This presentation contains insights of Capsule. giving details of complete Capsule technological process

2.  Introduction
 Recent Advancement In Capsule Formulation
 Recent Development In Capsule
 Development In Capsule Shell.
1. Animal capsule shell.
2. Vegetarian capsule shell. .
 Development In Capsule System.
 Capsule sealing technology.
 Newer Technologies Of Capsule For Pulsatile Realse.

3. INTRODUCTION
 Capsule are solid dosage form in which the medication
contained within gelatin shell. The medication may be
powder, a liquid, or a semisolid mass
 Capsule are intended to be swallowed whole by the
patient.
 In Instantances, whole patient are unable to swallow
capsule, the content of the capsule are used as a vehicle
to deliver premeasured medicine powder.
 They can be classified as :
1. Hard gelatin capsule
2. Soft gelatin capsule

4.  The hard gelatin capsule consists of a base or body and a shorter cap
,which fits firmly over the base of capsule.
 Advantages :
1. Mask the unpleasant taste, aromas, or appearance of drug.
2. Allow powders to be dispensed in an uncompressed form, thus
allowing for quicker dissolution and absorption of the drug.
3. can be made to alter the release rate of the drug.
 Modification of hard gelatin capsule :
1. Overcome the disadvantages associated with conventional capsules
.
2. Achieve modified drug release .
3. Encapsulation of various kinds of material .
4. Modified applications .

5.  Soft capsules are for solids, liquids and semi-solids. They may be
spherical, ovoid or cylindrical with hemispherical ends.
 The capsule shell consists of gelatin, water and plasticizer.
 Soft gelatin capsule are made up of gelatin but differ from hard gelatin
capsule in composition that sugar is replaced by plasticizer like sugar is
replaced by plasticizer like glycerol,sorbitol.
 Advantages :
1. Improved stability & bioavaibility .longer shelf life.
2. High accuracy in filled weight.
3. Can be encapsulated in various shapes, size ,colour
4. One piece capsule – no problem of microbial contamination,
oxidation & evaporation.

6.  The study of recent advancement of Solid dosage form capsule is
studying for better kind of dosage forms.
 There are two way approach for capsule dosage form innovation in
capsule shell and innovation in capsule system. The present review
focuses on innovation in capsule system.
 This review includes newer trends related to capsule shell, capsule
fill material, capsule sealing technique, and different capsule systems
to achieve modified drug release.
 encapsulation of various kind of materials and for modified
application like mapping of the drug for clinical evaluation.

7. 1. To reduce the frequency of dosing or to increase effectiveness of the drug
by localization at the site of action, reducing the dose required, or providing
uniform drug delivery.
2. The development of new generation of capsules are beneficial for night
time dosing and for the drugs having high first pass effect and having
specific site of absorption in Gastrointestinal tract.
3. To Enhanced bioavailability, reduced side effects, improved patient
compliance, reduced peak to trough ratio of drug in systemic circulation.
4. Modifications in conventional capsule delivery system are needed to
overcome the disadvantages associated with them and to provide products
of higher selectivity for medical treatment.

8. RECENT ADVANCEMENT In
Capsule
SHELL INCLUDE
Animal Capsule Non Animal
Capsule
Gelatine/ PEG Capsules
Press-fit® Gelcaps
LiCaps®
Posilok®
Minicasule
Ocean Caps Fish Gelatin
Capsule
 PC caps®
HPMC Capsules
PVA Capsule
Starch Capsule
V Caps®
 DR caps® Capsules

9. Animal Capsule
1. Gelatine/ PEG Capsules
Less brittle
Good for hygroscopic and moisture-sensitive
ingredients
Odourless, tasteless, three-year shelf life
Available in sizes from 00 to 4
The addition of PEG improves the mechanical strength
of
the capsule.
At moisture contents between 8% - 12%, gelatin/PEG
capsules have equivalent mechanical strength to
standard
gelatin capsules with moisture between 13% - 16%.

