Doshi et al.

/ IJDFR volume 2 Issue 3, May-June 2011

Available online at www.ordonearresearchlibrary.org ISSN 2229-5054

Review Article

INTERNATIONAL JOURNAL OF DRUG FORMULATION AND RESEARCH

A REVIEW ON RECENT INNOVATIONS IN CAPSULE DOSAGE FORM

R D Doshi*, P L Patel , M R Patel , K R Patel , N M Patel
Shri B.M. Shah College of Pharmaceutical Education and Research,
Modasa. 383315. Gujarat, India.
Received: 14 April 2011; Revised: 16 may 2011; Accepted: 13 June 2011; Available online: 5 July 2011

ABSTRACT
Capsule dosage form is most convenient and relevant dosage form. Innovation in capsule dosage form can be
made to provide product of higher “selectivity” for the drug for medical treatment. There are two way approach
for capsule dosage form innovation in capsule shell and innovation in capsule system. Basic rationale for capsule
shell innovation is to improve stability and consistency of of the filled drug. Shells are made up of animal origin or
non animal (vegetarian) origin. The present review focuses on innovation in capsule system. Various systems like
capsular systems, osmotic systems, pulsatile system based on the use of soluble or erodible polymer coating, use
of rupturable membranes and pulsatile system based on membrane permeability are summarized in this article.
These systems are beneficial for night time dosing and for the drugs having high first-pass effect and having
specific site of absorption in gastrointestinal tract.
Keywords : first-pass effect

INTRODUCTION [1] Mainly Two Types

Capsules are gelatin shells filled with the 1. Hard gelatin capsule
ingredients that make up an individual dose. 2. Soft gelatin capsule
Dry powders, semi-solids, and liquids that
do not dissolve in gelatin may be HARD GELATIN CAPSULE[2]
encapsulated. Capsules account for about The hard gelatin capsule consists of a base
20% of all prescriptions dispensed. or body and a shorter cap, which fits firmly
over the base of the capsule.

Figure 1: Hard Gelatin Capsule

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Advantages: rectal, or to be diluted for vaginal, rectal,

1. They may be used to mask the unpleasant
tastes, aromas, or appearance of a drug.
2. They allow powders to be dispensed in an
uncompressedform, thus allowing for
quicker dissolution and absorption of the
drug following oral dosing (as compared
with tablets).
3.They offer the pharmacist versatility to
prepare any dose desired for a variety of
administration routes (e.g. oral, inhalation,
Physical Specification For HSG:[3]
oral or topical use).
4. They may be easier than tablets for some
people to swallow.
5. They can be making to alter the release
rate of the drug.
7. They can be colored to protect the content
(photosensitive) from light and improve
the acceptability.

Typical Fill
Height or
Outer Diameter Actual Volume Weights (mg)
Size Locked Length
(mm) (ml) 0.70 Powder
(mm)
Density

000 9.91 26.14 1.37 960

00 8.53 23.30 0.95 665

0 7.65 21.70 0.68 475

1 6.91 19.40 0.50 350

2 6.35 18.00 0.37 260

3 5.82 15.90 0.30 210

4 5.31 14.30 0.21 145

5 4.91 11.10 0.13 90

Table 1: Physical Specification For Hard Gelatin Capsule

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STEPS OF MANUFACURING OF HARD GELATIN CAPSULE SHELL[4]

Figure 2: Steps Of Manufacuring Of Hard Gelatin Capsule Shell

GELATIN SPECIFICATION FOR HARD GELATIN CAPSULE[5]

GELATIN PROPERTIES ACID PIGSKIN FISH

BLOOM(G)0 240-255, 220-260

VISCOSITY, 6.67%,600(MPA,S) 4.2-4.8 3.5-4.5

MOISTURE (%MAX) 13.0 13.0

PH ,1% SOLUTION 5.2-5.8 5.5-6.0

MICROBIAL STANDARDS

TOTAL COUNT 500 500

Table 2: Gelatin Specification For Hard Gelatin Capsule

SOFT GELATIN CAPSULE[5,6,7,8]

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One piece hermetically sealed soft gelatin powders (with inert media) can be
shell containing a liquid, a suspension or encapsulated..
semisolid. 3. Lower dose of active ingredients.
Advantages 4. High accuracy in fill weights.
1. Products can be encapsulated in 5. Improved stability. Longer shelf life.
various shapes - various sizes - 6. Improved bioavailability..
various colors. 7. One piece Capsule - no problem of
2. Products with thick slurry type paste microbial contamination, oxidation
Medicaments to light oils and and evaporation.

