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Faculty of Pharmacy
B.PHARM.
SEM: 6 MU FINAL EXAM May: 2023
__________________________________________________________________________
Subject: - IP-1 13PH0605 Date:- 12/05/2023
Total Marks:-75 Time: - 3 HOURS
Instructions:
1. All Questions are Compulsory.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

Question: 1.

(a) Objective MCQ [10]

1. The purpose of conditioning agent on shampoo is

a. To bring moisture to nail
b. To bring moisture to hair
c. To bring moisture to skin
d. To bring greasiness to hair

2. Following is not the preservative

a. Methyl paraben
b. Butyl paraben
c. Phenol
d. Magnesium stearate

3. Intramuscular injection is given in the ?

a. veins
b. muscles
c. arteries
d. joints
4.Which of the following is used as tonicity adjuster ?
a. Nacl
b. PEG-4000
c. Methyl Cellulose
d. Lecithin
5.The parenteral preparation is called a Small Volume Parenteral if the volume loading
capacity is ?
a. Below 50 ml
b. Below 10 ml
c. Below 100 ml
d. Below 30 ml
6.Drug absorption is better with
a. Insoluble drugs
b. Powder
c. Lipid soluble drugs
d. Ionized drugs
7.Inadequate spreading of the coating solution before drying, a bumping effect is known as
a.Mottling
b. Roughness
c. Hazing orange peel effect
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d. Cracking
8.Low moisture content in tablet formulation which is acceptable acts as a
a.Lubricant
b. Glidant
c. Binder
d. Antiadhesive
9.Other than tablet hardness, which method is used to measure the tablet strength?
a.Thickness
b.Weight variation
c. Friability
d. Organoleptic properties
10. In sugar coating of a tablet, sub-coating is done
a. To smoothen the surface
b. To round edge and tablet size
c. Prevent the moisture
d. None of these

(b) Short Questions [10]

1. Give classification of excipients based on their functionality for tablet formulation.

• Diluent
• Binder and adhesive
• Disintegrants
• Lubricants and glidants
• Colouring agents
• Flavouring agents
• Sweetening agents

2. Define Oxidation.
Oxidation is the gain of oxygen, loss of hydrogen and/or loss of electrons.

It is very common pathway for drug degradation in both liquid and solid formulation.

3. Write down the formula of Hausner’s ratio.

Hausner's ratio: Tapped density/ Bulk Density

4. Enlist mechanisms of tablet disintegration.

• Wicking
• Swelling
• Deformation
• Particle repulsion force.

5. Define bloom strength.

Gel strength, also known as 'bloom' value, is a measure of the strength and stiffness of the
gelatin, reflecting the average molecular weight of its constituents, and is usually between 30
and 300 bloom (< 150 is considered to be a low bloom, 150–220 a medium bloom, and
220–300 a high bloom).

6. Define pellets.
In pharmaceutical industries, pellets are multiparticulate dosage form which was formed by
the agglomeration of fine powdered excipient and drugs together that leads to the formation
of small free flowing spherical or semi spherical particles. This technique is called as
pelletization process.

7. What is clarity test?

Clarity test

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It is done visual observation according to GMP all containers be visually inspected and that
any with visible particles be discarded.

For large volume parenteral limit of 50 particles of 10 µm and larger and 5 particles of
25µmand larger per ml.

Visual inspection of a product container is done by individual human inspection of each

externally clean container under a good light, baffled against black and white background,
with the contents set in motion with a swirling action.

A moving particle is much easier to see than that is stationary.

8. What is WFI?
•Water for injection must be like

üclear and colorless liquid; odorless.

üWater for injections is pyrogen-free. It contains no added substance.

üWater for injections is obtained from potable or Purified water by distillation in an

apparatus.

üThe distillate is collected and stored in conditions designed to prevent growth of

microorganisms and to avoid any other contamination.

