PPC 4 Exam 3 Pt. 2: Parenteral Products

What are the commonly used types of dosage forms for intravenous injection & infusion (IV)?

aqueous solutions or o/w emulsions

What are the commonly used types of dosage forms for subcutaneous injection (SC)?

aqueous solutions or suspensions,

e.g., insulin, heparin, implantation

T/F SC injections are not suitable for irritating drugs and thick suspensions because those would be painful

True

What are the commonly used types of dosage forms for intramuscular injection (IM)?

aqueous or oily solutions or (thick) suspensions; depot formation

Oily solutions are suspensions can be used for which route of administration?

IM

3 multiple choice options

How can the vehicle type (oil vs water) and dosage form type (solution vs suspension) affect drug absorption and onset of action?

oil vehicle & suspensions are absorbed slower and have a slower onset of action compared to water vehicles & solutions

2 multiple choice options

What are the requirements for parenteral products in terms of sterility?

No microorganisms

3 multiple choice options

What are the requirements for parenteral products in terms of particulate matter?

Solutions must be free from particulate matter (> 10 μm)

Suspensions and emulsions: size requirement, syringeability, and injectability

What are the requirements for parenteral products in terms of endotoxin?

endotoxin unit (EU) limited

0.2 (for intrathecal administration)

5.0 EU/kg h for other parenteral drugs; related to dose rate

What are the requirements for parenteral products in terms of pH and tonicity?

physiological pH (7.35 - 7.45)

isotonic (0.9% NaCl w/v)

What is depyrogenation?

Removing pyrogens by using dry heat at 250°C for 30 min to destroy

What are pyrogens?

substance released from certain gram-negative bacteria

e.g. LPS

toxic, potent

water soluble

not easily removed

Which type of ingredients must be avoided for parenteral products?

coloring agents

What is the mechanism of steam sterilization?

saturated steam under pressure; withstand heat, moisture penetration, surfaces can be wetted by steam

What are the applications of steam sterilization?

aqueous solutions or suspension

3 multiple choice options

What is the limitation of steam sterilization?

not for oleaginous preparations

What is the mechanism of dry heat sterilization?

High temperatures denature proteins and kills pathogens

What are the applications for dry heat sterilization?

for oils, fats, oleaginous preparations, heat stable powders

3 multiple choice options

T/F: Aqueous solutions and suspensions can be sterilized with dry heat

False

What is the mechanism of ionization radiation sterilization?

using gamma rays to sterilize

What are the applications of ionization radiation sterilization?

plastic bags

3 multiple choice options

What is the mechanism of gaseous sterilization?

using ethylene oxide to sterilize

What are the applications of gaseous sterilization?

containers

3 multiple choice options

T/F: Steam, dry heat, ionizing radiation, and gaseous sterilization are types of terminal sterilization

True

What is a form of non-terminal sterilization?

sterilization by filtration

What are the applications for sterilizing via filtration?

for solutions & gases; use sterilizing-grade membranes

What are the requirements for sterilizing-grade membranes?

0.2-µm pore size

What sterilization method is commonly used in sterile compounding?

terminal sterilization

What are the commonly used containers for parenteral products?

Single-dose or multiple-dose containers

Glass or plastic containers

What is overage?

slight excess in volume over the labeled size or volume of the package is permitted to allow withdrawal and administration of the labeled volumes

What are the major considerations in selecting glass containers?

Type I borosilicate glass is preferred as most resistant to chemical deterioration

soda-lime-silica glasses (Types II and III) are less inert

What are the major considerations in selecting plastic containers?

free of PVC/di-2-ethylhexylphthalate (DEHP) due to DEHP leach