This document defines vaccines as preparations made from weakened or killed pathogens that induce antibody formation and immunity. It describes three main types of vaccines: killed, live attenuated, and toxoids. The preparation, quality control, storage, and examples of common vaccines are outlined. Genetic engineering allows large-scale production of pathogen-derived polypeptides as subunit vaccines with advantages over traditional methods. Quality is ensured through testing for sterility, toxicity, and maximum levels of preservatives. Vaccines must be stored between 2-8°C and below -20°C if freeze-dried.
This document provides information on immunological products including definitions of key terms like antigen, antibody, and immunity. It discusses active and passive immunity and how vaccines and sera provide them. Vaccines contain live attenuated, killed, or inactivated microorganisms or toxins to induce immunity. Sera contain pre-formed antibodies obtained from immunized animals. The document describes various bacterial, viral, toxoid, and live attenuated vaccines and their methods of preparation and storage conditions. Overall, the document serves as an overview of immunological products like vaccines and sera, how they provide immunity, and basic information about their production and handling.
This document discusses the importance of maintaining a cold chain for vaccine storage and transportation. It outlines how vaccines must be kept within specific temperature ranges to maintain potency from the manufacturer to the point of use. Several types of cold storage equipment are described, including walk-in cold rooms, deep freezers, and ice-lined refrigerators. Proper vaccine handling and storage is essential to ensure vaccines are effective and public health programs maintain public confidence.
Vaccination failures in poultry can be caused by many factors beyond just vaccine quality. The bird's immune system, including maternal antibodies and stress, influence the effectiveness of vaccination. Proper handling, storage, and administration of vaccines according to the vaccination program are also critical. Other issues like disease challenges, poor management, and immunosuppression can reduce vaccine protection. To prevent failures, it is important to maintain the cold chain, vaccinate only healthy birds, and implement good hygiene and biosecurity practices.
Book reference: Essentials of Medical Pharmacology by K. D. Tripathi
Images and Charts: Google Search Results
Presentation for teaching in a 2nd Year MBBS class
This document provides an overview of vaccines, including their history, types, and uses. It discusses how Edward Jenner developed the smallpox vaccine in 1796 and how Louis Pasteur later developed vaccines for chicken cholera and anthrax in the 1880s. The document outlines seven main types of vaccines: live attenuated, inactivated, subunit, toxoid, conjugate, DNA, and recombinant vector vaccines. It also discusses saponins' potential as vaccine adjuvants and research efforts to develop vaccines, such as for HIV.
1. Vaccines contain weakened or killed pathogens that stimulate the immune system to develop antibodies against diseases.
2. There are several types of vaccines including live attenuated, inactivated, toxoid, subunit and recombinant.
3. Diphtheria toxoid is prepared from toxins produced by Corynebacterium diphtheriae. The toxins are treated with formalin to remove toxicity while retaining antigenicity.
This document defines vaccines as preparations made from weakened or killed pathogens that induce antibody formation and immunity. It describes three main types of vaccines: killed, live attenuated, and toxoids. The preparation, quality control, storage, and examples of common vaccines are outlined. Genetic engineering allows large-scale production of pathogen-derived polypeptides as subunit vaccines with advantages over traditional methods. Quality is ensured through testing for sterility, toxicity, and maximum levels of preservatives. Vaccines must be stored between 2-8°C and below -20°C if freeze-dried.
This document provides information on immunological products including definitions of key terms like antigen, antibody, and immunity. It discusses active and passive immunity and how vaccines and sera provide them. Vaccines contain live attenuated, killed, or inactivated microorganisms or toxins to induce immunity. Sera contain pre-formed antibodies obtained from immunized animals. The document describes various bacterial, viral, toxoid, and live attenuated vaccines and their methods of preparation and storage conditions. Overall, the document serves as an overview of immunological products like vaccines and sera, how they provide immunity, and basic information about their production and handling.
This document discusses the importance of maintaining a cold chain for vaccine storage and transportation. It outlines how vaccines must be kept within specific temperature ranges to maintain potency from the manufacturer to the point of use. Several types of cold storage equipment are described, including walk-in cold rooms, deep freezers, and ice-lined refrigerators. Proper vaccine handling and storage is essential to ensure vaccines are effective and public health programs maintain public confidence.
Vaccination failures in poultry can be caused by many factors beyond just vaccine quality. The bird's immune system, including maternal antibodies and stress, influence the effectiveness of vaccination. Proper handling, storage, and administration of vaccines according to the vaccination program are also critical. Other issues like disease challenges, poor management, and immunosuppression can reduce vaccine protection. To prevent failures, it is important to maintain the cold chain, vaccinate only healthy birds, and implement good hygiene and biosecurity practices.
Book reference: Essentials of Medical Pharmacology by K. D. Tripathi
Images and Charts: Google Search Results
Presentation for teaching in a 2nd Year MBBS class
This document provides an overview of vaccines, including their history, types, and uses. It discusses how Edward Jenner developed the smallpox vaccine in 1796 and how Louis Pasteur later developed vaccines for chicken cholera and anthrax in the 1880s. The document outlines seven main types of vaccines: live attenuated, inactivated, subunit, toxoid, conjugate, DNA, and recombinant vector vaccines. It also discusses saponins' potential as vaccine adjuvants and research efforts to develop vaccines, such as for HIV.
1. Vaccines contain weakened or killed pathogens that stimulate the immune system to develop antibodies against diseases.
2. There are several types of vaccines including live attenuated, inactivated, toxoid, subunit and recombinant.
3. Diphtheria toxoid is prepared from toxins produced by Corynebacterium diphtheriae. The toxins are treated with formalin to remove toxicity while retaining antigenicity.
This document provides information on basic immunization and immunization in special situations. It discusses different types of immunity, immunizing agents like vaccines, immunoglobulins, and antisera. It describes various types of vaccines including live, attenuated, inactivated, toxoids, and recombinant vaccines. It also discusses vaccination schedules, potential adverse reactions to vaccination, maintaining the cold chain, and precautions that should be taken with vaccination. Finally, it covers special considerations for vaccination in situations like immunocompromised individuals, preterm infants, hepatitis B-positive mothers, and adult females.
This document provides an overview of vaccines including what they are, how they work, different types of vaccines, and methods for producing vaccines. It defines a vaccine as a biological preparation that improves immunity to disease. The main types of vaccines discussed are killed/inactivated, attenuated/live, toxoids, subunit, peptide, conjugate, DNA, and recombinant vector vaccines. General methods for vaccine production include generating the antigen, isolating and purifying the antigen, adding other components like adjuvants, and packaging the final vaccine product.
