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NTA Level 4 • Semester 2 • PST04209 Procedures for preparing Specialized food products used in Tanzania …………………………………………………………………………………………………..109 Compounding of Pharmaceutical Preparations • Source Session/Topic 16 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 16: Procedures for preparing Specialized food products used in Tanzania …………………………………………………………………………………………………..109 PST 04101 Dispensing NTA Level 4 Semester 1 Facilitator Guide iii Background There is currently an ever increasing demand for pharmaceutical personnel in Tanzania. This is due to expanding investment in public and private pharmaceutical sector. Shortage of trained pharmaceutical human resource contributes to poor quality of pharmaceutical services and low access to medicines in the country (GIZ, 2012). Through Public-Private-Partnership (PPP) the Pharmacy Council (PC) together with Development Partners (DPs) in Germany and Pharmaceutical Training Institutions (PTIs) worked together to address the shortage of human resource for pharmacy by designing a project named “Supporting Training Institutions for Improved Pharmaceutical Services in Tanzania” in order to improve quality and capacity of PTIs in training, particularly of lower cadre pharmaceutical personnel. The Pharmacy Council formed a Steering committee that conducted a stakeholder‟s workshop from18th to 22ndAugust 2014 in Morogoro to initiate the implementation of the project. Key activities in the implementation of this project included carrying out situational analysis, curriculum review and harmonization, development of training manual/facilitators guide, development of assessment plan, training of trainers and supportive supervision. After the curricula were reviewed and harmonized, the process of developing standardised training materials was started in August 2015 through Writer‟s Workshop (WW) approach. The approach included two workshops (of two weeks each) for developing draft documents and a one-week workshop for reviewing, editing and formatting the sessions of the modules. The goals of Writers Workshops were to build capacity of tutors in the development of training materials and to develop high-quality, standardized teaching materials. The training package for pharmacy cadres includes a Facilitator Guide, Assessment plan and Practicum. There are 12 modules for NTA level 4 making 12 Facilitator guides and one Practicum guide. PST 04101 Dispensing NTA Level 4 Semester 1 Facilitator Guide iv Acknowledgement The development of standardized training materials of a competence-based curriculum for pharmaceutical sciences has been accomplished through involvement of different stakeholders. Special thanks go to the Pharmacy Council for spearheading the harmonization of training materials in the pharmacy after noticing that training institutions in Tanzania were using different curricula and train their students differently. I would also like to extend my gratitude to St. Luke Foundation (SLF)/Kilimanjaro School of Pharmacy –Moshi for their tireless efforts to mobilize funds from development partners. Special thanks to John Snow Inc (JSI), Deutsche Gesellschaft Für Internationale Zusammenarbeit (Giz), Merck Kgaa, Boehringer Ingelheim Gmbh and Bayer Pharma Ag and action medeor.V for the financial and technical support. Particular thanks are due to those who led this important process to its completion, Mrs Stella M. Mpanda Director, Childbirth Survival International, and Members from the secretariat of National Council for Technical Education (NACTE) for facilitating the process. Finally, I very much appreciate the contributions of the tutors and content experts representing PTIs, hospitals, and other health training institutions. Their participation in meetings and workshops, and their input in the development of this training manual/facilitators guide have been invaluable. These participants are listed with our gratitude below: Mr.Wilson A.Mlaki Director Saint Luke Foundation Mr.Samwel M. Zakayo Pharmacy Council Ms. Ester A. Tuarira MUHAS Ms. Tumaini H. Lyombe MUHAS Mr, Wensaa E. Muro KSP Ms. Dilisi J. Makawia KSP Ms. Julieth Koimerek KSP PST 04101 Dispensing NTA Level 4 Semester 1 Facilitator Guide v Rev.Baraka A.M. Kabudi MEMS Mr. Kelvin E. Mtanililwa Royal Pharmaceutilcal Training Institute Ms. Rose Bulilo CEDHA Ms. Diana H. Gamuya CEDHA Dr.Melkiory C. Masatu CEDHA Dr.Benny Mboya CEDHA Mr. Habel A. Habel City College of Health and Allied Sciences Ms. Zaina Msami Meru District Council Director of Human Resources Development Ministry of Health, Community Development, Gender, Elders and Children PST 04101 Dispensing NTA Level 4 Semester 1 Facilitator Guide vi Introduction Module Overview This module content is a guide for tutors of Pharmaceutical schools for training of students. The session contents are based on sub-enabling outcomes and their related tasks of the curriculum for Basic Technician Course in Pharmaceutical Sciences. The module sub- enabling outcomes and their related tasks are as indicated in the Basic Technician Certificate in Pharmaceutical Sciences (NTA Level 4) curriculum. Target Audience This module is intended to be used by tutors of pharmaceutical schools. The module‟s sessions give guidance on the time, activities and provide information on how to teach the session. The sessions include different activities which focus on increasing students‟ knowledge, skills and attitudes. Organization of the Module The module consists of sixteen (16) sessions; each session is divided into several parts as indicated below: • Session Title: The name of the session • Total Session Time: The estimated time for teaching the session, indicated in minutes • Pre-requisites: A module or session which needs to be covered before teaching the session. • Learning Tasks: Statements which indicate what the student is expected to learn by the end of the session • Resources Needed: All resources needed for the session are listed including handouts and worksheets • Session Overview: The session overview box lists the steps, time for each step, the activity or method used in each step and the step title • Session Content: All the session contents are divided into steps. Each step has a heading and an estimated time to teach that step as shown in the overview box. Also, this section includes instructions for the tutor and activities with their instructions to be done during teaching of the contents • Key Points: Key messages for concluding the session contents at the end of a session This step summarizes the main points and ideas from the session, based on the learning tasks of the session • Evaluation: The last section of the session consists of short

NTA Level 4 • Semester 2 • PST04209 Procedures for preparing pharmaceutical Compounding of Pharmaceutical Preparations • Source Session/Topic 15 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 15: Procedures for preparing pharmaceutical solutions of liquid in liquid for oral and external use Total Session Time: 120 minutes + 30 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Describe Procedures for Preparing Solutions of Liquid in Liquid • Prepare Pharmaceutical Solutions of Liquid in Liquid for Oral and External Use (e.g. emulsions) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Objectives 45 minutes Presentation Procedures of preparing of Liquid Solutions 2 Buzzing from liquid in liquid 60 minutes Presentation Preparation of Pharmaceutical Liquid in Liquid 3 Demonstration Solutions for Oral and External Use 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 104 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Procedures of preparing of liquid solutions of Liquid in liquid (45 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is a Solution? 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 • A solution is a homogeneous liquid preparation that contains one or more dissolved medicaments. • General procedures for preparation of a liquid solutions: o Write out the formula either from the prescription (unofficial) or from an official text (official). o Calculate the quantities required for each ingredient in the formula to produce the required final volume. o Prepare a suitable label. o For liquid to liquid solution measure the accurate volumes required. o Make up to final volume with remaining vehicle. o Transfer to a suitable container, label and dispense to the patient. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 105 STEP 3: Preparation of Pharmaceutical Solutions of liquid in Liquid (60 minutes) Activity: Demonstration (40 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 solution of liquid in liquid with students REFER students to the official formula of preparing Benzaldehyde Pcx In the Tanzania Pharmaceutical Handbook DEMONSTRATE the procedure of preparing solution of liquid in liquid according to the instruction under the official formula in the Tanzania Pharmaceutical Handbook (Mitte 50 mL) 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 Benzaldehyde spirit Pcx o Benzaldehyde ………..…………………………….. 1.0mL o Alcohol (90%)…………………………………………80.0mL o Purified water, freshly boiled and cooled ………… to 100.0mL Thus: Total amount of official formula = 100mL Total amount required = 50 mL Amount of each ingredient (x) =? FACTOR = total amount required . Total amount of official formula FACTOR = 50 mL / 100mL FACTOR = 0.5 CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 106 Then, amount of each ingredient can be obtained as summarized in table below, Total amount of the official FACTOR total amount required Benzaldehyde ….. 1.0mL 0.5 mL Alcohol (90%)……..80.0mL 40.0mL Purified water………………………………to 0.5 to 50mL • Measure 0.5mL of Benzaldehyde liquid and 40 mL by using pipette • The benzaldehyde is dissolved in the alcohol, water is added to produce the required volume and preparation is well mixed STEP 4: Key Points (5 minutes) • A solution is a homogeneous liquid preparation that contains one or more dissolved medicaments • Solutions of liquid in liquid are obtained by mixing two or more miscible liquids, these liquids can be mixed to form a homogenous system (Solution), by simple stirring or shaking. STEP 5: Evaluation (5 minutes) • What is a solution of liquids in liquids • What is a miscible liquids? STEP 6: Practices (30 hours) • DIVIDE students in small manageable groups and conduct practices under facilitator‟s supervision on the following. • CHLOROFORM SPIRIT P.CX • LEMON SPIRIT P.CX • PEPPERMINT SPIRIT P.CX • PEPPERMINT EMULSION, CONCENTRATED P.CX CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 107 References 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: School of Pharmaceutical Sciences, Institute of Allied Health Sciences, Muhimbili University of Health and Allied Health Sciences. Pharmaceutical Society of Great Britain., & Pharmaceutical Society of Great Britain. Department of Pharmaceutical Sciences. (1994). The Pharmaceutical Podex, Principles and Practice of Pharmaceutics (W. Lund Ed. 12th ed.). London,: Pharmaceutical P. Langley, C. A., & Belcher, D. (2008). Pharmaceutical Compounding and Dispensing. London: Pharmaceutical Press. Ansel, H. C., Allen, L. V., & Popovich, N. G. (1999). Pharmaceutical dosage forms and drug delivery systems (7th ed.). Philadelphia, Pa.: Lippincott-Williams & Wilkins. Royal Pharmaceutical Society of Great Britain. (2007). Martindale : the complete drug reference (S. C. Sweetman Ed. 35th ed.). London: Pharmaceutical Press. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 108 ← Previous TopicNext Topic →View all Compounding of Pharmaceutical Preparations topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes

NTA Level 4 • Semester 2 • PST04209 Procedures for Preparing Mixture of Solids in Solids Compounding of Pharmaceutical Preparations • Source Session/Topic 14 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 14: Procedures for Preparing Mixture of Solids in Solids Total Session Time: 120 minutes + 10 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Describe Procedure of Preparing Mixtures of Solids in Solids (e.g. divided powders, bulky powders) • Prepare Mixtures of Solids in Solids (e.g. divided powders, bulky powders) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers, • LCD projector and computer • Worksheet 14.1: Practice on Compounding of Oral Powders SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 40 minutes Presentation, Procedure of Preparing Mixtures of Solids in 2 Small Group Solids Discussion 65 minutes Presentation 3 Preparation of Mixtures of Solids in Solids Demonstration 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 98 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: procedure of preparing mixtures of solids in solids (40 minutes) • The term “Powder” when used in the context of dosage form, describes a formulation in which a drug powder has normally been mixed with other powdered excipients to produce a final product. o Therefore Powders for oral Preparations are mixtures of finely divided solids intended for oral administration and comprise of the active ingredients plus excipients (such as diluents, sweeteners, and dispersing agents) where necessary. o They are usually mixed with water or other suitable liquid before administration. • Powders for oral preparations may be presented as bulk oral powders or oral divided powders. o Bulk oral powders, are usually contains multiple doses of non-potent medicaments, such as antacids, where the accuracy by which the patient measures the dose is not critical. o Divided powders, are individually packaged powders for each separate dose, these are for medications which accuracy of each dose is more required (i.e. potent). Activity: Small Group Discussion ( 30 minutes) DIVIDE students into small manageable groups ASK students to discuss on the following question • What are the procedures of compounding oral powders? ALLOW students to discuss for 15 minutes ALLOW few groups to present and the rest to add points not mentioned CLARIFY and SUMMARIZE by using the contents below • Great care must be taken in the mixing of solids in order to obtain a uniform product, which shows an even composition throughout the whole preparation so as when any sample from any part of the mixture is taken, should contain the different components in the same proportions. • The powders are mixed by triturating in a mortar by geometric mixing/dilution, starting with the solid of the smallest quantity to which the other solids are added according to CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 99 increasing amount and at each addition an amount added should be approximately equal to that in the mortar. • General procedures of preparing mixtures of solids in solids. o The particle size of each solid should be reduced to fine powder by grinding them in a mortar with a pestle, and if necessary the powder may be sifted. o The amounts of each required ingredient are determined/calculated and accurately weighed. o After each addition trituration should be done for 3 to 5 minutes, followed by scrapping. o When the amount of active ingredient is very small, possible pores in the mortar are first closed by triturating a little amount of diluent in the mortar before starting with the medicament. This applies frequently in the preparation of divided powders for internal use. o For divided powders weigh each dose and pack in a suitable package likewise to bulk powders, label and the preparation is ready for dispensing. STEP 3: Preparation of mixtures of solids in solids (65 minutes) Activity: Demonstration (60 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 powder preparation with students REFER students to the general procedures of preparing ORAL REHYDRATION SALTS (ORS), recommended by WHO. (TPH) DEMONSTRATE the procedure of preparing ORS 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” • The powders are mixed geometrically, the powders are packaged in a wrapped metal foil. • Normally Oral Bulk Powders are dispensed in glass or plastic jars with a screw caps, if not available, alternatively a paper/metal foil bag may be used. • Divided powders are individually enclosed in folder papers and dispensed in a suitable box or paper bag. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 100 • For Hygroscopic or volatile substances should be wrapped first in metal foil or waxed on parchment papers. STEP 4: Key Points (5 minutes) • Procedures of preparing mixtures of solids in solids includes: o Reduction of particle size of solids. o Calculate the amount of each required ingredient and accurately weighed. o For divided powders weigh each dose and pack in a suitable package likewise to bulk powders, label and the preparation is ready for dispensing. STEP 5: Evaluation (5 minutes) • What are procedures for preparing mixtures of solids in solids? • What are bulk oral powders? •

