Experiment No.

- Date-

Serial No.-

Evaluation of the Ophthalmic Preparations

Pre-Test Questions
1. Eye drops are prepared by-
i.Normal Water ii. Water for injection
iii. Distilled Water iv.All of these
2. For eye-drop, the amount of NaCl should be
i.0.9%w/w ii. 0.9%w/v
iii. 0.9%v/v iv. All of these.
3. Eye drops are sterilised by-
i.Radiation ii.Auto clave
iii.membrane filtration iv. All of these

4.Opthalmic preparations should be isotonic to

i.Blood ii.Lachrymal fluid
iii.Cornea iv. All of these
5. The viscosity of lachrymal fliud is between
i. 1.05-5.97 cP ii. 2.67- 7.78 cPiii. 3.56- 3.75 cP iv.5.12-5.92cP
6. Common viscosity enhancer used are
i. Polyvinyl glycol ii. Polyacrylic acid
iii. Polyvinylpyrrolidone iv. All of these
Theory
Eye Drops
Eye drops are sterile, aqueous or oily solutions or suspensions of one or more
medicaments intended for instillation into the conjunctival sac. They may
contain suitable auxiliary substances such as buffers, stabilizing agents,
solubilizing agents and agents to adjust the tonicity or viscosity of the
preparation.

Eye Ointments
Eye ointments are sterile, semi-solid preparations of homogenous appearance
intended for application to the eye. They may contain one or more
medicaments dissolved or dispersed in a suitable basis. Bases, which are
usually nonaqueous, may contain suitable auxiliary substances such as
stabilizing agents, antimicrobial preservatives and antioxidants. The base
selected must be non-irritant to the conjunctiva, allow the drug to diffuse
throughout the secretions of the eye and retain the activity of the
medicaments for a reasonable period of time under the stated conditions of
storage.
Techniques for evaluation of opthalmic preparations
1.Uniformity of volume
The volume of the ophalmic preparations is measured accurately, to
check whether the dose is more or less than the claimed volume by
the pharmaceutical company.
2.Particle size
For eye drops.
This method is used for eydrop suspensions. Definite volume is taken
on a counting cell onto a microscope & & particle size is calculated
using the scale on the microscope.
For eye ointment.
The required volume of ointment is spreaded on a thin microscope
slide, & scanned for solid particles. More than 100µm sized particles
should not be present in the ointment. Atleast 50 fields should be
scanned.
3.pH value.
Normal lachrymal fluid has the pH range of 7.2-7.4. So the eyedrops
must be maintained at the recommended pH, else it can cause high
irritation to the eyes
4.Viscosity
For optimum penetration of drug into the cornea the viscosity of the
eye drops should be in the the range of 15-25 cP. Various viscosity
enhancers like carboxymethyl cellulose, poloxamer 407 etc is used.
Capillary viscometer methods, rolling ball viscometer methods are
applied to find the viscosity of eye
For eye ointments the viscosity should be within the range
prescribed by the various pharmacopoeia & are evaluated within
same methods of the eye drops.
5.Sterility testing
This technique is followed to check whether the ophthalmic
preparations contain any micro-organism or not. Various
microorganisms of streptococci group & Pseudomonas pyocyanea ,
Bacillus pyocyaneus etc. may be present & impart harmful effect on
the eye.
Membrane Filtration & Direct inoculation method are generally
applied to the test the sterility of the product.
6. Osmolarity
USP recommends the measurement of osmolarity by the method of
freezing point depression of the solution using the osmometer.
7.Bottle volume
This method of evaluation is applied for eye drops.
The volume of a drop is dependent on the physicochemical
properties of the formulation, particularly surface tension, the design
and geometry of the dispensing orifice, and the angle at which the
dispenser is held in relation to the receiving surface. Manufacturing
controls must be in place to provide a uniform drop size throughout
the shelf life of the product.
Drop sizes may typically range from 20–70 µL.
Evaluation of Eye Drops
1. Sterility test
Requirements: Membrane filter(Cellulose nitrate filter),
culture media(Soybean-casein digest medium or
Thiogallate solution, test sample, incubator.
Membrane Filtration
Procedure
1.Eye Drops
The test sample was filtered through the membrane filter.
Eye Ointments
Ointment is diluted to 1% in isopropyl myristate R. If
heating required then upto 40°C & filtered rapidly as
possible.
2. The membrane was transferred into the culture media
aseptically.
3. The whole setup was incubated for 7-14days.
Soybean-casein digest media- 20-25°C for 14 days
Fluid thioglycollate- 30-35°C for 7 days
Direct Inoculation Method
1.Eye drops
Transfer the required amount of sample directly to the
culture medium.
Eye ointments
Dilute the test sample with sterile diluent like peptone in
presence of suitable emulsifying ointment & transfer it
directly to the culture medium.
2.Incubate it for the recommended time.
Soybean-casein digest media- 20-25°C for 14 days.
Fluid thioglycollate- 30-35°C for 7 days.

Clarity test
Procedure
Visual Inspection
Under a well lighted area, the product was taken in a
transparent container & was observed against a black &
white back ground.

Precautions.
1. Test should be carried out in a aseptic conditions.
2. Necessary body coverings should be worn during
handling of the instruments.
 Results

Conclusion

Critical Thinking Questions

1.Define Sterility. What are the 2 basic methods for sterility
testing? Write in brief.
2.What are the different tests for evaluation for ophthalmic
products?
3.Write about the isotonicity of ophthalmic products.
4.Why sterilisation is necessary in ophthalmic products?

Attendance Cleanliness Conduct & Accuracy Critical Viva Voce

(10) & Involvement (4) Thinking (10)
Manual (4) Questions
Maintenance (8)
(4)