PST04104 Pharmaceutical Dosage Forms

NTA Level 4 • Semester 1 • PST04104 Introduction to Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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 Pharmaceutical Dosage Forms Total Session Time: 120 minutes Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define Dosage Form • Classify Pharmaceutical Dosage Forms According to their Physical Forms and Routes of Administration • Explain the Importance of Dosage Forms Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction of Learning Tasks | |2 |10 minutes |Presentation |Definition of Dosage Forms | | | |Brainstorming | | |3 | |Presentation |Classification of Dosage Forms | | |75 minutes |Small Group | | | | |Discussion | | |4 |20 minutes |Presentation |Importance of Dosage Forms | | | |Buzzing | | |5 |05 minutes |Presentation |Key Points | | 6 |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 Dosage Forms (10 minutes) | Activity: Brainstorming (5 minutes) | |ASK students to brainstorm on the following question | |What is dosage form? | |ALLOW few students to respond | |WRITE their responses on the flip chart or board | |CLARIFY and SUMMARIZE their responses using the contents below. | • Dosage forms: o These are the means by which drug molecules are delivered to the sites of action in the body o They are the drug delivery systems o Example of pharmaceutical dosage forms are tablets, capsules, syrups, suspensions, injections, creams and ointments o Selection of right dosage forms depends on the situation of a patient (emergency or unconscious) and the location of the disorder STEP 3: Classification of Dosage Forms (75 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the classes of Pharmaceutical dosage forms? | | | |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 | • Dosage forms are classified according to Physical forms and Route of administration • Classification according to physical forms o Solid dosage forms ▪ The solid dosage forms are mainly of two types, tablets and capsules. Others are powders, pills and cachets ▪ Tablet is a compressed solid dosage form (of uniform volume of particles) containing medicaments with or without excipients ▪ Capsules are solid preparations with hard or soft containers “shells”, (commonly but not exclusively of gelatine) of various shapes and capacities, usually containing a single dose of active ingredient(s) ▪ he solid dosage forms are advantageous as they ensure the means for accurate dosing, portable (lighter) and easy handling , cheap for large scale production, easy to control quality and masking unpleasant tastes o Semisolid dosage forms ▪ Semisolid preparations comprise a number of products, which when applied to the skin or accessible mucous membranes tend to alleviate or treat a pathological condition or offer protection against a harmful environment ▪ They are intended for local drug delivery on the skin, cornea, rectal tissue, nasal mucosa, vagina and others ▪ Most of them are non-irritating ▪ Examples are ointments, creams, gels, pastes and poultices o Liquid dosage forms ▪ Liquid dosage forms are homogeneous or heterogeneous preparations containing one or more active ingredients in a suitable vehicle ▪ The liquid dosage forms are advantageous as they are more readily available for absorption, easily swallowed than tablets or capsules and therefore suitable for children and elderly patients ▪ The gastric irritation caused by certain drugs when they are administered as a solid dosage form may be reduced or avoided when liquid dosage forms are used ▪ The disadvantages of liquid dosage forms include; less stability in liquid formulation, susceptibility to microbial contamination, difficultness in masking unpleasant taste and inconvenience to store and transport due to bulkiness ▪ Also administration of the correct dose is less precise since in involves the use of 5ml spoon, an oral syringe or volumetric dropper and the dispersion systems have to be shaken before use to allow accurate dosage ▪ Examples of liquid dosage forms are solutions, suspensions, spirits, tinctures, mixtures and others. o Gaseous dosage forms ▪ The small drug particles are usually compressed with air ▪ These forms include aerosols and inhalers • Classification according to Route of Administration o Oral dosage forms ▪ Are usually intended for systemic effects resulting from drug absorption through the various mucosa of the gastrointestinal tract ▪ It is the simplest, most convenient and safest means of drug administration ▪ The onset of action depends on the rate of absorption ▪ The disadvantages include relatively slow onset of action, possibilities of irregular absorption and destruction of certain drugs by enzymes or secretions of the gastrointestinal tract ▪ The most popular oral dosage forms are tablets, capsules, suspensions, solutions and emulsions o Parenteral dosage forms ▪ These are medicines which injected via a hollow needle in to the body at various sites. ▪ The main parenteral routes are subcutaneous (S.C), intramuscular (I.M) and intravenous (I.V) and the less frequently used intrathecal ▪ The parenteral route is preferred when rapid absorption is essential, as in emergency situations or when patients are unconscious or unable to tolerate oral dosage forms ▪ Absorption after parenteral drug delivery is rapid ▪ Injectable preparations are usually sterile suspensions or

