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).
In this slide contains Quality-by-Design in Pharmaceutical Development.
Presented by: T. MOUSAMI BHAVASAR (Department of pharmaceutics). RIPER, anantapur
CLINICAL SIGNIFICANCE OF BIOEQUIVALENCE STUDIES, BIOEQUIVALENCE, REASONS TO PERFORM BIOEQUIVALENCE STUDIES , NEED FOR BIOEQUIVALENCE STUDIES, IMPORTANCE OF BIOEQUIVALANCE STUDIES, DETERMINATION OF BIOEQUIVALENCE OF A DRUG PRODUCT, CLINICAL SIGNIFICANCE.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Statistical modeling in pharmaceutical research and developmentPV. Viji
Statistical modeling in pharmaceutical research and development , Statistical Modeling , Descriptive Versus Mechanistic Modeling , Statistical Parameters Estimation , Confidence Regions , Non Linearity at the Optimum , Sensitivity Analysis , Optimal Design , Population Modeling
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
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
Dissolution is a process in which a solid substance solubilizes in a given solvent.
Method for dissolution are-
1. Beaker methods
2. Open flow through compartment system
3.Dialysis concept
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).
In this slide contains Quality-by-Design in Pharmaceutical Development.
Presented by: T. MOUSAMI BHAVASAR (Department of pharmaceutics). RIPER, anantapur
CLINICAL SIGNIFICANCE OF BIOEQUIVALENCE STUDIES, BIOEQUIVALENCE, REASONS TO PERFORM BIOEQUIVALENCE STUDIES , NEED FOR BIOEQUIVALENCE STUDIES, IMPORTANCE OF BIOEQUIVALANCE STUDIES, DETERMINATION OF BIOEQUIVALENCE OF A DRUG PRODUCT, CLINICAL SIGNIFICANCE.
Dissolution : Official and Non official methods, Alternative methods of dissolution testing and transport models, Drug release testing, Invitro drug release testing
Statistical modeling in pharmaceutical research and developmentPV. Viji
Statistical modeling in pharmaceutical research and development , Statistical Modeling , Descriptive Versus Mechanistic Modeling , Statistical Parameters Estimation , Confidence Regions , Non Linearity at the Optimum , Sensitivity Analysis , Optimal Design , Population Modeling
DISSOLUTION
Dissolution is a process in which solid substance solubilizes in a given solvent
DISSOLUTION TESTING
A dissolution test uses an apparatus with specific test conditions in combination with acceptance criteria to evaluate the performance of the product. In-vitro test must predict the in-vivo behaviour
Factors in design of dissolution tests:
Factors relating to dissolution apparatus
Factors relation to dissolution fluid
Process parameters
Need of Dissolution Testing:
Development and optimisation of dosage forms
Batch to batch drug release uniformity
Quality, safety, efficacy and stability of the product
IVIV Correlation
Bioequivalence
Assessing pre and post approval changes
DISSOLUTION APPARATUS
Dissolution apparatus evolved to prepare a sample under controlled conditions thereby making the test repeatable.
Principle types of dissolution apparatus-
Close-compartment apparatus
Open-compartment apparatus
Dialysis systems
Ideal features of Dissolution Apparatus:
The fabrication, dimensions, and positioning of all components must be precisely specified and reproducible
Simple in design, easy to operate and useable
Sensitive
Nearly perfect sink conditions
Provide an easy means of introducing the dosage form into the dissolution medium
Provide minimum mechanical abrasion
Easy withdrawal of samples
Elimination of evaporation of solvent medium
DISSOLUTION METHODS
The Standard Dissolution Methods Database has been prepared by the Division of Bioequivalence, Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA).
