25 Questions
What is a requirement for IV infusions?
They must be sterile and isotonic
What kind of stability must be maintained in IV products throughout their shelf life?
Both physical and chemical, as well as microbiological stability
What is meant by 'microbiologically stable' in the context of IV products?
The product is sterile and free from pyrogenic and visible particulate contamination
What would happen if IV infusions were not isotonic?
Cellular destruction or creation would occur
Why must IV products be sterile?
To prevent microbiological contamination
What are the two common sources of heat for ovens?
Gas and electricity
How are the ovens controlled?
Thermostatically
Why are higher temperatures and longer periods of exposure required in dry heat?
Because dry heat is less effective
What type of heat is less effective in killing microorganisms?
Dry heat
What is the advantage of using moist heat?
It is more effective in killing microorganisms
What is a key characteristic of the selected vehicle?
It should be nonirritating
What is the primary concern when selecting a vehicle?
Its nontoxic properties
What should be avoided when selecting a vehicle?
A vehicle that is sensitizing
What is the main consideration when administering a vehicle?
The amount of the vehicle administered
What should the selected vehicle not be?
Sensitizing
What is the primary focus of topic 4 in the context of parenteral preparations?
Formulation of small and large volume preparations
What is the primary focus of topic 8 in the context of ophthalmic preparations?
Eye anatomy and pathogenesis
What is the primary focus of topic 5 in the context of parenteral preparations?
Additives used in parenteral preparations
What is the primary focus of topic 6 in the context of parenteral preparations?
Quality control tests for parenteral preparations
What is the primary focus of topic 10 in the context of ophthalmic preparations?
Different dosage forms that can be applied into the eye
What is the primary purpose of parenteral products?
For administration via hypodermic injection
What type of sterile product is used for instillation in the eye?
Ophthalmic
What is an example of a topical product for exposed tissues?
Ointment
What is the purpose of implants in parenteral therapy?
To act as a matrix for insertion into a defect site
What is an example of a pulmonary dosage form?
Inhalation delivery system
Study Notes
Sterile Products
- IV infusions must be isotonic to ensure safe administration.
- Sterile products must be stable, not only chemically and physically, but also microbiologically, maintaining sterility, freedom from pyrogenic and visible particulate contamination throughout their shelf life.
Characteristics of Vehicles
- Vehicles must be nonirritating, nontoxic in the amounts administered, and not sensitizing.
Sterilization
- Dry heat is less effective in killing microorganisms than moist heat, requiring higher temperatures and longer periods of exposure.
- Different methods of sterilization are used in the preparation of sterile dosage forms.
Routes of Administration
- Sterile dosage forms can be administered through different routes, including parenteral, ophthalmic, topical, and pulmonary routes.
Types of Sterile Products
- Parenterals: packed in a manner for administration via hypodermic injection, either in the form prepared or after addition of a suitable solvent or suspending agent.
- Ophthalmic: intended for instillation in the eye.
- Irrigating solutions: for contact with blood vessels of wounds or abraded mucous membranes.
- Topicas for exposed tissues: ointments, creams, gels, for burns, wound healing, and other skin damage.
- IV systems: administration devices.
- Implants: a matrix for insertion into a defect site.
- Pulmonary dosage forms: inhalation delivery system.
Parenteral Therapy
- Parenteral therapy is used to produce a localized effect.
This quiz assesses your knowledge of IV infusions, focusing on the importance of isotonicity, sterility, and freedom from contamination. Understand the stability requirements for IV products, including chemical, physical, and microbiological stability.
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