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.
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: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
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.
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: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
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.
(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_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)Prachi Pandey
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.
The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:
Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.
Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.
Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.
Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.
Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.
Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.
Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.
Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.
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
(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_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)Prachi Pandey
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.
The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:
Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.
Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.
Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.
Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.
Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.
Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.
Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.
Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.
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
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
Niosome An Non-Ionic Surfactant Vesicles.pptxPrachi Pandey
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.
Niosomes (Formulation and evaluation).pptxPrachi Pandey
Niosomes are a novel drug delivery system that encapsulates the medication in a vesicular system made up of non ionic surfactants.
The vesicle is made up of a bilayer of non-ionic surfactants, thus the name niosomes.
Niosomes are extremely small and microscopic (on a nanometric scale).
Despite having a similar structure to liposomes, they have several advantages over them.
Niosomes are biocompatible, nonimmunogenic, and biodegradable in nature and exhibit flexibility in their structured characterization
Based on the vesicle size, niosomes can be divided into three groups.
Small unilamellar vesicles (SUV, size=0.025-0.05 μm),
Multilamellar vesicles (MLV, size=>0.05 μm), and
Large unilamellar vesicles (LUV, size=>0.10 μm).
In the formulation of niosomes, the selection of surfactants is based on hydrophilic-lipophilic balance (HLB) value. HLB values between 4 and 8 recommended for the facile formation of niosomes and surfactants with an HLB value of more than 8 are required to optimize cholesterol concentration.
However, it has been widely observed that HLB value between 4 and 8 is highly recommended for better encapsulation efficiency, of niosomes. For example, long stearyl and short lauryl chain length increase and decrease the entrapment efficiency of niosomes, respectively.
Long hydrophilic chains result in increased encapsulation of hydrophilic drugs, and long hydrophobic chains result in improved encapsulation of lipophilic drugs.
Long Hydrophilic Chains and Increased Encapsulation of Hydrophilic Drugs:
Surfactants with longer hydrophilic chains create larger aqueous compartments within the niosome bilayer. This provides more space for water-soluble drugs to reside, leading to higher encapsulation efficiency.
Example: Span 60 (HLB 4.7) has a longer hydrophilic chain compared to Span 20 (HLB 8.6). Studies have shown that using Span 60 in niosomes resulted in significantly higher encapsulation efficiency of the hydrophilic drug gentamicin, compared to formulations using Span 20.
Long Hydrophobic Chains and Improved Encapsulation of Lipophilic Drugs:
Long hydrophobic chains increase the affinity of the niosome bilayer for lipid-soluble drugs. These drugs can partition and entrap themselves within the bilayer structure, leading to improved encapsulation.
Example: Tween 80 (HLB 15) has a longer hydrophobic chain compared to Tween 20 (HLB 16.7). Niosomes prepared with Tween 80 demonstrated superior encapsulation of the lipophilic drug curcumin compared to those made with Tween 20.
Pegylation is a process where polyethylene glycol (PEG), a biocompatible and hydrophilic polymer, is attached to the surface of niosomes. This modification offers several advantages for drug delivery:
Benefits of Pegylation:
Increased Stability: PEG creates a steric barrier, preventing proteins and other molecules in the blood from adhering to the niosome surface. This reduces aggregation and opsonization (recognition by immune cells).
Non-ionic surfactant vesicles, commonly referred to as niosomes, have garnered significant attention within the pharmaceutical industry due to their remarkable capacity to encapsulate both hydrophilic and hydrophobic drugs. Recent studies have demonstrated the potential of these vesicles to enhance the bioavailability of drugs, making them a promising strategy for delivering various therapeutic agents such as gene materials, protein therapeutics, and chemical pharmaceuticals. This approach offers minimal toxicity and desirable targeting effectiveness. Niosomes are substantially more stable during the preparation and storage procedure than liposomes. The desired pharmacokinetics property can be attained through the optimization of constituents or surface modifications. This novel method of distribution is also facile to establish and expand, while maintaining cost-effective manufacturing expenses. This review article elucidates the fundamentals of niosomes as non-ionic surfactant vesicles, including their structure and components, as well as various formulation methods. Additionally, the article explores the diverse applications of niosomal in the analgesics.
