Compounding of Creams – PST05208 Pharmaceutics Theory and Compounding
NTA Level 5 • Semester 2 • PST05208 Compounding of Creams Pharmaceutics Theory and Compounding • Source Session/Topic 9 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 9: Compounding of Creams Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: Define creams Describe procedures for preparing creams Prepare creams Label prepared cream Dispense prepared cream into suitable containers and closure Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Figure 9.1: Cream jars and tube SESSION OVERVIEW Step Time Activity/Method Content 1 05 Minutes Presentation Introduction, Learning Tasks 15 Minutes Presentation Definition of creams 2 Buzzing 3 15 Minutes Presentation Procedures for preparing creams Presentation 4 Preparing of Creams 30 Minutes Demonstration Presentation 5 Labeling of prepared creams 30 Minutes Demonstration 15 Minutes Presentation Dispensing of prepared creams into suitable 6 Brainstorming containers and closure 7 05 Minutes Presentation Key Points 8 05 Minutes Presentation Evaluation 65 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 Creams (15 minutes) Activity: Buzzing (05 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are creams? 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 • Creams are semi-solid emulsions intended for application to the skin or mucous membrane, they are viscous semisolid emulsion system with opaque appearance • Usually they are of two types, namely: o Aqueous creams, i.e. oil-in-water emulsions (O/W). This creams contain oil-in-water emulsifying agent o Oily creams, i.e. water-in-oil emulsions (W/O). This cream contain water-in-oil emulsifying agent. • Aqueous creams are relatively non-greasy and are most useful as water-washable bases whereas oily creams are emollient and cleansing. • Patients often prefer a w/o cream to an ointment because the cream spreads more readily, is less greasy and the evaporating water soothes the inflamed tissue. • O/w creams („vanishing‟ creams) rub into the skin; the continuous phase evaporates and increases the concentration of a water-soluble drug in the adhering film. • Consistency and rheological characters depend on weather the cream is w/o or o/w. • Creams intended for application to large open wounds should be sterile. 66 STEP 3: Procedures for Preparing Creams (15 minutes) • Emulsified creams are prepared by heating the components of the oily phase including the emulgent until molten and then cooling to 60°C. • The components of the aqueous phase are mixed in a separate vessel and also heated at 60°C. • The aqueous phase is then added to the oily phase at the same temperature, this is very important and the thermometer should be used. • The resulting emulsion should be stirred until cool. • Rapid cooling may result in separation of high melting point components and excessive aeration caused by vigorous stirring may also lead to a granular product. • If necessary the product may be homogenized after cooling. • Dilution of creams o Should be done under hygienic conditions o Stability and bacteriocidal properties of original cream should NOT be reduced on dilution o The diluent should be compatible with ingredients and the whole original preparation o Dilution may alter extent of release of medicament from creams o Information on suitability of diluent should be available, otherwise DO NOT DILUTE • Preservation & hygiene during preparation o Creams can support growth of micro-organisms, hence most need preservatives o Accidental contamination will almost certainly occur during bench scale manufacture, but good technique can keep this to a minimum o All apparatus and final containers should be thoroughly cleansed before use and purified water should be used in the preparation of products 67 STEP 4: Preparing of Creams (30 minutes) Activity: Demonstration (15 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 pastes with students REFER students to the official formula of preparing aqueous calamine cream PCx In the Tanzania Pharmaceutical Handbook DEMONSTRATE the procedure of preparing cream 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” • Official formula given for aqueous calamine cream PCx Calamine……………………………………………………………… 4.0g Zinc oxide……………………………………………………… 3.0.0g Emulsifying wax………………………………………………… 6.0g Arachis oil (0.86g/mL)…………………………………………….. 30.0g Purified water, freshly boiled and cooled ………………………… 50.0g Mitte 50.0g for Okeyo Odhiambo o Thus, amount of official formula = 100g o Total amount required = 50g o Amount of each ingredient (x) =? o FACTOR= Required amount Official amount = 50gm 100gm = 0.5 68 Then, amount of each ingredient can be obtain as summarised in the table below: Formula Official amount Factor Required amount Calamine 4.0gm 2.0g Zinc oxide 3.0gm 1.5g Emulsifying wax 6.0gm 0.5 3.0g Arachis oil (0.86g/mL) 30.0gm 15.0g Purified water, freshly 57.0gm 28.5g boiled and cooled Method of preparation • Melt oily phase (heat up to 75oC, and cool to 60oC) • Prepare aqueous phase and heat to 60oC • Add aqueous phase to oily phase with slow but constant agitation until cold • Incorporate insoluble medicinal ingredient • Then transferred to suitable container, label and ready for dispensing to a patient. STEP 5: Labeling of Prepared Creams (30 minutes) • The preparation should be labelled “For External Use Only” in red ink and