Alternative to gelatin capsule,mainly focused on non animal origin,explained and market product included in this,most of vegetarian people wont eat animal so we come to new non animal origin region like plants those are HPMC capsule,Pullulan capsule,PVA capsule,Alginatecapsule...

1. AN ALTERNATIVE TO GELATIN
CAPSULE
Chouthri.D
1st M.Pharm
Department of Pharmaceutics
JSS college of pharmacy, ooty
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2. CAPSULES are solid dosage forms in which one or more
medicament and inert ingredients either in solid or liquid form are
enclosed in a small shell usually made of gelatin.
Apart from these gelatin most of the material used in
manufacturing of capsule shell.
INTRODUCTION
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These are some gelatin capsule manufacturing companies
CAPSUGEL producing 200 billion empty capsules per year for a
network of manufacturing sites in the Americas, Europe, India,
China, Japan and Indonesia.
ACG ACPL produces over 83 billion capsules annually.

3.  The drugs which are hygroscopic absorb water from the capsule
shell making it brittle and hence are not suitable for filling into
capsules.
 The concentrated solutions which require previous dilution are
unsuitable for capsules because if administered as such lead to
irritation of stomach.
 Indigestion
 Stomach upset
 Bloated stomach
 Allergic reaction or hypersensitivity
 Exposure to toxins
 As gelatin is often used as a protein supplement, excessive
consumption of protein can cause strain on the liver and kidneys.3
Disadvantage of gelatin capsule:

4. Gelatin Contamination of animal diseases ie,BSE.
 First noted in UK(1980)

 By mid-June 2014, there had been over 200 reported deaths worldwide.
 Overcome these disadvantage some new material used in capsule shell.
those are,
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Gelatin and Bovine Spongiform Encephalopathy
risk
Stated
1992
Manufacturer
&
Distributor
should
take steps
to ensure no
ingredients
from
countries
where BSE is
controlled
unsatisfactory
Mad cow
disease
Effect cattle's brain
due to
FDA
BSE is commonly
known

5. TYPES OF CAPSULE SHELL METERIAL
NON ANIMAL
CAPSULE SHELL
 HPMC Capsules
 Pullulan Capsules
 PVA Capsule
 Alginate Capsule
 Starch Capsule
 V Caps
ANIMAL CAPSULE
SHELLS
 Gelatine/ PEG
Capsules
 Coni-Snap
 Press-fit Gelcaps
 LiCaps
 Posilock
 Minicapsule
 OceanCaps
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6. 1. Non-animal capsule shell
• First vegetable capsule - HPMC produced - 1989 by G S
Technologies - Trade name Vegicaps.
• For gelatin capsule alternative, the first patient registered in-
1950 by H W Murphy of Eli Lilly and Company for
methyl cellulose.
Release Mechanism - HPMC based pharmaceutical devices
strongly depends on the design (composition and geometry) of
the particular delivery system. Drug molecules are released at the
surface, as well as diffusing into the inner swelling polymer (a
dissolution process) and then diffusing outwards through the
swelling polymer and finally through the outer gel layers.
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A. HPMC CAPSULES(HYPROMELLOSE)

7.  The shell is made from seaweed extract and gluten free starch
and contains no modified sugars and artificial colors.
Features:
• Chemically stable.
• Low moisture content than Gelatin capsule, Less brittle
• Fast dissolution
• Lower water vapor permeability than Gelatin capsule.
(Gelatin>PEG-Gelatin>HPMC)
• High tolerance to temperature
• Chemical inactivity
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8. QUALI-V® :(Marketed product)
o Plant derived hypromellose
o A New Key for Dry Powder Inhalers
Features of QUALI-V Capsule:
 Made from non-animal materials
 Chemically stable
 Low moisture content
 Less brittle even in low humidity
 Fast dissolution
 No crosslinking
 Suited to automatic capsule filling machines
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9. 9
PROPERTY COMPARISON BETWEEN TWO CAPS
Quali-V Gelatin
Moisture content 4-6% 13-16%
Water vapor permeability Lower than gelatin Low
Cross linking No Yes
Static charge Weak Strong

10. • low water permeability
• high elasticity
• Globally acceptable regulatory compliance with Vegetarian
(gelatin-free)
• Capsules easier to swallow
• Superior elegance - high shell transparency
• Sugar and gluten free
• Manufacture of capsules easier
• Process designed to provide oxidation protection
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Advantage of HPMC:

11.  High manufacturing cost.
 HPMC shells are less resistant and have lower tensile strength
than gelatin shells, which results in processing problem.
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Disadvantage:

12. B. PULLULAN CAPSULES
 Pullulan is a Neutral glucan like Amylose, Dextran, Cellulose
 Water-soluble polysaccharide
• Derived by bacterial fermentation from corn.
• Odorless, tasteless, and completely biodegradable .
• Dried capsules are comparatively weak in physical strength
• Requires water to act as a film plasticizer, which may have a
negative effect on active ingredients.
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13. NP CapsTM:(Marketed Product)
Made up of pullulan.
 Pullulan is very stable and well-characterized, and has achieved
wide regulatory acceptance with its proven safety record.
 No chemical modification,
 Starch-free
 Preservative-free
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14.  Capsules are clear and shiny, which makes them visually
attractive.
 Pullulan is chemically inert and does not react or cross link with
the contents.
 Best choice for oxygen sensitive materials.
 Stronger than gelatin capsules.
 Environment friendly with no toxic chemicals involved in
harvesting pullulan.
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Advantages of Pullulan:

