Pharmaceutical Formulation Questions and Answers

For questions 1-6, answer with true or false

1. In the compaction of tablets, the first step to occur as the punch enters the die is elastic Deformation.

2. Although direct compression eliminates exposure of a drug to heat and moisture, it does not Significantly reduce the number of steps involved in tablet manufacture.

3. The major problem in producing tablets of highly potent drugs (low dose) by direct compression is achieving adequate homogeneity and uniformity of drug content.

4. In general, the hardness and friability of a tablet are directly proportional to the compressive Force used to form it.

5. True lubricants reduce tablet ejection force by reducing the residual die wall force.

6. It’s impossible to make a tablet of a large dose poorly compactable drug by direct compression with microcrystalline cellulose.

For each of the disintegrants listed below, choose from the column on the right the term which best describes its mechanism of action in a compressed tablet after exposure to moisture.

7. Croscarmellose	a. Recovers shape with little or no increase in volume
8. Starch	b. Overall swelling – a significant increase in volume
9. Sodium starch glycolate	c. Deformed fiber-shaped particles swell primarily radially and tend to straighten out.

Questions 10-14 refer to the following tablet formulation for a new drug.

The tablets are manufactured by wet granulation, The drug is known to have poor solubility:

Ingredient mg per tablet

xy1000 (active)……………………350 mg

Lactose, USP Powder…………...106 mg

Microcrystalline cellulose……..…90 mg

PVP………………………………...30 mg

Sodium starch glycolate NF…….18 mg

Magnesium stearate ……………..6 mg

Total Tablet Weight………………600 mg

10. Replacing magnesium stearate with an equal amount of calcium stearate in the formulation would be expected to __________ the dissolution rate of xy1000 from the tablets.

a. increase

b. decrease

c. has little or no effect on

d. cannot predict without more information

11. The formulation for xy1000 tablets specifies that the magnesium stearate should be blended for 15 minutes. Reducing the lubricant blending time from 15 minutes to 2 minutes would be

expected to __________ the dissolution rate of xy1000 from the tablets.

a. increase

b. decrease

c. have little or no effect on

d. cannot predict without more information

12. Replacing sodium starch glycolate with an equal amount of starch is likely to __________ the dissolution rate of xy1000 from the tablets.

a. increase

b. decrease

c. have little or no effect on

d. cannot predict without more information

13. xy1000 Tablets were first manufactured using an arbitrary compression force of 850 kg. Increasing the compression force to 1000 kg is likely to ___________ the disintegration rate.

a. increase

b. decrease

c. have little or no effect

d. cannot predict without more information

14. The sodium starch glycolate is best added:

a. 100% extragranularly

b. 100% intragranularly

c. 50% intragranularly/50% extragranularly

d. Just prior to tableting with only 2-5 minutes blending.

15. A filler-binder commonly used in chewable tablets is:

a. Dipac

b. Ditab

c. Calcium carbonate

d. Polyvinyl pyrrolidone

e. Starch 1500

16. Given a new drug with a dose of 500 mg that is to be formulated into tablets. The drug melts a 50o C. Its half-life in aqueous solution at 25o is exceedingly short. The pure drug exhibits a high angle of repose and forms soft tablets with high friability in a standard lab compression test. Which process is the most acceptable as a first attempt at making these tablets? (Assume in all cases that appropriate levels of a suitable disintegrant and lubricant(s) will be included in the formulation)

a. Granulate with 10% aqueous polyvinyl pyrrolidone solution.

b. Directly compress by adding an appropriate amount of microcrystalline cellulose to serve a filler-binder.

c. Granulate with 10% alcoholic solution of polyvinyl pyrrolidone

d. Dry mix with Starch 1500 and granulated with water.

e. Granulate with a 10% alcoholic solution of crospovidone

17. Which of the following liquids cannot be used as vehicles for soft gelatin capsule fill materials?

a. Cottonseed oil

b. Polyethylene glycol 400

c. Polysorbate 80

d. None of the above (i.e., all can be used)

18. Most soft gelatin capsules are made using a:

a. Rotary die process

b. Reciprocating die process

c. Oscillating die process

d. Bubble method

e. None of the above

19. A dosage form that provides for rapid release of a drug (or drugs) at a time other than immediately following oral administration is called a:

a. Prolonged release dosage form

b. Extended-release dosage form

c. Sustained release dosage form

d. Delayed release dosage form

e. None of the above

20. Which of the following is not likely to be found in an effervescent tablet?

a. Citric acid

b. Croscarmellose sodium

c. Tartaric acid

d. Sodium bicarbonate

e. None (i.e., All are likely to be found)

21. Piroxicam, a poorly soluble drug, is commercially available in powder-filled hard gelatin `capsules in 10 mg and 20 mg doses. Potentially, how could formulation of piroxicam as a soft gelatin capsule significantly improve over powder-filled hard gelatin capsule formulations?

a. Improved content uniformity

b. Improved weight variation

c. Faster absorption

d. (a) or (b)

e. (a) or (b) or (c)

22. The phenomenon known as capping may indicate:

a. Too little binder

b. Excessive elastic deformation and recovery

c. Too much magnesium stearate

d. (a) and/or (b)

e. (a) and/or (b) and/or (c)

For questions 23-26, answer with true or false

23. Most automatic capsule filling machines used commercially employ tamps or pistons that form Powder plugs by compression and eject them into empty capsule bodies.

24. Although they are generally more costly to produce than tablets, capsules have the advantage

That they can be filled on automatic high-speed equipment without the need for a formulation lubricant such as magnesium stearate.

25. Interlocking caps and bodies, banding and liquid sealing not only prevent the accidental Separation of capsules during shipping and handling but also ensure that the filled capsules Tamper proof.

26. In making effervescent granulation the fusion process, which avoids the use of water, is Preferred over the wet process for moisture sensitive drugs.

Also see:

• Pharmaceutical Interview Questions - Quality
• Pharmaceutical Interview Questions - Production

Submittrd  by:

Basel .S. Hejazi.

Senior formulator drugs pharmacist

Pharma international company (R&D labs)

Jordan

E-mail- bh-1980@hotmail.com

Answer Keys:

1. False, 2. False, 3. True, 4. False, 5. False, 6. False 7. c, 8. a, 9. b, 10. c, 11. a, 12. b, 13. d, 14. c, 15. a, 16. c, 17. d, 18. a, 19. d, 20. b, 21. e, 22. e, 23. True, 24. False, 25. False, 26. False