MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION

(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
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.
8) As per the policy decision of Maharashtra State Government, teaching in English/Marathi and Bilingual (English
+ Marathi) medium is introduced at first year of AICTE diploma Programme from academic year 2021-2022.
Hence if the students write answers in Marathi or bilingual language (English +Marathi), the Examiner shall
consider the same and assess the answer based on matching of concepts with model answer.

Q. Sub Answers Marking

No. No. Scheme
1 Answer any SIX of the following: 30M
1 a Define parenterals. State any 3 ideal properties of parenterals. Differentiate between 5M
small volume parenterals and large volume parenterals.
Marking Scheme:
Definition: 1M
3 ideal properties: 0.5 mark for each property × 3= 1.5M;
Difference between small volume parenteral and large volume parenteral- 0.5M for
each point of differentiation × 5 points= 2.5 marks
Answer:
Definition:
Parenteral preparations are sterile solutions, suspensions, emulsions, powders, gels or 1M
implants intended to be administrated directly into the tissue or the systemic circulation in
humans or animals.
Ideal properties of parenterals
• These must be free from microorganism (Sterile). 1.5M
• These must be free from pyrogens. (0.5M
• These must be isotonic with blood or body fluids. for
each)
• These must be free from fibers, dust and other foreign particles.
• These must have optimum pH.
• These must be chemically and physically stable.
Small Volume Parenterals Large volume parenterals 2.5M
These are sterile solutions, suspensions, or These are aqueous solutions of drugs or (0.5M
emulsions of drug or medicament in a medicaments. for each
suitable vehicle. point)
May be pyrogen free. Must be pyrogen free.
May be isotonic with blood or body fluids. Must be isotonic with blood or body fluids.
Page No: 1 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Commonly administered in volume up to Commonly administered in volume more
10 ml than 10 ml
May contain antimicrobial preservatives. Must not contain antimicrobial
preservatives.
May not provide basic nutrition. May provide basic nutrition.
Not used for maintenance or replacement May be used for maintenance or
therapy. replacement therapy.
Cannot be used as vehicle for other drug Can be used as vehicle for other drug
substances. substance.
Can be administered by all injection routes Mostly administered by IV route.
like SC, IM, IV etc.
Example: Morphine HCl Injection Dextrose Injection IP, Sodium Chloride and
Dextrose Injection IP, Mannitol injection,
Ringer injection IP
1 b Define 5M
i) Filtration ii) Filter media
State and explain Darcy’s Equation for theory of filtration.
Marking Scheme:
Definition: 1 M for each × 2= 2M
State Darcy’s equation: 1M
Explanation of Darcy’s equation: 2 M

Answer:
Definition of Filtration: 1M
Filtration is the process where solid particles are separated from the fluid (liquid or gas), by
passing it through a porous medium that retains solids and allows the fluid to pass.
Definition of Filter media:
1M
The surface on which solids are retained in the process of filtration is known as filter media
or filter medium.
Darcy’s Equation
𝐾𝐴∆𝑃
𝑄= 1M
𝜂𝑙
Where Q = Volumetric flow rate
K = Permeability coefficient (Depends upon nature of precipitate to be filtered and
filter medium)
A = Area of the filter bed
∆𝑃 = Pressure difference on the liquid and below the filter medium
η (eta) = Viscosity of the fluid
𝑙 = Thickness of filter cake

Page No: 2 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Darcy’s law explains us that Filtration rate is:
• Dependent upon the nature of precipitate to be filtered. 2M
(0.5M
• Dependent upon porosity of filter media and size of pores of filter media. for each
• Directly proportional to area of filter media used. point)
• Directly proportional to the pressure difference across the filter media.
• Inversely proportional to viscosity of fluid/slurry to be filtered.
• Inversely proportional to thickness of filter cake formed on the surface of filter
media.
1 c List out salient features of Fifth edition of IP. Write importance of pharmacopoeia 5M
with respect to i) Pharmaceutical industry, ii) Drug administration, iii) Academics
Marking Scheme:
Listing salient features of Fifth Edition of IP: Any four × 0.5 = 2M
Importance of pharmacopoeia with respect to Pharmaceutical industry (1M),
Drug administration (1M), Academics (1M)
Answer:
2M
Salient Features of Fifth Edition of Pharmacopoeia of India (2007)-
(0.5M
1. Labelling and storage are featured at the end of a monograph. for each
2. Limit of bacterial contamination has been introduced for controlling the microbial point)
quality of all medicinal products.
3. Test methods for determining compliance with quality standards of the drug,
information on the category of a drug, dosage and usual available strengths of dosage
forms have been omitted.
4. Solubility was previously given in the informatory section of a monograph. But now
a separate section listing solubility of all active pharmaceutical ingredients and
pharmaceutical aids has been included.
5. The main titles for monographs of formulated preparations are given in the terms of
the active moiety rather than of the salt (with few exceptions).
6. Classical chemical tests for the identification of an article have been almost
eliminated and the more specific infrared and ultraviolet spectrophotometric tests
have been given. The concept of relying on published infrared spectra as a basis for
identification has been continued.
7. The use of chromatographic methods has been greatly extended for more specificity
in assays and in assessing the nature and extent of impurities in ingredients and
products.
8. The test for pyrogen involving the use of test animals has been virtually eliminated.
The test for bacterial endotoxins introduced in the previous edition is now applicable
to more items.
9. The test for abnormal toxicity is now confined to certain vaccines.