9. Explain air-tight containers.

Air-tight containers: These are also called hermetic containers. These containers have
air-tight sealing or closing. These containers protect the products from dust, moisture and air.

Where as air-tight sealed containers are used for injectables,air-

tight closed containers are meant for the storage of other products.

10. Explain single dose containers.

Single dose containers : These containers are used to supply only one of medicament and
hold generally parenteral products.

Ex: ampoules and vials

Question: 2.

(a) Discuss various stages of sugar-coating giving suitable examples of excipients used.
[08]

1. Sealing/Waterproofing: provides a moisture barrier and hardens the tablet surface.

2. Sub-coating: causes a rapid build-up to round off the tablet edges.
3. Grossing/Smoothing: smoothens out the sub-coated surface and increases the tablet size to predetermine
dimension.
4. Colouring: gives the tablet its colour and finished size.
5. Polishing: produces the characteristics gloss.

Sealing/waterproofing:

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• Prior to applying any sugar/water syrup, the tablet cores must be sealed, thoroughly dried and free of all
residual solvents.
• The seal coat provides a moisture barrier and hardness on the surface of the tablet in order to minimize
attrition effects.
• Core tablets having very rapid disintegration rates conceivably could start the disintegration process
during the initial phase of sugar coating.
• The sealants are generally water-insoluble polymers/film formers applied from an organic solvent solution.
• The quantities of material applied as a sealing coat will depend primarily on the tablet porosity.
• since highly porous tablets will tend to soak up the first application of the solution,
• Thus, preventing it from spreading uniformly across the surface of every tablet in the batch.
• Hence, one or more further applications of resin solution may be required to ensure that the tablet cores are
sealed effectively.

Common materials used as a sealant:

Shellac,
Zaine,
Cellulose acetate phthalate (CAP),
Polyvinyl acetate phthalate (PVAP),
Hydroxyl propyl cellulose (HPC),
Hydroxypropyl methylcellulose (HPMC), etc.

Sub-coating:
• Sub-coating is the actual start of the sugar-coating process.
• Provides the rapid build-up necessary to round up the tablet edge.
• It also acts as the foundation for smoothing and colour coats.

Two methods are used for sub-coating:

• The application of the gum-based solution is followed by dusting with powder and then drying. This
routine is repeated until the desired shape is achieved.
• The application of a suspension of dry powder in gum/sucrose solution followed by drying.
• Thus, sub-coating is a sandwich of an alternate layer of gum and powder.
• It is necessary to remove the bulk of the water after each application of coating syrup.

Grossing/ smoothing:
• The grossing/smoothing process is specifically for smoothing and filling the irregularity on the surface
generated during sub-coating.
• It also increases the tablet size to a predetermined dimension.
• If the sub-coating is rough with a high number of irregularities, then the use of grossing syrup containing
suspended solids will provide more rapid build-up and better filling qualities.
• Smoothing usually can be accomplished by the application of a simple syrup solution (approximately
60-70 % sugar solid).
• This syrup generally contains pigments, starch, gelatine, acacia or opacifier, if required.
• Small quantities of colour suspension can be applied to impart a tint of the desired colour when there are
irregularities in the coating.

Colour coating:
• This stage is often critical in the successful completion of a sugar-coating process.
• Involves the multiple application of syrup solution (60-70 % sugar solid) containing the requisite
colouring matter.
• Mainly soluble dyes were used in the sugar coating to achieve the desired colour.
• Since the soluble dye will migrate to the surface during drying.
• But nowadays the insoluble certified lakes have virtually replaced the soluble dyes in pharmaceutical
tablet coating.
• The most efficient process for colour coating involves the use of a pre-dispersed opacified lake
suspension.

Polishing:

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Sugar-coated tablets need to be polished to achieve a final elegance.

Polishing is achieved by applying a mixture of waxes like,
• Beeswax,
• Carnauba wax,
• Candelilla wax,
• Hard paraffin wax to tablets in polishing pan.

