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Pharmaceutics I > Sterile Dosage Forms Parenteral Dosage Forms > Flashcards

Sterile Dosage Forms Parenteral Dosage Forms Flashcards

1
Q

Define sterile dosage forms

A
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2
Q

What preparations are sterile dosage forms ?

A

Parenteral
Ophthalmic
Irrigating preparations

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3
Q

Sterile products are more frequently what ?

A

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

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4
Q

From what did parenteral dosage form derived from?

A
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5
Q

What are parenteral dosage forms ?

A

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

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6
Q

How are parental drugs administered ?

A

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

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7
Q

What are the parenteral routes

A
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8
Q

What type of preparations are used for intravenous ?

A

Aqueous solutions
Microemulsions

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9
Q

What types of preparations are used for intramuscular ?

A

Aqueous and oil solutions
Suspensions
Emulsions

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10
Q

What are the general requirements for parenteral dosage forms ?

A
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11
Q

How are parenteral classified ?

A

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

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12
Q

Define SVP

A

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

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13
Q

Define LVP

A
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14
Q

What is the cartridge type package of prefilled syringe ?

A
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15
Q

What are the aqueous vehicles used for parenteral DFs ?

A

Water for injection
Bacteriostatic water for injection
sterile water for injection

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16
Q

What are water miscible vehicles ?

A

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

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17
Q

What are water miscible vehicles used for ?

A

Primarily to affect solubility of drugs and to reduce hydrolysis

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18
Q

What are the examples of water miscible vehicles ?

A

Ethyl alcohol
Liquid propylene glycol
Glycerin

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19
Q

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

A
20
Q

What are antibacterial agents ?

A
21
Q

What are examples of antimicrobial agents ?

A
22
Q

What are buffers ?

A
23
Q

What are example of buffers ?

A
24
Q

What are antioxidant ?

A

To protect from oxidation

25
Q

What are the two types of antioxidants ?

A
26
Q

What are chelating agents ?

A

To remove trace elements that catalyze oxidative degeneration

27
Q

Give example of chelating agent

A

Ethylene diamine tetra acetic acid

28
Q

Why are surfactants added ?

A

To solubilize the active ingredient

29
Q

Give example of surfactants

A

Polyoxythylene sorbitan monooleate
Sorbitan

30
Q

Why are tonicity agents used ?

A
31
Q

What are examples of tonicity agents ?

A
32
Q

What are other excipients added to parenteral dosage form

A

Bulking agents - for freeze dried preparations
Suspending agents
Emulsifying agents

33
Q

What are examples of bulking agents ?

A

Mannitol
Lactose
Sucrose
Dextrose

34
Q

What are examples of suspending agents

A

CMC
Methyl cellulose
Gelatin

35
Q

What are examples of emulsifying agents ?

A

Lecithin
Polysorbate 80

36
Q
A
37
Q

What materials are used in labeling parenteral dosage forms ?

A

Paper
Foil
Fabric

38
Q

What are the types of parenteral containers ?

A

Vials
Ampoules
Bottles
Plastic bags
Prefilled syringes

39
Q

What is rubber material used for ?

A

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

40
Q

What is aluminum used for ?

A

To seal vials

41
Q

What is paper used for ?

A

Paper cart boards used for final packaging of parenteral products

42
Q

How many classification of glass there are ?

A

4

43
Q

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

A
44
Q

Multi dose containers are generally expected to contain how much ?

A

30 ml or less

45
Q

What is the expiry date of a multi dose container ?

A

28 days

46
Q

What are the quality control test for parenteral dosage forms ?

A

Content uniformity test
Leaker test
Pyrogen test
Sterility test
Particulate test

Pharmaceutics I (13 decks)

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