International Journal of Pharmaceutical Research and Applications

Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

Detailed Study of Formulation and Evaluation of Capsule Dosage

Form: A Review
Satish P. Mohitkar1*, Sanchit V. Akhare1, Bhagyashree D. Balpande1
1,
Hi-Tech college of pharmacy, chandrapur, Maharashtra, india.
Corresponding Author: Satish [Link]
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Submitted: 15-05-2023 Accepted: 30-05-2023
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ABSTRACT: dosage forms. medicament completely. Instead, of

Polymeric film forming materials and gelatin, denatured gelatin, methyl cellulose and
manufacturing technologies used in the production polyvinyl alcohol can also be used to make the
of capsule shells have been developed to offer capsule shells" There are mainly two types of
additional consumer acceptability, to improve the capsules which areHard-shelled capsules, which
dosage form physical and chemical stability, and to contain dry, powdered ingredients or miniature
modify release of the encapsulated contents from pellets made by e.g. processes of extrusion or
the dosage form. These developments resulted in spheronization. These are made in two halves: a
the use of hypromellose and starch based polymeric smaller-diameter "body" that is filled and then
materials as alternate to the animal source gelatin sealed using a larger-diameter "cap".Both of these
in the manufacture of capsule shells. Hypromellose classes of capsules are made from aqueous
capsule shells have lower moisture content and solutions of gelling agents, such as animal protein
hygroscopicity than gelatin capsule shells. As a (mainly gelatin) or plant polysaccharides or their
result, moisture transfer from the hypromellose derivatives (such as carrageenans and modified
capsule shells into the encapsulated fill material is forms of starch and cellulose). Other ingredients
lower and thus the physical and chemical stability can be added to the gelling agent solution including
of hypromellose shell based products containing plasticizers such as glycerin or sorbitol to decrease
compounds prone to water induced precipitation the capsule's hardness."[1-2]
and hydrolysis is improved. Gelatin and non-
gelatin capsule shells can also be formulated to Advantages
modify the release of their fill contents in a site-  Fewer developmental problems in capsules,
specific manner in the GIT either by coating the hence allow quicker submission of a new drug
filled capsules with a modified release polymer or for clinical trials.
by incorporating the polymer within the capsule  It is easier to vary the dose.
shell before filling. These modified release capsule  Less adjuncts are necessary than for tablets
shells are soluble in or disintegrated by the  Capsule manufacturing requires fewer steps
intestinal secretions but resistant to the acid than tablet manufacturing.
secretions of the stomach.  Easy to swallow hence improves patient
KEYWORDS: Capsule, Rotary process, compliance
Plasticising agents, soft gelatin capsule, Hard  Simple separation of two incompatible
gelatin capsule products (combination)
 More possibilities for product identification
I. INTRODUCTION (printing) Drug with high dose and low
Capsule: Capsules are defined as unit solid dosage compressibility can be incorporated in
form of medicaments available as small containers capsules.[3]
(shells) made up of gelatin enclosing accurately
measured drug substances. The term capsule is Disadvantage (3)
derived from the Latin word capsula, meaning a  Capsules are not suitable for liquids that
small container. Capsule occupy a significant dissolve gelatin, such as aqueous or hydro
position in the drug development. They are often alcoholic solution
believed as the primary oral dosage form because  The concentrated solution which require
of their manufacturing process compared to other previous dilution are unsuitable for capsule

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 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

because if administered as such lead to c. Water

irritation into stomach. Water usually accounts for 30-40% of the
 Not useful for efflorescent or deliquescent wet gel formulation and its presence is important
material. Efflorescent cause capsule soften & both during the manufacturing process (to facilitate
Deliquescent may dry the capsule shell to manufacture) and in the finished product to ensure
brittleness. that the capsule is flexible. The desirable water
content of the gelatin solution used to produce a
Types of capsule[4] soft gelatin capsule shell depends on the viscosity
1. Hard gelatin capsule. of the specific grade of gelatin used. It usually
2. Soft gelatin capsule. ranges between 0.7 and 1.3 parts of water to each
part of dry gelatin.

d. Preservatives
Preservatives are often added to prevent
the growth of bacteria and mould in the gelatin
solution during storage. Examples of commonly
used as preservatives include potassium sorbate,
and methyl, ethyl, and propyl hydroxybenzoate.

