Industrial Pharmacy

2. 2

3. INTRODUCTION
The word capsule was derived from the Latin „capsula’, meaning a small
box.
 Capsules are solid unit dosage form in which one or more
medicaments are enclosed in a water soluble, biodegradable shell
made up of gelatin.
Mainly for oral administration (intended to be swallowed whole) but
some soft gelatine capsules are intended for rectal or vaginal
insertion also
Advantages
Capsules are tasteless, odorless and ease of
that it is smooth, slippery and easy to swallow.
use due to the fact
 The drugs having un-pleasant odor and taste can be administered
easily
3

4.  Can embossed or print easily on their surface like name /code of
product
 Shipping is easy as compared to liquid dosage form
 They can be filled quickly and conveniently
 They are economical and capsule shell is inert and biocompatible
 Better bioavailability as compared to tablet
 Economical and easily available
Disadvantages
Hygroscopic drugs (like Zinc chloride (ZnCl2), sodium chloride
(NaCl) and sodium hydroxide (NaOH) Sucrose and CuO) are not
suitable for filling into capsules, because they absorb water present in
capsule shell makes shell very brittle and ultimately lead to crumble
into pieces.
4

5. The concentrated solutions which require previous dilution are unsuitable
for capsules because if administered as such lead to irritation into stomach.
Not suitable for highly soluble substances like potassium chloride,
potassium bromide, ammonium chloride as there rapid release in GIT may
cause irritation due to the formation of high concentration in localized area.
Not suitable for highly efflorescent (loss of water from hydrated salts )or
deliquescent
potassium
(dissolved by absorbing water vapour e.g.. Sodium hydroxide,
hydroxide, ammonium chloride, sodium nitrate, calcium
chloride)materials.
Capsules are of two types: Hard gelatin capsules and Soft gelatin
Capsules
Hard gelatin capsules
also known as dry-filled capsules
Hard gelatin capsules consists of two parts known as capsule body (longer
part) and the capsule cap (the shorter part)
5

6. The drug substance placed in the body and the caps are slided over it,
hence enclosing the drug substance.
CAP
Body
Capsule Shell containe contain 12 - 16 % moisture and typically filled
with dry solids like Powders, Granules, Pellets/ Microsphere/
Microcapsules/Nano powers etc
For human use, empty capsules ranging in size from 000 (the largest) to
5 (the smallest) are commercially available.
•Generally encapsulates between 65 mg to 1g of powdered material.
•Amount to be filled depend upon the density powder. 6

7. Shell composition of
 Gelatin
 Plasticizers
 Colorants
 Opaquing agents
 Preservatives
 Water
Gelatin
HGC: HGC shell is made up of following -
Gelatin is a heterogeneous product derived
extraction of treated animal collagen.
by irreversible hydrolytic
Sources of Gelatin:
(i)Animal bones
(ii) Frozen pork skin
(iii) Hide portion
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8. • It is commonly used as a gelling agent in food, pharmaceuticals,
photography, and cosmetic manufacturing.
• Two type of gelatin are there. TypeAand Type B type
8
Properties TypeA Type B
Hydrolysis Acid Alkaline
Manufactured from Pork skin Animal bones
Isoelectric points 7-9 4.8-5
Properties Plasticity, clarity Firmness
Drawback - Hazy & brittle films

9. Properties of gelatin that are most important to capsule
manufacturers are the Bloom strength, viscosity and Iron content.
 Bloom is determined by measuring the weight in grams (force)
required to move a plastic plunger that is 0.5 inches in diameter,
4 mm (at a speed of 0.5 mm/sec) into a 6.67 % w/ v gelatin gel
that has been held at 10° C for 17 hrs.
The gelatin used in hard capsule manufacture is of a higher
Bloom strength (200–250 g) than that used for soft capsules (150
g) because a more rigidity is required for the manufacturing
process.
10
 Bloom strength, often referred to as Bloom value or Bloom number, is a
measure of the gel strength or gelatin strength of a gelatin sample.
 It is determined through the Bloom test, which involves measuring the force
required to penetrate a gel prepared from a standardized gelatin solution under
specific conditions.