NTA Level 4 • Semester 1 • PST04104 Solid Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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: Solid Pharmaceutical Dosage Forms Total Session Time: 120 minutes + 1 Hour assignment Prerequisites • Session 1 : Introduction to Pharmaceutical Dosage Forms Learning Tasks By the end of this session students are expected to be able to: • Define Solid Dosage Forms • List Major Types of Solid Dosage Forms • Explain Mode of Administration for Solid Dosage Forms • Explain the Characteristics of Tablets and Capsule Dosage Forms • Explain Advantages of Tablets and Capsule Dosage Forms • Explain Disadvantages of Tablets and Capsule Dosage Forms Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 | |Presentation |Definition and Types of Major Solid | | |20 minutes |Brainstorming |Dosage Forms | |3 |10 minutes |Presentation |Mode of Administration for Major | | | |Buzzing |Types of Solid Dosage Forms | |4 | |Presentation |Characteristics of Tablet and | | |10 minutes | |Capsule Dosage Forms | |5 | |Presentation |Advantages of Tablet and Capsule | | |35 minutes|Small Group |Dosage Forms | | | |Discussion | | |6 | |Presentation |Disadvantages of Tablet and Capsule | | |20 minutes |Buzzing |Dosage Forms | |7 |05 minutes |Presentation |Key Points | |8 |05 minutes |Presentation |Evaluation | |9 |10 minutes |Presentation |Assignment | 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 and Types of Major Solid Dosage Forms (20 minutes) |Activity: Brainstorming (5 minutes) | |ASK students to brainstorm on the following question | |What is a solid dosage form? | |What are the major types of solid dosage forms? | |ALLOW few students to respond | |WRITE their responses on the flip chart or board | |CLARIFY and SUMMARIZE their response using the content below | Definition of Solid Dosage Forms • Solid dosage forms are forms of drug dosages that do not (or contain) very little water Major types of solid dosage forms: • There are two major types of solid pharmaceutical dosage forms i.e.tablets and capsules o Tablet ▪ Is defined as a compressed solid pharmaceutical dosage form that contain medicament (s) ▪ They are prepared by compression of uniform volume of particles (drugs and excipients) o Capsules ▪ Capsules are solid pharmaceutical dosage forms with hard or soft containers “shells” (commonly but not exclusively of gelatin) of various shapes and capacities, usually containing a single dose of active ingredient ▪ A capsule may contain a medicinal or inert agent • Types of Capsules o Hard gelatine capsules ▪ Manufactured in two pieces that fit together and hold the drug which is in a powder or granular form o Soft gelatin capsules ▪ Made in one piece containing drug in liquid form inside a soft shell • Other types of solid dosage forms o Lozenges ▪ It is a solid preparation that contains one or more medications, usually in a flavoured, sweetened base ▪ It is intended to dissolve or disintegrate slowly in the mouth ▪ A lollipop is a lozenge on a stick o Powder ▪ A powder is an intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use o Pill ▪ A pill is a small, round, solid dosage form that contains a medicinal agent. It is taken by mouth STEP 3: Mode of Administration for Major Types of Solid Dosage Forms (10 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What is/are the mode(s) of administration for tablet and capsule dosage| |forms? | | | |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 | • Tablets and capsules are intended for oral administration o Swallowed whole (intact) with a sufficient quantity of potable water o Chewed and swallowed for quick absorption and action o Sublingual tablets are placed under the tongue o Dispersible tablets are dissolved in water and the solution is drunk/swallowed STEP 4: Characteristics of Tablet and Capsule Dosage Forms (10 minutes) • Characteristics of tablet and capsules dosage forms includes o Must have correct dose o Must be elegant and free of defects like chips, cracks, discoloration, and contamination o Should be uniform in size, weight and appearance o Must be biocompatible i.e. no excipients or micro-organisms which can cause harm to the patient o The tablet must be able to release the medicinal agents in a predictable and reproducible manner o Must be chemically, physically and microbiologically stable during its lifetime o Must be able to withstand mechanical shock during production, packaging, shipping and dispensing during all its life time o Must be packed in a safe manner STEP 5: Advantages of Tablet and Capsule Dosage Forms (35 minutes) | | |Activity: Small Group Discussion (15 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following questions | |What are the advantages of tablet dosage forms | |What are the advantages of capsule dosage forms | | | |ALLOW students to do the assignment for 10 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using

NTA Level 4 • Semester 1 • PST04104 Semisolid Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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: Semisolid Pharmaceutical Dosage Forms Total Session Time: 120 minutes + 1 hour Assignment Prerequisites • Session 1 : Introduction to pharmaceutical dosage forms Learning Tasks By the end of this session students are expected to be able to • Define Semisolid Dosage Form • List the Ideal Properties of Semisolid Dosage Forms • Explain the Types and Uses of Semisolid Dosage Forms Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Presentation |Definition of Semisolid Dosage Form | | | |Brainstorming | | |3 |20 minutes |Presentation |Ideal Properties of Semisolid Dosage| | | |Buzzing |Forms | |4 | |Presentation |Types and Uses of Semisolid Dosage | | |65 minutes |Small group |Forms | | | |discussion | | |5 |05 minutes |Presentation |Key Points | | 6 |05 minutes |Presentation |Evaluation | | 7 |10 minutes |Presentation |Assignment | 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 Semisolid Dosage Form (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is a semisolid dosage form? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • A semisolid dosage form is a product of semisolid consistency applied to skin or mucous membranes for therapeutic or protective action or cosmetic function • Semisolid dosage forms are intended for local drug delivery for treatment of conditions such as rashes, skin irritation, stings, infections (fungal, viral or bacterial) and infestations STEP 3: Ideal Properties of Semisolid Dosage Forms (20 minutes) |Activity: Buzzing (05 minutes) | | | |ASK students to pair up and buzz on the following question for 5 | |minutes | | | |What are the ideal properties of semisolid dosage forms? | | | |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 | • The ideal properties of semisolid dosage forms are divided into physical and physiological o Physical properties: ▪ Smooth texture ▪ Elegant (neat) in appearance ▪ Non dehydrating ▪ Non gritty (no small pieces of sand or dust) ▪ Non greasy and non-staining ▪ Non hygroscopic o Physiological properties: ▪ Non-irritating ▪ Do not alter membrane / skin functioning ▪ Miscible with skin