IPQC & FPQC tests for creams

IPQC & FPQC Tests For Creams
Quality Control And Quality Assurance
M. Pharmacy II-Sem
Pharmaceutical Analysis
Mehul H Jain
122025201014

IPQC
• IPQC (In Process Quality Control) is the controlling procedures involved in
manufacturing of dosage forms starting from raw material purchase to dispatch in
final packaging.
• It prevent errors during processing.
• Human errors during process can be minimized.
• The primary objective of an IPQC system is to monitor all the features of a
product that may affect its quality and to prevent errors during processing.

FPQC
• FPQC (Finished Product Quality Control) are tests that are performed when the
manufacturing process is completed in order to check qualitative and quantitative
characteristics along with test procedures and their acceptable limits by which the
finished product must comply throughout its valid shelf-life.
• In order to determine the specifications of the finished product, the quality
characteristics related to the manufacturing process should be taken into account.
• An appropriate specification for each aspect of quality studied during the phase of
development and during the validation of the manufacturing process should be
determined.

CREAMS
• Creams are semisolid viscous preparations which contain one or more drug
substances dissolved or dispersed in a suitable base and are used for topical
application on the skin or mucous membranes.
• They usually contain a water soluble base due to which they can be easily removed
from the skin.
• They are of softer consistency and have light weight in comparison to true ointments
when applied to the skin, creams leave no visible evidence of their presence on the
skin.
Types of creams:
Creams are of two types-
a) Aqueous creams (oil-in-water creams)
b) Oily creams (water-in-oil creams)

ADVANTAGES DISADVANTAGES
Convenient and easy to apply.
Skin irritation of contact dermatitis may occur
due to the drug and /excipients.
Less greasy and smoother consistency.
Poor permeability of some drugs through the
skin.
Application of cream on skin leaves no visible
evidence of its presence.
Possibility of allergic reactions.
They have soothing action on inflamed areas
of the skin.
Can be used only for drugs which require very
small plasma concentration for action.
Interfere less with the functions of the skin.
Avoid first pass metabolism.
Exhibit better contact with the skin.
Creams are more stable than emulsions due to
very less possibility of creaming and
coalescence.

Ideal Properties
• Easy to apply.
• Spread easily on the skin.
• Pleasant in appearance.
• Less irritation to the skin.
• Melt or liquify when applied on to the skin.

OIL-IN-WATER (O/W) CREAMS:
Dispersed phase: Oil
Continuous phase: Water
They are less greasy and more easily washed off using water.
Eg: Fluocinolone Acetonide Cream.
WATER-IN-OIL (W/O) CREAMS:
Dispersed phase: Water
Continuous phase: Oil
More difficult to handle. Hydrophobic and drug will be released more readily from a
W/O cream than an O/W Cream.
Eg: Moisturizing & Cold Cream.

EVALUATION OF CREAMS
1. Physical Methods
a. Test for Rate of Absorption
Creams are those from which the drug
initially moves into the deeper skin
tissues and finally into the systemic
circulation. Such creams should be
evaluated for the rate of drug absorption.
the cream is applied over a definite area
of the skin and at regular intervals of
time, serum and urine samples are
analyzed for the quantity of drug
absorbed.
b. Test for Irritancy
The bases used in the formulation of
creams may cause irritation or allergic
reactions. Irritancy of the preparation is
evaluated by patch test. Mark an area
(1sq.cm) on the left-hand dorsal surface.
The cream was applied to the specified
area and time was noted. Irritancy,
erythema, edema, was checked if any for
regular intervals up to 24 hrs. and
reported.

c. Test for Rate of Drug Release
Method I
i. A clean test tube is taken and its
internal surface is coated with the
test preparation in the form of a thin
layer.
ii. Saline or serum is poured into the
test tube.
iii. After a certain period of time, the
saline is analyzed for the quantity of
the drug. The amount of drug when
divided by the time period gives the
rate of drug release.
Method II
i. Empty cream jar is filled with the
test preparation and its mouth is
closed with cellophane.
ii. The jar is placed in a water bath in
an inverted position for a definite
period of time.
iii. The water is then analyzed for the
drug content, from which the rate of
drug release is determined.

