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: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
(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 Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
(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 Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
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
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
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
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Animal Testing: Rationale for conducting studies, CPCSEA Guidelines
The use of animals in research is currently an essential component of the drug discovery process.
Animals help us advance our scientific understanding, serve as models to study disease, help us develop and test potential new medicines and therapies.
Animal testing has benefited researchers in understanding how to treat and prevent various conditions such as high blood pressure, diabetes, tuberculosis, polio, muscular dystrophy, and Parkinson's disease.
Education:
Undergraduate teaching to demonstrate effects of various drugs although this has been phased out in most institutes.
Postgraduate teaching to demonstrate the effects of various drugs, to determine the nature of an unknown drug for bioassay, screening methods and to learn skills e.g. administering drugs.
Research:
A larger number and a greater variety of animals are used in pure research than in applied research. This usually involves studies on embryogenesis, developmental biology, behaviour and breeding in Fruit flies, nematodes, mice and rats.
INTRODUCTION
The motto of Prevention of Cruelty to Animals (PCA) Act 1960 as amended in 1982 is to prevent infliction of unnecessary pain or suffering on animals.
The Central Government has constituted a Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), which is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them.
The goal of these guidelines is to promote the human care of animal used in biomedical and behavioural research and testing.
To avoid/minimize pain and suffering inflicted on experimental animals
Inspection of animal house facilities
It provides guidelines for -
Proper care, housing, breeding, maintenance, handling and use of experimental animals.
Source of experimental animals
Acceptable experimental procedures for anaesthesia and euthanasia.
Registration of establishments conducting animal experimentation or breeding of animals for this purpose.
Selection and assignment of nominees for the Institutional Animal Ethics Committees (IAEC) of the registered establishments.
Approval of Animal House Facilities on the basis of reports of inspections conducted by CPCSEA.
Permission for conducting experiments involving use of animals.
Recommendation for import of animals for use in experiments.
Action against establishments in case of established violation of any legal norm/stipulation.
Conduct of Training Programmes for the Nominees of CPCSEA.
Conduct/Support of Conference/Workshop on Animal Ethics.
To assure quality maintenance and safety of animals used in laboratory studies while conducting biomedical and behavioural research and testing of products.
Quarantine
2. Personal hygiene
3. Environment
4. Physical facility
5. Animal husbandry
6. Animal disposal
7. Documentation
Slide contains aspects of animal use in pharmacology laboratory.
Along with CPCSEA Guidelines (now CCSEA).
Laboratory animals experiment benefits as well as limitations.
Different animals used in laboratory.
Pharmaceutical Jurisprudence. Based on the PCI Syllabus. Ethics to be considered for handling the animals in experiments. Reference from Pharmaceutical Jurisprudence by B. M. Mithal.
Ethical issues related to animal biotechnologyKAUSHAL SAHU
Introduction
Why are genetically modified animals produced?
Examples of transgenic animals
Why are animals used instead of genetically modified microbes or plants?
Ethical issues
Religious concerns
Responsibility of Scientists
Need for Guidelines
Conclusion
References
• The Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) is a statutory Committee of Department of Animal Husbandry and Dairying (DAHD), Ministry of Fisheries, Animal Husbandry and Dairying (MoFAH&D) constituted under the Prevention of Cruelty to Animals (PCA) Act, 1960.
• CPCSEA is duty bound to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after performance of experiments on them.
INTRODUCTION
• For this purpose, the Committee formulated the Breeding of and Experiments on Animals (Control & Supervision) Rules, 1998 (amended in 2001 & 2006) to regulate the experimentation on animals.
• Under the provisions of the above rules, establishments who are engaged in Bio-medical research, breeding and trading of laboratory animals are required to get themselves registered with CPCSEA.
• There are 19 members in the present CPCSEA wherein Dr. O. P. Chaudhary, Joint Secretary (Animal Welfare) is the Chairman of CPCSEA and Dr. S. K. Dutta, Joint Commissioner (Animal Welfare) is the Member Secretary of CPCSEA.