Fig 1: Types of capsule e. Colorant and/or opacifier

A colourant (soluble dyes, or insoluble
[Link] gelatin pigments or lakes) and/or opacifier (e.g., titanium
Originally developed in the 19th century dioxide) may be added to the shell for visual appeal
to mask unpleasant taste and odour of drug and/or reducing the penetration of light for the
substances, soft gelatin capsules are used in many encapsulation of a photosensitive drug. The colour
applications, for pharmaceutical, health and of the capsule shell is generally chosen to be darker
nutrition products, cosmetic applications and even than that of its contents.
recreational products such as paint [Link]
capsules are used in many applications, for f. Other excipients
pharmaceutical, health and nutrition products, Other, infrequently, used excipients can include
cosmetic applications and even recreational flavouring agents and sweeteners to improve
products such as paint balls[5-6] palatability.
Manufacture of Soft Gelatin Capsules
Basic components of soft gelatin capsule shell Soft gels are manufactured using the following
The various components of the soft gelatin capsule methods
shell are as follows:
a. Gelatin Plate process
Similar to hard gelatin capsule shells, the This is the oldest commercial process used
basic component of soft gelatin capsule shell is in the manufacture of soft gelatin capsules. In this
gelatin. A large number of different gelatin shell process, a warmed sheet of plain or coloured
formulations are available depending on the nature plasticized gelatin is placed over a die plate having
of the liquid fillmatrix. Most commonly, the gelatin a number of depression or moulds or numerous die
is alkali- (or base-) processed (type B) gelatin and pockets. By applying vacuum, the sheet is drawn
it normally constitutes 40% of the wet molten gel into these depressions or pockets to form capsule
mass. Type A acid-processed gelatin can also be wells. The capsule wells are then filled with
used. [Link] agents medication-containing liquid. A second sheet of
Plasticizing agents are added in a soft gelatin gelatin is carefully placed on top of the filled wells
capsule formulation to ensure adequate flexibility. followed by the top plate of the mould. Pressure is
The most common plasticizer used for soft gelatin then applied to the combined plate to form, seal
capsules is glycerol. Sorbitol, mannitol, and and cut the capsules into individual units. This
polypropylene glycol can also be used in method is used for small scale preparation of soft
combination with glycerol. gelatin capsules and capsules formed generally, had
one flat sideThe major problems with this method
of manufacturing softgels were the lack of dosage

DOI: 10.35629/7781-080315901599 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1591
 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

uniformity, high manufacturing losses, and its closed by bringing the body and the cap
labour-/cost-intensiveness. This equipment is no together.[8-9]
longer available.[7]
Basic component of hard gelatin capsules
Rotary Die Process a. Gelatin
Most soft gelatin capsules are prepared by Gelatin is by far the most common and
the rotary die process, a method developed and most well known material used to produce hard
perfected in 1933 by Robert P. Scherer. This capsule shells. It is a generic term for a mixture of
process almost eliminated all the problems purified protein fractions obtained from irreversible
associated with the plate process and produced soft hydrolytic extraction of collagen obtained from the
gelatin capsules with improved uniformity and high skin, white connective tissue, and bones of animals.
standards of Accuracy .In this process, two [10-11]
plasticized gelatin ribbons (prepared in the rotary-
die machine) are continuously and simultaneously b. Plasticizer
fed with the liquid, semiliquid or paste fill between Plasticizers are added to gelatin to reduce
the rollers of the rotary die mechanism. The forced the rigidity of the polymer and make it more
injection of the feed material between the two pliable. Common examples of plasticizers are
ribbons causes the gelatin to swell into the left- and glycerine and polyhydric alcohol. Water is also a
right-hand die pockets which govern the size and good plasticizer and is naturally present in the
shape of the softgels as they converge. As the die gelatin.
rolls rotate, the convergence of the matching dies
pockets hermetically seals and cuts out the filled
[Link] drawing of a rotary-die soft
gelatin capsule filler.

