CAPSULE

INTRODUCTION

✓ The term capsule is derived from the Latin word capsula,

meaning a small container.
✓ The first capsule prepared from gelatin was a one- piece
capsule patented in France by Mothes and Du Blanc in
1834.
✓ Capsules are solid dosage forms in which the drug
substance is enclosed within either a hard or soft soluble
shell, usually formed from gelatin.
 TYPES OF CAPSULES
✓ Hard gelatin capsule:-
• Disintegration time is 30 minutes
• Made up from gelatin +sugar + water
• Dry filled capsules
✓ Soft gelatin capsule:-
• Disintegration time is 60 minutes
• Made up from gelatin +plasticizer + water
• Soluble elastic and soft elastic caps
• Liquid filling capsule
 GELATIN
Gelatin derived from hydrolytic extraction of animal collagen. Common
source of gelatin is skin, bones , white connective tissue frozen ,pork
skin.
TYPES OF GELATIN
TYPE A TYPE B
Pharma gel A (cationic) Pharmagel B (anionic)
By acid treatment By alkali treatment
Isoelectric point (pH-9) Isoelectric (pH-4.7)
Processing of an acid bone From green bones
gelatin , isoelectric point pH –
5.5 -6
 BLOOM /GEL STRENGTH
➢ Measure cohesive strength of cross linking between gelatin molecules.
➢ Bloom strength α molecular weightt of gelatin(directly proportional).
➢ Determined by weight in grams required to move a plastic plunger
that is 0.5 inches in diameter ,4mm into 6% of gelatin gel that has
been held at 10 degree celsius for 17 hours.
➢ Range is 150-250 gram.
➢ Higher the bloom strength →higher the physical stability of capsule
shell.
➢ Cost of gelatin directly proportional to bloom
strength.
➢ Higher bloom gelatin are used to improve
physical stability for large capsule.
 VICOSITY
➢ Determines on 6% concentration of gelatin at 60 degree celsius →measure of
molecular chain length and determine manufacturing characteristics
➢ Viscosity for gel range from 25-45 milli poise
➢ But individual manufacture set a narrow range 382 milli poise for a particular
type of gelatin
➢ Low viscosity (25 to 32 milli poise ) high bloom (180-250 g )gelatins are used
in the conjunction with the capsulation of hygroscopic vehicles of solids and
standard gelatin formulas can be modified so as to require up to 50 % less
water for satisfactory operation on the capsulation machine.
➢ IRON→ present in raw gelatin concentration depends on iron
content of the large quantity of water used in manufacturing ,
➢ Gelatin used in the soft gelatin capsule should not contain
≥15ppm iron
 PLASTICIZER
✓ Plasticizer are more common for soft gelatin capsule .
✓ The ratio (w/w) of dry plasticizer to dry gelatin determines the hardness of
gelatin shell assuming that there is no effect from the capsulated material.
✓ Some of the examples of glycerin /gelatin ratios are shown in table:
HARDNESS OF GELATIN CAPSULE = WT.OF DRY PLASTICIZER ÷WT.OF DRY GELATIN

Hardness Ratio=dry glycerine : dry Usage

gelatin
Hard 0.4/1 Oral, oil based shell, softening product and those destined
primarily for hot humid areas
Medium 0.6/1 Oral, tube, vaginal oil based water miscible -based , or shell
hardening products and those destined primarily for
temperate areas.
Soft 0.8/1 Tube, vaginal, water miscible based or shell hardening
products and those destined primarily for cold , dry areas.
 ADDITIONAL COMPONENTS
Ingredient Concentration Purpose
Methylparaben (4 parts ), propyl 0.2% Preservative
paraben (1 part)
FD&C and D&C water soluble q.s Colorants
dyes ,certified lakes , pigments
and vegetable colors alones or in
a combination
Titanium dioxide 0.2 to 1.2% Opacifier
Ethyl vanillin 0.1% Flavoring for odour and taste
Essentials oils Upto 2 % Flavoring for odor and tatse
Sugar (sucrose) Upto 5 % To produce chewable shell and taste
Fumaric acid Upto 1 % Aids solubilty :reduces aldehydic
tanning of gelatin
 POINTS TO BE REMEMBER

➢ Formalin treatment :- decrease solubility of gelatin and cross linking of

gelatin molecules takes place
➢ 40% of formaldehyde →formalin
➢ Roto fill (Eli lily company) designed for filling of pellets
➢ Roto sort →for removing the loose powder
➢ Turett → to hold upper and lower punch
➢ Cam track →guide the movement f punches
➢ Fette machine →used to provide cool temperature
➢ Emptying capsule moisture content →12- 16%
➢ Humidity range → 30 - 40%
HARD GELATIN
CAPSULE
METHOD OF MANUFACTURING OF EMPTY GELATIN

STEPS DESCRIPTION
Dipping One hundred and fifty pairs of theses pins are dipped in a gelatin solution to form
bodies and caps simultaneously
• Temperature of pins = 22 C
• Solution temperature = 50 C
• Time = 12 second
Spinning Pins are rotated to distribute the glatin uniformly around the pins during which
time the gelatin may be set or gelled by a blast of cool air.
Drying By use of dry air and dehumidification
Stripping By bronze jaws
Trimming By stationary knives
Joining Cap and body are joined
Polishing Polishing by the polymer
 POINTS TO BE REMEMBER

✓ Thickness of the capsule wall is controlled by the viscosity of the gelatin

solution and speed and time of dipping.

