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Hypromellose
Vcaps
Pullulan
Npcaps
Functional Characteristics
Moisture Content
Dimensions
14%
6%
12%
WW Specification
WW Specification
WW Specification
Sizes
Cross Link
Susceptible to Maillard Reaction
Gelling Agent
Gelling Promoter
Machineability
In Vitro Disintegration*
In Vivo Disintegration*
Oxygen Barrier Properties*
All
00 - 4
00 - 5
Yes
No
No
Yes
No
No
Self Gelling
Gellum Gum
Carageenan
None
Potassium Acetate
Potasium Chloride
Excellent
Good
Excellent
2.18
2.54
1.46
28
Excellent
Poor
Best
Extensive
Limited
Will be Extensive
Glass-Like
Natural Looking
Glass-Like
No?
Yes
Yes
Limited Locations
Yes
Yes
Limited Locations
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Limited
Yes
Difficult
Yes
No Experience
No
Yes
Yes
Approx. 5 sec
Approx. 12 sec
Approx. 4 sec
Extensive
Extensive
Extensive
Appearance
Colour Pallet
Appearance
Certifications
Non-GMO
Halal
Kosher-KO
Kosher-OU
Non-Animal
GRAS Status
Gluten Free
Starch Free
Preservative Free
Non- Animal Approval Japan
General
Manufacturing Locations
Enteric Coat
Cold Water Soluble
Oesophageal Transit Time
Excipient Compatability
Gelatin
Hypromellose =
Vcaps
Pullulan
NPcaps
Gelatin
116.6
335
21.9
24.3
Isoleucine
Proline
Phenylalanine
Tyrosine
Serine
Threonine
Cystine
Methionine
Arginine
Histidine
Lysine
Aspartic acid
Glutamic acid
Hydroxyproline
Hydoxylysine
10.8
124.2
14.0
1.2
32.8
18.3
3.9
48.0
4.2
27.6
46.7
72.6
93.3
4.3
Hypromellose
Partly methylated and hydroxypropylated cellulose,
varying in MW from 10 000 to 1 500 000.
Pullulan
Maltotriose:
Maltose:
Source:
Pullulan production
Corn syrup; certified Non- GMO
Nutrient
Microorganism
Fermentation
Filtration
Concentration
Pullulan
Gel
Forming
Equilibriu
m
Moisture
Content at
50% RH
Practically
odorless and
tasteless slightly
yellow colored
powder
Insoluble in
cold water.
Soluble in
hot water.
Cooling <
40C of a
soln. above
a min.
critical
conc.
~ 14%
Hypromello
se
10 - 1500
(Vcaps)
Odorless and
tasteless, white or
creamy-white
powder
Soluble in
cold water
Thermo
gelling ~
60C
~ 6%
Pullulan
(NPcaps)
Odorless and
tasteless, white
powder
Soluble in
cold water
No
~ 12%
Polymer
Gelatin
M.W. 103
15 - 250
10 - 400
Description
Capsule Composition
Component
Gelatin
Vcaps
NPcaps
Polymer
Gelatin
Hypromellose
Pullulan
Gelling agent
Self gelling
Gellan gum
Carrageenan
Gelling promoter
None
Potassium acetate
Potassium
chloride
Capsule Properties
Gelatin capsules
Dissolution behaviour similar for all suppliers
Non-gelatin capsules
Dissolution properties dictated by the gelling agent
(gellan or carrageenan). i.e. Shionogis Quali-V will have
similar dissolution properties to NPcaps as both contain
carrageenan as gelling agent.
Capsule Properties
Other capsule properties, i.e.
hygroscopicity, mechanical properties,
permeability depend on the properties
of the base polymer.
Appearance
Gelatin
Vcaps
Smooth
Rough surface
surface
Natural look
High degree of
transparency
High gloss
NPcaps
Smooth surface
High degree of
transparency
High gloss
Hygroscopicity
Fill material can influence capsule properties if fill is hygroscopic capsule moisture content could decrease with tendency to brittleness.
Oxygen Permeability
Permeability test performed based on
oxygen transmission rate test
Standard ASTM D-3985 Unit cm 3/m2/day for 100 m film thickness
Oxygen Permeability
Capsules with wheat germ oil stored at 22C/50% for 3 months.
Peroxide
value
Oxygen Permeability
Csutomer Relevance?
Disintegration
EP Monograph
Capsules should disintegrate within 15 min
NPcaps Shelf-Life
Shelf-life test methodology
Storage conditions 15 - 25C/35 - 65% RH in original closed carton
Visual aspect and transparency
Water content (LOD)
Mechanical performance (Tube-test)
Dissolution/disintegration behavior
Pre-lock, closing force
Filling test performance (GKF 400)
NPcaps: Stability of
Ascorbic Acid
Comparison of gelatin and NPcaps
filled with ascorbic acid and stored
for six weeks at 40C/75%RH
Gelatin
NPcaps
NPcaps Stability
Customer Relevance?
Anticipate shelf life to be identical to gelatin.
Avoid oxidation
Use less anti-oxydant
Vcaps
Limited range
Iron oxides
Riboflavin
NPcaps
Under investigation
Hypromellose
Vcaps
Pullulan
Npcaps
Functional Characteristics
Moisture Content
Dimensions
14%
6%
12%
WW Specification
WW Specification
WW Specification
Sizes
Cross Link
Susceptible to Maillard Reaction
Gelling Agent
Gelling Promoter
Machineability
In Vitro Disintegration*
In Vivo Disintegration*
Oxygen Barrier Properties*
All
00 - 4
00 - 5
Yes
No
No
Yes
No
No
Self Gelling
Gellum Gum
Carageenan
None
Potassium Acetate
Potasium Chloride
Excellent
Good
Excellent
2.18
2.54
1.46
28
Excellent
Poor
Best
Extensive
Limited
Will be Extensive
Glass-Like
Natural Looking
Glass-Like
No?
Yes
Yes
Limited Locations
Yes
Yes
Limited Locations
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
No
Limited
Yes
Difficult
Yes
No Experience
No
Yes
Yes
Approx. 5 sec
Approx. 12 sec
Approx. 4 sec
Extensive
Extensive
Extensive
Appearance
Colour Pallet
Appearance
Certifications
Non-GMO
Halal
Kosher-KO
Kosher-OU
Non-Animal
GRAS Status
Gluten Free
Starch Free
Preservative Free
Non- Animal Approval Japan
General
Manufacturing Locations
Enteric Coat
Cold Water Soluble
Oesophageal Transit Time
Excipient Compatability