MAHARASHTRA STATE BOARD OF ... - Msbte Study …msbte.engg-info.website/sites/default/files/805... · WINTER – 14 EXAMINATION ... The model answer and the answer written by candidate

MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION (Autonomous)

(ISO/IEC - 27001 - 2005 Certified)

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WINTER – 14 EXAMINATION

Subject Code: 0805 Model Answer Page No: 1/ 32

Important Instructions to examiners:

1) The answers should be examined by key words and not as word-to-word as given in the

model answer scheme.

2) The model answer and the answer written by candidate may vary but the examiner may try

to assess the understanding level of the candidate.

3) The language errors such as grammatical, spelling errors should not be given more

Importance (Not applicable for subject English and Communication Skills).

4) While assessing figures, examiner may give credit for principal components indicated in the

figure. The figures drawn by candidate and model answer may vary. The examiner may give

credit for any equivalent figure drawn.

5) Credits may be given step wise for numerical problems. In some cases, the assumed constant

values may vary and there may be some difference in the candidate’s answers and model

answer.

6) In case of some questions credit may be given by judgement on part of examiner of relevant

answer based on candidate’s understanding.

7) For programming language papers, credit may be given to any other program based on

equivalent concept.



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1. Answer any ten of the following: ( Consider any 8, 2 marks each) 16

A) List the different types of material used for making of the containers. (1/2 mark for each)

Ans. Types of materials are: i) Glass ii) Plastic iii) Metal iv) Paper and board

B) Enlist the methods of size reduction.(1/2 mark for each)

Ans. i) Cutting ii) Compression iii) Impact iv) Attrition iv) Combined impact & attrition

C) Define the term immunity.(2 mark)

Ans. The power of the body to resist the effects of the invasion of micro-organisms is called

immunity.

D) Differentiate between organized and unorganized drugs.(2 marks)

Sr. No Maceration of organized drugs Maceration of unorganized drugs

1. Drug along with the whole of the

menstruum is used in maceration process.

Drug along with 4/5th

of the menstruum

is used in the maceration process.

2. The period of maceration is 7 days. The period of maceration is 2 -7 days as

specified.

3. Strain off the liquid and press the marc. Decant the liquid. Marc is not pressed.

4. Mix the pressed liquid with the macerate

and clarify by subsidence or filtration.

Filtrate is not adjusted to volume.

Filter the liquid and pass the remaining

1/5th

of menstruum through filter to make

up the final volume.

5. Examples of tinctures: Tincture of Orange,

Tincture of Lemon, Tincture of Capsicum

Examples of tinctures: Compound

Tincture of Benzoin, Tincture of Tolu,

Tincture of Myrrh



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E) Give the classification of dosage forms. ( 2 Marks)

F)In what proportion should 20% HCl be mixed with 10% HCl to obtain 15% HCl

solution? (2 Marks)

Ans. 20% 5 parts

15%

10% 5 parts

5 parts of 20% HCl should be mixed with 5 parts of 10% HCl to obtain 15% HCl

solution



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G)List the pharmacopoeias commonly used in India.(Any 4= 2 Marks)

Ans. i) Indian Pharmacopoeia (I.P)

ii) British Pharmacopoeia (B.P.)

iii) United States Pharmacopoeia (U.S.P)

iv) European Pharmacopoeia

v) International Pharmacopeia

vi) Japanese Pharmacopoeia

vii) Martindale Extra Pharmacopoeia

H)Write the advantages of alcohol as solvent for extraction.(any 4 = 2 Marks)

Ans. i) The mould and bacteria cannot grow in an alcoholic solution (20% or more).

ii) It is neutral and hence extraction products obtained are compatible with other

products.

iii) It is non-toxic in the concentration mostly present in the preparations.

iv) A small amount of heat is required to concentrate the alcoholic preparations.

v) It dissolves selective active ingredients of drugs.



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I)Write the difference between hard and soft gelatin capsules.(any 4 = 2 Marks)

Ans.

Sr.No Hard gelatin capsules Soft gelatin capsules

1. The hard gelatin capsule shell

consists of two parts: Body and

cap

The soft gelatin capsule shell becomes a

single unit.

2. They are cylindrical in shape. They are available in round, oval and tube-

like shapes.

3. The contents usually consist of

medicaments in the form of

powder, beads or granules.