MOISTURE CONTENT

✓ Optimum moisture content of capsule shell ranged between 12-15%.

✓ Below 10 % moisture content they become brittle and suffer dimensional
changes .
✓ Moisture content above 16% may cause problem in the filling and in loss
of mechanical strength.
 CAPSULE SIZE WITH THEIR QUANTITIES

CAPSULE SIZE BP(ml) IP(ml)

0 0.75 0.68
1 0.55 0.51
2 0.45 0.37
3 0.30 0.30
4 0.25 0.21
5 0.15 0.13
TRICK = to learn the BP (ml) quantity go to decreasing order which is
highlighted like 7,5,4,3,2,1 and after these digits 5 is common in every number
SOFT GELATIN
CAPSULE
 BASE ADSORPTION

✓ One laboratory tool for this purpose is base adsorption of the solid to be
suspended.

✓ Base adsorption is expressed as the number of grams of liquid base required to

produce a capsulable mixture when mixed with 1 gram of solid.

✓ Base adsorption of solid is influenced by such factors.

• Solid particle size
• Shape
• Physical state (fibrous , amorphous & crystalline )
 Practical procedure for determination of base
adsorption
In separate 150 ml
Weigh a definitely Add small amt. of Should possess
beaker place
amount of solid solid in liquid a mixture like
about 100 g of
into 150 ml beaker base and stir well soft ointment
liquid base

Check flow by
doing tilt at 45
degree and cut
off.

BA = weight of base / weight of solid

Conclusion of this test

i.e base adsorption is
determined by this
formula
✓ Base adsorption mixture is milled /homogenized /deaerated &
specific gravity is taken.
✓ Specific gravity :- is the wt. of mixture (w) per cubic centimeter or
16.23 minim (v).BA is used to determine the “minim per gram” factor
of solid.

✓ Minim per gram is the volume in minims that is occupied by 1 gram of

the solid + weight of liquid base required to make capsulatable
mixture

m/g =(BA+S)* V / weight of solid

POINTS TO BE REMEMBER :-
➢ Sealing temperature is in the range of 37-40 degree celsius
➢ Manufacture temperature in the range of 20-22 degree celsius
➢ Humidity control to a maximum of 40% operating areas ,20-30% in
drying areas
➢ Measurements and control records= primtometic scale
➢ Gelatin preparation is done by pony mixer .
➢ Filling by positive displacement pump
➢ Drying is done by → infra red drying
➢ Moisture content of shell by → toluene distillation & azeotropic
distillation
➢ Soft gelatin moisture content → 6 -10%
➢ Wet shell thickness vary from → 0.022- 0.045 inch
➢ Ph of pony mixer is → 2.5-7.5
PHARMACEUTICAL
SUSPENSION
 Introduction
✓ Pharmaceutical suspension may be defined as a
dispersion in which insoluble solids (drugs ) are
suspended in a liquid medium .

✓ Pharmaceutical suspension is a
heterogeneous system consisting of two
phases in which internal phase is
dispersed uniformly throughout the
external phase.
✓ The internal phase consists of particulate matter that is
essentially insoluble but dispersed uniformly throughout
the continuous phase with aid of single or combination of
suspending agent.
✓ The external phase (suspending medium) is
generally aqueous in some instance, may be an
organic or oily liquid for non-oral use.
✓ A good pharmaceutical suspension is one in
which the particle size distribution lies
between 1 and 50 um.
 Marketed Examples
Route Trade name Constituents Category
Oral Gelusil Aluminium Antacid
hydroxide gel
magnesium
hydroxide
Intramuscular Tricort 40 Triamcinolone Steroidal analogue
acetonide with anti-
inflammatory
activity
Opthalmic Genticyn HC drops Gentamycin and Antibiotic and anti-
hydrocortisone inflammatory
Rectal - Barium sulfate X ray contrast
medium
 Advantages
STABILITY
✓ Most of the drugs are not stable in solution form so it is necessary to prepare an
insoluble form of that drug.
✓ Suspension can improve chemical stability of certain drug.
✓ For example:- Procaine penicillin G.
MASK THE TASTE
✓ Drugs having unpleasant taste can be masked by adding suitable flavor
and sweetener to make it palatable .In some case drugs are suitably
modified into insoluble form and administered as suspension .
✓ Chloramphenicol palmitate is preferred over
chloramphenicol which has bitter taste
✓ Quinine tannate is preffered instead of other
quinine salts .
PROLONGED ACTION DOSAGE FORMS
✓ Insoluble solids act as a reservoir and continuously supply the drug into
solution which is absorbed over a long period
✓ For example:- Protamine Zinc-Insulin suspension , procaine penicillin
G being insoluble.
BIOAVAILABILITY
✓ Drug in suspension exhibits higher rate of bioavailability than other dosage
forms.
✓ Solution > Suspension > Capsule > Compressed Tablet > Coated tablet
✓ Particle size affects the drug release .This is due to
larger surface area and high dissolution.
✓ For example :- antacid suspension provides immediate
relief compare to antacid tablets
EASE OF ADMINITRATION
✓ Suspension are liquid preparation which are easily swallowed and flexibly
dose as compared to solid dosage form.
✓ These particularly true in case of children and elderly patients and permits
patient compliance.
 Characteristics of an Ideal
Suspension
✓ Solid particles should be of such size that they do settle rapidly.
✓ If sediment is formed, it should not form a hard cake at the bottom of container.
✓ If sedimentation occurs it should be easily redispersable on shaking.

