Pharmaceutical Dosage Forms

dr. Erny Tandanu, M.Bmd

Department of Pharmacology and Therapeutics
Faculty of Medicine
University of Prima Indonesia
 Drug

 An agent or substance,
intended for use in the
diagnosis, treatment, cure
or prevention of disease
in human beings or
animals
 Drugs are rarely
administered in their
original or crude forms.
They are administered in
different dosage forms by
converting them into Crude Drug
suitable formulation.
Dosage Forms

 Dosage forms are the carrier through which drug

molecules are delivered to sites of action within the
body
 Every dosage forms is a combination of the drug and
different kinds of non-drug components called as
Excipients or additives
 The additives are used to give a particular shape to
the formulation, to increase stability, palatability &
more elegance to preparations.
Need for Dosage Forms

 Accurate dose
 Protection e.g. coated tablets, sealed ampules
 Protection from gastric juice, e.g. enteric coated tablets
 Masking unpleasant taste and odor
 Provide drugs within body tissues, e.g. injection
 Sustained release medication
 Facilitation of insertion of drugs into body cavities (rectal,
vaginal)
 Provide optimum drug action through inhalation therapy
 Provide drug action through topical administration at
local area of body. E.g. creams, ointment, emulsion,
lotion, etc
 Use of desired vehicle for insoluble drugs
Based on Route/Method
of Administration
Forms of oral drugs

Fastest ➢ Liquids: syrups, elixirs

➢ Suspensions
➢ Powders

Slowest ➢ Pills
➢ Capsules
➢ Tablets
 Drug administration

Enteral Parenteral
 Oral  Intravenous
 Sublingual  Intramuscular
 Buccal  Subcutaneous
 Rectal  Intracutaneous
 Intraarterial
 Intrathecal
 Intraperitoneal
 Topical
 Implant
 Inhalation
Oral Administration

 Easy to take, safe, comfortable and economic

 Slow onset of action
 Absorption may be affected by food
 Drugs can be destroyed by gastric secretion and low
pH
 First pass metabolism in liver
 Drugs may irritate GI mucous
 Can’t be given to unconscious patient
Clinical application

 For easier ingestion, tablet can be crushed and mixed

with a small amount of liquid or soft food
 Drug are given before, with or after meal
 For unconscious patients, drugs can be given via NGT
(naso gastric tube)
Sublingual administration

 Drug is absorbed from oral mucous

 Fast absorption and high bioavailability
 Fast effect
 No first past metabolism in liver
 Drugs are not destroyed by GI secretion
 Absorption do not affected by food
 Distasteful
 May irritate oral mucous
Clinical application

 Oral mucous should be wet to facilitate drugs

dissolution and absorption
 Avoid drinking water after administer the drug
 Nitrate preparations are used to be administered by
this route
 Rectal application

 Less first pass metabolism in liver

 Can be given to unconscious or
vomiting patients
 Advantages when medication has an
objectionable taste or odor
 Avoid irritation to upper GI tract
 Drug absorption is not complete
 Several drugs may irritate rectal
mucous
 Clinical application

 Rectal suppositories are given to provide a local effect (e.g

laxative, anti hemorrhoid) or systemic effect (e.g analgesia,
antibiotic)
 When inserting suppositories, the patients position are left lateral
 After inserting suppositories, press the patients buttocks together
for few seconds
Intravenous injection

 Desirable plasma concentration can be achieved

rapidly and accurately
 Irritative and hypertonic drugs may be given by this
route
 May provide a precise and continuous drug therapy
using IV infusion
 Adverse drug reaction may occur rapidly
 Insoluble or oily substance may cause embolism
 Aseptic procedure may cause infection
 Clinical Application
 Appropriate in emergency cases which required rapid
effect
 Also appropriate when the medications are too
irritating to be given by other routes (e.g cancer
chemotherapy)
 Establish an iv line if we are going to administer the
medication by IV route repetitively
 Always use sterile technique to prevent infection
Subcutaneous injection

 Drugs injected at subcutaneous layer

 Slow absorption
 Combination with vasoconstrictor agents may
decrease absorption rate
 Avoid irritative drugs
Clinical application