Method III
i. This method is suitable for drugs with
bactericidal action.
ii. Five nutrient agar broth tubes are taken to
which suitable medium is added.
iii. Staphylococcus aureus is inoculated into all the
tubes.
iv. Under aseptic conditions, the inoculated
medium is transferred into sterile petri plates.
v. In the central portion of each plate, wells are
made.
vi. Small quantity of preparation is added to these
wells under aseptic conditions.
vii. All the plates are incubated after which the
diameter of zone of inhibition of microbial
growth is measured.
viii.The average diameter of zone of inhibition is
calculated and interpreted as the rate of drug
release.

d. Physical Properties
The cream was observed for the color, odor and appearance.
e. pH
The pH meter was calibrated with the help of standard buffer solution. Weigh 0.5
gm of cream dissolved it in 50.0ml of distilled water and its pH was measured with
the help of digital pH meter.
f. Spread ability test
The cream sample was applied between the two glass slides and was compressed
between the two-glass slide to uniform thickness by placing 100 gm of weight for 5
minutes then weight was added to the weighing pan. The time in which the upper
glass slide moved over the lower slide was taken as a measure of spread ability.
Spread ability = m*l/t
Where, m = weight tight to upper slide
l = length moved on the glass slide
t = time take

g. Test for Rheological Properties
Using brookfield viscometer, the viscosity of the preparation is determined. The viscosity
of the preparation should be such that the product can be easily removed from the
container and easily applied onto the skin.
h. Test for Content Uniformity
The net weight of contents of ten filled cream containers is determined. The results should
match with each other and with the labelled quantity. This test is also called minimum fill
test.
i. Saponification Value
Take 2gm of the substance and reflux it with the 25ml of 0.5N alcoholic KOH for 30
minutes. Then add 0.1ml of phenolphthalein as a indicator and titrate it with the 0.5N
HCL.
Saponification value = (b-a) * 28.05/W
Where, a = volume of titrate (blank)
b = volume of titrate (sample)
w = weight of substances in gram

j. Acid Value
Take 10 gm of the cream dissolved in accurately weighed in 50 ml mixture of the
equal volume of alcohol and solvent ether. Then attached the flask with the condenser
and reflux it with the slow heating until the sample gets completely dissolve then add
1 ml of phenolphthalein and titrate it with 0.1 N NaOH until it gets faint pink color
appears after shaking in 20 seconds.
Acid value = n * 5.61/w
Where, w = weight of the substances
n = the number of ml in NaOH required.
k. Dye Test
The scarlet red dye is mixed with the cream. Place a drop of the cream on a
microscopic slide then covers it with a cover slip, and examines it under a
microscope. If the disperse globules appear red the ground colorless. The cream is
o/w type. The reverse condition occurs in w/o type cream i.e. the disperse globules
appear colorless.

2. Microbiological Methods
a. Test for Microbial Growth
Agar media was prepared then the formulated cream was inoculated on the plate’s agar
media by streak plate method and a controlled is prepared by omitting the cream. The
plates were placed in the incubator and are incubated in 37˚C for 24 hours. After the
incubation period, the plates were taken out and the microbial growth were checked and
compared with the control.
b. Test for Preservative Efficacy
Requirements
Microorganisms: Cultures of Aspergillus niger, Candida albicans, Escherichia coli,
Pseudomonas aeruginosa and Staphylococcus aureus, each containing 100000 to
1000000 cells/mL
Medium: Tryptone Azolectin Tween (TAT) broth.

Procedure
i. Using pour plate technique, the number of microorganisms initially present in
the preparation are determined.
ii. Solutions of different samples of the preparation are made and mixed with TAT
broth separately.
iii. All the cultures of the microorganisms are added into each mixture, under
aseptic conditions and incubated.
iv. The number of microorganisms in each sample are counted on 7th, 14th, 21st and
28th days of inoculation.
Microbial Limits
i. On the 14th day, the number of vegetative cells should not be more than 0.1% of
initial concentration. The viable yeasts and moulds should be below or equal to
initial concentration.
ii. On 28th day, the number of organisms should be below or equal to initial
concentration.