✓ Viscosity of the suspension should be such that the product can be easily poured
from the bottle.
✓ Suspension for topical use should spread when applied
and leave a film of medicament at the site of application.
✓ Suspension for oral use should have an acceptable taste .
 Classification of Suspension
S. No. Class Examples
1. Based on physical state a. Suspension
b. Aerosols
c. Foams
2. Based on Proportion of Solid Particles
a. Dilute suspension (2 to10% w/v cortisone acetate, prednisolone acetate
solid).
b. Concentrated suspension zinc oxide suspension
(50%w/v solid).
3. Based on electro kinetic nature Flocculated Suspension, Deflocculated Suspension
of solid particle
4. Based on Size of Dispersed a. Molecular Dispersion (Particle size is less than 1 nm)
Particles b. Colloidal Dispersion (Particle size between 0.1-0.2 µm)
c. Coarse Dispersion (Particle size is greater than 0.2 µm)
5. General classification of Oral Suspension, Topical Suspension and Parenteral Suspension
Suspension
 Difference Between
Flocculated and Deflocculated Suspension
DEFLOCCULATED SUSPENSION FLOCCULATED SUSPENSION
Pleasant appearance , because of Slightly sediment and clear
uniform dispersion of particles. supernatant layer.
Supernatant remains cloudy Supernatant is clear
Particles experience repulsive force Particles feel attractive forces
Particles exist as separate entities Particles forms loose aggregates
Rate of sedimentation is slow as the Rate of sedimentation is high , as flocs
size of the particles are small are the smaller particles (higher size)
The sediment is closely packed and Sediment is loosely packed network
form hard cake. and hard cake cannot form.
Can not be redispersed Easy to redisperse
In the potential energy curves , it In the potential energy curve , it
represents the primary minimum. represents the secondry minimum
Bioavailability is relatively high Bioavailability us comparatively less.
 Factors Influencing Particle Settling
✓ Ideal characterstics of suspensions have highlighted the need to prevent
the settling of particles.
✓ The study of theories relating to sedimentation provides information
regarding factors that affect the settling of solids.
✓ Particle shape
✓ Theory of Brownian movement
✓ Theory of sedimentation
✓ Particle size
✓ Viscosity of medium
✓ Density of the medium
 Theory of Brownian Movement

✓ Brownian movement of particles prevents sedimentation.

