COLLEGE OF PHARMACY – AGRA (0234)

D.Pharm I Year, 1st Sessional Examination, Session: 2021-22

Subject: Pharmaceutics, Paper Code: ER20-11T
Time: 1 Hour Max. Marks: 40

Section-A: Objective Type Questions Attempt All Questions 1 Mark Each

Q1. The Drug & Cosmetic Act and Rules were established in.
a. 1946 b. 1949
c. 1945 d. 1956

Q2. Which rubber is stable at high temperature, and is translucent and flexible?
a. Butyl rubber b. Nitrile rubber
c. Silicon rubber d. Polyisoprene

Q3. Which of the following is not the source of mineral?

a. Kaolin b. Talc
c. Lactic acid d. Silica

Q4. Cyclone separator works on the principle of __________.

a. Centrifugal force b. Impaction
c. Crushing d. Sieving

Q5. Which method is used for extracting hard and tough drugs?
a. Fractional distillation b. Percolation
c. Lyophilization d. Drying

Q6. ETP stands for ____________________.

Q7. Tincture of Belladonna is an example of ____________________ extraction method.
Q8. Write two demerits of plastic as a material for container.
Q9. Define the term pharmaceutical aids.
Q10. Ball mill works on which principle?

Section-B: Short Answers Attempt Any 5 Questions 3 Marks Each

Q1. Write a short note on Indian Pharmacopoeia.

Q2. Define packaging. Enlist objectives of packing.
Q3. What are preservatives? Mention their ideal properties.
Q4. Define mixing. Discuss the objectives.
Q5. What are coloring agents? Mention their advantages and disadvantages.
Q6. Explain the construction and working of Ball mill.

Section-C: Long Answers Attempt Any 3 Questions 5 Marks Each

Q1. What are the various methods of size reduction? Give the principle, construction, working for Hammer mill.
Q2. Explain the construction and working of Silverson mixer homogenizer.
Q3. Explain flavoring agents with its classification, advantages and disadvantages.
Q4. Define glass and gives its classification.
 Section-A: Objective Type Questions

Q1. (c) 1945

Q2. (d) Polyisoprene
Q3. (c) Lactic acid
Q4. (a) Centrifugal force
Q5. (b) Percolation
Q6. Electrolytic Tin Plate
Q7. Simple Percolation
Q8. Demerits of plastic as a material for container are:
(a) Its expansion rate is high.
(b) May be attacked by organic substances (solvents).
Q9. Pharmaceutical aids are elements with little or no therapeutic value, but are basically used in production or
compounding of various pharmaceuticals.
Q10. Ball mill works on the principle of impact and attrition.

Section-B: Short Answers

Q1. Indian Pharmacopoeia

 It is an official document that contributes to product safety, efficacy, and affordability.

 It is published by the Indian Pharmacopoeia Commission, regulated by the MoHFW.

Edition Year Volume Color

1st edition 1955 1
2nd edition 1966 1
3rd edition 1985 2
4th edition 1996 2
5th edition 2007 3 Blue
6th edition 2010 3
7th edition 2014 4 Dark Red
8th edition 2018 4 Orange

Salient features of IP-2018 –

220 New monographs

366 Revised monographs
7 Omitted monographs

Q2. Packaging is the art and science of preparing the articles for their transport, storage, display, and use.
Objectives of Packaging:
1. Physical protection
2. Barrier protection
3. Containment or Agglomeration
4. Information transmission
5. Marketing
6. Security
7. Convenience
8. Portion control.

Q3. Preservatives are natural or synthetic substance that is added in the products to avoid decomposition by
microbial growth or by unwanted chemical changes.

Ideal Properties of Preservatives

1. It should be non-irritant.
2. It should be non-toxic.
3. It should have physical and chemical stability.
4. It should be compatible with other ingredients added in formulation.
Q4. Mixing is dispersing of two or more components to form a uniform mixture.
Objectives:
1. Chemical reaction enhancement.
enhancement
Mixing increase close contact among reacting substances.
2. Simple physical mixtures
Mixing of two or more miscible
cible liquids, hom
homogeneously divided solids, etc.
3. Physical changes.
Mixing increase super-saturat
saturation which leads to crystal formation.
4. Achieving dispersion
Mixing of two or more immiscible liquids and one or more liquids with finely divided solids.

