Lecture 2: Capsules/USP

Question 1

USP

Answer 1

non profit science organization
no role in enforcement, but can be adopted into government/organization worldwide
develops and disseminates quality standards

Question 2

USP 795

Answer 2

General chapter
Standards for nonsterile compounding
1. general principles
2. stability criteria and BUD
3. compounding documentation
4. facilities, equipment, storage, handling
5. quality control, patient counseling, training
6. animal patients
7. responsibilities

Question 3

Stability criteria and BUD

Answer 3

BUD: date/time after which CSP or CNSP may not be stored or transported
- calculated from the time of compounding
D date and time after which the compounded prep is at risk for chemical degredation, microbial contamination, impact on integrity of container-closure system

Question 4

Compounding Documentation

Answer 4

enables compounder to systematically trace, evaluate, replicate steps

Question 5

What should compounding documentation include?

Answer 5

1. Master formulation record
2. compounding record
3. standard operating procedures (SOP)
4. material safety data sheets (MSDS)

Question 6

How long do you retain compounding documentation records?

Answer 6

must comply with SBOP
Retained for same time as any RX

Question 7

Master formulation record vs compounding record

Answer 7

Master formulation - recipe
Compounding record - data & tracking info (lot, exp, RPh initial, BUD)

Question 8

Advantages of capsules

Answer 8

1. masks bad smell, taste, appearance
2. loose powder inside absorbs faster
3. many routes of administration (oral, inhalation, rectal)
4. easier to swallow than tablets
5. DR formulation available

Question 9

Disadvantages of capsules

Answer 9

1. can be tampered with
2. humidity/moisture concenerns
3. Dry - crack; humid-dissolve
4. Can’t contain hydroscopic or deliquescent materials
5. aqueous liquids dissolve gelatin shell

Question 10

how many capsule sizes are there?

Answer 10

Eight different sizes for human use
* 000 (largest)
* 00
* 0
* 1
* 2
* 3
* 4
* 5 (smallest)

small size better for children
large size better for sprinkling

Question 11

Rule of 7

choosing a capsule size

Answer 11

1. convert capsule amount to grains
2. calculate: 7– grains = capsule #
3. round # to nearest whole number

Question 12

converting mg to grains

Answer 12

1000 mg = 15.43 grains
1g = 15.43 grains

Question 13

Excipients

Answer 13

1. fillers
2. binders
3. glidants
4. disintegrants
5. coloring agents
6. flavoring agents
7. etc

Question 14

fillers

Answer 14

solid qs agents aka bulking

Question 15

Binders

Answer 15

for tablets
maintain physical integrity

Question 16

Glidants

Answer 16

help with mold release

Question 17

Disintegrants

Answer 17

aid in GI absorption

Question 18

Coloring agents

Answer 18

aesthetic, elegance

Question 19

Flavoring

Answer 19

compliance

Question 20

Capsule quality control

Answer 20

+/- 5% of capsule dose mass
if dose = 400mg
acceptable mass +/- (0.05*400mg)

Question 21

Capsule compounding

Answer 21

1. make 1 extra dose
2. calculate bulking agent amount (total trituration mass)
3. determine capsule size

Question 22

Capsule procedure

Answer 22

1. count out _+1 extra dose amount of drug source, empty and weigh contents (____g)
2. weight out (____g) of capsule content mass. place in glass mortar
3. weight out (_____g) of bulking agent. Geometrically combine with mortar contents
4. transfer contents to pill tile
5. fill # capsules of capsule size each with ____mg of trituration using the punch method
6. polish capsules and place in dispensing vial
7. label vial and dispense