Need of cpcsea
FUNCTIONS
Institutional Animals Ethics Committee (IAEC)
(a) Every experiment shall be performed by or under the supervision of a person duly qualified.
(b) That experiments are performed with due care and humanity and as far as possible experiments involving operations are performed under the influence of some anaesthetic of sufficient power to prevent the animals from feeling pain;
(c) That animals who, in the course of experiments under the influence of anaesthetics, are so injured that their recovery would involve serious suffering, are ordinarily medically allowed to death while still under influence of anaesthetic;
(d) That experiments on animals are avoided wherever it is possible to do so.
(e) That experiments on larger animals are avoided when it is possible to achieve the same results by experiments on small laboratory animals like guinea-pigs, rabbits, mice, rats etc;
(f) That, as far as possible, experiments are not performed merely for the purpose of acquiring manual skill;
(g) That animals intended for the performance of experiments are properly looked after before, during and after experiments;
(h) That suitable records are maintained with respect to experiments performed on animals
Members of iaec
• A. IAEC members from the establishment (05 members):
• i. One biological scientist
• ii. Two scientists from different biological disciplines
• iii. One veterinarian involved in the care of animal
• iv. One scientist in charge of animal facility of the establishment concerned
• B. Nominees from the CPCSEA:
• i. Main Nominee (01)
• ii. Link Nominee *
• iii. Scientist from outside the Institute (01)
• iv. Socially Aware Nominee (01)
Institutional Biosafety Committee (IBSC)
• Institutional Biosafety Committee (IBSC) is to be constituted in all centers engaged in genetic engineering researc
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 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.
Nucleic Acid Based Therapeutics Delivery.pdfRAHUL PAL
Nucleic acid-based therapeutics (NATs) are a promising new class of drugs that have the potential to treat a wide range of diseases, including cancer, genetic disorders, and infectious diseases. NATs work by directly targeting the genetic material of cells, either to alter gene expression or to repair damaged DNA or RNA.
However, delivering NATs to cells can be challenging. Nucleic acids are large and fragile molecules, and they can be easily degraded by enzymes in the body. Additionally, NATs need to be able to cross the cell membrane and enter the cytoplasm in order to function.
Nucleic acid-based therapeutics delivery is a rapidly evolving field, and new delivery systems are being developed all the time. As delivery systems improve, NATs are becoming more and more viable as treatments for a wide range of diseases.
Prof. Mahadeva Lal Schroff is regarded as India's founder of pharmacy. He attained this distinction as a result of his accomplishments, which included steering India's pharmaceutical sector and educational system in the proper direction.1
The history of pharmacy profession or practice in India starts with opening of chemist shop in 1811 by Scotch M Bathgate opened in Kolkata. This was probably the beginning of pharmacy practice in India.
The world's oldest known prescriptions were recorded on a clay tablet in Mesopotamia (modern-day Iraq), ca. 2400 BC. This Sumerian cuneiform document describes methods for making poultices, salves and washes.
Gas Chromatography in Analytical Analysis.pptxRAHUL PAL
Gas chromatography is a common type of chromatography used in analytical chemistry for separating and analyzing compounds that can be vaporized without decomposition. Typical uses of GC include testing the purity of a particular substance, or separating the different components of a mixture.
Monoclonal Antibody-Preparation & Application - MPH201T.pptxRAHUL PAL
Monoclonal antibodies (mAbs) are proteins produced by a single type of B cell. They are identical to each other and recognize a specific antigen. Antigens are molecules that the body's immune system recognizes as foreign. When an antigen binds to a monoclonal antibody, it triggers a series of reactions that can lead to the destruction of the antigen.
Monoclonal antibodies can be used to treat a variety of diseases, including cancer, autoimmune diseases, and infections. They are also used in research and diagnostics.
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.
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Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Laboratory animal facility.pptx
1. UNIT: IV
CPCSEA Guidelines for
Laboratory animal facility
Presented & Written By: *Rahul Pal, Prachi Pandey
M. Pharm (Pharmaceutics).
*Department of Pharmaceutics, NIMS Institute of Pharmacy, NIMS University, Jaipur,
Rajasthan, 303121, India.