 Hormones (e.g implant), local anesthetic, heparin and

insulin are used to be administered by this route
 In repeated injections, the site of injection need to be
varied in order to minimize tissue damage, aid
absorption and avoid discomfort.
Intramuscular injection
 Medications that irritate subcutaneous tissue (e.g
penicillin) may safely be given by this route
 Absorption rate is greater than subcutaneous injection
 Larger volume of fluid may be given
 Frequently used sites are dorsogluteal, ventrogluteal,
vastus lateralis, rectus femoralis, deltoid and triceps
muscles
 Only healthy muscles should be used for injection
 Intracutaneous injection

 Drug is injected into the dermal layer

just beneath the epidermis
 Only small amount of liquid is used
(0,1 mL)
 This method is indicated frequently
for allergy skin tests, tuberculin tests
and vaccinations
 Common sites for injection are inner
lower arm, upper chest and the
back beneath the scapulae
Intra arterial injection

 This route is reserved for situation requiring localization

of drug in particular organs
 Localized drug concentration, so reduces the toxic
concentration in systemic circulation
 E.g. injecting an anti neoplastic nitrogen moustard at
a tumor site
 Sterile procedures are needed as well
Intrathecal injection

 Drugs injected to subarachnoid space

 In order to achieve rapid effect to cerebrospinal axis
 Used in treatment of CNS infections and spinal
anesthesia
Intraperitoneal injection

 Rare, more often used for laboratory animal

 Large surface area, rapid absorption
 High infection risk (peritonitis) and peritoneal
adhesions
 Used for dialysis method
Inhalation

 Drawings of air/substances into lungs, any drug/solution of drugs

administered by nasal/oral respiratory route
 Used to treat respiratory problem
 Common medication: broncodilators and steroid
 Advantages:
 Range delivery
 High bioavailability – avoid 1st pass metabolism
 Minimal side effect
 Emergency condition
 Direct to the target tissue
 Self conduction
 Intended to local effect at respiratory tract but systemic
absorption via alveoli may occur
Disadvantages

 High cost
 Special equipment
 Irritation → candidiasis
 Complex application
 Restricted dosage via inhalation
 Spread infection
Topical: on the skin

 Not absorbed
 Have local effect
 Absorbed
 Transdermal: usually slowly over a day
Based on Physical Form of
Dosage Form
Classification based of physical
form of the dosage form
Dusting Pills
powder

Granule

Tablets Capsule

Solid Dosage Forms

Solid dosage forms

 Solid dosage forms one of the oldest dosage forms

and most of the solid forms are available in Unit dose
 Unit dose may be defined as a exact quantity of the
drug administered at once. E.g. tablets, capsule, pills,
powders etc
 When drugs are to be administered orally in dry state,
then tablets, capsules are most convenient dosage
forms
 Some solids are supplied in bulk (Means quantity
available in large). Bulk powder can be supplied as
Internal (Granules, Fine powders) as well as external
(Dusting Powders, etc)
Dusting Powders

 Dusting powders are applied externally to skin

 Are prepared by mixing of more than one ingredients
in which either starch, kaolin or talc are used in their
formulation. Generally talc or kaolin are used because
they are inert in nature
 Are used for antiseptic, astringent, absorbent,
antiperspirant, etc
Granules
 Granulation is the process in which primary powder
particles are made to adhere to form larger
multiparticle or large particles entities called granules
 The bitter, nauseous, unpleasant powders can not be
given tablets, capsule due to bulk quantity are
required to be taken, as well as they are not given in
liquid dosage forms due to their stability such powders
are given in the granules forms
 These powders are mixed with suitable excipient along
with granulating agent, prepare a coherent mass then
dried & passed through the sieve to obtained desired
size of granules.
 E.g. Effervescent granules
Effervescent Granules

 For internal use

 They contained medicaments mixed with citric acid,
tartaric acid & sodium bicarbonate, sometime
saccharin or sucrose may be added for sweetening
taste
 Before, administration desired quantity of granules are
dissolved in water, the acid & bicarbonate reacts with
each other to produce effervescence
Tablets

 Prepared by moulding or by compression with or

without excipients
 The tablets can be prepared by two methods namely
as a
 Dry granulation
 Wet granulation
 Capsule

