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Pharm 125 > Capsules > Flashcards

Capsules Flashcards

1
Q

what kind of dosage form is a capsule

A

solid dosage form

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2
Q

describe a capsule

A

solid dosage form where API and excipients enclosed withing SOLUBULE container or shell or coated on the capsule shell

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3
Q

what are shells composed of

A

two pieces
-body and cap

OR

one single piece

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4
Q

Shell materials: gelatin

A

traditional polymer for manufacture of capsules

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5
Q

Shell materials: hydpromellose or hydroxypropyl methylcellulose (HPMC)

A

plant based shell

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6
Q

Pullulan (polysaccharide) and starch hard shells have been developed

A

true

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7
Q

Advantages of hard shells (5)

A

1) mask unpleasant taste and odor of a drug
2) allow powders to be dispensed in an uncompressed form

3) versatility for multiple filling formulations
+ dry powders, pellets, granules, tablets, semi-solids and non-aqueous liquids

4) may be easier for SOME people to swallow
5) better bioavailability than tablets

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8
Q

do capsules have better bioavailability than tablets

A

yes

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9
Q

why do capsules have better bioavailability than tablets

A

not compressed, release drug faster

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10
Q

disadvantage of elongated shape

A

may stick in esophagus

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11
Q

Disadvantages of capsules (6)

A

easily affected by humidity (gelatic shells)

may be difficult to swallow (stick to esophagus)

filling speeds of capsule machines are lower than tablet presses

can be tampered (sealing steps available

not compatible with certain materials

cost of capsule shells and manufacturing

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12
Q

how is gelatin produced

A

produced by hydrolysis of collagenous material (bone skin catillage etc)

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13
Q

moisture content of gelatin

A

13-16%

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14
Q

dissolution properties of gelatin

A

consistent dissolution (readily soluble in h20 and GI fluids at body temperature

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15
Q

describe gelatin film

A

strong flexible film

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16
Q

effect of crosslinking in elatin

A

cross-linking may occur and modify the dissolution

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17
Q

mechanical stability of gelatin

A

dependent on water content

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18
Q

what are the two types of gelatin

A

type A
-derived from pork skins via acid processing (7-10 days)

Type B
-derived from bones and animal skins by alkaline processing

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19
Q

gelatin manufacturing: ingredients of gelatin capsule shell

A

Gelatin (25-30%)

water

colouring agents
-mostly synthetics
+indigo carmine (E132), quinoline yellow (E104), iron oxides and opacifiers (titanium dioxide)

flavouring agents

processing acids
- <0.15% of sodium lauryl sulfate (help gelatin cover uniformly the molds

preservatives
-parabens

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20
Q

how are hard gelatin shells made: process

A

dip molding process

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21
Q

dip molding process (4 steps)

A

1) pair of dipping pins dip into a warmed warmed to 50degC aq gelatin (25-30% w/w) solution to form a film around the pins
2) pins withdrawn from sol’n, rotated around to distribute and cool gelatin film
3) dried film removed from pins and cut to length
4) two parts joined to the pre-locked position

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22
Q

what is larger the cap or the body

A

the cap is smaller than the body

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23
Q

Hard capsule shell types

A

hydroxypropyl methylcellulose (HPMC)

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24
Q

HPMC - origin

A

plant based origin

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25
Q

HPMC polymer

A

non-ionic polymer,

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26
Q

HPMC used for what release

A

immediate and modified release options

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27
Q

moisture content of HPMC

A

low moisture content (2-9%)

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28
Q

dissolution of HPMC

A

consistent dissolutipon

-NO CROSS-LINKING

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29
Q

HPMC physical stability

A

great phsical stability

-break less in dry conditions

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30
Q

how is HPMC prepared

A

prepared by dip molding process
- needs gelling agents such as carrageenan or gellan gum

OR

thermogellation
-no additives

31
Q

HPMC capsule surface

A

rough capsule surgace

-good for coating (adhere better), dosent look as nice

32
Q

HPMC colouring relative to gelatin shells

A

hard produce uniform colouring compared to gelatin shells

33
Q

do HPMC withstand larger ranges of mositure without breaking and softening?