NTA Level 4 • Semester 2 • PST04209 Procedures for preparing solutions and Mixtures Compounding of Pharmaceutical Preparations • Source Session/Topic 13 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 13: Procedures for preparing solutions and Mixtures of solids in liquids Total Session Time: 120 minutes + 30 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Describe Procedures for Preparing Solutions of Solid in Liquid • Prepare Solution of Solids in Liquid (e.g. simple syrup etc.) • Prepare Mixtures of Solids in Liquid (e.g. pharmaceutical mixtures, suspensions etc.) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Worksheet 13.1: Practice on Compounding of Solutions and Mixtures SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 30 minutes Procedures for Preparing Solutions and Presentation 2 Mixtures. Buzzing 55 minutes Presentation 3 Preparation of Solids in Liquid Solutions. Demonstration 4 20 minutes Presentation Preparation of Solids in Liquid Mixtures 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 89 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Procedures for Preparing Solutions of Solid in Liquid (30 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is a solution? • What is a mixture? 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 • Mixture refers to a combination of two or more substances with or without chemical union. (Synonym: Mistura ) • Mixtures is often referred both oral solutions and suspension. • A solution is a homogeneous liquid preparation that contains one or more dissolved medicaments. Since, by definition, active ingredients are dissolved within the vehicle, uniform doses by volume may be obtained without any need to shake the formulation. • A suspension is a heterogeneous mixture of a solid and a liquid in which the solid does not dissolve. OR • A suspension is a two-phase system comprising solid particles (the disperse phase) dispersed in a liquid (the continuous phase or dispersion medium) • General procedures for preparation of solutions: o Write out the formula either from the prescription (unofficial) or from an official text (official). o Calculate the quantities required for each ingredient in the formula to produce the required final volume. o Prepare a suitable label. o Weigh all solids in case of liquid to liquid solution measure the accurate volumes required. o Identify the soluble solids and calculate the quantity of vehicle required to dissolve the solids fully. If more than one solid is to be dissolved, they are dissolved one by one, in order of solubility (i.e. the least soluble first). CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 90 o Transfer the appropriate amount of vehicle to a glass beaker. o If necessary, transfer the solid to a mortar and use the pestle to reduce particle size to aid dissolution o Transfer the solid to the beaker and stir to aid dissolution. If a mortar and pestle have been used to reduce particle size, ensure that the mortar is rinsed with a little vehicle to ensure complete transfer of the powders. o When all the solid(s) has/have dissolved, transfer the solution to the conical measure that will be used to hold the final solution. o Rinse out the beaker in which the solution was made with a portion of the vehicle and transfer the rinsing to the conical measure. o Add any remaining liquid ingredients to the conical measure and stir. o Make up to final volume with remaining vehicle. o Transfer to a suitable container, label and dispense to the patient. • General procedure for preparation of solid in liquid mixtures (Suspensions) o Write out the formula either from the prescription (unofficial) or from an official text (official). o Calculate the quantities required for each ingredient in the formula to produce the required final volume. o Prepare a suitable label. o Weigh all solids and measure the accurate volumes of the liquids required. o The solids, if necessary, are reduced to a fine powder in a mortar and mixed thoroughly mixed with any included suspending agents. o The small proportion of the vehicle is added and triturated until a smooth creamy paste free from lumps is formed. o If there are soluble solids, they are dissolved in the vehicle and the solution is added in portions to the mortar and the mixture is triturated to a smooth consistency after each addition. o Then the mixture is transferred to conical measure. o The vehicle is used to rinse the mortar and make up to final volume. o Then transferred to suitable container, label and ready for dispensing to a patient. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 91 STEP 3: Preparation of Solution of Solids in Liquid (55 minutes) • In preparation of solid in liquid solutions, every official formula has got its procedures on how to carry out the preparation, although the general procedures remain as mentioned on step 2 above. Activity: Demonstration (45 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 solution of solid in liquid with students REFER students to the official formula of preparing Sodium Chloride Solution Pcx In the

