Capsules & USP Ch. 795

Question 1

Components of USP Chapter 795 most pertinent to nonsterile compounding

Answer 1

1. personnel are appropriately trained
   
   2. ingredients are of high quality and purchased from reliable sources
   3. bulk containers are labeled
   4. equipment is clean
   5. environment is suitable
   6. only authorized personnel allowed in area
   7. processes are reproduceable
   8. procedures are adequate for preventing errors
   9. appropriate documentation
2. procedures/records are kept to investigate/correct failures

Question 2

BUD for capsules

Answer 2

non-preserved aqueous - 14d
preserved aqueous - 35d
non-aqueous - 90d
solid form - 180d

Question 3

BUD - non-preserved aqueous

Answer 3

14 days

Question 4

BUD - preserved aqueous

Answer 4

35 days

Question 5

BUD - non-aquous

Answer 5

90 days

Question 6

BUD - solid form

Answer 6

180 days (6 months)

Question 7

Describe record keeping components as recommended by USP 795 (5)

Answer 7

1. comply w/ state board of pharmacy
2. kept for same period of time that rx is kept under state law
3. include master formulation record AND compounding record
4. standard operating procedures in place
5. material safety data sheets file

Question 8

Advantages of Capsules (5)

Answer 8

1. mask unpleasant taste/smell/appearance
2. dissolve/abs more quickly than tablets
3. admin via multiple routes (oral, inhale, rectal)
4. easier to swallow
5. can delay drug release if DR

Question 9

Disadvantages of Capsules (4)

Answer 9

1. can be tampered with
2. humidity/moisture concerns
3. aqueous liquids dissolve shell
4. cannot use hydroscopic/deliquescent materials

Question 10

Rule of 7s is used to…

Answer 10

determine capsule size

Question 11

largest size capsule

Answer 11

size 000

Question 12

smallest size capsule

Answer 12

5

Question 13

Rule of 7s:

Answer 13

a. convert capsules to grains (using the total mg “qs to” on rx – total wt of capsule)
b. subtract that value from 7
c. round to nearest whole #
d. try this capsule 1st

Question 14

1 gram = ___ grains

Answer 14

15.43 grains = 1 gram

Question 15

USP Chapter 795

Answer 15

standards for compounding nonsterile mediations to ensure patient benefit and decr risk of contamination, infection, or incorrect dosing

Question 16

Master Formulation Record

Answer 16

recipe for compound

Question 17

Compounding Record

Answer 17

more specific to actual product you are making —- sheet we write on at work to record materials used/exp dates/amounts/etc

Question 18

excipient

Answer 18

inactive ingredient

Question 19

examples of excipients

Answer 19

a. fillers - bulking agents
b. binders - physical integrity (tablets)
c. glidants - mold release
d. disintegrants - aids in GI abs
e. coloring agents - pharm elegance
f. flavoring agents - patient compliance

Question 20

capsule storage points

Answer 20

1. avoid areas of high humidity
2. place cotton on top of vial to abs moisture

Question 21

when weighing out powder….

Answer 21

always weigh out enough powder to include 1 extra dose (without actually making that extra dose)

Question 22

capsule procedure

Answer 22

1. count out # of capsules – empty and weigh contents
2. weight out mass of capsule content needed for 1 dose — place in glass mortar
3. weigh out mass of bulking agent you are qs-ing to (for 1 dose)
4. geometrically combine 2 powders and transfer to pill tile
5. fill # size #X capsules each with the desired total mass
6. polish and place capsules in dispensing vial
7. label and dispense