This document discusses various types of vaccines including live attenuated vaccines and killed vaccines. It provides a brief history of vaccines such as the smallpox vaccine from 1798 and polio vaccine from 1955. Live attenuated vaccines provide longer lasting immunity but carry a small risk of latency, while killed vaccines provide shorter immunity but no risk of latency. The document also outlines the vaccination schedule in India and provides details on specific vaccines including BCG, oral polio, hepatitis B, typhoid, cholera, and rabies.
This document discusses different types of vaccines and factors that can lead to vaccine failure. It describes several types of vaccines including live attenuated, inactivated/killed, toxoid, subunit, recombinant subunit, recombinant vector, DNA, and transitional vaccines. It compares advantages and disadvantages of different vaccine types. The document also lists numerous potential causes of vaccine failure, such as use of expired vaccines, improper storage, genetic resistance, health status of individuals receiving the vaccine, immunosuppression, mycotoxins, stress, genetics, administration errors, water quality, and presence of maternal antibodies or variants in the field.
1. The cold chain refers to the system used to transport and store vaccines at temperatures between 2-8°C from manufacture to point of use to maintain potency. Proper cold chain storage using equipment like walk-in cold rooms, deep freezers, and ice-lined refrigerators is important for vaccine effectiveness and compliance with regulations.
2. Vaccines are biological products that lose potency over time if not stored at proper temperatures. Maintaining the cold chain ensures vaccines provide maximum benefit and protects scarce health resources by preventing wastage from temperature excursions.
3. The immunization schedule approved by the Indian Academy of Pediatrics outlines the vaccines recommended to accelerate control of vaccine-preventable diseases and
There are several types of bacterial vaccines that work through different mechanisms of the immune system. Active immunization stimulates the body's own immune response by introducing an antigen from the bacteria. This induces long-term immunity through memory B and T cells. Passive immunization provides immediate, short-term protection by transferring pre-formed antibodies. Common bacterial vaccines include those targeting Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, diphtheria, tetanus, pertussis, Lyme disease, anthrax, tuberculosis, and typhoid fever. These vaccines contain inactivated toxins, purified proteins, capsular polysaccharides, or live attenuated bacterial strains.
The document discusses various vaccines that are part of national immunization schedules. It describes the different types of vaccines including live attenuated, killed/inactivated, toxoid, conjugate and subunit vaccines. It provides details about vaccines for diseases like BCG, polio, diphtheria, pertussis, tetanus, measles, mumps, rubella, Hib, hepatitis B, typhoid, varicella, rotavirus and pneumococcus. It discusses the appropriate ages, doses, routes of administration, storage requirements and schedules for these vaccines. It also provides guidance on vaccination of high-risk groups and management of infants born to hepatitis B positive mothers.
The document discusses India's immunization program, which began in 1978. It outlines key terms like immunity, immunization, vaccines, and herd immunity. It describes the national immunization schedule and strategies to reduce morbidity and mortality from vaccine-preventable diseases through vaccination. It also discusses monitoring systems and highlights the importance of maintaining the cold chain to ensure vaccine quality as the program aims to universally protect children from prevalent diseases.
The document discusses fish vaccination, including its importance for sustainable aquaculture, types of vaccines, and mechanisms of action. Vaccination provides an alternative to antibiotics for combating bacterial and viral diseases. Major types include whole organism vaccines using killed or attenuated pathogens, as well as purified subunit and recombinant vaccines. Development of new fish vaccines takes 5-8 years and involves disease characterization, laboratory testing, field trials, and licensing. Current commercially available vaccines protect against diseases such as furunculosis, vibriosis, and spring viraemia of carp.
Vaccines work by exposing the immune system to agents that resemble disease-causing pathogens, stimulating the body's immune response without causing illness. The document traces the history of vaccine development from Edward Jenner's smallpox vaccine in 1796 to current types including whole-organism, purified components, recombinant, DNA, and multivalent subunit vaccines. The long and complex process of developing a new vaccine can take 10-15 years and involves identifying the pathogen, developing animal models, conducting safety and efficacy trials, and addressing challenges like antigenic variation.
This document provides an introduction to vaccines, including their principles, types, and examples. The main types discussed are inactivated/killed vaccines, live attenuated vaccines, toxoids, subunit vaccines, DNA vaccines, and recombinant live vaccines. Inactivated vaccines use killed disease-causing microbes, and stimulate a weak immune response but require boosters. Live attenuated vaccines use weakened live organisms to stimulate excellent lifelong immunity but rarely carry risk of disease if attenuation fails. Toxoids are made from inactivated toxins and cannot cause disease but may require adjuvants or boosters. DNA vaccines work by directly introducing genetic material that codes for antigens. They allow for rapid, low-cost production and generate therapeutic potential for chronic infections.
Toxoid vaccines are vaccines that are made from the toxins (harmful chemicals) from bacteria. There are some bacteria that cause disease through releasing a protein called a toxin. Scientists can inactivate these toxins in the lab using a chemical called formalin (a solution of formaldehyde) and sterilized water, which are completely safe to use in small quantities in the human body. Once the toxin is inactivated, it’s called a toxoid, and it can no longer cause harm. The body learns how to fight off the bacteria’s natural toxin once exposed to the toxoid through producing antibodies that bind into the toxin like keys into a lock
A vaccine is a biological agent that provides active acquired immunity to a particular disease. A vaccine usually contains an agent that resembles a disease-causing microorganism. It is often made from killed or weakened forms of the microbe, its toxins or one of its surface proteins. Body's immune system is stimulated to recognize the agent as a threat and destroy it, and any of these microorganisms that it later encounters.
Cold Chain The ‘cold chain’ is the system of transporting and storing vaccines at recommended temperature from the point of manufacture to the point of use. Manufacturer Distributor Vaccine Depots Provider office Client.
This document discusses viral hepatitis, focusing on hepatitis A, B, C, D, and E. It provides details on the definition, causes, epidemiology, transmission, signs and symptoms, diagnosis, treatment and prevention of each type of viral hepatitis. Key points include that hepatitis A, B, C, D and E viruses are the main causes of viral hepatitis in humans. They differ in their transmission routes, clinical presentations, risk of chronic infection and availability of treatment. Vaccination is an effective way to prevent hepatitis A and B infection.
Hypersensitivity reactions for Medical StudentsNCRIMS, Meerut
Hypersensitivity (animated) for MBBS Students
Hypersensitivity refers to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system.
Hypersensitivity reactions require a pre-sensitized state of the host.
Four types of hypersensitivity
Type I – anaphylactic
Type II – cytotoxic
Type III – immune complex mediated
Type IV – contact, tuberculin and granulomatous
Anaphylaxis is defined as a life-threatening allergic reaction set in action by a wide range of antigens and involving multiple organ systems.
The true incidence is difficult to estimate, but in 1973 the Boston Collaborative Drug Surveillance Program reported six anaphylactic reactions and 0.87 deaths from anaphylaxis per 10,000 patients.
