1

CHAPTER 1
PHARMACOPOEIA
1. Write the Silent features of Indian pharmacopoeia.
SALIENT FEATURES OF INDIAN:
The term salient feature is defining elements that distinguish one target from another. Following are some
important distinguishing features of each edition of IP:
First Edition 1955:
• The titles of monographs have been given in Latin language. Abbreviated titles for use in prescription
have been given immediately below the Latin title.
• The English title has also been given below the abbreviation title.
• The weights and measures have been given in metric system.
• Doses are expressed both in the metric system as well as in the English system.
• A list of preparations has been given at the end of some of the monographs.
Second Edition 1966:
• The titles of monographs have been changed from Latin to English and the words of the title, for
example, Injection of Aminophylline' have been changed to 'Aminophylline Injection'.
• Doses are expressed in the metric system only.
• Solubility is expressed in parts of solvent per unit part of solute.
• The preparations of a drug have been given immediately after the monograph on the parent drug.
• The test for sterility has been modified to provide for detection of fungi in addition to aerobic and
anaerobic bacteria.
Third Edition 1985:
• The new analytical techniques such as Flame Photometry, Fluorometry, Electrophoresis and
Photometric Hemoglobinometry have been introduced.
• Dissolution test has been introduced in the case of certain tablets.
• Disintegration test has been amended
• A microbial limit test has been prescribed for certain pharmaceutical liquid preparations.
• The pyrogen test has been revised to make the test less time-consuming.
Fourth Edition 1996:
• The text is available in two volumes.
• The computer-generated structural formulae have been introduced.
• Some titles have been changed to include the more commonly accepted names of India, for example,
'Hyoscine Hydrobromide' as 'Scopolamine Hydrobromide'.
• Infra-red and ultra-red absorption spectrophotometric tests for identification of drug substance
have been introduced as alternative tests to the classical chemical tests.
Fifth Edition 2007:
• This edition is presented in three volumes.
• General chemical tests for identification have been almost eliminated and more specific infrared and
ultraviolet spectrophotometric tests have been given.
• The test for pyrogens involving the use of animals has been eliminated and the test for bacterial
endotoxins has been introduced.
• The test for abnormal toxicity is confined to certain vaccines.
• The use of chromatographic methods has been extended in assays to large number of
pharmaceutical products.
Sixth Edition 2010:
• The number of monographs of excipients, anticancer drugs, herbal products and antiretroviral drugs
has been increased.
• Monographs of Vaccines and Immunosera are upgraded in view of development of latest technology
in the field.
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• A new chapter on Liposomal products and a monograph of Liposomal Amphotericin B injection is
added.
• A chapter on NMR is incorporated in Appendices.
• The chapter on microbial contamination is updated to a great extent to harmonize with prevailing
international requirements.
Seventh Edition 2014:
• This edition includes advanced technology and experimental methods widely adopted in India and
abroad.
• The standards are prescribed for drugs produced and/or marketed in India to contribute the control
and assurance of the quality of the medicines.
• This edition is presented in four volumes.
• It incorporates 2548 monographs of drugs out of which 577 are new monographs consisting of APIs,
excipients, dosage forms, antibiotic monographs, insulin products and herbal products etc.
Eighth Edition 2018:
• The new edition of Indian Pharmacopoeia has been brought out in 4 Volumes.
• Standards for new drugs and drugs used under NHP are included.
• 53 New Fixed Dose Combinations (FDCs) monographs have been included, out of which 25 FDC
monographs are not available in any Pharmacopoeia.
• More specific infrared, ultraviolet spectrophotometer and HPLC tests have been given emphasis.
2. Write a note on pharmacy as career.
Career In Pharmacy
1. As a pharmacist:
• The pharmacy diploma/degree holders can work in hospitals as hospital pharmacist, community
pharmacist, consultant pharmacist or industrial pharmacist.
2. Central and State Governments:
• Drug inspectors and pharmacists at the government health services.
3. Pharmaceutical Industry:
• In production and manufacturing, research and development, quality control, quality assurance,
pharmacovigilance, regulatory affairs, business operations, sales, and administration, etc.
4. Pharmaceutical Sales:
• Registered pharmacists can sell bulk drugs as a bulk drug distributor or supplier and pharmaceutical
products as distributor, wholesaler, and retailer.
5. Pharmaceutical Marketing:
• As medical representatives.
6. Academics:
• As assistant teacher and laboratory assistant in D. pharm colleges.
7. Pharmaceutical Journalism:
• Pharmaceutical journalism is another opportunity for pharmacists which have great potential.
8. Consultancy:
• Consultant in regulatory affairs.
9. Clinical Research:
• In clinical research organization (CRO) pharmacists are employed as Clinical Research Associate,
Regulatory Affairs Associate, Clinical Data Manager, Clinical Development and Project Manager.
10. Organizational Management:
• They can work in managerial positions with health and welfare agencies.
11. Opportunities Abroad:
• There are lots of higher education and research opportunities in developed countries.
12. Medical Transcription:
• A pharmacist can work with physicians as medical transcriptor to maintain the patient treatment
history, the drug to which patients are allergic etc.
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3. Elaborate upon history of pharmaceutical education in India.