10. Viscosity – is determined on (6.66%w/ v) concentration of gelatin in
water at 60° C , is a measure of the molecular chain length and
determines the manufacturing characteristics of the gelatin film.
Range-25-45 milli-poise
Iron Content- should not contain more than 15ppm of this element.
Iron show color reaction with certain organic compounds.
Plasticizers: Glycerin , Sorbitol
The ratio by weight of dry plasticizer to dry gelatin determines the
hardness of the gelatin Shells.
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Hardness Ratio dry glycerin/dry gelatin
Hard 0.4/1
Medium 0.6/1
Soft 0.8/1

11. Colorants
Certified colors are used.
May be dyes (Soluble) and pigments (insoluble) or mixture of both.
Dyes may be into the azo dyes (those that have an –N=N– linkage) and
the non-azo dyes.
Most dyes used currently are non-azo and the three most widely
used are erythrosine (E127), indigo carmine (E132) and quinoline yellow
(E104).
Two types of pigment are used: iron oxides (E172) : black, red and
yellow and titanium dioxide (E171)- which is white and is
the capsule opaque.
used to make
Play a role in identification and patient compliance
Opaquing agent
Provide protection against light or to conceal the contents eg. Titanium
dioxide 12

12. Preservatives: - Prevent décomposition during manufacture of gelatin.
Sulfur dioxide (15%), Methyl Parabens and Propyl
preserve the characteristics of gelatin.
are usually added to
Sodium lauryl sulfate : The USNF describes the use of gelatin containing
not more than 0.15% w/w of sodium lauryl sulfate for use in hard gelatin
capsule manufacture.
Essential oil (up to 2 %)
and taste
and Ethyl vanillin (0.1%): Favoring for odour
Water - hot , de-mineralised water is used for the preparation of capsule
shell.
Ready empty capsule shell should contain 12 to 16 % moisture.
Sugar: Sucrose (up to 5 %) to produce chewable shell and taste
Fumaric acid: upto 1
of gelatins
%, Aids in solubility and reduce the aldehydic tannin
13

13. Manufacture of capsule Shell
The process in use today is the same as that described in the original patent
of 1846.
The difference today is that the operation is now fully automated, carried out
as a continuous process on large machines housed in air conditioned
buildings.
Preparation of Gelatin
The first step in the
concentrated solution
demineralized hot water,
This is stirred until the
Solution
process is the preparation of the raw materials.
of gelatin, 30–40% w/v, is prepared using
60–70 °C, in jacketed pressure vessels.
gelatin has dissolved and then a vacuum is applied
to remove any entrapped air bubbles.
required amounts of dye solutions and pigment suspensions added and
other additives are added.
The viscosity is measured and adjusted to a target value by the addition of
hot water. 14

14. Viscosity is used to control the thickness of capsule shells during
production: the higher the viscosity, the thicker the shell wall produced.
Machine Used for manufacturing Shell
Machine Involved: The Coulton Machine
The manufacturing machines are approximately
and 3 m high. They consist of two parts, which
each other: on one half the capsule cap is made
10 m long, 2 m wide
are mirror images of
and on the other the
capsule body. The machines are also divided into two levels, an upper
and a lower.
The moulds, commonly referred to as „pins‟, are made of
stainless steel and are mounted in sets on metal strips, called „bars‟.
There are approximately 50, 000 mould pins per machine.
The machines are housed in large rooms where the humidity and
temperature are closely controlled.

