INTRODUCTION TO

DOSAGE FORMS

By
Suryakant Verma
Assistant Professor
Department of Pharmaceutics
DR. K. N. MODI INSTITUTE OF PHARMACEUTICAL
EDUCATION AND RESEARCH, MODINAGAR
Mob. No. 9760989460
 Contents
1. Introduction
2. Classification of dosage forms
 Solid dosage forms
 Liquid dosage forms
 Semi solid dosage forms
3. New drug delivery system
 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 Patient
Safety/Benefit Safety/Benefit
 Introduction
Dosage form (Medicines) = API + Excipients
The means (or the form) by which drug molecules are delivered to sites
ofaction 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 active ingredient.
o Inactive ingredients may also be referred to as inert ingredients or
excipients, and generally have no pharmacological effect.
o Examples of inactive ingredients include binding materials, dyes,
preservatives, and flavoring agents,sweetening agents,coloring agents
etc.
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.
 Some API are chemically unstable in light, moisture, O2
 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.
 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.
CLASSIFICATION OF DOSAGE FORMS

Based on Route of Based on Physical Form

Administration

Oral
Parenteral Solid
Topical Semi-solid
Transdermal Liquid
Respiratory/Inhaled Gases
Ophthalmic
Rectal
Veginal
Otic
 Based on Route of Administration
Enteral Route
Tablets, Capsules, Syrups, Suspension, Emulsion etc.
Oral Dry Powder Inhaler (DPI), pressurized Metered Dose Inhaler
(pMDI) – Nebulizer, Vaporizer
Sub-lingual & Buccal Orally Disintegrating Tablet (ODT), Lozenges , Chewing tablets,
Mouthwash, Toothpaste, Ointment, Oral spray
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
 Based on Physical Form
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, Collodions etc

Gaseous Dosage Forms

Medicinal Gases Aerosols: Inhalation/volatile anesthetics
Aerodispersions Antiasthmatics sprays
 Classification

Solid dosage Semi solid dosage

forms Liquid dosage
forms forms

Unit dosage Bulk

forms Biphasic Monophasic Internal External

Tablets Emulsion
Capsule Suspension Internal External Suppositories Ointment
Powders External Pessaries Creams
Pills Liniments pastes
Internal Lotions Jellies
Dusting powders Syrups Gargles
Throat paints
Insufflations Elixirs Mouth washes
Fine
Dentifrice Linctus Sprays
powders & Eye lotions
Snuffs Drops Eye drops
granules Nasal drops
Ear powders
 CLASSIFICATION OF SOLIDS

SOLID ORAL DOSAGE FORMS

Tablets Capsules Powder Granules

 CLASSIFICATION OF LIQUIDS

Monophasic Liquid Dosage Forms

Liquid for External

Liquid for Internal
administration
administration

Liquid Liquids instilled - Syrups

Liquids used
applied to into Body
in Mouth - Mixtures
the skin Cavities
- Elixirs
- Eye Drops - Linctuses
- Gargles - Lotions
- Ear Drops
- Mouthwashes - Liniments
- Nasal Drops
- Throat paints - Collodions - Douches
- Paints - Enemas
 Biphasic Liquid Dosage Forms

Solids in Liquid Liquid in Liquid

Oral Parenteral External Oral External

SUSPENSION LOTION EMULSION LINIMENTS

 SEMI-SOLID DOSAGE FORMS

Cream

Paste SEMI-SOLID Gel

Ointment
 INHALED DOSAGE FORMS

Inhalation

Lung Nose

Gases Liquids Aerosols Solids

Liquids Aerosols Semi- Solids

solids
Vapors
Medical gases
Solution DPIs
Suspension Solution Gels
Emulsion Suspension MDIs Powders for
MDIs Emulsion inhalation
DPIs
Other pressure systems
 RECTAL & VAGINAL DOSAGE FORMS

Suppository

RECTAL&
VAGINAL

Pessaries Enema
 SOLID DOSAGE FORMS

1 -TABLET
 A tablet is unit dose of one or more medicament. Prepare by compression or mould
method.