Pharmacy Education in India

• Pharmacy education in India is regulated by the PCI, under the Pharmacy Act of 1948, and the All-India
Council for Technical Education (AICTE), under AICTE Act of 1987.
• The first college in India was Madras Medical College established in 1835.
• In 1836, Calcutta Medical College was started at Kolkata.
• The first pharmacy college in Asia was started in Goa in 1842 by the Portuguese.
• The first two-year professional course 'Chemist and Druggist Diploma' was started in Madras Medical
College in 1874.
• An industry oriented 3-year Bachelor of Pharmacy (B. Pharm.) program was started by Mahadeva Lal
Schroff, the Father of Pharmacy Education in India' at Banaras Hindu University Varanasi in 1932.
• Prof. Schroff started a separate branch of Pharmaceutical Sciences at Banaras Hindu University (BHU)
Varanasi.
• The first M. Pharm. program was introduced in 1940 at BHU.
• In 1943 a committee appointed by Indian Government under the chairmanship of Sir Joseph Bhore
recommended 3-tier system for pharmacy education.
• In 1944, B. Pharm. course was started at the Punjab University Lahore
• In 1945, 'Doctor of Philosophy (Ph.D.) program was introduced at BHU.
• In 1947, GOI through Legislature brought the 'Pharmacy Bill' to regulate, control and standardize
pharmacy education in India.
• In the same year, L M. College of Pharmacy was established at Ahmadabad (Gujarat).
• The first class of 'Chemists and Druggists' was conducted at Madras Medical College in 1870. It was a
training programs to gain skills in the practice of pharmacy profession.
• Pharmacy Act in 1948 provided minimum standard of educational qualification for pharmacy practice
to regulate the practice, education, and profession of pharmacy.
• Pharmacy degree programs offered in India includes
o Diploma in Pharmacy (D. Pharm, 2 years)
o Bachelor of Pharmacy (B. Pharm, years)
o Master of Pharmacy (M. Pharm, 2 Years)
o Doctor of Pharmacy (Pharm. D, 6 years)
o Doctor of Philosophy in Pharmacy (Ph.D., 4 years)
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Chapter 2
4. Classify packaging material with suitable example for each class.
Containers are the devices that holds the drugs and may or may not be in contact with the drug.
Materials used are glasses, plastic, rubber, metals, cork etc.

Glasses are composed of sand, soda ash, limestone and cullet.

Type
Lime-soda glass Sulphur glass
Borosilicate glass Neutral glass
Silicone-treated glass Amber colour glass
Advantages:
1. They are transparent.
2. They are available in various shapes and sizes.
Disadvantages
1. Glass is fragile, so its containers are easily broken when dropped or knocked.
2. Glass containers are heavy, which increases the cost of transportation from one place to another.
3. Glass containers may release alkali to aqueous preparations.

Plastics are synthetic polymers of high molecular weight. Plastic is made from one or more polymers
together with certain additives.
Advantages: Disadvantages:
1. They are light in weight and can be handled 1. They are permeable to water vapour and
easily. atmospheric gases.
2. They are poor conductor of heat. 2. They cannot withstand heat without softening
or distorting.
3. They have sufficient mechanical strength. 3. They are relatively expensive.

Metals are used for the construction of containers commonly used for this purpose are aluminium, tin plated
steel, stainless steel, tin and lead.
Advantages: Disadvantages:
(1) They are sturdy. (1) They are expensive.
(2) They are impermeable to light, moisture and (2) They may shed metal particles into the
gases. pharmaceutical product.
(3) They can be made into rigid unbreakable (3) They react with certain chemicals or drugs.
containers by impact extrusion