NTA Level 4 • Semester 2 • PST04209 Labelling and Dispensing of Prepared Liquid Compounding of Pharmaceutical Preparations • Source Session/Topic 12 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 12: Labelling and Dispensing of Prepared Liquid Dosage Form Total Session Time: 60 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Label Prepared Preparations • Dispense Prepared Preparations into Suitable Containers and Closures Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board ,chalk/whiteboard markers, • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 35 minutes Presentation 2 Labeling of Prepared Preparations Demonstration 10 minutes Dispensing of Prepared Preparations into 3 Presentation Suitable Containers 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 82 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning objectives and clarify ASK students if they have any questions before continuing. STEP 2: Labelling of Prepared Preparations (35 minutes) • Label means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stencilled, marked, embossed or impressed on or attached to a container of any food, drug, cosmetics or medical devices o A label is an important, integral part of a drug preparation o A label gives clear instructions on how and when to take or use the medication o The label contributes a good appearance of dispensed medicine, thus increasing the confidence of the patient o The label should be written in a legible, neat, and well balanced way o The size of the label should be appropriate to that of the container • The main label should clearly state the following: o The name (underlined) and quantity of the preparation o The patient‟s name o The date of dispensing (preparation date) o Dose and instruction for use. o The expiry date, where applicable and/ or manufacturing date o Storage condition o The name of the dispenser (initial) o The name and address of the dispensing institution. o Required dispensing information, such as Shake well before use. • Preparations intended for application to the skin should be labelled “for External Use Only” in red; those to be used in the mouth but not to be swallowed, get an auxiliary label “Not to be Swallowed”. “Not to be Taken” is used for liquid preparations which are not administered orally and which are not applied to skin surfaces such as ear drops, eye- drops, nasal drops, enemas and for solid dosage forms which might, by error, be administered orally such as inhalation capsules, pessaries and solution tablets. Alternatively, such preparations can be labelled with instructions on the restricted use e.g. “For Use in the Eye Only” or “Rectal Use only” or “For Vaginal Use Only”. All heterogeneous liquid preparations such as emulsion and suspensions, must carry the instruction “Shake before use”. Special storage conditions are also given on the auxiliary label such as “Store at a Cool Place” or more precise instructions like “Store between 20 C and 80C”. Preparations containing easily inflammable liquids are labelled “Highly Inflammable” or “Keep away from Open Flames” • All dispensed medicines should have the instruction: “Keep out of Reach of Children”. • A label have the following important characteristics o Neat (orderly and in a clean condition) o Clear (easily deliver a well-defined message in a simple language) CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 83 o Fit the container (not too large or too small) o Attractive (pleasing or appealing to the senses) 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” • Example of labels: For External Use Only CALAMINE LOTION PCx 100 mL Apply to the affected parts at night until cured. The name of the dispenser and the name and address of the dispensing Institution Preparation date Expiry date SHAKE THE BOTTLE BEFORE USE Keep Out of Reach of Children CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 84 STEP 3: Dispensing of Prepared Preparations into Suitable Containers (10 minutes) • Selection of a suitable container is more crucial, because container forms an integral part of dispensed medicines and should maintain the quality, safety and stability of its contents. Therefore it should comply with the following requirement: o Be strong enough to protect the contents from normal mechanical hazards of handling and transport. o Prevent leakage o Provide protection from environmental conditions, such as moisture, microorganisms, oxygen, carbon dioxide and light. o Be sufficiently transparent to inspect liquid preparation. o Do not react with the contents. • Some general guidelines on selection of container for preparations made in small scale compounding are: o Liquid medicines. Preparations for external use, for application to the mouth and throat, and for instillation into body cavities should be dispensed in fluted bottles, whereas those for internal use should be dispensed in plain bottles, as officially recommended. o This difference gives warning to user of the medicine. When someone touches a bottle which is fluted will be cautioned that the medicine should not be swallowed. Even though this is not more practicable now a days. o Medicines which