Steps of Mfg. of SGC [6]

Figure 3: Steps Of Mfg.Of SGC

Gelatin Specification For SGC[8]

GELATIN PROPERTIES ACID OSSEIN FISH

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BLOOM(G)0 180-210 160-210

VISCOSITY, 6.67%,600(MPA,S) 2.7-3.2 3.0-3.5

MOISTURE (%MAX) 13.0 13.0

PH ,1% SOLUTION 5.0-6.0 5.0-6.0

ISO IONIC POINT,PH 6.0-8.0 7.0-9.4

CLARITY (45% solution in 30% glycerol) Clear no precipitate

MICROBIAL STANDARDS

TOTAL COUNT 500 500

Table 3: Gelatin Specification For SGC

INNOVATIONS IN CAPSULES: Targeted to :

 Improvement in the shell property
1. Innovations in Capsule Shells: It  Provide physical strength
includes modification of capsule  Protection from moisture
shell to improve shell property.  Protection from microbial
2. Innovations in Capsule System: It contamination
includes modification of the system  Protection from light and oxygen
to achieve modified release.  Improve compatibility of fill material
with capsule shell.

1] INNOVATIONS IN CAPSULE
SHELLS: IT INCLUDES:
Non animal Capsule Animal Capsule
 HPMC Capsules  Gelatine/ PEG Capsules
 Pullulan Capsules  Coni-Snap® Capsule(OceanCaps)
 PVA Capsule  Press-fit® Gelcaps
 Starch Capsule  LiCaps®
 V Caps®  Posilock
 Minicasule
 DBcaps® Capsules
1. Non Animal Capsule  Chemically stable.
 Low moisture content than Gelatin
capsule, as determined by
A. Hpmc Capsules(Hypromellose):[9,10] Microbalance system.
QUALI-V, developed by Shionogi
 Less brittle even in low
Qualicaps, is the first HPMC capsule
humidity(≤1% moisture content)
developed for eventual use in
 Fast dissolution (No change in
pharmaceutical products.
dissolution profile under stress
The features of QUALI-V are summarized
conditions) and soluble in water at
as following:
room temperature.
 Made from non-animal materials,
 No cross linking.
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 Lower water vapor permeability
than Gelatin capsule.(Gelatin>PEG-
Gelatin>HPMC)
 Low static electricity and light
protected.
 No Millard reaction with fillings.
 Not substrate for protease.
 Chemical inactivity and solubility at
room temperature.
 In these type of capsules powder,
tablet, granules, pellets, liquids and
semisolids are filled.
 Suited to automatic capsule filling
machines.
B. Pullulan Capsules:[11]
 Water-soluble polysaccharide
 Derived by bacterial fermentation
from corn.
 Widely use in Japan
 They are odorless, tasteless, and
completely biodegradable
 Used in production of foods,
pharmaceuticals and cosmetics.
 The film formation properties of
Pullulan are similar to gelatin.
 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.
 For Example: NP CAPSTM:
12,13]
C. Pva Capsules:[
 PONDAC Capsule (name)
 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.
 The oxygen permeability of PVA
copolymer capsule is significantly
low.
 The gelatin capsule was developed in
the 19th century.
 The HPMC capsule was developed
in the 20th century.
 The PONDAC capsule is the hope
for the 21st century
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Figure 4: Plot of Dissolution vs Time
D. Starch Capsules:[14]
 Made from potato starch and
represent a direct alternative to hard
gelatin capsule.
 Manufactured by the injection
moulding technique developed by
Capsugel (Capill®).
 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.
 Different size capsules are
manufactured ( number 0, 1, 2, 3, 4)
by changing the mold.
 Officially recognized in USP 23 and
NF 18
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.
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