5. Describe in detail about Glass with advantages and disadvantages

Glass is composed by sand, lime stone, soda ash and cullets
Types of Glass.
I. Lime-soda glass: It is composed of SiO2 (75%), Na₂O (15%), CaO (10%). Used to store solid
medicaments.
II. Borosilicate glass: It is composed of SiO2 (80%), B₂O3 (12%), Al2O3 (6%) and mixture of Na2O, CaO and
other oxides (2%). It is chemically more inert than lime-soda glass. It is a highly resistant glass.
III. Silicone-treated glass: Glass is treated with silicone so that it can be used for preparing containers to
store alkali sensitive products.
IV. Sulphur glass: It is a cheaper variety of glass used for construction of containers for parenteral
products. The soda-lime glass is exposed to moist SO₂ at about 500°C to get sulphured glass. It does
not liberate alkali.
V. Neutral glass: It is composed of Sio₂ (72-75%), B₂03 (7-10%), Al2O3 (4-6%), Na₂O (6-8%), BaO (2-4%)
and K2O (0.5-2%). It is used for the preparation of multidose vials, transfusion bottles and ampoules.
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VI. Amber color glass: Amber color glass container is used for storage of photosensitive pharmaceutical
products because it has the capacity to filter out U.V. radiations. It is obtained by adding C, S or Fe
and MgO₂.
Glasses used to storage of parenteral preparations.
i. Type I glass: It is also called borosilicate glass or neutral glass. It offers high hydrolytic resistance due
to its chemical composition.
ii. Type II glass: It is a soda-lime-silicate glass with high hydrolytic resistance because of an appropriate
surface treatment with ammonium sulphate or Sulphur dioxide. The containers made from this glass
are suitable for most acidic and neutral aqueous preparations.
iii. Type III glass: It is a soda-lime-silicate glass with only moderate hydrolytic resistance. Used to store
non-aqueous preparations for parenteral use and for powders for parenteral use (except for freeze-
dried preparations)
6. Describe the selection criteria for selection of packaging material
There are a few factors that influence selection of packaging material:
(1) Physical Characteristics:
• Packaging material selection decisions are influenced by certain physical characteristics of the
product like the physical state, weight, stability, fragility, rigidity, surface finish etc. to be packaged.
(2) Formulation Components:
• Stability and compatibility with the formulation contents are major concerns.
(3) Stability:
• Certain environmental factors like moisture, oxygen, light, flame, bacteria, fungi, chemical action,
etc., affect stability of formulation.
(4) Economy:
• The packaging material should not be too expensive.
(5) Convenience:
• Packaging must necessarily be easy to open and close, easy to dispense, easy to dispose of, etc.
(6) Rules & Laws of the government:
• Packaging and labeling may be subject to government regulation in the countries. Some countries
have specified packaging standards for certain products.
(7) Buyer Specifications:
• In some cases, buyers like the exporters to give packaging specification.
(8) Retailing characteristics:
• It should give good impression and confidence for customer to buy it.
(9) Environmental Factor:
• The packaging material should be capable of withstanding the stresses and hazards of handling and
transportation, stacking, storing etc., under diverse conditions globally.
(10) Disposability:
• One of the qualities required for good package is that it could be easily disposed of or recycled.
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Chapter 3
7. What ate preservatives.? Write two examples each for Antimicrobial, Antioxidant and natural
preservatives
• Preservative is a substance commonly added to pharmaceutical product in order to prolong its shelf
life.
• Preservatives are added in pharmaceutical preparation to inhibit growth of bacteria, yeasts or
Molds that can cause disease.
Antimicrobial agents: These are agent that acts against microorganisms responsible for causing
degradation of pharmaceutical preparation.
Examples: Sodium benzoate, sorbates, methyl paraben, propyl paraben, etc.
Natural Preservatives: These are substances obtained from natural sources such as plant, mineral
sources and animals which act as antimicrobial agents. Examples: Neem oil, sodium chloride, lemon, honey,
etc.
Antioxidant preservatives: Vitamin E & Vitamin C

Ideal Properties of Preservatives:

i) It should be non-irritant, non-toxic and physico-chemically stable.
ii) It should be compatible with other ingredients used in formulation.
iii) It should act as antimicrobial agent and exert wide spectrum of activity.
iv) It should be potent and act effectively in small concentrations.
v) It should maintain activity throughout product manufacturing, shelf life and usage.

