lecture 6 - capsules Flashcards
capsules are a solid dosage form in which medicinal agents/excipients are enclosed in a small shell of what
either gelatin or synthetic polymers
what may be encapsulated in capsules?**
any liquid/solid/semisolid that DOES NOT DISSOLVE GELATIN (or synthetic polymers
true or false
liquids can be encapsulated in capsules
true they can
as long as they don’t dissolve gelatin/synthetic polymers
what are HGC and SGC
hard/soft gelatin capsules
which solid dosage form allows powders to be delivered in a LOOSE FORM**
capsules - do not need to be compressed!!! no granulation required
can be dispensed in UNCOMPRESSED form
true or false
capsules are more stable and easier to transport and store than liquids
true
true or false
capsules cannot be easily identified, which is a disadvantage
FALSE
they can many colors lines symbols
a disadvanttage of capsules is that they are subject to the effects of what 2 things**
relative humidity and microbial contamination
geltain and polymers can easily absorb water fro the air – becomes both stability and microbial issue bc they grow in free water
true or false***
a major disadvantage of capsules is that hygroscopic and deliquescent substances cannot be formulated into capsules
TRUE
will absorb the water from the shell and the shell will become brittle
what will happen if an efflorescent material is formulated into a capsule
water will be liberated and the shell will absorb, making the shell SOGGY
true or false
capsules are not suitable for pediatric patients
true - this is a disadvantage
name the components of hard gelatin capsules vs soft gelatin capsules
gelatin
water
sugar
for soft gelatin: gelatin, glycerin or sorbitol, preservatives, water
the larger and narrow portion of the capsule is called ___ while the wider and smaller called ____
larger and narrow - body
smaller and wider - cap
****typical moisture content of hard gelatin capsule
what happens if outside the range?
10-15%
if lower than 10 = brittle
higher than 15 = sticky
which are the most commercially used and also easier to compound in the facility - soft or hard gelatin capsules
hard
what is added to hard gelatin capsules to make them opaque
titanium dioxide
what is the purpose of glycerin or sorbitol being in a soft gelatin capsule
as a plasticizer - makes the capsule elastic and pliable
which capsules contain preservatives and why
SOFT GELATIN - bc they have high moisture content at greater than 20%***888
how are soft gelatin capsules sealed
HERMETICALLY - no cap and body like hard
true or false
soft gelatin capsules are difficult to compound
true
true or false
soft gelatin capsules can incorporate volatile liquids
false
only water miscible or immiscible NON volatile liquids
what is the main component of a capsule shell
gelatin
explain the solubility of gelatin and how this is used to our advantage
insoluble in COLD WATER
soluble in HOT water – warm gastric fluid!!! rapidly dissolves in stomach to expose the drug and become available for absorption
as mentioned, gelatin is insoluble in cold water
however,
softens up by absorbing water – up to 10x its weight – this is how capsules lose their integrity
what is a major patient-related issue with capsules
has gelatin in it — relgious or dietary reasons – pt may not want
what are the types of gelatin and where do they come from
what does each contribute to?
Type A - comes from pork skin - contributes to plasticity and clarity
Type B - comes from animal bones - contributes to firmness
they’re both combined to obtain optimal shell characterisitics
type a gelatin is prepared by ___ while type b gelatin is prepared by ____
type a - acid hydrolysis
type b - alkaline hydrolyssi
which is NOT a gelatin alternative**
pullulan
plantcaps
hypromellose
conisnap
vcaps
conisnaps
name 2 gelatin alternatives and give an example of each*****
pullulan (polysaccharide) —- PLANTCAPS
cellulose derivatives - HPMC (hypromellose) — VCAPS
name 2 tamper resistant capsule shells
coni snap
coni snap supro
explain the 3 features of coni snap that make it tamper evident
tapered rims to avoid telescoping
indentations/dimples to prevent premature opening
locking grooves that lock the 2 parts after capsule is filled
basically, once it clicks it’s extremely difficult to reopen it
what is the difference between coni snap and coni snap supro
coni snap supro has all the features of coni snap except it is smaller and has the lower protion of the capsule concealed except for the very end where it is rounded — makes it more difficult to open
more tamper resistant
what is the GOAL of the API content in capsules
plus/minus 5% of prescribed amount (doesnt NEED to be - but that’s goal)
TRUE OR FALSE
the powder incorporated into capsules should be uniform in size and fine state of subdivision
true
use particle size reduction methods like trituration to achieve this reduction in particle size as well as uniform mixture
when calculating amount of powder to make for capsules what is very important to consider
there’s risk for losing powder - CALCULATE FOR 2 EXTRA CAPSULES
in compounding capsules, the ___ is always filled and not the ____
body is filled and not the cap
name 2 techniques to achieve uniform distribution for the powder incorporated into capsules
trituration and geometric dilution
d.t.d
give of such dose
give 3 ex of inert diluent used in capsules
lactose
sucrose
dextrin
lactose is most frequently used as diluent for capsules
what are options for lactose intolerant patients
calcium or mg salts
sucrose
dextrin
starch
what is the largest capsule size and what is the smallest*****
largest is 000
smallest is 5
the weight of your capsules will differ depending on….
the density of your powder mixture
TRUE OR FALSE
the SMALLEST capsule size that is able to hold your powder mixture is preferred
TRUE
name 3 ways that capsule size can be determined
- best way is by trial
- rule of 6
- rule of 7
rule of 6 is fairly accurate when the bulk density of the powdered material is about….
0.6g/mL
explain how to do the rule of 6****
6-cap size
that result is the weight in GRAINS
1 grain = 65mg
grains to mg conversion***
1 grain = 65mg
differentiate between the weight variation tests of hard gelatin vs soft gelatin capsules**
hard gelatin - 10 capsules weighed individually
soft gelatin - gross weight of 10 capsules determined individually. each capsule cut open and contents are removed with a solvent. this solvent is evaporated at room temp and the empty dried shells are weighed
net content weight calculated from difference of gross weight - capsule shell
in content uniformity testing for capsules, ____ out of ____ should have drug strength in what range
9/10
85%-115%
what is moisture permeation test
done on capsules
dessicant pellet will change color in the presence of moisture
also, pre and post test weights are measured to determine how much water absorbed — weight changes
differentiate between disintegration test and dissolution test
disintegration - how long capsule content disintegrates completely into a soft mass with no firm core.
dissolution - rate at which the drug is being released