secretion ▪ Have low sensitization effect • Generally semisolid dosage forms are easily applicable with efficient drug release and high aqueous wash ability STEP 4: Types and Uses of Semisolid Dosage Forms (65 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the types of semisolid dosage forms? | | | |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 | • The followings are the types of semisolid dosage forms with their corresponding uses o Ointments ▪ Are soft hydrocarbon based semisolid preparations, composed of fluid hydrocarbon meshed in a matrix of higher melting solid hydrocarbon, example petrolatum ▪ Ointments are of greasy nature thus they stain clothes, are generally poor solvent for most drugs and usually decrease the drug delivery capabilities of the system ▪ The main rule of the local therapy is that if the skin is dry, use an ointment o Creams ▪ Are viscous semisolid emulsion system with opaque appearance compared with the translucent ointments ▪ Consistency and rheological characters depend on whether the cream is water in oil (w/o) or oil in water (o/w) ▪ Properly designed water in oil creams are elegant drug delivery system, pleasing in both appearance and feel after application ▪ Oil in water creams are non-greasy and easy to rinse ▪ Creams are good for most topical purposes especially wet skin o Pastes ▪ Pastes are basically ointments into which a high percentage of insoluble solid has been added ▪ The extraordinary amount of particulate matter stiffens the system ▪ Pastes are less penetrating than ointments ▪ Pastes make particularly good protective barrier when placed on the skin. In addition to forming an unbroken film, the solid they contain can absorb and thereby neutralize certain noxious chemicals before they ever reach the skin ▪ Like ointments, pastes form an unbroken relatively water impermeable film ▪ Unlike ointments, the film is opaque and therefore, an effective sun block consequently o Gels (Jellies) ▪ Gels are semisolid coherent systems in which a liquid phase is constrained within a polymeric matrix (consisting of natural or synthetic gum) having a high degree of physical or chemical crosslinking ▪ Gels are transparent or translucent non-greasy semisolid gels ▪ Some gels are as transparent as water itself, have an aesthetically pleasing state while others are turbid because the polymer is present in colloidal aggregates that disperse light ▪ Gels are used for medication or lubrication o Poultices ▪ Are soft, viscous, pasty preparations for external use ▪ Poultice must retain heat for a considerable time because they are intended to supply warmth to inflamed parts

NTA Level 4 • Semester 1 • PST04104 Liquid Pharmaceutical Dosage Forms for Internal Use Pharmaceutical Dosage Forms • 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: Liquid Pharmaceutical Dosage Forms for Internal Use Total Session Time: 120 minutes + 2 hours assignment Pre-requisites • Session 1 : Introduction to dosage forms Learning Tasks By the end of this session students are expected to be able to: • Define Oral Liquid Dosage Form • Describe the Preparation of Oral Liquid Dosage Forms • Explain the Types of Oral Liquid Dosage Forms • List the Advantages and Disadvantages of Oral liquid Dosage Forms Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Projector • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 | |Brainstorming |Definition and Preparation of Oral | | |20 minutes |Presentation |Liquid Dosage Forms | |3 | |Presentation |Types of Oral Liquid Dosage Forms | | |60 minutes |Small Group | | | | |Discussion | | |4 |15 minutes |Presentation |Advantages and Disadvantages of Oral| | | |Buzzing |Liquid Dosage Forms | |5 |05 minutes |Presentation |Key Points | | 6 |05 minutes |Presentation |Evaluation | |7 |10 minutes |Presentation |Assignment | 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 and Preparation of Oral Liquid Dosage Forms (20 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is oral liquid dosage form? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Oral liquid dosage forms are essentially pharmaceutical products in a liquid form that involves the mixing of active drug component and non- drug components (excipient) to the suitable vehicle for oral use • They are usually prepared by: o Dissolving drug substance in to aqueous or non-aqueous (e.g. ether, alcohol, glycerine) solvent o Suspending the drug in appropriate medium o Incorporating the drug substance into water or oil phases • The preparation is done by the following stages : o Selection of small bottles and corks o Weighting of ingredients o Measurement of solvent(s) o Dissolution o Percolation or filtration o Packaging STEP 3: Types of Oral Liquid Dosage Forms (60 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the different types of oral liquid dosage forms? | | | |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 | • The types of oral liquid dosage forms include : o Syrups ▪ These are concentrated aqueous solutions of sucrose or other sugars to which medicaments or flavouring agents may be added ▪ Glycerol, sorbitol or any other polyhydric alcohol are sometimes added in small amounts to medicated syrups to retard crystallization of sucrose or increase solubility of other ingredients ▪ Flavouring syrups are usually used as vehicles or flavours for extemporaneous preparations o Elixirs ▪ These are clear, sweetened, hydroalcoholic liquids intended for oral use ▪ Available in liquid form for drugs which are stable in moisture and as flavoured powder or granules for reconstitution with water immediately before administration ▪ Paediatric elixirs are usually formulated with a fruit syrup as a base flavouring agent ▪ Dose is measured in 5mL or using a volumetric dropper o Linctuses ▪ Are viscous preparations usually prescribed for the relief of cough ▪ These preparations consist of the active pharmaceutical ingredient in high concentration of sucrose and other sweetening agents ▪ Usually possesses demulcent, expectorant or sedative properties ▪ The vehicle syrup has soothing effect on the soar mucous membrane of the throat o Suspensions ▪ Belongs to heterogeneous system ▪ The insoluble solid is dispersed as small particle in a liquid ▪ The solid is called the dispersed phase