Compounding of Ointments
Session 7: Compounding of Ointments
Total Session Time: 120 minutes
Prerequisites
Learning Tasks
By the end of this session students are expected to be able to:
Define ointment
Describe procedures for preparing ointment
Prepare ointment
Label prepared ointment
Dispense prepared ointment into suitable containers and closure
Resources Needed:
SESSION OVERVIEW
Step Time Activity/ Method Content
1 05 minutes Presentation Introduction, Learning Tasks
2 10 minutes Presentation Buzzing Definition of Ointment
3 25 minutes Presentation Procedures for Preparing Ointment
35 minutes Presentation
4 Preparing Ointment
Demonstration
5 20 minutes Presentation Labeling of Prepared Ointment
15 minutes Presentation Dispensing Prepared Ointment into Suitable
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Brainstorming Containers and Closure
7 05 minutes Presentation Key Points
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8 05 minutes Presentation Evaluation
SESSION CONTENTS
STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)
READ or ASK students to read the learning tasks and clarify
ASK students if they have any questions before continuing.
STEP 2: Definition of Ointments (10 minutes)
Activity: Buzzing (5 minutes)
ASK students to pair up and buzz on the following question for 2 minutes
ALLOW few pairs to respond and let other pairs to add on points not mentioned
WRITE their response on the flip chart/board
CLARIFY and SUMMARIZE by using the content below
surfaces, and it is usually applied on the skin and the mucus membranes of the eye, vagina, anus,
and nose. An ointment may or may not be medicated.
which to medications are incorporated. They may be readily applied to the skin with inunction
(smearing or rubbing)
STEP 3: Describe Procedures for Preparing Ointments (25 minutes)
o Weighing
o Measuring liquids
o Size reduction
o Size separation (sieving)
o Mixing (Fusion or Trituration)
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o Properties of the medicaments
o Type of basis
o Quantity of ointment required
o Used when medicament to be incorporated is insoluble in the ointment basis or liquid is
present in small amount
o Involves incorporation of drug by levigation
o Used for small quantities of relatively soft ointment
o Employs a slab and a spatula of flexible metal or plastic for mixing and incorporation of
liquids or solids
o Steel spatula are suitable for most substances but should not be used for ointments containing
Hg salts, tannic acid, salicylic acid or iodine
o Insoluble powders must be finely powdered and levigated with some of the melted basis or
with a suitable liquid
o Wool fat, glycerol are good levigating agents
o Water soluble salts should be dissolved in minimum amount of water and then incorporated
with aid of small amount of lanolin
o Mortar and pestle is used if liquids are used for larger quantities of ointment
o After levigation or dissolution the concentrate is diluted geometrically with the basis, with
scrapping off of material from the sides of the mortar and pestle
o Trituration is done until the preparation is uniform
o Used for large-scale manufacturing or for ointments in which waxes or solids or high melting
points are mixed with semi-solids or oils
o Also used when large volume of water are to be incorporated
o Constituents are melted successively in decreasing order of melting point
o The fluid mixture stirred until cooled, avoiding aeration
o Crystals of fatty alcohols form (in systems with paraffin) if not well stirred
o Volatile medicaments are added when ointment has cooled below 40⁰C
o Insoluble powders in form of levigated dispersion are incorporated when ointments begin to
thicken
o Soluble, heat-stable can be dissolved in melted basis before congealing thickening
o Roller mills or colloid mills may be used to improve homogeneity to attain uniform
distribution of insoluble solids and elimination of larger particles
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o Dilution of stronger ointment is done when strength prescribed is not available
o Only recommended diluents should be used e.g. soft paraffin
o In tropical climates, the bases which are too soft are stiffened by addition of fats, hard paraffin, or
waxes
o This addition is permitted if active ingredients content or action is not altered
-Trituration using tile and spatula – Trituration using motor and pestle
Electric Mortar and Pestle
Source: Pharmaceutical Compounding and Dispensing (2008)
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STEP 4: Preparation of Ointment (35 minutes)
preparation, although the general procedures remain as mentioned on step 3 above.
Activity: Demonstration (25 minutes)
DIVIDE students in small manageable groups.
PREPARE equipment and materials needed for demonstration
POSITION students so that everyone can see and hear
REVIEW steps of preparing ointments with students
REFER students to the official formula of preparing calamine ointment PCx In
the Tanzania Pharmaceutical Handbook
DEMONSTRATE the procedure of preparing ointments according to the instruction under
the official formula in the Tanzania Pharmaceutical Handbook (Mitte 50g)
ALLOW one student from each group to do a return demonstration and let others comment
on it
CLARIFY and SUMMARIZE Using the content below
INFORM the students that “every student will practice in the skills laboratory under
supervision until is competent”
Calamine, finely sifted……………………………………………………….15.0g
White soft paraffin……………………………………………………………85.0g
Mitte 50.0g for Anna Juma
Official amount
100g
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Then, amount of each ingredient can be obtained as summarised in the table below:
Formula Official amount Factors Required amount
Calamine, finely sifted 15.0gm 0.5 7.5gm
White soft paraffin 85.0gm 42.5gm
Method of preparation
STEP 5: Labeling of Prepared Ointment (20 minutes)
o “For External Uses Only” (red) and “Store at a Cool Place” when appropriate
o Strength of active ingredient should be given as % w/w, (or %v/v) or %w/v
o If diluted product should indicate,“Should Not be Used Later than Two Weeks After
Issue” unless otherwise stated
o If preserved, name and concentration should appear on the label
o Is sterile, should be labeled “Sterile”
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Activity: Demonstration (25 minutes)
DIVIDE students in small manageable groups.
PREPARE equipment and materials needed for demonstration
POSITION students so that everyone can see and hear
REVIEW steps of writing a label
REFER students to the important things required to appear on the label.
DEMONSTRATE on how to write a good label
ALLOW one student from each group to do a return demonstration and let others comment
on it
CLARIFY and SUMMARIZE by using the content below
INFORM the students that “every student will practice in the skills laboratory under
supervision until is competent”
For External Use Only
CALAMINE OINTMENT PCx
100g
Apply to the affected parts every twelve hours after bath for seven days
The name of the dispenser and the name and address of the dispensing Institution
Preparation date
Discard after
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Keep Out of Reach of Children
Keep it away from heat
STEP 6: Dispensing of Prepared Ointment into Suitable Containers and
Closure. (15 minutes)
Activity: Brainstorming (05 minutes)
Ask students to brainstorm on the following question:
ALLOW few students to respond?
WRITE their responses on the flip chart/ board
CLARIFY and SUMMARISE by using the content below
Containers
slip-on lids
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Figure 7.1: Ointment jars.
Source: Pharmaceutical Compounding and Dispensing (2008).
STEP 7: Key Points (5 minutes)
surfaces, it is usually applied on the skin and the mucus membranes of the eye, vagina, anus, and
nose. An ointment may or may not be medicated.
which to medications are incorporated. They may be readily applied to the skin with inunction
(smearing or rubbing)
size separation (sieving) and mixing (Fusion or Trituration
STEP 8: Evaluation (5 minutes)
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References
Britain, R. P. S. o. G. (1994). The Pharmaceutical Codex (12 ed.). London: London Pharmaceutical
Press.
Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.)British
Wolverton, SE. Comprehensive Dermatologic Drug Therapy. WB Saunders. 2001. pp 563-572.New
York
Singh Malik, D; Mital, N; Kaur, G (2016). "Topical drug delivery systems: a patent review". Expert
opinion on therapeutic patents. 26 (2): 213–28. Sudan
Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania
Pharmaceutical Handbook (2nd ed.). Dar es salaam.
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