10. 2. Press-fit® Gelcaps
Features
Easy-to-swallow
Masks taste and odour
 A unique dosage form
consisting of a high
gloss
gelatin coating(Taste
Free)
that encases a caplet
core.
The elegant, geometric
shape of this is distinct
in the marketplace.
Manufactured by
exclusive

11. 3.LiCaps®
Features
Two-piece gelatin as well as
HPMC
capsules that have been
specially
designed to be sealed for secure
containment of liquids and semi
solids.
In combination with a liquid fill,
provides an attractive and viable
dosage form, particularly for
poorly
soluble compounds.
The use of hot melts is also
viable

12. 4.POSILOK®
POSILOK® is the registered trademark for the locking
system
used by Qualicaps.
It ensures that the contents reach the consumer intact,
and
are protected at all times from external contamination.

13. 5.Minicapsule
The amount of material needed for
testing
is often very small(in mg).
 Qualicap’s Minicapsule(size9) provides
a
dependable method of delivering the
material directly into animal’s stomach
with minimal waste & great flexibility in
dosing & available in gelatin & HPMC.
 Scientists have great flexibility in
dosages
because each capsule is filled
individually
and can be adjusted to the weight of

14. 6. Ocean Caps Fish Gelatin Capsule
OceanCaps™ capsules are a marine-based capsule well-
matched to the needs of health conscious consumers.
 OceanCaps™ capsules are
ideally suited for marine
supplements such as fish
oil DHA, EPA, salmon liver
oil,
shark cartilage and
glucosamine.
 Made from high quality,
farmed fish gelatin, a
renewable resource
Preservative-free, starch-
free, gluten-free

15. 7. PC caps®
PCcaps® capsules present an exceptional solution to carrying
out your pre-clinical animal studies with improved effectiveness.
Features
 Prevent GI Irritation
 Deliver exact dose to rodents
without
any excipients
 Avoid Use of solvents that are
incompatible with API
 Capsules also possess locking
rings, for improved closure.

16. Non-Animal Capsule
1. HPMC Capsules
QUALI-V, developed by Shionogi Qualicaps, is the first
HPMC capsule developed for eventual use in pharmaceutical
products.
 QUALI-V Composition
Base Polymer Hypermellose USP, EP, JP
Gelling Agent Carageenan USNF, EEC,
JPE
Gelling
Promoter
Potassium
Chloride
USP, EP, JP

18. Features
 Made from non-animal material
 Chemically stable
 Low moisture content than Gelatin capsule
 Less brittle even in low humidity(≤1% moisture content)
 Fast dissolution (No change in dissolution profile under
stress
conditions) and soluble in water at room temperature.
 No cross linking.
 Lower water vapor permeability than Gelatin capsule.
(Gelatin>PEG-Gelatin>HPMC)
 Low static electricity and light protected.
 High tolerance to temperature
 Chemical inactivity and solubility at room temperature.
 Suited to automatic capsule filling machines.

19. 2. PULLULAN
CAPSULES
NPcaps®, a non-animal capsule made of pullulan, a
vegetable-derived, water-soluble polysaccharide
produced through a fermentation process.
Multiple Uses
Vegetarian – Vegetable origin,
starch-free and preservative-
free,
Gluten Free
Elegant appearance
Ideal capsule for oxidation
sensitive ingredients
Excellent machinability
Proven commercial viability
Outstanding quality

20. 3. PVA Capsule
PONDAC Capsule (name)
Insoluble drugs can be
dissolved in solvent such as
macrogol 400 being filled in
capsule insoluble drugs can be
improved very much
The oxygen permeability of
PVA
copolymer capsule is
significantly low.
The PONDAC capsule is the
hope

21. 4. STARCH CAPSULES
alternative to hard gelatin capsule.
Manufactured by the injection moulding
technique developed by Capsugel (Capill®).
Made from potato starch and represent a direct
Offers advantages like.
•pH independent dissolution
•Suitable for enteric coating
•Tamper evident
•Produced from non-animal derived ingredients
Consists cap and body; which are sealed
together at the time of filling to prevent
separation.
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.
Officially recognized in USP

22. ENTERIC STARCH
CAPSULES
Overcome coating problems
encounter during coating of HGC.
Coating of starch capsules appear
to be less problematic because of the
smooth seal, coupled with the higher
bulk density of capsules, which
provide
for a more uniform coating bed.
Stability of coated starch capsule
evaluated.
Eg. TARGIT®

23. 5. VCaps®
Two-piece capsules made from
cellulosic raw
materials(HPMC)
that satisfy vegetarian and
cultural needs
easy to swallow
effectively mask taste and
odour
allow product visibility
Vcaps capsules are also starch
free, gluten-free and
preservative free, and meet the
strict dietary
needs of customers that
choose a lifestyle.
Vcaps vegetable capsules are
manufactured in a GMP facility