(b) Enumerate the chemical properties affecting preformulation studies in designing a

dosage form and discuss any two in detail giving suitable illustrations [08]

Describe in detail the following

OR

(b) Write in detail about metals as pharmaceutical packaging materials.

[08]
Metals are used for construction of containers. The metals commonly used for this purpose
are aluminium ,tin plated steel, stainless steel, tin and lead.

ADVANTAGES:

They are impermeable to light, moisture and gases.

They are made into rigid unbreakable containers.

They are light in weight compared to glass containers.

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Labels can printed directly on to their surface.

DISADVANTAGES:

They are expensive.

They react with certain chemicals

Write in detail about all metals

Question: 3.

(a) Define Hygroscopicity and give its classification. [03]

Many drug substances, particularly water –soluble salt forms, have a tendency to adsorb atmospheric
moisture.

Adsorption and moisture content depend upon the atmospheric humidity, temperature, surface area, exposure
and the mechanism of moisture uptake.

The degree of Hygroscopicity is classified into four classes:

Slightly hygroscopic: increase in weight is ≥ 0.2% w/w and < 2% w/w

Hygroscopic : increase in weight is ≥ 0.2 % w/w and < 15 % w/w

Very hygroscopic : increase in weight is ≥ 15% w/w

Deliquescent : sufficient water is adsorbed to form a solution.

(b) Explain Bulk density in detail with its measurement methods. [06]
Bulk density of a compound varies substantially with the method of crystallization, milling or
formulation.

The bulk density of a material is the ratio of the mass to the volume (including the interparticulate
void volume) of an untapped powder sample.

The tapped density is obtained by mechanically tapping a graduated cylinder containing the
sample. The bulk density of a powder is the ratio of the mass of an untapped powder sample and
its volume including the contribution of the inter-particulate void volume.

Hence, the bulk density depends on both the density of powder particles and the spatial
arrangement of particles in the powder bed.

The bulk density is expressed in grams per milliliter (g/mL) although the international unit is
kilogram per cubic meter (1 g/mL = 1000 kg/m3) because the measurements are made using
cylinders. It may also be expressed in grams per cubic centimeter (g/cm3).

The bulking properties of a powder are dependent upon the preparation, treatment and storage of
the sample, i.e. how it was handled.

The particles can be packed to have a range of bulk densities and, moreover, the slightest
disturbance of the powder bed may result in a changed bulk density.

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Thus, the bulk density of a powder is often very difficult to measure with good reproducibility
and, in reporting the results, it is essential to specify how the determination was made.

The bulk density of a powder is determined by measuring the volume of a known mass of powder
sample, that may have been passed through a sieve into a graduated cylinder (Method 1), or by
measuring the mass of a known volume of powder that has been passed through a volumeter into
a cup (Method 2) or a measuring vessel (Method 3). Method 1 and Method 3 are favoured.

Method: Graduated cylinder

Bulk method 1: The bulk density is obtained by adding a known mass of powder to a graduated

cylinder. The density is calculated as mass/volume.

Tapped method 1:The tapped density is obtained by mechanically tapping a graduated cylinder
containing the sample.

The tapping can be performed using different methods.

The tapped density is calculated as mass divided by the final volume of the powder.

The interparticulate interactions that influence the bulking properties of a powder are also the
interactions that interfere with powder flow.

(c) Explain Coulter counter method used for determination of particle size with a schematic
diagram. [06]
A Coulter counter is an apparatus for counting and sizing particles

suspended in electrolytes.

A typical Coulter counter has one or more microchannels that separate two chambers containing
electrolyte solutions.

As fluid containing particles or cells is drawn through each microchannel, each particle causes a
brief change to the electrical resistance of the liquid.

As each particle passed through hole, it is counted & sized according to the resistance generated
by displacing that particles’s volume of conducting medium.

Process:

- Sample preparation is done by dispersing material in conducting medium such as isotonic

solution with few drop of surfactant & aid of ultrasound.