Fig 3: Hard gelatin capsules

c. Colourants
Most frequently, hard gelatin capsules are
coloured to enhance the aesthetic properties and
also to act as a means of identifying the product.
Colorants used must meet the regulatory
requirements of those countries where the product
will be sold. Examples of commonly used capsule
colourants include synthetic dyes such as azo dyes
Fig 2: Rotary Die Process and xanthene dyes. Iron oxide pigments are also
used.
[Link] gelatin capsule
Hard gelatin capsules are made of two d. Opacifying agents
shells: the capsule body and a shorter cap. The cap Opacifiers (e.g.. titanium dioxide) may be
fits tightly over the end of the capsule body. The included to make clear gelatin opaque. Opaquse
basic hard gelatin capsule shells are made from capsules may be employed to provide protection
mixtures of gelatin, sugar, and water. They are against light or to conceal the contents.
clear, colourless, and essentially tasteless. Hard
gelatin capsule shells are fabricated and supplied e. Preservatives
empty to the pharmaceutical industry by shell Preservatives (often parabens esters) were
suppliers and are then filled in a separate operation. formerly added to hard capsules as an in-process
During the capsule filling unit operation, the body aid in order to prevent microbiological
is filled with the drug substances and the shell is contamination during manufacture. Manufacturers
operating their plants to Good Manufacturing

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 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

Practice (GMP) guidelines no longer use them. In Step 6: Joining of the trimmed capsule shell
the finished capsules, the moisture levels, 12-16% Once trimmed, the two halves (the cap and body)
w/ v, are such that the water activity will not are joined to the pre-closed position using a pre
support bacterial growth because the moisture is lock mechanism. At this point, printing is done if
too strongly bound to the gelatin molecule. needed before packing in cartons for shipping.

Manufacture of Hard Gelatin Step 7: Printing

Hard gelatin capsules are manufactured After formation, the capsule shells can be
using a dip-coating method and the various stages printed to improve identification. Printing can be
involved are as follows: [12] achieved using one or two colours, containing
information such as product name or code number,
Step 1: Preparation of the gelatin solution manufacturer’s name or logo and dosage details.
(dipping solution) Printing reduces the risk of product confusion by
A concentrated solution of gelatin is the numerous handlers and users of the product
prepared by dissolving the gelatin in demineralized including manufacturers, pharmacists, nurses,
water whichhas been heated to 60–70°C in doctors, caregivers, and patients.
jacketedpressurevessels. This solution contains 30
– 40% w/w of gelatin and is highly viscous, which
causes bubbles as a result of air entrapment. The
presence of these bubbles in the Final solution
would yield capsules of inconsistent weight and
would also become problematic during capsule
filling and upon storage. To remove the air
bubbles, a vacuum is applied to the solution; the
duration of this process varies with batch size.

Fig 4:Manufacture of Hard Gelatin Capsule

Step 2: Dip-coating the gelatin solution on to
metal Filling of hard gelatin capsules
pins (moulds)Capsule shells are manufactured The filling of hard gelatin capsules is an
under strict climatic conditions by dipping pairs established technology, with equipment available
(body and cap) of standardized steel pins arranged ranging from that for very small-scale manual
in rows on metal bars into an aqueous gelatin filling (e.g., Feton capsule filling machine),
solution (25 – 30% w/w) maintained at about 50 ° through intermediate-scale semiautomatic filling to
C in a jacketed heating pan. large-scale fully automatic filling. Hard gelatin
capsules can also be hand-filled one at a time, as
Step 3: Rotation of the dip-coated pins done in a compounding pharmacy.
Following adsorption of the gelatin solution on to
the surface of the pins, the bar containing the pins The basic steps in filling hard gelatin capsules
is removed and rotated several times to evenly  Rectification of capsules (placing empty gelatin
distribute the solution around the pins, correct capsules on the removable plate with bodies facing
gelatin distribution being critical to uniform and downward).
precise capsule wall thickness and dome strength.  Separation of caps from bodies.
 Dosing of fill material (The body is filled with
Step 4: Drying of the gelatin-coated pins the formulation manually using a plastic spatula,
Once the gelatin is evenly distributed on the mould, and the excess powder is removed Hand Operated
a blast of cool air is used to set the gelatin on the methods or Semi Automatic Capsules Devices.
mould. At this point, the gelatin is dried, and the Punch Method or Manual Filing.
pins are then passed through several drying stages Automatic Filing ex:Osaka filling machine filing
to achieve the target moisture content. machine,macofar capsule filing machine. [13]

