This document provides information about small volume parenterals. It begins by defining parenterals as routes of administration other than the alimentary canal. It then discusses various parenteral routes including subcutaneous, intramuscular, intravenous, and large volume parenteral. The document outlines the advantages and disadvantages of the parenteral route. It provides details on containers, closures, formulation, production facilities, processing, and evaluation of parenteral preparations. Evaluation includes sterility testing, clarity testing, leakage testing, pyrogen testing, and assay testing. The document emphasizes the importance of aseptic conditions for parenterals due to risk of contamination.
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
DISSOLUTION
Dissolution is defined as a process in which a solid substance solubilises in a given solvent.
(i.e. mass transfer from the solid surface to the liquid phase.)
Three Theories:
Diffusion layer model / Film theory
Danckwert’s model / Penetration or Surface renewal theory
Interfacial barrier model / Double barrier or Limited solvation theory
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
It is defined as “the predictive mathematical model that describes the relationship between in vitro property (such as rate & extent of dissolution) of a dosage form and in vivo response (such as plasma drug concentration or amount of drug absorbed)”.
DISSOLUTION
Dissolution is defined as a process in which a solid substance solubilises in a given solvent.
(i.e. mass transfer from the solid surface to the liquid phase.)
Three Theories:
Diffusion layer model / Film theory
Danckwert’s model / Penetration or Surface renewal theory
Interfacial barrier model / Double barrier or Limited solvation theory
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Parenterals, most useful presentation for GPAT aspirant and UG PG students of Pharmacy field. Details regarding parenteral routes, formulation consideration and quality control tests
topic name is parental drug delivery system which include their use , advantages, disadvantages, necessities,
parentral routes of administration, formulation
bacterial growth, their phases
pyrogen testing
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.
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.
Title: Sense of Taste
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 structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
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.
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
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.
- 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
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
2. Parenteral
Parenteral refers injectable route of
administration.
It derived from Greek words Para (Outside) and
enteron (Intestine).
So it is a route of administration other than the
alimentary canal. This route of administration
bypasses the alimentary canal.
3. PRIMARY PARENTERAL ROUTES
Routes Usual volume
(mL)
Needle
commonly used
Formulation
constraints
Types of medication
administered
SVP
Sub cutaneous 0.5-2 5/8 in. ,
23 gauge
Need to be isotonic Insulin, vaccines
Intra muscular 0.5-2 1.5 in. ,
23 gauge
Can be solutions,
emulsions, oils or
suspensions
Isotonic preferably
Nearly all drug
classes
Intra venous 1-100 Vein puncture
1.5 in. ,
20-22 gauge
Solutions, emulsions
and liposomes
Nearly all drug
classes
LVP 101 and larger
(infusion unit)
Venoclysis
1.5 in. ,
18-19 gauge
Solutions and some
emulsions
Nearly all drug
classes
4. S. No. ADVANTAGES DISVANTAGES
1. Quick onset Wrong dose or over dose can be
fatal
2. Vomiting and unconscious
patients can take
Pain at site
3. Prolonged action by
modified formulation
( Depot)
Trained person required
4. Nutritive fluids (glucose,
electrolytes) can be given
Expensive
5. Drugs with poor absorption
or instability from GIT
NECESSITY OF ASEPTIC
CONDITIONS IN PRODUCTION,
COMPOUNDING AND
ADMINISTRATION
5. Small Volume Parenteral
• According to USP : “ an injection that is
packaged in containers labelled as containing
100 ml or less”
6. INTRODUCTION :
• All the sterile products packaged in vials, ampoules,
cartridges, syringes, bottles or any other container
that is 100ml or less fall under the class of SVP.
• Ophthalmic products packaged in squeezable
plastic containers, although topically applied to the
eye rather than administered by injection, also fall
under the classification of Small Volume Injections
(SVI) as long as the container size is 100ml or less.
• SVP aqueous solutions can be administered by
intravenous route because of local irritation. Small
volume parenteral products can be formulated and
packaged in several ways and include a wide
variety of products like :
7. • Pharmaceutical products, Biological products,
Allergenic extracts, Radiopharmaceutical products,
Genetically engineered or biotechnology products,
Liposome and lipid products.
