2. DEFINITION:
*Drug: Substances and specified devices meant for treatment, mitigation or
prevention of diseases or disorders in human being or animals, intended to affect any
function or any structure of human body are termed as drug. E.g., Paracetamol,
pantoprazole.
*Dosage form: It is a transformation of pure chemical compound into predetermined
form of admixing drug compound with different types of non-drug components.
e.g., Tablets, capsules, creams etc.
Dosage forms are the means by which drug molecule are derived to sites of action
within the body.
The need for the dosage form:
1.Accurate dose.
2. Protected e.g., capsules, ampules.
3. Protects form the gastric juice.
4. Masking the taste and odour.
5. Placement of the drug into the body tissue.
6. Sustained release medication.
7. Controlled released medications.
8. Optimal drug action.
9. Insertion of drugs into the body cavities (vaginal, rectum).
10. Use of the desired vehicle for the insoluble drugs.
3. Need for different dosage form of the same drug:
To minimize the discomfort and instant relief and improve the
patient compliance.
Desirable properties of dosage form
Should:
1.Convenient to handle, use and store.
2. Stable during storage and use.
3. Withstand machinal shock during transport.
4. Flexibility in different drug strength.
5. Provided excepted therapeutic effect.
6. Extent, drug release, onset, intensity, duration of action predictable.
7. Economical and elegant.
4. TYPES OF DOSAGE FORMS
They are classified according to:
• Route of Administration * Physical Form
-Oral - Solid
- Topical - Semi-solid
- Rectal - Liquid
- Parenteral -Gaseous
- Vaginal
- Inhaled
- Ophthalmic
- Otic
5. CLASSIFICATION OF DOSAGE FORMS
Dosage forms may be classified on the basis of physical form of the final
product which are
as follows:
1. Solid dosage forms.
2. Liquid dosage forms.
3. Semi-solid dosage forms.
4. Gaseous dosage forms.
6.
7. SOLID DOSAGE FORMS
The solid dosage forms are mostly available in the unit dose form, such as tablets, capsules,
pills, powders.
• When drugs are administered orally in dry state, tablets and capsules are more convenient
forms.
• They, are effective and patients have no problem in their handling, identification and
administration.
• The bulk forms meant for internal use are supplied either as granules or fine powder.
• The bulk powders is meant for external use are dusting powders, insufflations, snuffs and
the tooth powders.
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8. *Powders are the solid dosage form of medicament, which are meant for
internal or external use. They are available in crystalline or amorphous
form.
- The powders are generally used in the following forms:
1. Bulk powder for internal used e.g., fine powders or granules.
2. Bulk powders for external use e.g., Snuffs, dusting powders and tooth
powders.
3. Simple and compound powders for internal use.
4. Powders in the form of compressed tablets and tablet triturates.
5. Powders enclosed in cachets and capsules.
9. DUSTING POWDERS
• These are meant for external application to the skin and generally
applied in a very fine state of subdivision to avoid local irritation.
• Hence, dusting powders should be passed through a number 80 sieve
to enhance their
effectiveness.
Dusting powders are of two types:
* Medical
* Surgical
10. Medical dusting powders are used mainly for superficial skin conditions.
• Surgical dusting powders are used in the body cavities and also on major
wounds as a result of burns and umbilical cords of infants.
• Surgical dusting powders must be sterilised before their use, whereas
medical dusting powders must be free from dangerous pathogenic
microorganisms.
• Dusting powders are generally prepared by mixing of two or more
ingredients.
• One of which must be either starch, kaolin, or talc as one of the
ingredients of the formulations.
11. • Talc, and kaolin are more commonly used because these are
chemically inert.
• However, since such ingredients are really contaminated with
pathogenic bacteria they must be sterlised before their use.
• The dusting powders are mainly used for their antiseptic,
astringent, absorbent, antiperspirant and antipuritic (anti-itching)
action.
12. • Insufflations: These are medicated dusting powders meant for introduction into the body
cavities such as nose, throat, ears and vagina with the help of an apparatus known as
“Insufflations”.
- It sprays the powders into a stream of finely divided particles all over the site of
application.
• Snuffs: These are finely divided solid dosage forms of medicament which are inhaled into
nostrils for its antiseptic, bronchodilator and decongestion action.
