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NTA Level 5 • Semester 2 • PST05208 Compounding of Pastes Pharmaceutics Theory and Compounding • Source Session/Topic 8 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 8 Compounding of Pastes Total Session Time: 120 Minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to:  Define paste  Describe procedures for preparing paste  Prepare paste  Label prepared paste  Dispense prepared paste 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 8.1: Paste jars and tube SESSION OVERVIEW Activity/ Step Time Content Method 1 05 Minutes Presentation Introduction, Learning Tasks 2 10 Minutes Presentation Definition of Paste 20 Minutes Presentation Procedures for Preparing Paste 3 Buzzing 45Minutes Presentation 4 Preparing Paste Demonstration 20 Minutes Presentation 5 Labeling of Prepared Paste 10Minutes Presentation Dispensing of Prepared Paste into Suitable Containers 6 Brainstorming and Closure 7 05 Minutes Presentation Key Points 57 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 Paste (10 minutes) • Pastes are external semi-solid preparations containing large proportions (20% -60%) of solids finely dispersed in the basis • Pastes are like ointments but contain more solid materials and are stiffer • Pastes are basically ointments into which a high % of insoluble solid has been added • There are two types of paste: o Fatty pastes e.g.: Lassar's paste o Non greasy pastes e g: Bassorin paste • Examples of pastes o Coal tar paste P.CX (astringent, antipruritic) o Compound zinc paste P.CX (astringent) o Zinc and Salicylic acid Paste P.CX (Lassar‟s paste) astringent • Characteristics o Contain more solids than ointments o Are stiffer than ointments o Are less greasy than ointments o Cause less maceration of the skin o Are less occlusive than ointment  This is because of high porosity caused by high powder content o Are more absorbent to exudate weeping lesions o Pastes are less penetrating and less macerating and less heating than ointment o Like ointments; paste forms an unbroken relatively water – impermeable film o Unlike ointments; film formed by pastes is opaque, thus can be used as an effective sun block accordingly. 58 STEP 3: Describe Procedures for Preparing Pastes (20 minutes) Activity: Buzzing (10 minutes) Ask students to brainstorm on the following question: • What are procedures for preparing pastes? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Preparation more less like ointments o e.g. Compound Zinc Paste P.CX (Syn Zinc Paste) o Zinc oxide, finely sifted ……………….. 25.0g o Starch, finely sifted……………………….25.0g o White soft paraffin……………………….50.0g o The powders are triturated with the melted soft paraffin STEP 4: Preparation of Pastes (45 minutes) 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 pastes with students REFER students to the official formula of preparing compound zinc paste 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 59 until is competent” • Official formula given for compound zinc paste PCx Zinc oxide, finely sifted………………………………………………………..25.0g Starch, finely sifted……………………………………………………………..25.0g White soft paraffin………………………………………………………………50.0g Mitte 50.0g for Alex Shabani Thus, amount of official formula = 100g Total amount required = 50g Amount of each ingredient (x) =? FACTOR = required amount Official amount = 50gm = 0.5 100gm Then, amount of each ingredient can be obtain as summarised in the table below: Formula Official amount Factor Required amount Zinc oxide, finely 25.0gm 0.5 12.5gm sifted Starch, finely sifted 25.0gm 12.5gm White soft paraffin 50.0gm 25.0gm Method of preparation • Weigh 12.5g of Zinc oxide, finely sifted and 12.5g Starch, finely sifted • Transfer the weighed ( 12.5g) of Zinc oxide, finely sifted and Starch, finely sifted into a mortar • Weigh 25.0g of white soft paraffin • Add to the powders about two or three times their weight of melted white soft paraffin • After each addition trituration should be done for 3 to 5 minutes • Triturate until it is completely uniform • Then transferred to suitable container, label and ready for dispensing to a patient. 60 STEP 5: Labeling of Prepared Paste (20 minutes) • Labeling o As for ointments Activity: Demonstration (10 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 ZINC AND SALICYLIC ACID PASTE PCx 100g Spread paste on white lint and place on to the affected area every twenty four hours for five days. The name of the dispenser and the name and address of the dispensing Institution Preparation date Expiry date Keep Out of Reach of Children Keep away from heat 61 STEP 6: Dispensing of Prepared pastes into

