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Pharm 125 > Capsules > Flashcards

Capsules Flashcards

(74 cards)

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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
HPMC polymer
non-ionic polymer,
26
HPMC used for what release
immediate and modified release options
27
moisture content of HPMC
low moisture content (2-9%)
28
dissolution of HPMC
consistent dissolutipon | -NO CROSS-LINKING
29
HPMC physical stability
great phsical stability | -break less in dry conditions
30
how is HPMC prepared
prepared by dip molding process - needs gelling agents such as carrageenan or gellan gum OR thermogellation -no additives
31
HPMC capsule surface
rough capsule surgace | -good for coating (adhere better), dosent look as nice
32
HPMC colouring relative to gelatin shells
hard produce uniform colouring compared to gelatin shells
33
do HPMC withstand larger ranges of mositure without breaking and softening?
yes
34
what can hard capsules be filled with (6)
``` dry powders pellets granules tablets semi-solids non-aqueous liquids ```
35
punch method (hand filling) (5)
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
developing packing statistics (4)
how much powders fits into capsule capsule body is 100% filled capacity is dependent on density of the powder determines capsule size needed
37
procedure for each ingredient in punch method (4)
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
tapped bulk density
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
INDUSTRIAL FILLING METHODS - powder, granulate and pellets filling +filling requirements +common exciptients
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
industrial: dependent methods
- volume of capsule shell controls dose - require capsule shell be 100% filled for correct weight uniformity Auger or Screw method
41
industrial: independent method - desc - methods
- 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
industrial, independent: dosator method
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
industrial, independent: dosator method - what dosing - not suitable for what
suitable for dosing greater than or equal to 20mg not suitable for highly cohesive
44
industrial, independent: dosing disc and tamping pins method - desc - suitable for what dose
tamping pins pushed through a powder bed and dose is transferred into a dosing plate suitable for >30mg doses
45
industrial, independent: vacuum filling method - desc - doses
powder is drawn into dosator by vacuum suction -used for low dose inhalation products
46
industrial, filling method: liquid and semi-solids filling
sealing step required prevent leakage filling using volumetric methods easier technology than softgel capsules
47
industrial, filling method: liquid and semi-solids filling -liquid excipients +lipophillic +hydrophillic +amphiphilic
lipophilic excipients - vegtable oils, esters, fatty acids, fatty alcohols hydrophilic excipients amphiphilic excipients
48
soft gelatin capsules
liquid or semi-solid matrix inside a one-piece plasticized gelatin shell
49
common shapes of soft shells
round oval tube oblong
50
Advantages of softgels (6)
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
disadvantages of softgels (5)
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
Softgel formulation (%w/w) ingredients ``` -gelatin water plasticizers preservatives colour and opacifiers ```
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
what are other polymers used in softgel shell formulations
starch and carrageenam, propylcinyl alcohol (PVA)
54
fill formulation properties | -dispersion
fast and uniform rate of dispersion in GI tract after softgel ruptures and releases fill matrix
55
what is important for the fill formulation wrt capacity to dissolve drug
capacity to dissolve drug dose in small volume
56
fill formulation properties | - compatability with softgel pH
pH of fill formulation should be between 2.5 - 7.5 to not decompose gelatin
57
fill formulation properties | - for manufacture and shelf - life / contact with GI fluids
prevent ppt of solubilized drug during manufacturing and shelf- life and in contact with GI fluids
58
fill formulation properties | -temperature
withstand higher T from the sealing step (60-70degC)
59
types of fill formulations (7)
solutions suspensions emulsions microemulsions self-emulsifying drug delivery system (SEDDS) self microemulsifying drug delivery system (SMEDDS)
60
softgel manufacture methods | -rotary die process
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
softgel manufacture methods | - seamless (bubble) process or concentric nozzle dropping technique or goblex method
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
quality control for hard capsules - weight variation - content uniformity
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
quality control for softgels
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
quality control for capsules: disintegration
similar to tablets
65
quality control for capsules: dissolution
similar to tablets softgels are complicated by "burst" release of shell
66
quality control for capsules: stability testing
influence of T, humidity, light, formulation components, and containers
67
quality control for capsules: moisture permeation test (3)
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
other oral solid dosage forms
lozenges, troches and lollipops
69
lozenges, troches and lollipops - how work - how made
dissolve or disintegrate slowly in mouth can be made by compression or molding
70
types of lozenges
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
uses of lozenges, troches and lollipops
analgesics, anesthetics, antimicrobials, antiseptics, antitussives, corticosteroids, decongestants, other combinations of drugs
72
chewing gum | -therapies
smoking cessation, gingivitis, pain relief, motion sickness
73
chewing gum | -delivery use
localized delivery of drugs in mouth
74
chewing gum | -how make
made by compression or by mixing ingredients with melted gum base, rolling and cutting finished units

Pharm 125 (5 decks)

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