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PDF LEC > FINAL > Flashcards

FINAL Flashcards

1
Q

refers to the injectable routes of administration. It derives from the Greek words para (outside) and enteron (intestine) and denotes routes of administration other than the oral routes.

A

parenterals

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2
Q

Are sterile preparations intended to be administered by injection under or through one or more layers of the skin or mucous membranes. They are usually packed in ampules or vials.

A

parenteral

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3
Q

parenteral solutions which are administered by intravenous route.

A

transfusion fluid

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4
Q

commonly used as injections and available in single dose containers or multiple dose containers

A

solutions/emulsions of medicaments for injection

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5
Q

these drugs are supplied as dry sterile solids which are dissolved in a suitable solvent for administration into the body.

A

sterile solids

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6
Q

Available in dry solids because drugs are not stable in solution form.

A

sterile solids

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7
Q

sterile suspensions of drugs in a suitable solvent and are administered by intramuscular route.

A

sterile suspensions

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8
Q

Liquid preparations that are drug substances or solutions thereof

A

[drug] injection

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9
Q

Dry solids that, upon the addition of suitable vehicles, yield solutions conforming in all respects to the requirements for Injections.

A

[drug] for injection

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10
Q

Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium.

A

[drug] injectable emulsion

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11
Q

Liquid preparations of solid suspended in a suitable liquid medium.

A

[drug] injectable suspension

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12
Q

Dry solids that, upon the addition of suitable vehicles, yield preparations conforming in all respects to the requirements for Injectable
Suspensions.

A

[drug] for injectable suspension

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13
Q

sterile preparations should be free from all types of microorganisms.

A

sterility

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14
Q

Ophthalmic formulations must be especially free from Pseudomonas aeruginosa, gram-negative bacteria which is commonly found in ophthalmic formulations and can cause serious infections to cornea.

A

sterility

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15
Q

Parenteral preparations should be isotonic with blood plasma and body fluids.

A

isotonocity

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16
Q

Ophthalmic formulations must be isotonic with lachrymal secretions.

A

isotonocity

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17
Q

sterile formulations must be free from pyrogens and toxins.

• These products must pass pyrogen test as pyrogens are responsible for rise in body temperature.

A

free from pyrogens

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18
Q

these products must be free from foreign particles, dust, fibers and must pass clarity test.

A

free from foreign particles

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19
Q

pH of tears is about 7.4. pH plays crucial role in therapeutic activity, solubility, stability, and comfort to the patient.

A

pH of ophthalmic preparations

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20
Q

physical and chemical stability of sterile formulations should be maintained during storage.

A

stability

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21
Q

Commonly used non-aqueous vehicles

A

alcohols and oils

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22
Q

properties of sterile dosage forms

A

sterility
isotonicity
free from pyrogens
free from foreign particles
pH of ophthalmic preparations
stability

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23
Q

general process of sterile dosage forms

A

accumulation and selection of components
production facilities and procedure
control
packaging and labeling

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24
Q

vehicles, solutes, containers, and closures

A

accumulation and selection of components

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25
Q

the sequential steps of preparing the product, filtering the solutions, filling containers, and sterilizing the product

A

production facilities and procedures

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26
Q

evaluation and determination of components

A

control

27
Q

all steps necessary to properly identify the finished product.

A

packaging and labeling

28
Q

the component present in largest quantity. Normally, a it has no therapeutic value and is non-toxic. Nevertheless, it is of great importance in the formulation since it presents to the body tissues in the form of active ingredients or constituents’ absorption.

A

Vehicle

29
Q

packaged in single-dose containers not larger than 1 L.

it must be pyrogen- free but does not have an allowable endotoxin level, not more than 0.25 USP EU/mL.

A

water for injection, usp

30
Q

sterile water for injection containing one or more suitable antimicrobial agents. It is packaged in prefilled syringes or in vials containing not more than 30 mL of the water.

A

bacteriostatic water for injection, usp

31
Q

may not contain any added substances.

A

water for injection

32
Q

may not contain any antimicrobial agent or other added substances.