 Common excipients used in tablet are :

 Diluents – Provide bulkiness of tablet.
 Disintegrants – To ensure that the tablet breaks up in the digestive tract.
 Binder – Important for granulation of powder.
 Glidants and Lubricants – Provide good flow and ensure efficient tabletting.
 Sweeteners and Flavors – To mask the taste ofAPIs.
 Pigments – To mask uncoated tablets visually attractive.
 A coating may be applied to mask taste, smooth tablet for easy swallow, expending
shelf life, and prevent gastric degradation of drug.
2 - 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 through the
mucous membrane of mouth.
Drug reaches in systemic circulation without affecting by gastric juices and
metabolizing enzymes of the liver.

 Examples – Vasodilators, Steroidal hormones.

3 - 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 :

 Tablet immediately dissolve or dispersed
 Pleasant taste of carbonated drink

4 - CHEWABLE TABLET

 They are tablets that chewed prior to swallowing.

 They are designed for administration to children e.g. vitamin products.
5 - CAPSULES

 Solid unit dosage form that contain a solid, semi-solid, and liquid fill and a gelatin
shell.
 Common excipients used in capsules are :
 Gelatin – Commonly used as gelling agent.
 Plasticizers – To ensure elasticity or mechanical stability.
 Additional Additives – 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.
6 - 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 to the
lozenge and facilitating slow release of the medicament.

7 - 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 and sugar.
8 - DENTAL CONES

 A tablet from intended to be placed in the empty socket following a tooth extraction,
for preventing the local multiplication of pathogenic bacteria associated with tooth
extractions.
 These tablets contain an excipients like – lactose, sodium bicarbonate, and sodium
chloride etc.

 Cones may contain an antibiotic or antiseptic.

9 - 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.

10 – 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.

11 – 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.
 LIQUID DOSAGE FORMS

1 – ORAL SOLUTION
 Oral solutions are clear Liquid preparations for oral use containing one or
more active ingredients dissolved in a suitable vehicle.

2 – 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.

3 – 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.
4 – 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.

5 – 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.

6 – MOUTHWASHES
 These are similar to gargles but are used for oral hygiene and to treat infections
of the mouth.
7 – 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.

8 – 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.

9 – 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.

10 – 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.

11 – 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.

11 – COLLODION
 Collodion is a solution of nitro cellulose in ether or acetone, some times with
the addition of alcohols.

 As the solvent evaporates, it dries to a celluloid-like film.

 It is highly flammable.
 Compound Wart Remover consists of acetic acid and salicylic acid in an
acetone collodion base used in treatment of warts by Keratolysis.

12 – 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.
 PARENTERAL DOSAGE FORMS
An injection is an infusion method of putting liquid in to the body, usually with a
hollow needle and a syringe which is pierced through the skin.

Intravenous Injection
• It is a liquid administered directly into the bloodstream via a vein.
• 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.

Subcutaneous Injection
• It is injecting into the subcutis, the layer of skin directly below the
dermis and epidermis.
• It is highly effective in administering vaccines and insulin.
 SEMI-SOLID DOSAGE FORMS

1 – 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.

2 – 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.
 3 – CREAMS

Oil-in-water (O/W) Water-in-oil (W/O)

• It composed of small droplets of • It composed of small droplets of

oil dispersed in a continuous water dispersed in a continuous
aqueous phase. oily phase.
• Less greasy and more easily • More difficult to handle but used
washed off using water. for hydrophobic drug preparation.
• Reduces water loss from the
stratum corneum maintain
moisture of skin.
4 – 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.

Greasy Pastes Non-greasy Paste

• Leaser’s paste • Bassorin paste
 INHALED DOSAGE FORMS

1 – 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.

2 – 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 is then
inhaled by the patient.
Generally prefer to inhalers for patients, due to advantages such as:
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.
 RECTAL & VAGINAL DOSAGE FORMS

1 – 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.

2 – ENEMA
 An enema is the procedure of introducing liquids into the rectum and
colon via the anus.

Evacuant Enema Retention Enema

• Used as a bowel stimulant to treat • Their volume does not exceed 100
constipation. ml.
• Their volume up to 2 liters. • No warming needed.
• Warmed to body temperature. • Example – barium enema &
• Example - soft soap enema & nutrient enema.
Magnesium sulphate enema
3 – PESSARY
 Pessaries are solid medicated preparations designed for insertion
into the vagina where they melt or dissolve.

Moulded Compressed Pessaries Vaginal

Pessaries • Prepare by compression Capsules
• Cone shape and as similar manner to oral • Prepare same as
prepared by tablets. soft gelatin
molded method. • Available in different capsules and
shape. various size and
shape.
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