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*RahulPal, Prachi Pandey
Master’sof Pharmacy(M. Pharm)
“Pharmaceutics”
2. “COVERED SYLLABUS”
“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.
3. INTRODUCTION
“CPCSEA” stands for, The Committee for the Purpose of Control
and Supervision of Experiments on Animals.
It was originally established in 1964, under the Prevention of
Cruelty to Animals (PCA) Act, 1960.
In 2022, the name of the committee was changed to the Committee
for Control and Supervision of Experiments on Animals (CCSEA).
Under the dedicated leadership of Ms. Maneka Gandhi.
4. GOALS
› The CPCSEA's primary goal is to promote the humane treatment of
animals used in research, education, and testing.
› Minimizing animal suffering.
› Ensuring scientific validity and quality.
› Fostering transparency and accountability.
› Building a collaborative environment.
5. VETERINARY CARE
Veterinary care plays a crucial role in upholding the CPCSEA's goal.
The committee emphasizes several key aspects of veterinary care:
› Qualified supervision.
› Preventive measures.
› Humane procedures: Pain management and Euthanasia.
› Recordkeeping.
› Collaboration with researchers.
Veterinary care is an integral part of the CPCSEA's framework for
ensuring animal welfare in research.
6. QUARANTINE
It involves the isolation of newly acquired animals from the existing
animal population for a specific period. This serves several important
purposes:
1. Disease prevention: Unknown pathogens.
2. Acclimatization and stabilization: New environments can be
stressful for animals, Stabilizes physiological and psychological
factors.
3. Minimizing cross-contamination.
By implementing quarantine protocols, the committee able to create a
responsible and sustainable environment for animal research.
7. SURVEILLANCE
Surveillance plays a pivotal role in the CPCSEA's mission to ensure
animal welfare and uphold ethical research practices. It involves the
systematic observation and monitoring of animals.
To identify any potential health problems, distress, or deviations
from expected behavior. The several key aspects of surveillance under
CPCSEA include:
› Daily observations.
› Environmental monitoring.
› Body weight and condition scoring.
› Behavioral observations.
› Recordkeeping and data analysis.
8. DIAGNOSIS
Diagnosis plays a crucial role in ensuring animal welfare and upholding ethical
research practices. It involves identifying the cause of an animal's illness or
distress.
The several aspects of diagnosis under CPCSEA include:
Clinical examination.
Diagnostic tests: Blood tests, imaging techniques like X-rays or ultrasound.
Differential diagnosis.
Consulting specialists.
Animal welfare considerations.
Documenting the diagnosis.
By promoting effective diagnostic practices, the CPCSEA strives to ensure that
animals used in research receive timely and accurate medical attention.
9. TREATMENT AND CONTROL OF
DISEASE
CPCSEA extends to the effective treatment and control of diseases
within animal facilities.
The various steps how CPCSEA guidelines address this crucial
aspect:
1. Proactive Disease Prevention.
2. Prompt Diagnosis and Treatment.
3. Hygiene and Sanitation.
4. Recordkeeping and Reporting.
5. Collaboration and Training: Veterinarians/researchers,
Training of animal caring staff.
10. CONT…
PROACTIVE DISEASE
PREVENTION
› Vaccination
› Parasite control
› Nutritional management
› Environmental enrichment
PROMPT DIAGNOSIS
AND TREATMENT
› Daily monitoring
› Qualified veterinary care
› Appropriate medication
› Pain management
› Isolation and quarantine
11. PERSONAL HYGIENE
Maintaining high standards of personal hygiene is an essential aspect of
animal welfare under the CPCSEA. This not only protects the animals
from potential infections but also ensures the validity of research data.
The various aspects for personal hygiene as followings:
› Clean clothing, footwear and Hand hygiene.
› Jewellery and accessories.
› Eating, drinking, smoking, hair and beard.
› Protective equipment, Training and awareness.
› Facilities and supplies.