* Dentifrices (Tooth powders): These are applied with the help of a tooth brush for cleaping the
surface of the teeth.
13. GRANULES
• The bitter, nauseous and unpleasant powders cannot be given in the tablet or in a
capsules because a large number of them are required to be taken as a single dose.
• These powders are not given in liquid form because of stability problem. Such
medications are given in the form of granules.
• The drug is mixed with sugar, a flavouring agent and a granulating agent to
prepare a coherent mass which is passed through a sieve to convert it into granules
and then dried.
• There are two preparations of granules which are official in I.P.
- Bephenium hydroxynaphthate granules.
- Sodium aminosalicylate granules.
14. Effervescent Granules
*The effervescent granules are specially prepared dosage form of medicament, meant for
internal use. They contain a medicament mixed with citric acid, tartaric acid and sodium
bicarbonate.
• Saccharin or sucrose may be added as sweetening agent.
• Before admistrstration, the desired quantity is dissolved in water, the acid and
bicarbonate react together producing effervescence.
• Method of preparation. There are two methods of preparations of effervescent
granules:
1. HEAT METHOD
2. WET METHOD
15. These are solid unit dosage forms of medicament or medicaments which are
prepared by moulding or by compression.
• Certain excipients are also added to the medicaments in the formulation of
tablets.
• The compressed tablets are prepared in the bulk by the large-scale
production methods.
16. * The capsule are solid unit dosage form in which one or more
medicaments and inert substances are enclosed within a small shell.
* Generally, prepared from a suitable form of gelatin. Depending on
their formulations, the gelatin capsule shell may be hard or soft.
17. • Pills are small, round solid dosage forms containing medicament and are intended to
be administered orally.
• The medicaments are mixed with excipients to form a firm plastic mass.
• In the older days, pills were preferred because of their spherical shape which can be
easily swallowed.
• The pills are sometimes coated with varnish, silver leaf, gold leaf to improve the finish,
mask the unpleasant tastes and increase stability.
18. MERITS DEMERITS
Unit dose system Swallowing is difficult for
children
Physical, Chemical,
Physiological stability &
hence long shelf life
Onset of action is slow and
depends on
disintegrating and dissolution.
Economic
Ease of Transportation
Tasteless & elegance
19. LIQUID DOSAGE FORM
• Liquid stage forms are meant for internal, parenteral or external use.
• They are available in : 1. Monophasic
2. Biphasic forms.
20. • Monophasic liquid dosage forms are represented by true or colloidal
solution.
• The component of the solution which is present in a large quantity known
as “solvent”. Water is mainly used as solvent.
• A solution is homogenous because the solute is in ionic or molecular form
of subdivision. In case of colloidal solutions, the solute are present as
aggregates although they cannot be seen by the naked eye or under
ordinary microscope.
21. Simple syrups is a saturated solution of sucrose in purified water. The
concentration of sugar is 66% w/w. The syrups are sweet viscous
preparations.
• The syrups containing medicinal substance are called “ Medicated syrups”.
• Those containing aromatic or flavoured substances are known as
“Flavoured syrups”.
- Syrups are very common used for the following reasons:
1. Syrups retards oxidation because it is partly hydrolysed into reducing
sugars, such as lavulose and dextrose.
2. It prevents decomposition of many, vegetable substances. Syrups have
high osmotic pressure which prevents growth of bacteria, fungi and
moulds which are the chief causes of decomposition in solutions of
vegetable matter.
3. They are palatable. Due to the sweetness of sugar it is a valuable vehicle
22. 1. Elixir are sweet aromatic preparations and are usually coloured.
2 hey are ethyl alcohol (4-40%), water, glycerin or propylene glycol, flavoring
agents, syrup and preservatives.
3. The medicated elixirs usually containing very potent drug such as
antibiotics, antihistamines or sedatives.
4. The flavoring elixirs are used as flavors and vehicles.
23. 1. Linctures are viscous liquid and oral preparations that are generally
prescribed for the relief of cough. They contain medicaments which
demulcent, sedative or expectorant action.
2. They should be taken in small doses as well as it should be taken without
diluting them with water for maximum and prolonged effect of
medicatios.
3. Simple syrups is used generally as a vehicle for the most of linctuses.
4. Tolu syrup is preferred in certain cases because of its aromatic odour and
flavor. Moreover, it is believed to have a mild expectorant action.
