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WorksheetsPharmaceutics III: Sterile Dosage Forms
Total questions: 39
Worksheet time: 25mins
Select all Sterile dosage forms
Parenteral injections
Ophthalmic preparations
Irrigation fluids
Dialysis solutions
Biologics
What are injections?
Dry solids that upon addition of suitable vehicle yields injectable suspensions
Liquid preparations that are drug substances or solutions of APIs
Liquid preparations of drug substance dissolved or dispersed or suspended in a suitable medium
Dry solids that upon addition of suitable vehicles form solutions
What are injectable emulsions/suspensions?
Dry solids that upon addition of suitable vehicle yields injectable suspensions
Liquid preparations that are drug substances or solutions of APIs
Liquid preparations of drug substance dissolved or dispersed or suspended in a suitable medium
Dry solids that upon addition of suitable vehicles form solutions
Define "For injections".
Dry solids that upon addition of suitable vehicle yields injectable suspensions
Liquid preparations that are drug substances or solutions of APIs
Liquid preparations of drug substance dissolved or dispersed or suspended in a suitable medium
Dry solids that upon addition of suitable vehicles form solutions
An injection packaged in containers upto 100 mL
Define "For injectable suspensions".
Dry solids that upon addition of suitable vehicle yields injectable suspensions
Liquid preparations that are drug substances or solutions of APIs
Liquid preparations of drug substance dissolved or dispersed or suspended in a suitable medium
Dry solids that upon addition of suitable vehicles form solutions
A single dose injection intended for IV use and is packaged in container larger than 100 mL
Which of the following are injections packaged in containers of up to 100 mL?
Small-volume parenterals (SVP)
Injectable emulsions/suspensions
Large-volume parenterals (LVP)
For injectable suspensions
Which of the following are single dose injections intended for IV use and are packaged in containers larger than 100 mL?
Small-volume parenterals (SVP)
Injectable emulsions/suspensions
Large-volume parenterals (LVP)
For injectable suspensions
Which USP compounding chapter is for sterile preparations?
USP 797
USP 795
USP 897
USP 697
USP 800
What is sterilization in pharmaceutical terms ?
Destruction of ALL living organisms and their spores or their complete removal from the preparation
Destruction of some living organisms and their spores or their complete removal from the preparation
Destruction of ALL living organisms and their spores or their partial removal from the preparation
All of the following are methods of sterilization except?
Wet-heat sterilization
Gas Sterilization
Ionizing Radiation
Moist-heat Sterilization
Dry-heat Sterilization
Filtration
Select all that apply to Moist/Steam Sterilization.
Conducted in autoclaves
Often the method of choice
Temperature is responsible for sterilization, pressure increases temperature
Most autoclaves operate at 121 °C
Carried out in ovens heated by gas or electricity
Select all that apply to Dry Heat Sterilization.
Conducted in autoclaves and often the method of choice
Used for sterilizing glassware, surgical instruments, oils, glycerin, mineral oil and heat stable powders
Higher temperatures and longer sterilization times are required
Carried out in ovens heated by gas or electricity
150 -170 °C and no less than 2 hours
Cannot be used with most drugs (heat-sensitive)
What is associated with Sterilization by Filtration?
Higher temperatures and longer sterilization times are required
Removal of bacteria and spores by filtration, using a 0.22µm filter
Plastic membranes with millions of uniform pores
Sterilization of heat- and moisture-sensitive materials, medical supplies and appliances
What are the advantages of Sterilization by Filtration?
Speed
Relatively inexpensive
Inspection needed
Faulty assembly
Gas sterilization utilizes mixtures of ethylene oxide or propylene oxide gas with inert gases (carbon dioxide or fluorinated hydrocarbon), which are very flammable with air.
True
False
Gas sterilization is used for?
Some bulk pharmaceuticals & medical devices
Sterilization of heat- and moisture-sensitive materials, medical supplies and appliances
Removal of bacteria and spores by filtration, using a 0.22µm filter
Sterilizing glassware, surgical instruments, oils, glycerin, mineral oil and heat stable powders
Which apply to Ionizing radiation?
Uses gamma and cathode rays
Has limited applications:
Highly specialized equipment.
Irradiation effects on the products and containers.
Personnel safety issues.
Very reliable
Used for some bulk pharmaceuticals & medical devices
Carried out in ovens heated by gas or electricity
Validation of sterility uses USP methods such as Biological indicators - standard preparations of specific microorganisms resistant to a particular sterilization process.
False
True
Select all that apply to Intravenous (IV) injections.
