zulfiayu

definition

Semisolid preparations for external application to the body

Soft, semisolid preparations usually containing medicaments and are

intended to the body or to the mucous membranes
Definition

Pharmaceutical ointment are semisolid systems that are applied

externally, primarily to the skin and also to mucous membranes, e.g.
the rectum, the vagina/vulva, the eye.
For treatment of infection, inflamation, and pruritus.
Non medicated are used due to their emolient/lubricating properties
 definition

Sediaan setengah padat ditujukan untuk pemakaian topikal pada kulit

atau selaput lendir. (FI IV)
Sediaan setengah padat yang lembut dan mudah dioleskandan
memiliki aliran plastis
 Aplication and Utility

Why ointment base used?

as protectives and emolients for the skin
Vehicles or bases for the topical application of medical
substances
Also may be applied to the eye or eyelids
The site of application

Moist or dry
Dry ointment are often used to occlude the site, thereby retaining
moisture.
Occlusive ointment bases are not applied to the sites in which there
is fluid exudate
The required rate of drug release

Following application, the therapeutic agent must be released to

exert it pharmacological effect,either locally or after absorption,
systemically.

Drug release from the ointment base required solubility (albeit

partial) of the therapeutic agent within the formulation.

This will allow diffusion of the therapeutic agent (a molecular

process) through the ointment base until it reaches the biological
substrate

Therefore the choise of ointment base is partially dictated by the

physicochemical properties (and in particular solubility) of the
therapeutic agent.
 Ideal Ointments

The ointment base must be :

Compatible with the skin
Stable
Permanent
Smooth and pliable
Nonirritating
Nonsensitizing
Inert
Readily able to release its incorporated medication
 Type of ointment
according to the effect

1. Surface effects
2. Stratum corneum effect
3. Epidermal, dermal, local, and systemic effects
Surface effect

In the form of a film, an action against surface microorganisms or a

cleaning effect
Basis salep : petrolatum
Ex : zink oxide
sunscreen
cleanser
Stratum corneum effects

Basis minyak nabati dan lemak nabati

ex: sunscreen
keratolytic agent
DERMAL effects

Basis lanolin hidrat, lanolin anhidrat dan minyak teobroma

ex: iodida
 Type of ointment base
(composition)

1. Oleaginous (hidrokarbon)
2. Emulsifiable/Adsorbent (serap)
3. Emulsion bases (dapat dicuci air)
4. Water-soluble (larut dalam air)
The choice of ointment base is dependent on several factors, including
:
The site of application
The required rate of drug release
The chemical stability of the drug
The effect of the therapeutic agent on formulation viscosity
 Oleaginous oint.bases

Include fixed oils of vegetable origin, fats obtained

from animals and semisolid hydrocarbons obtained
from petroleum.
Dasar salep ini dikenal sebagai dasar salep berlemak
antara lain vaselin putih dan salep putih.
Hanya sejumlah kecil komponen berair dan dapat
dicampurkan ke dalamnya.
Dasar Salep Hidrokarbon

Salep ini dimaksudkan untuk memperpanjang kontak bahan

obat dengan kulit dan bertindak sebagai pembalut penutup
Dasar salep hidrokarbon digunakan terutama sebagai
emolien, dan sukar dicuci.
Tidak mengering dan tidak tampak berubah dalam waktu
lama
 Advantages : high degree of compatibility with a variety of
medicaments, optimum stablity of medicaments (ab), permits some
latitude in vehicle selection
Disadvantages of vegetable oils and animal fats : their water
absorbing capacity is low and they have a tendency to become
rancid.
Properties of oleaginous bases

Emollient
Occlusive
Non water-wasable
Hydrophobic
greasy
 Oleaginous oint.bases

White Ointment
Yellow Ointment
White wax...50 g Yellow Wax 50 g
White petrolatum...950 g Petrolatum 950 g
To make..1000 g To make.. 1000 g

Simple Ointments
 Oleaginous oint.bases

Cetyl Ester Wax White Petrolatum

Oleic Acid Spermaceti
Olive Oil Starch Glycerite
Paraffin White Wax
Petrolatum Yellow Wax

Components
 Absorbent Ointment Bases

Have the ability to absorb additional

water
Water absorbing or emulsifying
properties of these bases and not to
describe their action on the skin
Anhydrous substances which have the
property of adsorbing (emulsiying)
considerable quantities of water and
still retaining their ointment-like
consistency
 Absorbent oint.bases

Anhydrous Lanolin
Hydrophilic Petrolatum
Hydroxystearin Sulfate
Components
Dasar salep serap

