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Introduction to Dosage Forms, solids, liquids, semi-solids, gaseous
- 1. INTRODUCTION TO DOSAGE FORMS By: Mr. Bhavin D. Pandya M.Pharm (Pharmaceutical Technology) Assistant Professor Department of Pharmaceutics Krishna School of Pharmacy & Research (KSP) Drs. Kiran & Pallavi Patel Global University (KPGU)
- 2. CONTENTS • Introduction • Classification of dosage forms Solid dosage forms Liquid dosage forms Semi solid dosage forms
- 3. DOSAGE FORM OF DRUGS • Dosage forms are the means by which drug molecules/APIs are delivered to sites of action within the body to produce optimum desired effects and minimum adverse effect. Need of Dosage Forms Drug Safety/Benefit Patient Safety/Benefit
- 4. INTRODUCTION Dosage form (Medicines) = API + Excipients The means (or the form) by which drug molecules are delivered to sites of action within the body. Drug (Active pharmaceutical ingredients ) Chemical compound intended for used in diagnosis, treatment prevention of disease. OR The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects. Excipients o Do not increase or affect the therapeutic action of the activeingredient. oInactive ingredients may also be referred to asinert ingredients or excipients, and generally have no pharmacological effect. oExamples of inactive ingredients include binding materials, dyes, preservatives, and flavoring agents,sweetening agents,coloring agents etc.
- 5. TYPES OF EXCIPIENTS For Tablets and Capsules, • Diluents (Fillers), Binders, Disintegrants, Coating agents, Lubricants, Glidants, Colouring agents, Sweetening agents, etc. For Liquids, • Solvents, Colouring agents, Sweetening agents, Preservatives, etc.
- 6. DIRECT CLINICAL USE OF THE ACTIVE DRUG SUBSTANCES IS RARE: WHY?? API handling and Accurate dosing can be difficult or impossible (e.g., potent drugs: low mg and µg doses). API administration can be impractical/unfeasible because of size, shape, smell/odour, taste and low activity. SomeAPI are chemically unstable in light, moisture,Oxygen. API can be degraded at the site of administration (e.g., low pH in stomach). API may cause local irritations or injury when they are present at high concentrations at the site of administration. Administration of active substance would mean to have no chance for modification (improvement) of its PK profile.
- 7. NEED OF DOSAGE FORMS Provide safe and convenient delivery of accurate dosage. Example – T ablets, capsules, syrups Protection of a drug substances from atmospheric oxygen or moisture. Example – Coated capsules, sealed ampoules Protection of a drug substances from gastric acid after oral administration. Example – Enteric coated tablets Conceal bitter taste, or odor of a drug substances. Example – Capsules, coated tablets, flavored syrups Provide liquid preparation of drug that insoluble or unstable in the desired vehicle. Example – Suspension Provide liquid dosage forms of substances soluble in desired vehicle. Example – Solution.
- 8. Provide optional drug action from topical administration sites. Example – Ointment, cream, ear and nasal preparations. Provide for insertion of a drug into one of the body’s orifices. Example – Rectal and vaginal suppositories. Provide extended drug action through controlled release mechanisms. Example – Controlled release tablets, capsules,suspensions. Provide for the placement of drugs within body tissues. Example – Implants. Provide for the optimal drug action through inhalation therapy. Example – Inhalants.
