Small volume parenterals are sterile preparations intended for injection that have volumes between 1-30 mL. They include ampules, vials, dry powders, and prefilled syringes. Key considerations for their formulation include using water for injection, appropriate solutes, added substances like antimicrobial agents or antioxidants, and ensuring sterility through various techniques like moist heat sterilization, filtration, or radiation. Their quality must be assured through testing for leaks, sterility, clarity, and presence of pyrogens.
PARENTERAL ROUTES OF DRUG ADMINISTRATIONZainab Riaz
PARENTERAL ROUTE OF DRUG ADMINISTRATION
The term parenteral refers to injectable routes of administration of drug.
So as a hole it means outside of intestine.
PARENTRAL MEDICATIONS AND STERILE FLUIDS:
The parenteral route of drug administration are:
1. Intravenous IV
2. Intramuscular IM
3. Intradermal
4. Subcutaneous
PYROGENS: The water used in parenteral should be free of pyrogens.
METHODS OF REMOVING PYROGENS:
1. Distillation
2. Reverse osmosis
3. Heating at 180 degree celcius for 3 to 4 hours
4. Adsorption method
OFFICIAL TYPES OF INJECTIONS:
SOLVENTS AND VEHICLES USED FOR INJECTIONS:
STERILE WATER FOR INJECTION USP
BACTERIOSTATIC WATER FOR INJECTION
NaCl injection USP
BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP
RINGER INJECTION USP
LACTATED RINGER INJECTION USP
NON AQUEOUS VEHICLES
ADDED SUBSTANCES USED IN PARENTERALS
SOLUBILIZING AGENTS
STABILIZERS
ANTIMICROBIAL AGENTS
ANTI OXIDANTS USED IN PARENTERALS.
PARENTERAL ROUTES OF DRUG ADMINISTRATIONZainab Riaz
PARENTERAL ROUTE OF DRUG ADMINISTRATION
The term parenteral refers to injectable routes of administration of drug.
So as a hole it means outside of intestine.
PARENTRAL MEDICATIONS AND STERILE FLUIDS:
The parenteral route of drug administration are:
1. Intravenous IV
2. Intramuscular IM
3. Intradermal
4. Subcutaneous
PYROGENS: The water used in parenteral should be free of pyrogens.
METHODS OF REMOVING PYROGENS:
1. Distillation
2. Reverse osmosis
3. Heating at 180 degree celcius for 3 to 4 hours
4. Adsorption method
OFFICIAL TYPES OF INJECTIONS:
SOLVENTS AND VEHICLES USED FOR INJECTIONS:
STERILE WATER FOR INJECTION USP
BACTERIOSTATIC WATER FOR INJECTION
NaCl injection USP
BACTERIOSTATIC SODIUM CHLORIDE INJECTION USP
RINGER INJECTION USP
LACTATED RINGER INJECTION USP
NON AQUEOUS VEHICLES
ADDED SUBSTANCES USED IN PARENTERALS
SOLUBILIZING AGENTS
STABILIZERS
ANTIMICROBIAL AGENTS
ANTI OXIDANTS USED IN PARENTERALS.
Parenterals, most useful presentation for GPAT aspirant and UG PG students of Pharmacy field. Details regarding parenteral routes, formulation consideration and quality control tests
Parenterals, most useful presentation for GPAT aspirant and UG PG students of Pharmacy field. Details regarding parenteral routes, formulation consideration and quality control tests
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.
Site Master File (SMF) is a document, which give a complete and factual information regarding a site of a pharmaceutical manufacturing plant.
• The Document should not be very massive and at the same time it should be not be very brief.
A system for designing, analyzing & controlling manufacturing through timely measurements (i.e during processing) of critical quality & performance attributes for raw & in-process materials & processes with the goal of ensuring final product quality.”
IPQC is concerned with providing accurate , specific, & definite descriptions of the procedures to be employed, from, the receipt of raw materials to the release of the finished dosage forms
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
- 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
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2. Parenterals Sterile
pyrogen-free preparations intended for
administration by injection under or
through one or more layers of skin or mucous
membranes
– TYPES-
– 1) Small Volume Parenterals - Volume ranges
from 1-30 ml . May be given single dose or
multiple dose.
– 2) Large Volume Parenterals- Volume ranges
from 100-1000 ml. Mostly given as single dose.