 Capsules are solid unit dosage forms in which one or

more medicaments enclosed within a shell
 Capsules mainly divided into two parts namely as-
 Body (longest part of capsule shell)
 Cap (smallest part of capsule shell)
 Generally prepared by gelatin
 Depending on their formulation, two types of gelatin
are used namely as
 Hard gelatin
 Soft gelatin
Capsule

 Hard gelatin capsule

 Made up of gelatin, sugar and water. The capsule shell
contains low moisture content.
 Hard and cylindrical in shape
 Contain powders, granules or pellets inside the capsule
 Soft gelatin capsule
 Made up of gelatin, water, glycerin or sorbitol.
 Contain high moisture than hard gelatin capsule
 Used for the filling of liquid or semisolid preparation
 Soft and vary in shape like round, oval etc
Pills
 These are small, rounded solid dosage forms
containing medicaments intended for oral use
 The medicaments are mixed with excipients to forms a
firms plastic mass
 The mass is rolled to uniform pill pipe, which cut into
numbers of uniform pills. The pills are spherical in shape
& produced by rolling them under wooden pill
rounder
 Sometimes pills are coated with varnish, gold leaf to
improve finish, unpleasant taste & stability
Liquid Dosage Forms
Liquid Dosage Form

 It may be defined as “a solution is a liquid-preparation

that contains one or more soluble chemical
substances dissolved in a specified solvent”
 Liquid dosage forms are intended for external, internal
or parenteral use
 The component of the solution which is present in a
large quantity is known as “SOLVENT” where as the
component present in small quantity is termed as
“SOLUTE”
 They mainly classified into two category namely as:
 Monophasic Liquid dosage forms
 Biphasic liquid dosage forms
Advantage

 Administration convenient, particularly for infants,

psychotic patients
 Easy to color, flavor & sweeten
 Liquids are easier to swallow than solids and are
therefore particularly acceptable for pediatric patient
 A solution is an homogenous system and therefore the
drug will be uniformly distributed throughout the
preparation
 Some drugs like aspirin, KCl can irritate gastric mucosa
if used orally as a solid dosage forms. But this effect
can be reduced by solution system
Disadvantage

 Less stable in aqueous system. Incompatibility is faster

in solution than solid dosage form
 Patients have no accurate measuring device
 Accident breakage of container results in complete
loss
 Solution often provide suitable media for the growth of
micro organisms
 The taste of a drug, which is often unpleasant, is
always more pronounced when in solution than in a
solid form
 Bulky than tablets or capsule, so difficult to carry
transport
Monophasic Liquid Dosage Forms
For Internal Use
Elixirs

 It is clear, sweetened, aromatic,

hydroalcoholic preparation meant
for oral use
 The medicated elixirs are generally
contained potent drug like as
antibiotics, antihistamine or
sedative
 The composition of elixirs contained
mainly as ethyl alcohol (active
ingredients), water, glycerin or
propylene glycol, colouring agent,
flavouring agent & preservative
 Linctuses

 These are viscous liquid

preparations that’s are used for
the treatment of cough
 They contain medicaments
which have demulcent,
sedative, expectorant action
 They are taken in small doses
without diluting with water to
have prolonged effect of
medicines
 Simple syrup is used as a vehicle
for most of the linctuses
 Tolu syrup is preferred in certain
cases because of its aromatic
odour & flavor. Moreover it have
a mild expectorant action
Syrup

 A concentrated or saturated solutions of sucrose in

purified water
 The concentration of sucrose is 66.7% w/w & due to
that it is a viscous preparations
 The syrup which contains medical substance called as
a medicated syrup & those containing aromatic or
flavored substance known as a flavored syrup.
 It prevent decomposition of many vegetable
substance because its have high osmotic pressure
which prevent the growth of bacteria
 They are palatable due sweet taste
Drops

 These are liquid preparations meant for oral

administration
 The oil soluble vitamins, such as vitamin A & D
concentrates in fish – liver oil are presented as drops
for administration
 Since these preparation contain potent medicaments,
the dose must be measured accurately
 The following two methods are commonly used for this
purpose
 Use of a dropper which is accurately graduated in
fractions of a milliliters
 Use of a pre-calibrated dropper
Monophasic Liquid Dosage Forms
For External Use
 Liniments
 Liquid or semi-liquid preparations
meant for external application to
the skin
 Usually applied to the skin with
friction & rubbing of the skin
 Alcoholic and oily liquid
preparations (monophasic) or
emulsion (biphasic)
 Alcoholic liniments are used
generally for their rubbing and
counterirritant effect. Such
liniments penetrate the skin more
readily than do those with an oil
base
 Should not be applied to skin that
are bruised or broken
Lotions