- known volume of suspension (0.5-2ml) is drawn into tube through small aperature, across which
the voltage is applied

- each particle pass through hole, it is counted & sized according to the resistance generated by
displacing volume of conducting medium.

diagram

OR
(a) Discuss dissolution test IP for tablet. [03]
Answer :
Definition,

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Types of dissolution apparatus as per IP,

A brief discussion on dissolution procedure,

Criteria of dissolution test passing as per IP.

(b) Enlists various evaluation parameters of the tablet. Explain weight variation and content
uniformity as per USP. [06]
Pharmacopoeial or official tests:

Content of Active Ingredient/ Absolute drug content test

Uniformity of Weight

Uniformity of Content

Disintegration time test

Dissolution test

Non-pharmacopoeial or non-official tests:

Tablet Hardness or Crushing Strength Test

Friability Test

Tablet Thickness

Explain weight variation and content uniformity as per USP.

It should include:

Importance,

Sampling requirement,

Instrument functioning,

Settings of an instrument,

Passing criteria for both tests.

(c) Define tablets. Give their types. Explain methods of tablet granulation. [06]
Answer :
Definition,

Types of tablets,

Enlisting of granulation methods,

A detailed explanation of each method with its advantages and disadvantages.

Name of instruments used, if any applicable.

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Question: 4.

(a) List out and explain the steps involved in the filling process of the Hard gelatine capsule.
[06]

Rectifications:

Separation of caps from bodies:

Dosing of fill material:Replacement of caps and ejection of filled capsules:

(b) Describe in detail the dipping and spinning steps included in the manufacturing of HGC
empty shell. [06]
From the feed tank, the gelatin is gravity fed to specially engineered Dipper section.

Here, the capsules are molded onto stainless steel Pin Bars which are dipped into the gelatin
solution

(10m long, 2 m wide and 3 m high)

Once dipped, the Pin Bars rise to the upper deck allowing the cap and body to set on the Pins.

Two and half spine is to be applied to spread gelatine evenly

Describe everything in detail with diagram.

(c) Write a note on non-aqueous vehicles used for parenterals. [06]

•Non-aqueous vehicles:

•Non-aqueous vehicles are employed for the production of:

•Non-aqueous parenteral solutions of therapeutic agents that are water-insoluble

•Non-aqueous parenteral suspensions of therapeutic agents that are water-soluble and/or exhibit
aqueous instability

•The internal phase of parenteral emulsions.

•Fixed oils are predominantly used as non-aqueous vehicles

•(e.g. corn oil, cottonseed oil, peanut oil, sesame oil);

•however, Non-aqueous esters may be used, e.g. ethyl ethanoate:

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•Sesame oil is generally the oil of choice as it is more stable.

•Oils must be free from rancidity and must not contain mineral oils or solid paraffin.

•Two major problems associated with the use of non-aqueous pharmaceutical solutions are:

•1. Pain/irritation on injection.

•It should be noted that the viscosity of fixed oils increases at lower storage temperatures. This
will, in turn, affect the ease of administration by injection and the pain/irritation at the site of
injection.

•It is essential to ensure that the viscosities of oil-based solutions and suspensions are minimized
both to reduce pain on injection and to enhance the ease of administration (injection).

•2. Sensitivity

•Patients may exhibit sensitivity to the oils and therefore the oil used in the formulation must be
explicitly stated on the Label /patient information.

•In some oily formulations, agents may be added to enhance the solubility of the therapeutic agent
in the oil vehicle. Benzyl benzoate (itself a non-aqueous vehicle) may be used for this purpose.

OR
(a) Explain the evaluation of eye ointments. [03]
Evaluation of final product:
Evaluation is the test of the finished ophthlmic products are free from of micro organism
or not.Evaluation of the opthalmic products is done by following tests.1. Sterility test2.
Clarity test3. Leaker test4. Metal particles in ophthalmic ointments

(b) Draw and explain a sample design of a parenteral facility [06]

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Explain in detail.