The contents usually consist of liquids or

semisolids.

4. These are prepared from gelatin,

titanium dioxide, colouring agent

and plasticizer.

These are prepared from gelatin, more

amount

of plasticizer (sorbitol or glycerin) and

preservative.

5. Filling and sealing takes place in

different steps.

Filling and sealing are done in a combined

operation of machines

6. Shell is perfectly dry. Shell is not perfectly dry

7. These capsules can be adulterated These capsules cannot be adulterated



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J}Write the advantages of tablets. .(any 4 = 2 Marks)

i) The tablets are easy to be administered.

ii) Easy to be dispensed.

iii) More stable dosage forms.

iv) Maintain accuracy of dosage.

v) Bitter and nauseous substances can be given easily in tablet form after coating.

vi) Lightest and the most compact of all dosage forms.

vii) Easiest and cheapest with regard to packing and transport.

viii) Better suited to large scale production.

ix) Economical dosage form.

K)Write the applications of simple distillation in pharmacy. .(any 4 = 2 Marks)

Ans. i) Preparation of distilled water and water for injection.

ii) Preparation of many volatile oils and aromatic waters.

iii) Organic solvents are purified by distillation.

iv) Many official compounds are prepared by distillation e.g. Spirit of nitrous ether and

Aromatic spirit of ammonia.

v)Concentration of liquid and to separate non-volatile solid from volatile liquids such as

alcohol and ether.



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Subject Code: 0805 Model Answer Page No:7/ 32

L)Write the main objectives of mixing.( 2 Marks)

i) Simple physical mixing of materials to form a uniform mixture.

ii) To promote the chemical reaction to get uniform product.

iii) Dispersion of solid in liquid to form suspension or paste.

iv) Dispersion of two immiscible liquids to form an emulsion.

2. Answer any four of the following: 12

A) Explain factors affecting rate of filtration.

Ans. Factors which affect the rate of filtration are: (any 6 points, 3 marks)

1. Pressure: The rate of filtration of liquid is directly proportional to the pressure difference

between the filter medium and filter cake. Thus, the rate of filtration can be increased by

applying pressure on the liquid being filtered or by decreasing the pressure beneath the

filter.

2. Viscosity: The rate of filtration is inversely proportional to the viscosity of the liquid

undergoing filtration. Liquids which are very viscous get filtered slowly. Reduction of

viscosity of a liquid by raising the temperature is frequently done in order to accelerate

filtration.

3. Surface area of filter media: The rate of filtration is directly proportional to the surface

area of filter media. Filter press works on this principle.

4. Temperature of liquid to be filtered: Viscosity is reduced by a rise in temperature and

filtration of viscous oils, syrups, etc. is often accelerated by filtering them while they are

still hot.



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5. Particle size: The rate of filtration is directly proportional to the particle size of the solid

to be removed. It is easier to filter a liquid having coarse particles than that having finely

divided particles.

6. Pore size of filter media: The rate of filtration is directly proportional to the pore size of

filter media.

7. Thickness of cake: The rate of filtration is inversely proportional to the thickness of the

filter cake formed during filtration. As the filtration process proceeds, thickness of cake

increases which decreases the rate of filtration.

B) Write advantages and applications of autoclaving.

Ans. Advantages: (1.5 Marks)

i) More efficient that dry heat and the material is exposed to lower temperature for a

shorted period.

ii) Equipments or parts of rubber and plastic such as nylon and PVC can withstand

the temperature and pressure required for sterilization.

iii) A large quantity can be sterilized in one batch using a big autoclave.

Applications: (1.5 Marks)

i) The method is used for sterilization of surgical dressings and surgical

instruments.

ii) The containers and closures are sterilized by autoclaving.

iii) Used for sterilization of a majority of official injections.



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C) Write a short note on elutriation process.( 2 Marks)

Ans. The size separation of powder is based on the low density of fine particles and

high density of coarse particles. Elutriating tank is used to separate the coarse and

fine particles of powder after levigation. The dry powder or paste is kept in an

elutriating tank and mixed with large quantity of water. The solid particles are

uniformly distributed in the liquid by stirring and then it is allowed to settle down.

Depending on the density of the solid particles, it will either settle down or remain

suspended in water. The sample is withdrawn at different heights through the outlets.