 Usually aqueous, alcoholic or

oily liquid preparations
 Are intended for external
application without friction or
rubbing to the affected area
 Usually applied with the help
of some absorbent material
such as cotton wool or gauze
 Generally used to provide
cooling, soothing and
protective & antiseptic
action
Gargles

 Aqueous solutions used for treating throat infection

(pharynx and nasopharynx part)
 Supplied in concentrated forms with direction of
dilution with warm water before use
 Used into intimate contact with the mucous
membrane of throat for few seconds, before they are
thrown out of the mouth
 Used to relieve soreness in mild throat infection
 Also used for their antiseptic, antibiotics and/or
anesthetics
Mouth wash

 Aqueous solution with pleasant or acceptable taste &

odor
 Used to make clean & deodorize the buccal cavity or
used for oral hygiene and to treat infections of the
mouth
 They mainly contain antibacterial agent, alcohol,
glycerin, sweetening agent, flavoring agent & coloring
agent
Types of Mouth wash
 Fluoride mouthwashes
 Contain sodium fluoride → strengthen the teeth as well as
adding extra protection against tooth decay
 Cosmetic mouthwashes
 Used more as a means of disguising bad breath (halitosis)
 Antiseptic mouthwashes
 Contain chlorhexidine gluconate → a chemical stops the growth
of bacteria and is suitable for people with a mouth infection

 Natural mouthwashes
 Alcohol-free (contain no fluoride) and work in much the
same way as conventional mouthwashes
 Can also treat a mouth infection or injury
 Total care mouthwashes
 Contain anti-bacterial ingredients which help to reduce
the build up of plaque and prevent gum disease
Throat/ Mouth paints

 Viscous liquid preparations used for mouth and throat

infections
 Glycerin is commonly used as a base because being
viscous and sticky, adheres to mucous membrane for
long period and it posses a sweet taste
 Uses:
 Pharyngitis or tonsilitis
 Oral thrust
Nasal drops

 Drugs in solution may be instilled into the nose from a

dropper or from a plastic squeeze bottle
 The drug may have local effect, e.g antihistamine,
decongestant
 Alternatively the drug may be absorbed through the
nasal mucosa to exert a systemic effect
 The use of oily nasal drops should be avoided → cause
damage to cilia of nasal mucosa & long term use may
reach the lung & cause lipoid pneumonia
 Preparation is maintained similar to nasal secretions
(aqueous nasal solutions), usually isotonic and
maintain a pH of 5.5 to 6.5
 Nasal Spray

Nasal Drop
Eye drops

 Sterile, aqueous/oily solutions or suspension intended

for instillation in eye sac
 Eye drops may contain buffers, stabilizing agents,
dispersing agents, solubilizing agents, anti-oxidants &
agents required for tonicity/ viscosity adjustment
Eye lotions

 Aqueous solutions used for washing the eyes

 These are supplied in concentrated forms & are
required to diluted with warm water immediately
before use
 They should be free from foreign particles to avoid
irritation to the eye
 They are required to prepared fresh& should not be
stored for more than two days to avoid microbial
contaminations
Ear drops

 Solutions of drugs that are instilled into ear cavity with

the help of dropper
 Generally used for cleaning the ear, softening the wax
& for treating the mild infections
 The solutions is generally prepared in water, glycerin,
propylene glycol & dilute alcohol

Adults

Children
Biphasic Liquid Dosage Forms
Biphasic liquid dosage form

 The liquid which consist of two phases

 Subcategorized into 2 different forms:
 Emulsion
 Suspension
 In emulsion both phases are available in liquid where
as in suspension, finely divided solid particles are
suspended in liquid medium.
 Emulsion

 Drug in which one liquid is

spread by means of small
droplet over another liquid
of fat globules in water or
water globules in fat
Suspension

