L54 - Processing of capsules Flashcards
What are capsules like in pharmacy?
edible package filled with formulation to produce a unit dose
What are the types of capsules? (2)
- regular capsules (hard/soft gelatin or HPMC)
- controlled release systems (coated granules/dispersion)
What is HPMC?
HydroxyPropylMethylCellulose
What are the uses of hard shell capsules? (3)
- alternative oral dosage form to tablet (may not be first choice due to speed of production)
- dry powder inhalers
- fills of alternatives formulation (beads, pellets, semi-solid fills)
What are other uses of hard shell capsules? (4)
- rapid development programmes
- bulk drug in capsule
- drugs not suitable for compression
- binding of other dosage forms for clinical trials
What is gelatin?
protein substance commonly derived from collagen in the tendons, ligaments, and tissues of animals
What is gelatin produced by?
partial hydrolysis of connective tissues, bones and skin of animals
What are the 2 types of gelatin?
- type A - produced by acid hydrolysis
- type B - produced by basic hydrolysis
What does gelatin form? and what is it used as?
- strong, transparent gels and flexible films
- preservative and as jellies in the food industry
What is dipping? (2)
- stainless steel pins are dipped into a solution of gelatin at controlled temps
- pins withdrawn, rotated and dried
What is the manufacturing of empty capsules? (3)
- hard gelatin - cap and body
- soft gelatin - manufactured and filled in one operation
- add plasticiser - make them soft and elastic
- add colorants and preservatives
What is a dosator? (3)
- dose range - 15-2000mg
- for filling capsules with continuous machines
- control fill weight by adjusting powder bed height and dosator pin position
What is hard gelatin capsule formulation?
- uniform capsule filling depends on powder flow
- diluents - low dose drugs
- glidant and lubricant - dec friction and improve flow
What is non-powder filling of hard gelatin capsules? (4)
- granules and pellets
- tablets / multiparticulates
- semisolids
- non-aq liquids
What are potential problems with hard shell capsules?
- cross linking
- embrittlement
- sticking/solvation
- leaking
How is cosslinking a problem?
gelatin crosslinking between polypeptide chains = insoluble capsule
How is embrittlement a problem?
water loss to fill material/atmosphere = capsules crumbles
How is sticking/solvation a problem?
water ingress hydrates capsules = sticky and starts to dissolve
How is leaking a problem?
poor seal or trapped fill material = leaking
What are vegetarian capsules? (3)
- made from cellulosic raw materials
- meets strict dietary needs of customers
- formulated from HPMC, starch, pullulan or PVA
What are soft gelatin capsules? (3)
- continuous gelatin shell around liquid/semi- solid matrix material
- capsules formed, filled and sealed in one operation
- many dif sizes and shaped
What compounds benefit from soft gelatin capsules?
compounds which are soluble/ dispersible in oil/hydrophilic liquid or combo benefit from formulation
What are advantages of soft gelatin capsules? (4)
- dont need to compress - usually poorly compressible at high doses
- no uniformity/powder flow issues - drug dissolves or dispersed in liquid vol dosed
- chem stability of drug - oily vehicle protects from ox and hydro
- self-emulsifying oils inc oral bioavailablity (SEDDS)
What are limitations of soft gelatin capsules? (4)
- drugs/excipients contain hich conc of water/gelatin solvents - not incoporated
- not recommended for o/w or w/o - unstable as water lost from shell
- surfactants affects capsule seal
- avoid pH <2.5 and >7.5