✓ In general particles are not in state of Brownian movement
in suspensions .due to larger particle size and higher
viscosity of the medium.
✓ Brownian movement can be observed , if
the size of the particles 2 to 5 um provided
densities of the particles and viscosity of
the medium are favourable.
 Theory of Sedimentation
✓ The rate of sedimentation of particles can be expressed by the
stokes law, using this equation
Rate of sedimentation = d2(p1-p2)g/18n
Where,
d= diameter of the particles , cm (m)
P1= density of the dispersed phase , g/cm3 (kg/m3)
P2= density of the dispersion medium , g/cm3(kg/m3)
N= viscosity of the dispersion medium
G=acceleration due to gravity , 980.7 cm/s2
Stokes law is applicable in the following conditions
I. Particles should be spherical , but in the suspension ,
particles are largely irregular.
II. Particles should settle freely and independently such a
conditions can be satisfied by dilute suspension (0.5 to
2% solids per 100mL. But most suspensions contain
dispersed solids in concentrations of 5 to 10 % or
higher.
 Crystal Growth and Polymorphism
✓ In a suspension the suspended solids may grow in size
during storage .This phenomena is known as crystal
growth.
✓ The following are the mechanism
▪ Ostwald ripening
▪ Temperature changes
▪ Polymorphic transformation
 Physical Stability
✓ Physical stability is defined as the condition in which the particles
remain uniformly distributed through out the dispersion without
any sign of sedimentation
✓ The extent of sedimentation is quantitively expressed by two
parameters. They give a gross picture on the stability and are
normally used for the purpose of comparison of different
suspensions. These are applicable to flocculated suspensions only.
1. Sedimentation volume (F)
2. Degree of flocculation( B)
 Sedimentation Volume
It is defined as Vu= ultimate volume of sediment
Vo= initial volume of the suspension
✓ F is denoted as sedimentation volume.it is a dimension less number.
✓ If sedimentation volume measured in measuring cylinder then the equation
can be written as Hu/Ho where H represents height of sediment.
✓ F can assume a value of one when there is no sedimentation which is a desirable
property of an ideal suspension
✓ F value is between these limits 0 to 1 .higher the
sedimentation volume better the physical stability.
✓ Sedimentation volume method is used as one of the
common basic quality control tools because it is simple and
easy to estimate.
 Degree of Flocculation
F F = sedimentation volume of flocculated system
B
Fa Fa= sedimentation volume of deflocculated system
It is defined as
Vu Vu=ultimate sediment volume of flocculated system
B
Va=ultimate sediment volume of deflocculated system
Va
✓ If F =Fa then b will be one.
✓ If the b value is nearer to one then the suspension does not
represent a flocculated suspension. It it indicates that the
system under study is a deflocculated system.
✓ In general higher the value of B the greater be the physical stability.
✓ It is a destructive method of testing because the flocculated system
is converted to a deflocculated by the addition of deflocculating
agents such as electrolytes.
Formulation of Pharmaceutical
Suspension
Caking zone Non caking Caking zone
zone

Apparent zeta potential

Conc.KH2PO4
 Formulation of Suspension
Desired
suspension
Flocculated Deflocculated

One approach involves the use of structured

vehicles to keep particles in deflocculated state.
2 approach
commonly used Second approach keep the particles in a
flocculated state in order to prevent cake
formation.
➢ Third method uses a combination of these
approaches to prevent settling .
 Approaches used in Formulation of
Suspensions
Particles
Addition of wetting agent and dispersion
medium

Uniform dispersion of Addition of

deflocculated particles flocculating agent

Incorporation of Addition of Flocculated suspension

structured vehicle flocculating agent
Incorporation of
Deflocculated suspension Flocculated suspension as structured vehicle
in structured vehicle as final product
Flocculated suspension in
final product
structured vehicle as final
product
 Wetting Phenomena
➢Wetting is an adsorption process in which an intimate
contact of the solids with liquid phase is achieved .
Contact Angle
Contact angle Comment Examples
90 Float Sulfur , charcoal
0 Complete wetting Zinc oxide
180 Insignificant -
wetting
 Contact Angle
Drugs Contact angle
Indomethacin 90
Tolbutamide 72
Nitrofurantoin 69
Phenylbutazone 109
Chloramphenicol 122
palmitate
Ampicillin 21
Lactose 30
 Water miscible cosolvents
✓ The dispersion of solids in a vehicle (water ) can be achieved by the use of
water miscible cosolvents and wetting agents (surfactants)
✓ Water miscible cosolvents such as alcohol , glycerin and propylene glycol are
commonly used to disperse hydrocolloids. Process of wetting by glycerin is
given below in figure
Initial Complete Glycerin
contact contact coating

Glycerin in voids

Water
Water wetting Solids
Particles separated

Sequence of steps involved in the wetting process of solids by glycerin.

 Surfactants
✓ Surfactant aid in dispersion by reducing the interfacial
tension between the solid particles and the vehicle.

✓ As a result the contact angle is lowered and air is displaced

from the surface of solids. Surfactant in the HLB range of 7
to 9 are used as wetting agents.
✓✓Examples
In case of:- sodium laurayl sulfate
ionic surfactant di-octyl
the head sulfosuccinate
portion adsorb on, non-ionic
the solid
surfactants
surface and such
the as tweens
tails also
project assumesand
outwards partial negative
forms bridgescharge in
between
aqueous dispersion
the particles .Suchand form a network
arrangement brings like
aboutstructure between
flocculation and
particles.
prevents the precipitation of solids .
 Structured Vehicles –Deflocculated
suspension
✓ Structured vehicles is another technique for the
preparation of stable suspension in which the
viscosity of the preparation under static condition .
✓ The vehicle is said to behave like a false body that is
able to maintain the suspended particles in
suspension.
✓ Structured vehicles are avoided for the
preparation of parenteral suspension ,
owing to their high viscosity.
 Effects of electrolytes on the flocculation
✓ When bismuth subnitrate is dispersed in water , the bismuth particles assume
a large positive charge or zeta potential (25mV or above)
✓ The like charges on the surface experience repulsive forces and the system
becomes deflocculated .These particles resist collisions even if they are
brought together by agitation.
Caking zone Non caking Caking zone
✓ When a flocculating agent zone