Page No: 3 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Importance of Pharmacopoeia with respect to- 1M
1. Pharmaceutical industry:
Pharmacopoeia provide detailed information of drug substances and products which
can be used as a standard reference in pharmaceutical industry that helps to detect
adulteration in raw materials. Pharmacopoeia helps to identify and maintain quality
of drugs and products.
Pharmacopoeia gives various evaluation tests to make safe dosage forms.
1M
2. Drug administration:
Pharmacopoeia provide detailed information of drug substances and products along
with their identification test to quality control tests. These can be act as reference for
regulatory authorities to check quality and adulteration in drugs and products.
3. Academics: 1M
Pharmacopoeia is considered a standard reference of drug substances and products
for academics. Pharmacopoeia helps in research activities to the academics.
1 d Define i) Immunity, ii) Immunological products. Write a note on BCG vaccine 5M
highlighting its i) Method of preparation, ii) Description, iii) Storage, iv) Use, v) Dose
Marking Scheme:
Definition of Immunity: 1M
Definition of Immunological products: 1M
BCG vaccine Information:
i) Method of preparation: 1M
ii) Description: 0.5M
iii) Storage: 0.5M
iv) Use: 0.5M
v) Dose: 0.5 M
Answer:
1M
Immunity:
The power of the body to resist the effects of the invasion of pathogenic
microorganisms is called as Immunity.
Immunological Products:
1M
Immunological products are the preparations that improves immunity of our body
for the prevention, treatment and diagnosis of various microbial diseases.
Information of BCG Vaccine: 1M
Method of Preparation:
• The bacilli are grown in a suitable culture media (Suitable growth-1 mg plated out
culture media when grown on suitable medium shows NLT 20 million colonies
within NMT 14 days).
• Then they are separated in the form of cake.

Page No: 4 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
• The cake is homogenized in a grinding flask and suspended in a sterile liquid
medium which preserves its antigenicity and viability.
• Suspension is Freeze-dried after transferring into the final sterile container. It
contains no anti-microbial agent.
Description: 0.5M
Available as white pellets which give opalescent suspension after reconstitution.
Storage:
0.5M
Between 2-8°C. A reconstituted vaccine should be used immediately.
Use: 0.5M

As an immunizing agent against tuberculosis.

Dose: 0.5M
0.05 ml immediately after birth. 0.1 ml after 1 year by Intradermal route
1 e Differentiate between hard and soft gelatine capsules. Explain the method of 5M
manufacturing of soft gelatine capsule by rotary die process.
Marking Scheme:
Each point of differentiation 0.5 × any four points= 2M
Manufacturing of soft gelatine capsule by rotary die process:
• Construction: 1M
• Working: 1M
• Diagram: 1M
Answer:
HARD GELATIN CAPSULES SOFT GELATIN CAPSULE 2M
The hard gelatin capsule shell has two parts The soft gelatin shale is a single unit. (0.5M
viz. Body & Cap for each
The hard gelatin capsules have a cylindrical The soft gelatin capsules are available in point)
shape only. oval, round and oblong shapes.
The hard gelatin capsules are used for fillingThe soft gelatin capsules are used for
solids only like powders, granules, etc. filling solids, liquid as well as semisolid
substances.
The hard gelatin capsule shells are made up The soft gelatin capsule shells are made
of Gelatin, color, and Titanium oxide. up of Gelatin, color & plasticizers like
glycerin or sorbitol.
The hard gelatin capsules are less flexible. The soft gelatin capsules are more
flexible.
In a hard gelatin capsule filling of capsule In a soft gelatin capsule filling & sealing
and sealing of the capsule takes place at two takes place at a single stroke.
different stages.
In a hard gelatin capsule, hand-filling is In a soft gelatin capsule, hand-filling is
possible. not possible only mechanical filling is
possible.

