PART 1

PART 2

PART 3

 

1) Define Tablet?

Ans: Tablet is a solid dosage form which contains an Active pharmaceutical ingredient (API) along with the excipients.

2) Define API?

Ans:  API stands for Active pharmaceutical Ingredient. It is the first and most important ingredient in any drug formulation. It is a biologically active component responsible for the drug effect.

3) What are excipients and give any two examples with their use?

Ans: Excipients are Inactive or inert components of the drug formulation and are intended for improving the tablet characteristics.

Examples of excipients are:

Diluents- Used for increasing the bulk volume of a tablet. Also used for improving the flow properties while compressing the tablet.

Lubricants- Used for improving the flow properties while compressing the tablet.

4) What are the examples of diluents and lubricants?

Ans:  Diluents- Ex: Mannitol, sorbitol, starch, lactose, sucrose etc.

Lubricants – Ex: Magnesium stearate, calcium stearate, stearic acid etc.

5) Name the tablet preparation methods?

Ans: There are 3 methods and named as: Wet granulation, Dry granulation, direct compression method.

6) Explain about wet granulation, dry granulation and direct compression in brief?

Ans: Wet granulation: It involves mixing, wet sieving, drying, dry screening and compression.

Dry granulation: It involves mixing, slugging, screening and compression.

Direct compression: In this method, blend of API and Excipients are directly compressed to form tablets without changing physical nature of material itself.

7) Name any three tablet processing problems and explain it?

Ans: Mottling, Capping and lamination.

MottlingUnequal colour distribution of a tablet.

CappingPartial or complete separation of a tablet top or bottom crowns.

Lamination Separation of tablets into two or more layers.

8) What is the difference between picking and sticking?

Ans:  Picking- Because of adhesion to the punch faces, Localised portion missing from the surface of the tablet.

Sticking- Adhesion of tablet localised portion to the punch faces resulting in rough and dull appearance.

9) Define capsule and how many types of capsules are available?

Ans: Capsule is a solid dosage form. It contains API and excipients enclosed in a water soluble shell which is made up of gelatin.  Two types of capsules are available. Hard gelatin and soft Gelatin capsules.

10) Explain about hard gelatin capsules?

Ans:  It contains two parts called body and cap. Body, a long narrow section. Cap, a smaller wide portion, fixes over the body.

11) What is the biggest and smallest capsule size?

Ans: Biggest capsule size is 000, Smallest capsule size is 5.

12) Define parenterals?

Ans: Parenteral are Sterile dosage form which are administered using injections through one or more layers of the skin.

13) Explain about Water For Injection (WFI)?

Ans:  Purified water without any pyrogen, prepared by distillation or reverse osmosis.

14) What is pyrogen?

Ans:  Metabolic products of microorganisms. Produced from living or dead microorganisms.

15) Difference between water for injection (WFI) and sterile water for injection (SWFI)?

Ans:  WFI – Purified water without any pyrogen

SWFI – Purified and sterile water without any pyrogen

16) Difference between ampule and vial?

Ans:  Ampule- simple dose unit. Vial- Multiple dose unit.

17) Use of additives in the parenteral formulations?

Ans:  Additives are used for increasing the stability of solutions.

18) What is the recommended storage conditions for empty hard gelatin capsules?

Ans: 15 – 25 degree C & 35 -55% RH (Relative Humidity).

19) What are the standard number of rotations used for friability test?

Ans: 100 rotations

20) Give the examples of tonicity modifiers?

Ans:  Sodium chloride and Dextrose.

21) Whether colours can be added in parenteral formulations?

Ans: NO colours can’t be added in parenteral formulations.

22) Explain what is Kanban?

Ans: Kanban is a scheduling system which advises manufacturers about how much to produce, what to produce and when to produce.  In this system, inventory is re-filled only when visual cues like an empty bin or cart is seen.

23) Explain what is MES?

Ans: MES stands for Manufacturing execution system- a system that manages and controls the production on the factory floor with the motive of reducing the total time required to produce an order.

24) Explain what is Six Sigma?

Ans: Six sigma is a data-driven methodology and approach for eliminating defects in any process from manufacturing to transactional and from product to service.

25) How many Tablets shall be taken for checking friability?

Ans: For tablets with unit mass equal or less than 650 mg, take sample of whole tablets corresponding to 6.5g. For tablets with unit mass more than 650 mg, take a sample of 10 whole tablets.

26) Explain about different types of additives with examples?

Ans: Name of different Additives are:

  1. i) Anti oxidants – Used for preventing the auto-oxidation of medicament/drug in the formulation.

e.g.: Ascorbic acid, Butylated Hydroxy Anisole (BHA), Butylated Hydroxy Toulene (BHT)

  1. ii) Synergists: Enhances the activity of anti- oxidants.

e.g.: Citric acid, Citarconic acid, Phosphoric acid, Tartaric acid etc.

iii) Preservatives-Help to prevent the microbial growth in the formulation.

e.g.: Benzalkonium chloride, phenyl mercuric acetate, Thiomersol.

27) What precautions shall be taken while collecting inprocess samples?

Ans: While collecting inprocess samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.

28) What is in-process checks?

Ans: In process checks are checks performed during an activity, In order to monitor and, if necessary, to adjust the process to ensure that product confirms to its specification.

29) What is the difference between disintegration and dissolution?

Ans: Disintegration is a disaggregation process, in which an oral dosage form falls apart in to smaller aggregates. (Disintegration time is the ‘break up’ time of a solid dosage form).

Whereas dissolution is a process by which solid substance enters in the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent.

In other word disintegration is a subset of dissolution.

30) Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / width wise?

Ans: Position of oblong tablets should be length wise because the probability of breakage is more in this position.

 

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