15.  Pullulan is more sensitive than other materials
 e.g. gelatin or HPMC
 This sensitivity causes increase in shell brittleness at low
water content. Unsatisfactory brittleness means higher
manufacturing losses, a poorer quality and higher costs.
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Disadvantage of pullulan capsule shell:

16. C. PVA CAPSULES:
Water soluble
Less hygroscopic than gelatin
Oxygen permeability through PVA copolymer is significantly less
than through gelatin and HPMC capsule
Insoluble drugs can be dissolved in solvents such as macrogol
400, being filled in capsules.
The bioavailability of insoluble drugs can be improved very much.
E.g. PONDAC Capsule (name)
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17. Property PONDAC
(PVA caps )
GELATIN HPMC
Water content 4-6 % 13-15 % 4-6 %
Oxygen
permeability
Very Low Low High
Filling of macrogol
400
Possible Impossible Impossible
Light degradation No Yes No
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Property comparison of 3 different capsules

18. Novel hard capsules are made of alginate which is derives from
marine algae. Itis safer for consumer (all ingredient of the capsule are
non-animal based materials),more stable during shelf life (stable in
boiling water) and cheaper than gelatin capsules.
Product / technology benefits
 Globally acceptable regulatory compliance with Vegetarian (gelatin-
free)
 Capsules easier to swallow
 Smaller Capsule: Seamless thinner capsule shell, allowing for capsules
30% smaller than traditional gelatin for a given fill volume
 Superior elegance - high shell transparency
 Sugar and gluten free
 Manufacture of capsules easier
 Favourable unit cost
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D.Alginate Capsule

19. 19

20. E. STARCH CAPSULES:
 Made from potato starch
 Manufactured by the injection moulding technique developed
by Capsugel (Capill®).
 Sealing is achieved by applying a hydro alcoholic solution to
inner section of the cap, immediately prior to its being placed
on to the body.
 advantages
 pH independent dissolution
 Suitable for enteric coating
 Tamper evident
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21. Coating of starch capsules appear to be less
problematic because of the smooth seal, coupled with the
higher bulk density of the capsules, which provides for more
uniform coating bed.
 VCaps®:
 Two-piece capsules made from cellulosic raw materials
 Vcaps capsules are also starch-free, and preservative-free
 Easy to swallow
 Effectively mask taste & odor
Enteric starch;
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22. 2. Animal capsule shell
 It contain all-natural marine supplements
 Ideally suited for fish-eating vegetarians looking For fish
capsules, and marine supplements such as fish oil, salmon liver
oil, shark cartilage, glucosamine iron, zinc, calcium and vitamins
B2 and B12 .
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A. OCEAN CAPS TM:

23. C. LICAPS®:
 specially designed to be sealed for secure containment of liquids
and semi-solids.
 They may be filled at temperatures up to 70° C.
D. POSILOK®:
 The locking system used by Qualicaps.
 It ensures that the contents reach the consumer intact, and are
protected at all times from external contamination.
 First preservative free gelatin capsule
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24. E. GELATIN/PEG CAPSULES:
 advantages
 Reduce the brittleness of standard gelatin capsules when
exposed to a low-moisture content thus making the capsules
more compatible to hygroscopic formulations or moisture-
sensitive ingredients
 At moisture content b/w 8-12 %, gelatin / PEG capsules have
equivalent mechanical strength to standard capsules with
moisture b/w 13-16 %.
Gelatin/PEG Features
 Less brittle
 Good for hygroscopic formulations
 Good for moisture-sensitive ingredients
 Odorless, tasteless
 Three-year shelf life
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25. REFERENCES:
 www.capsugel.com
 http://en.wikipedia.org/wiki/Hypromellose
 http://www.japer.in/oldjaper/Issue/Issue%202%20Apr-Jun%202014/224.pdf
 http://www.fmcbiopolymer.com/Pharmaceutical/Products/AlginateCapsuleTec
hnology.aspx
 https://www.researchgate.net/publication/264555979_ADVANCEMENT_IN_MANUFACT
URING_OF_NON-GELATIN_CAPSULE_SHELL-A_REVIEW
 Magenta oral dosage formulation “Introduction to the Novel Alginate Capsules
Technology”, FMC.
 A REVIEW ON RECENT INNOVATIONS IN CAPSULE DOSAGE FORM, R D Doshi*,
P L Patel , M R Patel , K R Patel , N M Patel, INTERNATIONAL JOURNAL OF DRUG
FORMULATION AND RESEARCH, volume 2/Issue 3, May-June 2011, page no.77-92
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26. Thank you
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