15. At the front end of the machine is a hopper, called a „dip pan‟ or „pot‟.
This holds a fixed quantity of gelatin at a constant temperature,
°C.
between45
and55
Steps involved in making empty gelatin capsules…
1.
2.
3.
4.
5.
6.
Dipping
Spinning
Drying
Stripping
Trimming and Joining
Polishing
The process of capsule shell production with the pin method:
Dipping→Spinning → Drying → Stripping→ Trimming→ Joining →
Polishing
Steps involved
1. Dipping
Pairs of the stainless steel/manganese /Bronze pins (which are at room
temperature, 22 °C,) are dipped into the dipping solution
°C) to simultaneously form the caps and bodies. Time
seconds.
(dip pan, 45 and 55
to cast film is 12
16

16. 2. Spinning
The moulds are slowly withdrawn from the solution and then rotated
(during their
distribute the
thickness and
transfer to the upper level of the machine) in order to
gelatin over the pins uniformly to form a film of uniform
to avoid the formation of a bead at the capsule ends.
3.

Drying
The gelatin is dried by a blast of cool air to form a hard
The pins are moved through a series of air drying kilns to
water
drying must not be too rapid to prevent case hardening.
shells.
remove

 Over drying cause the film to spilt on pins due to shrinkage. Under
drying leave the film sticky.
4. Stripping
 A series of bronze jaws (softer than stainless steel) strip the cap
and body portions of the capsules from the pins.
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17. 5. Trimming and joining
 The stripped cap and body portions are trimmed to the required
length by stationary knives.
 After trimming to the right length, the cap and body portion are
joined and ejected from the machine.
The machines are normally operated on a 24-hour basis, 7 days per
week, stopping only for maintenance. The output per machine is over 1
million capsules per day, depending upon the size: the smaller the
capsule, the higher the output.
The capsules now pass through a series of sorting and checking
processes , polishing as well as printing
6. Sorting:
it can be either mechanical
ones as possible.
E.g., imperfect cuts, dented
bodies, grease inside etc.
or electronic, to remove as many defective
capsule, capsule with a hole, splitted, long
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18. 7. Polishing
Pan Polishing : Acela-cota pan is used to dust and polish.
Cloth Dusting : Capsule are rubbed with cloth.
Brushing : Capsule are feed under soft
8. Printing
 Capsules are printed prior to filling
 Machine: offset rotary press
 0.75 Million capsules/ hour
Precaution
rotating brush.
During production the thickness of the capsule wall is controlled
by the viscosity of the gelatin solution, speed and time of dipping.
• Empty capsules should not be subjected to temperature above 38
ºC.
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19. • moisture Content between 12% and 16% which acts as a
plasticizer for the film.
• Below 10%-- brittle, and above 16% ----soft. Not suitable for
filling
• Shell should be store in sealed containers.
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20. 21

21. Sizes and shapes
For human use, empty capsules ranging in size from 000 the
are
largest to 5 the
encapsulate
smallest.
between
Generally, hard gelatin
gram.
capsule
used to 65 mg to 1
23
Size Volume in ml Size in mm Fill weight
(density=.8g/cm3)
000 1.37 26.3 1.096
00 0.95 23.7 0.760
0 0.68 21.8 0.544
1 0.50 19.2 0.400
2 0.37 18.3 0.296
3 0.30 15.3 0.240
4 0.21 14.7 0.168
5 0.15 11.9 0.104

22. The size selected for use is determined by the amount of fill material
to be encapsulated. The density and compressibility of the fill will
largely determine to what extent it may be packed into a capsule shell.
Sealing and Storage
• Sealing prevent separation during shipping and handling.
FINISHED
• To maintain a relative humidity of 40-60% when handling and
storing capsules 24