and the liquid is called continuous phase or dispersion medium ▪ The dispersion medium is usually aqueous but may occasionally be oily o Mixtures ▪ Are liquid oral preparations consisting of one or more medicaments dissolved or suspended in an aqueous vehicle, or occasionally in a suitable non aqueous vehicle o Solution ▪ A solution is a clear, homogeneous liquid dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents o Emulsions ▪ Is one of heterogeneous liquid dosage forms ▪ Consist of two immiscible phases one of which is finely subdivided and uniformly dispersed in the other, the continuous phase ▪ The system is stabilized by the presence of an emulsifying agent (emulgent) ▪ There are two main types of emulsions which are oil in water and water in oil emulsions STEP 4: Advantages and Disadvantages of Oral Liquid Dosage Forms (15 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the advantages and disadvantages of oral liquid dosage forms? | | | |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 | • Advantages o They are better for patients who have trouble swallowing solid dosage forms o Faster absorption than solids

NTA Level 4 • Semester 1 • PST04104 Liquid Pharmaceutical Dosage Forms for External Use Pharmaceutical Dosage Forms • 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: Liquid Pharmaceutical Dosage Forms for External Use Total Session Time: 120 minutes Pre-requisites • Session 1: Introduction to Pharmaceutical Dosage Forms • Session 3: Semisolid Pharmaceutical Dosage Forms • Session 4: Liquid Pharmaceutical Dosage Forms for Internal Use Learning Tasks By the end of this session students are expected to be able to: • Define Topical Liquid Dosage Forms • Explain the Types of Topical Liquid Dosage Forms • List the Advantages and Disadvantages of Topical Liquid Dosage Forms Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Presentation |Definition of Topical Liquid Dosage | | | |Brainstorming |Forms | |3 | |Presentation |Types of Topical Liquid Dosages | | |70 minutes |Small Group |Forms | | | |Discussion | | |4 |25 minutes |Presentation |Advantages and Disadvantages of | | | |Buzzing |Topical Liquid Dosage Forms | |5 |05 minutes |Presentation |Key Points | | 6 |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 Topical Liquid Dosage Form (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is a topical liquid dosage form? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Topical liquid dosage forms are essentially pharmaceutical products in a liquid form that involves the mixing of active drug component and non- drug components (excipient) to the suitable vehicle for topical use • The preparation procedures are similar as those used in oral liquid preparations • Are usually used for the treatment and relief of skin and mucous membrane conditions STEP 3: Types of Topical Liquid Dosage Forms (70 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the types of topical liquid dosage forms? | | | |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 | • Solutions o These are liquid preparations containing one or more soluble ingredient(s ) usually dissolved in water o Solutions have many appellations (designations) o For topical use, solutions may be issued sterile or unsterilized, depending on the intended use e.g. sterile for ophthalmic preparations (eye drops) or unsterile for skin and other mucous membrane preparations (nasal drops, ear drops, skin antiseptics, enemas) o Ear drops ▪ These are simple solutions of drugs in water, glycerol, propylene glycol or alcohol/water mixture for local use in the ear ▪ Ear drops may be prepared as antibiotics, anti-inflammatory, antiseptics, cleansing solutions and wax softeners o Eye Drops ▪ Are sterile solutions ▪ May contain active ingredients for use in conjunctivitis, contact lens rewetting(as lubricants),glaucoma, prevention of eye infections after surgery or transplant ,dry eye conditions ,allergic conditions and ophthalmic procedures o Nasal Drops ▪ Are small volume (isotonic) solutions for instillation into the nasal cavity ▪ Are used for local use and contain antibiotics, anti- inflammatories and decongestants o Enemas ▪ These are aqueous or oily solutions (also emulsions and suspensions) for rectal administration of medicaments for cleansing, diagnostic or therapeutic reasons • Lotions o Are liquid or semi-liquid preparations containing one or more active ingredients in a suitable vehicle intended for application to the unbroken skin to treat skin diseases/conditions or antiseptics, or as protectives o Lotions are applied on the skin without friction o Lotions may contain humectants so that moisture is retained on the skin after application of the product, or alcohol which evaporates quickly, imparting a cooling effect and leaving the skin dry o Examples of lotions ▪ Calamine lotion BP ▪ Sulphur lotion, Compound BP ▪ Antifungal lotion ▪ Zinc sulphate lotion BP • Liniments o Are liquid preparations intended for massage into the skin o They can contain counter-irritant ingredients such as methyl salicylate or camphor o Examples include Liniment alba • Colloids and Paints o Liquids for application on mucous membranes or skin in small amounts with a brush are called paints o Colloids are similar to paints but leave a tough, flexible film which seals small cuts or hold a drug in intimate contact with the skin • Gargles and Mouth Washes o Are aqueous solutions for prevention and treatment of mouth and throat infections o They usually contain antiseptics, analgesics, and or astringents o They are usually diluted with water before use STEP 4: Advantages and Disadvantages of Topical Liquid Dosage Forms (25 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the advantages and disadvantages of topical liquid dosage | |forms? | | | |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 | • Advantages o Avoidance of first pass metabolism o Convenient and easy to apply o Avoids fluctuations in drug levels o Ability to terminate medication