Official methods:
Rotating Basket
Rotating Paddle
Reciprocating Cylinder
Flow-Through Cell
Paddle Over Disc
Rotating Cylinder
Reciprocating Disc
Non-official methods:
Static Disc Method
Beaker Method
Flask Stirrer Method
Peristalsis Method
Rotating Bottle Method
Dialysis Method
Diffusion Cell Method
Dissolution Apparatus Types and their Applications
Problems associated with dissolution apparatus
USP Performance Verification Test (PVT):
The USP Performance Verification Test (PVT) assesses the suitable performance of apparatus used in dissolution testing.
Responsible for detecting problems associated with the dissolution apparatus that are found to be within mechanical tolerances.
REFERENCES
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
Dissolution is a process in which a solid substance solubilizes in a given solvent.
Method for dissolution are-
1. Beaker methods
2. Open flow through compartment system
3.Dialysis concept
Bioavailability & Bioequivalence ppt, Objectives, Improving bioavailability, Assessment of bioavailability, Urinary excretion studies, Blood serum studies, in vitro drug dissolution testing, need for dissolution testing, in vitro drug dissolution testing models, Bioequivalence, Therapeutic equivalence, Types of bioequivalence studies, Pharmacokinetic studies, Methods to enhance dissolution rate.
Dissolution apparatus, invivo-invitro corelation, factor affecting,BCS classification ..
Complete dissolution topic in this slide & easy way to write..
Cheak it now and give feedback
The objective of in vitro dissolution testing is to evaluate the variables that effect the rate and extent of release of a drug substance from the finished dosage form, and in turn, the in vivo performance of the drug product.
Software Used In Formulation Design Process- Minor Project [Bachelor].pdfRAHUL PAL
In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosome An Non-Ionic Surfactant Vesicles.pptxRAHUL PAL
Niosomes are novel drug delivery systems that have garnered significant interest in the pharmaceutical field. They are essentially vesicles composed of non-ionic surfactants and cholesterol, forming a bilayer structure similar to liposomes. However, unlike liposomes, which are composed of phospholipids, niosomes are formed by self-assembly of non-ionic surfactants in aqueous media. This unique composition offers several advantages such as improved drug solubility, stability, and biocompatibility.
The introduction of niosomes as drug carriers has revolutionized the field of drug delivery due to their ability to encapsulate both hydrophilic and hydrophobic drugs. This versatility allows for targeted and controlled release of therapeutics, enhancing their efficacy while minimizing side effects.
Moreover, the surface of niosomes can be modified to achieve specific targeting of drugs to desired sites within the body, thus enhancing therapeutic outcomes and reducing systemic toxicity.
Overall, niosomes hold great promise in the pharmaceutical industry and continue to be a subject of intense research for their potential applications in various fields including cancer therapy, gene delivery, and vaccine development.
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); The Curre...RAHUL PAL
Targeted drug delivery systems are employed to administer pharmaceutical medication,
facilitating the precise delivery of drugs to specific diseased areas. Several drug delivery
systems utilise carriers such as antibodies, transdermal patches, biodegradable polymers,
nanoparticles (NPs), liposomes, niosomes, and microspheres. Niosomes, on the other hand,
represent a promising and innovative category of vesicular systems. Niosomes are vesicles
formed by hydrating a combination of nonionic surfactants and cholesterol. These non-ionic
surfactant vesicles serve as carriers for both amphiphilic and lipophilic drugs. In the drug
delivery system using niosomes, the medication is enclosed within a vesicle. Niosomes in
tuberculosis (TB) possess biodegradable and biocompatible properties, are non-immunogenic,
and demonstrate versatility in their structural composition. It’s a serious and potentially deadly
infectious disease caused by a bacteria called Mycobacterium tuberculosis. In the recent
update, WHO still estimates 9.9 million new TB cases in 2022 at the latest. Involvement of
niosomes improves the treatment of TB with much more advanced technology and an advanced
drug nanocarrier with better treatment. The main highlights of this review paper are to
summarise the structure, compositions, preparation methods, and ICH stability guidelines for
the formulation of niosomes and their applications in TB with their several stages of treatment
by niosomal formulations.