3. Stability Studies
The stability studies are carried out as
per ICH guidelines. The cream is filled
in the bottle and kept in humidity
chamber maintained at 30 ± 2°C/65 ±
5% RH and 40 ± 2°C/75 ± 5% RH for 2
months. At the end of studies, samples
are analyzed for all the evaluation
parameters.

Marketed Products of Creams
Drugs Commercial Products
Betamethasone propionate 0.05% Diprolene
Clobetasol propionate 0.05% Temovate
Halobetasol propionate 0.05% Ultravate
Mometasone furoate 0.1% Elocon
Calcipotriol 0.005% Dovonex
Calcitriol 0.005% Daivonex
Dithranol 1% Micanol
Salicylic acid 6% Seton
Clobetasol propionate 0.05% + Salicylic acid 3% Kelypso
Clobetasol propionate 0.05% + Salicylic acid 6% Clopinate S

Formulation and Evaluation of Polyherbal
Cold Cream
Drug
Extract of turmeric (Curcumin longa), Neem (Azadirachta indica) oil.
Uses
Neem oil: Treat psoriasis, eczema, acne, heal wounds, minimize warts and moles etc.
Turmeric extract: Antimicrobial agent, lightening agent, moisturizer.
Extraction of Turmeric
Accurately weighed quantity of turmeric is taken. Then extract it with n-hexane for 2
hrs. Discard the n-hexane extract with acetone for 2 hrs. Distil off the acetone and
dry the crystals. Then recrystallize the curcumin with the help of ethanol.
Neem oil
Herbal pure neem oil is procured from the local market.

Composition of polyherbal cold cream for 100gms
Preparation of polyherbal cold cream
Formulation can be prepared by adding two different phases which are as follows.
Phase 1
Melt the solid ingredients by indirect heat then add all the oils in it and stir well.
Sr. No. Ingredients Quantity
1 Beeswax 15gm
2 Jojoba oil 1.5ml
3 Turmeric extract 9gm
4 Neem oil 46gms
5 Coconut oil 1.5ml
6 Powdered borax 0.5gm
7 Rose water 26ml

Phase 2
Dissolve the borax in water with the help of heat.
While still hot add the phase 1 into the phase 2 gradually with constant stirring to
the wax and oil mixture. Continue this process for 5 minutes, stir, then remove from
the heat and stir until it gets cold. As compare to other creams this cream may be
made heavier by adding more wax.
Evaluation Parameters
1. Physical properties
2. pH
3. Viscosity
4. Spread ability test
5. Irritancy test
6. Test for microbial growth
7. Saponification value
8. Acid value
9. Dye test

1. Physical properties
The cream is observed for the color, odor
and appearance.
2. pH
Weigh 0.5 gm of cream, dissolve it in 50
ml of distilled water and its pH is
measured with the help of digital pH
meter.
The pH of the cream was found to be in
range of 5.6 to 6.8 which is good for skin
pH.
Sr.No. Parameter Evaluation
1 Color Green
2 Odor Pleasant
3 Texture Smooth

3. Viscosity
Viscosity of formulated cream was determined by brook field
viscometer at 20 rpm using spindle no. LV-4(64). The viscosity
of cream was in the range of 499990 to 30000cp which
indicates that the cream is easily spreadable by small amount
of shear.
4. Irritancy test
Mark an area (1sq.cm) on the left-hand dorsal surface. The
cream is applied to the specified area and time is noted. The
formulated cream shows no redness, edema, irritation and
inflammation during studies. The formulated cream is safe to
use.

