Sterile Dosage Forms Parenteral Dosage Forms

Question 1

Define sterile dosage forms

Answer 1

Question 2

What preparations are sterile dosage forms ?

Answer 2

Parenteral
Ophthalmic
Irrigating preparations

Question 3

Sterile products are more frequently what ?

Answer 3

Solutions or suspensions, but may even be solid pellets for tissues implantation

Question 4

From what did parenteral dosage form derived from?

Answer 4

Question 5

What are parenteral dosage forms ?

Answer 5

Sterile solutions, emulsion or suspension of a drug in aqueous or oily vehicle

Question 6

How are parental drugs administered ?

Answer 6

Directly into the vein, muscles or under the skin, or more specialized tissues such as spinal cord

Question 7

What are the parenteral routes

Answer 7

Question 8

What type of preparations are used for intravenous ?

Answer 8

Aqueous solutions
Microemulsions

Question 9

What types of preparations are used for intramuscular ?

Answer 9

Aqueous and oil solutions
Suspensions
Emulsions

Question 10

What are the general requirements for parenteral dosage forms ?

Answer 10

Question 11

How are parenteral classified ?

Answer 11

Small volume parenteral (SVP)
Large volume parenteral (LVP)

Question 12

Define SVP

Answer 12

An injection that is packed in containers labeled as containing 100ml or less of

Question 13

Define LVP

Answer 13

Question 14

What is the cartridge type package of prefilled syringe ?

Answer 14

Question 15

What are the aqueous vehicles used for parenteral DFs ?

Answer 15

Water for injection
Bacteriostatic water for injection
sterile water for injection

Question 16

What are water miscible vehicles ?

Answer 16

The number of solvents that are miscible with water has been used as a portion of a vehicle

Question 17

What are water miscible vehicles used for ?

Answer 17

Primarily to affect solubility of drugs and to reduce hydrolysis

Question 18

What are the examples of water miscible vehicles ?

Answer 18

Ethyl alcohol
Liquid propylene glycol
Glycerin

Question 19

What are the non aqueous vehicles used in parenteral dosage forms ?

Answer 19

Question 20

What are antibacterial agents ?

Answer 20

Question 21

What are examples of antimicrobial agents ?

Answer 21

Question 22

What are buffers ?

Answer 22

Question 23

What are example of buffers ?

Answer 23

Question 24

What are antioxidant ?

Answer 24

To protect from oxidation

Question 25

What are the two types of antioxidants ?

Answer 25

Question 26

What are chelating agents ?

Answer 26

To remove trace elements that catalyze oxidative degeneration

Question 27

Give example of chelating agent

Answer 27

Ethylene diamine tetra acetic acid

Question 28

Why are surfactants added ?

Answer 28

To solubilize the active ingredient

Question 29

Give example of surfactants

Answer 29

Polyoxythylene sorbitan monooleate Sorbitan

Question 30

Why are tonicity agents used ?

Answer 30

Question 31

What are examples of tonicity agents ?

Answer 31

Question 32

What are other excipients added to parenteral dosage form

Answer 32

Bulking agents - for freeze dried preparations Suspending agents Emulsifying agents

Question 33

What are examples of bulking agents ?

Answer 33

Mannitol Lactose Sucrose Dextrose

Question 34

What are examples of suspending agents

Answer 34

CMC Methyl cellulose Gelatin

Question 35

What are examples of emulsifying agents ?

Answer 35

Lecithin Polysorbate 80

Question 36

Answer 36

Question 37

What materials are used in labeling parenteral dosage forms ?

Answer 37

Paper Foil Fabric

Question 38

What are the types of parenteral containers ?

Answer 38

Vials Ampoules Bottles Plastic bags Prefilled syringes

Question 39

What is rubber material used for ?

Answer 39

Rubber closures used to seal cartridges, vials, and bottles and allows needle to withdraw content

Question 40

What is aluminum used for ?

Answer 40

To seal vials

Question 41

What is paper used for ?

Answer 41

Paper cart boards used for final packaging of parenteral products

Question 42

How many classification of glass there are ?

Answer 42

4

Question 43

What are the two types of glass used for parenteral dosage form ?

Answer 43

Question 44

Multi dose containers are generally expected to contain how much ?

Answer 44

30 ml or less

Question 45

What is the expiry date of a multi dose container ?

Answer 45

28 days

Question 46

What are the quality control test for parenteral dosage forms ?

Answer 46

Content uniformity test Leaker test Pyrogen test Sterility test Particulate test