Dosage Form
Dosage Form
Dosage Form
the body to produce optimum desired effects and minimum adverse effect.
• Dosage form = API + Excipents
• The means by which drug molecules are delivered to sites of action with in the body.
• A dosage form is a pharmaceutical preparation consisting of drug and excipients to
facilitate dosing, administration, and delivery of the content to the drug product
• API
• Chemical compound intended for use in diagnosis, prevention and treatment of disease
• It is the part of any drug that produces its effect.
• Excipents
• Donot increase or affect the therapeutic action of active ingredients
• Inactive ingredients may also be reffered to as inert ingredient or excipient and generally have no
pharmacological action
• Examples are binding material, dyes, preservative, flavouring agent, sweetening agent, coloring agent etc
• Importance of dosage form
• Dosage uniformity
• Stability
• Bioavailability
• Direct use of API is rare because of:
• API handling and accurate dosing can be difficult or impossible
• API administration can be impractical/unfeasible because of size,
shape, smell, taste and low activity.
• Some API are chemically unstable in light ,moisture,oxygen
• API can be degraded at the site of administration(low pH in stomach)
• API may cause local irritation or injury when they are present at high
concentration at site of administration
Need of dosage form
• A tablet should have elegant product identity while free of defects like chips, cracks, discoloration, and
contamination.
• Should have sufficient strength to withstand mechanical shock during its production packaging, shipping and
dispensing.
• Should have the chemical and physical stability to maintain its physical attributes over time
• The tablet must be able to release the medicinal agents in a predictable and reproducible manner.
• Must have a chemical stability over time so as not to follow alteration of the medicinal agents.
Types of tablets
• Pharmaceutical powder are solid dosage form of medicament in which one or more drug are
dispensed in finely divided state with or without excipient
• They are available in crystalline or amorphous form
• Advantage
• It is both used internally or externally
• It is more stable then liquid dosage form
• Onset of action is faster as compared to tablet, capsule
• Easy to carry
• Easy to administration to the patient orally by dissolving in suitable liquid
• Disadvantage
• Drug have bitter taste, nausea and unpleasant taste cannot be administered in powder form
• Deliquescent and hygroscopic drug cannot be dispensed in powder form
• Drug which get affected by atmospheric condition are not suitable for dispense
• Classification of powder
• Bulk powder for internal use
• Bulk powder for external use
• Simple and compound powder for internal use
• Powder enclosed in cachets and capsule
• Compressed powder(tablet)
• Eg Rhubarb powder, dentifrices, medical dusting powder, surgical
dusting powder
granules
• Granules are prepared agglomerates of smaller particle of powder
• Reason for granulation
• To prevent segregation of the constituent of powder mix
• To improve flow property of powder mix
• To improve compaction characteristics of powder mix
• Eg Biaxin granules for oral suspension
• Omnicef for oral suspension
• Effervescent granule
Suppository
• Drug delivery system where drug is incorporated in inert vehicle
• Suppositories are solid, single-dose preparations
• The shape, volume and consistency of suppositories are suitable for rectal administration
• Excipients such as diluents, adsorbents, surface-active agents, lubricants, antimicrobial preservatives and colouring
matter, authorised by the competent authority, may be added if necessary
• Suppositories may contain medicaments, dissolved or dispersed in the base, which are intended to exert a systemic effect
• The bases used either melt when warmed to body temperature or dissolve or disperse when in contact with mucous
secretions.
• Alternatively the medicaments or the base itself may be intended to exert a local action
• Suppositories are prepared extemporaneously by incorporating the medicaments into the base and the molten mass is
then poured at a suitable temperature into moulds and allowed to cool until set
• Eg metronidazole suppository, paracetamol suppository
Lozenges
• It is a solid dosage form containing a drug along with flavouring and
sweetening agent
• These are solid preparation that are intended to dissolve or
disintegrate slowly in mouth
• Most often used for localized effect in oral cavity
• They are available in flat, circular, octagonal, biconvex and cylindrical
form
• Eg Medicated lozenges: Strepsil, Clotrimazole, Nystatin
• Non medicated lozenges: candies lollipop
Solution
• Stable homogenous mixture of two or more components
• One or more solute is dissolved in one or more solvents
• Solvent is often aqueous but can also be oily or alcoholic
• Formulations: --- oral dosage forms, mouthwashes, gargles, nasal drops, ear drops or available for external
applications
• Eg cough syrup, PCM, potassium chloride, Theophylline oral solution, dicyclomine HCL syrup
(anticholinergic), chlorpomazine HCL syrup (antiemetic),sodium valproate syrup, cyproheptadine HCl syrup
(antihistamine), lactulose syrup (cathartic), metoclopramide syrup (GI stimulant)
Syrup
• Contains one or more insoluble medicaments in a vehicle with other additives such as preservatives,
flavours, colours, buffers and stabilizers.