Page No: 5 of 22
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Construction:
1M
The rotary machine has the following parts:
1. Two hoppers:
a) One hopper: Liquid gelatin mixture is kept in one hopper.
b) Another hopper: Liquid or semisolid medicament which is to be filled is kept
in another hopper.
2. Two rotating dies that move in opposite directions and are arranged close to each
other. Each rotary plate has sufficient width, and, on the periphery, dies are
embossed with sufficient depth to hold gelatin liquid.
3. Short tubes to carry liquid gelatin from the hopper to the rotary dies.
4. Short tube to carry liquid medicament from hopper to the pump.
5. A pump is attached at the end of tubes carrying liquid medicament and it can be
adjusted so that a predetermined dose of a medicament can be released after each
stroke.
Working:
1. From the gelatin hopper hot liquid gelatin is transferred to the two rotary dies through 1M
two pipes in the form of a gelatin ribbon.
2. At the same time, the liquid medicament is transferred to the pump through the pipe.
3. Each die forms a half shell of a soft gelatin capsule. Each half moves towards the
other because of the opposite movement of the die.
4. A predetermined dose of medicament is introduced into the capsule with a stroke of
the pump.
5. With the movement of dies both the halves of the capsule shell fuse with each other.
6. Sealing takes place because of the heat of liquid and the pressure of rotating dies.
7. The capsules formed are washed thoroughly and dried.
8. The capacity of the rotary machine is ranging from 25000 to 30000 capsules per
hour.

1M

Page No: 6 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
1 f Explain the detail components of suspension formulation. Add a note on methods of 5M
preparation of suspension.
Marking Scheme:
Explanation of component of suspension in details (any four)- 4M
Method of preparation of suspension: 1M
Answer:
Components / Formulation ingredients / Additives in suspension:
For the preparation of stable suspension following additives may be used in suspension as-
A. Flocculating agents
B. Thickening agents
C. Wetting agents
D. Preservatives
E. Organoleptic additives
A. Flocculating agents:
Flocculating agents are used for the stability of deflocculated suspensions. These 1M
decrease strong interparticle bonding between solid particles and stabilize the
suspension. Thus, flocculating agents help to re-disperse the solid particles uniformly in
the vehicle or a dispersion medium. A flocculating agent is a surfactant or protective
colloid. Some of the commonly used flocculating agents are sodium lauryl sulfate,
tweens, span, carbonates, etc.
B. Thickening agent:
These are hydrophilic colloids, and they form colloidal dispersion when they are mixed
1M
with water which increases the viscosity of the continuous phase and the solid particles
remain suspended for a prolonged period and uniform accurate dosage is possible.
Some commonly used thickening agents can be classified as follows.
a. Polysaccharides: Gum acacia, Tragacanth, Starch, Sodium alginate
b. Inorganic agents: Clay, Aluminium hydroxide
c. Synthetic agents: Carbomer, Colloidal silicon dioxide
C. Wetting agents:
Wetting agents are used to reduce the interfacial tension between suspended solid
1M
particles and liquid medium. It helps to produce the suspension of desired quality.
Wetting agents when added to the formulation get adsorbed at the solid or liquid surface
thus it helps to increase the affinity of solid particles towards the liquid medium. This is
achieved by decreasing inter-particular forces. Some of the commonly used wetting
agents are alcohol, glycerin, alginate, polysorbate, etc.
If the wetting agent is used in excess it may produce foaming and development of bad
taste and odor in the preparation.

Page No: 7 of 22
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
D. Preservatives: 1M
Suspensions are susceptible to bacterial growth. To prevent deterioration of suspension
suitable preservative is added to the suspension. The preservative used must have a broad
spectrum of antibacterial activity. Some of the preservatives used in suspension are
Benzoic acid, sodium benzoate, methylparaben propylparaben, etc.
E. Organoleptic additives:
To increase the acceptability of the suspension and to improve the aesthetic value of the
suspension coloring agent, a flavoring agent and sweetening agent are used in internal
suspensions. Whereas suitable flavoring agents and coloring agents are added to the
suspension for external use.

Method of Preparation of Suspensions:

1M
a. Weigh the powders to be added in suspension. Make them fine.
b. In a mixer take vehicle. Add required quantity of suspending agent or flocculating
agent or wetting agent if needed.
c. Transfer the powder mixture in vehicle mixture and mix well.
d. Pass the suspension through a homogenizer or mill.

1 g Classify granulation techniques and describe the wet granulation method with 5M
advantages and disadvantages.
Marking Scheme:
Classification of granulation techniques: 1M
Description of wet granulation method: 2M
Advantages of wet granulation method (Any two): 1M
Disadvantages of wet granulation method (Any two): 1M
Answer:
Classification of Granulation techniques:
1. Wet Methods 1M
a. Paste or Mass method
b. Fluid bed method
2. Dry Methods
a. Using roll compactor
b. Slugging
Wet granulation method description:
Paste or mass method: 2M
It is one of the basic and widely used wet methods. In this method, the first drug and
excipients are mixed and the resulting powder mixture is then moistened with a
granulating agent to form a dough mass or paste.