Introduced directly into the bloodstream
Generally administered slowly so that they are diluted by the blood
Volume limitations: 2 ml-5 ml
Much greater volumes can be administered
Introduced into the loose interstitial tissues – ‘give slowly’
Intravenous (IV) injections could cause thrombosis, phlebitis, embolism, and infections.
True
False
Select all that apply to Intramuscular (IM) injections.
More painful than IV
Onset of action is longer than IV (takes 10 – 30 min to “work”) but shorter than that of SQ
Volume limitations: 2 ml-5 ml
Limited sites are available for administration
Less hazardous and easier to use than IV
Subcutaneous (SQ/SC) injections are:
Introduced into the loose interstitial tissues – ‘give slowly’
Absorbed at a slower rate
Useful for short–term and long-term therapies
Administered in greater volumes
Solutions, suspensions, and emulsions
Subcutaneous (SQ/SC) injections have a 2mL max and take approximately 30 mins to start working.
True
False
Parenteral route is used when?
Rapid action is required
Patient is uncooperative or unconscious
Patient is unable to tolerate or accept oral medication
Drug itself is ineffective by other routes
Aseptic procedures are not required
Parenteral administration is an inexpensive non-invasive route.
True
False
What are the disadvantages of parenteral administration?
Must be administered by trained personnel
The effect of overdose or hypersensitive reaction to the drug is difficult to reverse
Aseptic procedures are required
Contamination of dosage form prior to injection is possible
Not effective for rapid delivery of a drug
Water for injections (WFI), USP is the vehicle of choice for?
Freely soluble APIs (injections)
When physical or chemical factors limit the use of aqueous vehicles
Poorly water soluble APIs (suspensions)
The external phase for injectable emulsions
Water for injections (WFI), USP must:
Meet the same standards as does Purified Water, USP (clear, odorless, pH 5-7, purity, total amount of dissolved solids NMT 1 mg/100 mL)
Be pyrogen-free
Be non-sterile and is used in preparation of terminally sterilized preparations
Be the internal phase for injectable emulsions
Be stored in tight containers at temperatures below or above the range of microbial growth (5 ° C or 60-90 ° C)
When using bacteriostatic water for injection:
Container label must state the names and proportions of the antimicrobial agents
Should be packaged in pre-filled syringes or multiple-dose vials NMT30 ml
Must be used only for SVP
(typically up to 5 mL) due to the presence of antimicrobial agents
Compatibility of the antimicrobial agents and APIs has to be considered
It may NOT contain any antimicrobial agent or other added substances
Bacteriostatic water for injections is Sterile WFI + one or more antimicrobial agents.
True
False
Benzyl alcohol as a microbial agent:
Has 0.9% w/v benzyl alcohol which is often used to prepare bacteriostatic WFI
Can be used in neonates
Has a USP labeling requirement: “NOT FOR USE IN NEONATES”
Can cause benzyl alcohol poisoning which leads to gasping syndrome
Large volume parentals must contain bacteriostatic agents or other additives.
True, this is how they are sterile.
False, they must NOT contain bacteriostatic agents or other additives.
Non-Aqueous vehicles are used when physical or chemical factors limit the use of aqueous vehicles, such as:
Water-insoluble APIs
Susceptibility of APIs to hydrolysis
To create the internal phase of parenteral emulsions
Water-soluble APIs
What are the disadvantages of non-aqueous vehicles?
Pain/irritation on injection
Patients can be sensitive to the oils and therefore the oil used in the formulation must be explicitly stated on the label
No chance of an allergy
Painless injection
Parenteral sterile dosage forms must be?
Immediate physiological action (IV solution) or prolonged action (sustained release suspension/emulsion)
Pyrogen-free
Free of insoluble material
Isotonic
Non-sterile
What are the most commonly used agents for controlling isotonicity?
Water
NaCl
Glycerol
Mannitol
Glucose
Most parenteral drugs have a neutral pH around 7.35 - 7.45
True, must match physiological pH
False, aim is typically a pH 3-8
Which are true regarding preservatives?
Multiple-dose containers must contain one or more preservatives regardless of the method of sterilization
Bacteriostatic APIs must contain one or more preservatives
Typically, NO preservatives added to injections of volume more than 15 ml
Maximum limits for use in parenteral preparations:
Hg-containing & cationic surfactants: 0.01%
Chlorobutanol, cresol, phenol: 0.5%
Sulfur dioxide and sulfites: 0.2%
Which are used for pyrogen testing?
Pyrogen Test (USP)
Autoclave Test
Bacterial Endotoxin Test (USP)
Heated Oven Test
