Exam November 2018, questions and answers PDF

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MPH209 MCQ PRACTICE QUESTIONS...

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GREEN=UNSURE YELLOW=ANSWER 1. (Pel 1) Which of the following is not a test for quality of pellets? (Points: 1) Sphericity Yield in a defined particle size fraction Surface tensile strength Porosity Uniformity of weight 2. (Pel 2) Which of the following regarding melt granulation pelletization is incorrect? (Points: 1) Dried binder is used Shear applied affects quality of pellet Temperature affects the shape of the pellet The process requires a start up core material Longer massing time leads to a larger pellet 3. (Pel 3) Which of the following is not regarded as a common role for pellets? (Points: 1) Used as intermediate in production of suspension Used as intermediate for production of capsules Can be used to produce modified release preparations A means to separate incompatible drugs in a single unit A means to increase bulk volume of powder 4. (Pel 4) Which of the following characteristics of extrudate for pelletization is not important for the downstream process? (Points: 1) Plasticity Fluidity Self-lubricating effect Rigidity Contact angle 5. (Pel 5) Which of the following is not an advantage of using a layering technique to produce pellets? (Points: 1)

1. 2. 3. 4. 5.

Relative good yield Highly reproducible final product Not easy to scale up Narrow particle size distribution Use conventional equipment normally used for film coating

6. (Pel 6) Which of the following raw materials is not commonly found in a pellet formulation manufactured by extrusion/spheronisation? (Points: 1) 1. Drug substance 2. Spheronising aid 3. Filler 4. Liquid binder 5. Surfactant 7. (Pel 7) Which of the following technique produces heterogenous pellets? (Points: 1) Layering technique Extrusion/s pheronisation Wet granulation pelletization Melt granulation pelletization Spray drying 8. (Coat 8) Which of the following regarding the sugar coating of tablets is correct? (Points: 1) It is applied for modified release purposes It leads to change in the shape of tablet The film is less than 0.1 mm Logo is indented onto the surface of the sugar coat It is produced using fluid bed coating device

9. (Coat 5) Which of the following is commonly found in a film coating formulation? (Points: 1)

Sucrose Lubricant Glidant Filler Plasticiser 11. (Coat 10) Which of the following quality control test is not required for coated tablet? 1. Dissolution test Friability 2. 3. Disintegration test 4. Uniformity of weight 5. Uniformity of content for low dose formulation 12. (Coat 4) Which of the following regarding a plasticiser used in a film coating formulation is correct? (Points: 1) Reduce film flexibility Increase the glass transitional temperature of polymer Increase polymer- polymer interaction Decrease opacifying effect Chemically similar to the film coating polymer 10. (Coat 3) Which of the following regarding a plasticiser used in a film coating formulation is incorrect? 1. Improve film flexibility 2. Reduce film brittleness 3. Improve adhesion of the film to the surface of the tablet 4. Compatible with the film coating polymer Increase glass transition temperature of the polymer 5.

13. (Coat 6) Which of the following will not affect the droplet properties in a coating device? (Point1

Type of nozzle Movement of the core materials Temperature Rate of the exhaust air Type of compression force 14. (Coat 7) Which of the following is not a step in sugar coating process? (Points: 1) Sealing Screening Smoothing Colouring Polishing 15. (GMP 4) Which of the following regarding rinse sampling analysis in a cleaning protocol is incorrect? (Points: 1) Samples are taken from the final rinse solvent It allows for sampling of large areas It is useful to collect samples where it is difficult to be reach physically It collects samples by applying appropriate swabs to the surface It uses known quantity of solvent to rinse the surface of the equipment 16. GMP 6) Which of the following regarding validation for the manufacturing of a medicinal product is incorrect? (Points: 1) It forms part of the GMP requirement It is a way to demonstrate to the regulator of adherence to GMP It is a means to safeguard the quality of the product It provides documented assurance that pre-determined specifications of a medicinal product have been met It is usually performed after the launch of a medicinal product 17. (GMP 5) Which of the following is not a main consideration when defining the residue limit of a contaminant in a cleaning procedure? (Points: 1)

Product type Solubility of contaminant How long it will take to clean the equipment Toxicity of the ingredients used to produce the medicinal product Choice of detergent 18. (GMP 1) Which of the following terms associated with medicinal product is not considered for GMP? (Points: 1) Safety Purity Validity Identity Strength 19. (GMP 2) Which of the following related to medicinal product is not a part of GMP? (Points: 1) Correct strength and potency within the stated shelf life The label said what the product was The product is free from expected side effects The quality met the specification in the claim The product is made in consistent manner 20. (GMP 8) Which of the following regarding qualification is correct? (Points: 1) Performance qualification is done immediately after installation of equipment Design qualification is performed to prove that functional design reflects user requirement specification Calibration data of an equipment is gathered during installation qualification Equipment description is gathered during operational quantification Validation is part of qualification 21. (GMP 9) Which of the following is correct for the abbreviation of ‘VMP’? (Points: 1) Validation management plan Value management plan