 Contain fine, undissolved

particles of a drug
suspended in a liquid base
 Important to always shake
before use
Advantage of suspension
 Suspension can improve chemical stability of certain
drug.
 E.g. Procaine penicillin
 Drug in suspension exhibits higher rate of bioavailability
than other dosage forms
Compressed Coated
Solution Suspension Capsule
tablet tablet

 Suspension can mask the unpleasant/ bitter taste of

drug
 E.g chloramphenicol
 Duration and onset of action can be controlled.
 E.g. Protamine Zinc-Insulin suspension
Disadvantage of suspension

 Physical stability, sedimentation and compaction can

causes problems
 It is difficult to formulate
 Uniform and accurate dose can not be achieved
unless suspension are packed in unit dosage form
 All suspensions are required to be shaken before
measuring of dose
 The storage of suspension may lead to changes in
disperse system especially, when there is fluctuations in
temperatures.
Ideal qualities of good
suspension
 It should settle slowly & easily re-dispersed on shaking
 It should readily & evenly pour from container
 It should be chemically inert
 It should not forms hard cake
 It should prevent degradation of drug or to improve
stability of drug
 It should mask the taste of biitter of unpleasant drug
 Cream

Gels
Ointment

Suppository

Paste

Semisolid Dosage Forms

Ointment

 For application to skin or mucous membrane

 Mainly used for their protective or emollient properties
 It may be defined as a medicament or medicaments
dissolved, suspended or emulsified in ointment base
 There is no single ointment base which possesses all
the qualities of ideal ointment base, so it become
necessary to use more than one ointment base in the
preparation of ointment
Ideal ointment base

 It should be inert, odorless & colorless & smooth

 It should be physically & chemically stable
 It should be compatible with the skin & with
incorporated medicaments
 It should be of such consistency that it spread & soften
when applied to skin with stress
 It should not retard healing of wound
 Its should not produce irritation or sensitization of the
skin
Creams

 These are viscous semisolid emulsions which are meant for

external use
 Cream is divided into two types namely as
 Aqueous creams
 Oily creams
 In case of aqueous creams the emulsions are o/w type &
it is relatively non greasy. The emulsifying waxes are
anionic, cationic & non-ionic used. Generally
polysorbate, triethanolamine soap are used as
emulsifying agent
 In case of oily creams w/o type & it is relatively greasy.
The emulsifying agent such as wool fat, wool alcohols,
beeswax & calcium soap is used
 The cream should be store in collapsible tube & supplied
in well closed container to prevent evaporation &
contamination
Pastes
 Intended for external application to skin
 Generally very thick & stiff
 They do not melt at ordinary temperature & thus forms
a protective coating over the area where they are
applied
 Pastes are differ from ointment as they contain a high
portion of finely powdered medicaments
 Mainly used as an antiseptic, protective, soothing
dressings
 Pastes should be stored & supplied in containers made
of materials which do not allow absorption or diffusion
of content
Gels/Jellies
 Transparent or translucent,
non greasy, semi solid
preparations mainly used for
external application to skin
 Also used for lubricating
catheters, surgical gloves &
rectal thermometer
 The substance like gelatin,
starch, tragacanth, sodium
alginate & cellulose
derivatives are used for the
formulation of jellies
 Three types:
 Medicated jellies
 Lubricating jellies
 Miscellaneous
Suppositories

 Contains solid medicated cone shape inserted into

rectum, vagina or urethra which melts at body
temperature.
 It release drug after melting for local or systemic
action
Gaseous Dosage Forms
Sprays

 Preparation of drugs in media

which may be aqueous,
alcoholic or glycerin
 Applied to mucous
membrane of throat or nose
with an atomizer
 The throat sprays must be
sprayed from a special type
of atomizer known as a
nebulizer, which removes the
large droplets by baffling
system. Only precaution
should be taken that the fine
droplet will used to easily
reach the lungs
Inhalant

 Liquid preparations containing volatile substance &

are used to relieve decongestion & inflammation of
respiratory tract
 The volatile substance in inhalations would be volatile
at room temperature so that they should be placed
on some adsorbent pad or handkerchief
 In some cases inhalations will added to hot water
(65oC) then vapors will inhaled
New drug delivery system

Nanoparticles
Implants

Buccal strips
Released Erythrocytes
Thank You