect this stability include temperature, light, pH, oxidation and enzymatic degradation. Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules.
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.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration. e ICH Q1A guideline and defines the
stability data package for a new drug substance or drug product that is sufficient for
a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to other areas of the world. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative
approaches can be used when there are scientifically justifiable reasons.
ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. It does not seek necessarily to cover the testing for registration in or export to other areas of the world. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative
approaches can be used when there are scientifically justifiable reasons.
2.Sagar Goda Biological classification system (BCS); its significance on diss...Sagar Goda
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Stability Testing.pptx ,M.PHARM,1ST year ,1st semesterManshiRana2
Stability testing of dosage forms is an important aspect of pharmaceutical development and manufacturing. It involves evaluating the physical, chemical, and microbiological attributes of a dosage form over a specific period of time under various storage conditions.
The purpose of stability testing is to ensure the efficacy, quality and safety of the drug throughout its shelf life.
.
SCOPE OF STABILITY TESTING Provide evidence as to how the quality of drug product varies with time.
Determine recommended storage conditions.
Establish shelf life for the drug product.
Establish quality of a drug product or substance .
Determine container and closure system suitability .
In vivo is the Latin word which means with in the living body.
When effects of various biological entities are tested on whole, living organism or cells, usually animals including humans and plants.
Animal testing and clinical trials are major elements of in-vivo research.
In vivo testing is often employed over in vitro because it is better suited for observing the overall effects of an experiment on a living subject in drug discovery.
example, verification of efficacy in vivo is crucial, because in vitro assays can sometimes yield misleading results with drug.
Harry Smith found that sterile filtrates of serum from animals infected with Bacillus anthracis were lethal for other animals, whereas extracts of culture fluid from the same organism grown in vitro were not.
In microbiology Once cells are disrupted and individual parts are tested or analyzed, this is known as in vitro.
In vitro studies within the glass, i.e., in a laboratory environment using test tubes, petri dishes, etc. Examples of investigations in vivo include: the pathogenesis of disease.
In vitro toxicology:-
The bridge exists between new drug discovery and drug development.-
Provide information on mechanism of action of a drug
Provides an early indication of the potential for some kinds of toxic effects, allowing a decision to terminate or to proceed further.
In vitro methods are widely used for:-
Screening and ranking chemicals
Get a platform for animal studies for physiological actions
Studying cell, tissue, or target specific effects
Improve subsequent study design
Advantages and Disadvantages:-
Faster than in vivo studies
Less expensive to run
Less predictive of toxicity in intact organisms
In vitro to in vivo extrapolation (IVIVE) refers to the qualitative or quantitative transposition of experimental results or observations made in vitro to predict phenomena in vivo, biological organisms.
The problem of transposing in vitro results is particularly acute in areas such as toxicology where animal experiments are being phased out and are increasingly being replaced by alternative tests.
Results obtained from in vitro experiments cannot often be directly applied to predict biological responses of organisms to chemical exposure in vivo.
Therefore, it is extremely important to build a consistent and reliable in vitro to in vivo extrapolation method.
Two solutions are now commonly accepted:
Increasing the complexity of in vitro systems where multiple cells can interact with each other in order recapitulate cell-cell interactions present in tissues (as in "human on chip" systems).
Using mathematical modeling to numerically simulate the behavior of a complex system, whereby in vitro data provides the parameter values for developing a model.
The two approaches can be applied simultaneously allowing in vitro systems to provide adequate data for the development of mathematical models. To comply with push for the development of alternative testing methods.
Immunomodulation is modulation (regulatory adjustment) of the immune system. It has natural and human-induced forms, and thus the word can refer to the following:
Homeostasis in the immune system, whereby the system self-regulates to adjust immune responses to adaptive rather than maladaptive levels (using regulatory T cells, cell signaling molecules, and so forth)
Immunomodulation as part of immunotherapy, in which immune responses are induced, amplified, attenuated, or prevented according to therapeutic goals
Immunosuppressants:-
Immunosuppressants stop your immune system from damaging healthy cells and tissues. People with organ transplants and stem cell transplants take these medicines to prevent transplant rejections. The drugs also treat autoimmune disease symptoms. Immunosuppressants are powerful drugs that require careful monitoring to avoid problems.
Introduction
Types of polymer
Classification of Polymer
Polymerization
Biodegradable Polymer
Application of biodegradable polymer
Natural polymer
They occur naturally and are found in plants and animals. For example, proteins, starch, cellulose, and rubber. To add up, we also have biodegradable polymers called biopolymers.
Semi-synthetic Polymers:
They are derived from naturally occurring polymers and undergo further chemical modification. For example, cellulose nitrate, and cellulose acetate.
Synthetic Polymers
These are man-made polymers. Plastic is the most common and widely used synthetic polymer. It is used in industries and various dairy products. For example, nylon-6, 6, polyether’s etc.
Thermosetting polymers These polymers greatly improve the material’s mechanical properties. It provides enhanced chemical and heat resistance. For example, phenolics, epoxies, and silicones. Addition Polymerization: For Example, poly ethane, Teflon, Polyvinyl chloride (PVC) Condensation Polymerization: Example, Nylon -6, 6, perylene, polyesters.
