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CREAM

Dr. apt. Widyastuti, S.Si., M.Farm


PENGANTAR
• Creams are defines as “a semisolid
dosage form containing one or more
drug substances dissolved or
dispersed in a suitable base
• Cream are semisolid emulsions of
oil and water
• They are of a softer consistency
and lighter body than true ointment
• Semisolid emulsion of either o/w or
w/o type
O/W CREAMS

• o/w creams which are composed of small droplets of


oil dispersed in a continuous phase

• More comfortable and cosmetically acceptable as they


are less greasy and more easly washed off using water

• Emulsifying agents of natural origins (bees wax, wool


alcohols, wool fat)

• Emollient and creamy, white or translucent and stiff

• e.g. Vanishing Cream


W/O CREAMS
• w/o creams which are composed of small
droplets of water dispersed in a
continuous oily phase

• More difficult to handle but many drugs


which are incorporated into creams are
hydrophobic and will be released more
readly from a w/o cream than an o/w
cream

• More moisturizing as they provide an oily


barrier which reduces water loss from
the stratum corneum, the aoutermost
layer of the skin

• e.g. Cold Cream


COSMETIC CREAMS
All purpose cream, baby cream, barrier
cream, bleaching cream, cleansing cream,
cold cream, hair cream, hand cream,
vanishing cream

KOSMETIK
MEDIK MEDICATED CREAMS
• Medicated creams are contains active
pharmaceutical ingredients.
• e.g. cetrimide cream used as antiseptic, ZnO
cream used as astringent, hydrocortisone
cream treat rashes like poison oak or poison
ivy
PREPARATION OF
01 THE OIL PHASE
• Flake/powder ingredients, sometimes dry
blended in advance, are dispersed into
mineral oil or silicone oil. Heating may be
MANUFACTURING
02
required to melt some ingredients

HYDRATION OF AQUEOUS
P R O C E S S
PHASE INGREDIENTS
• Emulsifiers, thickeners and stabilizers are
dispersed into water in a separate vessel.
Heating may be required to accelerate
hydration

03 FORMING THE EMULSION


• The two phases are blended under
vigorous agitation to form the emulsion

04 DISPERSION OF THE ACTIVE


INGREDIENT
• The active ingredient often makes up only
a small proportion of the formulation, this
must be efficiently dispersed to maximize
yield and product effectiveness
ADVANTAGES OF DISADVANTAGES OF
CREAM CREAM
1. They gives prolong contact in their
site of application than any other 1. Stability is not as good as ointment
pharmaceutical semisolid dosage 2. They are less hydrophobic than
forms other semisolid preparation, so risk
2. Injured area can be dried quickly by of contamination is high than the
cream than other semisolid other
preparation
3. Non-irritating when applied to the
skin
4. Easily water washable and easily to
wipe away
5. Less greasy compared to ointment
6. Easy to spread on the skin’s
surface and easy to apply
IDEAL CHARACTERISTIC
• It should liquefy at body
temperature
• It should penetrate the epidermis
(via natural opening)
• Its viscosity should be low
enough to permit easy spreading
• It should be non toxic
• It should be non irritant
• It should be non inflammatory
EVALUASI pH
KRIM Viskositas
Sifat alir
Tipe emulsi
Uji mikromeritik
Daya tercuci
Uji daya sebar
Stabilitas
Kadar zat aktif
Uji penetrasi
pH
• Pengujian menggunakan pH
meter digital
• Sekitar 1 gram cream
dilarutkan dengan 100 mL
aquadest dan simpan selama 2
jam
• Pengukuran setiap pH masing-
masing formula dilakukan
masing-masing 3x
pengulangan dan didapat nilai
rata-rata
VISKOSITAS
• Viskositas dari formula krim
dilakukan pengujian
menggunakan viscometer
Brookfield
• Pada 20 rpm temperature 25 oC
• Pengujian dilakukan pada
masing-masing formula
sebanyak 3x pengulangan dan
didapat nilai rata-rata
SIFAT ALIR
• Pengujian menggunakan
viscometer Brookfield, dimana
dilakukan pengujian viskositas
dengan rpm yang berbeda
• Pengujian menggunakan sediaan
sebanyak 100 g
• Rate of shear meningkat secara
bertahap dari minimum ke
maksimum dan pembacaan
dicatat; kemudian, rate of shear
diturunkan secara bertahap ke
nilai terendah dan pembacaan
dicatat
• Grafik dibuat antara persentase
torsi dan viskositas, dan
ditentukan sifat alir
TIPE EMULSI
PENGENCERAN DENGAN AIR
0,1 gram krim dilarutkan dengan 10 mL aquadest,
dilihat secara visual, apabila ada tampak tetesan
minyak berarti krim tipe w/o