• An injection is a preparation intended for
parenteral administration and/or for constituting
or diluting a parenteral article prior to
administration
• Types of preparations :-
Drug injection
Drug for injection
Drug injectable emulsion
Drug injectable suspension
Drug for injectable suspension
8. Contd…….
• Definition:- According to the USP 24/ NF 19 “As those
preparations intended for injection through the skin or
other external boundary tissue, rather than through the
alimentary canal”
• so that the active substance they contain are
administered using gravity or force directly into a blood
vessel,organ,tissue or lesion.
9. Containers:
1. Glass:
• Highly Resistant Borosilicate Glass
• Treated Soda lime Glass
• Regular Soda Lime Glass
• N.P (Non-parenteral) Glass
Type 4 is not used for parenteral packaging,
others all are used for parenteral packaging.
10. Contd…….
2. Plastic:
Plastic containers are used but they face following problems
• Permeation
• Sorption
• Leaching
• Softening
3. Rubber:
To provide closure for multiple dose vials, IV fluid bottles, plugs for disposable syringes and bulbs for
ophthalmic pipettes, rubber is the material of choice.
Problems associated with rubber closures are
• Incompatibility
• Chemical instability
• Physical instability
11. Closure:
• Characteristics of Good Pharmaceutical rubbers
• Good ageing qualities
• Satisfactory hardness and elasticity
• Resistance to sterilization conditions
• Impermeable to moisture and air
• Examples:
• Butyl Rubbers
• Natural Rubbers
• Neoprene Rubbers
• Polyisoprene rubbers
• Silicone Rubbers
13. PROCESSING OF
PARENTERALS
S.No. STEPS
1. Cleaning of containers, closures and equipments
2. Collection of materials
3. Preparation of parenteral products
4. Filtration
5. Filling the preparation in final containers
6. Sealing the containers
7. Sterilization
8. Evaluation of parenteral preparation
9. Labeling and packaging
14. Formulation of parenteral
products
• In the preparation of parenteral products, the following substances
are added to make a stable preparation:
The active drug
Vehicles
Aqueous vehicle (e.g. water for injection, water for injection free from CO2
)
Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)
Adjuvants
Solubilizing agents (e.g. Tweens & polysorbates)
Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)
Buffering agents (e.g. citric acid, sodium citrate)
Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol)
Chelating agents (e.g. EDTA)
Suspending, emulsifying & wetting agents (e.g. MC, CMC)
Tonicity factor (e.g. sodium chloride, dextrose)
15. Formulation of SVP :
• Aqueous vehicle :
• Types :- purified water, WFI, sterile WFI,
bacteriostatic WFI, sterile WF Irrigation.
• Preparation :- Distillation, ion exchange or
reverse osmosis.
• Except purified water all are pyrogen free
• Non aqueous vehicle :
• Because of safety
purity
biocompatibility
Several SVPs are marketed as oily solutions
16. The oil must be vegetable in origin (sesame, olive, or
cottonseed oil).
Product USP Oil
Ampicillin(suspension) Vegetable
Diethyl stilbestrol Sesame, cotton
Epinephrine(suspension) Sesame
Penicillin G procaine Vegetable
(suspension)
Co solvents :-
Are used to increase the stability of poorly soluble drug
in water and prevent drug chemical degradation by
hydrolysis.
Eg. propylene glycol or in combination with ethanol and
polyethylene glycol.
17. Ingredients or added substances
• Antimicrobial preservatives :
• Maintain the stability of the product during
storage.
• Phenylmercuric nitrate and Thimerosal
0.001% , Benzethonium chloride 0.01%,
Benzyl alcohol 0.5- 10.0%, Phenol or cresol
0.5%, chlorobutanol 0.5%.
• Buffers :
• Added to maintain pH Results in stability of
drug against hydrolytic degradation or
enhance the solubility of drug in solution.
18. • Common buffers used in SVPs
pH Buffer system Conc. %
3.5-5.7 Acetic acid-acetate 0.22
2.5-6.0 Citric acid-citrate 0.5
6.0-8.2 Phosphoric acid- 0.8-2
phosphate
8.2-10.2 Glutamic acid- 1-2
glutamate
Antioxidants :
Antioxidants function by preferentially with molecular oxygen and
minimizing or terminating the free radical auto-oxidation
reaction.
eg. Reducing agents: Ascorbic acid 0.02-0.1%, Sodium
Bisulfite 0.1-0.15%, Thiourea 0.005%
Blocking agents: Ascorbic acid esters 0.01-0.015%,
Tocopherols 0.05-0.075%
19. • Tonicity adjusters :
• Electrolytes: Nacl
• Non electrolytes: Glucose, Mannitol, Glycerine
• Eg. Of isotonic: Dextrose injection 5% & Nacl
injection 0.9%
• Some solutions are iso-osmotic but not isotonic
this is because the physiology of the cell
membranes must be considered.