These are dried and thus the powder with various size fractions is collected.

Nowadays, the particles are suspended in a moving fluid, generally water or air. The

apparatus consists of a vertical column with an inlet near the bottom for suspension,

an outlet at the base for coarse particles and an overflow near the top for fluid and

fine particles. One column will give a single separation into two fractions. If more

than one fraction is required, a number of tubes of increasing area of cross-section

can be connected in series. The velocity of fluid decreases in succeeding tubes as the

area of cross-section increases, thus giving a number of fractions. These fractions are

separated and dried.

Diagram (1Mark)



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D) Explain the advantages and disadvantages of freeze dryer.

Ans. Advantages: ( any 4= 2 Marks)

1. The product obtained is light and porous having excellent solubility.

2. The chances of hydrolysis are minimized as drying takes place at a very low

temperature.

3. Drying takes place under vacuum; hence oxidation is minimized as there is no contact

with air.

4. The heat-sensitive materials can be dried.

5. The loss of volatile material is minimum.

6. The freeze-dried material can be stored at room temperature if it is properly sealed in

an inert atmosphere.

7. The sterility of the product can be maintained.



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Disadvantages: (any 2 = 1 Mark)

1. The process is very expensive because a complicated plant is used.

2. The product obtained is very hygroscopic, so packaging requires special precautions.

3. The period of drying is quite long.(usually not less than 10 hours)

E) Explain the limitations of soxhelation with diagram.

Ans: Limitations: This process cannot be used in following cases: (1.5 Marks)

1. Physical character of the drug: If the drug would block the soxhlet apparatus then

this process cannot be used for extraction. Eg opium. Gum, resin, orange peel, etc.

2. Solvent: Only pure solvents or constant boiling mixtures can be used.

3. Chemical constituents of the drug: The process is unsuitable for drugs having

thermolabile active constituents such as enzymes, alkaloids, anthraquinone

derivatives, esters, etc.

Diagram (1.5 Marks)



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F) Write the principle behind the distillation under reduced pressure.

Ans. Liquid boils when its vapour pressure is equal to the atmosphere pressure. The

boiling point of the liquid may be lowered to the desired temperature by reducing the

pressure on its surface. Therefore, when boiling or distillation is carried out under

reduced pressure the rate of distillation increases.

Thus liquids which are unstable at their boiling points , at atmospheric pressure

may be distilled at much lower temp. under reduced pressure. So it is useful for

concentration of extracts containing thermolabile constituents in order to prevent its

decomposition.

Q 3. Answer any four of the following: 12

A) Write the advantages and disadvantages of plastic as a material for packing.

Ans: Advantages: (any 4, 2 marks)

1. Light in weight and can be handled easily.

2. Poor conductor of heat.

3. Sufficient mechanical strength.

4. Transported easily.

5. Unbreakable.

6. Available in various shapes and sizes.

7. Good protection power.

8. No formation of flakes.

Disadvantages: (any 2, 1 mark)

1. Permeable to water vapour and atmospheric gases.

2. Cannot withstand heat without softening or distortion.

3. May interact with certain chemical to cause softening or distortion.

4. May absorb chemicals such as preservatives.

5. Relatively expensive.

6. Special type of gum or adhesive required for labeling.



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Subject Code: 0805 Model Answer Page No: 13/32

B) Explain construction and working of Fluid Energy mill

Construction: (2 marks):

The mill consists of a loop of pipe of diameter 20 to 200 mm, depending upon the overall

height of the loop, which may be up to 2 meters. There is a series of nozzles through which inert

gas is passed. The discharge outlet is connected to a cyclone separator or a classifier, which

allows the air to escape but prevents the particles to pass until they become sufficiently fine. The

mill is made up of steel or iron.

Working (1 mark)

1. The material which is to be size reduced is fed in the grinding chamber from the

bottom through the feed inlet.

2. The air or inert gas is introduced with a very high pressure through nozzles.

3 .Due to high degree of turbulence, impact and attritional forces between the particles

there is size reduction.



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4.The air moves at a very high speed in elliptical part carrying with it fine particles

that pass through the outlet in a classifier and are collected.

5. The large particles are carried by centrifugal force to the end whereby they are

further exposed to the moving air.