A

yes

34
Q

what can hard capsules be filled with (6)

A 
dry powders
pellets
granules
tablets
semi-solids
non-aqueous liquids
35
Q

punch method (hand filling) (5)

A

1) reduce ingredients into fine uniform powder
2) mix ingredients by trituration
3) place poweder on glass slab and flatten with spatula about 1/3 length of the capsule being filled
4) fill body by repeatedly pressing it into powder or use spatula to push powders that are not cohesive into capsule body
5) cap and weight

36
Q

developing packing statistics (4)

A

how much powders fits into capsule

capsule body is 100% filled

capacity is dependent on density of the powder

determines capsule size needed

37
Q

procedure for each ingredient in punch method (4)

A

tare weight of empty capsule

fill 5 capsules with each ingredient

weigh each filled capsule and get an average

record weight for that capsule size to obtain the packing statistics for the individual ingredient

38
Q

tapped bulk density

A

fill plastic cylinder with powder to be measured and tap it on a hard surface a number of times to determine the tapped bulk volume

39
Q

INDUSTRIAL FILLING METHODS
- powder, granulate and pellets filling
+filling requirements
+common exciptients

A

filling requirements
-podwer flow, lubricity and compressibility (carr’s index between 18-35)

common excipients

  • fillers (MCC, lactose)
  • disintegrant (croscarmellose, sodium starch glycolate)
  • lubricant (Mg-stearate)
40
Q

industrial: dependent methods

A
  • volume of capsule shell controls dose
  • require capsule shell be 100% filled for correct weight uniformity

Auger or Screw method

41
Q

industrial: independent method
- desc
- methods

A
  • quantity of powder to be filled is measure away from the body
  • independent on filling the body 100%

1) dosator method
2) dosing disc method
3) vacuum filing method

42
Q

industrial, independent: dosator method

A

powder fed into dosage hopper

dosage tube enters powder bed
-forms a unit mass inside the tube (or powder plug)

powder plug lifted by dosator and ejected into capsule body

43
Q

industrial, independent: dosator method

  • what dosing
  • not suitable for what
A

suitable for dosing greater than or equal to 20mg

not suitable for highly cohesive

44
Q

industrial, independent: dosing disc and tamping pins method

  • desc
  • suitable for what dose
A

tamping pins pushed through a powder bed and dose is transferred into a dosing plate

suitable for >30mg doses

45
Q

industrial, independent: vacuum filling method

  • desc
  • doses
A

powder is drawn into dosator by vacuum suction

-used for low dose inhalation products

46
Q

industrial, filling method: liquid and semi-solids filling

A

sealing step required prevent leakage

filling using volumetric methods

easier technology than softgel capsules

47
Q

industrial, filling method: liquid and semi-solids filling

-liquid excipients
+lipophillic
+hydrophillic
+amphiphilic

A

lipophilic excipients
- vegtable oils, esters, fatty acids, fatty alcohols

hydrophilic excipients

amphiphilic excipients

48
Q

soft gelatin capsules

A

liquid or semi-solid matrix inside a one-piece plasticized gelatin shell

49
Q

common shapes of soft shells

A

round
oval
tube
oblong

50
Q

Advantages of softgels (6)

A

improved drug bioavailability

increased dose uniformity and reproductibility (especially for low dose drugs)

easy to swallow, lack odour and taste

avoid formation of dust during manufacture (safer to handle potent or cytotoxic drugs)

oils and low MP drugs that cannot be compressed

enhanced drug stability

51
Q

disadvantages of softgels (5)