Q5. Coloring agents are chemicals used to impart pleasing appearance to the drugs and cosmetics.
Advantages:
1. Providee grace and better eye
eye-appealing character to the product.
2. Help fast recognition of the medicine.
Disadvantages:
1. Vegetable and Animal Color
 Tinctorial powder create problem in the evaluation of the colorants.
 Coloring property was not elegant and long lasting in solution.
2. Coal Tar Color:
 Sometimes sunlight fades the color.
 Many behave as feeble indicator, alteration in pH lead to change in color.
color

Q6. Ball Mill

Construction:

1. Hollow cylinder
 Made up of metal with chromium lining.
 Metallic frame allow rotation on longitudinal axis.
 About 30-50% 50% volume is occupied by the steel balls.
2. Lid for material feed and withdrawal.

Working:
1. Cylinder of mill is filled with material and rotated.
2. Speed plays a key role.

Speed Characteristic Size Reduction

eduction
Low speed Balls only rolls and slide over each other. Little size reduction.
High speed Balls move towards walls. No size reduction.
Correct speed Balls move up to rood and then fall. Maximum size reduction.

3. Material is withdrawn from the container.

 Section-C: Long Answers

Q1. Mechanism Characteristic Equipment

Cutting Material cut with the help of sharp blades. Cutter Mill
Compression Pressure applied on material to crush it. Roller Mill
Impact Moving
oving object strikes stationary material. Hammer Mill
Impact & Attrition Both impact & attrition mechanisms work. Ball Mill, Fluid Energy Mill
Attrition Both surfaces move and produce shear forces. Colloidal Mill

Hammer Mill

Principle: Impact
Construction:

1. Hopper holds the material and is connected to a drum.

2. Shaft is centre part of the equipment to which hammers are attached.
3. Hammers are made up of stainless steel and its impact surface of abrasion resistant material.
4. Screen is removable, used for the passage of crushed materials.
5. Receiver is a container in which resultant powder is collected.

Working: 1. Material is feed in to hopper.

2. Allow the shaft to rotate.
3. Fast rotating hammers powder the material into required size.
4. Collect material in a receiver.

Q2. Silverson Mixer Homogenizer

Principle: Shearing forces and turbulence produced by the high-speed
speed rotors.
Construction:

1. Supporting columns are long and connected to motor.

2. Shaft is located in center with one end connected to motor and other to the head.
3. Turbine blades are present in head surrounded.

Working: 1. Equipment head is placed completely in vessel having g substances to mix.

2. Allow the motor to rotate at high speed.
3. Fluid is sucked inside head and forcefully expelled out.
4. Remove head of the equipment.
Q3. Flavoring agents mask the disagreeable taste of dosage forms.

Taste of Product
 Sweet  Salty  Sour  Bitter

Classification
1. Sweetening agents Sucrose, invert syrup, Saccharin sodium, Sorbitol, and Treacle.
2. Flavored syrups Fruit-flavored syrup, vegetable extract syrups, Cocoa syrup
3. Aromatic oils Volatile oil of Anise, Caraway, Cinnamon, Clove, Ginger, Lemon, etc.
4. Synthetic flavor Benzaldehyde and Vanillin.

Advantages:
1. Mask unpleasant taste of medicament.
2. Help in increasing patient compliance.

Disadvantages:
1. Certain flavors cannot be masked (Male fern extract), initially sweet, then astringent finally bitter.
2. Can cause dental cavities, raise blood sugar.
3. Can increase risk of cancer and destroy intestinal health.
4. May result in weight gain and poor nutrients.

Q4. Glass
Composition

Sand Pure Silica.

Soda-ash Sodium carbonate.
Limestone Calcium carbonate.
Cullet Broken glass serves as fusion agent for entire mixture.
Cations ‘𝑆𝑖’, ‘𝐴𝑙’, ‘𝐵’, ‘𝑁𝑎’, ‘𝐾’, ‘𝐶𝑎’, ‘𝑀𝑔’, ‘𝑍𝑛’, and ‘𝐵𝑎’ are commonly found.
Anion Oxygen.

Selection Criteria

 Limit of alkalinity and hydrolytic resistance.

 Thermal expansion properties.
 Sensitivity to ‘𝐵𝑎’ or ‘𝐶𝑎’ ions.

Types Properties Uses

Type-I Resistant to alkali leaching. Buffered and un-buffered.
Borosilicate glass Less brittle. Aqueous solution.
Low thermal expansion. Injectables.
Easy to clean and sterilize.
Type-II Surface alkali neutralized with 𝑆𝑂 . Buffered.
Treated Soda-lime glass Glass surface resistant to water. Aqueous solution (< 7.0 pH).
Dry powders.
Oleaginous solution.
Type-III Releases more alkali Dry powders.
Soda-lime glass Moderate hydrolytic resistance. Oleaginous solution.
Type-IV Tablets.
General purpose Oral solution.
Soda-lime glass Suspensions.
Ointments.
Liquids for external use.