PEWARNAAN
Sejumlah krim dicampurkan dengan pewarna larut
air (metilen blue), bila tercampur homogeny,
berarti krim tipe o/w
UJI MIKROMERITIK
• Sejumlah krim dioleskan pada gelas objek kemudian
diletakkan meja benda pada mikroskop.
• Ukuran droplet diamati yang terdispersi pada krim.
• Menggunakan perbesaran lemah untuk menentukan
objek yang akan diamati kemudian diganti dengan
perbesaran kuat.
• Diameter terjauh diukur dari tiap droplet sejumlah
500 droplet
DAYA TERCUCI
• Hanya emulsi M/A yang dapat mudah dicuci
dengan air dari tangan atau barang.

• Penghilangan suatu emulsi A/M menurut


pengalaman sering menunjukkan kesulitan
yang sangat berarti
UJI DAYA SEBAR
• Uji daya sebar sediaan krim dilakukan
langsung setelah pembuatan.
• Krim ditimbang seberat 1,0 gram,
diletakkan di tengah kaca bulat berskala.
• Di atas krim diletakkan kaca bulat lain
dan pemberat sehingga berat kaca bulat
dan pemberat 125 gram, didiamkan
selama 1 menit, kemudian dicatat
penyebarannya
UJI STABILITAS
1.Globule size
2.Phase separation
3.Moisture absorption studies
4.Shelf life
5.Spreadabality
GLOBULE SIZE
SHELF LIFE
• 1 mL of cream was diluted to 10 mL with glycerin
• The formulated product was stored in different
• A few drops of this were transferred onto a glass
temperature conditions like room temperature, 45 oC
slide and was focused in a microscope
and 55 oC to accelerate degradation for 1 month
• By using eyepiece micrometer, the diameters of
• Samples were withdrawn periodically every week and
200 particles were determined randomly
observed for drug decomposition by taking the
absorbance under UV spectrophotometer
• From the concentration, and the temperatures, the
PHASE SEPARATION shelf life of the product can be estimated
• The formulated cream was kept intact in a closed
container at 25 – 30 oC not exposed to light
• Phase separation was observed carefully every 24 SPREADABILITY
hours for 30 days • The spreadability was expressed in terms of time in
• Any change in phase separation was checked seconds
• Take two slides to slip off from the cream, placed in
between the slides, under certain load
• Lesser the time taken for separation of the two
MOISTURE ABSORPTION STUDIES
slides, better the spreadability
• About 50 mg of cream was taken on a watch glass
• A beaker was taken with full of water and wash kept in a
desiccator without adsorbents
• Watch glass with cream was introduced into desiccator
• It was left for 24 hours
UJI PENETRASI
• Simple, reliable, and reproducible, measuring drug release
from semisolid dosage forms.
• Consists of two primary chambers separated by a
membrane
• Test product is applied to the membrane via the top
chamber.
• Bottom chamber contains fluid from which samples are
taken.
• Determines the amount of active that has permeated the
membrane at each time point
• Constant temperature of 37°C
MACHINERY
REQUIRED
• Steam jacketed kettle
• Kettle with stirrer
• Tube filling machine
• Numatic tube sealing
machine
Steam jacketed kettle
Tube filling machine
Numatic tube sealing
machine
THANK YOU
TUGAS
Buatlah cream dari zat aktif dibawah ini:
1. Fluosinolon dan neomisin
2. Betametason dan gentamisin
3. Basitrasin dan hidrokortison
4. Kloramfenikol dan prednisolone
5. Asam fusidat dan klobetasol

Base cream:
1. Vanishing cream
2. Cold cream
3. Salep hidrofilik

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