- 9. CLASSIFICATION Soliddosage forms Liquiddosage forms Semisoliddosage forms Unitdosage forms Tablets Capsule Bulk Powders Pills Internal Fine powders& granules External Dustingpowders Insufflations Dentifrice Snuffs Earpowders Biphasic Monophasic Emulsion Suspension Internal External Ointment Creams pastes Jellies Suppositories Pessaries Liniments Lotions Gargles Throat paints Mouth washes Sprays Eye lotions Eye drops Nasal drops External Internal Syrups Elixirs Linctus Drops
- 10. CLASSIFICATION OF DOSAGE FORMS Based on Route of Administration Oral Parenteral Topical Transdermal Respiratory/Inhaled Ophthalmic Rectal V eginal Otic Based on Physical Form Solid Semi-solid Liquid Gases
- 11. BASED ON ROUTE OF ADMINISTRATION Enteral Route Oral Tablets, Capsules, Syrups, Suspension, Emulsionetc. Dry Powder Inhaler (DPI), Pressurized Metered Dose Inhaler (PMDI) – Nebulizer,Vaporizer Sub-lingual & Buccal Orally Disintegrating Tablet (ODT), Lozenges , Chewingtablets, Mouthwash, Toothpaste, Ointment, Oralspray Rectal & Vaginal Ointment, Suppository, Enema, Nutrient enema Parenteral (injections &infusions) Intravenous, Intramuscular, Intracardiac, Intraosseous, Intraperitoneal, Intracerebral, Intrathecal, Intradermal, Subcutaneous Topical Route Dermal Ointment, Liniment, Paste, Cream, Lotion, Lip balm, Medicated shampoo, Dermal patch Mucosal Ear drops, Eye drops, Nasal spray, Ointment, Hydrogel, Nanosphere suspension, Mucoadhesive microdisc(microsphere tablet) Percutaneous Transdermal patch etc
- 12. Solid Dosage Forms Shaped Tablets, Capsules, Implants, Transdermal patches Unshaped Powders for external/internaluse Semi-solid DosageForms Shaped Suppositories (for rectaladministration) Pessaries (vaginal suppositories) Unshaped Gels, Creams, Ointments, Pastes Liquid Dosage Forms Monophasic Solutions (syrups, spirits, elixirs, tinctures) Biphasic Emulsions, Suspension External Solutions Lotions, Liniments, Collodions etc Gaseous Dosage Forms Medicinal Gases Aerosols: Inhalation/volatileanesthetics Aerodispersions Antiasthmatics sprays BASED ON PHYSICAL FORM
- 13. CLASSIFICATION OF SOLIDS SOLID ORAL DOSAGE FORMS Tablets Capsules Powder Granules
- 15. Monophasic Liquid Dosage Forms Liquid forExternal administration Liquidsused in Mouth Liquid appliedto the skin Liquidsinstilled into Body Cavities Liquid forInternal administration - Syrups - Mixtures - Elixirs - Linctuses - Gargles - Mouthwashes - Throat paints - Lotions - Liniments - Collodions - Paints - EyeDrops - EarDrops - Nasal Drops - Douches - Enemas CLASSIFICATION OF LIQUIDS
- 16. BIPHASIC LIQUID DOSAGE FORMS Solids inLiquid Oral Parenteral External Liquid inLiquid Oral External SUSPENSION LOTION EMULSION LINIMENTS
- 19. Nose Lung Inhalation Gases Liquids Aerosols Solids Liquids Aerosols Semi- solids Solids V apors Medical gases Solution Suspension Emulsion MDIs DPIs Other pressure systems DPIs Solution Suspension Emulsion MDIs Gels Powdersfor inhalation INHALED DOSAGE FORMS
- 20. RECTAL & VAGINAL DOSAGE FORMS RECTAL& VAGINAL Suppository Enema Pessaries
- 21. SOLID DOSAGE FORMS 1 -TABLET Atablet is unit dose of one or more medicament. Prepare by compression ormould method. Common excipients used in tablet are: Diluents – Provide bulkiness of tablet. Disintegrants – Toensure that the tablet breaks up in the digestive tract. Binder – Important for granulation ofpowder. Glidants and Lubricants – Provide good flow and ensure efficienttabletting. Sweeteners and Flavors – Tomask the taste ofAPIs. Pigments – Tomask uncoated tablets visually attractive. Acoating may be applied to mask taste, smooth tablet for easyswallow, expending shelf life, and prevent gastric degradation of drug.
- 22. BUCCAL AND SUBLINGUAL TABLET Buccal tablets placing between the gum and the cheek. Sublingual tablets placing under the tongue. Medicaments of both systems rapidly dissolve in mouth and absorbed throughthe mucous membrane of mouth. Drug reaches in systemic circulation without affecting by gastric juicesand metabolizing enzymes of the liver. Examples – Vasodilators, Steroidal hormones.
- 23. EFFERVESCENT TABLET Effervescent tablets are uncoated and generally contain acid substances(citric and tartaric acids) and carbonates or bicarbonates , which react rapidly in presence of water and release carbon dioxide. They are intended to be dissolved or dispersed in water before use, it provide : Tabletimmediately dissolve or dispersed Pleasant taste of carbonated drink CHEW ABLETABLET They are tablets that chewed prior to swallowing. They are designed for administration to children e.g. vitamin products.