6.The design of the mill provides for the internal classification of the particles whereby

lighter, finer particles are discharged and heavier particles are retained due to effect

of centrifugal force to be reduced to smaller size.

7. Feed should be of 20 to 200 # size &mill produces particles of 1 to30 micron range

to get a very fine powder even upto 5μ,the material is pre-treated to reduce the

particle size to the order of 100# and then passed through fluid energy mill.

C) Describe working of filter press with neat diagram.

Working: (2 marks)

1. The slurry is pumped in under positive pressure up to 20 bar and fill each

frame.

2. The filtrate passes through the cloths on opposite sides of the frame and

runs down between the studs on the plate surface.

3. There is an outlet cock in the bottom right hand corner of the frame

allowing the filtrate to discharge in to channel.

4. The solid in the slurry build up to form cake in each frame which will

eventually meet in the centre of the frame.

5. When the process is stopped, the frame is emptied and cycle is restarted.

6. Thickness of cake can be varied by using frame of different thickness.

Diagram: (1 mark)



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D) Mention and explain with example the excipients used in capsules. (mentioning 1 mark,

explanation of any 4, 2 marks)

Ans) Different excipients used in capsules are diluents, absorbents, glidants, antidusting

compounds, disintegrating agents, etc.

1) Diluents: The diluents is needed in certain cases where the quantity of the medicament is too

small in bulk to get it filled in the smallest available capsule size .In such cases, diluents is added

to bring the medicament up to the desired bulk. The commonly used diluents are lactose,

mannitol, sorbitol, starch etc. The quantities of the diluents to be incorporated depend on the

dose of the medicament and the capsule size.

2) Absorbents: Sometimes the medicaments are physically incompatible with each other e.g.

eutectic substances or hygroscopic substances. In such cases, absorbents, such as oxides and



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carbonates of magnesium and calcium and kaolin are added to the powered drug. These inert

materials act as a protective sorbent.

3) Glidants: To ensure a regular flow of powder into the automatic capsule machine glidants are

mixed with the medicaments. The various glidants used for this purpose are talc, magnesium

stearate and calcium stearate.

4) Antidusting compounds: During the filling of capsules by an automatic filling machine, a lot

of dust comes out the machine. The dust is inhaled by the operator of the machine. It can pose a

serious health hazard if allowed to be unchecked, especially, when the dust of the potent drugs is

inhaled by the workers. To avoid this, some antidusting components, like inert edible oils, are

added to the formulation.

5) Disintegrating agents: Are particularly used as component of granules or pellets to be

encapsulated in hard shells. egs sodium starch glycolate, starch powder etc.

E) Write the history of Indian Pharmacopoeia. (3 marks)

Ans) The government of India directed the Drugs Technical Advisory Board to list the drugs that

are used in India, which are not mentioned in British Pharmacopoeia and also recommend the

standards to be prescribed to maintain uniformity and the chemical tests to be used to establish

identity and purity. The Government of India published the Indian Pharmacopoeal List in 1946

as a supplement to British Pharmacopoeia. The term list in the title was ‘misleading’ in that, the

book not only contained a list of drugs which were of substantial medicinal value but also laid

down standards.

The Indian Pharmacopoeial List contained about 180 monographs and a number of appendices

prepared on the lines of the British Pharmacopoeia. Approximately 100 monographs were on

vegetable drugs growing in India and on their galenicals. `The drugs of plant origin such as

artemesia, bael, berberis, cannabis, ispaghula, kaladana, kurchi, myrobalan,picrorhiza,

punarnava, rauwalfia, vasaka etc.were included in it. Similarly several oils such as ajowan,



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cassia, chaulmoogra, neem and pudina were included it. The appendices gave detail for a number

of determinations referred to in the monographs.

The Pharmaceuticals and Drugs Research Committee of the Council of Scientific and Industrial

Research decided in February 1947to compile a ’Brochure’ to highlight the information and

clinical users of the important indigenous drugs of India. Later on it was decided to prepare a

’Codex’ instead of Brochure on the lines of the British Pharmaceutical Codex. The first Indian

Pharmaceutical Codex published in 1953.The Codex consisted of two parts. The part carried

about 190 general monographs on natural product and drugs of vegetable and animal origin, and

a few chemicals. The second part consisted of formulary of galenicals and other preparations.