Medicines and Healthcare products Regulatory Agency(MHRA)TMU
What are regulatory bodies:- In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing. marketing and labeling of pharmaceutical products like:
USFDA(USA)
MHRA(UK)
TGA(Australia
AIMS:- Protecting public health through regulation, with acceptablebenefit-risk profiles for medicines and devices.
Promoting public health by helping people who use these productsto understand their benefits and risks.
Improving public health by encouraging and facilitating developments in products that will benefit people
GUIDELINES:- Guidelines for Manufacturers on Clinical Investigations to be carried out in the UK.
Inspected UK Contract GMP Quality Control Laboratories.
BLUE GUIDE: Advertising and Promotion of medicines in the UK.
ORANGE GUIDE: Rules and Guidelines for Pharmaceutical Manufacturers and Distributors.
Good Pharmacovigilance Practice Guide.
Guidelines on Process Validation
Guide to UK GLP Regulations 1999
Recommendations on the control and monitoring of storage and transportation temperatures of medicinal products.
Guide to defective medicinal products.
Introduction of a Risk Based Inspection Programme for GMP Labs.
SALIENT FEATURES, COMMITTEES/WORKING GROUPS:-
MHRA has the power to withdraw a product from market and suspend production of medicines.
A manufacturer or distributor can be prosecuted if the law has been broken.
Regulatory decisions are impartial D Different products are treated differently.
MHRA collaborates with :
US Food and Drug Administration
NPSA National Patient Safety Agency
NICE National Institute for Health and Clinical Excellence
INTRODUCTION
CLASSIFICATION: SEDATIVE AND HYPNOTICS
BARBITURATES
BENZODIAZEPINES
SITE OF ACTION
MECHANISM OF ACTION
NEWER NONBENZODIAZEPINES HYPNOTICS
PHARMACOKINETICS
SIDE EFFECTS
Mechanism of action
Benzodiazepines
Increase frequency of opening of cl- channels induced by GABA.
Increase binding of GABA to GABA® receptor.
Reduction of anxiety. Reduce anxiety by selectively enhancing GABAergic transmission in neurons having the α-2 subunit in their GABA® receptor.
The hypnotic effect are mediated by α1-GABA® receptor
Anticonvulsant effect is partially although not completely, mediated by α1-GABA® receptors.
REGULATORY REQUIRMENT FOR PRODUCT APPROVAL.pptxTMU
1.Introduction
2.API sourcing
3.API sourcing in other Countries
4.Regulatory filing
5.DMFs
6.Regulatory Guideline for API
7. Compression study of active pharmaceutical ingredients in different countries
8.Filling issue
WORKING PRINCIPLE AND APPLICATIONS OF GENOMIC AND PROTEOMIC TOOLS
DNA ELECTROPHORESIS
POLYMERASE CHAIN REACTION (PCR)
REVERSE TRANSCRIPTION PCR (RT-PCR)
MICROARRAY TECHINIQUE
ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
WESTERN BLOTTING
Health Education on prevention of hypertensionRadhika kulvi
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Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
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CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
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CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
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R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
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The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
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CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
Navigating Women's Health: Understanding Prenatal Care and Beyond
STABILITY STUDIES
1. STABILITY STUDIES
A
PRESENTATION
OF
MASTER OF PHARMACY
IN
PHARMACEUTICS 1ST SEM
COURSE CODE - MPH102T
COURSE NAME- MORDEN PHARMACEUTICS
DEPARTMENT OF PHARMACEUTICS
TEERTHANKER MAHAVEER COLLEGE OF PHARMACY
TEERTHANKER MAHAVEER UNIVERSITY
MORADABAD INDIA
SESSION: 2022-2023
SUBMITTED BY
PRAKHAR VARSHNEY
3. INTRODUCTION
Stability studies are performed in life sciences, chemical, and food and beverage
industries to determine the effects of environmental conditions on product quality.
Environmental conditions can impact product shelf life, and the viability of
product formulation.
DEFINATION
The capacity of a drug or product to remain within established specifications of
identity, quality, purity in a specific period of time.
4. COUNTINUED…….
OR
The capacity or the capability of a particular formulation in a specific
container to remain with in particular chemical, microbiological,
therapeutically, and toxicological specifications.
USP defines stability of pharmaceutical product as, "extent to which a
product retains with in specified limits and throughout its period of storage
and use (i.e. shelf life).
5. FACTORS EFFECTING DRUG STABILITY
The primary factors effecting stability:
PH, Temperature, Moisture, humidity, light, Storage closure and containers
Oxygen.
The major factors effecting drug stability are:
Particle size (suspension and emulsion), PH, additives and molecular binding
and diffusion of drugs and excipients.
6. OBJECTIVES
To determine maximum expiration date/ shelf life
.To provide better storage condition.
To determine the packaging components.
To gather information during Preformulation stage to produce a stable
product.
To establish transport condition.