Dasar salep ini dapat diabgi dalam 2 kelampok

1. Salep yang dapat bercampur dengan air membentuk emulsi air
dalam minyak (parafin hidrofilik dan lanolin anhidrat)
2. Emulsi air dalam minyak yang dapat bercampur dengan sejumlah
larutan iar tambahan (lanolin).
Dasar salep serap juga berfungsi sebagai emolien
properties

Emollient
Occlusive
Absorb water
Anhydrous
Greasy
 Emulsion Oint.Bases

Semisolid emulsion
Two groups : emulsion ointment base water in oil and
emulsion ointment base oil in water

definition
 Properties

w/o type
Emollient o/w type
Water washable
Occlusive
Nongreasy
Contain water Can be diluted by
Some absorb additional water
watet nonocclusiv
greasy
 Emulsion Oint.Bases

Cetyl Alcohol Glyceryl Monostearate

Lanolin Stearic Acid
Wool Alcohols

Components
properties

Usually anhydrous
Water soluble and washable
Nongreasy
Nonocclusive
Lipid free
Ointment vs creams
 Emulsion Oint.Bases

Semisolid emulsion
Two groups : emulsion ointment base water in oil and
emulsion ointment base oil in water

definition
 Water Soluble Oint.Bases

Washable Ointment
Include PEG
Dasar salep yang dapat dicuci dengan air

Dasar salep ini adalah emulsi minyak dalam air antara lain
salep hidrofilik dan lebih tepat disebut krim.
Dasar ini dinyatakan juga sebagai dapat dicuci dengan air
karena mudah dicuci dari kulit atau dilap basah, sehingga
lebih dapat diterima untuk dasar kosmetik.
Beberapa bahan obat dapat menjadi lebih efektif
menggunakan dasar salep ini daripada dasar salep
hidrokarbon.
Keuntungan lain dari dasar salep ini adalah dapat diencerkan
dengan air dan mudah menyerap cairan yang terjadi pada
kelainan dermatologik
 Sekarang ini batasan tersebut lebih diarahkan untuk produk yang
terdiri dari emulsi minyak dalam air atau dispersi mikrokristal asam-
asam lemak atau alkohol berantai panjang dalam air, yang dapat
dicuci dengan air dan lebih ditujukan untuk penggunaan kosmetika
dan estetika
Krim dapat digunakan untuk pemberian vaginal
 Water Soluble Oint.Bases

Polyethylene Glycols
Polyoxyl 40 Stearate Components
Dasar Salep larut dalam air

Disebut juga dasar salep tak berlemak.

Terdiri atas konstituen larut air
Dasar salep jenis ini memberi banyak keuntungan seperti dasar salep
yagn dapat dicuci dengan air dan tidak mengandung bahan tak larut
dalam air seperti parafin, lanolin anhidrat atau malam.
Dasar salep ini lebih tepat disebut gel.
Method of preparation
 Preparation

Triturating in a mortar
Rubbing with spatula
Levigation

Mechanical Mixing
 Preparation

When hard fusible bodies are to be incorporated with soft

fats, it is necessary to melt both these and the soft fats to
get a smooth, homogeneous mixture

Melt the body having the highest melting point first, then
add that having the next highest

Fusion
 fusion

The oil phase melted separately starting with the highest melting
point.
The water phase is heated several degress above the temperature of
the melted oil phase
Two phase are combined
 Preparation

The new product is formed by chemical reaction between

the ingredients

Ex : Rose water ointment (stainless iodized oint.), mercuric

nitrate oint (action of nitric acid on lard), mercuri nitrate (rx
mercury with nitric acid)

Chemical Reaction
Preservatives in ointment bases

To maintain the potency and integrity of the product forms and to

protect the health and safety of the consumer
USP topical product should be free from P. aeruginosa and S.
aureus
Desirable properties

Effective at relatively low consentrations agains a broad

spectrum or variety of microorganisms which could cause
disease or product deterioration
Soluble in required concentration
Nontoxic and nonsensitizing at in use-concentration
Compatible with the formulation and package components
Free from objectionable odors and colors
Stable over a wide spectrum of conditions
Inexpensives
 Storing and Dispensing

The manner in which ointments are stored very often

determines the degree to which they are stable
Should be stored in closed airtight containers away from
heat
Packaging and labelling

Are packaged in ointment jars or in metal or plastic tubes of the

convenient size
Paper labels may be used, labelling may be silkcreened onto plastic
surfaces, expiration dates and code lot numbers may be stamped on
as a part of the tube-crimping prosedure
KETIDAKSTABILAN

Petunjuk utama ketidakstabilan adalah perubahan warna

atau perubahan dalam konsistensi atau bau

Krim pecahnya emulsi, pembetnukan hablur, penciutan

karena penguapan air dan kontaminasi mikroba yang besar

Salep perubahan dalam konsistensi dan pemisahan

sejumlah besar cairan dan pembentukan granul atau butiran
kecil