NTA Level 5 • Semester 2 • PST05208 Compounding of Ointments Pharmaceutics Theory and Compounding • Source Session/Topic 7 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 7: Compounding of Ointments Total Session Time: 120 minutes Prerequisites • None 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: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Figure 7.1: Ointment jars. 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 6 Brainstorming Containers and Closure 7 05 minutes Presentation Key Points 47 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 • What is ointment? 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 • Ointment is a viscous semisolid preparation, oily in nature used topically on a variety of body 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. • Ointments are used as: emollients to make skin more pliable, protective barriers, vehicles in 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) • Basic Techniques for Preparation o Weighing o Measuring liquids o Size reduction o Size separation (sieving) o Mixing (Fusion or Trituration) 48 • Preparation • Method used depends on; o Properties of the medicaments o Type of basis o Quantity of ointment required • Trituration Method 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 • Fusion Method 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 • Dilution of Ointment 49 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) 50 STEP 4: Preparation of Ointment (35 minutes) • In preparation of ointments every official formula has got its procedures on how to carry out the 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” • Official formula given for calamine ointment PCx Calamine, finely sifted……………………………………………………….15.0g White soft paraffin……………………………………………………………85.0g Mitte 50.0g for Anna Juma Thus, amount of official formula = 100g Total amount required = 50g

NTA Level 5 • Semester 2 • PST05208 Reference and Formula in Pharmaceutical Pharmaceutics Theory and Compounding • Source Session/Topic 6 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 6: Reference and Formula in Pharmaceutical production Total Session Time: 120 minutes + 4 hours of Practical Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define monographs • List different types of references used in Pharmaceutical production • Identify Formula for Pharmaceutical preparations • Reduce or enlarge official formula to obtain required formula for compounding Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Worksheet 6.1: Take Home Assignment SESSION OVERVIEW Activity/ Step Time Content Method 1 05 Minutes Presentation Introduction, Learning Tasks 10 Minutes Presentation Definition of Drug Monographs 2 Buzzing 25 Minutes Presentation Types of References Used in Pharmaceutical 3 Production Demonstration 20 Minutes Presentation Identification of Formula for Pharmaceutical 4 Demonstration Preparations 40 Minutes Reduce or Enlarge Official Formula to Obtain Presentation 5 Required Formula for Compounding Group Discussion 6 05Minutes Presentation Key Points 34 7 05 Minutes Presentation Evaluation 8 10 Minutes Presentation Take home assignment 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 Drug monographs (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are drug monographs? 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 • Drug monograph refers to a publication that specifies for a drug ( or class of related drugs) the kind and amount of ingredients and may contain the conditions and imitations for which it may be offered, directions for use, warnings, and other information contained in its label • Drug monograph may also contain important information concerning interactions with other drugs STEP 3: Types of References Used in Pharmaceutical Production (25 minutes) • British Pharmacopoeia (BP) o Book of standards of purity and strength for medical substances, products, dressings, etc. together with „official‟ assays and tests. 35 • British Pharmaceutical Codex (BPC) 1973 o Provides a source of standards for some extemporaneous preparations not included in the BP and is now incorporated into the Pharmaceutical Codex. • Pharmaceutical Codex (PCx) 1979 o The PC is an encyclopedia of drug information and includes entries on diseases and conditions, aspects of pharmaceutics, surgical dressings and veterinary information as well as the formulae for medicines • European Pharmacopoeia (EP or Ph. Eur). o Prepared under the auspices of the council of Europe and was created to permit free circulation of drugs within the European community. • International Pharmacopoeia (IP) o Publication of the World Health Organization (WHO) providing recommended standards for international use. • United States Pharmacopoeia (USP) and National Formulary (NF) o The official standard reference of the United States of America (USA). There is a companion volume of dispensing information (USPDI). • European Pharmacopoeia (EP or Ph. Eur). o Prepared under the auspices of the council of Europe and was created to permit free circulation of drugs within the European community. • International Pharmacopoeia (IP) o Publication of the World Health Organization (WHO) providing recommended standards for international use. • United States Pharmacopoeia (USP) and National Formulary (NF) o The official standard reference of the United States of America (USA). There is a companion volume of dispensing information (USPDI). • Martindale: The Extra Pharmacopoeia o An authoritative reference book on drugs and medicines in current use throughout the world. Martindale provides detailed information on nomenclature, physical and pharmaceutical properties, adverse effects, actions and uses, etc. • Pharmaceutical Handbook o A reference manual for practitioners and students of pharmacy and the allied professions. Information such as „The preparation and supply of medicines‟, „methods of sterilization,‟ „nomenclature of organic compounds‟, desirable body weights and calculation of body surface areas which are useful data relevant to pharmacy. • British National Formulary (BNF) o Provides general guidance for prescribers together with the special requirements of particular groups of patient, e.g. the very young, the elderly, pregnant women and patient with renal or hepatic failure. 