Pharma Questions and Answers (Production)

A List of Pharmaceutical Interview Questions and Answers - Production

(Granulation, Compression & Coating)

Q1. Why used opacifier in Tablet coating?

Opacifier is used to make the ensuring system opaque, given excellent heat insulation when compacted under pressure.

Q2. What are the commonly used opacifiers?

Titanium dioxide, Aluminum hydroxide, Aluminum silicate.

Q3. Which excipients are used in Enteric coated tablet?

CAP, PVAP, Kollicoat, Eudragit etc.

Q4. Is Enteric coating is pH dependent?

Yes, enteric coating is pH dependent.

Q5. What is Kollicoat?

Methacrylic acid Ethyl Acrylate Copolymer (1:1)

Q6. What types of Kollicoat available for coating?

Kollicoat IR, Kollicoat SR 30D, Kollicoat MAE 100P, Kollicoat 30DP

Q7. What are the common problems of Tableting?

Capping, Lamination, Cracking, Low Hardness, More DT, Low Dissolution Rate.

Q8. How can overcome the low hardness problem of a Tablet?

Increasing binder amount, changing diluent type etc.

Q9. Why Plasticizer used in coating solution?

To increase the plasticity and flexibility.

To reduce the glass transition temperature (Tg) facilitating transition.

Q10. What are the commonly used plasticizers in coating solution?

Castor oil, Glycerin, PEG 1000, PEG 1450, PEG 3350.

Q11. Why Mg-stearate is added in the last stage before compression?

Mg-Stearate is added at the last stage of mixing (before compression) due to prevent the adversely affect on compressibility and dissolution characteristics.

Q12. What type of measurement should be taken for hygroscopic material?

Relative humidity should be under control (<45%).

Wet granulation should be omitted.

Q13. Which RH is preferable for Calvulanic acid combination product?

NMT 30%

Q14. Which parameter should be checked after granulation?

Assay (Blend homogeneity) , Granule size (PSD), Granules flowability (BD, TD) etc.

Q15. What is the mechanism of sodium perborate (preservative)?

Sodium perborate undergoes hydrolysis in contact with water, producing hydrogen peroxide and borate. It serves as a source of active oxygen.

Q16. Why Methylparaben and Propylparaben used in combination (9:1)?

They show synergistic effect with each other.

Q17. Why ophthalmic preparation should be sterile?

To ensure the safety regarding microbial growth.

Q18. What is the difference between RMG and Mass Mixer?

RMG is very fast and precise to mix effectively.

Q19. Which parameter should be checked after granulation?

Assay, Granule size, Granules flowability etc.

Q20. What is the mechanism of sodium perborate (preservative)?

Sodium perborate undergoes hydrolysis in contact with water, producing hydrogen peroxide and borate. It serves as a source of active oxygen.

Q21. Why Methylparaben and Propylparaben used in combination (9:1)?

They show synergistic effect with each other.

Q22. Why ophthalmic preparation should be sterile?

To ensure the safety regarding microbial growth.

Q23. What is the difference between RMG and Mass Mixer?

RMG is very fast and precise to mix effectively.

Q24. What is Absolute Advantage?

is the ability of a country, individual, company or region to produce a good or service at a lower cost per unit than the cost at which any other entity produces that same good or service.

Q25. What is Rheology?

the study of the flow of matter, primarily in a liquid state. It describes the interrelation between force, deformation and time.

Q26. Which water soluble lubricants are used in Pharmaceutical Products?

- Sodium lauryl sulphate
- Magnesium lauryl sulphate

Q27. Which artificial sweeteners are used in Pharmaceutical Products?

- Aspartame
- Neotame
- Acesulfame Potassium

Q28. What are the variables for wet granulation process?

- The variables are selected based on the risk assessment as impeller speed, liquid addition rate, wet massing time etc.

Q29. Which is confirmed the end point of granulation process?

- KW (which indicates the strength/hardness of granules/lump).

Q30. How can increase the flow properties of moisture sensitive fine powder during compression?

- Addition of crystalline excipients.
- Addition of dummy granules.

Q31. What is Diluent and Its Properties?

Diluents are fillers used to make required bulk of the tablet when the drug dosage itself is inadequate to produce the bulk. Secondary reason is to provide better tablet properties such as improve cohesion, to permit use of direct compression manufacturing or to promote flow. A diluent should have following properties:

1. They must be non toxic

2. They must be commercially available in acceptable grade

3. There cost must be low

4. They must be physiologically inert

5. They must be physically & chemically stable by themselves & in combination with the drugs.

6. They must be free from all microbial contamination.

7. They do not alter the bioavailability of drug.

8. They must be color compatible

Q32. What is additives or excipients?

