KENYA MEDICAL TRAINING COLLEGE

DIPLOMA IN PHARMACY

END OF SEMISTER TWO EXAMINATIONS

2016/2017 ACADEMIC YEAR

PHARMACEUTICS (100 MARKS)

INSTRUCTIONS

Read these instructions carefully before attempting the paper

1. Write your college number in the space provided and on ALL the answer sheets used.
2. The paper consists of three sections A, B and C. All questions in sections A and B are
compulsory. Choose ONE question in section C.
3. Section A (30 marks) consists of multiple choice questions. Select and write the letter
corresponding to the correct answer from the choices given.
4. Section B (50 marks) consists of Short answer questions. Attempt all the questions.
5. Section C consists of TWO essay questions (20 marks). Attempt ONE ONLY.
6. Section B and C must be answered in the provided examination answer booklet
7. Use of mobile phones is prohibited in the examination room
8. Communication between candidates during the exam is strictly prohibited

College Number: .................................................................

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SECTION A: MULTIPLE CHOICE QUESTIONS (30 MARKS)
Attempt all the questions

1. The following are preservatives used in eye products except

a. Benzalkonium chloride
b. Formadehyde
c. Chlorhexidine acetate
d. Phenyl mercuric nitrate
2. Excipients in ophthalmic products include all the following except
a. Buffers
b. Viscolizing agents
c. Preservatives
d. Glidant
3. The following chemical group is not vulnerable to oxidation
a. Catechol nucleus
b. Cyclic aliphatic compounds
c. Unsaturated bonds
d. Phenolic compounds
4. Factors that induce polymerization include all the following except
a. Ultraviolet light
b. Changes in pH
c. Extreme temperatures
d. Presence of oxygen
5. The following describes the process where substances migrate from the packaging material into the
pharmaceutical product
a. Leaching
b. Permeation
c. Adsorption
d. Absorption
6. The following are reasons why the practice of incorporating medicines into infusion bottles is
discouraged except.
a. Drug interactions may occur
b. Presence of sugars encourages bacterial growth
c. The presence of bacteriostatic agents in infusion bottles
d. Precipitation of drugs may occur
7. Which of the following is not true about large volume parenterals
a. They can be used to replenish electrolytes or fluids in the body
b. They do not contain bacteriostatic agents
c. They should be pyrogen free.
d. They are packed in multidose glass or plastic containers
8. All the following are true about use of oily vehicles in preparation of parenteral products except.
a. Are used when depot effect is desired
b. Mineral oils can be used as a vehicle
c. Can increase the stability of the preparation

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 d. Can be used for water insoluble drugs
9. Which of the following is an advantage of inhaled drug therapy?
a. Rapid onset of action
b. Increased incidence of adverse drug effects
c. Drugs experience first pass metabolism
d. Enterohepatic recycling is prevented
10. The following excipient is not found in single use parenteral products
a. Buffers
b. Isotonicity adjusters
c. Suspending agents
d. Antibacterial agents
11. Any product that has completed all processing stages apart from final packaging is referred to as
a. A batch
b. Intermediate product
c. Bulk product
d. Pharmaceutical product
12. The following is not a component of quality management relationship
a. Quality assurance
b. Quality control
c. Good manufacturing practices
d. Post marketing surveillance
13. Failure of quality systems may result to all the following except
a. Recalls
b. Gross contamination
c. Assured marketing authorization
d. Product defects
14. The following is usually referred to as the authorized person
a. Quality assurance manager
b. Quality control manager
c. G.M.P manager
d. Supplies and procurement manager
15. The following is not a responsibility of quality control department
a. In process quality control
b. Organizing self inspections
c. Releasing finished products
d. Verifying whether product specifications have been met
16. Ideal properties of topical preparations does not include
a. Sterility
b. Chemical stability
c. Aesthetic value
d. Predictable bio availability
17. Suppositories for urethral use are referred to as
a. Pessaries
b. Enemas

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 c. Bougies
d. Douches
18. All the following properties are shared between parenteral products and ophthalmic products except
a. Sterility
b. Isotonicity
c. pH buffered
d. Pyrogen free
19. Compressed propellants use in aerosols include all the following except
a. Fluorinated hydrocarbons
b. Nitrogen
c. Nitrous oxide
d. Carbon dioxide
20. The following is not a large volume parenteral product
a. Normal saline
b. Dextrous injection
c. Ringers lactate solution
d. Benzyl penicillin bolus
21. The following is not a pharmacodynamic drug interaction
a. First pass metabolism
b. Physiological antagonism
c. Synergism
d. Drug potentiation
22. The type of antagonism where the effect of histamine in reversed by adrenaline is referred to as
a. Competitive antagonism
b. Non competitive antagonism
c. Chemical antagonism
d. Physiological antagonism
23. Large volume Parenterals(LVP) are designed to provide all the following except?
a. Fluids (water)
b. Electrolytes
c. Multiple dose administration
d. Nutritional supplementation
24. The following sterilization method is used for thermolible pharmaceutical products
a. Ultra Filtration
b. Dry heat sterilization
c. Autoclaving
d. Chemical sterilization
25. Which of the following statements is false?
a. Suppositories can produce systemic effects
b. Inhalation pharmaceutical preparations are only meant to produce local effects
c. There are injectable ophthalmic formulations
d. Mineral oils should never be used as oily vehicles in parenteral preparations
26. Parenteral formulations for single use bolus administration are packed in?
a. Vials

