Hard Gelatin Capsules

collagen

gelatin comes from ______________

animal tissue

collagen comes from ___________________________: skin, bone, sinew, connective tissue

thermoreversible

liquid when hot and solid when cold

insoluble

gelatin is ___________ in cold water but can absorb up to 10 times its weight in water

soluble

gelatin is __________ in both warm water and warm gastric fluid

capsule

hard gelatin ___________ made of gelatin and water plus colorants, opacifying agents, and preservative

evaluation

tests bloom strength and viscosity

bloom strength

measure of gel rigidity

tapered rim

part of the capsule design that engages easily with the cao for problem-free closure

air vents

part of the capsule design that allow air to escape from the cap, which is critical when operating high speed filling machines

locking rings

part of the capsule design that provides full-circumference leak-free closure

dimples

part of the capsule design that maintains precise round capsule diameter, improving filling machine performance

larger

the _______ the capsule number, the smaller the size

veterinary

capsule sizes 000 and 00 are typically only for ________________ use

13-16

moisture content of capsules is ________%

water from pasule shell can and will equilibrate throughout package system

35-65

recommended relative humidity to store capsules

brittle

if capsules are stored at too low RH, water flows out of the capsules and they become _________________

swell

if capsules are stored at too high RH, water flows in to the capsules and they _____________

packaging

_______________ material must include polyethylene, polypropylene, PVC, PVDC, and aluminum foil

HPMC

alternative to gelatin; synthetic polymer that is more resistant to changes in relative humidity

gelatin crosslinking

causes formation of swollen, rubbery, water insoluble membrane (pellicle) during dissolution testing; insoluble film acts as a barrier to drug release; catalyzed by high humidity because it decomposes a stabilizer in corn starch forming ammonia and formaldehyde which can cause XL reactions

aldehydes

catalyst for chemical crosslinking of gelatin; present in active, excipients or packaging materials

liquid and semi-solid

___________ and _______________ filling eliminates dust, is good for potent drug containment, and dose uniformity

aguer fill

capsule filling method in which empty capsule bodies are held in a metal ring rotates under powder hopper

vibratory fill

capsule filling mechanism in which the capsule bodies pass under a powder feed frame; the feed frame has a perforated resin plate connected to a vibrator

piston tamp fill

capsule filling technique in which powders are converted into plus/soft tablet before filling in the capsule

ex: dosing disk, dosator

lubricity

formulation requirement for efficient plug ejection to prevent filming and reduce friction of sliding components

compactability

formulation requirement because coherent plugs are desirable for clean plug ejection

flow

formulation requirement if needed in auger feed in hopper aids filling of formulations with poor flow

lower

capsules have a ___________ compression force than tablets

greater

capsules have a _____________ height to diameter ratio than tablets

greater

tablets have a much ____________ breaking strength (hardness) than tablets

banding

prevents opening capsule (tampering), leakage of powders, liquids, congealing of semi-solids, and adds visual contrast

compendial tests

according to USP 36:

-identification

-assay (potency)

-impurities

-dissolution

-disintegration