23. Formulation for filling in Hard Gelatin Capsule: conisnap
are worlds most popular brands of two piece gelatine capsules
capsules
(1) Powder formulation
There are three main factors in powder formulation:
Good flow (using a free- owing diluent and Glidant)
No adhesion (using a lubricant)
Cohesion (plug-forming diluent).
The factor that contributes most to the uniform
good powder flow
filling of capsules is
Following ingredients are used for smooth filling of powder in capsules
1. Diluents: which give plug-forming properties.
 Those most frequently used are lactose,
microcrystalline cellulose.
starch 1500 and
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24. 2. Absorbents (optional): Some medicaments are physically
incompatible like hygroscopic substance. In case calcium
carbonate, Magnesium carbonate, Kaolin are
added to powder drug . These substance act as protective absorbent.
3. Lubricants: e.g. Magnesium stearate
4. Glidant: talc, magnesium stearate, colloidal silica
5. Wetting agents: which improve water penetration by reducing .
Eg. SLS
Disintegrant: which produce disruption of the powder mass e.g.
Cross povidone, Sodium starch glycolate
Stabilizers: which improve product stability. E.g. Sodium
metbisulphite, Sorbic acid
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such

25. Formulation for release of active ingredients
Disintegrate at 37 °C within 1 minute the shell will split.
Disintegration of capsule shell is the Rate controlling step in capsule
disintegration and product release
The availability of active content for absorption is depend upon the
properties of excipient used and as well as properties API (specially
particle size that govern the solubility / dissolution and permeability)
If the readily soluble diluent like lactose is supply with poorly
soluble drug like phenytoin, the bioavailability of phenytoin is some
what more than that when it is given with less soluble calcium sulfate.
On other hand, if readily soluble drug is supply with insoluble
diluents such as starch or microcrystalline cellulose, bioavailability of
drug will be unaffected /decrease depend upon the amount of
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additives

26.  The most commonly used lubricant for both encapsulation and
tableting is magnesium stearate (hydrophobic).
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27. Capsule filling Machine
1) Bench scale filling.(for small scale filling)
-Manual filling machine eg: feton capsule filling machine
2) Industrial scale-filling.
Comes in varying shapes and sizes
-Semi automatic machine e.g.. osaka model R-180
-Fully automatic machine: based on the principle of
 Auger filling
 Vibratory principle,
 Dosator principle
Steps involve in capsule filling
Regardless of their mechanical design, all hard shell capsule machines
have the same operational steps in common
filling
1. Rectification
is a mechanical process that causes the empty capsules lined up
all in the same direction i.e. body end downwards
2. Capsule separation
to be
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28. 3. Filling
 The filling material, such as powder, granules, or pellets, is
dispensed into the capsules.
 This can be done manually or automatically, depending on the
machine type.
 Manual Filling: For manual or semi-automatic machines, the
operator fills the capsules by spreading the filling material over the
capsules using a spatula or another tool.
 Automatic Filling: In fully automatic machines, the filling
mechanism (e.g., auger, vibratory system, or dosator) dispenses the
predetermined amount of filling material into each capsule.
4. Closure of the capsule
 the cap and body pieces are rejoined via push pins
5. Ejection of the filled and closed capsule from the machine by
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29. Rotosort: it removes loose powder,
removes capsules with loose caps
removes unfilled joined capsules,
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 Erweka KEA: for capsule dedusting and polishing machine
Steps on empty capsule filling

30. Cleaning and polishing capsules
 To remove the adhere martials on the surface
 should be removed before packaging or dispensing
 Most commonly used methods of cleaning and polishing
are
 Pan polishing
capsules
The Accela-cota cleaning vacuum affixed with capsule
machine for dusting and polishing capsules.
 Cloth dusting
rubbed with a cloth that may or may not be impregnated
an inert oil
Is a hand operation
Is a preferable method for removal of resistant materials
Brushing
serve to remove the dust from the capsule shell
with
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31. Recent Filling Equipments
Roto-fill: - 2 lakh capsules/day: filling the pellets into capsule
Acco-fill: - Fill Powder in hard gelatin andAccogel- Fill Powder in Soft Gelatin Cap
RotoWeigh: for weighing capsules
Scidenader PM60: for cleaning, polishing and printing
Vericap 1200: measures the change in dielectric constant or capacitance variation