Page No: 8 of 22
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No. No. Scheme
Then this mass or paste is passed through a screen or sieve of desired mesh size to
produce the desired size of granules. Generally, a 6-12 mesh screen is used for this
purpose. The granules are placed on drying trays and are dried by air or under heat.
The granules are periodically moved during drying to prevent adhesion into a large
mass. The dry granules are then screened through a 14-20 mesh screen. These
granules are then mixed with glidants, lubricants, and disintegrants and used for
compression.
On a large scale instead of mortar & pestle, various types of blending equipment are
used for mixing the powders. Mixing of powder with the granulating agent to form
dough mass is done in various equipment like sigma mixer, planetary mixer, etc. For
screening of dough mass to form granules, dough mass is passed through an
oscillating granulator having desired sized sieves.
Fluid bed processing:
Here a fluid bed processor is used for the preparation of granules. In this method, the
drug and excipient powder mixture is placed in a conical piece of equipment having
a perforated base. Then hot air is allowed to pass from the bottom of the conical
piece so that all the powder gets fluidized in the upper chamber. At the same time, a
fine spray of granulating liquid is sprayed on the fluidized powders. Due to liquid
droplets, particles get bind to one another forming granules. Then granules are
collected and dried.
Advantages of Wet granulation:
1M
• Wet granulation enhances the cohesiveness and compressibility of powders.
(0.5M
• Wet granulation leads to uniform distribution of powders and produces granules of for each
uniform composition. Thus, it assures content uniformity in tablets. point)
• Granules prepared by wet granulation have good flow properties. Thus, it ensures
uniformity of the weight of tablets.
Disadvantages of wet granulation:
• It is an expensive method with respect to labor, equipment, and space requirements. 1M
• It is a time-consuming method. (0.5M
for each
• It cannot be employed for moisture-sensitive drugs or medicaments.
point)
• If dough mass has color or dye, during drying of granules, chances of migration of
dye take place. Thus, at one end granules become dark-colored and at another end,
these become faint-colored.

Page No: 9 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
2 Answer any TEN of the following: 30 M
2 a Describe the steps involved in sugar coating with suitable examples of ingredients 3M
used in each step.
Marking Scheme: ½ marks for each step with one example. Consider any six methods.
Answer:
0.5M for
Sugar coating: The process involves the deposition of aqueous sugar solutions onto the
each
surface of the core tablet.
step
Steps involved in sugar coating process are:
A. Sealing:
Sealing or water proofing step involves coating core of tablet with polymer solution
to give protection against moisture penetration. Common materials used as sealants
include shellac, zein, Hydroxypropyl Methylcellulose (HPMC), Cellulose Acetate
Phthalate (CAP), or Polyvinyl Acetate Phthalate (PVAP).
B. Sub-Coating:
In this step tablet core is coated with sugar coating in large quantities leading to
increase in weight of tablet. It is performed by lamination or suspension method.
Eg. Gum (acacia/gelatin) based solution or sugar solution followed by dusting
with Talc or calcium carbonate powder
C. Smoothing:
It is used to make the tablet surface smooth. The irregularity in tablet surfaces are
filled with concentrated sucrose solution to make it smooth. E.g. Simple syrup
solution
D. Colouring:
Color is applied by mixing it in sucrose solution. E.g. Titanium dioxide, Iron oxide,
and D&C certified lakes (Aluminium lakes, Brilliant Blue Lake, Sunset yellow lake,
Amaranth lake, Indigo lake, carmine lake) etc.
E. Polishing:
It is used to give shining lustre to the tablets. For polishing carnauba wax in organic
solvent is sprayed over tablets. E.g. mixture of carnauba wax and beeswax
F. Printing:
Tablets are printed using edible ink which contains safflower, gardenia, squid ink,
etc.

Page No: 10 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
2 b Discuss any three types of glass used as a packaging material in pharmaceuticals. 3M
Marking Scheme: Each type of glass – 1M; For any three types – 3M.
Answer:
1. Type-I:
1M for
Also known as highly resistant borosilicate glass, composed of silica and boric acid each
with small amounts of aluminium oxide and sodium oxide. It is ideal for packing of type.
Consider
preparations with acidic, neutral and alkaline pH because of its high resistant nature only 3
due to the presence of boric oxide. Further has good resistance to thermal shocks and types
can be sterilized before or after filling.
2. Type-II:
Also known as treated soda lime glass, where the soda lime glass is treated with
sulfur to increase its hydrolytic resistance. It is appropriate for packing of acidic and
neutral parenteral preparations. Type-II glass containers can be sterilized before or
after filling.
3. Type-III:
Also known as soda lime glass with average hydrolytic and chemical resistance. It
is suitable for packaging of non-aqueous injectable preparations, powdered form
parenteral and non-parenteral preparations. Type-III glass containers be sterilized by
dry heat before filling.
4. Type-IV:
Also Known as non-parenteral glass/ general-purpose soda lime glass with low
hydrolytic resistance. It is used to store topical products and oral dosage forms. This
type of glass container cannot be autoclaved as it will increase erosion reaction rate
of the glass.
2 c Define 3M
i) Liniment ii) Lotion
Compare liniment with lotion in respect of
i) Type of preparation
ii) Application method
iii) Labelling instructions
iv) Example
Marking Scheme: Each definition - 0.5M; Each point of comparison - 0.5M.
Answer:
0.5M
Liniment:
Liniment are liquid & semi-liquid preparation meant for external application to the skin with
friction.
Or