The Application of Response Surface Methodology (RSM) In the Computational Op...Prachi Pandey
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 Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...Prachi Pandey
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.pdfPrachi Pandey
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.
Pharmaceutical Suspension Dosage Form (PPT)Prachi Pandey
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.
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 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).
THE CURRENT STATUS IN MUCOSALDRUG DELIVERY SYSTEM (MDDS)AND FUTURE PROSPECTUS...Prachi Pandey
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.
Operations management is an area of management concerned with designing and controlling the process of production and redesigning business operations in the production of goods or services.
The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General at CDSCO. Drug and Cosmetic Act 1945: It Contains provisions for classification of drugs under given schedules. Guidelines for the storage,sale,display and prescription of each schedule.
Microspheres are small spherical particles, with diameter 1 µm to 1000 µm.
They are spherical free flowing particles consisting of proteins or synthetic polymers which are biodegradable in nature.
PROTEINS: Proteins are the large organic compounds made of amino acids arranged in a linear chain and joined together by peptide bonds.
Protein > 50 amino acids
PEPTIDES: These are short polymers formed from the linking, in a defined order of amino acids.
Peptide < 50 amino acids
Three-dimensional (3-D) printing is elevating various growth in production viewpoint both at nanoscale and macro-scales. 3-D printing is being scouted for numerous bio-pharmaceutical administration and creation of nano-medicines employing supplementary production methods and shows assurance in capability in satisfying the demands for a patient-based customized approach. The previous outcome features the accessibility of novel natural bio-materials and finely designed polymeric substances, which can be created as unique 3-D printed nano-materials for numerous bio-pharmaceutical administrations as nano-medicines. Nano-medicine is described as the utilization of nanoscience in fabricating nano-materials for various pharmaceutical utilization, comprising identification, cure, scan, stopping, and management of diseases. Nano-medicine has also displayed a huge effect in the creation and evolve an accurate drug. In contrary the "one-size-fits-all" benchmark for the traditional drug is a personalized, structured, or accurate drug considering the variation in numerous characteristics, comprising genetics and pharmacokinetics of various victims, which have exhibited better outcomes over traditional cures. This article highlights the approaches advancements in the design and development of customized-made nano-medicine employing 3-D printing science.
TOTAL QUALITY MANAGEMENT, BUDGET & COST CONTROL.pptxPrachi Pandey
Definition: TQM has been defined as an integrated organization effort designed to improve quality at every level.
“ The process to produce a perfect product by a series of measures require an organized effort by the entire company to prevent or eliminate errors at every stage in production is called Total Quality Management (TQM).”
The Aim of TQM is “Prevention of defect rather than detection on defect.”
TQM is very important for pharmaceutical industries to produce the better product and ensure the maximum safety of health care system and also protect waste of money for both government and individual customer.
The word pharmacy is derived from the Greek word “Pharmakon”, meaning medicine or drug. In other term, “Pharmacy may defined as the art and science of preparing (manufacturing) and dispensing of drugs prepared by the natural and synthetic sources and using for the treatment as well as prevention of diseases”. In general sense, it is the place where medicine or drugs are sold. Pharmacy is a health profession that links health science with chemical science and aims to ensure the safe and effective use of pharmaceutical drugs. It includes the collection, identification, synthesis, purification, isolation and quality control of medical substance or pharmaceutical products.
The most important figures in the history of medical research is Louis
Pasteur. Pasteur was is known as medical microbiologist. A French
chemist and microbiologist who made significant contributions to the
understanding of infectious diseases. In the 1860s, Pasteur showed that
germs caused disease and that they could be killed by heat.
This discovery led to the development of pasteurization, a process of
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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.