Semisolid Dosage Forms

Semisolid Dosage Forms-
Ointments, Pastes & Jellies

Introduction
• DEFINITION:
Semi solids are the topical dosage
form used
for the therapeutic, protective or
cosmetic
function. They may be applied to
the skin, or
used nasally, vaginally, or
rectally…Pharmaceutical semisolid
dosage preparations
include :ointments, pastes, cream,
plasters, gels
etc..
• They contain one or more active
ingredients
dissolved or uniformly dispersed in a
suitable
base and any suitable excipients such
as
emulsifiers, viscosity increasing
agents, anti
microbial agents, antioxidants, or
stabilizing
agents etc..
Advantage of semi-solid
dosage form
• It is used externally
• Probability of side effect can be
reduce
• First pass gut and hepatic
metabolism is avoided.
• Local action and Site specific
action of drug on
affected area.
• Convenient for unconscious patient
or patient
having difficulty on oral
administration.
• Suitable dosage form for bitter
drugs.
• More stable than liquid dosage
form
Disadvantages of semi-solid
dosage
form
• There is no dosage accuracy in this
type of dosage
form
• The base which is used in the semi-
solid dosage
form can be easily oxidized.
• May cause staining.
• They are bulky to handle.
• Application with finger may cause
contamination.
• Physico-chemically less stable than
solid dosage
form.
• May cause irritation or allergy to
some patients
IDEAL PROPERTIES
OF SEMISOLIDS
PHYSICAL PROPERTIES:
• Smooth texture
• Elegant in appearance
• Non dehydrating
• Non gritty
• Non greasy and non staining
• Non hygroscopic
PHYSIOLOGICAL PROPERTIES
• Non irritating
• Do not alter membrane / skin
functioning
• Miscible with skin secretion
APPLICATION PROPERTIES
• Easily applicable with efficient drug
release.
• High aqueous wash ability.
PREPARATION OF SEMISOLIDS
DOSAGE FORMS
INGREDIENTS USED IN
PREPARATION:
• Bases
• Preservative
• Humectants
• Antioxidants
• Emulsifier
• Gelling agent
• Permeation enhancer
• Buffers
BASES
• It is one of the most important
ingredient
used in formulation of semisolid
dosage form.
Ointment bases do not merely act as
the
carriers of the medicaments, but they
also
control the extent of absorption of
medicaments incorporated in them.
IDEAL PROPERTIES OF
A BASE
They should be:
• Inert, non-irritating and non-
sensitizing.
• Compatible with skin pH and the
drug.
• Good solvent and/or emulsifying
agent.
• Emollient, protective, non-greasy
and easily
removable.
• Release medicament readily at the
site of
application.
• Pharmaceutically elegant and
possess good stability.
ANTIOXIDANTS
Oxygen is a highly reactive atom that is
capable of
becoming part of potentially damaging
molecules
commonly called “free radicals.”
Free radicals are capable of attacking
the healthy
cells of the body, causing them to lose
their
structure and function. To prevent this
an
antioxidants are added.
E.g. Butylated hydroxy anisole,
Butylated hydroxy
Toluene
PERMEATION
ENHANCERS
• Skin can act as a barrier. With the
introduction
of various penetration enhancers,
penetration
of the drug through the skin can be
improved.
• E.g. Oleic Acid
EMULSIFIER
• An emulsifier (emulgent) is a
substance that
stabilizes an emulsion by increasing
its kinetic
stability.
- Must reduce surface tension for
proper
emulsification.
- Prevents coalescence.
- Ability to increase the viscosity at
low
concentration.
HUMECTANT
A humectant is a hygroscopic
substance,
Humectants are used to :
• increase the solubility of the active
ingredient
• to elevate its skin penetration.
• elevate the hydration of the skin.
BUFFERS
Buffers are added for various purpose
such as :
- Compatibility with skin.
- Drug solubility.
- Drug stability.
- E.g. sodium acetate, sodium
citrate,
potassium metaphosphate.
Ointments
• Ointments are homogenous,
translucent, viscous
semi-solid preparations, most
commonly a greasy,
thick oil (oil 80% - water 20%)
intended for external
application to the skin or mucous
membrane.
• Drug ingredients can be dissolved,
emulsified or
suspended in the ointment base.
Classification of ointments
• On the basis of penetration
• On the basis of therapeutic use
On the basis of penetration
