Softgels Flashcards
What are soft gels?
consist of a liquid or a semi-solid matrix inside a one-piece outer gelatin shell
- either a water soluble or oil soluble liquid
- either a solution or suspension of drug
What are desirable characteristics of soft gels?
Elegant appearance
Easy to swallow
Masks odours
Contains correct dose
Improved bioavailability
Longer shelf-life
Shell ruptures rapidly
Fill-liquid released rapidly
Rapid therapeutic action
Safe
Efficient manufacturing process
Acceptable cost
What is the purpose of the following in soft gel manufacture?
die roll
die roll brush
stripper roller
medicine pump
injection wedge
lubrication rollers
cooling drum
cooling fan
die roll - individual capsules are formed, sealed and cut by cavities cut into the perimeter
die roll brush - removes any capsules remaining in the die rolls
stripper roller - removes any capsules remaining in the web
medicine pump - delivers metered and synchronised fill material into the injection wedge
injection wedge - heats the web and injects the fill material into the web to cause to material to fill the cavities in the die roll
lubrication rollers - applies lubricant to both sides of the web for encapsulation
cooling drum - cools and stores the gelatin web
cooling fan - aids in cooling the web for encapsulation
What is the rationale for choosing soft gels as a dosage form?
Improved drug absorption
- increased bioavailability, rate of absorption
- decreased plasma variability
Safety for potent and cytotoxic drugs
Can treat with oils and low melting-point drugs
Dose uniformity of low-dose drugs
- key benefit
Product stability
What are the types of formulations in soft gels?
coarse emulsion
micro/nano emulsion
fine suspension
- lipophilic
solution
- hydrophilic
How are nano/micro emulsions dissolved?
mechanism
- lipolysis
lipid formulation contains the dissolved drug
- spontaneously emulsifies in gastric juice
- nano/micro emulsion disperses
= micelles breakdown
What can soft gels consist of?
gelatin shell
- made of gelatin, plasticiser and water
enteric or delayed release coat
colours, opacifiers and flavours
How can absorption of hydrophobic drugs be improved?
formation of a nano/microemulsion without precipitation in gastro-intestinal tract
vehicle undergoing lipolysis