The CPCSEA aims to foster a culture of personal hygiene within animal
research facilities.
12. LOCATION OF ANIMAL
FACILITIES TO LABORATORIES
The CPCSEA lays down specific guidelines for the location of animal
facilities relative to laboratories. This aims to minimize stress, noise,
and other disturbances for the animals while ensuring research integrity
and practicality. The various key requirements:
1) Physical Separation: Separate building, wing, floor, or room,
Distance from disturbance.
2) Dedicated Access: Separate pathways, entrances and controlled
access points.
3) Environmental Considerations: Natural light, ventilation,
Temperature, humidity control and noise reduction.
4) Additional Guidelines: Waste disposal, Security and emergency
preparedness.
13. ANESTHESIA
Anesthesia plays a crucial role in achieving goal by ensuring animals are
pain-free and unconscious during painful procedures or surgeries. The
CPCSEA lays down specific guidelines for the use of anesthesia in
animals:
› Justification and minimization.
› Qualified personnel.
› Pre-anesthetic assessment, Appropriate anesthetic agents and dosages.
› Pain management: An integral part of anesthesia.
› Monitoring and recordkeeping.
› Recovery and post-operative care.
› Training and education.
14. CONT…
Anesthesia is a controlled, temporary state of unconsciousness,
painlessness, and muscle relaxation induced in animals through
medication. The different types of anesthesia can be used in animals,
including:
a) General anesthesia: This induces complete unconsciousness and
muscle relaxation, often through inhaled gases or injectable
medications.
b) Local anesthesia: This numbs a specific area of the body, allowing
for procedures on that area while the animal remains conscious.
c) Regional anesthesia: This numbs a larger area of the body, such as
a limb, while the animal remains conscious or lightly sedated.
15. Species: Rodent (rat or mouse)
Procedure: Tissue collection
Agent: Ketamine/xylazine
combination (injectable)
Dosage: Ketamine 80-100
mg/kg, xylazine 5-10 mg/kg,
both given intraperitoneally
Species: Rabbit
Procedure: Dental cleaning
Agent: Propofol (injectable)
Dosage: 5-10 mg/kg
intravenous bolus, followed by
a maintenance infusion of 1-5
mg/kg/hr
Species: Cat
Procedure: Ovariohysterectomy
(spaying)
Agent: Ketamine (injectable) and
medetomidine (injectable)
Dosage: Ketamine 5-10 mg/kg,
medetomidine 0.05-0.1 mg/kg, both
given intramuscularly
Species: Horse
Procedure: Colic surgery
Agent: Sevoflurane (inhaled gas)
and epidural analgesia (local
anesthetic)
Dosage: Sevoflurane 1-3% in
oxygen, epidural bupivacaine 0.5-
1.0 ml/segment
Species: Dog
Procedure: Neutering
Agent: Isoflurane (inhaled gas)
Dosage: 1-3% isoflurane in
oxygen, adjusted based on
individual response
SPECIFIED
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16. EUTHANASIA
Euthanasia refers to the intentional act of ending an animal's life to relieve
suffering or prevent further pain.
Purpose: The euthanasia having several purposes as followings:
› Painless death.
› Relief from suffering.
› Population control.
Euthanasia is a sensitive and ethical decision.
Methods: Various methods can be employed for euthanasia. These are like:
Overdose of anesthetic agents, Cervical dislocation, Carbon dioxide (CO2)
inhalation and barbiturate injection or electrocution.
17. PHYSICAL FACILITIES
CPCSEA to ensure the animals' physical and mental well-being,
minimizing stress and promoting their health and comfort.
The various key aspects of physical facilities for animals under CPCSEA:
› Caging and housing.
› Environmental sanitation and hygiene.
› Food and water: Nutritious diet, Fresh water.
› Veterinary care.
› Recordkeeping.
Animal facilities can create a safe, comfortable, and stimulating
environment for animals used in research.
18. ENVIRONMENT
CPCSEA recognizes the importance of a stimulating and stress-free
environment for animals used in research.
