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Pharmacy Practice Lab > Lab 11 > Flashcards

Lab 11 Flashcards

1
Q
A
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2
Q

Sterile means

A

Free from all microorganisms

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3
Q

Preparations must be sterile when….

A

-there is a possibility of infection
-when they are instilled directly into body tissues and cavities, bypassing the natural defenses of the body

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4
Q

Explain ophthalmic preparations

A

STERILE, can be liquid, semi-solid, or solid preparations that contain 1 or more APIs

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5
Q

Ophthalmic preparations are intended for application where?

A

To the conjunctiva, conjunctival sac, or the eyelids

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6
Q

Ophthalmic preparations are applied _____ to the eye to treat ____, ____, ____, and ——-

A

Ophthalmic preparations are applied TOPICALLY to the eye to treat INFECTION, ALLERGY, GLAUCOMA, and during the OCULAR EXAMINATION

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7
Q

the choice of base and any excipients used for ophthalmic preparations must be proven, through product development studies, not to what?

A

Adversely affect either the STABILITY OF THE FINAL PRODUCT or the AVAILABILITY OF THE ACTIVE INGREDIENTS AT THE SITE OF ACTION

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8
Q

is the addition of coloring agents recommended for ophthalmic preparations ?

A

NO. NOT RECOMENDED

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9
Q

Ophthalmic preparations supplied as_____ may include a suitable antimicrobial agent UNLESS______?

A

Ophthalmic preparations supplied as MULTIDOSE PREPARATIONS may include a suitable antimicrobial agent UNLESS THE ACTIVE INGREDIENT ITSELF HAS ANTIMICROBIAL ACTIVITY

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10
Q

The antimicrobial activity in ophthalmic preparations should remain effective for how long?

A

Should remain effective throughout the entire period of use

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11
Q

Name the different categories of ophthalmic preparations

A

Drops consisting of EMULSIONS, SOLUTIONS, SUSPENSIONS, AND OINTMENTS

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12
Q

what is the capacity of the eye ?

A

5-10 microliters

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13
Q

For most droppers, 1 drop measures about….

A

50 microliters

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14
Q

As mentioned, the capacity of the eye is 5-10 microliters. For most droppers, 1 drop measures about 50 microliters.

What can you conclude from this?

A

The excess solution that the eye cannot hold is quickly flushed away within a couple of minutes.

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15
Q

WHY is drug absorption through the eye very limited?

A

Due to the thickness (several layers) and composition of corneal and scleral tissue.

Only a small fraction of drug applied is absorbed through eye tissue

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16
Q

WHY are viscosity-enhancing agents included in ophthalmic preparations?

A
  1. To decrease the frequency of administration
  2. Increase the corneal contact time
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17
Q

What is a downside to adding viscosifiers to ophthalmic preparations?

A

May cause blurry vision

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18
Q

What is added to eye formulations for their soothing and emollient action?

A

Lubricants

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19
Q

Give an example of a lubricant used in ophthalmic preparations

A

Hydroxypropyl methyl cellulose

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20
Q

True or false

Ophthalmic preparations must be prepared in a sterile environment

A

TRUE

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21
Q

Opthalmic solutions must contain ____ to maintain sterility

A

Preservatives

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22
Q

Name 4 common opthalmic preservatives

A

-chlorobutanol
-phenylmercuric acid acetate
-thimerosal
-benzalkonium chloride

23
Q

Benzalkonium chloride concentration in eye preparations is ____%

A

0.01%

24
Q

Function of EDTA

A

Chelating agent

25
Q

What 2 things are used together in eye preparations to increase effectiveness against the pseudomonas bacteria ?

A

EDTA and benzalkonium chloride

26
Q

Ideally, the pH of opthalmic drugs should be ____

A

Physiologic pH (7.4)

27
Q

The pH and buffering agent selected for opthalmic formulations should be optimal for both the —— and ——-

A

For both the STABILITY OF THE API and the PHYSIOLOGICAL TOLERANCE

28
Q

When 1-2 drops are added to the eye, what adjusts the pH enough to prevent any kind of discomfort ?

