soft capsules Flashcards

1
Q

how are soft capsules made up?

A

Principal materials: gelatin(Softgels), thermoplastic potato starch (VegaGels)
•Continuous shell surrounding a liquid fill

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2
Q

what kind of administration are soft capsules suitable for?

A

oral- swallow bitten sucked
or inhilation- from cloth/ steam
rectal

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3
Q

what does the shape of the soft capsule tell you about it?

A

the route of admin
round/oval/oblong-oral
torpedo- rectal or vaginal use
tube like- topical

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4
Q

what are the advantages of soft capsules compared to tablets?

A

no compression
optimum uniformity content
longer shelf life for drugs prone to oxidation

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5
Q

what is the composition of soft gelatin capsules?

A
  • Higher elasticity than hard capsules and defined viscosity
  • Plasticizer (glycerol 15-30 %, often combined with sorbitol or PEG)
  • Water (water to dry gelatin1:1)
  • Colourants, pigments
  • Film coating (enteric coating: 4% cellulose acetate phthalate)•Storage and packaging related to composition of capsule shell
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6
Q

what is the composition of Thermoplastic potato starch soft capsules?

A
  • Plasticizer (glycerol, sorbitol, maltitol)
  • Anti-caking agent (glycerylmonostearate)
  • Water (final equilibrium concentration 30 – 50 %)
  • Final protective coating (vegetable wax)
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7
Q

what are the two ways you can manufacture soft capsules?

A

globex method

rotatory die method

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8
Q

describe the globex method?

A
  • Lipophilic fill & shell formulation stored in separate containers – both warm (in liquid state)
  • Fill and shell material pumped through a double capillary (fill is the inner one)
  • Pulsing action to give predetermined fill volumes, separating individual dose units
  • The high surface tension gives rise to droplets (reduce surface area) –seamless round capsules
  • Capsules fall through immiscible cooling bath (often liquid paraffin, 4 oC)•Capsules collected, washed and dried
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9
Q

what do you consider when filling soft capsules?

A
  • When filling - temperature, viscosity, surface activity
  • Suspensions
  • Pastes
  • Oily liquids: vegetable oils, liquid paraffin
  • Self-emulsifying systems (poorly water soluble drugs, self emulsify in contact with aqueous media to form fine dispersion e.g. mix of oil, surfactant and co-surfactant
  • Liquids miscible with water:PEGs 400-600 (liquid when low mwt)GlycerolIso-propanolTriethylacetateliquid triglycerides
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10
Q

what would you consider when filling Solid and semi-solid materials?

A

Waxes
Triglycerides
Higher molecular wtPEGs
Hydrogenated fatty oils

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11
Q

what are the general advantages of filling soft capsules?

A
  • Increased bioavailability of poorly soluble drugs
  • Prevention of partial dissolution and re-crystallisation of drugs
  • Masking bad taste, odour
  • Safe and simple manufacture
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12
Q

what are the limitations for filling materials?

A
  • Drugs or excipients containing water or other substances that dissolve gelatinor starch, or change their properties
  • Emulsions (o/w or w/o, unstable and will crack during manufacture due to loss of water)
  • Surfactants – affect sealing of capsule
  • pH limits for gelatin soft capsules
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13
Q

what are the ph limits for soft gelatin capsules?

A

< 2.5, hydrolysis of gelatin– capsules could leak

> 7.5, brown discolouration and reduced solubility of gelatin

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14
Q

what is your choice of filling affected by?

A

for drugs soluble in acidconditions (i.e. stomach):Water miscible filling, drug dissolved or suspended
For drugs practically insoluble in acidconditions: Drug must be dissolved in filling e.g. Improved bioavailability of 20 mg temazepamdose (drug dissolved in PEG)

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