Chapter 4

8. Explain the construction and working of hammer mill with a neat, labelled diagram.
A Hammer mill is an essential machine in the pharmaceutical industries. It is used to crush, pulverize,
shred, grind and reduce material to suitable sizes.
Principle:
▪ It operates on the principle of impact between rapidly moving
hammers mounted on rotor and the stationary powder bed.
Construction:
• It consists of a metal casing, enclosing a central shaft attached
with four or more swinging hammers.
• The lower part of the casing consists of a screen (Sieve),
through which material can pass and collected in a suitable
receiver, when the desired degree of size reduction is reached.
Working:
• The material is put into the hopper which is connected with the drum.
• The material is powdered to the desired size, due to fast rotation of hammers and is collected
under the screen.
• The mill can produce coarse to moderately fine powder.
• Due to high speed of operation, heat is generated which may affect thermolabile drugs or
materials. Moreover, high speed of operation also causes damage to the mill if foreign objects such
as stone or metal is present in the feed.
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9. Explain the construction and working of ball mill with a neat, labelled diagram.
Principle:
It works on the principle of impact and attrition. The material grinding occurs during impact of
falling grinding balls (Impact) and abrasion of the particles between the walls (attrition).
Construction:
• It consists of a hollow cylinder which is
mounted on a metallic frame in such a way,
that it can be rotated on its longitudinal
axis.
• The cylinder contains balls that occupy 30-
50% of the mill volume.
• The ball size depends on the size of the feed
and the diameter of the mill.
• The cylinder and balls are made of metal
and are usually lined with chrome.
• In pharmaceutical industry, sometimes the
cylinder & balls of the ball mill are lined with rubber or porcelain.
Working:
• The drug to be ground is put into the cylinder of the mill and is rotated.
• The speed of rotation is very important. At a low speed. the mass of balls will slide or roll over each
other and only a negligible amount of size reduction will occur (Fig. 5A).
• At a high speed, the balls will be thrown out to the walls by centrifugal force and no grinding will
occur (Fig B).
• Maximum size reduction occurs at about 2/3rd of the speed, the centrifugal force just occurs with the
result that the balls are carried almost to the top of the mill and then fall in. (Fig. C).
• After a suitable time, the material is taken out and passed through a sieve to get powder of the
required size.

Applications:
• It is used to produce very fine powders.
• Ball mills are used for wet grinding, e.g Suspensions.
• It is suitable for both wet and dry grinding processes.
• Ball mills can be used for grinding of hard and abrasive materials.
• Rubber ball mills are used for blending of explosive materials.
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10. Explain the construction and working of triple roller mixer. Give any two applications.
Principle:
The differential speed and the narrow space between the rollers develop high shear over the material.
Triple Roller Mill shear causes the crushing of aggregates, and particles and distributes the drug uniformly
throughout the semisolid base.
Construction:
• The construction of a triple roller mill is shown in Figure. It consists of three parallel rollers of equal
diameters.
• These are made up of hard abrasion-resistant material (silicon carbide), normally stainless steel.
• The rollers are mounted in a rigid framework horizontally. The pressure and gap between the
rollers are independently adjustable.
A hopper is arranged between the first two rollers. A scraper is attached to the last roller
Working
• The gap between the last two rollers is adjusted to be less than the gap between the first two
rollers. The rollers are rotated at different speeds. In practice, the first roller (receiving-roller)
rotates at a slower speed compared to the second roller. Similarly, the second roller’s speed is less
than that of the third roller (discharge roller).
• The material after passing through hopper comes between roller 1 and 2 and is reduced in size in
the process.
• The gap between roller 2 and 3 is usually less than that between 1 and 2, further crushes and
smooths the mixture which adheres to roller 2.
• A scraper is arranged in such a way that it can remove the mixed material from the roller no. 3 and
does not allow the material which has not passed between both sets of the rollers to reach the
scraper.
Applications:
• The triple roller mill is very useful for the purpose of mixing of solid powder in ointment base.
• A triple roll mill is effective mixing equipment used for squeezing (compression) and homogenizing
of pastes.
11. Explain the principle and working of turbine mixer.
Turbine Mixer
Principle:
• combination of centrifugal and rotational motion. This combined motion causes effective mixing of
low to medium viscosity fluids.
Construction:
• A turbine consists of a circular disc to which a few short blades are attached. There is a wide range of
turbine designs, Fig. 4.8.
• The blades may be straight, pitched, curved or disk type.
• The diameter of the turbine ranges from 30-50% of the diameter of the mixer vessel.
• Turbine rotates at a lower speed usually 50-200 rpm.
Working:
• A mixer is filled through with an opening at its top. Usually, it is a pan or drum within which mixing
blades revolve about the vertical axis.
• The variable speed drill with the turbine mixer whips air into the material mixture
• The air in the mixture yield bubbles contributing to mixing.
• The top entry turbine mixer is fitted with various impellers and turbines to suit heat and mass transfer
in solids, suspensions, and liquids.
• This type of mixer does not damage the product.
• Top entry high shear causes uniform emulsification and homogenization.
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• The mixing blades revolve about the vertical axis.
Applications:
• Highly used in chemical reactions and extraction operations. For example, liquid and gas reactions.
• Used in preparing emulsions, suspensions, and syrups.

12. Discuss the theory of filtration.

Theory of Filtration
❖ The theory of filtration gives an idea about the factors influencing the rate of filtration through the
filtering medium.
❖ The factors affecting the rate of filtration were studied by a scientist named Darcy and he expressed
it in the form of an equation, which is known as "Darcy's law". The equation is:
❖ V = ΚΑΔΡ/ ⴄl
Where,
V = Volume of filtrate
K = Permeability coefficient and is dependent on the nature of the precipitate to be filtered and the filter
medium
A= Area of filter bed
ΔP= Pressure difference on the liquid and below the filter medium
ⴄ = Viscosity of the fluid
l = Thickness of filter cake
The above equation makes it clear that the rate of filtration depends not only on the nature of liquid
undergoing filtration but also on so many other factors.