Apparent zeta potential

monobasic potassium phosphate is
added to the above suspension in
small quantities, the negatively
charged phosphate ions get
absorbed on the positively charged
bismuth particles.
Conc.KH2PO4
✓ The forces of repulsions decrease and the attractive forces Begin to operate.
✓ As a result the positive zeta potential decreases and the solids begin to form flocs
→ this evident from the maximum sedimentation volume.
✓ On further addition of electrolytes the zeta potential decreases gradually and
becomes zero. During this stage too suspended particles remain as flocs.
Caking zone Non caking Caking zone
zone
Apparent zeta potential

Conc.KH2PO4
✓ On further addition of electrolytes dispersed particles assume a negative charge
on account of excess adsorption of phosphate ion .
✓ As a result the zeta potential becomes sufficiently negative and once again
particles experience repulsive forces.
Caking Non caking Caking
✓ Thus the suspension changes to a zone zone zone

Apparent zeta potential

deflocculated state.

✓ This is the evident from its low

volume of sedimentation
✓ The main difference from the initial
state is that now the system has a Conc.KH2PO
4
negative zeta potential .
1. When bulk shipments of capsules are
made, they are temporarily protected
from normal changes in humidity by a
suitable moisture barrier that is
(a) 0.03 inch polythene bag
(b) 0.003 inch polythene bag
(c) 0.003 polypropylene bag
(d) None of the above
1. When bulk shipments of capsules are
made, they are temporarily protected
from normal changes in humidity by a
suitable moisture barrier that is
(a) 0.03 inch polythene bag
(b) 0.003 inch polythene bag
(c) 0.003 polypropylene bag
(d) None of the above
Explanation -
• When bulk shipments of capsukes are made they are temporarily protected from
norma changes in humidity by a suitable moisture barrier such as 0.003 inch
polythene bag wi standard fiber board carton.
• Since such packaging is not a permanent moisture barrier the capsule should be
retail packages as soon as possible after receipt.
2. Identify the condition for determination
of bloom strength of gelatin

(a) 4mm, 66.66 %w/w, 200C , 24 hours

(b) 4mm, 66.66 %w/w,100C , 24 hours

(c) 4mm, 6.66 %w/w,250 C, 20 hours

(d) 4mm, 6.66%w/w, 100 C 17hours

2. Identify the condition for determination
of bloom strength of gelatin

(a) 4mm, 66.66 %w/w, 200C , 24 hours

(b) 4mm, 66.66 %w/w,100C , 24 hours

(c) 4mm, 6.66 %w/w,250 C, 20 hours

(d) 4mm, 6.66%w/w, 100 C 17hours

Explanation -
Bloom Strength (Gel strength)
• It is measured in Bloom Gelometer. It indicates strength of cross-linked gelatin
molecules Le cohesive strength or filmness of the gel
• Bloom strength is in the range of 150-250 grams is suitable for capsules.
It is determined by measuring the weight required to remove a plastic plunger that
is inserted 4 mm into 6.66% gelatin solution at 10°C for 17 hours
3. Identify the correct steps for of empty gelatin
shell
(a) Dipping → Spinning → Drying → Stripping →
Trimming → Joining → Polishing
(b) Dipping → Spinning → Stripping →Drying →
Trimming Joining → Polishing
(c) Dipping → Spinning → Drying → Stripping →
Joining → Trimming → Polishing
(d) Spinning Dipping → Drying → Stripping →
Trimming → Joining → Polishing
3. Identify the correct steps for of empty gelatin
shell
(a) Dipping → Spinning → Drying → Stripping →
Trimming → Joining → Polishing
(b) Dipping → Spinning → Stripping →Drying →
Trimming Joining → Polishing
(c) Dipping → Spinning → Drying → Stripping →
Joining → Trimming → Polishing
(d) Spinning Dipping → Drying → Stripping →
Trimming → Joining → Polishing
Explanation -
STEPS DESCRIPTION
Dipping Temperature of pins = 22° C
Solution temperature = 50° C
Time required= 12 seconds.
Spinning Pins are rotated to distribute the gelatin uniformly around the pins
Drying By use of dry air and dehumidification
Stripping By bronze jaws
Trimming By stationery knives
Joining Cap and body are joined Polishing by the polymer
Polishing The entire cycle of machine lasts approximately 45 min.

