1.      Which of the following is a physical instability?

a)      Hydrolysis

b)      Photolysis

c)      Mold growth to a solution

d)      Change in organoleptic properties

2.      A closure

a)      It is intended for measuring a pharmaceutical formulation during administration

b)      Prevents the contents from escaping and allow no materials to enter into the container

c)      Can be amber colored to prevent degradation by photolysis

d)      Can either be glass, metal or plastic

3.      The following are sources of microbial contamination except?

a)      Water

b)      Light

c)      Air

d)      Raw materials

4.      Disadvantages of metal containers include?

a)      May undergo corrosion and precipitation

b)      May undergo leaching and release ingredients into the formulation

c)      May cause extraction of drug ingredients

d)      They can easily be broken

5.      Enteral route of administration includes the following except?

a)      Buccal route

b)      Sublingual route

c)      Mouth route

d)      Rectal route


6.      The following are true regarding inhalation route except?

a)      Used for local effects only

b)      Mainly involve the respiratory system

c)      Breathing of air vapor or volatile drugs into the lungs

d)      Can be used by unconscious patients

7.      Preservatives are an important part of a formulation because?

a)      They improve and mask unpleasant taste of a drug formulation

b)      They balance the alkaline/acidic media of drug enhancing stability

c)      They inhibit microbial growth to a drug formulation

d)      Prevent auto oxidation of metal ions present in a drug formulation

8.      Subcutaneous route of administration  

a)      Medications and fluids are administered directly into the blood stream

b)      Injections are made through the skin into the muscular tissue

c)      Small amount of drug in solution are given hypodermically

d)      Injection is made in the upper layer of the skin to the dermis

9.      When placed on the neck of the container, its threads engage with the corresponding threads moulded on the neck of the bottle

a)      Threaded screw cap

b)      Lug cap

c)      Crown cap

d)      Roll on closures

10.  Regarding metals, the following are true except?

a)      The mainly used include aluminum, tin and tin coated iron

b)      Possible to print on their surface

c)      Can be made into rigid, unbreakable or collapsible tubes or foil

d)      Not often available for extemporaneous dispensing


SECTION B: Write T for true statement and F for each multiple true and false question

1.      Regarding stability of pharmaceutical dosage forms

a)      ….. Chemical instability may influence physical instability

b)      ….. Instability contributes to treatment failure

c)      ….. Can either be physical or chemical only

d)      ….. The use of single does containers minimize microbial contamination

e)      …… Immediate container and closure influence product stability

2.      Concerning the materials available for containers

a)      ….. Glass is easy to label

b)      ….. Metals may undergo leaching and make the preparation unstable

c)      …. Plastic can be used to make both containers and closures

d)      ….. Metal is partly permeable to osmotic gases and moisture

e)      ….. Glass is cheap and easily available

3.      Topical route of administration

a)      …. A drug is applied locally to an intended site

b)      …. Has few side effects

c)      …. May have systemic effects if a drug enters a systemic circulation

d)      …. May be used to provide cleansing effect for removal of infected tissue

e)      ….  Intended for both local and systemic effects

4.      Regarding the components of pharmaceutical dosage forms

a)      …. Active pharmaceutical ingredient (s) and excipients are the major components

b)      ….. The excipient is pharmacologically inert

c)      ….. The API may fail to exert the intended therapeutic goal without the presence of excipients

d)      ….. The major components must be compatible

e)      ….. Excipients come in different classes depending on their roles


5.      Route of drug administration

a)      ….. There are mainly four major classes

b)      ….. Its choice depends on the state of the patient and existing preparations

c)      ….. All parenteral routes of administration break the skin barrier

d)      …. Sterile aseptic technique is a requirement for topical route

e)      ….. Enteral route involves a part of the GIT

6.      Oral route of administration

a)      ….. May break the skin barrier

b)      ….. The GIT provides a huge surface area for absorption

c)      ….. Can easily be taken by a patient at home

d)      ….. Inconvenient for patients with nausea and vomiting

e)      ….. Stomach contents may affect drug’s bioavailability

7.      Parenteral route of administration

a)      …. Sterile aseptic technique must be used to avoid infection

b)      …. An injected drug is retrievable

c)      …. Subcutaneous injections are rapid in action compared to intravenous injections

d)      …. Can be used during allergy testing

e)      …. Must be administered by trained medical personnel

8.      Regarding packaging

a)      …. If it’s cheap it will compromise the quality of the drug

b)      …. Secondary packaging comes into direct contact with the drug

c)      ….. The container system should be compatible with the drug inside

d)      ….. Spoons, cups or syringes for oral dose measurement and delivery are not necessarily a part of packaging system

e)      ….. It is an important part during drug inspection by regulatory authorities



SECTION C: Match column A with a corresponding response from column B. 10 marks



        I.            Flavoring agents

A.      A tiny single dose container with a sealed neck

      II.            Buffering agents

B.      Keeps a preparation dry so as to prevent denaturation caused by water

    III.            Preservatives

C.      For example adding a taste of fruits to a pharmaceutical preparation

    IV.            Antioxidants

D.     They are chemically and ectrochemically active

      V.            Coloring agents

E.      Formulated with an  API so as to a preparation from drying

    VI.            Metal containers

F.       Added to a preparation to prevent it from microbial contamination e.g. sodium benzoate

  VII.            Plastic containers

G.     May react with some contents and become soft or distorted

VIII.            Glass containers

H.     Used to impart color to a formulation contributing to preparation’s elegance

    IX.            Vial

I.        It is a single piece of squeezable container having an in built dropper

      X.            Ampoule

J.        A container used for storing multidose injectable preparations.


K.      Added to a formulation prevent denaturation by oxygen to oxygen sensitive ingredients


L.       It is available in both clear and light resistant forms in small and large sizes.


M.   Balance the pH of a pharmaceutical preparation enhancing stability


SECTION D: Short answer questions 40 marks

1.      a) Define route of administration. 2 marks

b) What are the selection criteria for a route of administration? 2 Marks

c) What are the key routes of administration? 4 marks

2.      Classify pharmaceutical containers. 8 marks

3.       a) Differentiate between active pharmaceutical ingredient and excipient. 2 marks

b) Why is it important to add excipients to a pharmaceutical formulation? 6 marks

4.      a) Briefly describe stability.  3 marks

b) In a tabular form, mention a factor affecting stability and its corresponding solution of how to overcome? 5 marks

5.      a) Define pharmaceutical packaging materials.  2 marks

b) Why do we package pharmaceutical products? 6 marks


SECTION E: Essay questions 20 marks

1.      Explain the selection criteria for pharmaceutical packaging materials.

2.      Explain the various types of stability of pharmaceutical dosage forms.

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