13. Write a note on cyclone separator.

Principle:
• In cyclone separator, the centrifugal force is used to separate solids from fluids.
• The separation depends not only on the particle size but also on density of particles.
• The centrifugal force causes the particles to migrate to the outside of the chamber and after, they fall
down to the bottom because of gravity.
Construction:
• It consists of a cylindrical vessel with a conical base.
• In the upper part of the vessel is fitted with a tangential inlet and a
fluid outlet and at the base it is fitted with solid outlet.
Working:
• The suspension of a solid in gas (usually air) is introduced tangentially
at a very high velocity, so that rotary movement takes place within
the vessel.
• The fluid is removed from a central outlet at the top.
• The rotatory flow within the cyclone separator causes the particles
to be acted on by centrifugal force.
• The solids are thrown out to the walls, thereafter it falls to the
conical base and discharged out through solids outlet.
Applications:
• Separation of suspensions of a solid in a gas or air or liquids.
• It is mostly used for separation of fines from coarse granules.
• Cyclone is connected to the extraction line of a tablet press, intercepting waste powder before it
reaches the central extraction system.
• It can be used in air-handling systems to produce particle free clean air.
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14. What are membrane filters? Give its applications.

Membrane Filter
A membrane is a thin layer of semi-permeable material that separates substances when a driving force is
applied across the membrane.
Principle:
It works on the principle of physical separation. The principle is quite simple that the membrane acts as a
very specific filter that allows water to flow through, while it catches suspended solids and other substances.
Construction:
• Membrane filters are plastic membranes based on cellulose acetate, cellulose nitrate or mixed
cellulose esters with pore sizes in the micron or submicron range.
• The filters are between 50 and 150 µ thick and are available in sizes up to 60 cm².
• A membrane filter has 400 to 500 million pores per square centimeter of filter surface.
• The pores are absolutely uniform in size and occupy about 80% of filter volume.
Working:
• The membrane separation process is based on the presence of semi-permeable membranes.
• The principle is membrane acts as a very specific filter that will let water flow through, while it catches
suspended solids and other substances.
• During use, membrane filters are supported on a rigid base of perforated metal, plastic or coarse
sintered glass.
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15. Explain the working fluidized bed dryer with neat, labelled diagram. Give any two applications.
Fluidized bed dryer
Principle
• Hot air is passed at high pressure through a perforated bottom of container containing granules to
be dried.
• The granules are lifted from the bottom and suspended in stream of air hence this condition is
known as fluidized state.
• The hot gas surrounds every granule to completely dry them .Thus material granules are uniformly
dried.
Construction

The dryer is made up of stainless steel.

• Detachable bowl is placed at the bottom of the dryer which is used for charging and discharging
• The bowl has perforated bottom with a wire mesh support for placing material to be dried.
• A fan is mounted in the upper part of circulating hot air.
• Fresh air inlet, pre-filter and exchanger are connected serially to heat the to the required
temperature.
• the temperature of hot air and exist is monitored.
• Bag filters are placed above the drying bowl for the recovery of the fine powder
Working
• Granules to be dried are placed in the detachable bowl and then bowl is pushed into the dryer.
• Fresh air allow to pass through the prefilter, which subsequently get heated by passing through a
heat exchanger.
• The hot air flows through the bottom of bowl. Simultaneously fan is allow to rotate.
• The air velocity is gradually increased
• When the velocity of air is greater than settling velocity of granules. The granules remains
partially suspended in the gas stream.
• Due to the increase in pressure the granules risen in container due to high velocity and latter fall
back in a random boiling motion, this condition is said to be fluidized state.
• The gas surrounds the granules completely dry them.
Applications:
• FBD is used for drying and mixing powders and agglomeration of materials.
• It is used in granulation and coating powders, granules, tablets, pellets, beads.
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• It is used as a fluidized bed reactor, for solids separation and for heat/mass transfer.