Reactions to insect stings alone are responsible for at least 50 deaths in the United States each year.
These figures reveal the importance of continued research into the biology of anaphylaxis along with developing new (and improving existing) therapies.
This document presents information about vaccines. It begins with a brief introduction defining a vaccine as a biological preparation that provides immunity against a disease. The history section then discusses how Edward Jenner developed the smallpox vaccine in 1796 and how Louis Pasteur later developed vaccines for chicken cholera and anthrax in the 1880s. The document goes on to describe the main types of vaccines as live attenuated, killed/inactivated, toxoid, subunit, conjugate, DNA, and recombinant vector vaccines. It also provides examples of diseases each vaccine type is used for and discusses their advantages and disadvantages.
Vaccines are immunobiological substances designed to induce immunity against specific diseases. They work by exposing the immune system to antigens from pathogens in order to stimulate the body's own protective response through antibody and memory cell production. There are several types of vaccines including live-attenuated, killed/inactivated, toxoids, subunit, conjugate, DNA, and recombinant vector vaccines. Vaccines protect individuals and communities by training the immune system to recognize and combat pathogens, helping to prevent epidemics and eliminate diseases in a safe and cost-effective manner.
Vaccines are biological preparations that improve immunity to particular diseases. They contain agents that resemble disease-causing pathogens in order to stimulate the body's immune system. There are several types of vaccines including killed/inactivated, attenuated/live, toxoids, subunit, peptide, conjugate, DNA, and recombinant vector vaccines. Vaccines are produced through a multi-step process involving generation of the antigen, isolation, purification, addition of components, and packaging. Common side effects are mild but vaccines effectively boost immunity with a low risk of side effects.
This document discusses immunization and vaccination. It begins by defining immunization as a process that protects individuals from disease by introducing live, killed, or attenuated organisms to create immunity. The document then covers various topics related to immunization including the significance of immunization, types of immunity (active and passive), immunizing agents (vaccines, immunoglobulins, antisera), national immunization schedules, contraindications to vaccinations, and reactions to vaccines.
This document provides information on basic immunization and immunization in special situations. It discusses different types of immunity, immunizing agents like vaccines, immunoglobulins, and antisera. It describes various types of vaccines including live, attenuated, inactivated, toxoids, and recombinant vaccines. It also discusses vaccination schedules, potential adverse reactions to vaccination, maintaining the cold chain, and precautions that should be taken with vaccination. Finally, it covers special considerations for vaccination in situations like immunocompromised individuals, preterm infants, hepatitis B-positive mothers, and adult females.
This document provides an overview of vaccines including what they are, how they work, different types of vaccines, and methods for producing vaccines. It defines a vaccine as a biological preparation that improves immunity to disease. The main types of vaccines discussed are killed/inactivated, attenuated/live, toxoids, subunit, peptide, conjugate, DNA, and recombinant vector vaccines. General methods for vaccine production include generating the antigen, isolating and purifying the antigen, adding other components like adjuvants, and packaging the final vaccine product.
This document discusses various types of vaccines including live attenuated vaccines and killed vaccines. It provides a brief history of vaccines such as the smallpox vaccine from 1798 and polio vaccine from 1955. Live attenuated vaccines provide longer lasting immunity but carry a small risk of latency, while killed vaccines provide shorter immunity but no risk of latency. The document also outlines the vaccination schedule in India and provides details on specific vaccines including BCG, oral polio, hepatitis B, typhoid, cholera, and rabies.
This document discusses different types of vaccines and factors that can lead to vaccine failure. It describes several types of vaccines including live attenuated, inactivated/killed, toxoid, subunit, recombinant subunit, recombinant vector, DNA, and transitional vaccines. It compares advantages and disadvantages of different vaccine types. The document also lists numerous potential causes of vaccine failure, such as use of expired vaccines, improper storage, genetic resistance, health status of individuals receiving the vaccine, immunosuppression, mycotoxins, stress, genetics, administration errors, water quality, and presence of maternal antibodies or variants in the field.
1. The cold chain refers to the system used to transport and store vaccines at temperatures between 2-8°C from manufacture to point of use to maintain potency. Proper cold chain storage using equipment like walk-in cold rooms, deep freezers, and ice-lined refrigerators is important for vaccine effectiveness and compliance with regulations.
2. Vaccines are biological products that lose potency over time if not stored at proper temperatures. Maintaining the cold chain ensures vaccines provide maximum benefit and protects scarce health resources by preventing wastage from temperature excursions.
3. The immunization schedule approved by the Indian Academy of Pediatrics outlines the vaccines recommended to accelerate control of vaccine-preventable diseases and
There are several types of bacterial vaccines that work through different mechanisms of the immune system. Active immunization stimulates the body's own immune response by introducing an antigen from the bacteria. This induces long-term immunity through memory B and T cells. Passive immunization provides immediate, short-term protection by transferring pre-formed antibodies. Common bacterial vaccines include those targeting Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, diphtheria, tetanus, pertussis, Lyme disease, anthrax, tuberculosis, and typhoid fever. These vaccines contain inactivated toxins, purified proteins, capsular polysaccharides, or live attenuated bacterial strains.
The document discusses various vaccines that are part of national immunization schedules. It describes the different types of vaccines including live attenuated, killed/inactivated, toxoid, conjugate and subunit vaccines. It provides details about vaccines for diseases like BCG, polio, diphtheria, pertussis, tetanus, measles, mumps, rubella, Hib, hepatitis B, typhoid, varicella, rotavirus and pneumococcus. It discusses the appropriate ages, doses, routes of administration, storage requirements and schedules for these vaccines. It also provides guidance on vaccination of high-risk groups and management of infants born to hepatitis B positive mothers.
The document discusses India's immunization program, which began in 1978. It outlines key terms like immunity, immunization, vaccines, and herd immunity. It describes the national immunization schedule and strategies to reduce morbidity and mortality from vaccine-preventable diseases through vaccination. It also discusses monitoring systems and highlights the importance of maintaining the cold chain to ensure vaccine quality as the program aims to universally protect children from prevalent diseases.
The document discusses fish vaccination, including its importance for sustainable aquaculture, types of vaccines, and mechanisms of action. Vaccination provides an alternative to antibiotics for combating bacterial and viral diseases. Major types include whole organism vaccines using killed or attenuated pathogens, as well as purified subunit and recombinant vaccines. Development of new fish vaccines takes 5-8 years and involves disease characterization, laboratory testing, field trials, and licensing. Current commercially available vaccines protect against diseases such as furunculosis, vibriosis, and spring viraemia of carp.
