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CREAM, OINTMENT &

PASTE
Pn. Suryati bt. Syafri

2013

LEARNING OUTCOME
Upon completion of this topic students
should be able to :

Distinguish cream, ointments and pastes


Prepare cream, ointments and pastes
select an appropriate container in which
to package cream, ointments and pastes
prepare an appropriate label for cream,
ointments and pastes

IDEAL PROPERTIES OF SEMISOLID


DOSAGE FORMS
PHYSICAL PROPERTIES:
PHYSIOLOGICAL
Smooth texture
PROPERTIES
Elegant in appearance
Non irritating
Non dehydrating
Do not alter membrane /
Non gritty
skin functioning
Miscible with skin
Non greasy and non
secretion
staining
Have low sensitization
Non hygroscopic
index
APPLICATION PROPERTIES
Easily applicable with efficient drug
release.
High aqueous washability

Definition

CHARACTERISTIC

Opaque
to
use onappearance
dry and scaly lesion
Apply toamoist
Translucent
contain
high
appearance
proportion
and weeping
of powdered
lesion because
ingredients
fluid lesion
(20 will
50%)
be in
miscible
fatty
Containing
Greasy
good
protective
>20%
barrier
waterwhen
and volatiles
placed on
and/or
the skin
<50% hydrocarbons, wax
Non-greasy
containing
more
absorptive
<20%than
water
ointments
and volatiles and >50% hydrocarbon, waxes o
Less greasy
do not spread easily
Stiffness and impenetrability, not suited for hairy parts of the body

CREAMS

General Uses Of Ointments

1. Acts as protective or protectant serve as physical barrier to


environment
2. Acts as emollient - softens skin and
makes it pliable
3. Carrier of medicament - vehicle

Examples of Ointments and Creams

7. Antibacterial/Anti-infectives

Adrenocortical Steroids

a. Bacitracin - Baciguent ointment

1. Betamethasone Valerate Valisone cream and ointment

b. Gentamicin Sulfate - Garamycin


cream & ointment

2. Fluocinolone Acetonide Synalar cream and ointment

c. Nystatin - Mycostatin cream and


ointment

3. Hydrocortisone Acetate Cortaid cream and ointment

d. Mupirocin - Bactroban ointment

8. Antifungals

4. Triamcinolone Acetonine Aristocort A cream and ointment

a. Nystatin - Mycostatin cream and


ointment

5. Tretinoin - Retin A cream and


ointment (Antiacne Drug)

b. Miconazole Nitrate - MonistatDerm cream

6. Nitroglycerin - Nitro-Bid
ointment (Antianginal drug)

c. Naftidine HCl - Naftin cream

d. Tolnaftate - Tinactin cream

FACTORS DETERMINE THE CHOICE OF


OINTMENT BASE
1.
2.

The action or effect desired


The nature of the medication to be
incorporated

3.

4.

bioavailability
Stability
compatibility

The desired shelf-life of the finished


product
The area of application

DESIRABLE PROPERTIES OF
OINTMENT BASES
1.

2.

3.
4.
5.

6.

Chemically and physically stable under


normal condition of use and storage
Nonreactive and compatible with a wide
variety of drug and auxiliary agents
Free from objectionable odor
Non toxic, nonsensitizing and nonirritating
Aesthetically appealing, easy to apply and
nongreasy
Remains in contact with the skin until
removal is desired, then is removed easily

OINTMENT BASES

Oleaginous base
(hidrocarbon)

water-miscible base
(terlarutcampurkan air)

Absorption base
(Dasar pengabsorpsi )

Water-soluble base
(terlarut air)

Emulsion bases
(Dasar pengemulsi)

Water/oil emulsion

Oil/water emulsion

PROPERTIES OF OINTMENT BASES


Absorption

Water/oil
emulsion

Oil/water
emulsion

Composition

oleaginous
compounds

oleaginous
base+w/o
surfactant

oleaginous
base+water
(<45%w/w)
+w/o
surfactant
(HLB<8)

oleaginousbase
+water(>45% Polyethylene
w/w)+o/w
Glycols
surfactant(HLB (PEGs)
>9)

Water
Content

anhydrous

anhydrous

hydrous

hydrous

anhydrous,
hydrous

hydrophobic

hydrophilic

hydrophilic

hydrophilic

hydrophilic

difficult

difficult

moderateto
easy

easy

moderateto
easy

nonwashable

nonwashable

non-orpoorly
washable
washable

oilspoor;
hydrocarbons
better

unstable,
especially
alkalisoaps
andnatural
colloids

Oleaginous

Affinity for
Water
Spreadability
Washability

Stability

oilspoor;
hydrocarbons
better

Watersoluble

washable

unstable,
especiallyalkali
soapsand
stable
naturalcolloids;
nonionicsbetter

solids,oils,and
aqueoussolutions
(smallamounts)

solidand
aqueous
solutions
(small
amounts)

solidand
aqueous
solutions

poor,but>
oleaginous

fairtogood

fairtogood

good

yes

sometimes

no

no

emollients,
cleansingcreams,
vehiclesforsolid,
liquid,ornonhydrolyzabledrugs

emollients,
vehiclesfor
solid,liquid,
ornonhydrolyzable
drugs

drugvehicles

ColdCreamtype,
HydrousLanolin,
RoseWater
Ointment,
Hydrocream,
Eucerin,Nivea

Hydrophilic
Ointment,
PEG
Dermabase, Ointment,
Velvachol,
Polybase
Unibase

Drug
solidsoroils
Incorporation (oilsolubles
Potential
only)

solids,oils,and
aqueous
solutions(small
amounts)

Drug Release
Potential*

poor

Occlusiveness

yes

Uses

Examples

protectants,
protectants, emollients(+/-),
emollients
vehiclesfor
(+/-),
aqueous
vehiclesfor solutions,solids,
hydrolyzable andnondrugs
hydrolyzable
drugs

White
Petrolatum,
White
Ointment

Hydrophilic
Petrolatum,
Anhydrous
Lanolin,
Aquabase,
Aquaphor,
Polysorb

Preparation of ointments
1.