24. To provide modified release
 PORT CAPSULE TECHNOLOGY
 HYDROPHILIC SANDWICH (HS) CAPSULE
 CHEWABLE SOFT GELATIN CAPSULE
ENCAPSULATING LIQUID FILL
 INNERCAP TECHNOLOGY
 CAPSULE CAMERA

25. 1.PORT CAPSULE TECHNOLOGY
 Port stands for programmable oral release
technologies that use a unique coated in capsulated
system with opportunity to provide multiple program
release of drug.
 Port technologies offer significant flexibility in
obtaining unique and desirable release profile to
maximize pharmacological and therapeutic effects.
There are mainly two dosage forms for port
technology. The dosage from consist of a hard gelatin
capsule coated with the semi permeable, rate controlling
polymer.
 Inside coated capsule is the osmotic energy source,
which normally contains the therapeutic agents to be
delivers.
 The capsule is sealed with the water in soluble lipid
separators plug and immediate release dosage can be
edit above the plug the to complete the dosing option.
Example of port technologies:-

26. 26

27. 2.HYDROPHILIC SANDWHICH(HS)
CAPSULES
Simple and time delayed probe capsule
Based on a capsule within a capsule, in which the inter
capsular space was filled with a layer of hydrophilic polymer
(HPMC).
This effectively created a “ Hydrophilic Sandwich “
between two gelatin capsule
When the outer capsule dissolved, the sandwich of HPMC
formed a gel barrier layer that provided a time delay before
fluid could enter the inner capsule and cause drug release
The time delay was controlled by
◦ Molecular weight of polymer
◦ Inclusion of a soluble filler eg. Lactose

29. 4.CHEWABLE SOFT GELATIN CAPSULE
ENCAPSULATING LIQUID FILL
Chewable SGC require
mixture
of gelatin having different
bloom values.
It contains ingredients like
•Low bloom gelatin
•Medium bloom gelatin
•Plasticizers
•Water
•Moisture retaining agent

30. Convenient and easily portable; no water or messy liquid
needed
Pleasant tasting, no chalky, Masks odors
Provides prolonged contact with mouth tissues
Drug ingredients can be formulated in a clear solution or
opaque
suspension
Liquid Soft softgels are particularly suitable for pediatric
populations and seniors and/or those who have difficulty
swallowing
Can help optimize the performance of poorly soluble
compounds
Possibility of localized drug delivery
Dosage is premeasured – no over dosing due to human
error
Perceived ability to deliver medication faster
Enhanced taste compared to gritty chewable tablets
No liquid spills or mess

31. 5.INNER CAP
TECHNOLOGY
The combination example consists of a high potency
insoluble
active in a lipid emulsion, sustained release tablet and a
cocktail of two crystalline active materials.
A combination of release profiles can be incorporated in
the
system.
Can deliver incompatible and compatible drugs using
different
physical phases.
The combination dosage form consists of a primary HPMC
capsule containing an emulsion, pH coated tablet,

32. The combination dosage form
consists of a primary
HPMC capsule containing an
emulsion,
pH coated tablet,
crystalline filled HPMC
capsule beadlet filled gelatin
capsule

34. 6.CAPSULE
CAMERA
Capsule endoscopy is the most recent innovation in
gastrointestinal endoscopy
The capsule contains a video camera that photographs the
bowel for 8 hours after the capsule has been orally ingested
and transmits the images for interpretation to a computerized
workstation
Ethical considerations of the use of capsule endoscopy
should cover the following main issues: justification of the
procedure, its potential benefits and harm, and patient
autonomy.
Advantages
• painless
• does not require sedation
•easy to perform and for the first time enables
exploration of the entire small bowel at high

36. CAPSULE SEALING TECHNOLOGY:
A. Banding technology
B. Liquid encapsulated Microspray sealing technology (LEMST)
1..BANDING TECHNOLOGY
 The capsules are first rectified
and then passed once or twice over
a wheel that revolves in a
temperature controlled gelatin bath.
 A quantity of gelatin is picked up
by the edges of wheel and applied
to the junction of the cap and body.
 The banded capsule are
transferred to continuous loop
conveyor belt in the drying unit
 The bands are dried using
filtered air at ambient room
condition.