- 24. CAPSULES Solid unit dosage form that contain a solid, semi-solid, and liquid fill and agelatin shell. Common excipients used in capsules are : Gelatin – Commonly used as gelling agent. Plasticizers – Toensure elasticity or mechanical stability. AdditionalAdditives – Preservative, coloring and opacifying agents . They are mainly two types are : Hard gelatin capsules used for dry powder ingredients. Soft gelatin capsules used for semi-solid and for active ingredients that are dissolved or suspended in oil.
- 25. LOZENGE It is a solid preparation that used to medicate the mouth and throat for the slow administration of indigestion or cough remedies. It consisting of sugar and gum, the latter giving strength and cohesiveness tothe lozenge and facilitating slow release of the medicament. PASTILLES It is a solid medicated pill or candy preparation that design to dissolve slowly in the mouth. They are softer than lozenge and their base are glycerol, gelatin, acacia andsugar.
- 26. DENTAL CONES Atablet from intended to be placed in the empty socket following a toothextraction, for preventing the local multiplication of pathogenic bacteria associated with tooth extractions. These tablets contain an excipients like – lactose, sodium bicarbonate, andsodium chloride etc. Cones may contain an antibiotic or antiseptic. PILLS It is a solid oral dosage form which consists of spherical masses prepared from one or moreAPIs with inertexcipients. Pills are now rarely used.
- 27. ORAL GRANULES They are consisting of solid, dry aggregates of powder particles withirregular shape often supplied in single-dose sachets. Some granules are placed under the tongue and swallowed with water and other are intended to be dissolved in water before taking. Effervescent granules evolve carbon dioxide when added to water. ORALPOWDER Bulk Powders are multi dose preparations consisting of solid, loose, dry particlesof varying degrees of fineness. Contain one or more active ingredients, with or without excipients and, if necessary, coloring matter and flavoring substances. Usually contain non-potent medicaments such as antacids since the patient measures a dose by volume using a 5 ml medicine spoon.
- 28. LIQUID DOSAGE FORMS ORAL SOLUTION Oral solutions are clear Liquid preparations for oral use containing one or more active ingredients dissolved in a suitable vehicle. ORAL EMULSION Oral emulsions are stabilized oil-in-water dispersions, either or both phases of which may contain dissolved solids either oil is dispersed in finely divided form in water or vice versa. ORAL SUSPENSION Biphasic liquid preparations for oral use containing one or more active ingredients suspended in a suitable vehicle. It sediment which is readily dispersed on shaking to give a uniform suspension which remains sufficiently stable to enable the correct dose to be delivered.
- 29. SYRUP It is a concentrated aqueous solution of a sugar, usually sucrose towhich medicaments are added. Flavored syrups are a convenient form of masking disagreeabletastes. ELIXIR It is pleasantly flavored clear liquid oral preparation of potent or nauseousdrugs. The vehicle may contain a high proportion of ethanol or sucrose togetherwith antimicrobial preservatives which confers the stability of the preparation. MOUTHWASHES These are similar to gargles but are used for oral hygiene and to treatinfections of the mouth.
- 30. LINCTUSES It is viscous, liquid oral preparations that are usually prescribed for the relief of cough. It contain high proportion of syrup and glycerol which have a demulcent effect on the membranes of the throat. The dose volume is small (5ml) and, to prolong the demulcent action, they should be taken undiluted. ORAL DROPS Oral drops are liquid preparations for oral use that are intended to be administered in small volumes with the aid of a suitable measuringdevice. They may be solutions, suspensions or emulsions.
- 31. GARGLES They are prepared in a concentrated solution with directions for thepatient to dilute with warm water before use. They are aqueous solutions used in the prevention or treatment of throatinfections. LOTIONS It is mono-phasic liquid preparations (aqueous) for external application without friction either dabbed on the skin or applied on a suitable dressing and covered with a water proof dressing to reduce evaporation. NASALDROPS & SPRA YS Drugs in aqueous solution may be instilled into the nose from a dropper or froma plastic squeeze bottle. Used for local effect, e.g. antihistamine, decongestant.
