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Dosage forms
- 1. DOSAGE FORMS Reshma Fathima K Assistant Professor
- 2. Introduction to dosage forms 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.
- 3. 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 Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability. They do not increase or affect the therapeutic action of the active ingredient.
- 4. Inactive ingredients may also be referred to as inert ingredients or excipients, and generally have no pharmacological effect. Examples of inactive ingredients include binding materials, dyes, preservatives, and flavoring agents, sweetening agents, coloring agents etc.
- 5. Need of Dosage forms Provide safe and convenient delivery of accurate dosage. Example – Tablets, capsules, syrups Protection of a drug substances from atmospheric oxygen or moisture. Example – Coated capsules, sealed ampules 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. 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.
- 7. CLASSIFICATION OF DOSAGE FORMS Dosage forms are classified on the basis of route of administration and physical form Based on route of administration Enteral route Oral Tablets, Capsules, Syrups, Suspension, Emulsion etc. Sublingual and buccal Orally Disintegrating Tablet (ODT), Lozenges , Chewing tablets, Mouthwash, Toothpaste, Ointment, Oral spray Vaginal and rectal 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 Percutaneous Transdermal patch etc
- 8. Solid Dosage Forms Shaped Tablets, Capsules, Implants, Transdermal patches Unshaped Powders for external/internal use Semi-solid Dosage forms Shaped Suppositories (for rectal administration) Pessaries (vaginal suppositories) Unshaped Gels, Creams, Ointments, Pastes Liquid Dosage forms Monophasic Solutions (syrups, spirits, elixirs, tinctures) Biphasic Emulsions, Suspension External solutions Lotions, Liniments Gaseous Dosage forms Medicinal gases Aerosols: Inhalation Based on Dosage Forms
- 10. Solid Dosage forms Tablets Tablets may be defined as the solid unit dosage form of medicament or medicaments with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, compressed or compacted from a powder into a solid dose Buccal and Sublingual tablets 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 through the mucous membrane of mouth. Drug reaches in systemic circulation without affecting by gastric juices and metabolizing enzymes of the liver.
- 11. EFFERVESCENT TABLETS • 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 • Tablet immediately dissolve or dispersed • Pleasant taste of carbonated drink
- 12. • CHEWABLE TABLET They are tablets that chewed prior to swallowing. They are designed for administration to children e.g. vitamin products. CAPSULES Solid unit dosage form that contain a solid, semi-solid, and liquid fill and a gelatin shell. 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.
- 13. LOZENGES • 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 to the lozenge and facilitating slow release of the medicament. PILLS • It is a solid oral dosage form which consists of spherical masses prepared from one or more APIs with inert excipients. • Pills are now rarely used.
- 14. ORAL GRANULES • They are consisting of solid, dry aggregates of powder particles with irregular 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
- 15. ORAL POWDER • Bulk Powders are multi dose preparations consisting of solid, loose, dry particles of 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.
- 16. ORAL SOLUTION Oral solutions are clear Liquid preparations for oral use containing one or more active ingredients dissolved in a suitable vehicle. ORAL EMULSION • Emulsion is a biphasic liquid preparation, containing two immiscible liquids, one of which is dispersed as minute globules into the other. The liquid which is converted into minute globules is called as dispersed phase. The liquid in which the globules are dispersed is called continuous phase. • o/w • w/o LIQUID DOSAGE FORMS
- 17. • ORAL SUSPENSION • Suspensions are the biphasic liquid dosage forms of medicament, in which the finely divided solid particles ranging from 0.5 to 5.0 micron are dispersed in a liquid or semisolid vehicle. The solid particles act as a dispersed phase. Where as the liquid vehicle act as the continuous phase
- 18. SYRUP It is a concentrated aqueous solution of a sugar, usually sucrose to which medicaments are added. Flavored syrups are a convenient form of masking disagreeable tastes. ELIXIR It is pleasantly flavored clear liquid oral preparation of potent or nauseous drugs. The vehicle may contain a high proportion of ethanol or sucrose together with antimicrobial preservatives which confers the stability of the preparation.
- 19. MOUTHWASHES These are similar to gargles but are used for oral hygiene and to treat infections of the mouth. 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.
- 20. 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 measuring device. • They may be solutions, suspensions or emulsions. GARGLES • They are prepared in a concentrated solution with directions for the patient to dilute with warm water before use. • They are aqueous solutions used in the prevention or treatment of throat infections.
- 21. 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. NASAL DROPS & SPRAYS Drugs in aqueous solution may be instilled into the nose from a dropper or from a plastic squeeze bottle. Used for local effect, e.g. antihistamine, decongestant.
- 22. • PAINTS • Paints are mono-phasic liquids for application to the skin or mucous membranes. • Skin paints contain volatile solvent that evaporates quickly to leave a dry 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 affected site.
- 24. 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 (consisting of natural or synthetic gum) having a high degree of physical or chemical cross- linking. It is used for medication, lubrication and some miscellaneous applications like carrier for spermicidal agents to be used intra vaginally
- 25. 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 drug preparation.
- 26. PASTES • Pastes are basically ointments into which a high percentage of insoluble solid has 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 they contain can absorb and thereby neutralize certain noxious chemicals before they ever reach the skin.
- 27. SUPPOSITORY It is a semi solid medicated mass, usually cone shaped, that is inserted either into the rectum, vagina where it melts at body temperature. ENEMA An enema is the procedure of introducing liquids into the rectum and colon via the anus.