Validation master plan Validation management protocol Validation master process 22. (Gran 5) Identify the INCORRECT reason for granulation of pharmaceutical powders. (Points: 1) to enhance flow rate and flow rate uniformity to reduce dust formation to improve wetting of hydrophobic drugs to reduce flow rate and flow rate uniformity to improve compressibility and compactibility 23. (Gran 10) Choose the CORRECT statement. Fluidized bed granulation:

(Points: 1)

gives very high density granules gives a product with poor flow properties requires a binder solution is suitable for moisture-sensitive materials requires no temperature control 24. (Gran 9) During fluidized bed granulation, which of the following will not affect granule properties? (Points: 1) Initial particle size distribution. Binder nozzle pressure Concentration of binder Air pressure for fluidising powder exhaust filter pore size

25. (Gran 1) Choose the INCORRECT statement relating to granulation methods Wet massing: (Points: 1) is an example of a high shear granulation method involves transferring a wet mass to a granulator

involves forcing a wet mass through a screen initially mixes a powder with a binder produces moist granules that need to be dried 26. (Gran 7) Choose the CORRECT answer. Fluidised bed granulation may be used (generally): (Points: 1) For moisture-sensitive materials For heat-sensitive materials When a free-flowing product is required immediately after the granulation For small batch sizes of granules To produce very high density granules 27. (Cap 8) Choose the CORRECT statement: (Points: 1) Plasticizers are added to increase the brittleness of capsule shells. Removing the moisture from gelatin capsule shells gives a less brittle product. HPMC capsule shells have a lower moisture content than gelatin capsule shells Gelatin is very soluble in water at all temperatures. w/w.

The moisture content of gelatin capsule shells is normally in the range 3-5 %

28. (Cap 3) If the powder mass is 400 mg and the tapped bulk density is 0.7 g mL-1, calculate the volume of the powder formulation in mL. give your answer in mL to 2 d.p 0.4 (to match units duh) divided by 0.7 = answer That’s the formula. Follow it for next few questions you can do it.

Fill in 29. (Cap 1) If the powder mass is 450 mg and the tapped bulk density is 0.7 g mL-1, calculate the volume of the powder formulation in mL. give your answer in mL to 2 d.p Fill in

30. (Cap 5) If the powder mass is 500 mg and the tapped bulk density is 0.65 g mL-1, calculate the volume of the powder formulation in mL. give your answer in mL to 2 d.p Fill in

31. (Cap 7) If a capsule powder fill weight is 400mg and tapped bulk density of the powder is 0.70g/ml, the formulation will fit most suitably into a: (Points: 1) Size 0 capsule, 0.67 ml Size 1 capsule, 0.48 ml Size 2 capsule, 0.37 ml Size 3 capsule, 0.27 ml Size 4 capsule, 0.20 ml 32. (Cap 4) If the powder mass is 450 mg and the tapped bulk density is 0.65 g mL-1, calculate the volume of the powder formulation in mL. give your answer in mL to 2 d.p

33. (Cap 2) If the powder mass is 500 mg and the tapped bulk density is 0.6 g mL-1, calculate the volume of the powder formulation in mL. give your answer in mL to 2 d.p

34. (Cap 9) Which of the following steps is not part of the industrial manufacture of empty hard shell capsules? (Points: 1) Cutting Spinning Dipping Stripping

Drying 35. (MS 2) What mass should we expect for the molecular ion of a molecule C10H12ON2 using chemical ionization mass spectrometry? No rounding for Mwt (Points: 1) 176 177 178 179 36. (MS 5) Fragmentation of the ester methyl butyrate [CH3OC(=O)CH2CH2CH3] functional group by electron impact leads to the loss of : (Points: 1) The CH3-OThe C=O The ester functional group The CH3 37. (MS 4) Fragmentation of an aldehyde by electron impact leads to the loss of :

(Points: 1)

The hydrogen The C=O The aldehyde functional group The C-H

38. (MS 3) 2′-bromo-4′-epi-daunorubicin is an analogue of doxorubicin. Its molecular formula is C27H28BrNO10. By electron impact, the mass of the 81Br isotope containing molecule is : (Points: 1) 605 606 607 608 (607.512)

39. (IR 4) The molecular formula of fluorouracil is C4H3O2N2F. The number of double bound equivalent is : (Points: 1) 4.5 5 2 4

40. (IR 1) What wave number would you expect a band in the IR spectrum for the OH of an alcohol? (Points: 1) 1700cm-1 3000cm-1 1250cm-1 Below 1000cm-1

