hemraj ppt.pptx

MAHATMA GANDHI VIDYAMANDIR’S
PHARMACY COLLEGE, PANCHAVATI, NASHIK 422003
Sub: Quality Control & Quality Assurance
A SEMINAR ON IPQC TEST OF
OPHTHALMIC PRODUCT
Presented By
Mr. Hemraj Dinkar Mahale
First Year M.Pharm.Sem I (2019 Pattern)
Roll No:- 40
Under The Guidance Of
Dr. K.V. Bhambar Sir
Department of pharmaceutical
Quality Assurance
MGVS PHARMACY COLLEGE ,PANCHVATI, NASHIK
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 Vision:
 To be a centre of professional excellence by contributing honestly to the pharmacist
moulding process.
 Mission:
 Impart high quality education to graduates
 Contribute to all spheres to professional activities
 Up hold human values and ethics
 Nature them into globally competent professional

CONTENT:-
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 Ophthalmic Product
 Types Of Ophthalmic Product
 In Process Quality control test

What is OPHATHALMIC PRODUCT ……….?
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 Ophathalmic product is sterile,liquid,semi-solid product that may contain one or more active
pharmaceutical ingredient intended for application to the conjunctive,the conjunctival sac or the
eyelids

Types Of Ophthalmic Product
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 EYE DROP:- Eye drops are sterile aqueous or oily solutions or suspensions of drug for instilling
into conjunctiva sac with dropper
Used for anesthetic, anti – inflammatory , antiseptic , miotic , mydriatic
 EYE OINTMENT :-Semisolid preparations based on oleaginous/ water washable bases packed
in collapsible tubes for easy transfer in to eye cavity by pressure.
 LOTION :- These are sterile aqueous solutions intended for washing the eyes to remove irritant
or foreign body

In Process Quality control test for ophthalmic preparation
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 pH
 Isotonicity
 Uniformity of volume
 Partical size
 Sterility test
 Clarity test
 Leakage test
 Presence of metal particles

1) Ph :-
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 The pH of the ophthalmic pharmaceuticals is very important. Normal tears have a pH of about
7.4 and possess some buffer capacity.
 In some cases pH may vary between 3.5 and 8.5. Some drugs, notably pilocarpine hydrochloride
and epinephrine bitartrate, are more acid and overtax the buffer capacity of the lacrimal fluid.
 Ideally the pH of all the ophthalmic preparations should be same i.e. 7.4.
 But practically it is not possible to maintain 7.4 pH and most drugs are chemically unstable at pH
levels approaching 7.4.
 The final pH of the solution is often a compromise, because many ophthalmic drugs have limited
solubility and stability at the desired pH of 7.4.
 Buffers or pH adjusting agents or vehicles can be added to adjust and stabilize the pH at a desired
level.

2) Isotonicity :-
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 A solution is said to be isotonic when its effective osmole concentration is the same as that of
another solution.
 In biology, the solutions on either side of a cell membrane are isotonic if the concentration of
solutes outside the cell is equal to the concentration of solutes inside the cell.
 An amount equivalent to 0.9% sodium chloride (NaCl) is ideal for comfort and should be used
when possible.
 The eye can tolerate tonicities within the equivalent range of 0.6 to 2% NaCl without discomfort.
 A hypotonic ophthalmic solution will require the addition of a substance (tonicity adjusting
agent) to attain the proper tonicity range.
 Sodium chloride, sodium nitrate, sodium sulfate, and dextrose are common neutral tonicity
adjustors.