3. Small volume parenteral
Usually range 1-30 ml in volume.
Mostly given as multiple doses.
Different types are:
1. Ampules
2. Vials
3. Dry powders
4. Prefilled syringes
4. Ampules
Sealed glass containers with an elongated neck that must be
broken off.
Most ampules are weakened around the neck for easy
breaking; these will have a coloured band around the neck.
A 5 micron filter needle should be used when drawing the
contents of an ampule into a syringe since glass particles may
have fallen inside the ampule when the top was snapped off.
In addition, it is useful to wrap an alcohol wipe or small piece
of gauze around the top of the ampule before breaking it. This
will provide some protection to the fingers if the ampule
shatters and will also reduce the possibility of glass splinters
becoming airborne
6. Vials
Drugs and other additives are packaged in vials either as
liquids or lyophilized
powders.
Made of glass or plastic and are sealed with a rubber
stopper.
A needle is used to add contents to or withdraw contents
from the vial.
Before withdrawing contents from a vial, an equal volume
of air is usually injected into the vial to pressurize the vial
and aid in withdrawing the contents.
Vials may be designated for single-dose or multi-dose use.
Multi-dose vials contain a preservative to inhibit bacterial
contamination once the vial has been used
8. Dry powders
Dry powder formulations are lyophilized or freeze-dried
powders that must be reconstituted with some suitable solvent
to make a liquid formulation before being withdrawn from
the vial.
Some drugs are not stable in liquid form and so these drugs
are put into the powder form and reconstituted just prior to
use.
There are several solvents that might be used to reconstitute
the dry powders; The most common solvents are Sterile Water
for Injection, Bacteriostatic Water for Injection, Sodium
Chloride Injection etc.
9. Prefilled syringes
It consists of syringes which are prefilled with the drug solution.
There are two varieties of prefilled syringes. One type, a cartridge
type package, is a single syringe and needle unit which is to be
placed in a special holder before use.
Once the syringe and needle unit is used, they are discarded but
the holder is used again with a new unit.
The other type of prefilled syringe consists of a glass tube closed at
both ends with rubber stoppers. The prefilled tube is placed into a
specially designed syringe that has a needle attached to it.
After using this type or prefilled syringe, all of the pieces are
discarded.
12. Water for injection (WFI)
Sterile Water for Injection, USP is a sterile, non-pyrogenic
preparation of water for injection which contains no
bacteriostatic, antimicrobial agent or added buffer and is
supplied only in single dose containers to dilute or dissolve
drugs for injection.
According to USP, it contains 10 CFU/100 ml water.
For IV injection, add sufficient amount to a solute to make an
approximately isotonic solution-pH 5.0 to 7.0.
No therapeutic activity and non-toxic.
Water purified by reverse osmosis and distillation.
13. SOLUTES:
1. Added to give good stability and efficacy to the
preparation.
2. Eg. Sucrose, Mannitol, Lactose.
ADDED SUBSTANCES:
1. All substances that can safeguard quality of
preparation.
2. It may affect the solubility of the preparation,
provide a preservative effect and enhance
isotonicity.
ANTIMICROBIAL AGENTS
1. Eg. Phenol 0.5% w/v
14. ANTIOXIDANTS:
1. To preserve products because of the ease with
which many drugs get oxidized.
2. Eg. Sodium bisulphite 0.1%
BUFFERS:
1. To stabilize pH.
2. Eg.. Citrates,
3. acetates
15. PYROGENS
Metabolic products of microbial growth causing an increase in
body temperature.
Come from sources like solvent, medicament, apparatus and
improper storage.
It is very difficult to remove pyrogens because they are:
1) Thermostable
2) Water soluble
3) Unaffected by common bactericides.
The bacterial substance lipopolysaccharide (LPS) in the cell
wall of bacteria is an example of pyrogen.
16. STERLIZATION
1. Moist heat sterilization
2. Dry heat sterilization
3. Sterilization by filtration
4. Gas sterilization
5. Sterilization by ionizing radiation
18. MOIST HEAT
STERILIZATION
Bacterial death by moist heat is due to denaturation and coagulation of essential protein
molecules (enzymes) and cell constituents.
It can be used for a large number of injections, ophthalmic solutions etc.