After the publications of the Indian Pharmacopoeial List the Government of India,

constituted an eleven member Indian Pharmacopoeial Committee in 1948, in their notification

No. F.1-1/48-DS dated 23rd

November, 1948, for preparing the Pharmacopoeia of India. The

tenure of the office of the members of the Committee was five years. It was extended by one

year vide Government notification no F.6-10/53-DS dated 21st November 1953. In compiling the

monographs of the first Pharmacopoeia of India, help was taken from all available established

scientific data in the modern Pharmacopoeia, such as British Pharmacopoeia, the United States

Pharmacopoeia, and the international Pharmacopoeia and from scientific institutions interested in

drugs and Pharmaceuticals products. The first edition of Pharmacopoeia of India was compiled

and then published in 1955.

F) Draw a neat diagram of ball mill. Mention disadvantages of ball mill.

Ans) Diagram: (2 mark)



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NN

Disadvantages(1 mark)

1) The ball mill is a very noisy machine.

2) Wear occurs from balls as well as from the casing, which may result in

contamination of the product

Q 4 Answer any four of the following 12 marks

A) What precautions are taken while using eye drops?( :( 3 points, each carries 1 mark)

Ans. Following precautions are to be taken while using eye drops:

i) Use within one month after opening.



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ii) Do not touch tip of the dropper.

iii) If irritation persists discontinue the use and consult the physician.

B) Define evaporation and draw a labelled diagram of evaporating still.

Ans: Definition :( 1 mark)

Evaporation may be defined as the free escape of vapour from the surface of liquid or a

solution of solid below its boiling point.

Diagram (2 marks)



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C) Special applications of capsules :( 3 points, each carries 1 mark)

1. Enteric-coated capsules: These capsules do not disintegrate in the stomach but break up in the

intestine. On a commercial scale, a coating of cellulose acetate phthalate and mixtures of fatty

acids or their esters is given.

The following categories need enteric coating:

i) Drugs which cause irritation to gastric mucosa and lead to nausea and vomiting.

ii) Drugs destroyed by gastric juice.

iii) Drugs intended to act in the intestine. E.g. amoebicides and anthelmintics.

iv) Drugs required to produce a delayed action.

2. Sustained release capsules: In order to maintain a proper concentration of the medicament and

reducing the number of doses per day, a capsule containing numerous coated pellets is

administered that release the drug successively over a long period.

3. Rectal capsules: Soft gelatin capsules may be used as substitutes for rectal and vaginal

suppositories. Various shapes and sizes are used, but the pear-shaped form is commonly used.

4. Capsules containing ophthalmic ointments: Soft gelatin capsules are used for filling

ophthalmic ointments. These are intended for a single application to the eye.

D) Enlist manufacturing defects of the tablets. Explain any two. (Enlist-1 mark, explain any

two -1 mark each)

Ans: Manufacturing defects in tablets are binding picking and sticking capping and lamination,

chipping and cracking, mottling, weight variation, hardness variation and double impression.

1) Binding: The resistance of tablet to eject from the die cavity due to adherence to die wall

is called ‘Binding’ in the die.

This may occur due to improper granules and insufficient lubrication.

This can be overcome by reducing granule size or by increasing punch or die clearance.

2) Picking and sticking: The material is removed or picked up by the

upper punch from the upper surface of the tablet .In case of sticking, the material sticks to

the wall of the die. ’Sticking’ is also known as ‘filming’.



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These defects appear because of use of warned dies & punches or use of small quantity of

lubricants or presence of moisture.

This can be overcome by use of new set of dies & punches, proper quantity of lubricants in

granules

3) Capping and lamination: The top or the uppermost layer of tablet is cracked around the edge

or separated as a cap. In lamination tablet splits or cracks on the sides by air expansion.

This occurs due to defective punches and dies, excessive fines, high speed of tablet compression

machine, too dry granules etc.

This can be overcome by setting dies & punches properly, reducing fines, polishing punches,

regulating speed of machine.

4) Chipping and cracking: Chipping is the defect in which pieces are broken or chipped out of

the tablet either from faces but usually from edges. Cracking refers to tablets that are cracked

anywhere but often in the centre of the top.

These occurs due to sticking, damaged punches and dies, incorrectly set tablet machine,

expansion & binding.

