Evaluation Of Ocular Drug Delivery System. Various Evaluation tests for ODDS

1. Bengal School of Technology
A Presentation submitted on -
EVALUATION OF OCULAR
DRUGS DELIVERY SYSTEM
Name- ANAL MONDAL
M.PHARM
PHARMACEUTICS

2. INTRODUCTION
Ocular administration of drug is
primarily associated with the need to
treat ophthalmic diseases.
Eye is the most easily accessible site for
topical administration of a medication.
Ideal ophthalmic drug delivery must
be able to sustain the drug release and
to remain in the vicinity of front of the
eye for prolong period of time.

3. Water - 98%, Solid -1.8%,
Organic element – Protein - 0.67%,
sugar - 0.65%, NaCl - 0.66% Other
mineral element sodium, potassium
and ammonia - 0.79%.

4. THICKNESS OF THE FILM:
Measured by dial caliper at different
points and the mean value is calculated.
DRUG CONTENT UNIFORMITY:
The cast film cut at different places and
tested for drug as per monograph.
UNIFORMITY OF WEIGHT:
Here, three patches are weighed.

5. PERCENTAGE MOISTURE
ABSORPTION:Here ocular films are weighed and placed in
a dessicator containing 100 ml of saturated
solution of aluminium chloride and 79.5%
humidity was maintained.
After three days the ocular films are
reweighed and the percentage moisture
absorbed is calculated using the formula:
% moisture absorbed = Final weight –
initial weight/ initial weight x 100

6. BOTTLE METHOD:
In this, dosage forms are placed in the bottle
containing dissolution medium maintained at specified
temperature and pH.
The bottle is then shaken.
A sample of medium is taken out at appropriate
intervals and analyzed for the drug content.
DIFFUSION METHOD:
Drug solution is placed in the donor compartment and
buffer medium is placed in between donor and receptor
compartment.
Drug diffused in receptor compartment is measured at
various time intervals.

7. MODIFIED ROTATING BASKET
METHOD:Dosage form is placed in a basket assembly connected to a
stirrer.
The basket is lowered into a jacketed beaker containing
buffer medium and temperature 37 degrees Centigrade.
Samples are taken at appropriate time intervals and
analyzed for drug content.
MODIFIED ROTATING PADDLE APPARATUS:
Here, dosage form is placed into a diffusion cell which is
placed in the flask of rotating paddle apparatus.
The buffer medium is placed in the flask and paddle is
rotated at 50 rpm.
The entire unit is maintained at 37 degree C.
Aliquots of sample are removed at appropriate time intervals
and analyzed for drug content.

8. Here, the dosage form is applied to one eye of
animals and the other eye serves as control.
Then the dosage form is removed carefully at
regular time interval and are analyzed for drug
content.
The drug remaining is subtracted from the
initial drug content, which will give the amount
of the drug absorbed in the eye of animal at
particular time.
After one week of washed period, the
experiment was repeated for two time as before.

9. These are carried out to predict the
breakdown that may occur over prolonged
periods of storage at normal shelf condition.
Here, the dosage form is kept at elevated
temperature or humidity or intensity of light,
or oxygen.
Then after regular intervals of time sample
is taken and analyzed for drug content.
From these results, graphical data
treatment is plotted and shelf life and expiry
date are determined.

10. • Metal Particles Test
• This test is required only for ophthalmic ointments.
•• It is performed using 10 ointment tubes.
•• The content from each tube is completely removed onto
a clean 60 - mm - diameter Petridish which possesses a
flat bottom.
•• The lid is closed and the product is heated at 85 ° C for
2h.
•• Once the product is melted and distributed uniformly, it
is cooled to room temperature.
•• The lid is removed after solidification.
•• The bottom surface is then viewed through an optical
microscope at 30x magnification.

11. • Sterility Tests
•• Ophthalmic semisolids should be free from anaerobic and
aerobic bacteria and fungi.
•• Sterility tests are therefore performed by the:
1. Membrane filtration technique .
2. Direct - inoculation techniques.

12. • Leakage test
• This test is mandatory for opthalmic ointments, which
evaluates the intactness of the ointment tube and its seal.
• Ten scaled containers are selected, and their exterior
surfaces
are cleaned
• They arc horizontally placed over absorbent blotting paper
• Maintained at 60 ± 3 ° C for 8 h.
• The test passes if leakage is not observed from any tube.
• If leakage is observed , the test is repeated with an
additional 20 tubes.
• The test passes if not more than 1tube shows leakage out of
30 tubes .

13. References
 1. Chein Y.W, Novel Drug Delivery Systems, 2nd
edition, Page – 269-300
 2.N.K Jain, Advances in Controlled and novel drug
delivery, CBS Publication, Pg 219-223
 3. https://www.ncbi.nlm.nih.gov/pubmed/19552545