1. If 30 g of a 1% hydrocortisone ointment were diluted with 12 g of Vaseline,  the percentage concentration of hydrocortisone in the mixture will be

A. 0.50%

B. 0.30%

C. 0.63%

D. 0.92%

E. 0.71%

2. The following acids and salts are used as antimicrobial preservatives for pharmaceutical products EXCEPT

A. Sodium Chloride

B. Benzoic acid

C. Sorbic acid

D. Sodium metabisulphite

E. Sodium sulphite

3. One of the following is true concerning sterile formulations

A. Should be physically and chemically unstable

B. Are contaminated with  particulates

C. Should contain pyrogen

D.  Have same osmotic pressure as blood plasma

E. Should not have the same pH as the blood

4. Which of the following is an example of  Absorbable haemostats

A. Oxidized cellulose

B. Lidocaine

C. Heparin

D. Polypropylene

E. Gauze pads

5.  Requirements necessary to achieve strict asepsis do not include

A. Sterile containers

B. Suitable technique by trained personnel

C. Uncontrolled environment

D. Sterile starting materials

E. Sterile handling materials


6. The incorrect statement concerning basic rules for effective aseptic processing is

A. Use a touch technique whenever possible

B. Reduce air disturbances to a minimum

C. Consider the arrangement of objects under the laminar air flow (LAF)

D. Refuse to be distracted

E. Handle small articles with sterile forceps

7. Concerning well maintained premises for sterile production, all of the following statement(s) are true EXECEPT

A. The facilities for the manufacture of sterile products should be designed for near to perfect level of cleanliness

B. The maximum degree of cleanliness must be achieved in the aseptic filling rooms

C. The surrounding areas should provide a buffer area in which standards of cleanliness are only slightly lower than the aseptic rooms

D. The prevention of contamination must not be the primary objective in the design of these facilities.

E. Well-maintained premise is a good indicator that production of infusions is done in clean environment that reduces risks of contamination to the product.

8. One of the physiological properties of semisolid preparations is

A. Non hygroscopic

B. High aqueous washability

C. Elegant in appearance

D. Have high sensitization index

E. Miscible with skin secretion

9. Concerning labeling of prepared ointment, container should be labeled as

A. For External Uses Only” (blue)

B. If diluted product should indicate, should  be used more than two weeks after issue”

C. If preserved, name and concentration should appear on the label

D. Is sterile, should be labeled “Pyrogenic”

E. Strength of active ingredient is not important

10. Semisolid dosage forms that contain one or more drug substances intended for topical application to the skin are

A. Powders

B. Premixes

C. Gels

D. Ointments

E. Pastes





• This section consists of eight (8) questions with five (5) options each

• Write the word “TRUE” and NOT letter ‘T’ for a correct statement and the word “FALSE” NOT letter ‘F’ for incorrect statement in the space provided before each option

• All responses should be in CAPITAL letters

• Half (½) a mark will be awarded for each correct response

• Responses with letters “T” and “F” will not be awarded any mark

• There will be a penalty of half (½) of allocated marks for responses with small letters.