32. Process flow diagram for automated capsule filling
31

33. Quality control of capsules
Whether produced on a small or large scale, all capsules must pass
quality control testing to ensure that the final product meets
specifications.
Quality control tests are divided into
1.
2.
Physical Test: Disintegration test, Weight variation
Chemical Test: Dissolution test, Assay, Content uniformity,
Stability testing, Moisture permeation test
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34. Physical Test:
Disintegration test
The disintegration test: to evaluate whether capsules disintegrated with
a prescribed time when placed in a liquid medium under the prescribed
integral conditions .
According to B.P and which applies to both hard and soft capsules
introduce one capsule in each tube (6 cap in 6 tube) and suspend
apparatus in a beaker containing 60ml water at 37 0C.
the
 if hard capsules float on surface of water, the disc may be added.
Result: Disintegration time for hard gelatin capsule is 30 min and for soft
not
gelatin capsule is 60 min. For enteric coated capsule, it should
disintegrate for 2 hrs in 0.1 N HCL flowed by
Phosphate buffer of pH 6.8 within 1 hr (total 3 hr).
disintegration in mixed
The test is said to
Repeat the test
pass if no residue is left on the screen of the apparatus.
for 12 capsules if more than 1 or 2 capsules fails to
test passes if 16 out of 18 capsules disintegrate or 3
e7lse
disintegrate The

35. Chemical Test:
Weight variation
20 capsules are individually weighed, average weight and percentage deviation
from the average weight is determined. Weight variation limits are average weight ±
10% when average weight < 300 mg and 7.5% when average weight is 300 mg or
more .
If not all of capsule fall within the limit, weigh 20 capsule individually again.
Remove the net content of each capsule.
Weight the empty shell individually.
Net weight of contents individually = Gross weight − Weight of shell
Determine the average net content from the sum of individual net weight.
Then determine the differences between each individual net content and average
net content.
The net weights of the not more than 2 capsules should fall outside the average net
weight ± 10% values and net weight of no capsule should be outside the average net
weight ±25% limit.
If the net weights of 3-6 capsules deviate by ±10 to +25%, the net weights of 40
more capsule determined . Out of the 60 capsules tested, the net weights of not more
the 6 capsules should deviate from the average net weight by 10- 25% and none by
38
more than 25%.

36. Uniformity of the drug content (Test forAPI)
Asample of 30 capsule is taken and 10 are assayed individually.
The drug content of 9 capsule should be within the limits of average drug
content ±15% and the drug content of none of the capsule fall outside the
average drug content ±25%.
If 1-3 capsules falls outside the average drug content ±15%, the
remaining 20 are assayed. The drug content of at least 27 out of 30 assayed
should be within the average drug content ±15% limits and none of the
capsules falls outside the average drug content ±25% limits.
The test is prescribed for capsules when active ingredient is <10
10% of fill weight.
mg or
Moisture permeation test
The degree and rate of moisture penetration is determined by packaging
the dosage unit together with a color revealing desiccant pellet
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37. Expose the packed unit to known relative humidity over a specified
time
Observe the desiccant pellet for colour change
Any change in colour indicates absorption of moisture
By measuring pre test weight and protest weight of pellet, amount
of moisture can be calculated.
Dissolution test: Carried out by means of tablet dissolution test
apparatus. Specifications like tablets
Physical stability of capsules shell
These tests known as “shell integrity tests” are used for determination
of the effect of capsule content on the gelatin shell, but not the
stability of active ingredients of the capsule.
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38. 41
SOFT GELATIN CAPSULES
 Soft Gelatin capsules are one piece, hermetically sealed (airtight) ,
soft gelatin shells containing a liquid, a suspension, or a semisolid.
 Available in different shape: oblong, oval or round; and in a
variety of colors and color
Numbers represent nominal
capacity in minims.
combinations
1cc=16.23 minims
Selection of capsule size:
The maximum capsules size
and shape for convenient oral
use in humans is
20 minims oblong,
16 minims oval
9 minims round