Page No: 11 of 22
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Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Liniments are solutions or mixture of various substances in oil, alcoholic solution of soap
or emulsion or occasionally semi-solid preparations intended for external application to the
skin with rubbing or massaged.
Lotion: 0.5M
Lotions are liquid suspension or dispersions meant for external application to the skin or
body without friction or rubbing.
Or
Lotion is medium to low viscous topical formulations meant for external application to the
skin without friction or rubbing with the help of some absorbent material for medical and
non-medical use. 2M
(0.5M for
Sr. No Liniment Lotion each point
1 Types: Types: of
comparison
1. Alcoholic liniments 1. Medicated lotion
2. Oleaginous liniments 2. Non-medicated lotion
2 Application method: Application method:
Liniments are usually applied to the They are applied direct to the skin
skin with friction and rubbing. without friction with the help of some
absorbent material (Cotton wool, cloth
or cotton gauze).
3 Labelling instructions: Labelling instructions:
• For external use only. • For external use only.
• Shake the bottle before use. • Shake the bottle before use.
• Avoid broken skin • Can be applied to broken skin.
4 Examples: Examples:
• Camphor liniment • Calamine lotion
• Turpentine Liniment • Salicylic acid & mercuric
• Soap liniment chloride lotion

2 d Classify Novel drug delivery systems on approach of Novel drug delivery system with 3M
one example of each.
Marking Scheme: One type with example – 1M; Any three types with examples – 3M
Answer:
Based on technical sophistication, NDDS are divided into four categories including
1M for
1. Rate pre-programmed DDS each
2. Activation-modulated DDS class
3. Feedback-regulated DDS with
example
4. Site-targeted DDS
1. Rate pre-programmed DDS
They are further divided into following types:
a. 1. Dissolution Controlled DDS E.g. Ambien CR ER tablet
Page No: 12 of 22
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No. No. Scheme
b. 2. Diffusion Controlled DDS E.g. Wellbutrin XL ER tablet
c. 3. Erosion Controlled DDS E.g. Acutrim tablet
d. Combination of dissolution, diffusion and/or erosion-controlled DDS – E.g.
CATAPRES-TTS® transdermal patch
2. Activation-modulated DDS
Based on the nature of stimuli, they are further classified into:
A. Based on physical mean
a. Osmotic pressure activated - E.g. Acutrium tablet, Adalat (OROS), Alpress LP,
Alzet osmotic pump
b. Hydrodynamic pressure activated - E.g. Valrelease Capsule
c. Vapor pressure activated - E.g. Implantable infusion (Infusaid) pump for insulin,
Heparin & morphine
d. Mechanically activated - E.g. Metered dose inhalers/ nebulizers (Buserelin)
e. Magnetically activated - E.g. Hemisphere (bovine serum albumin) Magnetic
microsphere, magnetic liposomes
f. Sonophoresis activated - E.g. Topical anesthesia coupled with ultrasound
g. Iontophoresis activated - E.g. Phoresor by motion control
h. Hydration activated - E.g. Valrelease tablet (Valium)
B. Based on chemical mean
a. pH activated DDS - E.g. Enteric coated tablet
b. Ion activated DDS - E.g. BETOPTIC-S ophthalmic suspension
c. Hydrolysis activated DDS - E.g. Tegretol XR tablet
C. Based on biochemical means
a. Enzyme-activated DDS E.g. 5-fluorouracil loaded albumin microspheres
b. Biochemical activated DDS
3. Feedback-regulated DDS
They are further classified into three types:
a. Bioerosion regulated DDS - E.g. Hydrocortisone triggered insulin DDS
b. Bioresponsive regulated DDS - E.g. Glucose triggered insulin DDS
c. Self- regulated DDS - E.g. Self- regulated insulin delivery system
4. Site-targeted DDS
Depending upon the release of the drug at the active site they are divided into three parts:
a. First order targeting: The DDS, release the drugs at the targeted site such as organ,
tissue, cavity, etc.
b. Second order targeting: The DDS, release the drugs at the specific cell such as
tumors cells not to the normal cells.