41. (IR 3) The carbonyl functional group of an ester absorb IR light at a wave number of 1740cm1. What is the wavelength of the radiation? (Points: 1) 5.74um 4.52um 1.740um 5.22x106 nm Notes: the constant = c = 3x1010 cm/s = 3x103 nm (3x103) X (1.74x103) = the answer Question 41. =

A=CxAxL A= C x 1740 C is given as 3x10^19 cm/s = 3x10^3mm

1740 converted to 1.74x10^3 42. (AA and FP 1) Speed of light c=300.106 m/s Planck constant h=6.63x10-34 m2.kg/s 1eV=1.602.10-19 Joule Flame emission spectroscopy is used to analyze sodium atoms. Given that the emission of sodium is measured at 300nm, the difference in energy between the excited and ground states is: (Points: 1) 6.63 x 10-31 Joule 66.3 x 10-19 Joule 4.14 eV 6.63 x 10-19 eV 43. (AA and FP 3) In flame photometry, the energy required to promote electronic transition is delivered by: (Points: 1) The flame The hollow cathode lamp The detector The nebulizer

44. (UV & Flu 3) The absorbance of a 1cm-layer of aspirin is 0.435. Given that the molar absorptivity Ɛ value of paracetamol under these conditions is 10,250L/mol/cm, the concentration of aspirin in the solution is: (Points: 1) 4.24 x 10-5 g/100mL 0.042 M 4.24 x 10-5 mol/L 0.042 % (w/v) 45. (UV & Flu 5) Solvent can affect the position of the lambda max of a given analyte. An increase to longer wavelength is termed: (Points: 1)

Bathochromic Hypsochromic Hyperchromic Hypochromic 46. (UV & Flu 2) Speed of light c=300.106 m/s Planck constant h=6.63x10-34 m2.kg/s 1eV=1.602.10-19 Joule The absorbance of a solution of paracetamol is 0.706 at 250nm. The corresponding energy of the wavelength is: (Points: 1) 7.956 x 10-19 joules 4.97 x 10-9 eV 7.956 x 10-28 joules 4.97 x 109 eV 47. (UV & Flu 1) The energy of the UV irradiation required to promote the required electronic transition in aspirin above was 6.89*10-19 joules the corresponding wave length is speed of light c = 300*106ms Plancks Constant h = 6.63*10-34m2kg/s. 1eV = 1.602*10-19 joules a. b. c. d.

285nm 285um 285cm 2.85mm

obviously look at the units you dickhead

48. (NMR 1) What signals would you expect in the spectrum of propane-1-ol? (Points: 1) 1 sextuplet, 2 triplets and 1 singlet 2 Triplets and a sextuplet 1 quadruplet, 1 sextuplet and 2 triplets 2 Triplet, 1 quintuplet and 1 doublet 49. (NMR 4) What signals would you expect in the spectrum of butan-1-ol? (Points: 1) 1 Doublet, 1 quintuplet, 1 quadruplet, 1 doublet and 1 triplet 1 Triplet, 1 sextuplet, 1 quintuplet, 1 triplet and 1 singlet

1 Doublet, 1 quintuplet, 1 quadruplet and 2 doublets 2 Triplets, 2 sextuplets, and one doublet 50. (NMR 3) The structure of isopropanol is given below:

How many types of chemical environment do you find in this molecule? (Points: 1) 3 2 5 4

51. (Dry 4) For fluid-bed driers, the main method of heat transfer to dry powders and granules is: (Points: 1) Dynamic convective drying Static convective drying Conductive drying Radiation drying None of the above 52. (Dry 7) One of the main aims of the freeze drying process is to dry: (Points: 1) Heat sensitive materials Heat resistant materials Non-oxidative materials

Non-hydrolysable materials All of the above 53. (Dry 1) For tray driers, the main method of heat transfer to dry powders and granules is: (Point1 Dynamic convective drying Static convective drying Conductive drying Radiation drying None of the above 54. (Dry 9) In freeze drying process, secondary drying stage removes

(Points: 1)

Frozen water from the products Impurities from the products Oxygen from the compounds Non-frozen water (at elevated temperature) from the products Hydrogen from the compounds

55. (Dry 2) Regarding vacuum oven driers, the main method of heat transfer to dry powders and granules is: (Points: 1) Dynamic convective drying Static convective drying Conductive drying Radiation drying None of the above 56. (Dry 3) The terminology “Dew point” means:

(Points: 1)

Cooling of air until vapour pressure becomes less than saturation vapour pressure of water for a given temperature Heating of air Ambient temperature

Drying of the powders Cooling of air until vapour pressure exceeds saturation vapour pressure of water for a given temperature 57. (Dry 10) 1. Regarding the advantages of freeze drying process which of the following statements are correct a. b. c. d. e.