39. Differences between hard and soft gelatin capsules
42
Hard gelatin capsule Soft gelatin capsule
Two piece (large body & short cap) One piece & hermetically sealed.
Cylindrical shape. Available in round , oval & tube/oblong
like shapes.
Powder drug or pellets coated with Liquid & Semi liquid fill & unstable
drug are encapsulated. substances are encapsulated.
Gelatin in Hard form is used Molten gelatin are used.
Capsules are sealed after they are Filling & sealing of soft gelatin capsules
filled to ensure that the medicaments are done in a combined operation on
may not come out of the capsule due machine.
to rough handling.
8 different type of sizes are available No specific sizes are available

40. Advantages and reasons to use soft elastic capsules
Smooth and easy to swallow
Tasteless themselves, and good for drugs with unpleasant odor or taste
liquids
 High accuracy and precision possible as procedure is automated
 For some poorly water-soluble drugs, may improve bioavailability
 Reduced dustiness, no compression stage in the manufacturing process
 Can make specialty shapes (round, oval)
Limitations
Stability issue – more contact between shell and contents
Not appropriate for more than one kind of fill in the same capsule
Usually costs more to produce than hard capsules or tablets
 Some liquids cannot filled in soft gelatin capsules are:
 Water – will dissolve shell
 PEG, glycerin, LMW solvents – can migrate through the shell
 Strong acids, salts of strong acids or bases – may hydrolyse gelatin
 Strong bases &Aldehydes – may cross link gelatin and reduce
solubility
 Emulsions – may release water 43

41. Soft capsule shell components
Gelatin – Most commonly the gelatin is alkali (base) processed (type B).
Even typeAmay be used.
 Gelatin alternatives now available that are not animal byproducts, such as
modified
products
hydroxypropylmethyl cellulose (HMPC) or hydrolysed starch
 Plasticizer ( to provide for a more flexible and thicker capsule): glycerol
(most common), although sorbitol and propylene Glycol
 Water : 30 – 40 % of the wet gel formulation
 Colouring agent:soluble dyes, or insoluble pigments or lakes)
Opacifier: Titanium-dioxide (white opaque)
Preservatives: methylparaben and/or propylparaben
Viscosity: range of 25 -45 milipoise.
FlavouringAgent: not more than 2%
SweeteningAgent: not more than 5%
44

42. Core Materials (to be encapsulated)
Liquids, solutions and suspensions for filling capsule Shell:
room
should be homogeneous, air free and flow by gravity at
temperature.
Soft Gelatin Capsules
methods:
1. Rotary die process
2.Accogel machine
are manufactured by following four
3.
4.
Plate process
Reciprocating die
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43. Manufacture of soft gel capsule
Rotary Die Process
In this machine the soft gelatin capsules are prepared and then filled
immediately with liquid medicaments, it is having
rotating dies
• Gelatin mixture is placed in one hopper and the
another Hopper.
• The two rotating dies rotate in opposite directions
two hoppers and two
liquid medicament in
when the fluid gelatin
mixture enters the machine from the hopper it produces two continuous
ribbons.
• These half shells of the capsule are formed.
• At this stage the measured quantity of the medicament is filled in to it with
the stroke of a pump with the subsequent movement of the dies, the other
half capsule is formed.
• The two halves of the capsules are sealed together by the heat and
pressure of the rotating dies.
• As the die rolls rotate, the convergence of the matching dies pockets seals
and cuts out the filled capsules.
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44. 47

