Softgel Capsules

softgel capsules

are one piece, hermetically sealed, soft gelatin shells containing fill material

shell

_________ componants: gelatin, plasticizer, and water

gelatin

shell component that provides the shell structure and strength

placticizer

shell component that delivers the shell softness or elacticity

water

shell component that is a processing aid that allows the gel mass to be manufactured; solubilizes the gelatin and plasticizer

minums

volume of softgel is based on ___________

16.23

1 mL = ___________ minums

advantages

___________ of softgels:

-enhanced absorption of poorly soluble drugs because there is more drug in solution and better permeability across the GI wall

-improved stability of drugs: protect against oxidative degredation, lipophilic systems protect against hydrolysis, against photodegradation

-safer handling of potent drugs

-dosage accuracy for low dose drugs

-elegance

-ease of swallowing

-adaptibility

-product security

-product identification

uniformity of dose

the _____________ _____ ________ for solutions is generally less than +/- 1% and +/- 3% for suspensions

disadvantages

________________ of softgel capsules:

-more interaction with the liquid material and capsule shell

-active drug can migrate into the capsule shell acting as a "initial dose"

-drug may leach out

versitility

softgel capsules provide ______________ in the fill material, pH of the fill material, and routes of administration

2.5

pH less than __________ hydrolyzes gelatin

7.5

pH greater than _____________ degreases gelatin solubility

primary

swallowing or chewing are the ____________ routes of administration

secondary

rectal, vaginal, or topical dermatological and cosmetic are the ____________ routes of administration

viscocity

flow property of gelatin solution related to gelatin chain length

bloom strenth

how strong a solution of gelatin is related to hydrogen bonding between gelatin chains

glycerin

plasticizer that is primarily used for lipophilic fills; migrages into hydrophilic fills

sorbitol

placticier that is non-migrating into fill

sorbitol special blend

plasticizer that is a blend of sorbitol and glycerin to prevent blooming

polysorb

plasticizer that contains sorbitol and sorbitans, is non-migrating into fill, and does not bloom

manufacturing

key_____________ steps:

1) fill material preparation

2) gelatin preparation

3) encapsulation

4) packaging

plate process

method of softgel manufacturing in which there is one layer of gelatin, add the drug, and then add the second layer

rotary die process

method of softgel manufacturing in which the fill material gets placed between two gel ribbons forming capsules

acogel process

softgel manufacturing process that is the rotary process for powders and granules

bubble method

manufacturing process in which concentric tube dispensers simultaneously discharge the molten gelatin from the outer rim and liquid content from the inner part of the tube

in-process

_______________ testing:

-seal checks

-fill and shell weights

-bubble light check

bulk

________ capsule testing:

-microbiological testing

-potency assay/content uniformity

-dissolution

-acceptable quantity limit (AQL)

AQL (acceptable quality limit)

the worst-case quality level, expressed as a percentage of defects in a population that is still considered acceptable

BSE (Bovine Spongiform Encephalopathy)

"mad cow" disease caused by a prion; preventative measures are in place since gelatin comes from animal tissues