A- Epidermic ointments
• These ointments are intended to
produce their
action on the surface of the skin and
produce local
effect,they are not absorbed.
• They acts as protectives, antiseptics
and
parasiticides.
B- Endodermic ointments
release the
medicaments that penetrate into the
skin. They are
partially absorbed and acts as
emollients,
stimulants and local irritants.
C- Diadermic ointments
release the
medicaments that pass through the
skin and
produce systemic effects.
On the basis of therapeutic
use
• Antibiotic Ointments e.g bacitracin
• Antifungal Ointments e.g Benzoic
acid
• Anti-inflammatory Ointments e.g
fluocinolone
acetonide
• Antipruritic Ointments e.g
benzocaine
• Counter-irritant Ointments e.g
Methyl salicylate
• Antidandruff Ointments e.g. Salicylic
acid
OINTMENTS BASES
• Oleaginous bases or Hydrocarbon
bases
• Absorption bases
• Water-miscible bases/removable
bases/Emulsifying bases
• Water-soluble bases
Oleaginous bases
(Hydrocarbon bases)
• Oleaginous bases are non-aqueous
formulations which provides
emollient &
protective properties.
• It is difficult to remove hydrocarbon
bases
from skin due to their oily nature.
• E.g. Hard Paraffin, White or Yellow
soft
paraffin, Liquid paraffin, Mineral oil
etc..
Petrolatum (Soft Paraffin): It is
purified mixture of
semi-solid hydrocarbons obtained
from petroleum.
There are two types of soft paraffin
one is yellow &
other is white soft paraffin. White
soft paraffin
prepared by bleaching the yellow soft
paraffin. The
melting point of soft paraffin is 38 to
560C. White
soft paraffin not be used in
ophthalmic ointment
preparations because small amt of
bleaching agents
involved in that & they causes
irritation in the eye.
• Hard Paraffin: It is purified
mixture of solid
hydrocarbons & obtained from
petrolatum. It is
colourless or white translucent,
odorless, tasteless
wax like substance. It is used to
harden or soften
the ointment base.
Liquid Paraffin: It consist of mixture
of liquid
hydrocarbons & obtained from
petroleum by
distillation. It is also called white
mineral oil or
liquid petroleum. It is colourless,
odourless,
tasteless it is soluble in ether &
chloroform but its
insoluble in water & alcohol.
• Now a days oleaginous bases are
not used
commonly bec..
• They are greasy, so its difficult to
remove from skin
& clothing.
• They retain body heat which may
produce an
uncomfortable feeling of warmth.
• They do not help in the absorption
of
medicaments.
Absorption bases
• In the absorption bases contains
small amt. of
water & they provide relatively less
emollient
properties than hydrocarbon bases.
• These bases are generally
anhydrous substances
which have the property of absorbing
considerable
quty. of water but still retaining their
ointment like
consistency.
• They have 2 types : 1. Non-
emulsified bases
2. Water in oil emulsion bases
Non-emulsified bases:
Those bases absorb water &
aqueous solution producing W/O
emulsion.
e.g. Wool fat, Wool alcohol, BeesWax
etc..
• Water in oil emulsion bases:
Those bases have the capability of
absorbing more water & have the
properties of
non- emulsified bases.
e.g. Hydrous wool fat (Lanolin)
Wool Fat: It is also known as
anhydrous lanoline &
It is the purified fat-like substance
obtained from
wool of sheep. It can be absorb about
50% of its
weight of water. So it is used in
ointments where
the proportion of water or aqueous
liquids too
large. It is mainly used in eye
ointment base & in
simple ointment base.
• Wool Alcohol: It is obtained from
wool fat by
treating with alkali & separate out
cholesterol &
other alcohols. It contains not less
than 30% of
cholesterol. It is used as an
emulsifying agent for
the preparation of w/o emulsion. It is
also used for
improving the texture, stability &
emollient
properties of o/w emulsion.
Bees Wax: It is purified wax obtained
from honey
comb of bees. It is available in yellow
& white
form. White bees wax prepared by
bleaching
treatment. It is used for stiffening
agent in paste
& ointments.

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Semisolid Dosage Forms-

Ointments, Pastes & Jellies

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