• For eg. the cell membrane of the RBC is not semi-
permeable to all drugs it allows ammonium
chloride, alcohol, boric acid, glycerin, propylene
glycol, and urea to diffuse freely.
• In the eye the cell membrane is semi permeable to
boric acid and a 2% solution is an isotonic
ophthalmic solution.
20. • But even though a 2% solution of boric acid is an
isotonic with the eye and is iso-osmotic, it is not
isotonic with blood since boric acid can freely diffuse
through the RBC– and it may cause HEMOLYSIS.
• Tonicity can be measurement by: osmometer
• Other ingredients :
• Bulking agents – for freeze dried preparations(solids) eg
mannitol, lactose sucrose, dextrose.
• Suspending agents – Carboxy methyl cellulose, sorbitol.
• Emulsifying agents – lecithin, polysorbate 80
• Ophthalmic ointments bases – petrolatum.
21. Production facilities of parenterals
• The production area where the parenteral
preparation are manufactured can be divided
into five sections:
Clean-up area
Preparation area
Aseptic area
Quarantine area
Finishing & packaging area
22. Contd…….
Clean-up area:
It is not aseptic area.
All the parenteral products must be free from foreign particles &
microorganism.
Clean-up area should be withstand moisture, dust & detergent.
This area should be kept clean so that contaminants may not be carried
out into aseptic area.
Preparation area:
In this area the ingredients of the parenteral preparation are mixed &
preparation is made for filling operation.
It is not essentially aseptic area but strict precautions are required to
prevent any contamination from outside.
23. Contd…….
Aseptic area:
The parenteral preparations are filtered, filled into final
container & sealed should be in aseptic area.
The entry of personnel into aseptic area should be limited &
through an air lock.
Ceiling, wall & floor of that area should be sealed & painted.
The air in the aseptic area should be free from fibers, dust and
microorganism.
The High efficiency particulate air filters (HEPA) is used for air.
UV lamps are fitted in order to maintain sterility.
24. Contd…….
Quarantine area:
After filling, sealing & sterilization the parenteral
product are held up in quarantine area.
Randomly samples were kept foe evaluation.
The batch or product pass the evaluation tests are
transfer in to finishing or packaging area.
Finishing & packaging area:
Parenteral products are properly labelled and packed.
Properly packing is essential to provide protection
against physical damage.
The labelled container should be packed in cardboard
or plastic container.
Ampoules should be packed in partitioned boxes
25. EVALUATION OF PARENTERAL
PREPARATIONS
• The finished parenteral products are subjected to
the following tests, in order to maintain quality
control:
• A) sterility test
• B)clarity test
• C)leakage test
• D)pyrogen test
• E)assay
26. A) sterility test
• It is a procedure carried out to detect and
conform absence of any viable form of microbes
in or on pharmacopeia preparation or product.
