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SoM 2 sim > Soft-Shell Capsules > Flashcards

Soft-Shell Capsules Flashcards

1
Q

Soft shell capsules are hermetically sealed. What does this mean?

A

Airtight

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2
Q

What are the main characteristics of soft shell capsules?

A
  • made of gelatin, water and a plasticizer (like HS capsules)
  • opaque or transparent
  • colouring agents can be added
  • flavouring agents can be added
  • can be coated to delay release
  • water content should be insufficient to allow microbial growth, preservatives not normally added
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3
Q

What are soft shell capsules used to encapsulate?

A
  • liquids (non-aqueous)
  • semi-solids
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4
Q

What is the fill temperature of hard shell and soft shell?

A

Hard: <70 degrees

Soft: <35 degrees

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5
Q

Describe the effectiveness of soft shell capsules in terms of barrier.

A

Less effective barrier to water, light and oxygen compared to hard shell

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6
Q

List the advantages of soft shell capsules

A
  • increased bioavailability due to improved absorption
  • easy to swallow
  • acceptable to patients
  • good organoleptic properties
  • avoids issues linked to handling powders
  • liquid flow easier to predict and control
  • improved stability
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7
Q

List the disadvantages of soft shell capsules

A
  • manufacturing can be expensive
  • specialist manufacture equipment required
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8
Q

List the main ingredients used in soft-shell capsules

A
  • Gelatin (mainly type B)
  • plasticizer
  • additives
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9
Q

What bloom strength is used for gelatin?

A

150g

stronger strength would increase production cost

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10
Q

What is the use of plasticizers and what are common ones?

A

15-30 wt% used, make the shell flexible and elastic

  • glycerol (glycerin)
  • sorbitol, mannitol, maltitol
  • propylene glycol
  • low MW propylene gylcol

may affect disintegration, dissolution and stability

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11
Q

What can opacifying agents be used for?

A

protects contects and light-induced degradation

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12
Q

How do the shells provide some protection against oxygen?

A

Thickness of shell

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13
Q

If contents of shell are susceptible to oxidation, what should be done?

A
  • plasticizer conc should be kept low
  • capsules should be stored in cool, dry place
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14
Q

What can happen to shells in a high humidity environment?

A

become soft and sticky

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15
Q

What can happen to shells in a low humidity environment?

A

become hard and brittle

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16
Q

What should moisture content be for contents susceptible to hydrolysis?

A

low moisture content, especially if drug dissolved or dispersed in an oily vehicle

17
Q

Discuss capsules to be swallowed whole, chewable capsules, suckable capsules and meltable capsules

A

Swallowed whole

  • with a glass of water
  • disintegration expected in stomach

Chewable

  • chewing triggers drug release
  • drug may be added to shell
  • organoleptic properties important

Suckable

  • shell contains medicant
  • inside is empty or contains suitable liquid

Meltable

  • pessaries or suppositories
18
Q

What can softgel capsules be filled with?

A
  • solutions
  • suspensions
  • emulsions
19
Q

List softgel capsule imcompatabilities

A
  • high water content
  • very high solid content
  • large proportion of hygroscopic ingredients
  • high conc of various salts
  • very high or low pH
  • high conc of solvents eg ethanol
  • high viscosity eg molasses
20
Q

What are the considerations when formulating a softgel capsule filling?

A
  • solubility of drug in chosen vehicle
  • how quickly contents will disperse in GIT
  • possible compatability issues with shell
  • possibility of optimising drug absorption and bioavailability
21
Q

How can lipophilic fill formulations be prepared?

A

use:

  • free fatty acids
  • fatty acid esters derivatives of hydrophilic compounds
  • triglycerides

Simple formulation: drug solubilised or suspended in triglycerides. This is a suitable for a number of agents inc. potent drugs and/or lipophilic drugs (logP > 4)

22
Q

Not all drugs will be soluble in long-chain triglycerides. What can you use as an alternative?

A
  • medium chain triglycerides
  • free fatty acides
23
Q

What must be ensured in a suspension?

A

that it is homogeneous, to ensure dose uniformity

24
Q

What are pre-concentrates?

A

Self-emulsifying systems, capsule is filled with oil phase

final emulsion will be formed in situ in intestines, once capsule contents are released and mix with the aqueous fluids in the small intestine

25
Q

What are the advantages of pre-concentrates?

A
  • improved drug solubility
  • high surface area of resting micro or nanoemulsion
    • rapid diffusion out of oil phase into intestinal fluids
  • improved pharmacokinetics
26
Q

Describe the use of hydrophilic liquids and give an example

A

Suitable polar, non-aqueous vehicles should have a MW large enough to allow the preparation of a solution or suspension

Eg: Poly(ethylene glycol) 400 Da

27
Q

Why is viscosity important of a hydrophilic liquid?

A

it will affect liquid flowand how easy it is to fill the capsules

28
Q

Why should lower MW solvents (such as ethanol) be used at lower concs (<10%) only?

A

To avoid destabilising the gelatin shell

29
Q

Can highly hygoscopic solvents be used in a hydrophilic liquid?

A

No

30
Q

What can affect the dissolution rate of soft-shell capsules?

A

Changes in:

  • polymorph
  • particle size
    • due to Otswald ripening in suspensions or emulsions
  • crystalline state of a drug formulated as a suspension
  • solubility of a drug solubilised with the help of hydrophilic solvent(s) or co-solvent(s)
    • upon release they will mis easily with aqueous fluids potentially triggering the precipitation of the drug
    • can be trigerred by migration of water from shell into capsule
31
Q

What can be assessed during the manufacturing process?

A
  • thickness of gelatin film
  • sealing of capsules (absence of leaks)
  • filling weight and shell weight
  • moisture content and hardness after drying
32
Q

What can be assessed after the manufacturing process?

A
  • uniformity of content
  • dissolution
  • disintegration

SoM 2 sim (21 decks)

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