NTA Level 4 • Semester 2 • PST04209 Reconstitution of Powders/ Granules for Oral Compounding of Pharmaceutical Preparations • Source Session/Topic 11 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 11: Reconstitution of Powders/ Granules for Oral Preparations Total Session Time: 60 minutes + 6 hours of Practices Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define Powders/ Granules for Oral Preparations • Describe Reconstitution of Powders/Granules for Oral Preparations • Perform Reconstitution of Powders/Granules for Oral Preparations Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Handout 11.1 Powders and granules for oral administration • Worksheet 11.1 Reconstitution of Oral Rehydrating Salt SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 10 minutes Presentation Definition of Powders/ Granules for Oral 2 Preparations Brainstorming 10 minutes Presentation Reconstitution of Powders/Granules for Oral 3 Preparations Buzzing 25 minutes Presentation Performing Reconstitution of Powders/Granules 4 Demonstration for Oral Preparations 5 05 minutes Presentation Key Points 6 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 72 SESSION CONTENTS STEP1: 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: Define Powders/ Granules for Oral Preparations (10 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What is powder? • What are powders for oral preparation? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • The term “Powder” when used in the context of dosage form, describes a formulation in which a drug powder has normally been mixed with other powdered excipients to produce a final product. o Therefore Powders for oral Preparations are mixtures of finely divided solids intended for oral administration and comprise of the active ingredients plus excipients (such as diluents, sweeteners, and dispersing agents) where necessary. o They are usually mixed with water or other suitable liquid before administration. • Granules that are used as a dosage form comprise powder particles that have been aggregated to form larger particles sufficiently robust to withstand handling. • Granules are obtained by granulation, where by dry primary powder particles are (i.e. single, discrete powder particles) are processed to adhere to form larger multi-particle entities. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 73 STEP 3: Reconstitution of Powders/ Granules for Oral Preparations (10 Minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is medicine reconstitution? 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 • Reconstitution refers to the process of adding a diluent to a dry ingredient to make it a liquid. o Therefore medicine reconstitution refers to use the given directions, or recipe, on a prescription label to mix the powder contained inside to a specific concentration as indicated. • Diluent is the liquid used to mix a medication during reconstitution, different medications use different diluents so be sure to read the medication label or package insert correctly so that you use the proper diluent and volume needed to reconstitute the medication. o If the correct diluent is not used, the medication may clump or crystallize making it unusable for administration o Examples of common diluent used in reconstitution of oral powders/granules are, purified water, syrup, normal saline (NS 0.9%), dextrose 5% in water (D5W). • The volume of diluents that should be added to a powder or granules to produce a specific volume of a final product with the required concentration varies between formulations. • Therefore before reconstituting any powdered/granulated medication it is important to read manufacturer‟s instructions (package inset), so as to know exactly which diluent to be used and the amount of diluent to be added in order to produce the required concentration. • If a large amount of diluent is to be added to the bottle, a portion of the diluent (usually half) should be added to medication and then mixed. Once the medication as started to dissolve, the second portion of diluent is added and mixed. Be sure the medication has dissolved completely before administering to the patient. • Example of the instruction for reconstitution are shown on figure 11.1 and figure 11.2 CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 74 • Figure 11.1: Instruction for Reconstitution of Amoxicillin Suspension • Source: Reconstituting medicine handout (2013). Figure 11.2: Instruction for Reconstitution of Amoxicillin Oral Suspension • Source: Elymox (Amoxicillin Oral Suspension B.P) package (2015). CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 75 STEP 4: Performing Reconstitution of Powders/ Granules for Oral Preparations (25minutes) Activity: Demonstration (20 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 that skill with students using a checklist REFER students to the checklist of reconstituting powders/granules for oral preparation DEMONSTRATE the procedure of reconstitution of Oral rehydrating Salts (O.R.S) 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” • Other Oral powders/granules preparations are recommended to be reconstituted prior to use, e.g. effervescent powders/granules (ENO, ANDREWS) and O.R.S where their shelf life after reconstitution is short, instruct patient on

