Lecture 2 Capsules

Question 1

What are the capsule components?

Answer 1

Active ingredients, Diluent or filler, Disintegrant, and Lubricant/glidant

Question 2

What is an example of diluent or filler in a capsule?

Answer 2

lactose, microcrystalline cellulose (brand name Avicel), and starch(absorbs moisture)

Question 3

What does a disintegrant do?

Answer 3

facilitates break-up and distribution of the capsule’s contents. Helps break it up once its in the body.

Question 4

What is an example of a disintegrant?

Answer 4

pregelantinized starch, croscarmellose, and sodium starch glycolate

Question 5

What does a lubricant/glidant do?

Answer 5

improve powder flow (want to use small amount)

Question 6

What is an example of a lubricant/glidant in a capsule?

Answer 6

Fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid, or talc

Question 7

How do you select a capsule size?

Answer 7

Trial and error but you can narrow your search by: Compare formulation characteristics to the characteristics of a known drug, volume occupied, The rule of sixes, the rule of sevens.

Question 8

What do you convert to when using rules of 6’s and rules of 7’s?

Answer 8

grains (65 mg in 1 grain)

Question 9

What does a hard gelatin capsule made of?

Answer 9

A body and a cap.

Question 10

When compounding a control substance you make extra capsules. T/F

Answer 10

False

Question 11

When developing the formulation and selection of capsule size you need to consider…

Answer 11

Accurate dosage, good bioavailability, ease of filling and production, stability, and elegancy(want them to look full and no powder on side).

Question 12

When compounding a potent powder what do we need to consider?

Answer 12

it needs to be evenly distributed (geometric dilution)

Question 13

What would you put a tablet within a capsule?

Answer 13

Protect from light, clinical trials (all look the same).

Question 14

What types of quality control would you do on capsules?

Answer 14

Drug content, fill weight, disintegration, dissolution, and stability.

Question 15

What types of preparations are there of capsules?

Answer 15

Extemporaneous (punch method and small capsule filling machines, 100-3–), Industrially (automated filling machines)

Question 16

What is disintegration testing?

Answer 16

Test drug by assimilating conditions in body (37 C temperature, gastric juices,) to see if drug will disintegrate in body.

Question 17

What is dissolution testing?

Answer 17

Test to see if the drug has actually gone into solution.

Question 18

What can the weight variation be according to USP?

Answer 18

Capsule shall not be less than 90 percent and not more than 110 percent of the theoretical calculated weight of each unit.

Question 19

What is content uniformity?

Answer 19

The amount of active ingredient should be within 85 to 115 percent of the label claim for 9 out of 10 dosage with no unit outside of 70 to 125 percent of label claim.

Question 20

What is the content labeling requirement?

Answer 20

Capsules must be labeled to express the quantity of each active ingredient in each dosage unit.

Question 21

What is stability testing?

Answer 21

Intrinsic stability of active drug molecule under different environmental factors (temperature, humidity, light, formulation components, and container and closure system).

Question 22

What is the USP 795 require in regards to stability?

Answer 22

6 months if prepared from USP/NF ingredients or 25% of remaining expiration dating if prepared from commercial products unless evidence is available to support other dating

Question 23

What is the moisture permeation test?

Answer 23

single-unit and unit-dose containers to ensure stability for packaging.

Question 24

What is a solid dosage form inn which the durg is enclosed within a hard or soft soluble container or shell. The shells are usually made from gelatin; however, they may also be made from starch or other suitable substances

Answer 24

Capsules

Question 25

What are the advantages of capsules?

Answer 25

Mask unpleasant tastes, aromas and appearances of a drugEasy to prepareCan vary dosage and combination of drugsEasy to swallowSolubilityStabilityEasy to carry

Question 26

What are the disadvantages of capsules?

Answer 26

Easily tampered withsensitive to humidity and microbial contaminationDifficult for some populations to swallowUnsuitable for aqueous liquidsNot suitable for administering very soluble ionic salts

Question 27

How is gelatin obtained?

Answer 27

From partial hydrolysis of collagen from skin, white connective tissue and bones of animals.

Question 28

Hard Gelatin Capsules are stable in air when dry, but subject to microbial decomposition when moist. T/F

Answer 28

True

Question 29

Hard Gelatin Capsules contain no moisture. T/F

Answer 29

False, they contain 13-16 percent moisture

Question 30

Hard Gelatin Capsules may absorb additional moisture and lose their rigid shape in high humidity. T/F

Answer 30

True

Question 31

Hard Gelatin Capsules may gain moisture in extreme dryness. T/F

Answer 31

False, Hard Gelatin Capsules may lose normal moisture in extreme dryness which leads them to become dry and brittle.

Question 32

What sizes do capsules run in? What is largest and what is smallest?

Answer 32

000 (largest) to 5 (smallest)

Question 33

How do you select an appropriate capsule size?

Answer 33

Compare formulation characteristics to the characteristics of a known drugVolume occupiedThe rule of sixesThe rule of sevens

Question 34

What is the rule of sixes?

Answer 34

Bulk densities of many powders average about 0.6 g/mL

Question 35

What is the rule of sevens?

Answer 35

Convert formulation weight to grains (65mg in 1 grain), subtract from seven; use table to determine appropriate size. *Only works if calculated values are between -3 and 5.

Question 36

How do you measure how much of the drug is being released?

Answer 36

By measuring the concentration of drug in the solution by dissolution testing.

Question 37

What is the capsule weigh variation?

Answer 37

Capsule weight should be not less than 90% and not more than 110% of the theoretical calculated weight of each unit.

Question 38

What is the content uniformity variation?

Answer 38

The amount of active ingredient should be within 85% to 115% of the label claim for 9 out of 10 dosage units assayed, with no unit outside of 70% to 125% of label claim.