Page No: 13 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
c. Third order targeting: The DDS, release the drugs at the intracellular site of targeted
site.
e Differentiate between powders and granules. 3M
Marking Scheme: ½ marks for each point difference. Consider any six points. (3 points
of either side)
Answer:
Sr.
Powders Granules 0.5 m
No.
for each
1 Any distinct/discrete particles having Aggregations of small particle of
point.
size less than 1000µm is known as powder varies in size between 0.2
powder. and 0.4 mm known as granules.
2 Having higher cohesive strength due to Having lower cohesive strength due
fine particle. to coarse particle.
3 Flow property is very low compare to High flow property compare to
granules and not suitable for tablet Powder can produce uniform tablet
compression weight.
4 During compression this can be Less chance of separation during
separated if it contains different compression though it contains
ingredients. different ingredients.
5 Due to high cohesive strength, it forms Due to low cohesive strength, it
high density layer at the upper portion forms uniform layer in every
create weight variation during portion produce Less weight
compression. variation during compression.
6 Air may be entrapped during Less chance of air entrapping
compression of tablets increase capping during compression so significantly
tendency. reduces capping tendency.
7 It may be blown from the die and cause It can't blow out from the die so less
frequently sticking problem during chance to cause sticking problem
tablet compression. during compression.
8 The Flow-Function [FF] value is lower The Flow-Function [FF] value is
limit, so it shows low flow property on higher limit, so it shows high flow
hopper. property on hopper ensure smooth
operation.
9 It requires steeper hopper angle to Not require to steeper hopper angle,
ensure flow property. work well in any suitable hopper.
10 Not suitable for compression tablet, Very much suitable to compress
Encapsulation process, may be used for tablet ad Encapsulation process,
dry solid preparation which further tend produce uniform tablet and
to form solution and suspension upon Capsule.
addition of solvent.

Page No: 14 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
2 f Define current good manufacturing practices. State importance and objectives of 3M
cGMP.
Marking Scheme: Definition: 1M; Importance: at least two importance (0.5M each)
Objective: at least two objective (0.5M each)

Answer:
Definition:
1M
cGMP is current Good Manufacturing Practice (cGMP) regulations given by the FDA under
the authority of Food, Drug and Cosmetics Act.
The cGMP regulations for drugs contain minimal essentials for the facilities, processes,
methods, procedures and controls followed in manufacturing, processing and packing of a
drug product. The regulations of cGMP assure the delivery of drug product for safe and
efficient use by confirming the claimed quantity of ingredients.
Importance: 1M
1. Avoids the unintentional addition of poisonous or toxic substances present in the drugs (0.5M
or excipients which are in poor quality. for each
point)
2. If the claimed quantity of the drug specified in the label is not present, there will not be
intended therapeutic effect.
3. Avoids risks in the pharmaceutical production like cross contamination, false labelling,
etc.
Objective of cGMP: 1M
1. Ensure that products are consistently manufactured and controlled to the specified (0.5M
quality. for each
2. Concerned with all aspects of production and quality control point)
3. In the manufacture of cosmetic products of specified quality
4. Ensure that the consumer receives products of specified quality.
5. CGMP regulations assures the identity, strength, quality, and purity of drug product
2 g Draw a neat diagram of Fluidized bed dryer and label the following components. 3M
i) Inlet
ii) Outlet
iii) iii) Fluidized solid
Marking Scheme: 1 ½ M for neat diagram; ½ M for label of each component
Answer:

Page No: 15 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
1.5M for
diagram

0.5 M
for each
label

Fig : Fluidized bed dryer

2 h State and explain any three types of ointment bases. 3M
Marking Scheme: Each type of ointment base: 1M; Any three types – 3M.
Answer:
"Ointments are semisolid oily preparation containing active medicaments dissolved,
emulsified or suspended in a suitable base intended for application to the skin." 1M
The ointment bases are classified into four categories; hydrocarbon or oleaginous bases, for each
type with
absorption bases, water-washable or removable bases, and water-soluble bases.
explainat
1. Hydrocarbon or Oleaginous bases ion.
2. Absorption bases Consider
any three
3. Emulsion or water washable or water removable bases types
4. Water soluble bases