1. Characteristics of Pastes include

A. TRUE         Are stiffer than ointments

B. FALSE       Are more greasy than ointments

C. FALSE       Cause more maceration of the skin

D. TRUE         Are less occlusive than ointment

E. FALSE       Are less absorbent to exudate weeping lesions

2. Regarding dilution of creams

A. TRUE          Should be done under hygienic conditions

B. FALSE        Stability and bactericidal properties of original cream should  be reduced

                     On dilution

C. FALSE       Information on suitability of diluent should not  be available

D. FALSE       The diluent should not be compatible with ingredients and the whole

                     Original preparation

E. TRUE        Dilution may alter extent of release of medicament from creams

3. The method of preparation of creams involves

A. TRUE       Melting oily phase, heating up to 75oCand cooling to 60oC

B. TRUE       Preparing aqueous phase and heating to 60oC

C. TRUE       Add aqueous phase to oily phase with slow but constant agitation until  


D. FALSE      Incorporate insoluble medicinal ingredient

E. TRUE        Transferring to suitable container, label and ready for dispensing to a    


4. Features of single-phase system gel are

A. FALSE    When gels appear to have discrete particles

B. FALSE    There are apparent boundaries between dispersed macromolecules and the liquid

C. FALSE      Consists of floccules of small distinct particles

D. FALSE      Semisolid on standing but liquefy on shaking

E. FALSE      Usually involve inorganics

5. Gelling Agents include

A. TRUE       Tragacanth

B. TRUE       Methylcellulose

C. TRUE       Alginic acid

D. TRUE       Gelatin

E. TRUE       Magnesium Aluminum Silicate

6. Limitations for use of antimicrobial preservatives are

A. FALSE     Possess a low activity against on bacteria or fungi

B. FALSE     Majority causes skin sensitivity reactions

C. FALSE     Are often non-selective in action

D. TRUE       Interact with other common excipients

E. TRUE       May be removed from solution by adsorption onto suspended solids like

                   betonies, kaolin, magnesium trisilicate and talc

7. Examples of Ophthalmic preparations are

A. TRUE     Eye lotions

B. TRUE     Eye ointments

C. TRUE     Soaking solutions

D. FALSE   Certain vitamins

E. FALSE   Inhaler solutions

8. The following are personnel requirements for sterile production

A. TRUE     Should be adequately trained and motivated

B. TRUE     Appropriate protective clothing should be worn. e.g. Boots, coats, caps,        

                 Gloves, hats, and mask

C. TRUE     They should be aware of the role that every movement has, in determining

                 The quality of the final product

D. TRUE     Aware of the hazards, which can be caused by using products of poor


E. TRUE     Removing outside street clothing










· This section consists of two (2) questions matching with five (5) options each.


· Each correct response is awarded one (1) mark.

· Each item from column B is used only once.

PART ONE: Match the Description in Column B Corresponding To Column A by Writing the Letter of the Correct Answer in the Space Provided




1. Instill 2 drops in each eye every four (4) hours as needed for pain


A. Appl. ung. left eye ad lib.

B. M. et ft. I.V. inj.

C. M. et ft. ung. Disp.

D. Gtt. ii each eye q. 4 h. p.r.n. pain.

E. Disp. supp. rect.

F. Appl. a.m. & p.m. for pain prn

G. Appl. ung. left eye ad lib

H. Tbsp. i in 1⁄3 gl. aq. q. 6 h.

2. Take one tablespoonful in one third glass of water every 6 hours


3. Apply morning and night as needed for pain


4. Apply ointment to the left eye as needed 


5. Mix and make an intravenous injection





PART TWO: Match the Description in Column B Corresponding To Column A by Writing the Letter of the Correct Answer in the Space Provided




1. Semisolid preparations intended for topical application to the skin, eye, ear, or various mucous membranes


A. Gels

B. Creams

C. Injections

D. Ointment

E. Irrigations

F. Pastes

G. Non medicated ointments

H. Ophthalmic ointments

2.  Serve as vehicles, or as ointment bases, in the preparation of medicated ointments


3. Semisolid dosage forms that contain one or more drug substances intended for topical application to the skin.


4. Sterile preparations intended for application to the eye


5. Semisolid systems consisting of either suspensions of small inorganic particles or large organic molecules interpenetrated by a liquid






• This section consists of eight (8) questions.

• Write your answers in the space provided on each question

• Write a readable handwrite; DIRTY WORK IS NOT ALLOWED.


1. Mention six(6) requirements for raw materials  used in  sterile production (6marks)

i. Should be of suitable quality

ii. Obtained from a licensed or reliable source.

iii. ‘In house’ check of quality may be made on starting materials.

iv. Materials should be fully identifiable and carry a clear batch identification and expiry date.

v. Appropriate storage conditions should be maintained and out-of-date stock safely disposed

vi. Should be pyrogens free

2. Outline eight (8) requirements for Equipment(s) used in sterile production(8marks)

i. Should be of appropriate design

ii. Suitable, well maintained and adequate for the work to be undertaken

iii. All equipment must be maintained in accurate working order

iv. Checked for cleanliness prior to each use

v. Should be simple to use

vi. Should be durable

vii. Spare parts should be available

viii. Service free

ix. Cheap

x. Should be stainless

3. Mention five(5) factors that affect percutaneous absorption(5marks)

i. Condition of the skin

ii. Age

iii. Temperature & humidity

iv. Skin site

v. Hydration








4. Mention four(4) storage properties of semi-solid preparations(4marks)

i. Should be stored at temperatures not exceeding 25°c unless otherwise authorized

ii. They should not be allowed to freeze and must be stored in a well-closed container or, if the preparation contains water or other volatile ingredients, store in an airtight container

iii. The containers are preferably collapsible metal tubes from which the preparation may be readily extruded.

iv. If the preparation is sterile, store in a sterile, airtight, tamper-proof container