Vaccines work by exposing the immune system to agents that resemble disease-causing pathogens, stimulating the body's immune response without causing illness. The document traces the history of vaccine development from Edward Jenner's smallpox vaccine in 1796 to current types including whole-organism, purified components, recombinant, DNA, and multivalent subunit vaccines. The long and complex process of developing a new vaccine can take 10-15 years and involves identifying the pathogen, developing animal models, conducting safety and efficacy trials, and addressing challenges like antigenic variation.
This document provides an introduction to vaccines, including their principles, types, and examples. The main types discussed are inactivated/killed vaccines, live attenuated vaccines, toxoids, subunit vaccines, DNA vaccines, and recombinant live vaccines. Inactivated vaccines use killed disease-causing microbes, and stimulate a weak immune response but require boosters. Live attenuated vaccines use weakened live organisms to stimulate excellent lifelong immunity but rarely carry risk of disease if attenuation fails. Toxoids are made from inactivated toxins and cannot cause disease but may require adjuvants or boosters. DNA vaccines work by directly introducing genetic material that codes for antigens. They allow for rapid, low-cost production and generate therapeutic potential for chronic infections.
Toxoid vaccines are vaccines that are made from the toxins (harmful chemicals) from bacteria. There are some bacteria that cause disease through releasing a protein called a toxin. Scientists can inactivate these toxins in the lab using a chemical called formalin (a solution of formaldehyde) and sterilized water, which are completely safe to use in small quantities in the human body. Once the toxin is inactivated, it’s called a toxoid, and it can no longer cause harm. The body learns how to fight off the bacteria’s natural toxin once exposed to the toxoid through producing antibodies that bind into the toxin like keys into a lock
A vaccine is a biological agent that provides active acquired immunity to a particular disease. A vaccine usually contains an agent that resembles a disease-causing microorganism. It is often made from killed or weakened forms of the microbe, its toxins or one of its surface proteins. Body's immune system is stimulated to recognize the agent as a threat and destroy it, and any of these microorganisms that it later encounters.
Cold Chain The ‘cold chain’ is the system of transporting and storing vaccines at recommended temperature from the point of manufacture to the point of use. Manufacturer Distributor Vaccine Depots Provider office Client.
This document discusses viral hepatitis, focusing on hepatitis A, B, C, D, and E. It provides details on the definition, causes, epidemiology, transmission, signs and symptoms, diagnosis, treatment and prevention of each type of viral hepatitis. Key points include that hepatitis A, B, C, D and E viruses are the main causes of viral hepatitis in humans. They differ in their transmission routes, clinical presentations, risk of chronic infection and availability of treatment. Vaccination is an effective way to prevent hepatitis A and B infection.
Hypersensitivity reactions for Medical StudentsNCRIMS, Meerut
Hypersensitivity (animated) for MBBS Students
Hypersensitivity refers to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system.
Hypersensitivity reactions require a pre-sensitized state of the host.
Four types of hypersensitivity
Type I – anaphylactic
Type II – cytotoxic
Type III – immune complex mediated
Type IV – contact, tuberculin and granulomatous
Anaphylaxis is defined as a life-threatening allergic reaction set in action by a wide range of antigens and involving multiple organ systems.
The true incidence is difficult to estimate, but in 1973 the Boston Collaborative Drug Surveillance Program reported six anaphylactic reactions and 0.87 deaths from anaphylaxis per 10,000 patients.
Reactions to insect stings alone are responsible for at least 50 deaths in the United States each year.
These figures reveal the importance of continued research into the biology of anaphylaxis along with developing new (and improving existing) therapies.
This document presents information about vaccines. It begins with a brief introduction defining a vaccine as a biological preparation that provides immunity against a disease. The history section then discusses how Edward Jenner developed the smallpox vaccine in 1796 and how Louis Pasteur later developed vaccines for chicken cholera and anthrax in the 1880s. The document goes on to describe the main types of vaccines as live attenuated, killed/inactivated, toxoid, subunit, conjugate, DNA, and recombinant vector vaccines. It also provides examples of diseases each vaccine type is used for and discusses their advantages and disadvantages.
Vaccines are immunobiological substances designed to induce immunity against specific diseases. They work by exposing the immune system to antigens from pathogens in order to stimulate the body's own protective response through antibody and memory cell production. There are several types of vaccines including live-attenuated, killed/inactivated, toxoids, subunit, conjugate, DNA, and recombinant vector vaccines. Vaccines protect individuals and communities by training the immune system to recognize and combat pathogens, helping to prevent epidemics and eliminate diseases in a safe and cost-effective manner.
Vaccines are biological preparations that improve immunity to particular diseases. They contain agents that resemble disease-causing pathogens in order to stimulate the body's immune system. There are several types of vaccines including killed/inactivated, attenuated/live, toxoids, subunit, peptide, conjugate, DNA, and recombinant vector vaccines. Vaccines are produced through a multi-step process involving generation of the antigen, isolation, purification, addition of components, and packaging. Common side effects are mild but vaccines effectively boost immunity with a low risk of side effects.
This document discusses immunization and vaccination. It begins by defining immunization as a process that protects individuals from disease by introducing live, killed, or attenuated organisms to create immunity. The document then covers various topics related to immunization including the significance of immunization, types of immunity (active and passive), immunizing agents (vaccines, immunoglobulins, antisera), national immunization schedules, contraindications to vaccinations, and reactions to vaccines.
Bacterial vaccines have helped eliminate or reduce several infectious diseases. Common bacterial vaccines protect against diphtheria, tetanus, pertussis, pneumococcal disease, Hib, meningococcal meningitis, typhoid, cholera and more. Vaccines work through active immunization by vaccination or passive immunization using antibodies. Ongoing research continues to develop new vaccines and improve vaccine effectiveness.
This document discusses immunization and immunity. It covers different types of immunity including active and passive immunity. It also discusses different immunizing agents such as antisera, immunoglobulins, and vaccines including live, attenuated, inactivated, toxoid, polysaccharide, and recombinant vaccines. It provides details on vaccination coverage, maintaining the cold chain for vaccine storage and transport, potential adverse reactions to immunization, and precautions that should be taken.
This document discusses various aspects of immunization and vaccines. It describes different types of immunity - passive and active immunity. It explains the different types of vaccines - live vaccines, live attenuated vaccines, inactivated vaccines, toxoids, polysaccharide/polypeptide vaccines, and recombinant vaccines. It discusses vaccination programs in India including the Universal Immunization Program and Pulse Polio Immunization program. It also covers the cold chain used to transport and store vaccines, potential adverse reactions or hazards of immunization, and methods to improve vaccination coverage.