(c) Write about the ideal properties of vehicles used in parenterals. [06]
Ideal properties of vehicle used should be:

• The vehicle should be pharmacologically inert.

• It should be non toxic and compatible with blood.

• It should maintain solubility of the, drug (API).

• It should be physically and chemically stable.

• It does not affect the pH of the dosage form.

• It must be free from pyrogen.

• It should not contain particulate matter.

The finished product must meet sterility standard.

• Water is the ideal vehicle for most injections since aqueous preparations

are well tolerated by the body.

• Easy visual inspection for particulate contamination, chemical precipitation

and colour change.

• It may accelerate drug hydrolysis resulting in inert or toxic products.

• Vehicle can be water, water-miscible co-solvents or non-aqueous solvents.

•Aqueous is preferred.

Question: 5.

(a) What are the ideal characteristics of pharmaceutical packaging? [03]

Material must have following characteristics:

They must protect the preparation from environmental conditions.

They must not be reactive with the product.

They must not impart to the product tastes or odors.

Must be non toxic.

They must be “FDA” approved.

They must meet applicable tamper – resistance requirements.

They must be adaptable to commonly employed high-speed packaging equipment

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(b) Write in detail about the regulatory aspects of packaging. [06]

Packaging Process:

Filling and assembling

Sterilization in the final container, if applicable

Placing labels on the container

Storage at the manufacturing and shipping sites.

Quality control:

Use to ensure consistency in the packaging components.

Physical Characteristics

Chemical Composition

Associated Components

Secondary Packaging Components

OR

(a) Write about the advantages and disadvantages of plastic containers. [03]
Advantages of Plastic:

They are light in weight and can be handled easily.

Theyaretransportedeasily.

Theyareunbreakable.

Theyavailableinvariousshapesandsizes.

Theyareresistanttoinorganicchemicals.
Ø Disadvantages of Plastic:

Theyarepermeabletowatervapourandatmosphericgases.

Theyarepoorconductortoheat.

Theymayabsorbchemicalsubstances,suchaspreservativeforsolutions.

(b) What is tamper-evident packaging? Explain Blister and Strip Packaging concept.
[06]
The requirement for tamper resistant packaging is now one of the major considerations in
the development of packaging for pharmaceutical products.

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Tamper resistant package is one having an indicator to entry in which, if breached or

missing, can reasonably be expected to provide visible evidence to consumers that
tampering has occurred.

FDAapprovesthefollowingconfigurationsastamperresistantpackaging:

Film wrappers, Blister package, Strip package, Bubble pack, Shrink seals and bands, Oil,
paper, plastic pouches, Bottle seals, Tape seals, Breakable caps, Aerosol

containers

---Best of Luck---

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– Bloom’S Taxonomy Report –

Sub: IP 1
Sem. 6
Branch: Pharmacy

Que. Paper weightage as per Bloom’s Taxonomy

LEVEL % of weightage Question No. Marks of
Que.
Remember/Knowledge 10 1(a1), 1(a7), 1(b2), 1,1,1,1,1,1,1,6,1
1(b5), 1(b8), 1(b9), 4B =13
(OR),1(b3)

Understand 20 1(A4), 1(A9), 1(b1), 1,1,1,1,3,6,6,6-

1(b10), 3A, 5B, =25
4C(OR),5B(OR)

Apply 25 2A,2B,3A(OR),4A,1(A3), 8,8,3,3,1,1,3,6=

1(b7),5A(OR), 4B 31

Analyze 27 2B(OR),3B,3C,4C,4B(OR 8,6,6,6,6,3=31

),5A

Evaluate 10 3B(OR),4A(0R),1(A2),1( 6,3,1,1,1=12

A8),1(b6)

Higher order 8 3C(OR),1(A5),1(A6),1(b 6,1,1,1,1=10

Thinking/ Creative 4),1(A10)

Chart/Graph of Bloom’s Taxonomy

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