5. List three(3) main methods for a successful formulation of topical dosage form(3marks)

i. By manipulating barrier function of skin

ii. By directing drugs to the viable skin tissues without using oral, systemic or other routes of therapy

iii. By using skin delivery for systemic treatment


6. Mention five(5) Basic Techniques for Preparation of Ointments(5marks)

i. Weighing

ii. Measuring liquids

iii. Size reduction

iv. Size separation (sieving)

v. Mixing (Fusion or Trituration)


7. Why do creams require preservatives? What kind of containers and closure are suitable for creams? (5marks)

· Because they can support growth of micro-organisms hence most need preservatives

· Suitable containers and closure for creams are: Flexible plastic tubes or collapsible  metal tubes and wide-mouth glass or plastic jars with plastic screw caps with impermeable liners or close fitting slip-on lids


8. The following is a formula for a diltiazem hydrochloride topical gel (4marks)

              Diltiazem Hydrochloride     2 g

              Propylene Glycol                10 mL

              Hydroxyethylcellulose         2 g

              Preserved Water qs ad          100 mL

If the specific gravity of propylene glycol is 1.04, how many grams of this agent may

be used in the formula?


                        10mL X 1.04=10.4grams



· This section consists of two (2) questions which are supposed to be answered in a  narrative way

· Write your answer on the empty pages of this question paper; each question should start on a new page.

· There will be a penalty of three(3) marks if questions are not answered in essay form

1. Preservation of pharmaceutical products is very important during production process, discuss preservatives using the following guidelines

a. Define a pharmaceutical preservative (2marks)

Is a substance added to multiuse non sterile liquids, ointments, and creams and sterile injectable products to protect them from microbial contamination that may be introduced inadvertently during use of the product (post manufacturing)

b. Give examples of  Agents  Used as Preservatives for Pharmaceutical Products (3marks)

i. Acids (organic) and Saltseg:Benzoic acid, ,sorbic acid,  like Sodium metabisulphite and Sodium sulphite

ii. sulphites Alcohols eg: Benzyl alcohol,  bronopol , chlorbutol ,  ethanol, phenoxyethanol, and phenylethanol

iii. Biguanideseg: .Chlorhexidine diacetate,  chlorhexidine digluconate and polyhexamethylene

iv. Hydroxybenzoates  ( or Parabens) eg: Methylhydroxybenzoate Methylparaben),  ethylhydroxybenzoate (Ethylparaben) ,propylhydroxybenzoate (Propylparaben), butylhydroxybenzoate

v. (Butylparaben) and benzylhydroxybenzoate.

vi. Mercurials(Organomercurial compounds)eg: Phenylmercuric Acetate PMA), phenylmercuric Nitrate (PMN), phenylmercuric Borate and thiomersal

vii. Phenols  eg:Chlorocresol, cresol and bisphenol

viii. Quaternary ammonium compoundseg: Benzalkonium Chloride and Cetrimide

ix. Other agentslike: Chloroform  (as Chloroform water), glycerol, sucrose, formaldehyde, hexetidine, hexamidine and triclosan


c. Describe five(5) properties that are normally required in preservative selection (5marks)

i. A broad spectrum of antimicrobial activity covering Gram-positive and Gram-negative bacteria, yeasts and moulds, and no vulnerability to resistance development

ii. Low toxicity for humans, enabling it to be used in topical, oral and parenteral products

iii. Good solubility in water; low oil solubility

iv. Stability and effectiveness over a wide pH range

v. Compatible with common formulation excipients and containers.

vi. Non-volatile, odorless and tasteless




2. The following is the formula for a dexamethasone ophthalmic ointment; each ingredient is needed to prepare 7.5 g of ointment.

                           Dexamethasone Sodium Phosphate                   55 mg

                           Lanolin, Anhydrous                                              5 g

                           Mineral Oil                                                           10 g

                           White Petrolatum ad                                           100 g

a. State the

i. Required amount(1mark)


ii. Total Official amount(1mark)


b. Calculate the factor(2marks)

       Factor= Required amount   =         7.5g  = 0.075

                        Total Official amount      100g


c. Calculate the quantity of each ingredient needed to prepare the above ointment(4marks)



Official amount per ingredient


Required amount of each ingredient

Dexamethasone Sodium Phosphate

55 mg





Lanolin, Anhydrous

5 g


Mineral Oil

10 g


White Petrolatum ad

100 g



          Required amount of White Petrolatum=7.5g-(4.125+0.375+0.75+7.5) = 2.25g

d. What is the percentage of Dexamethasone Sodium Phosphate in the 7.5g ointment? (2marks)

                                 4.125/7.5 X 100%= 55%

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