This is an immunology lecture for medical students. it helps student to understand the importance of immunization in clinical practice. resident doctors can also benefit immensely with this lecture.
basic imunization and immunization in sepecal situation.pptssuser2dcad1
This document provides information on basic immunization and immunization in special situations. It discusses different types of immunity including active and passive immunity. It describes various immunizing agents such as immunoglobulins, antisera, and different types of vaccines including live, attenuated, inactivated, toxoids, and recombinant vaccines. It also discusses vaccination schedules, adverse reactions to immunization, maintaining the cold chain, and provides guidance on immunization for special populations such as preterm infants, immunocompromised individuals, and hepatitis B-positive mothers and their newborns.
The document discusses immunization and the Expanded Programme on Immunization (EPI). It defines immunization and describes the two types: passive and active immunization. It provides details on passive immunization, which provides immediate protection without challenging the immune system, and active immunization, which develops resistance by activating the immune system. The document then discusses EPI, including its scope, objectives, vaccines used in Somalia under EPI, and the recommended immunization schedule. It also covers important aspects like herd immunity, types of vaccines, cold chain storage and transport, and vaccine vial monitors.
This document discusses vaccines and their storage conditions. It begins by listing many common vaccines such as those for cholera, dengue, diphtheria, hepatitis, Hib, HPV, influenza, Japanese encephalitis, malaria, measles, meningococcal meningitis, mumps, pertussis, pneumococcal disease, polio, rabies, rotavirus, rubella, tetanus, tick-borne encephalitis, tuberculosis, typhoid, varicella, and yellow fever. It then discusses COVID-19 vaccines, including those that use RNA, proteins, inactivated virus, and adenovirus vectors. The document provides guidelines for refrigerating and freezing vaccines, including maintaining temperatures
This document discusses immunization and immunity. It defines active and passive immunity and how they are acquired. It describes different immunizing agents including antisera, immunoglobulins, and vaccines. It discusses the different types of vaccines such as live, attenuated, inactivated, toxoids, polysaccharide/polypeptide, and recombinant vaccines. It also addresses vaccination coverage, maintaining the cold chain, potential adverse reactions to immunization, and precautions that should be taken.
This document discusses immunization and immunity. It provides information on active and passive immunity, as well as natural and acquired immunity. It describes different immunizing agents including antisera, immunoglobulins, and various types of vaccines such as live, attenuated, inactivated, toxoids, polysaccharide/polypeptide, and recombinant vaccines. It also discusses vaccination coverage, maintaining the cold chain, potential adverse reactions to immunization, and precautions that should be taken with immunization.
The document discusses the history and development of vaccines. It begins with early discoveries in the 18th-19th centuries relating to smallpox and rabies vaccines. It then outlines major vaccine discoveries from the 1890s-1990s for diseases such as diphtheria, polio, measles, and hepatitis B. The document also describes different types of traditional and modern vaccines, including how they are prepared and the microorganisms they contain. It provides details on live attenuated, inactivated, subunit, and viral vector vaccines.
This document provides information on immunization and immunity. It discusses active and passive immunity, different immunizing agents including vaccines, immunoglobulins, and antisera. It describes different types of vaccines and their use, routes of administration, immunization schedules, effectiveness of vaccines, and the cold chain system for vaccine storage and transport. Potential adverse reactions and precautions for immunization are also outlined. The document concludes with discussions on vaccination coverage and applications of active immunization.
The document summarizes the Expanded Programme on Immunization (EPI). It discusses that EPI is a global immunization program launched by the WHO in 1974 to prevent six major childhood diseases through vaccinations. The program aims to reduce illness, disability, and mortality from these preventable diseases. It outlines the eight diseases currently targeted and provides a brief history of EPI's development and objectives to achieve high immunization coverage rates and disease elimination goals. The document also discusses key aspects of EPI implementation including the vaccine schedule, supplemental immunization activities, disease surveillance, and the importance of maintaining the cold chain for vaccine effectiveness.
Vaccines are biological preparations that improve immunity to particular diseases. They work by containing an agent that resembles a disease-causing microorganism, which stimulates the immune system to recognize and destroy it. Vaccination is the most effective method of preventing infectious diseases and has been largely responsible for eradicating smallpox and restricting diseases like polio. There are several types of vaccines including live attenuated, inactivated, subunit, toxoid, conjugate, DNA, and recombinant vector vaccines. Vaccines must undergo clinical trials and require careful storage and transport to maintain effectiveness.
Dr. ihsan edan abdulkareem alsaimary
PROFESSOR IN MEDICAL MICROBIOLOGY AND MOLECULAR IMMUNOLOGY
ihsanalsaimary@gmail.com
mobile : 009647801410838
university of basrah - college of medicine - basrah -IRAQ
This document outlines objectives and information about immunization. It discusses types of vaccines including live, attenuated, killed, and toxoids. It provides the routine vaccine schedule and describes common vaccines like BCG, polio, DPT, measles, MMR, and hepatitis B. It also covers equipment for vaccine administration, side effects, storage, transportation using the cold chain system, and contraindications to immunization.
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A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
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The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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BIODEGRADABLE MICROSPHERE BASED VACCINE
1. Presented by
PRIYA DIWEDI
M Pharm ( Pharmaceutics)
Bhopal Institute of
technology and science ,
pharmacy Bhopal(M.P)
2. VACCINES
T-cell memory is very important for long-lasting immunity,
because T-cells control both humoral and cell mediated
immunity.
When the immune system recognizes a foreign antigen for the
first time, an immune response is produced. When T cells are
involved, immunological T-cell memory is produced.
When the body encounters same antigen subsequently, a
stronger immune response is produced. This is because of
existing immunological memory against that antigen.
Further antigenic stimulus increases the immune response.
First antigenic stimulus is “priming” whereas subsequent
stimuli are “booster”. This is the principle of active
immunization.
3. The term “vaccine” was coined by Louis Pasteur to
commemorate first successful immunization against
small pox by Edward Jenner.
The term vaccine was derived from “vacca”, meaning
cow, since Edward Jenner used cowpox virus
(Vaccinia) to prevent smallpox infection.
Vaccination involves deliberate exposure to antigen
under conditions where disease should not result.
4. Vaccination is aimed at inducing active immunity in an individual, so
that subsequent contact with the microorganism following natural
infection induces strong protective immune response.
The protective immunity may involve secretion of neutralizing
antibodies or production of memory CTL or Th1 cells.
The use of vaccines is now being extended to immunize against
tumors or to block fertilization (contraceptive vaccines).