37. IQUID ENCAPSULED SPRAY ENCAPSULED TECHNOLO
 This capsule sealing process uses the principle of lowering of
the melting point of gelatin by the application of moisture to the
area between the capsule body and cap.
 The first machine developed to seal capsules, involved dipping
the capsules into a bath of liquid and drying in a fluidized bed
chamber.
 During this process the capsules were subjected to
considerable stress. In contrast to this, in the redesigned process
every capsule is individually sprayed with a micro amount of
sealing fluid at the body and cap junction.
 Drying takes place by gently tumbling of capsules in a rotating
drum

38. SODAS® Technology
CODAS® Technology
PRODAS® Technology
PULSYSTM Technology
ORBEXA® Technology
Banner’s VersetrolTM Technology
Bijel Capsules: Co-release Micro-gel

39. 1.SODAS® Technology
Spheroidal Oral Drug Absorption System is Elan’s
multiparticulate drug delivery system. Based on the
production of controlled release beads.
It can provide no. of tailored drug release profiles, including
immediate release of drug followed by sustained release to
give rise to a fast onset of action, which is maintained for
24hours.
Alternatively the opposite scenario can be achieved and
additional option is pulsatile release

40. Elan’s SODAS®
 Technology is based on
the production of uniform
spherical beads of 1-2mm
in diameter containing drug
plus excipients and coated
with product specific
controlled release
polymers.
The most recent
regulatory approvals for a
SODAS® based system is
the once daily oral dosage
forms of Avinza™,
Ritalin®LA and
Focalin®XR.

41. 2.PRODAS® Technology
Programmable Oral Drug Absorption System is multiparticulate
technology; it combines the benefits of tabletting technology within a
capsule
PRODAS® system is presented as a number of minitablets combined
in a hard gelatin capsule. It can be used to pre-program the release rate
of a drug
It is possible to incorporate many different mini tablets, each one
formulated individually and programmed to release drug at different
sites within the GIT
PRODAS® technology, by incorporating mini tablets with different
release rates, can display the characteristics of no of different
conventional dosage forms:
• IR component will mimic conventional formulation.
• Delayed release can provide site/regional release and food resistance.
• Sustained release component provides additional controlled release

42. 3.PULSYS™ Technology
MiddleBrook™ Pharmaceuticals developed PULSYSTM,
an oral drug delivery technology that enables once daily
pulsatile dosing
PULSYS™ dosage form is a compressed tablet that
contains pellets, designed to release drug at different regions
in the GIT in a pulsatile manner
The dosage form is made up of multiple pellet types of
varying release profiles that are combined in a proportion so
as to produce a constant escalation in plasma drug levels in
the early portion of the dosing interval
Moxatag™ tablets contains amoxicillin and improved
bactericidal action in pulsatile manner was observed as

43. 4.Bijel Capsules: Co-release Micro-gel
Colloid scientists at the University of Edinburgh have
invented a new generic route to gel capsule
formulation, involving particles suspended in fluid-
bicontinuous mixture of two solvents
These capsules have highly tunable properties (eg,
shear modulus and release rate), which can be
selected for different applications, such as personal
care, foodstuffs, and home care
A key feature of these capsules is the internal
architecture: they have inter-penetrating domains of
immiscible fluids (bicontinuity)
The bijel capsules are made of two fluids
and hence they are both a gel and an emulsion.
The water and oil domains inside the capsules can
be used to deliver chemically different active
ingredients

44.  A Review on Recent Advancement in
Capsule Formulation
Paresh Mohan*1, Mo. Asad Ansari1, Saurabh Patel1, M. P.
Khinchi1, Dilip Agrawal1, Natasha Sharma1.
AMERICAN JOURNAL OF PHARMATECH RESURCH
 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

45. RECENT ADVANCES IN ORAL PULSATILE DRUG
DELIVERY
ANANTHA NAYAKI RAVULA*, BAIRI AGAIAH GOUD,
Journal of Advanced Pharmaceutical Sciences,Vol.1/Issue
1/2011, page no. 57-62
www.capsugel.com
www.capsuline.com
www.qualicaps.com

46. S C H O O L O F P H A R M A C Y , R K U N I V E R S I T Y , R A J K O T 46