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 b. Ampoules
c. Transfusion bottles
d. Hypodermic syringes
27. The following tests is not done for ophthalmic preparations
a. Sterility test
b. Clarity test
c. Pyrogen test
d. Viscosity test
28. Aqueous or oily solutions for rectal administration are referred to as
a. Enemas
b. Suppositories
c. Douches
d. Bougies
29. Pharmaceutical incompatibility of drugs can lead to all the following except
a. Toxicity
b. Compromised efficacy
c. Compromise patient adherence
d. Prolonged shelf life
30. The following body gives marketing authorization to pharmaceutical manufactures in Kenya
a. Pharmaceutical society of Kenya
b. Pharmacy and poisons board
c. Food and drug Authority
d. Kenya bureau of standards
SECTION B: SHORT ANSWER QUESTIONS (50 MARKS)-Attempt all the questions
31. List three active pharmaceutical ingredients that can be incorporated into ophthalmic preparations
(3marks)
 Chemotherapeutic agents-antibacterials, antivirals e.t.c
 Anti inflammatories e.g. steroids, anti histamines
 Amaesthetics e.g. lidocaine
 Mydriatics and cycloplegics e.g. atropine
32. Define the following terms as used in G.M.P (10 marks)
i. Authorised person-person recognized by the regulatory authority as having responsibility to
ensure that each batch of finished product is manufacture, tested and approved for release
in compliance to law
ii. Master formula-A document /set of documents specifying the starting materials with their
quantities and the packaging materials together with a description of procedures and
precautions and processing instructions including in process controls
iii. Quality assurance-Creation and operation of procedures, standards and management
systems to guarantee the quality of a product
iv. In process quality control-Checks performed during production to monitor and if necessary
adjust the process to ensure a product conforms to specifications
v. Batch-a defines quantity of starting material, packaging material or product processed in a
single process or series of processes so that it is expected to be homogeneous
33. (a) What are P.P.Es as used in good manufacturing practices( 1 mark)

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Personnel protective equipment
(b)List 3 P.P.Es (4 marks)
 Gloves
 Face masks
 Hair nets
 Dust coats
 Gowns
34. With reference to drug incompatibilities
a) List four ways drugs can be protected from oxidation(4 marks)
 Anti oxidants e.g. sodium meta bisuphite
 Protection from light-amber coloured bottles
 Ph buffering
 Protection from air-air tight containers e.g. ampoules
b) List four chemical incompatibilities(4 marks)
 Oxidation
 Hydrolysis
 Polymerization
 Decarboxylation
35. Explain five advantages of suppositories as a pharmaceutical dose form (5 marks)
 Convenient for paediatrics and comatose patients
 Decrease first pass metabolism
 Use for GIT irritant drugs
 Local effect
 In vomiting patients
36. (a) Define parenteral preparations and give two reasons why they are used in pharmacy(4 marks)
Sterile solutions/supensions of drugs in aqueus/oily vehices for intoduction in the body via injection
Rapid onset of action,use in comatose patients,high bio availability
(b) What are the Quality necessities of parenteral preparations? (4 marks)
 PH buffered
 Sterility
 Pyrogen free
 Particulates free
 Isotonicity
37. Give four advantages of aerosols (4 marks)
 Local effect hence reduces side effects
 Rapid onset of action
 No first pass metabolism
 Maintenance of sterility
 Metered doses
38. List 3 results of drug incompatibilities (3 marks)
 Toxicity
 Decrease efficacy
 Decrease aesthetic value hence decrease adherence
39. Give 4 disadvantages of topical preparations (4 marks)

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  Greasy hence cosmetically unacceptable
 Staining clothes
 Decrease physical stability due to hydrolysis
 High viscosity hence spreading difficulties
SEECTION C: ESSAY-Answer only one question
40. (a) Explain five requirements of good manufacturing practices (G.M.P) (10 marks)
 Trained personnel
 Clearly written procedures
 Appropriate resources-personnel, premises, equipment, materials
 Documentation and documents
 Critical steps validated
 Proper storage and distribution
(b) Explain five factors that facilitate drug oxidation stating how they can be avoided (10 marks)
 Presence of oxygen
 Light-u.v
 Temperature extremes
 Ph
 Pharmaceutical dosage form
 Pre oxidants
41. (a) Explain five excipients used in formulation of parenteral preparations (10 marks)
 Vehicle
 solubilizing agents
 Buffers
 Antibacterial agents
 Stabilizers
 Isotonicity adjusters
 Suspending agents
 Emulsifying agents
(b) Explain five types of suppositories as used in pharmaceutics

Rectal suppositories
 Vaginal suppositories (pessaries)
 Urethral suppositories(bougies)
 Nasal
 Enemas
 Douches