This document provides an overview of small volume parenterals (SVPs) and large volume parenterals (LVPs). It discusses the formulation, processing, and evaluation of parenterals. Key points include:
- SVPs contain less than 100ml while LVPs contain more than 100ml, such as hyperalimentation or cardioplegia solutions.
- Formulations include vehicles, antimicrobial agents, buffers, and tonicity adjusters. Common vehicles are water, oils, and glycerin. Glass and plastic are common packaging materials.
- Processing involves sterilization and testing for sterility, pyrogens, particulate matter, and isotonicity. Sterility is tested using membrane filtration
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
These are the sterile preparation intended to administered other than intestinal route to bypass first pass metabolism and directly goes to systemic circulation.
These preparation give quick onset of action and site specific activity.
Suitable for drugs which are inactive in GIT environment.
Can be given unconscious or vomiting or diarrheal patient.
The chapter deals with the preformulation studies that have to be considered while designing a dosage form and developing a formulation that is suitable for a patient. Here, physical and chemical properties of a drug substance are studied along with biopharmaceutical classification of drugs. Also a detailed study on the application of preformulation studies in different dosage forms are also studied.
Defination,test method, steps, principle, designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
Sterility testing products (solids, liquids, ophthalmic and other sterile pro...Ms. Pooja Bhandare
PHARMACEUTICAL MICROBIOLOGY (BP303T)Unit-IIIPart-6 Sterility testing products (solids, liquids, ophthalmic and other sterile products) according to IP, BP, USP.
Introduction: Test for Sterility. Culture Media. Fluid Thioglycollate Medium (FTM).
Alternative Thioglycollate Medium (ATM).
Soybean Casein Digest Medium (SCDM).
Tests for Culture Media:
Sterility of Media.
Growth Promotion Test.
Test for Bacteriostatic and Fungistatic.
Sterility Test Methods. Methods A: Membrane Filtration.
Method B: Direct Inoculation Pyrogen Test Methods. Rabbit Test. LAL Test.
Similar to Formulation of small & large volume parenteral (20)
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Hemodialysis: Chapter 3, Dialysis Water Unit - Dr.Gawad
Formulation of small & large volume parenteral
1. FORMULATIO
N OF
SVP & LVP
P R E S E N T E D BY – S AG A R S . B H O R
G U I D E D BY – D R . S H I TA L B U TA N I
2. CONTENTS
• INTRODUCTION TO SVP & LVP
• ADVANTAGES
• DISADVANTAGES
• FORMULATION OF SVP & LVP
• PROCESSING OF PARENTRALS
• EVALUATION OF PARENTRALS
• REFERENCE
3. INTRODUCTION
• Parentrals preparation refers to injectable route of
administration
• It is derived from Greek word para (outside ) & enteron
(intestine)
i.e other than oral route .
Administered the drug into layers of skin
4. Primary Parentral Routes -
Routes Volume
administered
Sub-cutaneous 2 ML
Intramuscular 3 ML
Intradermal 0.5ML
Intravenous 1-100 ML
5.
6. Advantages Of Parentral
Faster onset of action
Administration to unconscious patient
Avoid first pass metabolism
High bioavailability
Prolong action (depot)
7. Disadvantages –
Highly aseptic condition for manufacturing
Skilled person for req. for administration
Less patient acceptance
Pain at site of administration
Overdose can be fatal
9. SMALL VOLUME PARENTRAL -
• According to USP “ an injection that is packaged in containers
labelled as containing 100 ml or less contents “
• Generally contains drug formulation .
10. Large Volume Parentral
• Lvp mainly contains contents more than 100 ml
• LVP CONTAINS FOLLOWING
• Hyperalimentation Solution
large amount of nutrients to maintain a patient who is unable to take food
• Cardioplegia Solution
In heart surgery to help prevent ischemic injury to the myocardium during the time the
blood flow supply to the heart is clamped off & during reperfusion.,
• Solution are slightly alkaline & hypertonic in order to compensate for metabolic acidosis &
to minimize reperfusion injury resulting from tissue edema.
• Peritoneal Dialysis Solution
• Infused in abdominal cavity
• To remove the toxic substances from the body
• Irrigating Solutions
• Not given parentrally .
• Are intended to irrigate, flush, & aid in cleansing body cavities & wounds.
12. Vehicle –
• For dissolution of solute and other formulation
additives.
• Types of vehicles -
Vehicle
Aqueous
•WFI
•Sterile WFI
•Bacteriostatic WFI
Water miscible
•Sesame oil
•Olive oil
•Cotton seed oil
Non-Aqueous
•Glycerine
•Ethanol
•PEG
13. • Sterile Water for injection –
– Sterile
– Non-pyrogenic
– pH 5.5
• Bacteriostatic water for injection –
– 0.9% benzyl alcohol added as preservative
– Applied in multiple –dose container
– pH 5.7
14. Antioxidant
• Prevent oxidation process
• Used alone or in combination with chelating agent
Eg. Ascorbic acid , tocopherol ,Butylated hydroxy anisole (BHA)
Butylated hydroxy toluene (BHT)
• Antimicrobial agents –
– prevent microbial growth in preparation
– added only in SVP and not in LVP
4 classes of Antimicrobial agents used
1.quaternary ammonium compounds
2. alcohols
3.esters
4.mercurial acids
Eg. Thiomersal , benzyl alcohol, phenyl mercuric nitrate & acetate
15. Tonicity Adjustment Agent –
Minimises following -
A) Tissue damage & irritation
B) Haemolysis of blood cells
C) Prevent electrolyte imbalance upon administration
Eg.Dextrose , Nacl ,
Tonicity is important for Suubcutaneous (SC) , Intradermal (ID) ,
Intramuscular route (IM)
Buffers
acetic acid , glutamic acid ,citric acid , phosphoric acid
surfactant
improve solubility
eg. Sorbital monooleate etc. tweens 20(16.7 HLB) & 80 (HLB 15)
16. Packaging
• Packaging is an art and science which involves preparing articles for transport ,
storage purpose
Ideal requirements of good package
1) They should hold the product without loss of contents (leakage ,spoilage )
2) should protect from environmental condition like temp. light , moisture
3) should not permeate gases
4) Matter of packaging material should not interact with formulation
17. • Container & closure system –
Container
Glass
Plastic
18. GLASS CONTAINERS –
• Generally employed with Solid rubber stoppers are used for container closure
system .