NTA Level 4 • Semester 2 • PST04209 Stock Solution and Dilution of Concentrated Compounding of Pharmaceutical Preparations • Source Session/Topic 10 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 10: Stock Solution and Dilution of Concentrated Solution Total Session Time: 120 minutes + 20 hours of Practice Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define Terminologies Used in this Section • Describe Stock Solutions • Perform Trituration, Alligation medial and Alligation alternate for Dilution of Pharmaceutical Preparations • Dilute Concentrated Solutions for External Use (Preparations of Antiseptics and Disinfectants) Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board ,chalk/whiteboard markers • LCD projector and computer • Handout 10.1: Practice on Compounding of Antiseptic and disinfectant • Worksheet 10.1: Practice on Compounding of Antiseptic and disinfectant CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 57 SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 10 minutes Presentation Definition of Terminologies Used in this 2 Section Buzzing 3 20 minutes Presentation Stock Solutions 30 minutes Presentation Trituration, Alligation Medial and Alligation 4 Alternate for Dilution of Pharmaceutical Preparations 45 minutes Presentation Dilution of Concentrated Solutions for External 5 Use 6 05 minutes Presentation Key Points 7 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 58 SESSION CONTENTS STEP1: 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 Terminologies Used in this Section (10 Minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is Stock Solution? • What is Trituration? • What is Alligation Medial? • What is Alligation Alternate? 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 Stock Solution • Are solutions of known concentration that are frequently prepared for convenience in dispensing. They are usually strong solutions from which weaker ones may be made conveniently. When correctly prepared, these solutions enable the pharmaceutical staff to obtain small quantities of medicinal substances that are to be dispensed in solution. Trituration • Trituration is a method of diluting potent medicinal substances. These dilutions offer a means of obtaining conveniently and accurately small quantities of potent drug for compounding. Trituration may be done either manually in a mortar with a pestle or with a mechanical device. Or • Trituration referred to a pharmaceutical process of reducing substances to fine particles through grinding in a mortar and pestle. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 59 Alligation Medial • Alligation medial is a method by which the „weighted average” percentage strength of mixtures of two or more substances of known quantity and concentration may be quickly calculated. The percentage strength expressed as a whole number, of each component of the mixture is multiplied by its corresponding quantity and the sum of the products is divided by the sum of quantities to give the percentage strength of the mixture, provided of course that the quantities have been expressed in a common denomination whether of weight or of volume Alligation Alternate • Alligation alternate is a method to calculate the number of parts of two or more components of a given strength to prepare a mixture of required strength. The required strength of the mixture to be prepared must lie somewhere between the strengths of its components, i.e. the mixture must be stronger than its weakest component and weaker than its strongest component. The amounts of components to be mixed are found by the scheme as illustrated in the diagram of example number one. STEP 3: Stock Solutions (20 Minutes) • Stock solutions are invariably prepared on a weight in volume (w/v) basis and their concentrations are expressed as ratio strength or less frequently, as percentage strength. Examples • How many milliliters of a 1:400 (w/v) of stock solution should be used to make 4 liters of a 1:2000 (w/v) solution? 4L  4000mL 1 : 400  0.25% Then, 0.25% 4000 mL  0.05% x mL 0.05  4000 x 0.25 x = 800mL Answer CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 60 • How many milliliters of a 1% stock solution of a certified red dye should be used in preparing 4000mL of a mouth wash that is to contain 1:20000 (w/v) of certified red dye as a coloring agent? 1 : 20000  0.005% Then, 1% 4000mL  0.005% x mL 0.005  4000 x 1 x  20 mL, Answer • What is the % strength of an ointment which contains 1.5 g benzoic acid in 30g of the preparation? The answer is found as follows: 1.5 x  30 100 1.5  100 x  5% 30 The strength is 5% w/w, Answer. STEP 4: Trituration, Alligation Medial and Alligation Alternate for Dilution of Pharmaceutical Preparations (30 minutes) Trituration For example; in preparation of Antidandruff lotion, the following ingredients are used: Salicylic acid……………………………………………………. 1.0 g Cetrimide……………………………………………………….. 5.0 g Liquid paraffin…………………………………………………. 3.0 mL Alcohol (90%)………………………………………………….. 6.0 mL Purified water…………………………………………………… to 100.0 mL The 5g of Cetrimide is triturated with 3mL Liquid Paraffin; 1g of Salicylic Acid is dissolved in 6mL of the Alcohol (90%), and added. The mixture is triturated well, water is added to the required volume 100mL, and the preparation mixed. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 61 Alligation Medial • What is the percentage (v/v) of alcohol in a mixture of