Page No: 16 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
1. Hydrocarbon or Oleaginous bases
✓ The oleaginous bases include hydrocarbons which are derived from petroleum and
hence termed as hydrocarbon bases.
✓ These bases are oily or greasy in nature.
✓ They are anhydrous and not soluble in water.
✓ They are used to hydrate the skin or as an occlusive dressing.
✓ Generally, they are not preferred since they stain the clothes.
✓ Examples of hydrocarbon bases are petrolatum, liquid petrolatum, synthetic esters
such as glycerol monostearate, isopropyl palmitate.
2. Absorption bases:
✓ Absorption bases are the combination of both hydrocarbon base and water in oil
(w/o) emulsion. Hence, they can absorb water. They are used as an emollient but not
as an occlusive dressing.
✓ They are meant to decrease the scaling and drying of skin.
✓ Absorption bases contain oil in its external phase and hence difficult to remove with
water.
✓ The drugs can be added on any phase depending on the nature of the drug.
✓ The absorption bases are further classified into anhydrous bases and water in oil
(w/o) emulsion bases.
✓ The anhydrous hydrocarbon bases allow incorporating the aqueous solutions to form
w/o emulsion.
✓ In case if the bases are w/o emulsion, they easily allow the addition of aqueous
solutions. E.g. Lanolin, hydrophilic petrolatum.
3. Emulsion or water washable or water removable bases:
✓ Since these bases have aqueous external phase, they are water-washable or water-
removable. Hence, they are generally used as an ointment base in many ointment
preparations.
✓ This emulsion base consists of three constituents namely an internal oil phase
(hydrocarbon base), an emulsifying agent and an external aqueous phase.
✓ Depending on the nature of the drug/s, it can be incorporated to any one of the phase
to form emulsion.
✓ Examples of water removable bases are hydrophilic ointment, white soft paraffin,
and liquid paraffin.
4. Water soluble bases:
✓ Water soluble bases are water-washable.
✓ They do not contain lipids or oils and hence not occlusive.

Page No: 17 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
✓ They dehydrate skin and affect the percutaneous absorption since water soluble
bases absorb water from skin.
✓ Examples of water-soluble bases are carbowax, polyethylene glycol.

2 i Enlist the evaluation tests for parenterals. Discuss the sterility test in details. 3M
Marking Scheme:
List of evaluation tests for parenterals – 1M; Explanation of sterility test – 2M.
Answer:
Evaluation tests for parenterals:
1M
1. Sterility test
o Membrane filter method
o Direct inoculation method
2. Pyrogen test
o LAL Test
o In vivo Rabbit test
3. Clarity test/Foreign particulate matter test
4. Leakage test
5. Isotonicity
6. Content uniformity & Weight
7. pH
8. Viscosity
9. Extractable Volume
Test for Sterility:
Principle: These tests are based on the principle that if bacteria or fungi are placed in 0.5M
medium provided favourable conditions like nutritive material, moisture, temperature, the
organism will grow, and their presence can be indicated by the turbidity in clear solution.
This test should be carried out in strictly aseptic conditions.
Method of testing: Test of sterility may be carried out by
1. Membrane filtration method
0.5M
2. Direct inoculation method
1. Direct inoculation method:
The substance to be tested is aseptically drawn from the container by a suitable device 1M for
and transferred to the final culture medium in the test tube. The inoculated medium (test any one
tubes) is incubated at 20-25°C for fungi and 30-37°C for bacteria for the period of seven method.
days. Observe the growth of micro-organism in the medium.

Page No: 18 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
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(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
2. Membrane filtration method:
This method is preferred in the following cases- An oil or oily preparations, ointment, a
non-bacteriostatic solid, soluble powder or a liquid that possesses bacteriostatic and
fungistatic properties, liquid products where volume in a container is 100 ml or more.
Carry out filtration of sample under test through membrane filter having pore size of
0.45 µ and diameter of about 47 mm. After the filtration, the membrane is removed
aseptically from the metallic holder and divided into two halves. The first half is
transferred into 100 ml of culture media meant for fungi and incubated at 20 to 25°C for
not less than 7 days. The other half is transferred into 100 ml of fluid thioglycolate
medium meant for bacteria and incubated at 30 to 35°C for not less than 7 days. Observe
the growth of the media.
Results:
If no growth of micro-organism is found in any of the tubes, the sample is declared to
have pass the test and the same test is repeated for two times.
2 j Differentiate between Quality assurance and Quality control. 3M
Marking Scheme: ½ marks for each point difference. Consider any six points. (3 points
of either side)
Answer:
Sr. Quality assurance (QA) Quality control (QC)
0.5M for
No. each
1 This department ensures the overall This department is specifically point.
quality of the product and the responsible for sampling, analysis of
respective activities which impact on raw materials, in- process during
the quality of the product like GMP, production, finished products and
documentation, etc. maintaining the respective documents
including stability studies.
2 It plays a major role in quality It plays a significant role in quality
management system on providing management system by concentrating to
confidence to fulfill the requirements fulfill the requirements of quality.
of quality.
3 The activities performed in this The activities performed in this
department helps for the prevention of department helps to detect the both in-
defects by providing advanced testing process and finished product.
and development processes.
4 It is a managerial tool It is a corrective tool.
5 It is a proactive process in the quality It is a reactive process in quality of the
of the product. product.
6 It follows the guidelines of the It follows the Standard Operating
concerned regulations. Procedures (SOP) laid down by quality
assurance department.
Page No: 19 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
2 k Write the advantages and disadvantages of Liposomes. 3M
Marking Scheme: 1.5M for any three advantage; 1.5M for any three disadvantages
Answer:
Advantages:
1.5M
a) Liposomes increase the potency, bioavailability and therapeutic index as well as (0.5m
therapeutic safety of drug (e.g. actinomycin-D). for each
b) Liposomes are able to transport hydrophobic as well as hydrophilic drugs. point)
c) Liposomes are site specific drug delivery systems. Change in site specific drug delivery
can be achieved by modifying the surface of liposome.
d) They can entrap macromolecules like interleukin 2, interferon-g etc.
e) PEG-coated liposomes are able to deliver drug for longer periods of time.
f) Liposomes are seen to improve stability by the process of encapsulation.
g) Liposomes are non-destructive, flexible, biocompatible, bio-degradable
Disadvantages: 1.5M
a) Low solubility in aqueous solutions. (0.5m
b) Short half-life in the body environment. for each
point)
c) High production cost.
d) Leakage and fusion of the loaded drugs
e) Allergic reactions to some liposomal compounds
f) Sometimes phospholipid undergoes oxidation and hydrolysis-like reactions.
3 Attempt ALL questions 20 M
Important Instructions: In case, multiple answer options are observed for the
same sub question of question No. 3, the option (Answer) appearing first in
the answer book shall be treated as answer and assessed accordingly.
3 a Define Sublimation. 1M
Marking Scheme: 1M for correct definition.
Answer:
Sublimation is the process where a solid changes from solid to a vapor without passing
through the liquid state. OR
Sublimation is the transition of a substance from sloid phase to the gas phase without
passing through an intermediate liquid phase.