A

THE BUFFERING CAPACITY OF THE LACRIMAL FLUID

29
Q

When a buffer system is used in opthalmic formulation, it must not cause ____ or ____ of the active ingredient

A

Precipitation or deterioration

30
Q

For ophthalmic preparations, pH range of _____ is acceptable

A

4-9

31
Q

Is atropine sulfate an acidic or basic drug?

A

Basic

32
Q

Basic drugs are usually UNSTABLE at _______ (higher or lower) pH and may precipitate out of solutions

A

Higher

33
Q

True or false

Only active ingredients contribute to osmotic pressure

A

FALSE — both active and inactive ingredients contribute

34
Q

Ophthalmic solutions are made isotonic using _____ and _____

A

Sodium chloride and boric acid

35
Q

The amount of boric acid required to maintain isotonicty of opthalmic preparations is calculated how ?

A

Using sodium chloride equivalents

36
Q

Name the 6 routes used for injections

A

-intravenous
-intramuscular
-subcutaneous (into skin)
-intradermal (just beneath the dermis)
-intrathecal (in spinal cavity)
-intra-arterial

37
Q

What is unique about injections ? What can you conclude from this ?

A

They skip the natural defense systems and are delivered directly into the body

Therefore, they must be prepared with great care to prevent infection and toxicity

38
Q

Injectable and sterile irrigation solutions must be _____ free. Explain why

A

Pyrogen

Pyrogen is a metabolic byproduct of living microorganisms. In humans, pyrogens cause febrile (fever) reactions and cutaneous vasoconstriction

39
Q

How are pyrogens removed from opthalmic preparations ?

A

By treating with chemicals OR with the use of heat (250 degrees Celsius for at least 30 mins)

40
Q

True or false

Injectable solutions can be made up of both aqueous and non-aqueous solvents

A

TRUE —- all dependent on solubility and stability of the active compound

41
Q

Name 3 commercially available non-aqueous injectable formulations

A

-cyclosporin
-lorazepam
-haloperidol

42
Q

STERILIZATION means….

A

The destruction of ALL living organisms AND spores or their complete removal from the preparation

43
Q

Name the 5 general methods used to sterilization

A

-moist heat or steam
-dry heat
-filtration
-gas
-ionizing radiation

44
Q

The sterilization method is selected based on what?

A

The nature of the ingredients and the method of preparation

45
Q

True or false

Sterilization method chosen MUST be compatible with the stability of the ingredients and at the same time assure sterility

A

TRUE

46
Q

What is generally the sterilization method of choice ? Why? Explain how it works

A

Moist heat sterilization is generally the chosen method because it is the MOST EFFECTIVE and requires LOWER TEMP THAN DRY HEAT STERILIZATION (121 degrees Celsius for 20-30 mins vs 150-170 degrees Celsius for at least 2 hours)

47
Q

Filtration method of sterilization is used for ________. How does it perform its task?

A

Filtration is used for SOLUTIONS and it physically removed the microorganisms from the solution

48
Q

Filtration method of sterilization uses a filter with a pore size of _____

A

0.2 microns

49
Q

Filtration method of sterilization uses a filter with a pore size of 0.2 microns.
What can you conclude from this?

A

It will filter out most bacteria but is not suitable against viruses

50
Q

Name 3 ways in which the manufacturing area is maintained sterile

A

-using UV light
-filtered air supply
-sterilizing all sterilizing equipment and glassware befor use

51
Q

True or false

Rigid aseptic procedures are required to assure sterility

A

TRUE

52
Q

———— are designed to prevent microbial and particulate contamination in the workspace

A

LAMINAR FLOW HOODS

53
Q

Explain how laminar flow hoods work

A

Provides a steady stream of filtered sterile air that pushes out any microbial and particulate contamination from the workspace.

The air stream flows vertically in a vertical laminar flow hood (protects the user) and horizontally in the horizontal laminar flow hood

Provides an aseptic work area and contains the infectious splashes or aerosols generated during preparation

Pharmacy Practice Lab (10 decks)

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