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECT...RAHUL PAL
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Design of Experiments (DoE) manipulation in the formulation and optimization ...RAHUL PAL
Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of
India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in
India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also
monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is
responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States
(US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as
a food additive. The FDA has set limits on the amount of catechu that can be added to food
Objective: The primary objective of this research was to involvement of design of experiments (DoE)
manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried
extract of Senegalia catechu enhanced through statistical analysis.
Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical
herbarium garden. Subsequently, it underwent a drying process and was ground into a powder.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...RAHUL PAL
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Determination of Partition coefficient of Known and Unknown drug.pdfRAHUL PAL
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination (Pharmaceutics Practical).pptxRAHUL PAL
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)RAHUL PAL
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Utilization of Response Surface Methodology (RSM) In the Optimization of ...RAHUL PAL
The objective of the current studies to enhance the formulation of DS-loaded liposomes through the utilization of Response surface methodology (RSM) and involving the computation approach for their validation.
Investigational outcome represents the perceived responses were in related with the desired values and this represents the relationship of the RSM for optimization of % DR and % EE in DS loaded liposomal preparations.
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
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.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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
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.
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.
CLASS 11 CBSE B.St Project AIDS TO TRADE - INSURANCE
In-Vitro Dissolution and Alternative Methods Involving in Drug Release.pptx
1. IN VITRO DISSOLUTION
AND DRUG RELEASE TESTING
Submitted By: Prachi Pandey, Rahul Pal Submitted To: Dr. Tejpal Yadav
M. Pharm (Pharmaceutics), IInd Sem.
Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University Jaipur, Rajasthan
In-vitro dissolution testing is a very powerful tool to
easily and effectively obtain information about the
performance of drug products.
2. DEFINITION
• Dissolution is a process in which a solid substance solubilizes in a given solvent (mass
transfer from the solid surface to the liquid phase.)
• Dissolution testing measures the extent and rate of solution formation from a dosage form,
such as tablet, capsule, ointment, etc.
• The dissolution of a drug is important for its bioavailability and therapeutic effectiveness
3. NON SINK METHODS
For poorly water-soluble drugs, pharmaceutical scientists are increasingly applying in vitro dissolution
testing under non-sink conditions for a direct evaluation of their ability to generate and maintain
supersaturation as a predictive surrogate for ensuring product quality and in vivo performance.
NATURAL CONVECTION NON SINK METHODS:
a) Klein solvmeter method
b) Nelson hanging pellet method
c) Levy static disk method
ALTERNATIVE METHOD OF DISSOLUTION
4. FORCED CONVECTION NON SINK METHODS:
Tumbling method
Levy or Beaker method
Rotating disk method
Particle size method
USP Rotating basket apparatus
USP Paddle apparatu
NON-SINK METHODS
5. SINK METHOD
Sink condition is the ability of the dissolution media to dissolve at least 3 times the amount of drug that
is in your dosage form. Having sink conditions helps your dissolution have more robustness as well as
being more biologically relevant.
FORCED CONVECTION SINK DEVICES:
Wurster pollis adsorption method
Partition method
Dialysis methods
Rotating disk apparatus
SINK METHOD
6. SINK METHOD
CONTINOUS FLOW/FLOW THROUGH METHODS:
Pernarowski method
Langenbucher method
Baun and Walker
Tingstad and Reigelman
Modified column apparatus
Takenaka method
7. NON-SINK METHOD - KLEIN SOLVMETER
METHOD
KLEIN SOLVMETER METHOD
• Carrier device surrounded by flat and is immersed in
dissolution medium
• When dosage form is placed in the boat the bar moves and
as dosage form dissolves it moves upwards
• Amount of dosage form dissolved is revealed from the
difference in height of bar movemen
Figure (a) Klein solvmeter Method
8. NELSON HANGING PELLET METHOD
• Aluminum strip having provision for holding dosage form
which is in turn connected perfectly maintained balance arm
of strip
• Dosage form is mounted on aluminium strip with help of
wax .This method can be employed to know Intrinsic
dissolution rate.