NTA Level 4 • Semester 1 • PST04104 Parenteral and Gaseous Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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: Parenteral and Gaseous Pharmaceutical Dosage Forms Total Session Time: 120 minutes Prerequisites • Session 1 : Introduction to pharmaceutical dosage forms Learning Tasks By the end of this session students are expected to be able to: • Define Gaseous and Parenteral Dosage forms • Explain the Types of Parenteral Dosage Forms • Explain the Ideal Properties of Parenteral Dosage Forms • List the Advantages and Disadvantages of Parenteral Dosage Forms • List the Advantages and Disadvantages of erosols • Describe the Aerosols Packaging Components Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Presentation |Definition of Parenteral Dosage Form| | | |Brainstorming | | |3 |20 minutes |Presentation |Types of Parenteral Dosage Forms | |4 |10 minutes |Presentation |Ideal Properties of Parenteral | | | | |Dosage Forms | |5 | |Presentation |Advantages and Disadvantages of | | |25 minutes |Small group |Parenteral Dosage Forms | | | |discussion | | |6 |05 minutes |Presentation |Definition of Gaseous/Aerosols | | | |Brainstorming |Dosage Forms | |7 |20 minutes |Presentation |Advantages and Disadvantages of | | | |Brainstorming |Aerosols | |8 |15 minutes |Presentation |Aerosols Packaging Components | |9 |05 minutes |Presentation |Key Points | | 10|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 Parenteral Dosage Form (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What are parenteral dosage forms? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Parenteral dosage forms are those preparations which are intended for injection through the skin or other external boundary tissues • They are completely sterile and pyrogen free • Are given by injection either direct into the bloodstream or into the tissues • The routes used are subcutaneous, intravenous, intramuscular, intraarticular or intrathecal STEP 3: Types of Parenteral Dosage Forms (20 minutes) • According to the USP, injectable materials are divided into five general types o Injections ▪ Injections are liquid preparations, e.g. Insulin o For injections ▪ For injections are dry solids, that upon suitable solvent, give solutions conforming in all respects to the requirements for injections, e.g. Cefuroxime o Injectable emulsions ▪ It is liquid drug preparation dissolved or dispersed in a suitable emulsion medium, e.g. Propofol o Injectable suspension ▪ It is liquid preparation of solid drug suspended in a suitable liquid medium, e.g. Methyl- Prednisolone acetate suspension o For Injectable suspension ▪ It is dry solid drug that upon addition of suitable vehicle, yields suspension preparation conforming in all respects to the requirements for injectable suspensions, e.g. Imipenem and Cilastatin for injectable suspension STEP 4: Ideal Properties of Parenteral Dosage Forms (10 minutes) • The ideal parenteral medication should be: o Sterile (completely free from living micro-organisms) o Pyrogenic free o Free from microbial products such as toxins o Free from physical and chemical contaminants o ISOTONIC (i.e.; their osmotic pressure should be the same as that of body fluids) STEP 5: Advantages and Disadvantages of Parenteral Dosage Forms (25 minutes) |Activity: Small Group Discussion ( 10 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the advantages and disadvantages of parenteral dosage forms? | | | |ALLOW students to discuss for 10 minutes | | | |ALLOW few groups to present and the rest to add points not mentioned | | | |CLARIFY and SUMMARIZE by using the contents below | • Advantages: o For immediate action (as for emergency) o For drugs that cannot be given via enteric route of administration, e.g.insulin o Amount of solution to be administered can be varied from millilitres to litres. o For medical treatment, when drugs cannot be given orally for example children and unconscious patients o Suitable for modified form of drugs • Disadvantages: o Need trained personnel to administer the drug(s) o Injections cause pain at the site of injection o The administration of the drug through wrong route may be fatal o It is difficult to save the patient when wrong drug or over-dose is given o Need aseptic conditions for application STEP 6: Definition of Gaseous/Aerosol Dosage Forms (5 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is an aerosol? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Aerosol o Is a product containing therapeutically active ingredients dissolved, suspended, or emulsified in a propellant under pressure o In general an aerosol is a colloidal dispersion of solid or liquid particles in a gas o It is intended for inhalationor topical administration or administration into body cavities STEP 7: Advantages and Disadvantages of Gaseous/ Aerosol Dosage Forms (20 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What are the advantages of aerosol dosage forms? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE

NTA Level 4 • Semester 1 • PST04104 Routes of Drug Administration Pharmaceutical Dosage Forms • 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: Routes of Drug Administration Total Session Time: 120 minutes Prerequisites • None Students Learning Tasks By the end of this session students are expected to be able to: • Define Route of Drug Administration • Explain the Major Routes of Drug Administration • Explain Advantages and Disadvantages of Each Route of Drug Administration Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Presentation |Definition of Route of Drug | | | |Brainstorming |Administration | |3 |15 minutes |Presentation |Major Routes of Drug Administration | | | |Buzzing | | |4 | |Presentation |Advantages and Disadvantages of Each| | |80 minutes |Small group |Route of Drug Administration | | | |discussion | | |5 |05 minutes |Presentation |Key Points | |6 |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 Route of Drug Administration (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is a route of drug administration? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • A route of drug administration is the path by which a drug is brought into contact with the human body • The choice of which route of drug administration to be used depends on two factors which are: o The existing preparations of the drug o The state of the patient: Emergency or the impossibility of intake to some routes • When administering a drug, ensure that the pharmaceutical preparation is appropriate for the route specified STEP 3: Major Routes of Drug Administration (15 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the major routes of drug administration? | | | |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 | • There are four major routes of drug administration which are commonly used: o Enteral route ▪ This is the route which involves part of gastrointestinal tract ▪ Drugs are absorbed into the bloodstream and pass through the liver on the way to their target organ/tissue ▪ Enteral route includes Oral route, Sublingual route, Buccal route and Rectal route o Parental route ▪ This involves injection via a hollow needle into the body at various sites and to varying depth ▪ Parenteral routes includes Intradermal, Subcutaneous route (S.C), Intramuscular route (I.M), Intravenous injections (I.V) o Topical route ▪ Drugs are applied topically to the skin or mucous membranes, mainly for local action o Inhalation route ▪ Medication is sprayed or inhaled into nose, throat, and lungs STEP 4: Advantages and Disadvantages of Each Route of Drug Administration (80 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the advantages and disadvantages of the different routes of | |drug administration? | | | |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 | Enteral Route • Oral route: The mouth is commonly used route for administering drugs o Advantage of oral route administration ▪ Most convenient to use ▪ Safe, does not break the skin barrier ▪ The gastrointestinal tract provides a huge surface area for absorption ▪ The drug can be taken at home by a patient ▪ Portable ▪ No pain, easy to take o Disadvantage of oral route administration ▪ Absorption can be variable and depends on the chemical properties of a drug such as ionization, solubility and stability ▪ Absorption can also depend on the stomach contents. For example the absorption of tetracycline is inhibited in the presence of milk ▪ Drugs may affect gastric emptying and this may affect absorption ▪ Inappropriate for patient with nausea and vomiting ▪ Drug may have unpleasant taste and odour ▪ Inappropriate if patient cannot swallow or is unconscious ▪ Drugs may irritate gastric mucosa ▪ Some of the drugs may be partially absorbed or destroyed by the gastric juices example insulin • Sublingual route o The medication is placed under the tongue and allowed to dissolve slowly ▪ Because of the rich blood supply in this region, there is rapid onset of the action ▪ The patient is instructed not to move the drug with the tongue not to eat or drink anything until the medication has completely dissolved o Advantage of sublingual route administration ▪ Same as oral route, plus ▪ Drug can be administered for the local effects ▪ More potent than oral because the drug directly enter the circulation and bypasses the liver metabolism(first pass effect) o Disadvantage of sublingual route administration ▪ If swallowed drug may be inactivated by gastric juice ▪ Drug must remain under the tongue until dissolved and absorbed • Buccal route o The tablet or capsule is placed in the oral cavity between the

NTA Level 4 • Semester 1 • PST04104 Components of Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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: Components of Pharmaceutical Dosage Forms Total Session Time: 120 minutes Prerequisites • Session 1 : Introduction to pharmaceutical dosage forms • Session 2: Solid pharmaceutical dosage forms Learning Tasks By the end of this session students are expected to be able to: • Mention Major Components of Pharmaceutical Dosage Forms • Define a Pharmaceutical Excipient • Mention General Uses of Pharmaceutical Excipients • Explain Different Classes of Pharmaceutical Excipients Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 | |Presentation |Major Components of Pharmaceutical | | |10 minutes |Brainstorming |Dosage Forms | |3 |20 minutes |Presentation |Definition and General Uses of | | | |Buzzing |Pharmaceutical Excipients | |4 | |Presentation |Classes of Pharmaceutical Excipients| | |70 minutes |Small Group | | | | |Discussion | | |5 |05 minutes |Presentation |Key Points | | 6 |10 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: Major Components of Pharmaceutical Dosage Forms (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What are the major components of any pharmaceutical dosage form? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Major components of any pharmaceutical dosage form are: o Active Pharmaceutical Ingredient (API) ▪ This is the pharmacologically active component of the dosage form o Excipient ▪ This is the pharmacologically inert substance that is mixed with the API for various purposes STEP 3: Definition and General Uses of Pharmaceutical Excipients (20 minutes) • Definition of Pharmaceutical excipient o Is usually an inert substance added to the drug to give suitable consistency or definite form to the drug o It is a pharmacologically inactive (inert) substance that is formulated with the active pharmaceutical ingredient o Pharmaceutical excipients are also known as pharmaceutical necessity or aids • General uses of pharmaceutical excipients |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the general uses of pharmaceutical excipients? | | | |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 | o Pharmaceutical excipients are added for various purposes including: ▪ To facilitate handling of the active pharmaceutical ingredient during manufacturing ▪ To prevent denaturation of the dosage form ▪ Ease of administration to the target patient population(s) by the intended route ▪ To improve dosing compliance ▪ To allow for consistency and control of drug bioavailability ▪ To enable bioavailability ▪ To improve Active Pharmaceutical Ingredient (API) stability including protection from degradation ▪ To ensure a robust and reproducible physical product STEP 4: Classes of Pharmaceutical Excipients (70 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the classes of pharmaceutical excipients? | | | |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 | • Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the dosage form • Important classes of pharmaceutical excipients include the followings; o Antioxidants o Preservatives o Humectants o Buffering agents (Acidifying