In addition to active ingredients, tablet contains a number of inert materials known as additives or excipients.

Different excipients are:

1. Diluent

2. Binder and adhesive

3. Disintegrents

4. Lubricants and glidants

5. Colouring agents

6. Flavoring agents

7. Sweetening agents

Q33. What are the types of Tablets?

Ans:

(A) Tablets ingested orally:

1. Compressed tablet, e.g. Paracetamol tablet

2. Multiple compressed tablet

3. Repeat action tablet

4. Delayed release tablet, e.g. Enteric coated Bisacodyl tablet

5. Sugar coated tablet, e.g. Multivitamin tablet

6. Film coated tablet, e.g. Metronidazole tablet

7. Chewable tablet, e.g. Antacid tablet

(B) Tablets used in oral cavity:

1. Buccal tablet, e.g. Vitamin‐c tablet

2. Sublingual tablet, e.g. Vicks Menthol tablet

3. Troches or lozenges

4. Dental cone

1. Implantation tablet

2. Vaginal tablet, e.g. Clotrimazole tablet

(D) Tablets used to prepare solution:

1. Effervescent tablet, e.g. Dispirin tablet (Aspirin)

2. Dispensing tablet, e.g. Enzyme tablet

3. Hypodermic tablet

4. Tablet triturates e.g. Enzyme tablet

Q34. What is In process checks?

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.

Q35. If sticking observed during tablet compression what may the probable reason for the same?

1. If the granules are not dried properly sticking can occur.

2. Too little or improper lubrication.

3. Too much binder

4. Hygroscopic granula

Q36. What are the factors which influence tablet hardness?

1. Compression force

2. Binder quantity (More binder more hardness)

3. Moisture content

Q37. What is BFS technology?

BFS means Blow Fill Seal. This technology usually used for sterilized product like ophthalmic drops, where container preparation, material fill and sealing all are happen at a time.

Q38. List out the appearance defects of tables during compression activity?

1. Capping: Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press or during subsequent handling.

2. Lamination / Laminating: Lamination is the separation of a tablet into two or more distinct horizontal layers.

3. Sticking/filming: Sticking- refers to the tablet material adhering to the die wall. Filming- is a slow form of sticking and is largely due to excess moisture in the granulation.

4. Cracking: Small fine cracks observed on the upper and lower center surface of the tablets or very rarely on the side wall are referred to as cracks.

5. Chipping: Chipping is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.

6. Mottling: Mottling is the term used to describe an unequal distribution of color on a tablet.

7. Double Impression: Double impression involves only those punches which have a monogram or other engraving on them.

Q39. What is Lyophilization?

Lyophilization, or freeze drying, there is a water is frozen, followed by its removal from the sample, initially by sublimation (primary drying) and then by desorption (secondary drying). In this process, the moisture content of the product is reduced to such a low level that does not support biological growth or chemical reactions which give the stability to the formulation. This technique useful in formulation development of drugs which are thermolabile and/or unstable in the aqueous medium.

Q40. What are the main components of Effervescent tablets?

The effervescent tablet mainly consists of three components:

Active ingredient
Acid source
Alkaline compound, constituted by a carbonate or bicarbonate

Q41. Why granulation is required?

Granulation is carried out for various reasons, one of which is to prevent the segregation of the constituents of powder mix. Segregation is due to differences in the size or density of the components of the mix.

Q42. Why granulation process is important prior to tablet compression?

Granulation process is an important step in tablet manufacturing as it improves powder flow property and compressibility intended for compression. Granulation also prevents segregation of the constituents of the powder mix.

Q43. What is the difference between granules and pellets?

Granules are formed by the progressive enlargement of primary particles until their original identity is no longer visible and small in size. Where pellets are produced during a precise forming and mechanical handling operation and larger as compared to the granules.

Q44. How many types of granulation are there?

Granulation method can be broadly classified into two types: Wet granulation and Dry granulation. The most widely used process of granulation in pharmaceutical industry is wet granulation.

Q45. What is dry granulation method?

Dry granulation is a simple and low cost method, once extremely common and again becoming more popular because of its simplicity and cost efficiency. In dry granulation granules are form without using a liquid solution because the product may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders. In this process the primary powder particles are aggregated under high pressure. Dry granulation helps to increase the size of granules within powders, making it easier to form them into tablets or capsules.

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