Step 5: Stripping and trimming It consist of:

After the gelatin is dried, the capsule is stripped off  A bed having 200-300 holes
the mould and trimmed to the proper length.  A loading tray having 200-300 holes.

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Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

 A powder tray same time, reducing the number of doses per day,
 A pin plate having a rubber to is to administer a capsule containing numerous
 A lever coated pellets that release the drug successively
 A cam handle over a long period.
The finely powdered drug is first
converted into pellets, usually by attaching it to
sugar granules with an adhesive. The pellets are
then treated with protective coatings that delay
release of the drug, each batch receiving a different
thickness. The batches are mixedthoroughly and
suitable doses are filled into capsules. For example,
a mixture might contain 30 percent of uncoated
pellets, for immediate release of drug, 30 percent
each of coated pellets that release at 4 hours and 8
Fig 5:Hand Operator Method. hours, and 10 percent of neutral pellets, used solely
to fill the capsule. Each batch may be coloured
Special types of hard gelatin and soft gelatin differently to simplify identification and facilitate
capsules control of mixing[16]
Altered Release capsule [14]
The rate of release of capsule contents can Non gelatinous capsule
be varied according to the nature of the drug and [Link] Propyl Methyl Cellulose (HPMC)
the capsule excipients. If the drug is water-soluble Hypromellose (INN), short for
and a fast release is desired, the excipients should hydroxypropyl methylcellulose (HPMC), is a
be hydrophilic and neutral. If a slow release of semisynthetic, inert, viscoelastic polymer used as
water-soluble drug is desired, hydrophobic an ophthalmic lubricant, as well as an excipient and
excipients will reduce the rate of drug dissolution. controlled delivery component in oral
If the drug is insoluble in water, hydrophilic medicaments, found in a variety of commercial
excipients will provide a faster release; products[17-19]
hydrophobic and neutral excipients will slow its
release. A very rapid release of the capsule contents
can be obtained by piercing holes in the capsule to
allow faster penetration by fluids in the
gastrointestinal tract, or by adding a small quantity
of sodium bicarbonate and citric acid to assist in
opening the capsule by the evolution of carbon
dioxide.[15]

Coatingcapsule(15)
Coatings have been applied Fig 6: Non gelatinous capsule
extemporaneously to enhance appearance and
conceal taste, as well as to prevent release of the Appearance: HPMC is white or similar to white
medication in the stomach (enteric coated fiber or granular powder, Odourless, Properties:
products). Most coatings of capsules require Almost insoluble in ethanol, ether and acetone:
considerable formulation skill and quality control Quickly dispersed in 80-90 centigrade water,
equipment found in manufacturing facilities. The Aqueous solution is very stable in room
capsules can be coated to delay the release of the temperature; Has good wetting dispersing /
active drug until it reaches a selected portion of the adhesive thickening emulsifying water
gastrointestinal tract. preserving/film-forming properties;

Sustained release capsules Dissolving process

The traditional method of taking a dose HPMC will agglomerate when directly
three or four times a day leads to periods of excess added towater and then dissolve. In this way it
and deficiency in blood concentration of the dissolves very slow and hard. Suggested methods
medicament. One way of correcting this and, at the as followers: 1. in hot waterHPMC does not