The entire cycle of machine lasta approximately 45 min

4. Which substance is used as anticaking
agent in SGC cell

(a) Sodium phosphate

(b) Polyol

(c) Glycerin

(d) Silicone dioxide

4. Which substance is used as anticaking
agent in SGC cell

(a) Sodium phosphate

(b) Polyol

(c) Glycerin

(d) Silicone dioxide

Explanation -
COMPONENT OF SOFT GELATIN CAPSULE
Water Usually 30-50%
Preservatives Methyl paraben, Propyl paraben, BHA, EDTA, sodium
benzoate ect.
Solvent Polar glycerin, PEG, PEG 400, PEG 3350, ethanol, PPG, water
Nonpolar beeswax, coconut oil, triglycerine corn oil, mineral
oil soybean oil, D,L- a-tocopherol
Color pigment Titanium oxide, ferric oxide
Flavors Ethylvanillin, essential oils
Anticaking agent Silicone dioxide.
Humectant Polyol
Buffers Sodium phosphate
5. Which is a polishing machine of finished
capsule

(a) ROTOSORT

(b) PM-60

(c) VERICAP-4000

(d) ACCOFIL
5. Which is a polishing machine of finished
capsule

(a) ROTOSORT

(b) PM-60

(c) VERICAP-4000

(d) ACCOFIL
Explanation -
EQUIPMENTS USED IN CAPSULE FORMULATION
S. NO. EQUIPMENTS PURPOSE
1. Rotofill For filling of pellets
2. Rotosort New filled capsuk sorting machine
3. Rotoweigh Automatic capsuke weighing machine
4. Vericap-1200 Capsule weighing machine
5. Quali-seal Filling of liquids
6. Erweka KEA Dusting and Polishing machine
7. Seidenader PM60 For Cleaning & Polishing.
6. Green bones are used for the preparation
of gelatin of the type

(a) A

(b) C

(c) B

(d) A and B
6. Green bones are used for the preparation
of gelatin of the type

(a) A

(b) C

(c) B

(d) A and B
Explanation -
TYPE OF GELATIN
TYPE SOURCE PROCESSING ISOELECTRIC
POINT
Type A Pork Skin Acid processed pH - 9
Type B Bones AlkalI processed Ph - 4.7
7. The limit for iron content of gelatin in
capsule manufacturing is

(a) NMT 5ppm

(b) NMT 25 ppm

(c) NLT 15ppm

(d) NMT 15ppm

7. The limit for iron content of gelatin in
capsule manufacturing is

(a) NMT 5ppm

(b) NMT 25 ppm

(c) NLT 15ppm

(d) NMT 15ppm

Explanation -
CONTIDITION & SPECIFICATION OF CAPSULES
S. NO CHARACTERISTIC SPECIFICATION
1. Storage condition 1000 F (35°C)
2. Processing area temperature 220 C
3. Humidity (handling of empty capsule) 35-45% (In operating area
4. Bloom strength 150 – 250 gm .
5. Viscosity for gelatin 25-45 milipoise
6. Moisture content (Determine by Toluene distillation)
Hard gelatin capsule 12-16 %
Soft gelatin capsule 6-10 %
7. Disintegration test
Hard gelatin capsule 30 minutes
Soft gelatin capsule 60 minutes
8. Iron content NMT 15 ppm
8. Formalin treatment is given to capsule
shell

(a) To decrease solubility

(b) To increase bulkiness

(c) To prevent microbial attack

(d) To avoid stickiness

8. Formalin treatment is given to capsule
shell

(a) To decrease solubility

(b) To increase bulkiness

(c) To prevent microbial attack

(d) To avoid stickiness

Explanation -
FOLLOWING ARE THE COMPOSITION OF SOFT GELATIN CAPSULE
INGREDIENTS FUNCTION/PURPOSE
Gelatin Ideal substance for capsulation
Plasticizer (Glycerin USP, Sorbitol USP, Enhances its flexibility and to help its
and Pharmaceutical Grade sorbitol processing and ratio of dry plasticizer to dry
special their combination) gelatin measures the hardness of the capsule
shell
Preservative (Methylparaben: Prevent the growth of micro-organism
propylparaben (4:1), sorbic acid (0.2%)
Water-soluble dyes, certified lakes, Colorants
pigments
Titanium dioxide Opacifier
ethyl vanillin, essential oils Flavoring agent
Fumaric acid To aid solubility and 1% fumaric acid aids to
increase the acid solubility and reduces the
aldehyde tanning of gelatin
Formaldehyde (Formalin) Retards dissolution of gelatin shell
9. PONDAC is an alternate material for
preparation of shell of HCG which is a
copolymer of

(a) Polyvinyl alcohol and Methacrylates

(b) HPMC and Methacrylates

(c) Chitosan and HPMC

(d) None of the above

9. PONDAC is an alternate material for
preparation of shell of HCG which is a
copolymer of

(a) Polyvinyl alcohol and Methacrylates

(b) HPMC and Methacrylates

(c) Chitosan and HPMC

(d) None of the above

Explanation -
THE TYPES OF CAPSULE SHELL MATERIALS ARE GIVEN BELOW
NON-ANIMAL CAPSULE SHELL ANIMAL CAPSULE SHELLS
HPMC Capsules (Hypromellose Vegicaps) Gelatin/PEG capsules
Pullalan capsules Coni-snap
PONDAC which consists of copolymer of Press-fit Gelcaps
Polyvinyl alcohol & Methacrylates
Alginate capsules LiCaps
Starch capsules PoSilock
V-caps Minicapsule
Oceancaps
10. For capsulation of hygroscopic vehicle,
identify the best possible combination