36 o Contains notes on drugs and preparations classified under the diseases and conditions to be treated. o Information on indications, contraindications, cautions, side effects and doses are given for each drug listed. o A formulary for commonly used „official‟ extemporaneous preparations and information on drug interactions, cautionary and advisory labels, etc. for the pharmacists are included. STEP 4: Identification of Formula for Pharmaceutical Preparation (20 minutes) • After comprehended the request in the prescription, a compounder has to identify the correct formula from the reference book • The correct formulas from the reference book can be obtain through the following ways: o Find the name of the pharmaceutical preparation to be compounded through table of contents of the reference book and go to formulation, e.g. solution. o The formulation in the content indicates the page where the respective formula is indicated. o Find the name of the pharmaceutical preparation to be compounded through the index of the reference book o The index indicates the number of page where the respective formula is indicated Below are official formulas obtained from the reference book (TPH) under the indicated table of content of the book. • COMPOUND BENZOIC ACID OINTMENTPCx (Syn.Whitfield‟s Ointment) Benzoic acid, in fine powder……………………………… 6.0 g Salicylic acid, in fine powder……………………………….. 3.0 g Emulsifying ointment …………………………………….. 91.0g • SULPHUR OINTMENT PCx. Precipitated sulphur, finely sifted…………………………… 10.0 g Simple ointment…………………………………………… 90.0 g 37 Activity: Demonstration (10 minutes) DIVIDE students in small manageable groups.

NTA Level 5 • Semester 2 • PST05208 Semi Solid Preparations Pharmaceutics Theory and Compounding • Source Session/Topic 5 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 5: Semi Solid Preparations Total Session Time: 120 Minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to:  Define semi – solid pharmaceutical preparations  List ideal properties of semi – solid preparations  Explain rational approaches to topical formulation  List treatment target for semisolid preparations  Explain components of semi – solid pharmaceutical preparations 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 10 Minutes Presentation Definition of Semi- Solid Pharmaceutical 2 Buzzing Preparations 3 15 Minutes Presentation Ideal Properties of Semi – Solid Preparations 4 15 Minutes Presentation Rational Approaches to Topical formulation 35 Minutes Presentation 5 Treatment Target for Semisolid Preparations Brainstorming 30 Minutes Presentation Components of Semi – Solid Pharmaceutical 6 Preparations 7 05 Minutes Presentation Key Points 8 05 Minutes Presentation Evaluation 27 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 Semi – Solid Preparations (10 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are semi – solid pharmaceutical preparations? 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 • Pharmaceutical semisolid preparations: Are the topical products intended for application on the skin or accessible mucous membranes to provide localized and sometimes systemic effects at the site of application, it is a preparations designed to exert local activity when applied to the skin or mucous membranes • The main medicinal applications of semi-solids pharmaceutical preparations are as protective, emollient, and therapeutic agents, these semi-solid pharmaceutical preparations for external application are: ointments, pastes, creams, poultices/cataplasms and gels. STEP 3: Ideal Properties of Semi – Solid Preparations (15 minutes) • Physical properties: o Smooth texture o Elegant in appearance o Non dehydrating o Non gritty o Non greasy and non-staining o Non hygroscopic 28 • Physiological properties: o Non irritating o Do not alter membrane / skin functioning o Miscible with skin secretion o Have low sensitization index • Application properties: o Easily applicable with efficient drug release. o High aqueous washability. • Storage properties: o Should be stored at temperatures not exceeding 25°c unless otherwise authorized. o 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. o The containers are preferably collapsible metal tubes from which the preparation may be readily extruded. o If the preparation is sterile, store in a sterile, airtight, tamper-proof container. STEP 4: Rational Approaches to Topical Formulation (15 minutes) • There are three main methods for a successful formulation of topical dosage form o By manipulating barrier function of skin;  Topical antibiotics and antibacterials help damaged barrier to avoid infections  Sunscreen and the horny layer protect viable tissues from u.v. radiations  Emollients restore pliability to desiccated horny layer o By directing drugs to the viable skin tissues without using oral, systemic or other routes of therapy o By using skin delivery for systemic treatment  e.g. transdermal therapeutic systems provide systemic therapy for motion sickness, angina and hypertension 29 STEP 5: Treatment Target for Semi – Solid Preparations (35 minutes) Activity: Brainstorming (15 minutes) Ask students to brainstorm on the following question: • What are treatment target for semi – solid preparations? ALLOW few students to respond WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Five main target regions: o Skin surface, horny layer, viable epidermis and upper dermis, skin glands, and systemic circulation. • Surface treatment o Care for skin surface is mainly by cosmetic application, that form protective layer, or attack bacteria and fungi o Sunscreens, barriers that hinder moisture loss, antimicrobials and insect repellants) • Stratum corneum treatment o Main therapies aimed at the horny layer improve emolliency by raising water content or stimulating sloughing o E.g. keratosis, exfolients such as salicylic acid • Skin appendage treatment o Antiperspirants (aluminium) reduce hyperhidrosis of sweat glands o Exfolients (e.g. salicylic acid, tretinoin (retinoic acid), benzoyl peroxide) for acne o Topical antimicrobials, depilatories etc. • Viable epidermis and dermis treatment o Diseases can be treated provided that the preparation efficiently delivers drug to the receptor o E.g. anti-inflammatory drugs (steroids & non steroids), antitumor (e.g. methotrexate, 5- fluorouracil) anesthetics (e.g. benzocaine), antihistamines 30 • Systemic treatment via percutaneous absorption o In recent years considerable scientific work has led to the skin route being used to treat several conditions by means of transdermal patches o E.g. motion sickness (hyoscine), angina (nitroglycerin) STEP 6: Components of Semi – Solid Pharmaceutical Preparations (30 minutes) • Antioxidant o Prevents or slows oxidation of other components o Examples: Tocopherol, butylated hydroxy toluene, or a reducing agent such as ascorbic acid. • Base o Major classes or types of formulation compositions based on composition and physical properties. o Examples: Please refer to bases chapter. • Buffer o Acid-conjugate base mixture employed to control pH and therefore control ionization state of drug and impart stability o Examples: Citrate, phosphate, tartarate • Chelating agent o Have the ability to bind metal ions; prevents auto-oxidation phenomena frequently catalyzed by metal ions and enhances action of preservatives by binding iron and copper ions essential to microbial growth. o

NTA Level 5 • Semester 2 • PST05208 Percutaneous Absorption Pharmaceutics Theory and Compounding • Source Session/Topic 4 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 4: Percutaneous Absorption Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to:  Explain percutaneous Absorption  Explain factors affecting percutaneous absorption 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 Percutaneous Absorption Brainstorming 55 Minutes Presentation 3 Factors Affecting Percutaneous Absorption Buzzing 4 05 Minutes Presentation Key Points 5 05 Minutes Presentation Evaluation 19 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: Percutaneous Absorption (50 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is percutaneous absorption? 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 • Percutaneous absorption is the term used to describe the penetration of a substance through the skin and subsequent movement into the systemic circulation. • For drugs applied topically for therapeutic purpose, its necessary that: o The medicament is released from the base o Adequate amount of drug penetrate the skin o Sufficient concentration of the drug is maintained at the site of action. • In some instance, skin penetration of medicament is not necessary for a topical applied medicament • A surface film of the active medicament is necessary for this instance. e.g. for medicament applied topically purposely for: o Skin protection (against sunlight or moisture loss o For emollient effect o For antimicrobial activities in skin disinfection 20 • When skin penetration for local activity is the aim, the active substance should be retained for as longer as possible in the viable epidermis and dermis with minimal elimination by systemic circulation. • Therefore, by regarding skin as the route of drug administration, it‟s important to know the mechanism by which medicaments penetrates the skin barrier. • Structure of skin o The skin is divided into three layers:  epidermis  dermis  hypodermis (subcutaneous fat layer) • Epidermis o Is about 110µm