Sterile Dosage Forms Parenteral Dosage Forms Flashcards
Define sterile dosage forms
What preparations are sterile dosage forms ?
Parenteral
Ophthalmic
Irrigating preparations
Sterile products are more frequently what ?
Solutions or suspensions, but may even be solid pellets for tissues implantation
From what did parenteral dosage form derived from?
What are parenteral dosage forms ?
Sterile solutions, emulsion or suspension of a drug in aqueous or oily vehicle
How are parental drugs administered ?
Directly into the vein, muscles or under the skin, or more specialized tissues such as spinal cord
What are the parenteral routes
What type of preparations are used for intravenous ?
Aqueous solutions
Microemulsions
What types of preparations are used for intramuscular ?
Aqueous and oil solutions
Suspensions
Emulsions
What are the general requirements for parenteral dosage forms ?
How are parenteral classified ?
Small volume parenteral (SVP)
Large volume parenteral (LVP)
Define SVP
An injection that is packed in containers labeled as containing 100ml or less of
Define LVP
What is the cartridge type package of prefilled syringe ?
What are the aqueous vehicles used for parenteral DFs ?
Water for injection
Bacteriostatic water for injection
sterile water for injection
What are water miscible vehicles ?
The number of solvents that are miscible with water has been used as a portion of a vehicle
What are water miscible vehicles used for ?
Primarily to affect solubility of drugs and to reduce hydrolysis
What are the examples of water miscible vehicles ?
Ethyl alcohol
Liquid propylene glycol
Glycerin
What are the non aqueous vehicles used in parenteral dosage forms ?
What are antibacterial agents ?
What are examples of antimicrobial agents ?
What are buffers ?
What are example of buffers ?
What are antioxidant ?
To protect from oxidation
What are the two types of antioxidants ?
What are chelating agents ?
To remove trace elements that catalyze oxidative degeneration
Give example of chelating agent
Ethylene diamine tetra acetic acid
Why are surfactants added ?
To solubilize the active ingredient
Give example of surfactants
Polyoxythylene sorbitan monooleate
Sorbitan
Why are tonicity agents used ?
What are examples of tonicity agents ?
What are other excipients added to parenteral dosage form
Bulking agents - for freeze dried preparations
Suspending agents
Emulsifying agents
What are examples of bulking agents ?
Mannitol
Lactose
Sucrose
Dextrose
What are examples of suspending agents
CMC
Methyl cellulose
Gelatin
What are examples of emulsifying agents ?
Lecithin
Polysorbate 80
What materials are used in labeling parenteral dosage forms ?
Paper
Foil
Fabric
What are the types of parenteral containers ?
Vials
Ampoules
Bottles
Plastic bags
Prefilled syringes
What is rubber material used for ?
Rubber closures used to seal cartridges, vials, and bottles and allows needle to withdraw content
What is aluminum used for ?
To seal vials
What is paper used for ?
Paper cart boards used for final packaging of parenteral products
How many classification of glass there are ?
4
What are the two types of glass used for parenteral dosage form ?
Multi dose containers are generally expected to contain how much ?
30 ml or less
What is the expiry date of a multi dose container ?
28 days
What are the quality control test for parenteral dosage forms ?
Content uniformity test
Leaker test
Pyrogen test
Sterility test
Particulate test