3) Uniformity of volume :-
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This complies with the tests for contents of packaged dosage forms. Select a sample of 10 filled
containers, Clean and dry the outer of surfaces of the containers and weigh each container.
 Specification for eye drops
TEST IP BP USP
Uniformity of volume 91-109%(labelled amount is
50gm or less)
95.5-104.5% ( labelled amount
is 50gm -100 gm )
NS NS

4) Particle size :-
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This test is applicable only to eye drops that are suspensions. Introduce a suitable volume of
sample into a counting cell or onto a microscope slide, as appropriate. Scan under a microscope
an area corresponding to 10 ug of the solid phase. Scan at least 50 representative fields.
Test IP BP USP
Particle
Size
NMT 20 particles
> 25 dimension,
NMT 10 Particle >
50 um dimension
and none > 100
um dimension (
for 10 um of solid
phase)
NMT 20 particles >
25 um dimension,
and NMT 2>50 ug
dimension
None > 90 um
dimension . (for 10
um of solid phase)
NS

5) Sterility test :-
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The test must be carried out under aseptic conditions designed to avoid accidental
contamination of the product during testing.
The test is designed to reveal the presence of microorganisms in the samples used in the test .
• Two basic method for sterility testing:
I. direct inoculation method
II. membrane filtration method

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1) Direct inoculation method :-
a small volume of sample is removed aseptically from the sample unit and inoculated directly
into a suitable volume of growth medium before inculcation .
2) Membrane filtration method :-
Filtering of test sample using membrane filter Wash the membrane filter (wash to remove
inhibitory property) Transfer the membrane aseptically to the appropriate cutler media.
 Detection of contamination used to two culture media:
a. Soyabean-casein digest media:- incubated at 20 to 25 C
b. Fluid thioglycollate medium:- incubated at 30 to 35 C

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Test IP BP USP
Sterility Test If no evidence of
microbial growth is found
in 14 days, the product to
be examined complies
with the test for sterility
If no evidence of
microbial growth is found
in 14 days, the product to
be examined complies
with the test for sterility
NS

4.Clarity
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 Ophthalmic preparations have to be free from foreign particles.
 This is carried out by visual inspection under right light or with the aid of using Instruments
which include light scattering or video image projection
a. Visual inspection: - The preparation is tested under proper light, and viewed against a black and
white background with content set in movement with a swirling action
b. Instrumental method: -This technique makes use of the precept of light scattering, light
absorption, and electric resistance to gain particle count and size distribution-destruction of
product units An instrumental technique making use of video image projection detects
moving particles without destruction of product units-used for inline detection.

6) leakage test :-
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This test is carried out for an ophthalmic ointment with seal
10 sealed containers are chosen and exterior surfaces of each tube should be clean and dry
They are horizontally located over absorbent blotting paper in an oven saved at temperature 60
± 3 for eight hours.
If leakage is determined the test is repeated with extra 20 tubes. The test passes if not greater
than l tube indicates leakage out of 30 tube

7) Presence of metal particles:-
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 Extrude, as completely as practicable, the contents of 10 tubes individually into
separate,clear,flat-bottom,60-mm Petri dishes that are free from scratches
 Cover the dishes, and heat at 85 for 2 hours, increasing the temperature slightly if necessary to
ensure that a fully fluid state is obtained.
 Taking precautions against disturbing the melted sample, allow each to cool to room temperature
and to solidify
 Remove the covers, and invert each Petri dish on the stage of a suitable microscope adjusted to
furnish 30 times magnification and equipped with an eye-piece micrometer disk that has been
calibrated at the magnification being used

References
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1. THE INDIAN PHARMACOPΟΕΙΑ, GOVT. OF INDIA, MINISTRY OF HEALTH & FAMILY
WELFARE, "Monograph of parenteral", Volume 2, 2007, Pg no,39-42
2. USP. USP 36-NF 31, Ophthalmic Ointments 771. Rockville, MD: USP; 2013.
3. Gupta NV, Reddy GV. A Comparative study of quality control tests for eye preparations as per
IP, BP and USP. Int J Drug Dev Res. 2015;7(1):61-68.
Journal
4. Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS J. 2010;
12(3):348-360.
5. Gaudana R, Jwala j, Boddu SHS, Mitra AK. Recent perspectives in ocular drug delivery.
Pharm Res. 2009; 26(5):1197-1216.

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