and alkalizing agents) o Chelating agents o Colouring agents o Flavouring agents o Surface Active Agents o Solvents and co-solvents • Antioxidants o Are substances that are added into pharmaceutical dosage forms for the purpose of inhibiting oxidation in products that are subject to deterioration by oxidation processes o Common antioxidants include Ascorbic acid and Alpha Tocopherol • Preservatives o Are substances that prevent or inhibit growth of microorganisms o They are added to avoid spoilage of pharmaceutical preparations by microorganisms o Common preservatives include methyl paraben, ethyl paraben, propyl paraben, benzoic acid, sodium benzoate, Benzalkonium chloride, Benzyl alcohol, Chlorobutanol and Phenol • Humectants o Minimize water loss from pharmaceutical preparations i.e. they prevent drying out of a pharmaceutical preparation to ▪ Prevent drying of the product after application to the skin ▪ Prevent drying of product from the container after first opening ▪ Prevent cap-locking caused by condensation onto neck of container closure of a container after first opening o Examples of humectants are Propylene glycol, Glycerol and Polyethylene glycol • Sweetening Agents o Are substances that are added in oral liquid preparations in order to increase palatability of the therapeutic agent i.e. to mask unpleasant taste of the medicine • Acidifying agents o Are substances used in liquid preparations to provide acidic medium for the product stability • Alkalizing agents o Are substances that are used in liquid preparations to provide alkaline medium of product stability • Chelating agents o Are molecules with ability to bind metal ions and hence prevent auto- oxidation phenomena frequently catalysed by metal ions o Added to prevent auto-oxidation of drug molecules by metallic ions such as Iron ions • Colouring agents o These are substances

NTA Level 4 • Semester 1 • PST04104 Stability of Pharmaceutical Dosage Forms Pharmaceutical Dosage Forms • 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: Stability of Pharmaceutical Dosage Forms Total Session Time: 120 minutes Prerequisites • Solid, Liquid, Semisolid and Gaseous/aerosol dosage forms Learning Tasks By the end of this session students are expected to be able to: • Define Stability and State the Effects of Instability of Dosage Forms • Explain Physical, Chemical and Microbiological Stabilities of Dosage Forms • Factors Affecting Stability of Pharmaceutical Dosage Forms • Explain Effect of Packaging Material on Stability of Pharmaceutical Dosage Forms • Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board, chalk and whiteboard markers • Projector • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |10 minutes |Presentation |Definition of Stability and the | | | |Brainstorming |Effects of Instability of Dosage | | | | |Forms | |3 | |Presentation |Chemical, Physical and | | |60 minutes |Small Group |Microbiological Stabilities of | | | |Discussion |Dosage Forms | |4 |20 minutes |Presentation |Factors Affecting Stability of | | | |Buzzing |Pharmaceutical Dosage Forms | |5 |15 minutes |Presentation |Effects of Packaging Materials on | | | |Buzzing |Stability of Pharmaceutical Dosage | | | | |Forms | |6 |05 minutes |Presentation |Key Points | | 7 |05 minutes |Presentation |Evaluation | 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: Definition of Stability and The Effects of Instability (10 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is stability of a drug or dosage form? | | | |ALLOW few students to respond? | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Stability is the capacity of a drug/dosage form product to remain within specifications established to ensure its identity, strength quality and purity • It must retain, within specified limits, and throughout its period of storage and use (shelf-life), the same properties and characteristics that it possessed at the time of its manufacturing • The instability of a drug/dosage form may cause: o Undesired change in performance, i.e. dissolution/bioavailability o Substantial changes in physical appearance o Product failures STEP 3: Chemical, Physical and Microbiological Stabilities of Dosage Forms (60 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the implications of physical, chemical and microbiological | |stabilities to pharmaceutical dosage forms? | | | |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 | • There are three types of stability of pharmaceutical dosage forms o Physical stability o Chemical stability o Microbiological stability • Physical stability-implies : o The formulation is totally unchanged throughout its shelf life and has not suffered any changes by way of appearance, organoleptic properties, hardness, brittleness and particle size o It is significant as it affects: ▪ Pharmaceutical elegance ▪ Drug content uniformity ▪ Drug release rate and bioavailability o Examples of physical instabilities include: ▪ Loss in flavour, change in taste and precipitation of solutions ▪ Settling and caking of suspensions ▪ Creaming of emulsions ▪ Creaking of tablets ▪ Calescence of ointments • Chemical stability implies: o The lack of any decomposition in the chemical group that is incorporated in the formulation as the drug, preservatives or any other excipients o This decomposition may influence the physical and chemical stability of the formulation o Decomposition occur by degradation mechanisms which are: ▪ Hydrolysis – splitting by water ▪ Oxidation – loss of electrons and the loss of a molecule of hydrogen ▪ Photolysis – decomposition by light which can be prevented by suitable packing in amber coloured bottles, cardboard outers and aluminium foil over wraps o It is significant as it affects: ▪ Efficacy and therapeutic effects of a drug ▪ Safety of the drug ▪ Physical properties of a drug such a colour, flavour and taste • Microbiological stability implies that: o The formulation has not suffered from any microbiological attack and is meeting the standards with respect to sterility or lack of contamination o The sources of microbiological contamination can be: ▪ Water and air as they contain microorganisms ▪ Personnel during manufacturing, packaging and storage processes ▪ Raw materials o Microbiological contamination occurs mostly during storage and in order to prevent it, there must be: ▪ Suitable designed containers ▪ Containers for single dose use ▪ Proper storage conditions ▪ Preservative as antimicrobial substance e.g. benzoic acid o It is significant as it affects/causes: ▪ Physical properties of a drug ▪ Sterility of a drug(important for injections and other drugs applied direct to the systemic circulation) ▪ Risk of infection to the patient STEP 4: Factors Affecting Stability of Pharmaceutical Dosage Forms (20 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What are the factors affecting stability of the pharmaceutical dosage | |forms? | | | |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 | • Temperature o High temperature accelerates oxidation, reduction and hydrolysis