• Washed ,cleaned glass container should be held at minimum of 70 C to suppress
microbial growth.
• Pyrogens removed by subjecting to 210C for 3-4 hrs or 650 C for 60 sec.
22. TESTS FOR PLASTIC CONTAINERS
• 1. Leakage test
• 2. transparency test
• 3. water vapour permeability test
• Leakage test -
fill 10 conatiners with water & keep them in inverted position with intended closure
system for 24 hrs . Check for leakage after that period
• Transparency test –
fill 5 containers with nominal capacity with diluted suspension as described in IP
1966 . And cloudiness of each container Is checked as compared with container
filled with water
• Water vapour permeability test –
Fill five container with nominal volume and heat seal the bottle with aluminium foil .
Weigh accurately each container and keep them at 14 days at RH of 60+/- 5% and
temp in 20-25 C and reweight and loss in weight should not more than 0.2 %
23. LARGE VOLUME FLEXIBLE
CONTAINERS -
• Advantages –
– Durable & light weight
Bag collapses as it empties
• Material –
– Polyvinylchloride
– Ethylvinyl acetate films
24. BLOW FILL SEAL TECHNOLOGY (BFS)
• Technology originally developed in Europe
• Aseptic packaging of pharmaceutical products
• Machine fills volume from 0.1 ml to 1000 ml
Container
molding
Container
filling
Container
sealing
25. BFS PROCESS OUTLINE
• Polymer granules are fed to a machine hopper
• Within extruder, polymer is subjected to high temperatures (160'c)
and pressure (up to 350bar) and become molten.
• It is extruded through a die and pin set to form open-ended
tube of moltenpolymer known as PARISON,
• Parison - supported by sterile air that is fed into center of parison
through 3 sterilizing grade air filter,
26. • The nozzle assembly lowers into the parison until the nozzles form a
seal with the neck of the mould. Container formation is completed by
applying a vacuum on the mould-side of the container and blowing
sterile filtered air into the interior of the container.
• The patented electronic fill system delivers a precise dosage of product
into the container. The nozzles then retract into their original position.
• Following completion of the filling process, the top of the container
remains semi-molten. Separate seal moulds close to form the top and
hermetically seal the container. The moulds open and the container is
then conveyed out of the machine.
• Mold set in two halves moves over to the parison and closes around it
part moved to filling position and containers are sealed by second
mold set, which forms the neck and closure of BFS containers.
29. STERILITY TESTING -
• Sterility means complete absence of viable microorganisms.
• Test must be carried out in aseptic environment. (grade A laminar flow
)
• Exterior surface is cleaned with suitable antimicrobial agent .
• METHOD 1 – Membrane filtration
• Method 2 – Direct inoculation technique
Sterility
Membrane
filtration
Direct
inoculation
30. MEMBRANE FILTRATION
• Fluid thioglycolate media (FTG) – Anaerobic bacteria
• Soyabean casein digest media (SCD)- Fungi & aerobic bacteria
Transfer sub. onto
The membrane
Filter
Cut membrane in 2 pieces
Transfer 1in FTG & SCD media
Incubate for 14 days
32. PYROGEN TESTING
• Rabbit test
• LAL test
• Rabbit test –
– body temp of rabbits are measured upon injection of the formulation
– Temp recorded at 30 min interval between 1-3 hrs
– If any rabbit shows rise in temp more than 0.5 C then continue the test with 5 other
rabbits
– If not more than 3 rabbits out of 8 shows rise in temp by 0.5 C or more OR sum of temp
rise not more than 3.3 C then test passes .
• LAL test (Limulus Amebocyte Lysate)-
– Lysate derived from haemolymph cell of horseshoe crab limulus polyphemus
– Precipitation or gelation occurs upon addition of endotoxin containing sample .
33. Container Closure Integrity Test /
leaker test -
• Contents may leak outside & spoil the package
• The sealed container are dipped in colored solution of 0.5 – 1 % of methylene
blue & vacuum is applied . The solution inside leaked container shows blue
colour
• Particulate matter evaluation –
The parentral preparation should have particulate matter in range of 30-40
micrometer
USP states that all container should check visually inspected for visible particle
against dark background
34. • In lvp permitted limits of particulate matter is maximum of 50 particles
of 10 micrometer & 5 particles of 25 micrometer & no particle above
50 micrometer
• Coulter counter method & filtration method are used for monitoring
particulate matter
35. REFERENCE
• USP MONOGRAPH STERILE WATER FOR INJECTION
• TEXTBOOK OF REMINGTON
• Theory & practice of industrial pharmacy Leon Lachman , H. Liberman
• https://www.allfordrugs.com/large-volume-parenterals/
• PHOTOS FROM GOOGLE.COM