(a) Low viscocity & High bloom strength

(b) High viscocity & High bloom strength

(c) High viscocity & Low bloom strength

(d) Low viscocity & Low bloom strength

10. For capsulation of hygroscopic vehicle,
identify the best possible combination

(a) Low viscocity & High bloom strength

(b) High viscocity & High bloom strength

(c) High viscocity & Low bloom strength

(d) Low viscocity & Low bloom strength

Explanation -
• Low viscosity (25 to 32 millipoise), High bloom strength (180-250 g) gelatins are
used in conjunction with the capsulation of hygroscopic vehicles or solids and
standard gelatin formulas can be modified so as to require upto 50% less water
for satisfactory operation on the capsulation machine.
• These modified formulas afford less opportunity for the hygroscopic fill materials
to attract water from the shell and thereby improve the ingredients and physical
stability of the product.
11. What is the chemical degradation order
of Pharmaceutical suspensions

(a) First order

(b) Second order.

(c) Pseudo first order.

(d) Zero order

11. What is the chemical degradation order
of Pharmaceutical suspensions

(a) First order

(b) Second order.

(c) Pseudo first order.

(d) Zero order

Explanation -
KINETICS OF DRUGS DECOMPOSITION
• A drugs in suspension follows apparent zero order kinetics in which the
concentration of the drugs in the solution remains constant with time.
• When the drugs in the solution degrades or lost by any means new drugs
molecules from the suspended solid particks dissolved in the solution to
keep the concentration constant at the equilibrium solubility.
• That is the solid suspended particles act as reservoir of drugs.
12. Identify the wrong match pattern of DLVO
theory
(a) Primary minimum, High attraction,
Irreversible coagulation
(b) Primary maximum, High repultion, Prevents
coagulation
(c) Secondary minimum, Weak interaction,
Flocculation
(d) None of the above.
12. Identify the wrong match pattern of DLVO
theory
(a) Primary minimum, High attraction,
Irreversible coagulation
(b) Primary maximum, High repultion, Prevents
coagulation
(c) Secondary minimum, Weak interaction,
Flocculation
(d) None of the above.
Explanation -
Deryaguin, Landau, Verwey and Overbeek recognized the concept of balance
between electrostatic repulsive and van der Waaks attractive forces between
particles.
ZONE INDICATE EFFECT ON FORMULATION
Primary minimum High attraction Irreversible coagulation
Primary maximum High repulsion Prevents coagulation
Secondary minimum Weak attraction Flocculation
13. Particle size to not show Brownian
movement in a suspension should be

(a) 2 μ

(b) 4μ

(c) 6μ

(d) 5μ
13. Particle size to not show Brownian
movement in a suspension should be

(a) 2 μ

(b) 4μ

(c) 6μ

(d) 5μ
Explanation -
BROWNIAN MOVEMENT
• For particles having a diameter of about 2 to 5pm (depending on the density of the
particles and the density and viscosity of the suspending medium).
• Brownian movement counteracts sedimentation to a measurable extent at room
temperature by keeping the dispersed material in random motion.
14. A suspension should contain

(a) Particles of identical size with no agglomeration

(b) A distribution of particles from fine to coarse

(c) Particles with 10% fines

(d) Particles with 30% fines

14. A suspension should contain

(a) Particles of identical size with no agglomeration

(b) A distribution of particles from fine to coarse

(c) Particles with 10% fines

(d) Particles with 30% fines

Explanation -
PROPERTIES OF A SUSPENSION
• Suspension is a heterogeneous Mixture.
• The particles of a suspension can be seen by the naked eye
• The particles of a suspension scatter a beam of light passing through it and
make its path visible.
• Particles of identical size with no agglomeration and fine.
• The solute particles settle down when a suspension is left undisturbed that is, a
suspension is unstable. They can be separated from the mixture by the process
of filtration.
15. Stoke's formula for sedimentation
velocity V is given by