16. Explain the principle and working of Double Cone Blender. Give any two applications
Double cone blender

Principle of Double Cone Blender

i) The mixing occurs due to tumbling motion and shearing action with blade
ii) The Double Cone Blenders design is most often used for the intimate dry blending of free-flowing
solids.
iii) The solids being blended in these units can vary in bulk density and in the percentage of the
total mixture.
iv) Materials being blended are constantly being intermixed as the Double Cone rotates.
v) The conical shape at both ends enables uniform mixing and easy discharge
Working of Double Cone Blender
i) The powder is filled up to two thirds of volume of blender to ensure proper mixing.
ii) The rate of rotation should be 30-100 revolutions per minute.
iii) On rotation mixing occurs due to tumbling motion. The product can be discharged from the
bottom of the equipment
iv) The mixing tank can be slanted freely at the angle of 0° to 360° degrees for discharging and
cleaning purposes
Applications of Double Cone Blender
i) Double Cone Blender is efficient and versatile equipment for the homogeneous mixing of dry powders
and granules. Dry powder mixing for tablets and capsule formulations.
ii) Double Cone Blender can be used for pharmaceutical, food, chemical and cosmetic products etc.
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17. Explain the principle and working of Silverson’s mixer homogenizer

Principle:
• The principle of Silverson mixer is based upon shearing force.
• It produces intense shearing forces and turbulence by use of high-speed rotors.
• Circulation of material takes place through the head by the suction produced in the inlet at the
bottom of the head. Large globules in a coarse emulsion are broken into smaller globules by passing
them under pressure through a narrow orifice.

Working:
• The emulsifier head is placed in the vessel containing immiscible liquids, in such a way that it should
get dipped into it.
• When the motor is started, the liquids are sucked through the fine holes and the oil is reduced into
fine globules due to the rotation of the blades. So, a fine emulsion is produced which is then
expelled out.
Applications:
1. It is used for homogenization of vast variety of products such as creams and ointments, lotions, sauces
and flavor emulsions.
2. Silverson mixers can be used to disintegrate matter of animal, vegetable, mineral or synthetic origin
in a single operation.
It is also used in rapidly gelling, solubilizing and dispersing gums, alginates, Carbopol, etc., resulting
in an agglomerate-free solution within minutes
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Chapter 5
18. Define Tablet? Discuss in detail the various steps involved in the manufacture of tablets
• Tablet: these are the solid unit dosage form prepared by direct compression method i.e wet or dry
granulation method
• There are two types of method
I. Granulation method
II. Non Granulation method (Direct compression method )
Granulation method : There are two types
❖ Wet granulation method :

Dry granulation method :

Non granulation method :

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19. Classify different types of tablets with suitable examples.

CLASSIFICATION OF TABLETS
I. Tablets Ingested Orally
1. Compressed Tablets
2. Multiple compressed Tablets
3. Enteric coated Tablets
4. Sugar coated Tablets.
5. Film coated Tablets.
6. Chewable Tablets
II. Tablets used in oral cavities.
1. Buccal Tablets
2. Sublingual Tablets
3. Lozenges
4. Dental cone
III. Tablets used by other routes.
1. Implantation Tablets
2. Vaginal Tablets
IV. Tablets used to prepare solutions.
1. Effervescent Tablets
2. Dispersible Tablets
Hypodermic Tablets
20. Describe the method of preparation of syrup?
It is a concentrated aqueous solution of sugar (sucrose) in purified water.
The concentration of sugar is 66.7% w/w.
METHOD OF PREPARATION:
The different methods involved are:
a) Simple mixing or agitation (stirring) method:
The syrup is prepared by simply mixing or stirring the additives in vehicle.
Example, simple syrup, syrup ginger etc.
b) By heating:
The syrup is prepared by adding medicament and additives to vehicle and heating it to dissolve the
things.
It is also called as percolation method.
Care must be taken as overheating may cause inversion of the sugar.
c) By process of extraction:
The crude drug is boiled in water and then upon cooling the sugar solution is added.
Example: Tolu syrup.
d) By chemical reactions:
Syrup of ferrous Phosphate I.P is prepared by this method.
We get the required medicament by simple reactions

21. Define capsule. Differentiate hard and soft gelatin capsules.

Capsules are solid dosage forms in which medicament is stored inside the gelatine shell.

HARD GELATIN CAPSULE SOFT GELATIN CAPSULE

Hard gelatin capsules are used for enclosing solid Soft gelatin capsule is a solid capsule surrounding
medicament or dry powders of drug substance. a liquid or semi solid mass.
It is also known as dry filled capsule. They are also known as soft gel .
They are less flexible and consist of cap and body. They donot have cap and body
Prepared in many steps. Prepared in single step
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22. What are ointments? Classify with examples.