The key aspects of environment for animals under CPCSEA:
1. Sensory stimulation.
2. Social interaction.
3. Choice and control.
4. Species-specific considerations.
5. Regular monitoring and evaluation.
These guidelines for environmental enrichment to promote the animals'
physical and mental well-being.
19. ANIMAL HUSBANDRY
Animal husbandry practices for animals used in research fall under the
strict guidelines of the CPCSEA. These guidelines aim to ensure ethical
treatment, good welfare, and minimal suffering for animals throughout
their involvement in research.
How animal husbandry practices are addressed under CPCSEA:
› Housing and environment: Species-specific, temp. Humidity and
Lighting cycles
› Food and water
› Hygiene and sanitation
› Veterinary care and record keeping.
20. RECORD KEEPING
The Committee for the Purpose of Control and Supervision of
Experiments on Animals (CPCSEA) places great emphasis on
meticulous record keeping throughout all stages of animal
research.
› Detailed records: Maintain detailed records of all animal care
procedures, including housing conditions, diet, veterinary
care, observations, and any abnormalities. This ensures proper
monitoring and animal well-being.
› Animal identification: Each animal should have proper
identification tags or other methods to track individual health and
well-being.
21. SOPs
CPCSEA emphasizes the importance of standardized procedures to ensure the
ethical treatment and welfare of animals in research. These SOPs cover various
aspects of animal care and use, from housing and husbandry to experimental
procedures and recordkeeping. The key areas where SOPs are crucial under
CPCSEA guidelines:
› Animal Acquisition and Housing
› Institutional Animal Ethics Committee (IAEC).
› Animal Housing and Husbandry.
› Animal Experimentation: For drugs, emergency protocols etc.
› Recordkeeping and Documentation.
SOPs are not static documents. They should be regularly reviewed, updated, and
adapted based on new scientific knowledge, changes in animal welfare best
practices, and evolving regulatory requirements.
22. CONT…
› SOPs stands for Standard Operating Procedures. These are
detailed, step-by-step instructions that outline how specific tasks
related to animal care and use should be carried out.
› They are essential for ensuring the consistent, ethical, and humane
treatment of animals throughout their involvement in research.
23. PERSONNELAND TRAINING
The CPCSEA recognizes the crucial role of qualified and well-trained personnel
in ensuring the ethical treatment and well-being of animals used in research.
These individuals are responsible for various aspects of animal care, from
husbandry and handling to experimental procedures and recordkeeping.
› Qualifications and experience: Animal care personnel, Researchers and
technicians and Veterinarians.
› Training requirements: Regular refresher training and Specialized Training.
› Training content and delivery.
Qualified and well-trained personnel are not just an expense but an investment in
ethical research and animal welfare.
24. TRANSPORT OF LAB ANIMALS
The transport of laboratory animals brings unique challenges and ethical
considerations. Ensuring their safety, comfort, and well-being during
transportation is crucial. CPCSEA outlines specific guidelines to ensure
responsible and humane practices in this process.
The various key aspects to consider for the transport of lab animals under
CPCSEA:
Planning and preparation.
Transportation containers and environment.
Animal handling and care.
Post-transport care.
Adherence to regulations.
Responsible transport of lab animals requires careful planning, adherence to
ethical principles, and prioritizing animal welfare throughout the process.
25. REFERECES
1. Committee for the Purpose of Control and Supervision on Experiments
on Animals. (2003). CPCSEA Guidelines for laboratory animal
facility. Indian J Pharmacol, 35(4), 257-274.
2. Mahesh, N. M. IMPACT OF ‘CPCSEA’GUIDELINES ON
LABORATORY ANIMALS USE.
3. Pereira, S., Veeraraghavan, P., Ghosh, S., & Gandhi, M. (2004). Animal
experimentation and ethics in India: the CPCSEA makes a
difference. Alternatives to laboratory animals, 32(1_suppl), 411-415.
4. Qadri, S. S., & Ramachandra, S. G. (2018). Laws, regulations, and
guidelines governing research animal care and use in India.
In Laboratory animals (pp. 237-261). Academic Press.