• To prevent disintegration further high pressures can be
applied and also constant surface
NELSON HANGING PELLET METHOD
Figure (b) Nelson Hanging Pellet Method
9. LEVY STATIC DISK METHOD
LEVY STATIC DISK METHOD
• Acrylic holder containing dosage form is inserted into a
known volume of medium through rubber stopper
• The vial is inverted and placed in incubator at 37 C.
• At specific time intervals the vial is removed from incubator
and samples are analysed
• Disadvantages:- effect of conc. On dissolution medium is
ignored and the surface area of dosage form while dissolving
is assumed constant which is not impractical.
Figure (c) Levy Static Disk Method
10. SINK METHOD- WURSTER- POLLI ADSORPTION
METHOD
WURSTER- POLLI ADSORPTION METHOD
• In this method the dissolved drug is adsorbed by charcoal
or bentonite, care should be taken regarding the
adsorbent, adsorbent should not alter the viscorsity of the
medium.
Figure (d) Wurster- Polli
adsorption method
11. PARTITION METHOD
• In this device organic phase is employed to remove the
dissolved drug such that the drug would partition
between the lipophilic and hydrophilic phases.
selection of organic phase plays a critical role
PARTITION METHOD
Figure (c) Partition Method
12. ROTATING FLASK APPARATUS
• In this method a flask containing dissolution
medium is rotated around its horizontal axis in
a water bath kept at a temperature of 37 C.
• The flask has a provision of sampling such that
aliquots can be withdrawn and the fresh
medium can be replaced back.
• This apparatus is best suited for oral solid
dosage forms like tablets and capsules since
they do not require much agitation.
ROTATING FLASK APPARATUS
Figure (c) Receprocating cylinder type
13. FLOW THROUGH DEVICES
FLOW THROUGH DEVICES
• For the drugs which saturate rapidly in large volumes
of medium, USP apparatus will not serve the purpose.
• For this the suitable device is flow through device. In
this device unlimited quantity of fresh dissolution is
available.
• A dosage form is placed in a small cell and is subjected
to a stream of fresh dissolution media.
Figure (d) Flow through cell Method
14. PERNAROWSKI
PERNAROWSKI
• It consists of 10 mesh stainless steel basket stirrer assembly
with an adjustable stirrer.
• The chamber is 3 necked flask of 33 mm and the rest two of
20 mm diameter.
• 1 L of medium is employed within the flask.
• The dissolution characteristics are dependent upon the
amount of medium pumped through the dissolution
chamber.
15. LANGENBUCHER COLUMN TYPE
LANGENBUCHER COLUMN TYPE
• This device is according to the dissolution basic design.
• The screen is constructed such that the medium flows equally through the
entire cross section in a laminar pattern.
• This is again closed by a secondary screen, filter which prevents the
undissolved drug from being eluted.
16. TINGSTAD AND RIEGELMAN
TINGSTAD AND RIEGELMAN
• A cylindrical glass cell of 6.1 cm long and 1.9 cm in diameter
constructed with two glass filter funnels is used.
• The dissolution cell has filter membranes which prevents the
solid particles from being analyzed.
• There are also external valves to control the excess flow of
solvent into the system. the air trap averts air bubbles.
• The complete assembly is immersed in a temperature bath kept
at 37°C Figure (e) Tingstad and riegelman
17. MODIFIED COLUMN APPARATUS
Figure (f) Modified Column Apparatus
MODIFIED COLUMN APPARATUS
• The device consists of filter of 14 M -size made of
nylon.
• The tubing from the pump is connected to the
dissolution cell.
• The Teflon faced stainless steel supports the screen
resting on the bottom half of the filter holder.