thick o Is pierced by hair follicles & sebaceous gland o It is non vascular o The outer layer of the epidermis is called stratum corneum o The stratum corneum is transparent, tough coherent & viscoelastic properties. o The stratum corneum is composed of dead cells each packed with keratin. o Resistance to the diffusion of chemicals is greater in stratum corneum (sc) than in the underlying living skin tissue. o SC is the rate-limiting barrier to movement of materials & responsible tissue for impenetrability of the skin. o However the is not an absolute barriers and trace amount of penetrants can be detected; eg nickel, chromium ions, parathion & toxic gases. o The thickness of sc varies. It is thick on the plantar & palmar areas and thin behind the ear and on the eyelid. o Cells are formed through mitosis at the basale layer o The daughter cells move up the strata changing shape and composition as they die due to isolation from their blood source o The cytoplasm is released and the protein keratin is inserted. o They eventually reach the corneum and slough off (desquamation). o This process is called keratinization and takes place within about 27 days. o This keratinized layer of skin is responsible for keeping water in the body and keeping other harmful chemicals and pathogens out, making skin a natural barrier to infection. • Dermis o The dermis is the layer of skin beneath the epidermis that consists of connective tissue and cushions the body from stress and strain. 21 o The dermis is tightly connected to the epidermis by a basement membrane. o It also harbours many Mechanoreceptor/nerve endings that provide the sense of touch and heat. o It contains the hair follicles, sweat glands, sebaceous glands, apocrine glands, lymphatic vessels and blood vessels. o The blood vessels in the dermis provide nourishment and waste removal from its own cells as well as from the Stratum basale of the epidermis. 22 • Hypodermis o The hypodermis lies below the dermis o Its purpose is to attach the skin to underlying bone and muscle as well as supplying it with blood vessels and nerves. o The main cell types are fibroblasts, macrophages and adipocytes (the hypodermis contains 50% of body fat). Fat serves as padding and insulation for the body. Figure: 1.4. Structure of skin Source: Human Anatomy by Matthew Hoffman, MD (2014) STEP 3:Factors Affecting Percutaneous Absorption (55 minutes) Activity: Brainstorming (20 minutes) Ask students to brainstorm on the following question: • What are factors affecting percutaneous absorption? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below 23 • Factors affecting percutaneous absorption can be considered under three main heading o Condition of the skin o Physicochemical characteristics of the active substance o Effect due to the vehicle. • Condition of the skin. o Damage and disease.  Intact skin presents a barrier to absorption that can be reduced considerably when the skin is damaged or is in a disease state.  Skin can be damaged by: • Dryness • Irritation • Allergic reaction • abrasion o Injured skin has increased percutaneous than intact skin. • Age o Percutaneous absorption of infants is higher than in adult to a given medicament due to  large surface

NTA Level 5 • Semester 2 • PST05208 Requirements for Preparation of Sterile Pharmaceutics Theory and Compounding • Source Session/Topic 3 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 3: Requirements for Preparation of Sterile Pharmaceutical Products Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to:  Explain premise requirements for sterile production.  Explain personnel requirements for sterile production.  Explain raw materials requirements for sterile production.  Explain documentation requirements for sterile production.  Explain equipment requirements for sterile production. 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 30 Minutes Presentation 2 Buzzing Premise Requirements for Sterile Production. 30 Minutes Presentation 3 Brainstorming Personnel Requirements for Sterile Production. 15 Minutes Presentation 4 Raw Materials Requirements for Sterile Production. Buzzing 15Minutes Presentation 5 Documentation Requirements for Sterile Production. Brainstorming 15 Minutes Presentation Equipment Requirements for Sterile Production. 6 Brainstorming 7 05 Minutes Presentation Key Points 13 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: Premise Requirements for Sterile Production (30 minutes) • The quality of infusions produced will depends very much on the degree of care taken during its preparation. • Each step in the production process is a possible source of contamination to the manufactured product. • Hence, Manufacture of sterile preparations (e.g. infusions) needs special requirements to minimise the risks of particulate, microbial and pyrogens contamination. • Therefore, production of sterile preparations needs environmental control of particulate and microbial contamination, so as to reduce the introduction, generation, and retention of contaminants during preparation. • Well maintained premises: o The facilities