5. Spread ability test
The cream sample is applied between the
two glass slides and is compressed
between the two-glass slide to uniform
thickness by placing 100 gm of weight for
5 minutes then weight is added to the
weighing pan. The spread ability test
showed that the formulated cream has
good spreadable property.
6. Test for microbial growth
Agar media is prepared, then the formulated
cream is inoculated on the plate’s agar media
by streak plate method and a controlled is
prepared by omitting the cream. The plates
are placed in the incubator and are incubated
in 37˚C for 24 hours. There was no signs of
microbial growth after 24 hrs. of incubation
at 37ºC and it was comparable with the
control.

7. Saponification value
Take 2 gm of the substance and reflux it
with the 25 ml of 0.5 N alcoholic KOH
for 30 minutes. Then add 0.1 ml of
phenolphthalein as a indicator and titrate
it with the 0.5 N HCL.
8. Acid value
Take 10 gm of the cream dissolved in
accurately weighed in 50 ml mixture of
the equal volume of alcohol and solvent
ether. Then attached the flask with the
condenser and reflux it with the slow
heating until the sample gets completely
dissolve then add 1 ml of
phenolphthalein and titrate it with 0.1 N
NaOH until it gets faint pink color
appears after shaking in 20 seconds.
Sr.No. Parameter Evaluation
1 Saponification value 22.3
2 Acid value 5.7

9. Dye test
The scarlet red dye is mixed with the cream. Place a drop of the cream on a
microscopic slide then covers it with a cover slip, and examines it under a
microscope. The disperse globules appears colorless in the red ground i.e. w/o type
cream.

Packaging and Storage of Creams
Packaging
1. Jars
Wide-mouthed cream jars made of either glass
(opaque or transparent) or plastic are
recommended. Opaque jars (amber, dark green or
porcelain white colored) are used for packing
photosensitive products.
In large-scale manufacture, a pressure filler is used
which forces specified quantity of preparation into
the jars. In small-scale manufacture, the cream is
transferred carefully into the jars using a spatula
while avoiding entrapment of air. The jars are filled
only until the top but not more than that, as the
preparation might touch the lid when the jar is
closed.

2. Tubes
Tubes have the following advantages over jars.
a. They are relatively light in weight.
b. Their cost is low.
c. They provide more protection from
contaminants and environment than jars.
d. They are compatible with many of the
ingredients of creams.
Semisolids are frequently packed in 5-30gms
capacity tubes. Tubes made up of aluminum or
plastic are used for packing semisolid
preparations.
i. Aluminum Tubes
Uncoated aluminum tubes may interact with
the ingredients, therefore tubes coated with an
epoxy resin, lacquer or vinyl are used.

ii. Plastic Tubes
Plastics such as high density
polyethylene (HDPE), low density
polyethylene (LDPE) or a mixture
of polypropylene, polyethylene
terephthalate (PET) are used in
making these tubes. Foil and paper
laminates of 10 layer thickness are
also used.
Labelling
The label of a semisolid dosage form should
contain a cautionary advice For External Use Only
as these preparations are meant only for external
use.
Storage
Semisolid dosage forms should be stored in well
closed containers in a cool place to prevent
separation of the product due to heat and also to
avoid contamination.

References
• R.N. Shah, B.M. Methal, (2006) A Handbook of Cosmetic, Vallabh Prakashan.
• C.K. Kokate, A.P. Purohit, S.B. Gokhale (2014) Textbook of Pharmacognosy.
Nirali Prakashan 50th edition, p.p. 9.1 & 14.132.
• Himaja. N. (2017). Formulation and Evaluation of Herbal Cream from
Azadirachta indica Ethanolic Extract. IJournals: Int J Res Drug Pharm Sci, 1(1),
23-6.
• Mali, A. S., Karekar, P., & Yadav, A. V. (2015). Formulation and evaluation of
multipurpose herbal cream. International Journal of Science and Research,
International Journal of Science and Research, 4(11), 1495-1498.
• Mukherjee, P. K. (2002). Quality control of herbal drugs: an approach to
evaluation of botanicals. Business Horizons.
• N. R. Patel, H. U. Momin, R.L. Dhumal, K, L. Mohite, (2017), preparation and
evaluation of multipurpose herbal cream , Adv Pharm Life sci Res;5(1);27-32

IPQC & FPQC tests for creams

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