Drying of pharmaceutical products at very high temperature Reducing freeze dried products solubility Answer A and B There is contact with air Drying pharmaceutical products at very low temperatures

58. (Tab 1) Concerning direct compression as a method for tablet manufacture, which of the following statements are true? (Points: 1) It is a simple process and it can be applied for large scale production of tablets The morphology of particles is not important in direct compression Coloured tablets may be easily produced by direct compression It is not an applicable method for chewable tablet production Pharmaceutical industry does not apply the direct compression process for tablet production 59. (Tab 6) Concerning pharmaceutical tablets, which of the following statements are true? (Points: 1) Pharmaceutical tablets may include a disintegrant to improve tablet strength Pharmaceutical tablets may include magnesium stearate to prevent tablet adhesion to punches Pharmaceutical tablets include diluents such as colloidal silicone dioxide Pharmaceutical tablets may include starch as a lubricant Pharmaceutical tablets is not a popular dosage form 60. (Tab 15) Concerning plastic materials, which of the following statements are true? (Points: 1) They fragmented during compression They are brittle materials

They deform during compression and they retain their original shape after compression Answers A and B They undergo plastic deformation during compression and their shape changes permanently after compression. 61. (Tab 3) Adequate powder flow ensures that after tableting:

(Points: 1)

The drug is released more quickly Tablets of constant weight are produced Drug molecules are crushed Smooth tablets are produced The drug is released slowly

62. (Tab 11) During the first part of tablet compaction the particles undergo: Irreversible deformation Elastic deformation Brittle deformation Plastic deformation None of the above 63. (Tab 7) The dissolution rate of drugs from tablets may be increased by: (Points: 1) Increasing the compression stress during tableting Increasing the concentration of lubricant Increasing the concentration of disintegrant Increasing the amount of magnesium stearate Answers A and B

(Points: 1)

64. (Tab 13) Which of the following quality control tablet tests is not an official pharmacopoeial test? (Points: 1) Hardness Disintegration Friability Dissolution Content uniformity 65. (HPT 1) All the following are potential adverse effects of thiazide diuretics EXCEPT: (Points: 1) hyperuricemia hyperkalaemia hyperglycaemia hypercalcemia hyperlipidaemia 66. (HPT 8) Which of the following drugs may result in potentially serious hyperkalaemia when used in a patient also receiving potassium supplements: 1. ACE inhibitors 2. Angiotensin II receptor antagonists 3. Aldosterone receptor antagonists (K-sparing diuretic) 4. Calcium channel antagonists (Points: 1) 1 & 2 only 3 & 4 only 1, 2, & 3 only All 4 drug groups None of the above drug groups 67. (HPT 12) Which of the following is NOT a modifiable risk factor for developing hypertension? (Points: 1) cigarette smoking diabetes

ethnic origin physical inactivity high dietary salt intake 68. (HPT 15) Which of the following statements about angiotensin II receptor blockers (ARBs) is NOT true? (Points: 1) they reduce blood pressure partly by blocking AT1 receptors, leading to reduced vasoconstriction and peripheral vascular resistance they reduce blood pressure partly by blocking AT1 receptors, leading to reduced release of aldosterone, which results in reduced fluid retention and plasma volume one of their major adverse effects is a persistent, tickly and unproductive cough they reduce blood pressure partly by blocking AT1 receptors, leading to reduced sympathetic nervous activation, which results in reduced vasoconstriction and peripheral vascular resistance they have been shown in clinical trials to reduce the progression of diabetic nephropathy & new onset diabetes in hypertensive patients 69. (HPT 17) All the following statements are true EXCEPT:

(Points: 1)

hypokalaemia and hypercalcaemia, common side effects of some diuretics, enhance the actions of digoxin and increase the risk of serious adverse effects if a patient has a history of persistent cough while on ACE inhibitors, he or she should not be put on angiotensin II receptor blocker therapy ACE inhibitors are contra-indicated in patients with bilateral renal artery stenosis angioedema is a rare but potentially serious adverse effect that may be associated with ACE inhibitor therapy  -blockers should be used with caution in patients with diabetes mellitus, because they can mask the signs and symptoms of an impending hypoglycaemic crisis 70. (HPT 14) All the following conditions may be long-term consequences of untreated hypertensionEXCEPT: (Points: 1) diabetes intermittent claudication heart failure nephropathy ischaemic and/or haemorrhagic strokes

71. (HPT 7) Which of the following statements is NOT true? (Points: 1) unlike ACE inhibitors, angiotensin II receptor blockers (ARBs) do not have the potential to cause hyperkalaemia one of the major adverse effects of ACE inhibitors is a persistent tickly and unproductive cough both ACE inhibitors and angiotensin II receptor blockers (ARBs) are contraindicated i...