24. - These are liquid preparations meant for oral administrations. The oil soluble
vitamins and fish liver oil are presented as drops for the administration.
- They are liquid and semi-liquid preparations meant for application to
the skin.
- They are usually applied to the skin with friction and rubbing of the skin.
25. • The liquids which consist of two phases are known as Biphasic liquids e.g.,
Emulsions & Suspensions.
• In general both the phase are liquid, while in suspensions the finely divided
solids are dispersed in a liquid which acts as a continuous phase.
26. * An emulsions is a biphasic liquid preparations containing two
immiscible liquids, one of which is dispersed as minute globules into
the other.
* The liquid which is converted into minute globule is called the
‘dispersed phase’ and the liquid in which the globules are dispersed is
called the ‘continuous phase’.
• In this preparation, an emulsifying agent is added.
• The emulsions are of two types:
1. Oil in Water type (o/w) emulsions: In which oil is the dispersed phase
whereas water is the continuous phase. It is preferred for the internal
use.
2. Water in Oil type (w/o) emulsions: In which water is the dispersed
phase whereas oil is in the continuous phase. It is preferred for the
external use.
27. • The suspensions are the biphasic liquid dosage form of medicament in
which finely divided solid particles are dispersed in a liquid or semisolid
vehicle.
• The solid particles act as disperse phase whereas liquid vehicle acts as the
continuous phase. Suspensions are generally taken orally or by parenteral
route. They are also used for external applications.
• These days many suspensions are supplied as dry powders which are
converted into suspensions by adding the specified amount of a vehicle
before the use.
28. An ideal suspensions must posses the following properties:
• It should settle slowly and should be readily re-dispersed on gentle
shaking of the container.
• The particle size of the suspensions remains fairly constant throughout its
long period of undisturbed standing.
• The suspensions should pour readily and evenly from its container.
• It should be free from large particles which spoil its appearance, give a
gritty taste to oral preparations and also cause irritation to sensitive tissue
when applied externally.
29. MERITS DEMERITS
Onset of action is quick as
compare to tablets, pills,
capsules.
Dose has to be measured.
Certain medicinal substances
can only be given in liquid
form like Castor-oil and
paraffin.
Stability & preservation
presents a problem.
They are to be suspended or
diffused form to produced
maximum surface area like
Kaolin.
Storage & transportation
hazards.
Few drugs if taken in dry form
may cause pain and irritation.
E.g., Potassium bromide.
30. SEMI-SOLID DOSAGE FORM
• Semi-solid dosage forms are mainly meant for
external application. E.g., ointments, creams,
pastes jellies.
• The suppositories are also included in this
category although these are unit dosage
forms.
31. 1. Ointments are semi-solid preparations meant for application to
the skin or mucous membrane.
2. They usually contain a medicament or medicaments dissolved,
suspended or emulsified in the ointment base.
3. They may contain a suitable antimicrobial preservative.
1. These are viscous semi-solid emulsions which are meant for external
use. The creams are of two types, aqueous and oily creams.
2. In case of aqueous creams, the emulsions are oil-in-water type and in
case of oily emulsions are water in oil type.
3. The oil-in-water type cream is relatively non-greasy.
32. PASTES
- Pastes are semi-solid preparations intended for external use
application to the skin. They differ from ointment as they
contain a high proportion of finely powdered medicaments such
as zinc oxide, calcium carbonate etc. These substances make
the paste very thick and stiff.
- Jellies are transparent or translucent, non-greasy, semi-solid
preparations mainly used for external application to the skin.
- These are also used for lubricating catheters, surgical gloves
and rectal thermometers.
33. - ADVANTAGES:
1. Site specific application.
2. Convenient for unconscious patients.
3. Chemically stable.
4. Suitable for the bitter taste drugs.
-DISAVANTAGES:
1. Staining by oily ointments.
2. Less dose accuracy.
3. Contamination when applied by finger tip.
4. Bulky to handle than solids.
34. -INHALER:
1. They are solutions, suspensions or emulsions of
drugs in a mixture of inert prepollents.
2. Release of dose of the medicament under pressure
in an aerosols dispenser in the form of droplets of
50um diameter or less from the container through a
spring loaded valve incorporating a metering device.
3. It is commonly used in the treatment of asthma and
other respiratory disorders.