Ointments are semi-solid preparations meant for external application to the skin or mucous membrane.
Classification of Ointments may be classified as follows:
▪ According to their penetration property.
▪ According to their therapeutic uses.
Ointment classified according to properties based on penetration:
i) Epidermic ointments: These ointments are meant for action on epidermis and produce local effect.
They are not absorbed. These are mainly used as protectives, antiseptics, local anti-infectives.
ii) Endodermic ointments: These ointments are meant for action on deeper layers of cutaneous
tissues. They are partially absorbed and act as emollients, stimulants and local irritants.
iii) Diadermic ointments: These ointments are meant for deep penetration and release the
medicaments that pass through the skin and produce systemic effects.
Ointments classified according to therapeutic uses:
a. Antibiotic ointments: These ointments are used to kill microorganisms. The antibiotics used
are bacitracin etc.
b. Antifungal ointments: These ointments are used to kill the fungi. The commonly used
antifungal e
c. Anti-inflammatory ointments: These ointments are used to relieve inflammatory, allergic.
d. Antipruritic ointments: These ointments are used to relieve itching. The antipruritic drugs
commonly used are benzocaine and coal tar.
e. Astringent ointments: These ointments cause contraction of the skin and decrease
discharges. The astringents commonly used are made of zinc oxide.
f. Counter-irritant ointments: These ointments are applied locally to imitate the skin, thus
reducing, or relieving another irritation or deep-seated pain.
g. Parasiticide ointments: These ointments destroy or inhabit living insects, such as lice and
ticks, The drugs commonly mixed with ointment bases are benzyl benzoate etc.
h. Protectant ointments: These ointments protect the skin moisture, air, sun rays or other
substances such as chemicals. Example: calamine ointment.
23. Differentiate suspension and emulsion
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24. Explain the term ‘Immunological products’ discuss any two vaccines in brief
Immunological products are the preparation which are meant for the prevention of diseases , such
as vaccines, antitoxin and antiserum
BCG Vaccine:
• It contains live culture of the bacillus Albert Calmette and Camille Guerin strain of Mycobacterium
tuberculosis.
Preparation:
• The bacilli are grown on a suitable culture media.
• When 1 mg of bacilli plated out on suitable solid culture media, shows not less than 20 million
colonies.
• They are grown for not more than 14 days.

they are sepearted

bacilli on suitable
incubation for 14 not less than 20 in form of cake and
cultural media.
days million colonies suspended in
(1mg)
suitable media.

• After a suitable growth, they are separated by filtration in the form of a cake.
• The cake is homogenized in a grinding flask and suspended in a suitable sterile liquid medium
designed to preserve the antigenicity and the viability of the vaccine.
• The suspension is transferred into the sterile vials and freeze-dried. BCG vaccine contains no
antimicrobial agent.
Storage:
✓ It is store in hermetically sealed light resistant glass containers at 2-8 °C.
✓ The reconstituted vaccine must be used immediately after its preparation.
Use: As immunizing agent to provide protection against tuberculosis.
Dose: Prophylactic, 0.1 ml as a single dose by intracutaneous injection.

TAB and TABC:

• These mixed polyvalent vaccines are used in the prophylaxis of enteric infections.
• TAB vaccine is made by mixing simple vaccines B of Salmonella typhi;S. paratyphi A and S. Para
typhi.
• TABC vaccine is made from mixing TAB vaccine with vaccine of S. paratyphi C.
• The S. typhi and S. paratyphi C have antigen that increases the virulence of the cells.
• There are two methods of preparing these vaccines:
• In the first, the bacteria are destroyed by heat, and phenol is used as the preservative in the final
preparation.
• In the other, the organisms are killed by exposure to 75 % v/v alcohol and the preparation is
preserved with 25% v/v alcohol.
• These vaccines reduce the risk of typhoid fever by 75 %.
• Protection is for short term and re-immunization is needed after 6 months to a year.
• TAB can also be used in mixed form with tetanus vaccine (TABT vaccine) and with cholera vaccine
(TAB and Cholera vaccine).
• In the mixture containing tetanus vaccine the bacterial cells potentiate the antigenic activity of the
toxoid.
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25. What are the ideal requirements for an injectables?

• General Requirements for Parenteral Dosage Forms:
• The formulation of parenteral products involves careful consideration of the following
requirements:
1. Stability:
o The stability of parenteral preparation is very important.
o The physical as well as chemical stability of parenteral preparation must be maintained
during storage.
2. Sterility:
o The parenteral preparations should be free from all types of microorganisms.
o Aseptic conditions are required to be maintained during the preparation of parenteral
products and administration.
o The parenteral product must pass the test for sterling.
3. Free from pyrogens:
o The parenteral preparations the free from toxin and pyrogens.
o It is necessary that the parenteral must pass the test for pyrogen, because contaminated
parenteral causes rise in body temperature after its administration.
4. Free from foreign particles:
o The parenteral products be free from foreign particles such as dust and fibers.
o To this, the parenteral products must pass the clarity test.
5. Isotonicity:
o The parenteral preparations should be isotonic with blood plasma and body fluids.
o It is very important, in today complications on the administration of parenteral products
6. Specific gravity:
o The parenteral products meant for intra-spinal injections should have the same specific
gravity as that of spinal fluid into which the same are to be injected.

7. Chemical purity:
o The parenteral products should be free from chemical impurities.
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Chapter 6
26. Describe the basic structure of pharmaceutical manufacturing plants.