A vaccine is a suspension of whole (live or inactivated) or
fractionated bacteria or viruses that have been rendered nonpathogenic,
and is given to induce an immune response and prevent disease
5. DISEASES COMMONLY TARGETED BY ROUTINE
IMMUNIZATION IN INDUSTRIALIZED COUNTRIES
EXCLUDING DISEASES TARGETED BY TRAVEL VACCINE
Bacterial diseases Viral diseases
Pertussis Measles
Pneumococcal diseases (pneumonia,
meningitis, otitis media, and others)
Mumps
Meningococcal diseases
(meningitis and others)
Rubella
Tuberculosis Polio
Diphtheria Influenza A and B
Tetanus Hepatitis B
6. Bacterial diseases Viral diseases
Heamophilus influenzae type b
diseases (pneumonia, meningitis
and others
Chickenpox
Herpes zoster
Hepatitis A
Human Papilloma Virus diseases
(genital/cervical/oral warts and
cancers)
Japanese encephalitis (regional
importance)
Rabies (in at-risk groups)
Rotavirus
7. VACCINE COMPONENT
In addition to the bulk antigen that goes into a vaccine, vaccines
are formulated (mixed) with other fluids (such as water or saline),
additives or preservatives, and sometimes adjuvants.
Collectively, these ingredients are known as the excipients.
These ensure the quality and potency of the vaccine over its
shelf-life.
Vaccines are usually formulated as liquids, but may be freeze-
dried (lyophilized) for reconstitution immediately prior to the
time of injection.
9. TYPE OF VACCINE
Live, Attenuated Vaccines
Killed Or Inactivated Vaccines
Toxoids
Conjugate Vaccine
Recombinant Vector Vaccines
Anti-idiotypic Vaccine
10. Vaccine stability
All vaccines are sensitive biological substances that progressively
lose their potency (i.e., their ability to give protection against
disease).
This loss of potency is much faster when the vaccine is exposed to
temperatures outside the recommended storage range.
Once vaccine potency has been lost, returning the vaccine to
correct storage condition cannot restore it.
Any loss of potency is permanent and irreversible.
Thus, storage of vaccines at the correct recommended temperature
conditions is vitally important in order that full vaccine potency is
retained up to the moment of administration.
Although all vaccines are heat-sensitive, some are far more
sensitive than others are.
11. Those listed in section given below can be arranged in
order of decreasing sensitivity to heat as follows:
Least sensitive
•Adsorbed Diphtheria-Tetanus vaccine (DT, Td)
•BCG (Lyophilized) *
•Tetanus Toxoid (TT)
•Adsorbed Diphtheria-Pertussis-Tetanus vaccine (DPT)
Most sensitive•Live oral polio vaccine (OPV)
•Measles (Lyophilized)
• Hepatitis B Pertussis and Mumps (Lyophilized)
12. Vaccines damaged by freezing Vaccines unaffected by
freezing
DPT BCG *
DT OPV
TT Measles *
Hepatitis B Mumps
Td
Note: Vaccines freeze at temperatures just below zero.
•BCG and measles vaccines must not be frozen after reconstitution
•diluent for any vaccine must never be frozen.
Sensitivity of vaccines to freezing
13. Vaccine Vial Monitors (VVM)
VVMs, which measure exposure to heat, are time and
temperature sensitive labels attached to vials of vaccine at the
time of manufacture. Through a gradual colour change they warn
about the falling potency.
Importance of the cold chain
To ensure the optimal potency of vaccines, storage and
handling need careful attention adequate electrical power
and refrigeration are often lacking in developing countries,
where storage, handling and the heat stability of vaccines
are consequently matters of great concern.
New products have been developed for safe transport
and storage, while the reliability of vaccine supply has
been increased by the introduction of improved
management techniques.
14. Substantial drops in vaccine potency caused by
unsatisfactory conditions of delivery and storage have
been reported. The most commgon deficiencies in cold
chain performance reported from developed countries
are:
high temperatures during storage or transport;
exposure of adsorbed vaccine to freezing
temperatures; refrigerators without thermometers;
failure to take and record temperature readings
regularly; storage of drugs,
drinks, food and pathology specimens with vaccines
and failure to discard unused vaccine after sessions at
ambient temperature.
15. Freeze - Thaw Stability Testing
Freeze-thaw cycle testing is a part of stability testing that allows you to determine
if your formula will remain stable under various conditions. This type of test puts
your sample through a series of extreme, rapid temperature changes that it may
encounter during normal shipping and handling processes.
Freeze-thaw testing is conducted by exposing the product to freezing
temperatures (approximately -10°C) for 24 hours, then allowing to thaw at
room temperature for 24 hours.
The sample is then placed in a higher temperature (approximately 45°C) for 24
hours, and then placed at room temperature again for 24 hours. The sample is
analyzed for significant changes. This completes one cycle. If, after three cycles
of freeze-thaw testing, no significant changes are observed, you can be
confident that the stability of your product is sufficient for transport.
16. Biodegradable Polymers
Biodegradable materials are natural or synthetic in origin and are
degraded in vivo, either enzymatically or non-enzymatically or
both, to produce biocompatible, toxicologically safe by-products
which are further eliminated by the normal metabolic pathways.
The basic category of biomaterials used in drug delivery can be
broadly classified as:
synthetic biodegradable polymers, which includes relatively
hydrophobic materials such as the hydroxy acids (a family that
includes poly lactic-co-glycolic acid, PLGA), polyanhydrides,
and others, and
(naturally occurring polymers, such as complex sugars
(hyaluronan, chitosan) and inorganics (hydroxyapatite)
17. Microparticle Preparation Techniques
Solvent Evaporation Method
Double (Multiple) emulsion process
Phase Separation (Coacervation)
Phase separation of the coating polymer
solution,
Adsorption of the coacervate around the
drug particles, and
Quenching of the microspheres.
Spray Drying
Single emulsion process
18. Antigen profile (Hepatitis B Vaccine)
Hepatitis - B vaccine (r DNA) is a non-infectious
recombinant DNA Hepatitis B vaccine.
It contains purified surface antigen of the virus obtained
by culturing genetically-engineered Hansenula polymorpha
yeast cells having the surface antigen gene of the Hepatitis
B virus.
The Hepatitis-B surface antigen (HBs Ag) expressed in
the cells of Hansenula polymorpha is purified through
several chemical steps and formulated as a suspension of the
antigen adsorbed on aluminium hydroxide and thiomersal is
added as preservative.
The vaccine does not contain any material of human or
animal origin.
19. Stability of Hepatitis B Vaccine
Hepatitis B vaccine is one of the most heat-stable children’s
vaccines, maintaining stability for up to four years at temperatures
between 2°C and 8°C. T, for months at 20°C to 25°C, for weeks at
37°C and for days at 45°C.
As with other vaccines adsorbed on aluminum salts, freezing of
Hep B vaccine may cause a significant reduction of potency. The
freezing point of Hep B vaccine is about -0.5°C.
A 50 percent loss of potency of the vaccine has been reported to
be observed after 9 months at 20°C to 26°C, after one month at
36°C to 40°C and after three days at 45°C.