(a) D2(ρ1-ρ2)g /18η

(b) D2(ρ1+ρ2)g /18η

(c) D2(ρ1+ρ2)g /9η

(d) D2(ρ1-ρ2)g /9η

15. Stoke's formula for sedimentation
velocity V is given by

(a) D2(ρ1-ρ2)g /18η

(b) D2(ρ1+ρ2)g /18η

(c) D2(ρ1+ρ2)g /9η

(d) D2(ρ1-ρ2)g /9η

Explanation -
STOKES LAW
v = 2r2(ρ1-ρ2)g /9η =D2(ρ1-ρ2)g /18η
Where,
v=Velocity of sedimentation in cm/s; particle radius
D= Particle diameter in cm.
ρ1 and ρ2, Density of the particle and the liquid respectively, in g/ml
g= Gravitational constant 980.7 cm s² and
n= Viscosity of the medium in poise. i.e. g cm1 s1 in cgs units.
16. The principal limiting factor in the
rate of absorption from suspensions
is
(a) Dissolution rate
(b) Viscosity
(c) Physical stability
(d) Suspending agent
16. The principal limiting factor in the
rate of absorption from suspensions
is
(a) Dissolution rate
(b) Viscosity
(c) Physical stability
(d) Suspending agent
Explanation -
The drug released from suspensions is mainly through dissolution. Suspensions share many
physicochemical characteristics of tablets & capsules, with respect to the process of dissolution. As
tablets and capsules disintegrate into powders and form suspensions in the biological fluids, it can
be said that they share the dissolution process as a rate limiting step for absorption and bio-
availability.
17. In the suspensions, for stability
considerations

(a) Agglomeration are preferred

(b) Flocs are preferred

(c) Form hard cake

(d) None of the above

17. In the suspensions, for stability
considerations

(a) Agglomeration are preferred

(b) Flocs are preferred

(c) Form hard cake

(d) None of the above

Explanation -
Flocculation is the formation of flocs, i.e., light, fluffy groups of particles held
together by weak Van der Waal's forces.
They cause increase in sedimentation rate due to increase in size of sedimenting
particles, hence particles in flocculated suspensions in war sediment more rapidly.
Particles of flocculated suspensions, like tufts of wool with a loose fibrous
structure, also contain an appreciable amount of entrapped liquid, so that the
volume of final sediment is relatively large and hence, it does not form a hard cake
at the bottom of the container and is easily dispersed by gentle agitation; therefore,
a flocculated suspension is pharmaceutically more accepted as compared to
deflocculated suspension.
18. Identify the incorrect statement

(a) Brownian motion of particles give flocculated

suspension

(b) Brownian motion of particles can be observed if particle

size is 2-5 µm

(c) Brownian motion of particles makes suspension

unacceptable

(d) To eliminate Brownian motion of particles, 20% of

glycerine solution with viscosity of about 5 cps is used
18. Identify the incorrect statement

(a) Brownian motion of particles give flocculated

suspension

(b) Brownian motion of particles can be observed if particle

size is 2-5 µm

(c) Brownian motion of particles makes suspension

unacceptable

(d) To eliminate Brownian motion of particles, 20% of

glycerine solution with viscosity of about 5 cps is used
Explanation -
BROWNIAN MOVEMENT
Brownian movement can be observed if particle size is about 2-5 µm
Brownian motion
Below this range, particles tend to sediment In this context, NSD, 1.e. 'No
Sedimentation. Diameter can be defined. NSD refers to the diameter of the particles,
where no sedimentation occurs in the suspension systems. The values of NSD
depend on the density and viscosity values of any given system.
This typical motion, viz., Brownian motion of the smallest particles gives
flocculated suspension, which is pharmaceutically unacceptable: gives floccus.
Hence it is usually eliminated by dispersing the sample in 50 % glycerin solution
with viscosity of about 5 cps.
19. Flocculated suspensions have
sedimentation volume ______than
deflocculated suspensions
(a) Higher

(b) Equal

(c) Lower

(d) Zero
19. Flocculated suspensions have
sedimentation volume ______than
deflocculated suspensions
(a) Higher

(b) Equal

(c) Lower

(d) Zero
Glycoside may be defined as the organic compound from plants or animal sources which on enzymatic or acid hydrolysis give one or more sugar moieties along with non sugar moieties.

Explanation -
DEFLOCCULATED SUSPENSION FLOCCULATED SUSPENSION
Pleasant appearance , because of Slightly sediment and clear
uniform dispersion of particles. supernatant layer.
Supernatant remains cloudy Supernatant is clear
Particles experience repulsive force Particles feel attractive forces
Particles exist as separate entities Particles forms loose aggregates
Rate of sedimentation is slow as the Rate of sedimentation is high , as flocs
size of the particles are small are the smaller particles (higher size)
The sediment is closely packed and Sediment is loosely packed network
form hard cake. and hard cake cannot form.
Can not be redispersed Easy to redisperse
In the potential energy curves , it In the potential energy curve , it
represents the primary minimum. represents the secondry minimum
Bioavailability is relatively high Bioavailability us comparatively less.
20. The sedimentation volume of a
suspension, will be maximum at
(a) Zero

(b) Maximum

(c) 1

(d)-1
20. The sedimentation volume of a
suspension, will be maximum at
(a) Zero

(b) Maximum

(c) 1

(d)-1
Explanation -
• Sedimentation volume is a ratio of the ultimate volume of
sediment (Vu) to the original volume of sediment (Vo) before
settling.
• F = final volume of sediment (Vu)/ Initial volume of sediment
(Vo).
• F → dimensionless
• F = 0 (complete sedimentation)
• F = 1 (no sedimentation)
• Increase in sedimentation volume, increases physical stability.