NTA Level 4 • Semester 2 • PST04209 Weighing and Measuring Amounts of Ingredients Compounding of Pharmaceutical Preparations • 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: Weighing and Measuring Amounts of Ingredients Required for Compounding Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Weigh Amounts of Ingredients Required for Compounding • Measure Volumes of Ingredients Required for Compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board , chalk and whiteboard markers • LCD projector and computer SESSION OVERVIEW Activity/ Step Time Content Method 1 05 minutes Presentation Introduction, Learning Tasks 50 minutes Presentation 2 Buzzing Weighing Amounts of Ingredients Demonstration 55 minutes Presentation 3 Brainstorming Measuring Volumes of Ingredients Demonstration 4 05 minutes Presentation Key Points 5 05 minutes Presentation Evaluation CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 50 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: Weighing Amounts of Ingredients (50 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the instruments used for weighing of ingredients required for compounding? 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 • Weighing balance (either double pan balance, single pan balance, or electronic balance) is the common instrument used in weighing different amounts of ingredients required for compounding. • General rules for weighing solid ingredients required for compounding o Use a balance that is suitable for weighing the required quantity. The maximum weight that is accurately measured by the balance is determined by multiplying the smallest scale unit by 200. Never try to weigh quantities exceeding the capacity of the balance. Check whether the balance and the weights are calibrated for the SI unit system. If not, make sure the amounts to be weighed are converted to the same SI unit as in the weighing balance. o Check the instrument for inaccurate adjustment and sticking by releasing the beam on a trial swing and observing the movement of pointer over the calibrated scale (For non-electrical balance) o When using a non-electrical balance make sure the balance arm can move freely. This is checked by touching the balance pan with a forceps. Make sure the balance is in the down or is resting position, before transferring materials or weights to or from the pans. o When using a non-electrical balance always use forceps to transfer weights; never touch weights with your fingers. Put weights back into weight drawer or into their case immediately after use and close the weight drawer immediately. These procedures are to avoid corrosion and contamination of the weight and keep them accurate. CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 51 o Never weigh pharmaceutical materials directly on the balance pan. Use a piece of paper for solids, waxed paper for semisolids, and appropriate vessels for liquids. Vessels used for liquids requires cleaning after each weighing. o Use a suitable spatula for transfer of materials to the balance pan. Take care not to spill any material. Clean immediately after spilling material. The spatula should be cleaned after each weighing. o Some pharmaceutical material are corrosive or aggressive. Special containers and spatulas are sometimes needed. o After weighing a solid that has to be dissolved in a liquid, it can be washed off with that liquid. o Clean the balance thoroughly after use. Activity: Demonstration (30 minutes) DIVIDE students in small manageable groups. PREPARE equipment and materials needed for demonstration POSITION students so that everyone can see and hear REVIEW general rules for weighing ingredients using weighing balance with students. REFER students to the general rules of weighing pharmaceutical ingredients. DEMONSTRATE the procedure of weighing solid pharmaceutical ingredients for compounding. ALLOW one student from each group to do a return demonstration and let others comment on it CLARIFY and SUMMARIZE INFORM the students that “every student will practice in the skills laboratory under supervision until is competent” CMT 04101 Dispensing NTA L 4 Semester 1 Facilitator Guide Session X: ———— -(Title)———————- 52 STEP 3: Measuring Volumes of Ingredients (55 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What are the common apparatus used for measuring volumes for compounding? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Measurement by volumes is done with graduated cylinders/measures (measuring cylinder), pipettes, and a dropper or syringes. • General rules for measurement of volumes using measures/graduated cylinders. o Select a measure of a suitable size. Pharmaceutical measures show no scale lower than the minimum volume they can accurately measure. o Make sure the scale of the measure is in milliliters (mL), not otherwise. When the volume is stated in other units, convert the volumes to milliliters (mL) o Always read the scale at eye level, at the bottom of the liquid surface (meniscus) as shown on figure 9.1 below. When reading the scale is difficult, hold a piece of dark colored paper behind the measure. • Figure 9.1: Reading the scale of volumetric glassware • Source: graduated cylinders handout (2015). o Make sure no liquid remains in the measure. It may take some time for liquid to flow out completely, particularly when you are measuring viscous liquids. For water and aqueous solutions keep the measure top down for 15 seconds after all the liquid has flown out, and 2 minutes for syrup and