for the manufacture of sterile products should be designed for near to perfect level of cleanliness. o The maximum degree of cleanliness must be achieved in the aseptic filling rooms. o The surrounding areas should provide a buffer area in which standards of cleanliness are only slightly lower than the aseptic rooms. o The prevention of contamination must be the primary objective in the design of these facilities. o Well-maintained premise is a good indicator that production of infusions is done in clean environment that reduces risks of contamination to the product. • Methods of cleansing: o All equipment and surrounding work area must be cleaned thoroughly at the end of the working day. o After thorough cleaning, all surfaces should be disinfected, at least in the aseptic area. o An effective liquid disinfectant should be sprayed or wiped on all surface. 14 o Irradiation from UV lamps properly located will further reduce the viable microorganisms on surfaces and in the air. • Production Flow pattern: o The facility should be designed in such a way that it provides a continuous flow of production activities. o A change area has to be available before entering the facilities to allow change of street clothes into the appropriate production garments and gear. o There should then be a continuous process from supply storage to compounding of product, filling, sealing, sterilisation, labelling/packaging and finally to storage of the finished product. STEP 3: Personnel Requirements for Sterile Production (30 minutes) Activity: Brainstorming (5 minutes) Ask students to brainstorm on the following question: • What are the personnel requirements for sterile production ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Should be adequately trained and motivated e.g. Equipped with basic understanding of pharmaceutical technology, microbiology and hygiene. • They should be aware of the role that every movement has, in determining the quality of the final product. e.g. Aware of the sources of contamination. • Appropriate protective clothing should be worn. e.g. Boots, coats, caps, gloves, hats, and mask. • Personnel working in aseptic areas should be required to follow laid down preparatory procedures. o These include removing outside street clothing, scrubbing the hands and arms thoroughly with disinfectant soap, and wearing of prescribed uniforms. o Uniforms usually consist of sterile overalls, hats, facemasks and shoe covers. Sterile rubber gloves also may be required. o Uniforms are worn to control emission of particulate matter, which is continually shedding from body surfaces. o Aware of the hazards, which can be caused by using products of poor standards. 15 o Behaviour like smoking, eating, drinking, chewing, attending phone calls, in- and out- movements and any other activity that influence the product quality while in production processes are restricted STEP 4: Raw Materials Requirements for Sterile Production (15 minutes) • All materials purchased for use in compounding and dispensing o Should be of suitable quality and obtained from a licensed or reliable source. o „In house‟ check of quality may be made on starting materials. o Materials should be fully identifiable and carry a clear batch identification and expiry date. o Appropriate storage conditions should be maintained and out-of-date stock safely disposed o Should be pyrogens free STEP 5: Documentation Requirements for Sterile Production (15 minutes) • All compounding procedures should be fully documented and the record should include the following details: o The name of the product. o A written master formula & the working formula of the batch being prepared. o The method of preparation o The names, quantities and identification of each starting material (Supplier, batch number and date received) o The date of manufacture. o The appropriate container and closure. o The required storage conditions. o A copy of the label. STEP 6: Equipment Requirements for Sterile Production.(15 minutes) Activity: Buzzing (5 minutes) Ask students to brainstorm on the following question: •

NTA Level 5 • Semester 2 • PST05208 Aseptic Processing Pharmaceutics Theory and Compounding • Source Session/Topic 2 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 2: Aseptic Processing Total Session Time: 60 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Give introduction of aseptic processing. • Explain concept of aseptic processing • Identify basic rules for effective aseptic processing Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Figure.2. 1: Aseptic techniques SESSION OVERVIEW Activity/ Step Time Content Method 1 05 Minutes Presentation Introduction, Learning Tasks 15 Minutes Presentation Introduction to Aseptic Processing. 2 Brainstorming 10 Minutes Concept of Aseptic Processing Presentation 3 Buzzing 4 20 Minutes Presentation Basic Rules for Effective Aseptic Processing 6 05 Minutes Presentation Key Points 7 05 Minutes Presentation Evaluation 8 SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing. STEP 2: Introduction to Aseptic Processing (15 minutes) Activity: Buzzing (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What is aseptic processing? 