Pharm Sci 2 Exam 2

Question 1

3 parts of product quality paradigm

Answer 1

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

Question 2

Product Performance characteristics always done after product is finished

Answer 2

Assay, disintegration, content uniformity, dissolution

Question 3

What defines “Qualified” testing?

Answer 3

Telling the FDA how you are going to analyze

Question 4

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

Answer 4

False, given to drug-product batches

Question 5

Accuracy

Answer 5

How close are the individual values to the desired value

Question 6

Precision

Answer 6

How reproducible are the individual values

Question 7

Weight variation uniformity

Answer 7

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

Question 8

Content Uniformity

Answer 8

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

Question 9

When is content uniformity always used?

Answer 9

Soft capsule containing suspension, emulsion, or gel

Non-film coated tablets

Question 10

What happens if a batch fails the content uniformity test?

Answer 10

Cannot legally be sold

Question 11

Describe friability

Answer 11

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

Question 12

Describe the use of a roche friabilator

Answer 12

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

Question 13

Describe the hardness test

Answer 13

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

Question 14

Describe the disintegration test

Answer 14

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

Question 15

What two dissolution apparatuses are used most often?

Answer 15

Basket and paddle

Question 16

Dissolution basket method is used for

Answer 16

Capsules and floating tablets

Question 17

Dissolution paddle method is used for

Answer 17

Tablets

Question 18

What are the factors of stability that are tested?

Answer 18

Temperature, humidity, light, formulation components, container system

Question 19

How can moisture permeation be tested?

Answer 19

Use a color-revealing desiccant pellet and expose to moisture

Question 20

Shell of soft gelatin capsules

Answer 20

Plasticized gelatin

Question 21

Content of soft gelatin capsules

Answer 21

Solutions, suspensions, or semisolids

Question 22

Closure of soft gelatin capsules

Answer 22

Hermetically sealed

Question 23

Shell of hard gelatin capsules

Answer 23

Rigid, not plasticized

Question 24

Content of hard gelatin capsules

Answer 24

Dry solids, semisolids, or liquids

Question 25

Closure of hard gelatin capsules

Answer 25

Banding or mechanical interlocking

Question 26

Advantages of soft gelatin capsules

Answer 26

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

Question 27

Advantages of hard gelatin capsules

Answer 27

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

Question 28

Disadvantages of soft gelatin capsules

Answer 28

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

Question 29

Disadvantages of hard gelatin capsules

Answer 29

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

Question 30

Requirements of all hard gelatin capsule formulations

Answer 30

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

Question 31

Effect of lubricant on release

Answer 31

decreases the amount dissolved

Question 32

Effect of disintegrate on dissolution

Answer 32

Decreases time needed to release

Question 33

What type of capsule is widely used?

Answer 33

Starch capsule

Question 34

What makes Quali-V capsules hypoallergenic?

Answer 34

HPMC

Question 35

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

Answer 35

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

Question 36

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

Answer 36

0

Question 37

Name four shapes of soft capsules

Answer 37

Spherical, ovoid, tubes, pear shaped

Question 38

What is the benefit of particulate dosage forms?

Answer 38

Easy to inject and adapt to other routes