DOI: 10.35629/7781-080315901599 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1594
 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

dissolve in hot water. The primaryHPMC can be capsules lmay provide betterstability properties and
uniformly disperse in hot water. reduces susceptibilities to change on storage[20-22]
Appearance: HPMC is white or similar to white
fiber or granular powder, Odourless, Properties: Dissolution -Similar to that of gelatine capsules.
Almost insoluble in ethanol, ether and acetone: Advantages
Quickly dispersed in 80-90 centigrade water, -Ready for filling immediately following
Aqueous solution is very stable in room manufacturing
temperature; Has good wetting dispersing / -Offer greater resistance to humidity and heat than
adhesive thickening emulsifying water gelatin and allow easy filling as they are non-static.
preserving/film-forming properties; -Dissolution is independent of pH.
-Good surface finish.
Dissolving process -Coating of hard gelatine capsule with aqueous
HPMC will agglomerate when directly spray formulations can lead to softening of gelatin
added towater and then dissolve. In this way it shell or gelatin shell may become brittle due to
dissolves very slow and hard. Suggested methods water evaporation and drying. Especially at the
as followers: 1. in hot waterHPMC does not onset of coating. On the contrary, the coating of
dissolve in hot water. The primaryHPMC can be starch capsules seems to be less problematic
uniformly disperse in hot water. because of smooth seal of the filled unit, together
with the higher bulk density of the capsules, which
Manufacturing of (HPMC) capsules provide a more uniform coating bed.
Hard gelatin and HPMC capsules are
manufactured using similar equipment developed Manufacturing of starch hard capsules
by Eli Lilly. hard gelatin capsule manufacturing, -Hard gelatin capsules have been used
pins (moulds for making the capsules) at 22°C are most widely. Recently, however, starch capsules
dipped in a dip pan or pot that holds a fixed have been used in various controlled-release
quantity of gelatin at a constant temperature, products as well as in general use as demands for
between 45 and 55°C. The level of solution is non-animal based products increase. Starch
maintained automatically by a feed from the capsules are more easily coated than gelatin
holding hopper. Once the molds are dipped a film capsules. Gelatin shells may soften and solubilise
will be formed on them by gelling since they are at when sprayed with aqueous dispersion of coatings
lower temperature. The slowly withdrawn pins and can become brittle during the drying stage. The
from the dipping pan are rotated to. maintain higher bulk density of the starch capsule provides
uniform film thickness, where they arepassed for a more uniform coating bed.
through a series of drying kilns at controlled -Starch capsules are manufactured by an
temperature and humidity. The dried films (shells) injection molding process that yields exact
are stripped of the pins, cut to the correct length dimensions and provides an excellent seal between
and the two pieces (cap and body) are joined "top" and "bottom." The filling and sealing process
together. The pins are then cleaned and lubricated is simultaneous, resulting in a finished product that
to start the next cycle. is well-sealed, secure and relatively resistant to
The manufacture of HPMC based capsules. further
necessitates some modification to the molding
machine or to the formulation of the shell material 3)PVA Copoylmer Capsules
Because HPMC shell walls are much HPMC Hard capsules have been developed as an
gelling from solution occurs when the temperature edible container to mask the taste and odour of
is raised while it is converted to its original solution medicines. Traditionally used for powder or
as the temperature is lowered, granulated formulations, capsules have also been
adapted to contain oily liquids, tablets and even
2) Starch Capsules powders for inhalation. They are popular because
Properties of starch of their relative ease of manufacture (compared
Moisture content: Moisture content in with other dosage forms such as tablets) and
starch capsule lies between 12% to 14% w/w, with theirflexibility to accommodate a range of fill
more than 50% being tightly bound to starch. The weights. Additionally, capsules readily demonstrate
presence of this bound moistureindicates that starch bioequivalence between different strengths of the
same formulation. The solubility of many

DOI: 10.35629/7781-080315901599 | Impact Factor value 7.429 | ISO 9001: 2008 Certified Journal Page 1595
 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

compounds used in potential new drugs is very low fluid at 37 +2°C and observed over the time
because they are selected for their affinity to described in the individual monograph.
receptors, which increases as the lipophilicity of a
compound increases. Although these compounds
are expected to have a high clinical performance,
they often fail to become new drug entities because
of their low absorption in the gastro intestinal (GI)
tract - a result of poor dissolution. [23-25]