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 Aseptic processing • Is the processing and packaging of a commercially sterile product into sterilized containers followed by hermetic sealing with a sterilized closure in a manners that prevents viable microbiological recontamination of the sterile product. • It require careful control of the aseptic environment, of personnel practices and procedures, sterilization of equipment and components, extensive environmental monitoring, and many other controls. • The number of controls required and the severe consequences of control failure make aseptic processing one of the highest-risk pharmaceutical processes. Quality risk management is an essential tool in ensuring product quality. 9 STEP 3: Concept of Aseptic Processing (10 minutes) Activity: Brainstorming (5 minutes) ASK students to pair up and buzz on the following question for 2 minutes • What are the concepts of aseptic processing? 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 • Suitable measures must be taken to ensure the microbiological quality of pharmaceutical preparations during manufacturing but also during packaging, storage and distribution is maintained • The requirements necessary to achieve strict asepsis include: o sterile starting materials o Sterile equipment o Controlled environment o Sterile containers o Suitable technique by trained personnel Figure.2. 1: Aseptic techniques processing operation by Ranjith Kumar kankala (2012) 10 STEP 4: Basic Rules for Effective Aseptic Processing (20 minutes) • Use a „no touch‟ technique whenever possible. o Handle small articles with sterile forceps and, when sterile apparatus must be touched, handle as distant as possible from the part which will come into contact with a sterile liquid or solid, this rule applies even though sterile gloves may be worn • Reduce air disturbances to a minimum o Standard procedures should be designed to minimize movement of personnel within the clean room. Objects should be positioned within reach under the laminar air flow cabinet. Sharp and sudden movements should be avoided. • Consider the arrangement of objects under the laminar air flow (LAF) o Clean air should not flow over dirty articles to contaminate sterile articles, the cabinet should not be loaded with unnecessary equipment, and materials required should be carefully selected and arranged before beginning the procedure. • Refuse to be distracted o No interruption should be allowed until a set procedure has been completed. STEP 4: Key Points (5 minutes • Aseptic process requires careful control of the aseptic environment, of personnel practices and procedures, sterilization of equipment and components, extensive environmental monitoring and many other controls. • The number of controls required and the severe consequences of control failure make aseptic processing one of the highest-risk pharmaceutical processes. Quality risk management is an essential tool in ensuring product quality. STEP 5: Evaluation (5 minutes) • What is aseptic processing? • What is the requirements necessary to achieve strict asepsis 11 References Nelson, Philip (1993). Principles of Aseptic Processing and Packaging (3 ed.). USA: GMA Science and Education Foundation. Retrieved 19 April 2018. Sudan D., David, Jairus R. (2013). Handbook of aseptic processing and packaging. Graves, Ralph H., Szemplenski, Thomas. Boca Raton: Taylor & Francis. Hargreaves, Paul. (2018)"Recommendation on the Validation of Aseptic Processes". Pharmaceutical Inspection Co-Operation Scheme. PIC/S. Retrieved 8 May 2018.New York 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: 12 ← Previous TopicNext Topic →View all Pharmaceutics Theory and Compounding topicsOpen Complete Full Notes PDF / OFFLINE NOTES Unataka kutumiwa notes hizi kupitia WhatsApp?Kwa notes zilizopangiliwa vizuri kwa kusoma offline au PDF, bonyeza kitufe hapa chini. Ujumbe wenye Level, Semester, Module na Topic utaandaliwa moja kwa moja.TUMIWA NOTES WHATSAPP WhatsApp: 255620339260

NTA Level 5 • Semester 2 • PST05208 Introduction to Sterile Pharmaceutical Preparations Pharmaceutics Theory and Compounding • Source Session/Topic 1 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 1: Introduction to Sterile Pharmaceutical Preparations Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define sterile pharmaceutical products. • Explain categories of sterile pharmaceutical Products. • List qualities of sterile pharmaceutical products. • Explain the role of aseptic techniques in assuring quality in pharmaceutical production Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • LCD projector and computer • Handout 1.1: Categories of Sterile Pharmaceutical products & medical devices SESSION OVERVIEW Activity/ Step Time Content Method 1 05 Minutes Presentation Introduction, Learning Tasks 2 10 Minutes Presentation Definition of Sterile Pharmaceutical Products 25 Minutes Presentation Classification Categories of Sterile 3 Brainstorming Pharmaceutical Products 4 35 Minutes Presentation