2.

Preparation by Mechanical
incorporation
Preparation by Fusion

Preparation by Mechanical
incorporation

For liquid/semi solid base:


Soft

paraffin
lemak bulu (wool fat)
Liquid paraffin

Preparation by Mechanical
incorporation
1.

2.

3.

4.

Mechanical incorporation is performed by


TRITURATION in a mortar, or on a glass slab with a
spatula.
Insoluble powder is first triturated with small
amount of levigating agent.
The levigating agents could be an oil (mineral oil)
when preparing oleaginous ointment or glycerin and
propylene glycol when preparing hydrophilic
ointments.
Water soluble salts can be dissolved in water and
incorporated with anhydrous lanolin before being
incorporated with oleaginous base.

Preparation by Fusion

For solid or semi solid base


Example :

wax (lilin lebah)


hard paraffin
solid material ex : cetil alcohol, wool alcohol
(lemak alcohol), beeswax, emulsifying wax

Preparation by Fusion
1.

2.

3.

4.

5.

6.

Always make excess as transference losses will always occur.


Determine the melting points of the fatty bases and then melt
together. Starting with the base with the highest melting point,
each base should be melted at the lowest possible temperature.
Add the ingredients to an evaporating basin over a water bath to
avoid overheating
Adding the other ingredients in order of decreasing values, until
the softer oleaginous and perhaps liquid ingredients have all been
thoroughly incorporated by stirring.
The ointment should be stirred gently until it congeals to ensure a
homogenous preparation.
Powdered medicaments should be incorporated after the base
congeals using a small portion of the base as levigating agent.

MELTING THE BASE


INGREDIENTS

Beeswax 63C ----


Hard Paraffin 55C ---
Soft Paraffin 43C ---
Wool Fat 58C ----
Cetosteryl alcohol 43C ---
Spermaceti 46C ---

The incorporation of powders into an


ointment base

The incorporation of liquids into an


ointment base
Non-volatile, miscible liquids

CREAM PREPARATION - BEAKER METHOD


Melt the fatty bases
Water soluble in an evaporating dish
Identify
Component dissolve
oily soluble
over a water bath
In water &
and
at the lowest possible
water soluble
put in another temperature. Start with the
component
beaker
base with the highest melting point.
These should then be
cooled to 60C
The internal phase
both phases
is then added to
are heated
the external phase
to approximately 70C
Oily soluble
with stirring until
over a water bath
component dissolve
the product reaches
in oil & put in
one beaker, melted
Transfer into the jar

The incorporation of powders into an


ointment/cream base

Alternatively, if using a pre-prepared base,


soluble and insoluble solids may be
incorporated using the method employed for
insoluble solids

The incorporation of liquids into an


ointment/cream base
Non-volatile, miscible liquids

Alternatively, if using a pre-prepared base,


soluble and insoluble solids may be
incorporated using the method employed for
Volatile or immiscible liquids

GENERAL COMMENTS ABOUT


COMPOUNDING OINTMENT BASES
1.

2.

3.

4.

Make an excess of the ointment. Some general rules might


be to add 10% or 3 grams excess to the prescribed
amount.
When heat is used to melt ingredients, use a water bath or
special low temperature hotplate (around 70C)
When both an oil and aqueous phase are being mixed
together to make an ointment, it is helpful to heat the
aqueous phase a few degrees higher than the oil phase
prior to mixing.
When melting a number of ingredients, melt the ingredient
with the highest melting point first. Then gradually reduce
the heat to melt the ingredient with the next lowest
melting point.

5.

The cooling step in an ointment's


preparation is an important part of the
compounding process :
1.

Do not accelerate the cooling process by putting the


melt in water or ice

2.

If adding volatile ingredients such as oils, flavors, or


drugs, add them when the product is "cool to the back
of the hand." The melt will still be fluid enough for
adequate mixing but not hot enough to evaporate the
ingredient

3.

Ointments should be cooled until just a few degrees


above solidification before they are poured into tubes
or jars. They should be thick, viscous fluids

CONTAINER
Aluminiu
m tube

Ointment
Jar

Plastic
tube

Tube with nozzle --Eye


oinment

STORING AND LABELING

Keep in cool place, protect from the


light.
For external use only

EYE OINMENT

Eye ointments are sterile semi solid preparations


for application to the conjunctival sac or to the
eye lid margin.
It must be prepared carefully, because cell in
the eye is very sensitive
It must be prepared using clean and finely
material, and also free from microorganism.
They contain medicaments dissolved or
dispersed in a suitable non-irritant base.
Base : soft yellow paraffin, liquid paraffin or
yellow ointment

HOW TO USE EYE


OINTMENT
1.
2.

3.

4.

5.

Wash your hands


Dry them with a clean
towel or tissue.
Read the medication
label.
Lie down or tilt your head
back and gently pull your
lower eyelid down.
Carefully, place a line
(1cm) of ointment inside
the lower lid while being
careful not to touch your
eye with the tip of the
tube.

HOW TO USE EYE


OINTMENT
6.

7.

8.

9.

Your vision can become blurry for a few


moments, but it will clear quickly.
Close you eyes slowly and gently press a
finger against the inside corner of each
eye and keep them closed for
approximately 1 minute to allow the
medication to absorb.
Straighten your head and wipe away any
extra ointment.
If you are prescribed both eye drop and
eye ointment use the eye drop first.

THANK YOU

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