45. Nature of Capsule Content
N.B
AS
water
minor constituents (up to about 5% of the capsule content),
and alcohol can be used as co-solvents to aid in the
preparation of solutions for capsulation
 Up to 10% glycerin and/or propylene glycol can be used as
cosolvents with PEG or other liquids that have a shell-hardening
effect when capsulated alone.
 Preparations for encapsulation should have a PH b/n 2.5 and 7.5, since
preparations that are more acidic can cause hydrolysis and leakage of the
gelatin shell, and preparations that are more alkaline can
thus affect the solubility of the shell
tan the gelatin and
Accogel machine
accogel capsule machine uses a system of rotary dies but is
powder into a soft gelatin capsule.
successfully fill dry
48

46. Nature/formulation of capsule content
Miscible liquids
Solution of solid in liquids
Suspension of solid in liquid.
Materials are generally formulated to produce the smallest possible
capsule consistent with maximum stability, therapeutic effectiveness
and manufacture efficiency.
Cannot be incorporated in soft gelatin capsules
 liquids- water miscible and volatile-migrate via hydrophillic
gelatin shell.eg. Water, ethyl alcohol, emulsions
 Glycerin and propylene glycol-soften the gelatin shell
Can be incorporated in soft gelatin capsules
 Oily active ingredients
 V
egetable oils
 Mineral oils
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 Non-ionic surface active agents(polysorbate 80)

47. Quality Parameters
 Bloom Strength: It is the measure of the cohesive strength of the
cross-linking that occurs between gelatin molecules and it is
proportional to the molecular weight of the gelatin.
 . Bloom value is a measurement of the gelling power and the
strength of the resulting gel.
 It is determined by measuring the weight in grams required to
move plastic plunger that is 0.5 inch in diameter 4mm into a 6.67%
gel that has been held at 10oC for 17 hrs
 Bloom may vary with the
requirements of the individual
custom manufacturer but ranges
From 150-280g.
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48. Quality Parameters
Viscosity
 It is determined on a 6.67% concentration of gelatin in water at
60ºc.
The viscosity of gelatin ranges from 25-45 millipoise
Low viscosity (25-32 millipoise ) and high Bloom Strength (180-
280g) used to fill hygroscopic vehicle or solid
Iron
is always present in the raw gelatin and its concentration usually
depends on the iron content of large quantities of
manufacture
water used in its
 gelatin used in the manufacture of SGCs should
than 15ppm of this element
not contain more
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49. Finished product testing
Finished soft gels are subjected to a number of tests in accordance
with compendial requirements for unit dose capsule products
These normally include
capsule appearance
Disintegration test
 Weight variation
Content uniformity
 Microbiological testing
Dissolution test
55

50. Special quality control test on soft gelatin capsules:-
Seal thickness
Is measured under a microscope and it should one half to two third
of the ribbon thickness.
Total or shell moisture test
Moisture content is determined by the toluene distillation
SGC contain 6-10 % moisture in the cell.
method.
Capsule fragility or rupture test
Force required to rupture the capsule is determined.
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51. Packing:
Capsules should be packed well closed glass & plastic container &
stored at temperature not exceeding 30ºc.
 Capsules are individually protected by enclosing in strip & blister
packaging.
 In strip packing the capsule is hermetically sealed within the strips
of an aluminum or plastic film
57

52. Microencapsulation
is a means of applying relatively thin coatings to small particles of
solids or droplets of liquids and dispersions
Provides the means of converting liquids to solids
The applications of micro-ecapsulation might well include:
Sustained - release or prolonged-action medications
Taste – masking for chewable tablets, powders and suspensions
To reduce gastric irritation
Reduction volatility
Stabilization to oxidization
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53. Particle size: 50-5000 micron.
• 2 phases: a) Core material b) Coating material
a) Core material.
The solid core can be mixture of active constituents, stabilizers,
diluents, excipients and release-rate retardants or accelerators.
b) Coat or wall or shell material
•Compatible, non reactive with core material •Provide desired coating
properties like strength, flexibility, impermeability, optical properties,
non hygroscopicity, tasteless and stable 59

54. 61