Methods used:
1) Autoclave
2) Tyndallization
Autoclaving used to sterilize anything, which is not injured by steam and high
temperature of sterilization. These include aqueous parenteral solutions e.g.
distilled water, saline solutions etc.
Tyndallisation essentially consists of heating the substance to boiling point (or just a little
below boiling point) and holding it there for 15 minutes, three days in succession. After
each heating, the resting period will allow spores that have survived to germinate into
bacterial cells; these cells will be killed by the next day's heating.
19. DRY HEAT
STERILIZATION
The killing of microorganisms by heat is a function of the time-temperature
combination used. If the temperature is increased then the time required for
killing all the bacteria will be decreased.
The vital constituents of cells such as proteins (enzymes) and nucleic acids
are denatured by oxidation Cycles recommended as per BP 1988 are:
A minimum of 1800C for not less than 30 minutes.
A minimum of 1700 C for not less than 1 hour.
A minimum of 1600 C for not less than 2 hours.
Dry heat is used to sterilize glass ware( e.g. test tubes, petri dishes, flasks,
glass syringes etc. )
21. STERILIZATION BY
FILTRATION
This method is used for sterilizing thermo-labile solutions, which will
otherwise be degraded by other conventional heating methods.
The drug solutions are passed through the sterile bacteria proof filter unit and
subsequently transferring the product aseptically into the sterile containers
which are then sealed.
Different types are :
1) Sintered glass filter
2) Seitz filter
3) Ceramic filter
They are suitable for sterilizing aqueous and oily solutions but not for organic
solvents such as alcohol, chloroform etc.
24. GAS STERILIZATION
This process involves exposure of materials to
sterilizing gases such as ethylene oxide,
formaldehyde, glutaraldehyde, propylene oxide.
Ethylene oxide is the only gas that is successfully used
on a large scale of industrial and medical
applications.
It works by alkylation
25. RADIATION
STERILIZATION
Different types of radiation used for sterilization are
1) Ultraviolet radiation
2) Gamma radiation
3) Infrared radiation
4) X-rays
5) Alpha and beta radiation
Only a narrow range of wavelength (220 to 280 nm) of UV is effective in killing
micro-organisms, and wavelengths close to 253.7 nm are the most effective.
Radiation from the radioactive isotope of Cobalt 60, is used as a source of gamma
emission.
Radiation sterilization causes damage to DNA and results in cell death
28. Leaker's Test
1. It is performed by completely submerging the
sealed ampule in a deeply coloured dye
solution.
2. Generally 1% methylene blue solution is used.
3. The ampules if not sealed properly, the dye
solution present outside the ampules will
enter into the ampules and make the solution
coloured
29. Clarity Test
1. The parenteral product to be evaluated is
placed against a white and black background
with the contents set in motion in swirling
action.
2. It is kept in that motion until any particle
becomes visible or not.
3. Care is to be taken to avoid any air bubbles.
30. STERLITY TEST
Important to check if the product meets the
requirements of sterility according to the
official books or not.
2 methods:
The direct transfer of the samples to sterile
culture media.The membrane filtration
procedure.
31. PYROGEN TEST
Samples of production batch are tested in rabbits for the presence of pyrogens.
2 stages:
1) Sham test
2) Main test
1) Sham test:
If the animals are being used for the first time in pyrogen testing, then condition the
animals for 1-3 days by injecting 10 mg/kg body weight of pyrogen free solution IV.
Maintain animals like that for 18 hrs in room maintained at a temp of 3ºC.
Record the temperature of the animals beginning at least 90 mins before injection
and continuing for 3 hrs after injection.
Any animal showing variation of 0.6ºC or more must not be used for main test
32. Main Test:
Determine the control temperature of each rabbit by recording the
temperature not more than 30 mins prior to injection of test solution.
Inject into an ear vein of each rabbit 10 ml of the test solution per kg body
weight, completing each injection within 10 mins after start of
administration.
The test solution must be warmed upto 37±2ºC.
Record the temperatures at 1, 2 and 3 hrs subsequent to the injection.
Following are the requirements for passing the test:
1) Individual rise in temperature of 0.6ºC with respect to control and sum
of 3
individual rabbits does not exceed 1.4ºC, the sample passes the test.
2) If anything above the above mentioned requirements, continue the test
with 5 other rabbits.
3)Individual rise in temperature not more that 0.6ºC and sum of all eight
does not exceed 3.7ºC, the sample passes the test