NTA Level 4 • Semester 1 • PST04104 Pharmaceutical Packaging Materials Pharmaceutical Dosage Forms • 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: Pharmaceutical Packaging Materials Total Session Time: 120 minutes + 1 hour Assignment Prerequisites • None Learning Tasks By the end of this session students are expected to be able to: • Define a Pharmaceutical Packaging Material • Explain Characteristics and Selection Criteria of Pharmaceutical Packaging Materials • Explain the Role of Pharmaceutical Packaging Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • Overhead projector (OHP) • Computer SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |15 minutes |Presentation |Definition of a Pharmaceutical | | | |Brainstorming |Packaging Material | |3 |60 minutes |Presentation |Characteristics and Selection | | | |Small group |Criteria of Pharmaceutical Packaging| | | |discussion |Materials | |4 | |Presentation |The Role of Pharmaceutical Packaging| | |30minutes |Buzzing | | |5 |05 minutes |Presentation |Key Points | |6 |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 Pharmaceutical Packaging Material (15 minutes) |Activity: Brainstorming (5 minutes) | | | |Ask students to brainstorm on the following question: | | | |What is a pharmaceutical packaging material? | | | |ALLOW few students to respond | | | |WRITE their responses on the flip chart/ board | | | |CLARIFY and SUMMARISE by using the content below | • Packaging material is any material employed in the packaging of medicinal products, excluding any outer packaging used for transportation or shipment • Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product • Packaging component is any single part of a container closure system • Typical components are Containers , Container liners, Closures, Closure liners, Stopper over seals and Container inner seals • Primary packaging component is the one that is or may be in direct contact with the dosage form • Secondary packaging component is the one that is not and will not be in direct contact with the dosage form STEP 3: Characteristics and Selection Criteria of Pharmaceutical Packaging Materials (60 minutes) |Activity: Small Group Discussion ( 30 minutes) | | | |DIVIDE students into small manageable groups | | | |ASK students to discuss on the following question | |What are the characteristics to consider when selecting the | |pharmaceutical packaging materials? | | | |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 | The pharmaceutical packaging materials selected must have the following characteristics: • Suitability o The packaging materials should be suitable to the pharmaceutical product in terms of compatibility, safety and protection • Compatibility o The container closure system should be compatible with the product components o It should not cause unacceptable changes in the quality due to adsorption/absorption of the API/excipients, leachable / extractable, precipitation, pH changes or discoloration of the product or the packaging • Safety o Packaging materials should not leach harmful or undesirable amounts of substances o This is important particularly for those containers which are in direct contact with the product, for example, unreacted monomers and process impurities such as antioxidants in plastics o In some cases, substances may migrate from secondary components (e g. Ink and adhesives) • Protection o The container closure system should protect the product from factors that cause deterioration such as: ▪ Exposure to light ▪ Exposure to reactive gases such as oxygen ▪ Absorption of water vapour ▪ Loss of solvent ▪ Microbial contamination ▪ Exposure to other contamination sources such as dirt and dust • It should be cheap, economical and easy to label STEP 4: The Role of Pharmaceutical Packaging (30 minutes) |Activity: Buzzing (5 minutes) | | | |ASK students to pair up and buzz on the following question for 2 | |minutes | | | |What is the role of pharmaceutical packaging? | | | |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 | • Protecting the product from the environment and vice versa o Being an effective barrier to light, moisture, oxygen, bacteria, volatiles o Protection from damage • Providing all necessary information for: o Identification, preparation if required (e.g. reconstitution, dilution), use of the medicine including precautions o Storage and shelf-life of in-use product o Appropriate disposal of any unused medicine and the packaging itself • Enabling accurate dosing and compliance o For example, spoons, cups or syringes for oral dose measurement and delivery • Ensuring supply-chain integrity of the medicine o E.g. Anti-counterfeiting measures STEP 5: Key Points (5 minutes) • Pharmaceutical packaging material is any material employed in the packaging of medicinal products, excluding any outer packaging used for transportation or shipment • Pharmaceutical packaging materials should be chosen basing on suitability , compatibility, safety and protection • It is important to pack pharmaceutical products in order to protect and identify them STEP 6: Evaluation (5 minutes) • What is a pharmaceutical packaging material? • What are the characteristics of pharmaceutical packaging materials? • Why is it important to pack pharmaceutical products? References Aulton, M.E.,Taylor, M.K. (2001). Pharmaceutics: The Science of dosage form design (2nd ed.). USA: Churchill Livingstone. Cooper, J.W., Gunns, C., & Carter, S.J. (2008). Dispensing for Pharmaceutical Students (12th end).