These can be rectified by replacing the chipped punches, resetting tablet machine, increasing

binder, polishing punches, maintaining fines, reducing granule size.

5) Mottling: It refers to the unequal distribution of colour on the tablet surface with light & dark

zones appearing on it.

This occurs due to migration of dye in granules during the process of drying, use of different

coloration of medicament and excipients.

This can be overcome by drying the granules at low temperature, using dye which can mask the

colour of all ingredients.



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6) Weight variation: During compression of granules the tablets do not have uniform weight.

This occurs due to ununiform granule size, excess fines, improper mixing of lubricants,

ununiform flow of granules, and variation in speed of machine.

7) Hardness variation: As hardness depends on weight variation it also occurs due to ununiform

granule size, excess fines, improper mixing of lubricants, ununiform flow of granules, variation

in speed of machine.

E) Draw a flow chart for dry granulation process.(3 marks)

F) Write the applications of drying in pharmaceutical industry.(any 6 = 3 marks)

Ans)1) In pharmaceutical industry it is used as a unit process in the manufacture of granules

which can be dispensed in bulk or converted into tablets or capsules.



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2) Drying can also be used to reduce the bulk and weight of the material, thereby lowering the

cost of transportation and storage.

3 )It helps in the preservation of crude drugs of plant from mould growth, which occurs due to

presence of moisture.

4) It helps in the size reduction of crude drugs. The presence of moisture in the crude drug does

not allow it to get powdered easily.

5) Drying is also used in the processing of materials eg. the preparation of dried aluminium

hydroxide, the spray drying of lactose and in the preparation of solid extract.

6) Improves solubility of product, when powder is dried it gets solublised fast.

7) Drying ensures free flowing of powders.

5. Solve any Four

A. Moist heat sterilization: (1M)

Moist heat sterilization is a method of sterilization in which steam is used for

sterilization.

The steam has more penetration power than dry heat.

The steam can penetrate the spores & capsules of bacteria.

Condition for Moist heat sterilization: (0.5 X4 = 2M)

1. The material to be sterilized should be thermolabile, heat stables.

2. Powders and oils cannot be sterilized by this method.

3. Material which cannot withstand the temperature above 1150C should not be

for sterilization by this method.



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4. It is danger to operate moist heat sterilizer (Autoclave).

B. Sterilization: Sterilization is the process of complete destruction of all

microorganisms present in a system.(1M)

Limitations of Formaldehyde: (any 4 points = 2M)

1. Weak penetration.

2. Difficult to maintain high conc.

3. Require high humidity for effectiveness.

4. Readily inactivated.

5. Irritant to respiratory tract.

6. Difficult to remove adsorbed gas.

C. Aseptic technique: The method which is used to prevent the access of

microorganism during the preparation of parenteral product and their testing are

called “aseptic Technique”. (1 M)

Sources of contamination: (any 4 = 2M)

1) Atmosphere, which is contaminated with dust, droplet and droplet

nuclei becomes the breeding ground of microorganism.

2) The hands are a major means of transmitting infection.

3) Coughing ,sneezing and spitting can cause contamination at a

considerable distance.

4) The clothes which absorb dust particles are also a source of

contamination. A handkerchief is the richest source of

contamination.



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5) The hair, which is constantly exposed to atmospheric dust is source

of contamination. These dust particles are liberated from the hair

during brushing and shaking of the head.

6) The unsterile equipment.

7) The working surface.

D. Reasons Tablet coating: (any 2-1 M)

1. To mask the taste.

2. To improve the appearance of tablet.

3. To prevent the medicament from atmospheric effect.

4. To control the site of action.

5. To produce SR product.

Steps involved in tablet coating: (2M)

1. Sieving:

Tablets shaken in sieve to remove fine powder and broken tablets.

2. Sealing:

It is given to ensure the thin layer of water proof material, e.g. shellac

or cellulose acetate phthalate.

3. Sub-coating:

Coats of syrup and gelatin or acacia are given to round off tablet and to

help in building up the tablet size.



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4. Syrup coating:

Several coat of syrup are applied with colouring material and

opacifying agent.

5. Polishing:

Beeswax is dissolved in volatile organic solvent and few coats of it are

given.

These tablets are then rotated in a polishing pan made of canvas cloth.