 Stability of coated starch capsule
evaluated.
 Eg. TARGIT®
2. Animal Capsule
A. Gelatin/Peg Capsules:[3]
 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
Gelatin/PEG Features
 Less brittle
 Good for hygroscopic and moisture-
sensitive ingredients
 Odorless, 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%.
Gelatin/PEG capsules are available in
commercial pharmaceutical products
 Cardiovascular (Tocopherol
nicotinate)
 Vasodilators (Nifedipine)
 Antihypertensive (Captopril)
 Digestive Enzyme
B. Ocean Capstm:[15]
 OceanCapsTM is fish gelatin
capsules
 It contain all-natural marine
supplements
 Its over 40% of supplement users in
France, Germany and the UK
 US consumers continue to move
toward natural alternatives, and
look for products like marine supplements in
fish capsules
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Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011
 Ideally suited for fish-eating
vegetarians looking for fish capsules,
and marine supplements such as fish oil,
DHA, EPA, salmon liver oil,
shark cartilage and glucosamine.
 Perfect for the supplement needs of
fish-eating vegetarians, such as
iron,zinc, calcium and vitamins B2
and B12
 Certified origin from high quality,
farmed fish
 Preservative-free, starch-free, gluten-
free
Press fit® gelcaps:
 a unique dosage form consisting of a
high-gloss gelatin coating that
encases a caplet core.
 Press-Fit gelcaps combine the best
qualities of a gelatin capsule with the
density of a tablet, creating an
exciting new dosage form that can be
custom engineered to meet specific
product performance criteria.
 The elegant, geometric shape of
Press-Fit gelcaps is distinct in the
marketplace.
 The high gloss finish and extensive
selection of color combinations
provide additional opportunities for
unique trade dress and enhanced
consumer recognition.
 The outside gelatin shell is taste-free,
 Safe and effective utilization in oral
dosage applications.
Manufactured by exclusive cold-
shrink process on a special filling and
coating machine.
2] Innovations In Capsule System:
To provide modified release
• CAPSULE CAMERA
• PORT CAPSULE TECHNOLOGY:
• HYDROPHILIC SANDWICH (HS)
CAPSULE
• PULSINCAP
• INNERCAP TECHNOLOGY
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

a. Capsule Camera[16]
Capsule endoscopy is the most
recent innovation in gastrointestinal
endoscopy. The capsule contains a
video camera that photographs the
bowel for 8 h 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. Capsule endoscopy has
Figure 5: Capsule Camera
b. Port Capsule Technology: [17]
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Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011
several advantages over traditional
endoscopy. The procedure is
painless, does not require sedation, is
easy to perform and for the first time
enables exploration of the entire
small bowel at high magnification.
However, the clinician cannot
control its passive advance along the
bowel. In addition, the examination
may be incomplete, as the capsule
reaches the cecum in only 80% of
cases. This paper discusses the
problems related to the new
endoscopic procedure, the diagnostic
yield in comparison with other
procedures, proper indications for
the procedure, outcome and
complications.
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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 effect. There are mainly two
dosage forms for port technology.
Tablet dosage form description
The dosage form consist form of polymer
core matrix coated with the semi permeable,
rate-controlling polymer. Poorly soluble
drugs can coated with port properties
solubilization agent to insure uniform
control release from the dosage from
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Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011
Figure 6: Drug release mechanism from the
PORT tablet
Capsule dosage form description
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
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

Example of port technologies:-
 Delayed release pseudoephedrine
 Multiple program release of phenylpropanolamine
c. Hydrophilic Sandwich(Hs) Capsules:[18]
 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).
Figure 8: Hydrophilic Sandwich(Hs)
Capsules
 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
d. Pulsin Cap:[19,20,21]
Used for pulsatile drug delivery.
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In general consists of insoluble capsule body
and a soluble capsule cap.
 capsule body is made of gelatin
coated with ethyl cellulose.
 In the presence of fluid, the plug
swelled at a controlled rate that was
independent of the nature of pH of
the medium.
 As the plug swells it attains
frustroconical shape and it gets
slowly pulled out of the capsule.
 Pulse time is controlled by:
The length of the plug and insertion
distance of plug into the capsule.
 Disadvantage: not adopted for large
scale manufacturing because of high
cost.
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

Figure 9: Pulsin Cap
e. Inner Cap Technology:[22]
Figure 10: 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.
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Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011
 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, crystalline filled HPMC
capsule and a beadlet filled gelatin
capsule.
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