Manufacturing of PVA Capsule

Capsules made only of PVA are available,
although they are easily softened by surrounding
moisture. In the PVA copolymer, MMA was used
to increase the hardness of the capsule shell;
however, increasing the amount of MMA decreases
the polymer solubility. Thus, AA was Fig 7:Disintegration Appratus
copolymerized to increase the solubility at neutral
pH. The composition ratios of PVA, AA and MMA 2) Content uniformity test:
in the PVA copolymer can be modified; the best This test is performed only when the
copolymer is formed when the levels of PVA, AA content is specified in the individual monographs
and MMA are 70-80%, 2.5 5.0% and 15-25%, and when capsules fail weight variation test. If the
respectively. weight of capules is completely filled no need of
Drug capsules should dissolve in purified this test. Unless otherwise stated in the monograph
water, as well as in simulated gastric fluid (pH 1.2) for an individual capsule, the amount of drug
and simulated intestinal fluid (pH 6.8) of the substance, determined by assay, is within the range
disintegration test method listed in the Japanese of 85.0% to 115.0% of the label claim for nine (9)
Pharmacopoeia (JP). The dissolution of PVA of ten (10) dosageunits assayed, with no unit
copolymer cast film in the above media was outside the range of 75.0% to 125.0% of the
examined. The result showed that the film was labelled drug content. Additional tests
soluble in all three fluids, indicating that the areprescribed when two or three dosage units are
copolymer has suitable dissolution characteristics. outside ofthe desired range but within the stated
The film showed no erosion, swelling or extremes.
dissolution in macrogol 400.
3) Weight variation test:
Evaluation parameter of capsule[26]  20 capsules are selected or taken at randomly
[Link] test and weighed individually, take average and
[Link] uniformity test compare each capsule weight with average.
3 Weight variation test  Then test passes if none of the individual
4. Dissolution test weights are less than 90% and more than 110%
5 Moisture permeation test of average.
6. Stability testing  If test requirements are not met we have to
remove the powder, net content of powder can
1) Disintegration test: beweighed individually. They have to be
Disintegration of hard and soft gelatin averaged.
capsules isevaluated to ensure that the drug  Test requirements are met if not more than 2 of
substance is fully available for dissolution and the individual's difference is not greater than10
absorption from the gastrointestinal tract. The of average. In any case difference should not
compendial disintegration test for hard and soft be more than or equal to 25% .
gelatin capsules follows the same procedure and  If more than 2 and less than 6 net weights
uses the same apparatus described in the article determined, they deviates 10% Then we go
"Quality Control Tests for Tablets" foradditional 40 capsules.
The capsules are placed in the basket-rack  The average of 60 capsules is determined by
assembly, which is repeatedly lowered 30 times per weighing capsules individually and
minute into a thermostatically controlled bath of comparedwith average

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 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

 Test requirements are met if the difference capsules The test helps in improving
does not exceed more than of the 60 Capsule thequality of contents of capsule shell and for
 Deviation should not be more than 25% in any choosing the appropriate retail package
case  The capsule shells are to be stabilized to
 Then particular batch passes weight variation know atmospheric condition with relative
test humidity
 To weigh capsules we use Rotoweigh and
Varicap 1200 Packaging and storage of capsule
Finished hard gelatin capsules normally
4) Dissolution test: contain an equilibrium moisture content of 13 to
Dissolution test for capsules Drug 16%. This moisture is critical to the physical
absorption and physiological availability depend on properties of the shells since at lower moisture
the drug substance being in the dissolved state at contents (<12%), shells become too brittle and may
the site of drug absorption. The rate and extent of crack when exposed to the appropriate stress. At
dissolution of the drug from the capsule dosage higher moisture contents (>18%) they become too
form is tested by a dissolution test. This test soft and may lose shape. It is therefore important to
provides means of quality control in ensuring that, avoid extremes of temperature and to maintain a
different hatches of the drug product have similar relative humidity of 40 to 60% when handling and
drug release characteristics and also, a given batch storing capsules. [27]
has similar dissolution as the batch of capsales that Hard gelatin capsules can be individually
was shown initially to be clinically effective. protected by enclosure in strip or blister packs. In
the former, the units are hermetically sealed in
strips of aluminium foil or plastic film. In the latter
one of the films enclosing the units is formed into
blisters. An ideal foil or film forthese packs should
be:
 Heat stable
 Impermeable to moisture, water vapour, air,
andodours
 Strong enough for machine handling
 Reasonably easy for patients to tear and open
Fig 8:Dissolution Appratus