E. Evaluation of Tablets: (0.5 X 6 = 3M)

1. Shape of tablet.

2. Appearance.

3. Content of active ingredient.

4. Uniformity of weight.

5. Disintegration.

6. Dissolution.

7. Hardness test.

8. Friability test.

F.(3 marks)

METHOD OF PREPARATION OF BCG VACCINE:- It is freeze- dried preparation containing

live culture of the bacillus Calmette and Guerin strain of Mycobacterium tuberculosis.



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PREPARATION: The bacilli are grown on a suitable culture media until 1 mg when plated out on

a suitable solid culture media shows not less than 20 million colonies. The growth period should

not be more than 14 days in any case.

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 viability of the vaccine. The suspension is transferred into the final

sterile containers and freeze-dried. Then containers are sealed so as to prevent contamination or

deterioration of the vaccine. The vaccine contains no antimicrobial agent..

6. Solve any four:

A. Define followings: (1 x 4 = 4 M)

I. Anjana: These are medicated fine powder intended to be used in eye for

local effect, to relieve pain, especially in the head.

II. Churna: Fine powder of drug or drugs prepared by mixing dry mineral,

animal or vegetable substance in a pestle and mortar in known as churna.

III. Arista: These are the weak alcoholic preparations prepared by soaking the

drug in powder form or in the form of decoction in a solution of sugar or

jaggery as may have indicated for a specified period of time.

IV. Ghana: It is a semisolid preparation, prepared by evaporation of quaths to

semisolid consistency.

B. Working of hot air oven: (2M)

Wrap the material with paper.

Keep the Wrapped material in perforated shelves.

Material should not be kept at floor of the oven.

Close the door.



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Switch on the oven and set the temperature and time as required.

After time is over.

Switch off the oven.

Allow to cool.

Take out the material.

Diagram: (2M)

C. Construction of spray dryer: (1M)

It consists of cylindrical vessel with a conical base.

In upper part of vessel is fitted with a tangential air inlet and fluid inlet from

top with atomizer for spraying the suspension.

At the base it is fitted with dry product outlet and air outlet.



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Working: (1M)

The liquid to be dried is sprayed in the form of mist.

The minute droplets are rapidly evaporated by the hot air passing in and get

converted into solid particles, which fall to the bottom of chamber.

The vapours are transferred into separator where the fine dry particles which

are carried along with vapour are separated and collected.

Character of particles depend on spray/atomiser which are of two type:

1. Jet atomiser.

2. Rotatory atomizer.

Uses: (any 2 - 1M)

Useful for drying of thermolabile substance.

Citric acid, sodium phosphate, hexamine, gelatin and extract are dried by

spray drying.

Suspensions of starch, barium sulphate, and calcium phosphate are also dried.

Diagram: (1M)



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Subject Code: 0805 Model Answer Page No: 30 /32

D. Advantages of Parenteral: (6 points = 3M)

1. Quick onset of action.

2. The drug which cannot be administered by oral route can be administered by

this route.

3. It can be administered to unconscious patient.

4. Drug action can be prolonged by modifying the formulation.



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5. Transfusion fluids containing nutritive like glucose electrolytes such as

sodium chloride can be given by this route.

6. Parenteral administration can results in local effect for drugs when desired, as

in dentistry and anesthesiology.

Enema: An enema is a fluid injected into the lower bowel by way of the rectum

to relieve constipation or for bowel cleansing before a medical examination or

procedure. (1M)

E. Merits of Glass container: (any 4 = 2M)

Economical.

Available in variety of sizes and shapes.

Chemically inert, impermeable, strong and rigid.

Does not deteriorate with age.

Easy to label.

Excellent barrier against light.

Demerits of Glass Containers: (4 points = 2M)

Fragile, easy to break.

Heavy, Bulky to carry.

Leaching and absorption of alkalis.

Flak formation

http://en.wikipedia.org/wiki/Large_intestine

http://en.wikipedia.org/wiki/Rectum



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F. Diagram (3M):

Air-tight Container: (1M)

Protect the drug from deterioration due to dust, moisture and air.

These containers are also called as Hermetic container.

These containers are used for injectables and others products which

deterioration due environments.

Documents

MAHARASHTRA STATE BOARD OF ... - Msbte Study …msbte.engg-info.website/sites/default/files/805... · WINTER – 14 EXAMINATION ... The model answer and the answer written by candidate