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Pharmaceutical Sciences > Pharm Sci 2 Exam 2 > Flashcards

Pharm Sci 2 Exam 2 Flashcards

1
Q

3 parts of product quality paradigm

A
  1. Product performance characteristics
  2. Manufacturing
  3. Product composition
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2
Q

Product Performance characteristics always done after product is finished

A

Assay, disintegration, content uniformity, dissolution

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3
Q

What defines “Qualified” testing?

A

Telling the FDA how you are going to analyze

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4
Q

T/F Certificate of Analysis are given to drug-product formulas

A

False, given to drug-product batches

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5
Q

Accuracy

A

How close are the individual values to the desired value

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6
Q

Precision

A

How reproducible are the individual values

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7
Q

Weight variation uniformity

A

Needs greater than 25 mg of API and greater than 25% ratio of API weight to total DP weight

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8
Q

Content Uniformity

A

Assay individual units, superior to WV and can always be used

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9
Q

When is content uniformity always used?

A

Soft capsule containing suspension, emulsion, or gel

Non-film coated tablets

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10
Q

What happens if a batch fails the content uniformity test?

A

Cannot legally be sold

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11
Q

Describe friability

A

Helps to determine if the tablets can make it through the shipping process, how rough can you be before they break

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12
Q

Describe the use of a roche friabilator

A

Tablets = 6.5 g or 10 tablets if weight is greater than 650mg. Tablets dropped in and revolves

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13
Q

Describe the hardness test

A

Uses schleuniger tablet hardness tester to determine how much load can be applied before it cracks

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14
Q

Describe the disintegration test

A

In simulated GI fluid, arm moves up and down. 16/18 tablets must disintegrate and pass through the mesh screen below each cylinder

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15
Q

What two dissolution apparatuses are used most often?

A

Basket and paddle

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16
Q

Dissolution basket method is used for

A

Capsules and floating tablets

17
Q

Dissolution paddle method is used for

A

Tablets

18
Q

What are the factors of stability that are tested?

A

Temperature, humidity, light, formulation components, container system

19
Q

How can moisture permeation be tested?

A

Use a color-revealing desiccant pellet and expose to moisture

20
Q

Shell of soft gelatin capsules

A

Plasticized gelatin

21
Q

Content of soft gelatin capsules

A

Solutions, suspensions, or semisolids

22
Q

Closure of soft gelatin capsules

A

Hermetically sealed

23
Q

Shell of hard gelatin capsules

A

Rigid, not plasticized

24
Q

Content of hard gelatin capsules

A

Dry solids, semisolids, or liquids

25
Q

Closure of hard gelatin capsules

A

Banding or mechanical interlocking

26
Q

Advantages of soft gelatin capsules

A

accurate and precise, can be quickly filled and easily dissolve, enhanced bioavailability

27
Q

Advantages of hard gelatin capsules

A

Better bioavailability, easier to formulate, mask taste or smell, easier to swallow

28
Q

Disadvantages of soft gelatin capsules

A

Need special equipment, some partitioning from drug into shell, costly

29
Q

Disadvantages of hard gelatin capsules

A

Requires blending and lubrication, hydroscopic drugs change water content and cannot be dispensed, subject to microbial growth, costly

30
Q

Requirements of all hard gelatin capsule formulations

A
  1. Must be uniform
  2. Must release API in a form available for dissolution and subsequent absorption
  3. Must comply with requirements
31
Q

Effect of lubricant on release

A

decreases the amount dissolved

32
Q

Effect of disintegrate on dissolution

A

Decreases time needed to release

33
Q

What type of capsule is widely used?

A

Starch capsule

34
Q

What makes Quali-V capsules hypoallergenic?

A

HPMC

35
Q

What makes Quali-V capsules better than hard gelatin capsules?

A

Low moisture content, less brittle, suitable to be automatically filled, less moisture uptake

36
Q

Commonly used capsules are sized 0-4, what are the biggest?

A

0

37
Q

Name four shapes of soft capsules

A

Spherical, ovoid, tubes, pear shaped

38
Q

What is the benefit of particulate dosage forms?

A

Easy to inject and adapt to other routes

Pharmaceutical Sciences (2 decks)

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