- 32. COLLODION Collodion is a solution of nitro cellulose in ether or acetone, some timeswith the addition of alcohols. As the solvent evaporates, it dries to a celluloid-likefilm. It is highly flammable. Compound Wart Remover consists of acetic acid and salicylic acid inan acetone collodion base used in treatment of warts by Keratolysis. PAINTS Paints are mono-phasic liquids for application to the skin or mucous membranes. Skin paints contain volatile solvent that evaporates quickly to leave adry resinous film of medicament. Throat paints are more viscous due to a high content of glycerol that designed to prolong contact of the medicament with the affectedsite.
- 33. PARENTERAL DOSAGE FORMS • Intravenous Injection • It is a liquid administered directly into the bloodstream via a vein. (30 degree angle) • It is advantages when a rapid onset of action is needed. • Intramuscular Injection • It is the injection of aAPIs directly into a muscle. • Intramuscular injections are often given in the deltoid, vastus lateralis, ventrogluteal and dorsogluteal muscles. (90 degree angle) • Subcutaneous Injection • It is injecting into the subcutis, the layer of skin directly below the dermis and epidermis. (45 degree angle) An injection is an infusion method of putting liquid in to the body,usually witha hollow needle and a syringe which is pierced through the skin.
- 34. SEMI-SOLID DOSAGE FORMS OINTMENTS Ointments are semi-solid, greasy preparations for application to the skin, rectum or nasal mucosa. Base is usually anhydrous and immiscible with skin secretions. Ointments may be used as emollients or dissolved medicaments to the skin. GELS In gel a liquid phase is constrained with in a 3-D polymeric matrix (consistingof natural or synthetic gum) having a high degree of physical or chemical cross- linking. It is used for medication, lubrication and some miscellaneous applicationslike carrier for spermicidal agents to be used intra vaginally.
- 35. CREAMS Oil-in-water (O/W) • It composed of small droplets of oil dispersed in a continuous aqueous phase. • Less greasy and more easily washed off using water. Water-in-oil (W/O) • It composed of small droplets of water dispersed in a continuous oily phase. • More difficult to handle but used for hydrophobic drugpreparation. • Reduces water loss fromthe stratum corneum maintain moisture of skin.
- 36. PASTES Pastes are basically ointments into which a high percentage of insoluble solidhas been added. The extra ordinary amount of particulate matter stiffens the system. It provide less heating and penetration than ointment. It make good protective barrier when placed on the skin, the solid theycontain can absorb and thereby neutralize certain noxious chemicals before they ever reach the skin. GreasyPastes • Leaser’s paste Non-greasyPaste • Bassorin paste
- 37. INHALED DOSAGE FORMS INHALER Inhalers are solutions, suspensions or emulsion of drugs in a mixture of inert propellants. Release of a dose of the medicament under pressure in an aerosol dispenser in the form of droplets of 50 um diameter or less from the container through a spring loaded valve incorporating a metering device. It is commonly used in the treatment of asthma and other respiratory problems.
- 38. NEBULIZER OR ATOMIZER It is commonly used in treating asthma, and other respiratory diseases. It is a device used to administer medication in forms of a liquid mist to the air ways. It pumps air or oxygen through a liquid medicine to turn it into a vapor, which isthen inhaled by the patient. Generally prefer to inhalers for patients, due to advantages suchas: 1- Cheaper 2 More portable 3 Less risk of side effects. For that reason, are usually reserved only for serious cases of respiratory disease or severe attacks.
- 39. RECTAL & VAGINAL DOSAGE FORMS SUPPOSITORY It is a semi solid medicated mass, usually cone shaped, that isinserted either into the rectum, vagina where it melts at body temperature. ENEMA An enema is the procedure of introducing liquids into the rectumand colon via the anus. Evacuant Enema • Used as a bowel stimulant to treat constipation. • Their volume up to 2 liters. • W armed to body temperature. • Example - soft soap enema& Magnesium sulphate enema Retention Enema • Their volume does not exceed100 ml. • No warming needed. • Example – barium enema& nutrient enema.
- 40. PESSARY Pessaries are solid medicated preparations designed for insertion into the vagina where they melt or dissolve. Moulded Pessaries • Cone shape and prepared by molded method. Compressed Pessaries • Prepare by compression as similar manner to oral tablets. • Available in different shape. Vaginal Capsules • Prepare sameas soft gelatin capsules and various sizeand shape.
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