The vaccine should always be protected from being frozen,
especially at the end of the cold chain when it is transported in cold
boxes and may come into close contact with cold packs.
Freeze damage is the greatest threat to its integrity, and strategies
to mitigate the risk of freezing should be employed.
20. Maintaining optimal potency of vaccine is the prime
concern during storage and handling. Drop in vaccine
potency due to unsatisfactory conditions of storage
have been reported. In developing countries, lack of
adequate infra-structural logistics, uninterrupted power
supply and refrigeration are often lacking. Thus
stability of vaccine outside cold chain is important.
Apart from this, accidental freezing of vaccine during
maintenance of cold chain have also been reported.
This motivated us to microencapsulate model antigen
and assess heat shock and freeze thaw stability of this
microencapsulated antigen vis-à-vis marketed vaccine
formulation.
21. Literature survey
Characterization of antigen
• UV Scanning
• FTIR Spectroscopy
• Total protein content determination
Characterization of polymer
• FTIR
Preparation of antigen containing microsphere
Characterization of prepared microsphere.
• Particle size
• Antigen loading
• In-vitro release profile
• Surface morphology
Heat shock stability assessment
• By keeping microsphere based formulation and marketed formulation at 37 degree c
for1 month.
Freeze thaw stability
• Both formulations will be subjected to three cycle of freeze thaw.
Compilation of work
22. All vaccines are sensitive to heat, necessitating
use of a vaccine cold chain a global distribution
network of equipment and procedures for
maintaining vaccine quality during transport and
storage.
Many vaccines, including hepatitis B vaccine, are
also sensitive to freezing. Maintaining vaccines
within a specified temperature range, usually 2–8
◦C, to protect them from excessive heat and
freezing is a difficult task in both developing and
developed countries. Temperature excursions,
either too cold or too hot, during transport and
storage are frequently observed when
temperatures are monitored closely.
23. Moreover, there is evidence indicating that a single
vaccine shipment can be exposed to several episodes
of freezing temperatures within different segments of
the cold chain. Temperature monitoring studies also
suggest that the deviations from ideal storage
temperatures are more likely to happen in the
periphery of the cold chain (i.e., at the local storage
center or the immunization clinics) as opposed to the
central storage facility or at the vaccine
manufacturer’s site Among the factors contributing to
the problems are inappropriate cold chain equipment,
insufficient training, human error, and power
shortages.
24. Consequences of cold chain failure may include increases in
the cost of immunization due to vaccine wastage and staff time,
as well as immunization recall and potentially inadequate
protection of patients if affected products are not identified.
Therefore, a thermostable vaccine that could tolerate repeated
temperature excursions or be stored at ambient temperature for
all or a portion of its shelf life is highly desirable.
A microsphere preparation method and characterization of
prepared PLGA microparticles was described.
25. MATERIALS:
PLGA was purchased from Boennge Hmen.
Hepatitis B Antigen was purchased from Bharat
Biotech International Limited, Hyderabad.
Dichloromethane was purchased from HiMedia
Laboratories pvt.Ltd.Mumbai.
Potassium Dihydrogen phosphate was phosphate was
purchase from Ranbaxy fine chemicals Ltd.
Other reagent grade chemicals.
26. EQUIPMENTS:
UV/Visible-1800 spectrophotometer(SHIMADZU,Japan)
FT-IR
Remi Mechanical stirrer(Remi India Pvt.Ltd,New Delhi)
Remi cooling centrifuge(Remi India Pvt.Ltd,New Delhi)
Differential Scanning Calorimeter(DSC)
Zeta sizer(Malvern Instrument,UK)
CHARACTERIZATION OF ANTIGEN
UV Scanning:
HBs Ag was scanned in 200-400 nm and peaks were
recorded.
FTIR Spectroscopy:
FTIR Spectroscopy of hepatitis B vaccine was performed
at Sagar Institute of Research And Technology, Bhopal.
27. TOTAL PROTEIN CONTENT DETERMINATION:
Preparation of Standard Curve
Bradford reagent was prepared by dissolving 100 mg Coomassie
Brilliant Blue G-250 in 50 ml, 95% ethanol; thereafter 100 ml 85%
(w/v) phosphoric acid was added. Volume was made up to 1 liter
when the dye has completely dissolved, and was filtered through
Watman paper just before use.
Standards were prepared containing a range of 10µg/ml to
100µg/ml of protein (Bovine serum albumin). 5 ml of Bradford
reagent was added to each and incubated for 5 minutes. The
absorbance was measured at 595 nm.
Unknowns were diluted till we got absorbance in standard. 5 ml of
Bradford reagent was added and incubated for 5 minutes. The
absorbance was measured at 595 nm.
A standard curve of absorbance versus micrograms protein was
prepared and the amount of protein was determined from the curve.
28. CHARACTERIZATION OF POLYMER
FTIR Spectroscopy of PLGA microsphere
FTIR Spectroscopy PLGA microsphere was performed at
Sophesticated Analytical Instrument Laboratory, School of
Pharmaceutical Science, RGPV, Bhopal.
Preparation of PLGA microspheres containing Hepatitis B
Vaccine
Microspheres were prepared by W/O/W double emulsion solvent
evaporation techniques.
100 mg of PLGA was dissolved in 10 ml of dichloromethane.
The initial W/O emulsion was formed by adding 1ml of HBs Ag by
sonication.
W/O primary emulsion thus prepare was added drop wise through
syringe into 50 ml. of 5% PVA solution with constant stirring for 2 hrs
in mechanical stirrer.
The resultant microspheres were collected and separated by
filtration, washed with distilled water and finally air dried over a period
of 12 hrs.
29. CHARACTERIZATION OF PREPARED
MICROSPHERE
I. Particle size, Distribution and Zeta potential
Particle size, Distribution and Zeta potential was measured by
Malvern Instruments “Zetasizer” (DTSVer.5.03, Serial Number
MAL1023461).
II. Loading efficiency of the formulation:
Accuratly weight sample of microsphere sample (5mg) was taken
into 1ml, 5% SDS-0.1 M NaoH solution in an effenorf tube and
shaken in an incubator shaker at 37ºC till, it got clear solution.
After centrifugation at 3000 rpm for 4 min the supernatant was
collected and analysed.
30. III. In-vitro Antigen release profile of microsphere
In vitro release studies were carried out by suspending 100 mg
of microspheres in 60 ml of phosphate buffered saline (PBS, pH
7.4) containing 0.02% sodium azide as bacteriostatic agent and
0.01% Tween 80 to prevent the microspheres from aggregation
in the dissolution medium in stoppered flasks.
Amount of the protein was calculated from the calibration
curve. Protein-loading percentage and protein- loading
efficiency were calculated using the following formula.