27. Write a note on cGMP

• Good Manufacturing Practices (GMP) are guidelines and regulations that ensure consistent quality
standards in manufacturing processes
• GMP is basically a set of rules that companies must follow to make sure their products are
consistently safe and high quality.
The main parts are:
1. Quality Control
• Testing products to make sure they're good
• Checking everything from raw materials to finished products
• Regular quality checks throughout production
2. Cleanliness
• Keeping facilities and equipment clean
• Making sure workers follow hygiene rules
• Proper cleaning procedures
3. Documentation
• Writing down everything that happens
• Keeping detailed records of production
• Having clear instructions for all processes
4. Training
• Making sure workers know what they're doing
• Regular training sessions
• Clear instructions for all jobs
5. Equipment
• Using the right equipment
• Keeping machines well-maintained
• Regular equipment checks
Benefits of GMP:
• Consistent product quality
• Reduced risk of contamination
• Better regulatory compliance
• Enhanced consumer safety
• Improved operational efficiency
• Reduced waste and recalls
• Better market reputation
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Chapter 7
28. Define novel drug delivery systems? Classify with examples.
(1) Controlled Release Drug Delivery System (CRDDS):
(a) Encapsulation: In this system, drug release is controlled by dissolution controlling coating excipients like
cellulose, polyethylene, glycols, polymethylacrylates, and waxes.
Example: Ecosprin (aspirin), progesterone tablets.
(b) Dissolution and diffusion-controlled release system: In this system, the drug is encapsulated in partially
soluble membrane (coat) in which pores are formed that permits entry of aqueous medium into core and
drug release starts by diffusion of dissolved drug out of system. Example: Aspirin Tablet
(2) Microencapsulation:
Microencapsulation is a process in which active substances are coated by extremely small capsules.
Examples: Sulfasalazine Tablet, Mesalamine Tablet, Olsalazine Capsule, Balsalazide Tablet.
(3) Mucoadhesive Drug Delivery System (MDDS):
Mucoadhesive drug delivery systems can be classified as:
(a) Oral delivery system.
(i) Buccal delivery system.
(ii) Sublingual delivery system.
(b) Vaginal delivery system.
(c) Rectal delivery system.
(e) Nasal delivery system.
(4) Implantable Drug Delivery System (IDDS)
(a) Implants: Implants are drug delivery systems which provide a controlled delivery of drug over a period
of time at the site of implantation.
Example: Histrelin (Vantas),.
(5) Transdermal Drug Delivery System (TDDS): TDDS are drug delivery systems that are applied on to the
intact skin, usually patches, to deliver the drug through the skin at a controlled rate by diffusion, for local
and systemic effects.
Examples: Clonidine, Nicotine and Testosterone transdermal patches.
(6) Gastroretentive Drug Delivery Systems (GRDDS): GRDDS are dosage forms that can be hold within the
stomach which has ability to prolong gastric residence time (GRT) and control release of a drug thereby
increases drug concentration to improve bioavailability.
(a) Floating systems.
(b) Inflatable systems.
(c) Gastro-adhesive systems.
(7) Nasopulmonary drug delivery system (NPDDS): NPDDS is a system in which drugs are insufflated
through the nose. It involves inhalation of drug formulation through mouth and the further deposition of
inhaled drugs in lower respiratory airways.
(a) Inhalers. (b) nasal sprays
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29. Define Novel Drug Delivery Systems (NDDS)? Give its advantages and describe the challenges in
NDDS.
NDDS are safe with high efficacy exhibiting improved pharmacokinetics and decreased dosing frequency.
Advantages:
• Reduction in the total amount of drug administered over the period of treatment.
• It provides convenient route of administration.
• Increases the patient compliance.
• It helps to achieve targeting of drugs to specific sites with reduced side effects.
• It offers reduced blood level fluctuation characteristic of multiple dosing.
• It provides protection from the first pass metabolism and gastrointestinal tract degradation thus
maximizing availability with minimum dose.
CHALLENGES OF NDDS
• It demands high capital investment and is time consuming, expensive and faces the problem of
toxicity, low efficacy, biocompatibility, side effects, fast excretion, and degradability.
• There are no specific methodologies for testing effects of NDDS and establishing safety profile of
NDDS based product is challenge for regulatory approval of product.
• There are no specific regulatory guidelines for NDDS products and thus pharmaceutical companies,
to obtain market approval of product, have to convince regulatory authority based on scientific
concepts.
• Patent defending for NDDS is difficult because there are already existing patents of some NDDS.
The other patent issues include patent land grab and overlapping patents.
• There is lack of discussion platforms, for scientists to learn from failures in NDDS research, and
coordination amongst academia, industries, physician, patients, and economist for data gathering
about performance of marketed NDDS.