1) Method of sterility testing
i ) METHOD 1 Membrane filtration method
ii) METHOD 2 Direct inoculation method
27. Membrane filtration method
(METHOD 1):
Membrane filtration Appropriate for : (advantage)
• Filterable aqueous preparations
• Alcoholic preparations
• Oily preparations
• Preparations miscible with or soluble in aqueous or oily
(solvents with no antimicrobial effect)
All steps of this procedure are performed aseptically in a
Class 100 Laminar Flow Hood
28. Composition of culture medium for
sterility testing
Fluid
Thioglycollate
Soybean- casein
digest
L- cystine 0.5gm -
Sodium chloride 2.5gm 5.0gm
Dextrose 5.0/5.5gm 2.3/2.5gm
Pancreatic digest of casein 15.0gm 17.0gm
Papaic digest of soya bean - 3.0gm
Dibasic potassium phosphate - 2.5gm
Granular agar (moisture<15%) 0.75gm -
Yeast extract (water soluble) 5.0gm -
Sodium thioglycollate or
thioglycolic acid
0.5gm or
0.3ml
-
Resazurin (0.10%w/v fresh
solution)
1.0ml -
Purified water 1000ml 1000ml
Components Culture medium
29. Membrane filter 0.45μ porosity
Filter the test solution
After filtration remove the filter
Cut the filter in to two halves
First halves (For Bacteria) Second halves (For Fungi)
Transfer in 100 ml culture media
(Fluid Thioglycollate medium)
Incubate at 30-350 C for not less then 7 days
Transfer in 100 ml culture media
(Soyabeans-Casein Digest medium)
Incubate at 20-250 C for not less then 14 days
Observe the growth in the media Observe the growth in the media
30. Direct inoculation method (METHOD
2):
Suitable for samples with small volumes
volume of the product is not more than 10% of
the volume of the medium
suitable method for aqueous solutions, oily
liquids, ointments and creams
Direct inoculation of the culture medium suitable
quantity of the preparation to be examined is
transferred directly into the appropriate culture
medium & incubate for not less than 14 days.
31. B)clarity test
• Particulate matter is defined as unwanted mobile insoluble
matter other than gas bubble present in the product.
• If the particle size of foreign matter is larger than the size
of R.B.C.. It can block the blood vessel.
• The permit limits of particulate matter as per I.P. are
follows:
33. C)leakage test
• The sealed ampoules are subjected to small cracks which
occur due to rapid temperature changes or due to
mechanical shocks.
Filled & sealed ampoules
Dipped in 1% Methylene blue solution
Under negative pressure in vacuum chamber
Vacuum released colored solution enter into the ampoule
Defective sealing
Vials & bottles are not suitable for this test because the
sealing material used is not rigid
34. D)pyrogen test
Pyrogen = “Pyro” (Greek = Fire) + “gen” (Greek
= beginning).
Fever producing, metabolic by-products of
microbial growth and death.
Bacterial pyrogens are called “Endotoxins”.
Gram negative bacteria produce more potent
endotoxins than gram + bacteria and fungi.
Endotoxins are heat stable lipopolysaccharides
(LPS) present in bacterial cell walls, not present
in cell-free bacterial filtrates
35. Method
Dissolve the subs being examined in, or dilute it with a pyrogen free saline
solution
Warm the liquid being examined to approx. 38.5o C temp before injection
The volume of injection is NLT 0.5ml/kg & NMT 10ml/kg of body weight
Withhold water during test
Clinical thermometer is inserted into the rectum of rabbit to record body
temp
2 normal reading of rectal temp are should be taken prior to the test
injection at an interval of half an hr & its mean is calculated- initial temp
The solution under test is injected through an ear vein
Record the temp of each rabbit in an interval of 30 min for 3 hrs
The difference between initial temp & maximum temp is recorded- taken
as response
36. Limulus amebocyte lysate [LAL]
test
• Limulus amebocyte lysate [LAL] test another method
for the determination of pyrogenic endotoxins
• In this method the test solution is combined with a
cell lysate from the ameabocyte [blood cells] of horse
shoe crab
• Any endo toxin that might be present will be
coagulated with protien fraction of the ameabocytes
and results in the formation of a gel
• This consider to be simple,rapid and of greater
sensitivity that the rabbit test
37. E)assay
• Assay is performed according to method given In
the monograph of that parental preperation in
the pharmacopoeia
• Assay is done to check the quantity of
medicament present in the parenteral
preperation
38. References
• Lachman/Lieberman’s “The Theory and Practice Of Industrial
Pharmacy” Fourth Edition 2013, Edited by: Roop K Khar, SP
Vyas, Farhan J Ahmad, Gaurav K Jain, CBS Publishers and
Distributors Pvt Ltd, New Delhi.
• Doornbos C and Hann P. Optimization Techniques in Formulation
and Processing. In Encyclopedia of Pharmaceutical Technology.
Swarbrick J and Boylan JC, Eds., Vol. II, Marcel Dekker, New
York. 199
• Modern Pharmaceutics Fourth Edition, Revised and Expanded,
Edited By G.S.Banker & C.T.Rhodes, Marcel Dekker pg387-389.
• The Science & practice of Pharmacy, By Remington, Vol-01,
21st Edition, Lippincott Publication, pg-838-840.