Newer Technology(for pulsatile release):
SODAS® Technology:[23]
Spheroidal Oral Drug Absorption System is
Elan’s multiparticulate drug delivery
system. Based on the production of
controlled release beads, the
SODAS®Technology is characterized by its
inherent flexibility, enabling the production
of customized dosage forms that respond
directly to individual drug candidate needs.
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.
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 AvinzaTM ,Ritalin®LA
and Focalin®XR.
CODAS® Technology:[24]
A delay of drug action may be required for
different reasons. Chronotherapy is an
example of when drug release may be
programmed to occur after a prolonged
interval following administration.
Chronotherapeutic Oral Drug Absorption
System(CODASTM Technology) was
developed to achieve this prolonged interval.
Verelan® PM product using this
Technology is designed to begin releasing
Verapamil approximately 4-5hrs post
ingestion. Delay is introduced by the level of
release controlling polymer applied to the
drug loaded beads. The release controlling
polymer is a combination of water soluble
and water insoluble polymers.
As water from the GIT contacts the polymer
coat beads, the water soluble polymer
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Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011
slowly dissolves and the drug diffuses
through the resulting pores in the coating.
The water insoluble polymer continues to
act as a barrier, maintaining the controlled
release of the drug.
When taken at bad time, this controlled
onset extended release delivery system
enables a max. plasma concentration of
verapamil in the morning hours, when blood
pressure generally rises from its overnight
low.
PRODAS® Technology:[25]
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.
It is possible to incorporate mini tablets of
different sizes so that high drug loading is
possible.
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/protection.
PULSYSTM Technology:[26]
MiddleBrookTM Pharmaceuticals developed
PULSYSTM, an oral drug delivery
technology that enables once daily pulsatile
dosing.
PULSYSTM dosage form is a compressed
tablet that contains pellets, designed to
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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.
The transit property of pellets enhance the
overall absorption time window and offer
improved bioavailability compared to tablet
matrix forms.
MoxatagTM tablets contains amoxicillin and
improved bactericidal action in pulsatile
manner was observed as compared to
standard dosing regimen.
ORBEXA® Technology:[27]
Multiparticulate system that enables high
drug loading and provides a formulation
choice for products that require granulation.
It produces beads that are of controlled size
and density and suitable for formulation as
controlled release multiparticulates- using
granulation, spheronization and extrusion
technique.
The resultant beads can be coated with
functional polymer membrane for additional
release rate control and may be filled into
capsules or provided in sachet form. Process
allows for high drug concentration within
each bead. The technology is suited for use
with sensitive drugs such as proteins.

Figure 11: ORBEXA® Technology

Banner’s VersetrolTM Technology:[28]

Novel innovative Technology that provides
time controlled release for wide range of
drug.
Drug is incorporated in lipophilic or
hydrophilic matrix and that is than
incorporated in soft gelatin capsule shell.
Technology is versatile because depending
on physicochemical property of drug either
emulsion/suspension can be developed.
For lipophilic drugs suspension formulation
is preferred while for hydrophilic drugs
emulsion form is utilized. By applying
combination of lipophilic and hydrophilic
matrices desire release profile can be
achieved.

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2nd 3rd 4th

1st Generation 5th Generation
Generation Generation Generation

Structure

3 layers 3 layers
2 layers capsules capsules capsules
4 layers Development of
capsules Biocapsule
Development of Encapsulate Development
Concept
encapsulator hydrophilic of acid
Control of Incubation and
Reduction of substances resistance shell
release cultivation in capsule
shell ratio Mass Application to
production ethical drugs
Deepen DDS
Improve stability
Mixture with DDS Functional Semipermeable
Development of content
products Improvement Development membrane
of function Encapsulate
Burst impact of compliance of 4 layers Biotechnology
liquid
capsules
Solution in
mouth
Freezing +
Acid resistance
Shell resistance Solution in Semipermeable
Solubility Control of
Function Heat stomach membrane
release
resistance
Control of
release
Hydrophilic
Hydrophilic Lactobacillus
Flavor flavor
Content substance Functional oil Yeast
Functional oil Fruit juice
Bifidus powder DNA. cell
exstract
Chewing gum Crystal Dew Bifina
Twin clean
Health food Capsule Constipation
Application Plum Biotechnology
Tooth paste JINTAN OTC
Freshener
Instant noodle Ice cream Solmiran
Table 4: Diff. Generation of banner’s versetrolTM technology

Bijel Capsules: Co-release Micro-gel[29] these capsules is the internal architecture:

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
90
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. The
capsules can be designed to release or mix
the active ingredients in response to a
specific external stimulus.
Doshi et al. / IJDFR volume 2 Issue 3, May-June 2011

Figure 12: Bijel Capsules
Cross-linked DNA capsules templated on
porous calcium carbonate
microparticles:[30]
To prepare hollow microcapsules composed
of native DNA, we developed a templating
method using porous calcium carbonate
microparticles as sacrificial templates. At
first, DNA was adsorbed onto calcium
carbonate microparticles, and then the
adsorbed DNA was covalently cross-linked
with each other by using ethylene glycol
diglycidyl ether. After the dissolution of the
templates, the resultant DNA capsules
ranged from 1.5 to 8 μm in diameter,
according to ionic strength. The low cross-
linked and highly cross-linked DNA
capsules exhibited enzymatic degradability
and permeability that was dependent on the
molecular weight of macromolecular
solutes, respectively. This method has the
potential to be used for the preparation of
various single-component polymer capsules.
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