A

sterile water for injection

33
Q

these are used primarily to effect solubility of certain drugs and to reduce hydrolysis.

A

water-miscible vehicles

34
Q

these are often used as isotonic vehicles. The additional osmotic effect of the drug may not be enough to produce any discomfort when administered.

A

aqueous vehicles

35
Q

Fixed oils are the most important group of this and used particularly for certain hormones.

A

non aqueous vehicles

36
Q

factors that determine the quality of solutes for parenteral preparations

A

solutes

37
Q

Preparation in
containers are required to contain bacteriostatic or fungistatic agent in adequate amount at the time of use to prevent the multiplication of microorganisms inadvertently introduced into the preparation when withdrawing a portion of it.

A

antimicrobial agents

38
Q

Must be evaluated for their activity in the total formula to assure their activity when needed at the time of use.

A

antimicrobial agents

39
Q

Common Antimicrobial agents with their concentration limits:

A

Phenylmercuric Nitrate and Thimerosal - 0.1%
Benzethonium Chloride and Benzalkonium Chloride - 0.1%
Phenol and Cresol - 0.5%
Chlorobutanol - 0.5%

40
Q

Preserves the balance of acidity and alkalinity of a solution.

Used to stabilize a solution against a chemical degradation that would occur if there is a mark change in pH.

A

Buffers

41
Q

Commonly employed buffers

A

acid salts: acetates, citrates, phosphates

42
Q

most commonly used antioxidant

A

sodium bisulfate 0.1%

43
Q

has been found to enhance the activity of antioxidant in some cases apparently by chelating metallic ions that would otherwise catalyze the oxidation reaction.

A

Sodium salt of Ehtylenediamine Tetra Acetic acid

44
Q

known as bacterial endotoxins, are organic metabolic products shed from gram-negative bacteria, which can cause fever and hypotension in patients when they are in excessive amounts in intravenous injections.

A

pyrogens

45
Q

These are products of the growth of microorganisms, chemically lipids in nature, sometimes containing phosphorus, and is attached a polysaccharide or a protein or both.

A

pyrogens

46
Q

They are unwanted contaminants which are difficult to remove without affecting the product. This cause a febrile reaction in human being; these are rarely fatal but produces discomfort.

A

pyrogens

47
Q

the greatest potential source of pyrogens

A

water

48
Q

it will absorb pyrogens from water

A

ion-exchange resins

49
Q

the most reliable method for eliminating pyrogens from water as they do not distill over.

A

distillation

50
Q

this will remove pyrogens by absorption, but once the fibers are saturated, the rest of the pyrogens are no longer absorbed

A

Filtration with Asbestos filters

51
Q

It also introduces pyrogens especially reused containers

A

Equipment

52
Q

it may also contain pyrogens, hence must be purified by recrystallization, precipitate, washing or other means.

A

solutes

53
Q

at present the use of these
containers is limited to components of disposable injection units where in contact with the solution is brief.

A

plastic

54
Q

the container of choice for most injections. The basic structural network of glass is formed by Silicon oxide tetrahedron and boric acid enters the structure.

A

glass

55
Q

glass container in general, will be suitable for all products, although sulfur oxide treatment is done to increase its resistance.

A

Type I Borsilicate glass

56
Q

may be suitable for a buffered solution or one that has an acid reaction or is not reactive with glass.

A

Type II Soda-Lime treated glass

57
Q

suitable for anhydrous liquids or dry substances.

A

Type III soda-lime glass

58
Q

glass container not suitable for parenterals.

A

NP - Non-Parenteral Soda-lime glass

59
Q

Commercially available
vary in size from

A

0.5 ml to 1,000 mL

60
Q

sizes obtained as ampoules and vials

A

up to 1000 mL

61
Q

size of single-dose container

A

1,000 mL

62
Q

size of multiple dose containers

A

30 mL

63
Q

are made up primarily of natural rubber (latex), a synthetic polymer or both.

A

closures

64
Q

in pharmaceutical preparations, means destruction of all living organisms and their spores or their complete removal from the preparation.

A

Sterilization

PDF LEC (4 decks)

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