Qualities of Sterile Pharmaceutical Products 35 Minutes Presentation General Methods of Sterilizing Pharmaceutical 5 Buzzing Products 6 05 Minutes Presentation Key Points 7 05 Minutes Presentation Evaluation 1 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 Sterile Pharmaceutical Products (10 minutes) • Sterile pharmaceutical products refer to pharmaceutical products that are free from any viable microorganisms, these are pharmaceutical products from which viable micro-organisms must be totally absent. • The production of sterile products requires special care and attention in order to eliminate microbial and particulate contamination at all stages of manufacture and wherever possible also includes a terminal sterilization process. STEP 3: Categories of Sterile Pharmaceutical Products (25 minutes) Activity: Brainstorming (10 minutes) Ask students to brainstorm on the following question: • What are the classification categories of sterile pharmaceutical products? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • Not all pharmaceutical products need to be sterile. Sterility is insisted on the following products: o Parenterally administered products e.g. injections, irrigations, ophthalmology products etc. o Pharmaceutical products that come into direct contact with broken skin/mucous membrane or internal organs e.g. certain instruments, sutures, surgical dressings etc. • These products are required to be prepared and maintained in a sterile state until used. Handout 1.1 Categories of Sterile Pharmaceutical products & medical devices 2 STEP 4: Qualities of Sterile Pharmaceutical Products (35 minutes) Activity: Buzzing (10 minutes) Ask students to brainstorm on the following question: • What are the qualities of sterile pharmaceutical products? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • All products intended for sterilization should be manufactured under clean conditions and therefore will be of low microbial content (bio burden) prior to sterilization. • Sterile formulations must meet the following standard of quality: o Should be sterile o Free from particulate contaminants o Free from pyrogen o Should be physically and chemically stable o Should have the same pH as the blood; (isohydric means the same concentration of H+ (Hydrogen ions) or pH = 7.38 o Same Osmotic pressure as blood plasma (isotonic) 3 STEP 5: Role of Aseptic Technique in Assuring Quality in Pharmaceutical Production (40 minutes) Activity: Brainstorming (5minutes) Ask students to brainstorm on the following question: • What are the roles of aseptic techniques in assuring quality in pharmaceutical production? ALLOW few students to respond? WRITE their responses on the flip chart/ board CLARIFY and SUMMARISE by using the content below • This is a method of handling sterile materials by employing techniques, which minimize the chances of microbial contamination in order to obtain the sterile products. • The followings are the roles of aseptic techniques in assuring the quality in pharmaceutical production; o To minimize and reduce the risks of contamination o To disinfect working area, equipment and ingredients in order to attain sterility o To prevent access of viable micro-organisms and particulate contamination during preparation and testing of pharmaceutical products STEP 6: Key Points (5 minutes) • Sterile formulations must meet the following standard of quality: remained sterile, free from particulate contaminants, free from pyrogen, been physically and chemically stable, should have the same pH as the blood and same Osmotic pressure as blood plasma (isotonic) • The production of sterile products requires special care and attention in order to eliminate microbial and particulate contamination at all stages of manufacture and wherever possible also includes a terminal sterilization process. STEP 7: Evaluation (5 minutes) • What is sterile pharmaceutical products • What are the roles of aseptic techniques in assuring quality in pharmaceutical production? 4 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. A. J. Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.) British Britain, R. P. S. o. G. (1994). The Pharmaceutical Codex (12 ed.). London: London Pharmaceutical Press. 5 Handout 1.1. Categories of Sterile Pharmaceutical products & medical devices SN Types/Categories Examples 1. Injections • Intravenous infusions • Intravenous additives • Total Parenteral nutrition (TPN) fluids • Small-volume injections • Small-volume oily injections 2. Non-injectable sterile fluids • Non-injectable water, (Sterile water for irrigation) • Urological irrigation solutions, • Peritoneal dialysis solutions, • Haemodialysis solutions, • Inhaler solutions 3. Ophthalmic preparations • Eye drops • Eye lotions • Eye ointments • Contact lens solutions • Wetting solutions • Cleaning solutions • Soaking solutions 4. Intravenous additives • Potassium chloride • Lidocaine (lignocaine) These are sterile drugs or additives • Heparin regularly added to infusions • certain vitamins immediately before administration. • Antimalarial injection, eg. Quinine injection •