To establish retest period of pharmaceuticals.
7. TYPE OF STABILITY
I
AM STABLE
THERAP
EUTICAL
STABLE
PHYSICA
L
STABILI
TY
TOXICO
LOGIC
STABILI
TY
MICROB
IOLOGI
CAL
STABILI
TY
CHEMIC
AL
STABILI
TY
8. TYPES OF STABILITY THAT MUST BE CONSIDERED FOR
ANY DRUG
CHEMICAL
Each active ingredient retains its chemical integrity and labeled potency within the specified limit.
PHYSICAL
The physical stability properties includes appearance, palatability, uniformity ,dissolution and
suspendability are retained.
MICROBIOLOGICAL
Sterility or resistance to microbial growth is retained according to specified requirement.
THERAPEUTIC
Therapeutic activity remains unchanged.
TOXICOLOGIC
No significant increase in toxicity occurs.
9. REGULATORY REQUIREMENTS
Stability study requirement and expiration dates are covered in the current
GMP, USP and FDA
GMP (Good Manufacturing Practice) states that there will be written
testing program design to access the stability characteristics of drug
products. And result of such stability testing will be used to determine
appropriate storage condition and expiration dates
10. ICH GUIDELINES FOR STYABILITY TESTING
The ICH has so far released six guidelines for stability studies as indicated in table:
ICH GUIDELINES TITLE
Q1A Stability testing of new drug substances and products (second revision)
Q1B Stability testing: photo stability testing of new drug substance and products.
Q1C Stability testing for new dosage forms
Q1D Bracketing and matrixing designs for stability testing of drug substances and
products
Q1E Evaluation of stability data
Q1F Stability data package for registration application in climatic zones III and IV
11. CLIMATIC ZONESAS
AS per ICH and WHO guidelines ,world has been divided into four zones:
ZONE 1-TEMPERATE
ZONE2-SUBTROPICAL WITH POSSIBLE HIGH HUMIDITY
ZONE 3-HOT, DRY
ZONE 4-HOT,HUMID
12. LONG TERM STABILITY STUDIES
According to WHO, long term stability testing during and beyond expected
shelf life under storage conditions in the intended market.
RECOMMENDED CONDITIONS FOR LONG TERM STABILITY
STORAGE CONDITIONS
TEMPERATURE (‘C) RELATIVE HUMIDITY % MINIMUM TIME
25’C +/- 60 +/- 5% 12 MONTHS
30’C +/- 30 +/- 5% 6 MONTHS
13. ACCELERATED STABILITY STUDIES:
In general the accelerated stability conditions must be at least 15'C above the actual
storage temperature and appropriate relative humidity. Substances and drugs
products intended to be stored in a refrigerator. the accelerated stability studies
should be carried out at 25+/-2'c and 60+/-5% relative
STORAGE CONDITIONS
TEMPERATURE (C) RELATIVE HUMIDITY% MINIMUM TIME
40'C +/- 2'C 75 +/-5% 6 MONTHS
14. DEGRADATIVE PATHWAYS OF
PHARMACEUTICAL DOSAGE FORMS
Degradation of active drug leads to lowering of quantity of the therapeutic
agent in the dosage form.
It may not be extensive, a toxic product formation may take place due to
decomposition instability of drug product can lead to a decrease in its
bioavailability.
Changes in physical appearance of given dosage form may take place.
Degradation may increase or may decrease the potency of drug.
Sometimes active drug may retain its potency, but excipients like -
antimicrobial, preservatives, solubilizers, emulsifying or suspending agent
may degrade, lead to compromising the integrity of drug product
15. EXAMPLE:
• Drugs like 5-fluorouracil, carbamazipine, digioxin and theophylline have
narrow therapeutic indices these needs to be carefully treated in patient so
that plasma levels are neither too high as to be toxic nor too low as to be
ineffective
• The antimicrobial chloroquine can produce toxic reactions that are
attribute to the photochemical degradation of the substance.
16. DEGRADATION MAY BE OF TWO TYPES
• PHYSICAL DEGRADATION:
The physical stability properties includes appearance, palatability,
uniformity, dissolution and suspend ability are retained. Maintained
throughout the shelf life of the drug.
IT INCLUDES FOLLOWING:
• Loss of water
• loss of volatile oil
• Water Absorbance
• Polymorphism
• Color change
18. REFERENCE
K.Wolters:"Rehmington The science and practice of pharmacy":21st edition volume-
2005:published in Philadelphia College of Pharmacy and science";page no-1025-1033.
J.S Ptrick;"Martin's Physical pharmacy and pharmaceutical sciences";5th edition; published
byWolters Kluver Health(India) Pvt. Ltd. New Delhi. Page no - 428-432.
L Lachman, K.Herbert A.: The Theory and Practice of Industrial Pharmacy: special Indian
edition 2009; CBS Publishers and Distributors Pvt Ltd Page no-772,777,849.
ICH Q1B: "Photostability Testing of New Drug Substances and Products".
ICH Q1C: Stability Testing of New Dosage Forms".