Loading efficiency = weight of protein in
microspheres*100/ weight of
protein taken initially for
preparation of formulation.
31. The flasks were placed in a reciprocal shaking water bath
maintained at 37±0.5° at a speed of 60 cycles/min. At
predetermined time intervals of 2, 12, 24, 72, 120 and 168 h,
samples were collected and centrifuged at 1726 RPM for 15
min.
The supernatant was assayed for the protein release using
UV-Vis spectrophotometer at a detection wavelength of 280
nm.
The collected amount of supernatant was replaced with fresh
PBS to maintain sink conditions.
The percentage of protein release at different intervals was
calculated by using a freshly prepared calibration curve using
the standard samples which were run along with test samples.
Release experiments were done independently in triplicate
for each batch of microspheres.
32. IV. Size and Surface morphology
The prepared microspheres were subjected to light microscope
analysis to study the surface morphology. A drop of freshly prepared
microsphes was placed in a clean and dried glass slides which was
then covered with a coverslip to focus under the100X magnification.
This was carried out to study the morphology, size uniformity and
aggregation or coalescence of microsphere being prepared.
The surface morphology was visualized by scanning electron
microscopy. The samples for SEM were prepared by sprinkling the
microsphere powder on double adhesive tapes that was fixed on
aluminium stab. The stab was then coated with gold to a thickness of
about 300º by using sputter coater. The samples were then randomly
scanned and photograph were taken.
Surface morphology of prepared microsphere was performed at
MANIT, Bhopal.
33. V. Percentage yield of microsphere
The yield of microspheres was determined by comparing the whole
weight of microspheres formed against the combined weight of the co-
polymer and drug.
HEAT SHOCK STABILITY ASSESSMENT
By keeping microsphere based formulation and marketed formulation at 37⁰C
for 1 month and stability evaluated by FTIR and UV Spectroscopy.
FREEZE THAW STABILITY STUDIES
Both formulations were subjected to three cycle of freeze thaw and stability
evaluated by FTIR and UV Spectroscopy.
34. RESULTS AND DISCUSSION
Characterization of antigen
I. UV Scanning
Hepatitis B vaccine in Potassium Di hydrogen phosphate
buffer (1µg/ml) was scanned in range 200-400nm and
wavelength maxima was found at 280nm as shown in (Fg.no.
10) which was same as given in IP 1996.
II.FTIR Spectroscopy
HBs Ag show chracterstic peak at 1636.63 cm-1 which
indicates the presence of amide group. As shown in fig.11
35. III. Total Antigen content determination:
Standard curve of BSA in PBS (7.4)
Calibration graph was constructed by plotting absorbance on
ordinate and different concentrations of BSA on abscissa (Table &
Figure) For BSA the graph was found to be linear in the
concentration range of 10 µg/ml to 100 µg/ml with the following
regression equation
Y= 0.0138 x + 0.0523, R2 =0.9922
Visual inspection of the plotted calibration curves and the
correlation coefficient >0.99 confirmed the linearity over the
concentration range of 10 µg/ml to 100 µg/ml. As shown in
fig.no.12
36. Characteristic of polymer
I.FTIR Spectroscopy of PLGA polymer
PLGA show characteristic peaks such as OH stretching (3200-
3500 cm-1), –CH (2850-3000 cm-1), carbonyl –C=O stretching
(1700-1850 cm-1) and C–O stretching (1050-1250 cm-1)
Characterisation of prepared microsphere
I.FTIR of prepared microspheres
The FT IR spectrum illustrates the characteristics bands of
poly (DL-lactide-co-glycolide) microspheres and hepatitis B
vaccine at 1750 cm (-1) and 1650 cm (-1), respectively. Clearly
indicates the presence carbonyl group, saturated aliphatic esters
and primary amines.
37. II. In-vitro release profile of microspheres
The in vitro release profile showed that the entrapped
antigen was released gradually from d 1 and the peak antigen
was released on d 42. However, the percentage of total protein
and antigenic active protein and antigenic active protein
released from microsphere were entirely different.
It clearly indicates that there might be some degradation of
hepatitis B vaccine during micro encapsulation process, which
increases the loading capacity but unfortunately it results in
particle aggregation.
With respect to the release of antigen from PLGA
microsphere in vitro, the in-vitro results also confirmed the
release of antigen.
38. III. Average particle size and entrapment efficiency of
HBs Ag loaded PLGA microsphere
The size of the prepared microsphere was measured by light
microscopy-stage micrometer method. The values were
tabulated and average size of each formulation was calculated
with standard deviation.
The average size range of micrometer varied from 2.56µm to
41.27µm.On increasing the PLGA concentration by keeping
the PVA concentration as constant, the size of microsphere
increasing from 2.95µm to 37.18µm.
But on increasing the PVA concentration by keeping PLGA
concentration as constant, the size of microsphere decreasing
from 41.27µm to 2.56µm.
41. Heat shock stability assessment
I.FTIR Spectroscopy of Hepatitis B Vaccine by keeping at 37ºc
for 1 month
Intensity of antigen was decreased as compare to native antigen that is from
1636.63cm-1 to 1636.25cm-1
II. UV Spectroscopy of Hepatitis B Vaccine by keeping at 37ºc
for 1 month
Hepatitis B vaccine show absorbance at 0.1 nm and absorbance is measured at 280
nm wavelength
Freeze thaw stability
I. FTIR Spectroscopy of Hepatitis B Vaccine subjected to three
cycle of freeze thaw
Intensity of HBs Ag after freeze thaw was reduced that is from 1636.63cm-1 to
1636.24 cm-1
II. UV Spectroscopy of Hepatitis B Vaccine subjected to three
cycle of freeze thaw
Hepatitis B vaccine show absorbance at 0.064 nm and absorbance is measured at
280 nm.
54. : FTIR Spectroscopy of Hepatitis B Vaccine subjected to three cycle of freeze thaw
55. From the present study, it was concluded that hepatitis B
Microsphere can be prepared by W/O/W double emulsion
solvent evaporation technique by using PLGA polymer. By
encapsulating vaccine by a biodegradable polymer stability of
vaccine improved as well as also provides ease of
transportation.
Stability studies such as heat shock assessment and freeze
thaw stability studies reveals that intensity decreased as
compared to native antigen.
The above study demonstrated the possibility of making a
novel drug delivery system for hepatitis B vaccine, which will
be more efficacious and acceptable than the conventional drug
delivery of hepatitis B Vaccine it could be a drug delivery of
choice for treatment of hepatitis B infection.
56. Characterization parameters like size, zeta
potential, shape, drug release were
mechanically stable in all formulation.
In-vitro release rate study shows that the
drug release were more in selected
formulation show minimum drug release.
Formulation was found to be stable over
the storage period and condition tested.