A

subjective to effects of relative humidity

  • softgel water content 8-16% w/v
  • hard gelatin water content 13-16% w/v

may be difficult for some people to swallow

more expensive, requires specialized equipment, formulation optimization requires expertise

drug can migrate from oil vehicle into the shell

unsuitable for aqueous liquids

52
Q

Softgel formulation (%w/w) ingredients

-gelatin
water
plasticizers
preservatives
colour and opacifiers
A

gelatin - 40% of gel mass

water

  • 20-40% wet gel mass
  • 8-16% after drying

Plasticizers (glycerin sorbitol propylene glycol)
-20-30%

preservative (parabens)
-0.1%

colour and opacifier (TiO2) qs

53
Q

what are other polymers used in softgel shell formulations

A

starch and carrageenam, propylcinyl alcohol (PVA)

54
Q

fill formulation properties

-dispersion

A

fast and uniform rate of dispersion in GI tract after softgel ruptures and releases fill matrix

55
Q

what is important for the fill formulation wrt capacity to dissolve drug

A

capacity to dissolve drug dose in small volume

56
Q

fill formulation properties

- compatability with softgel pH

A

pH of fill formulation should be between 2.5 - 7.5 to not decompose gelatin

57
Q

fill formulation properties

- for manufacture and shelf - life / contact with GI fluids

A

prevent ppt of solubilized drug during manufacturing and shelf- life and in contact with GI fluids

58
Q

fill formulation properties

-temperature

A

withstand higher T from the sealing step (60-70degC)

59
Q

types of fill formulations (7)

A

solutions

suspensions

emulsions

microemulsions

self-emulsifying drug

delivery system (SEDDS)

self microemulsifying drug delivery system (SMEDDS)

60
Q

softgel manufacture methods

-rotary die process

A

main method of manufacture
-produces ~100,000 caps/hr

capsules produced, filled and sealed in single cts operation

requires gelatin mass and fill material to be formulated prior to encapsulation

61
Q

softgel manufacture methods

- seamless (bubble) process or concentric nozzle dropping technique or goblex method

A

gelatin runs through outer nozzle

fill dispensed form inner nozzle

produces droplets of fill material in molten gelatin envelope

capsules hardened slowly and detached from nozzle

forms smaller and spherical soft capsules

~5000 capsules/hr

62
Q

quality control for hard capsules

  • weight variation
  • content uniformity
A

weight variation
-10 capsules are individually weighed and contents removed
+emptied shells individually weighed and net weight of contents calculated by subtraction

content uniformity
API in ea capsule determined by HPLC

63
Q

quality control for softgels

A

weight variation

  • 10 intact capsules weight det individually
  • contents ea capsule removed and shells weighed
  • calculate net weight

content uniformity
-API in ea capsule is determined by HPLC

64
Q

quality control for capsules: disintegration

A

similar to tablets

65
Q

quality control for capsules: dissolution

A

similar to tablets

softgels are complicated by “burst” release of shell

66
Q

quality control for capsules: stability testing

A

influence of T, humidity, light, formulation components, and containers

67
Q

quality control for capsules: moisture permeation test (3)

A

done on single unit and unit dose containers

samples exposed to known relative humidity

assessment

  • colour change of desiccant pellet
  • comparison of pre-test and post-test weight of the packaged unit
68
Q

other oral solid dosage forms

A

lozenges, troches and lollipops

69
Q

lozenges, troches and lollipops

  • how work
  • how made
A

dissolve or disintegrate slowly in mouth

can be made by compression or molding

70
Q

types of lozenges

A

hard lozenges
-hard sugar candy base

soft lozenges (pastilles)

  • made with PEG or sucrose
  • acacia base
chewable lozenges (gummy)
-made with glycerinated gelatin base
71
Q

uses of lozenges, troches and lollipops

A

analgesics, anesthetics, antimicrobials, antiseptics, antitussives, corticosteroids, decongestants, other combinations of drugs

72
Q

chewing gum

-therapies

A

smoking cessation, gingivitis, pain relief, motion sickness

73
Q

chewing gum

-delivery use

A

localized delivery of drugs in mouth

74
Q

chewing gum

-how make

A

made by compression or by mixing ingredients with melted gum base, rolling and cutting finished units

Pharm 125 (5 decks)

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