5) Moisture permeation test:

The USP requires determination of the
moisture permeation characteristics of single-unit
and unit dose containers to assure their suitability
for packaging capsules. The degree and rate of
moisture penetration is determined by packaging
the dosage unit together with a colour revealing
desiccant pellet, exposing the packaged unit to Fig 9:Packaging of Capsule
known relative humidity over a specified time,
observing the desiccant pellet for colour change Future perspective(29)
(indicating absorption of moisture) and comparing • The study of recent advancement of Solid dosage
the pre-test and post-test weight of the packaged form capsule is studying for better kind of dosage.
unit forms.
6) Stability testing: There are two way approach for capsule
 Stability tests for capsules are performed to dosage form innovation in capsule shell and
known the integrity of gelatin capsule shell innovation incapsule system. The present review
but not focuses on innovation in capsule system.
 to know the stability of therapeutically active • This review includes newer trends related to
agent and for determining the shelf life of capsule shell, capsule fill material, capsule

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 International Journal of Pharmaceutical Research and Applications
Volume 8, Issue 3 May-June 2023, pp: 1590-1599 [Link] ISSN: 2249-7781

sealingtechnique, and different capsule systems to PhD Thesis, Freiburg [Link]., Germany,
achieve modified drug [Link] of 1988.
various kind of materials and for [3]. LA Augsburger "Hard and soft gelatin
modifiedapplication like mapping of the drug capsules" in Modern Pharmaceutics GS
forclinical evaluation. Banker & CT Rhodes, Eds., Marcel
1. To reduce the frequency of dosing or to increase Dekker, Inc.: New York, NY, pp 395-
effectiveness of the drug bylocalization at the site 440.1995
of action, reducing the dose required, or providing [4]. Felton, L. Remington Essentials of
uniform drug delivery. Pharmaceutics. UK: Pharmaceutical press,
2. To Enhanced bioavailability, reduced side 2012.
effects, improved patient compliance, reduced peak [5]. Ghosh, T. and Jasti, B. Theory and
to trough ratio of drug in systemic circulation4 Practice of Contemporary Pharmaceutics.
Modifications in conventional capsule delivery USA: CRC Press LLC, 2005.
system are needed to overcome the disadvantages [6]. Manufacturing Considerations. In Y. Qui,
associated with them and to provide products of Y. Chen, G. Zhang, L. Yu, and R. Mantri
higher selectivity for medical treatment. (Eds.), Developing Solid Oral Dosage
Forms - Pharmaceutical Theory and
II. CONCLUSION Practice, (2nd Ed.) (pp. 723-747). UK:
Polymeric film forming materials and Elsevier Inc, 2017.
manufacturing technologies used in the production [7]. Menard, R., Tomka, I., Engel, W. D. and
of capsule shells have been developed to offer Brocker, [Link] to manufacture starch-
additional consumer acceptability, to improve the containing shapedbodies, mass containing
dosage form physical and chemical stability, and to homogenized starch anddevice to
modify release of the encapsulated contents from manufacture soft capsules.
the dosage form. These developments resulted in InternationalPatent Application,; WO 0
the use of hypromellose and starch based polymeric 137 817,1999.
materials as alternate to the animal source gelatin [8]. Jones D. Fast track Pharmaceutics Dosage
in the manufacture of capsule shells. Hypromellose Form and Design. London:
capsule shells have lower moisture content and Pharmaceutical Press, 2008.
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