3 b Name the First pharmaceutical industry started in India. 1M

Marking Scheme: 1M
Answer: Bengal Chemicals and Pharmaceuticals Ltd.

Page No: 20 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
3 c Give two examples of natural gel forming substances. 1M
Marking Scheme: 1M (Any Two Examples)
Answer: Gelatine, Alginate, Carboxy Methyl Cellulose, Chitosan, Alginic acid.
3 d What is the pH value of Tears? 1M
Marking Scheme: 1M
Answer: The normal pH range was 6.5 to 7.6
3 e Which step involves moistening of drug during percolation process? 1M
Marking Scheme: 1M
Answer: Imbibition
3 f _______ container protects the product from dust, moisture and air. 1M
Marking Scheme: 1M consider any one of following
Answer: Air-tight containers or Hermetic containers.

3 g Give two examples of artificial sweetening agents. 1M

Marking Scheme: 1M (Any two examples)
Answer:
Saccharin, Aspartame, Acesulfame potassium (acesulfame-K, or Ace-K), Sucralose,
Neotame.
3 h Give the disintegration time of sugar-coated tablets. 1M
Marking Scheme: 1M
Answer: 60 Minutes
3 i Define Nasal drop. 1M
Marking Scheme: 1M
Answer:
Nasal drops are solutions, emulsions or suspensions intended for instillation into the nasal
cavities with a dropper.
3 j The preparations containing antibiotics are called as…… 1M
Marking Scheme: 1M
Answer: Antibacterials or Antimicrobials.
3 k The dissolution test has been introduced in………edition of I.P. 1M
Marking Scheme: 1M
Answer: Third Edition of I.P 1985
3 l Define pharmacy. 1M
Marking Scheme: 1M
Page No: 21 of 22
 MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2005 Certified)
WINTER– 2023 EXAMINATION
MODEL ANSWER - ONLY FOR THE USE OF RAC ASSESSORS
Subject Title: PHARMACEUTICS- THEORY Subject Code: 20111
Q. Sub Answers Marking
No. No. Scheme
Answer:
Pharmacy is the art, science of compounding, packaging, labelling and dispensing medicinal
drugs.
3 m The extraction of vegetable drugs with cold or boiling water for a short period of 1M
time is____
Marking Scheme: 1M
Answer: Infusion
3 n A major component of glass is___ 1M
Marking Scheme: 1M
Answer: iii) Silica
3 o An example of inorganic or mineral colour is___ 1M
Marking Scheme: 1M
Answer: i) Titanium dioxide
3 p Define sieve number. 1M
Marking Scheme: 1M
Answer:
The sieve number denotes the number of meshes present in the sieve within a one-inch
length of the sieve mesh.
3 q What will be the allowed variation if the average weight of tablet is 300mg. 1M
Marking Scheme:1M, consider any one correct option from following.
Answer: ii) ± 5.0% (as per IP) or
iv) ±7.5% (as per USP)
3 r Elixirs are________ 1M
Marking Scheme: 1M
Answer: i) hydroalcoholic liquids
3 s Which of the following is the example of artificial preservative. 1M
Marking Scheme: 1M
Answer: iv) Sodium benzoate
3 t Calamine lotion is used as a_______ 1M
Marking Scheme: 1M, consider any one correct use.
Answer:
Protective or Astringent or used to relieve the itching, pain, and discomfort of minor skin
irritations.

Page No: 22 of 22