• The direction of the flow is such that the particles
do not fall through the screen. the rest of the process
is the same.
18. TAKENAKA
TAKENAKA
• The release of drug is measured with the aid of in
vitro simulator device consisting of flow type
dissolution container.
• The dosage form is placed in the basket rotating at
94 rpm with 300 ml of medium.
• then the medium is removed by collecting
reservior using peristaltic pump.
• aliquots are withdrawn using syringe and then
filtered using Whatman filter paper and the same
volume is replaced immediately with fresh
medium.
Figure (g) Takenaka
19. IN VITRO DISSOLUTION AND DRUG
RELEASE STUDY INVOLVES
IN VITRO DISSOLUTION AND DRUG RELEASE STUDY INVOLVES
Preparation of solutions for calibration curve
Stock solution
Sample solution
Buffer solution
Determination of absorption maxima
Preparation of calibration curve
Dissolution study
Dissolution procedure was carried out.
Plot a graph between Time intervals on x-axis vs % of drug release on y-axis.
Find out the slope, concentration, amount of drug release, percentage of drug release and report it.
21. DRUG RELEASE TESTING
Drug release is the process by which a drug leaves a drug product
Drug release:
• Immediate release (IR)
• Sustained Release (SR)
• Sustained Action (SA)
• Extended Release (ER)
• Long Acting (LA)
• Prolong Action (PA)
• Controlled Release (CR)
• Timed Release (TR)
22. Immediate release drug products allow drugs to dissolve with no intention of delaying or prolonging
dissolution or absorption of the drug
Prolonged-release dosage forms Prolonged-release dosage forms are modified-release dosage forms
showing a slower release of the active substance(s) than that of a conventional-release dosage form
administered by the same route.
• Delayed release is defined as the release of a drug at a time other than immediately following
administration.
• Enteric Coated: Intended to delay the release of the drug (or drugs) until the dosage form has passed
through the stomach. Enteric-coated products are delayed-release dosage forms.
DRUG RELEASE
23. • Controlled release includes extended-release and pulsatile-release products
• Extended-release products are formulated to make the drug available over an extended period after
administration.
• Pulsatile release involves the release of finite amounts (or pulses) of drug at distinct time intervals that
are programmed into the drug product.
• Repeat action products contain two single doses of medication; one for immediate release; another one
for modified release
DRUG RELEASE
24. Targeted release drug release directed toward isolating or concentrating a drug in a body region, tissue
or site of absorption or for drug action Drug release and dissolution
Modified-release dosage forms include both delayed and extended-release drug productsModified-
release dosage forms are preparations where the rate and/or place of release of the active substance(s) is
different from that of a conventional- release dosage form administered by the same route.
DRUG RELEASE
25.
26. IN VITRO DRUG RELEASE TESTING
ROTATING BASKET METHOD:
• In vitro release study was carried out by the rotating basket method.
• Six tablets of each batch were taken and placed in rotating basket, respectively.
• Then the rotating basket was introduced into 900 mL of each dissolution medium (water, 0.1 M HCI
and pH 6.8 phosphate buffer) at 37°C ± 0.5°C with a rotation speed of 100 rpm.
• 5 mL of sample solution was collected a different time intervals (2, 4, 6, 8, 10, 12 h) and filtered
through a 0.45 um hydrophilic membrane.
IN VITRO DRUG RELEASE TESTING
27. • 1.0 mL of subsequent filtrate was taken accurately to add into a 100 mL volumetric flask and diluted
with the corresponding dissolution medium to 100 mL and mixed well.
• The amount of drug dissolved in the dissolution medium was measured using an UV-visible
spectrophotometer at 233 nm.
• The same volume of fresh dissolution medium at the same temperature was added to replace the
amount withdrawn after each sampling.
• The drug amount of cumulative release was calculated with a standard curve.
IN VITRO DRUG RELEASE TESTING
Editor's Notes
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