Evaluation of opthalmic parentrals .pptx

Parenterals are formulated to be sterile and in stable forms like suspensions, solutions, emulsions or powders for reconstitution to facilitate easy administration while maintaining purity and therapeutic activity. They undergo quality testing for leakage, clarity, pyrogenicity and sterility.Ophthalmic formulation development is receiving more attention in the pharmaceutical industry as of late thanks to advances in technology, increasing awareness of eye diseases, and an aging population. As people live longer, the need to find innovations in treating cataracts, macular degeneration, glaucoma, and diabetic retinopathy grows.

1. CONTAINERS

| PLASTICS 11» - GLASS
"Sorption © | It isemployed as
e the container of
characteristics choice y

: E Typel:Neutral
"borosilicate & -
7 Type2,3&4

2. GLASS

+ Type 2: Treated Soda lime

« Type 3: Regular soda lime glass of
limited Alkalinity..

» Type 4: Soda lime glass not suitable for
containers for parenterals..

3. COLOUR CODING

4. TYPES

Eye Eye Eye
DROPS Ointment Lotion
Ocular Contact
Inserts Lenses

5. EYE DROPS

Traditionally , Glass bottle with
Rubber teat dropper were widely

+ Example : Atropine eye drops..

6. Decto
Recommended

Brand

7. EYE LOTION

+ Eye lotions are packed in LDPE or
HDPE bottles

« Either it has a “Brush “
« Or it has a “roller” for administration...
° Eg : sodium chloride eye lotion

9. EYE OINTMENT..

« Flexible “Plastic or Collapsible Metal
tubes”

° Eg: Neosporin Eye Ointment &
Tetracycline Eye Ointment.

10. =

EYE OINTMENT

KDE VIAPOS
i (equivalent 10 250 1U/g vitamin

—

For ocular

59
u E

pr

11. OCULAR INSERTS

* Ocular inserts: prep meant for treating
ophthalmic diseases like GLAUCOMA

» Eg: Pilocarpine ocuserts..

13. CONTACT LENSES

° A thin plastic lens placed directly on the
surface of the eye to correct visual defects
¢ Packed in Polyester bags then 2* packing

is done by packing in a wide mouth
bottle..

14. CONTACT LENS

15. Ophthalmics

16. EVALUATION

« Evaluation of the Opthalmic product
was done by the following tests.
1) Sterility test
2) Clarity test
3) Leakage test
4) Metal particles in opthalmic products.
5) Assay
6) pH
7) Viscosity

17. STERILITY TEST

1. Direct inoculation method : The test samples are
“test using culture media. —
2. Membrane filtration method :
* Filtering of test samples using membrane
filter.
* Wash the membrane filter.
* Transfer it to the media
Eg . Soya digest media..
* Then check for microbial growth

18. Membrane filter & soya bean digest
medium

ge owe
riot
SA mr

ena ‘Casein Digest Medium (M011)

SH 2 St oe aureus ATCC 6538

3. Streptococcus pneumoniae ATCC 6305
4. Candida albicans ATCC 10231

5. Bacillus subtilis ATCC 6633

6. Escherichia coli ATCC 8739

7. Salmonella Typhimurium ATCC 14028

19. CLARITY TEST

° Visual inspection: Bottles are viewed in light &
dark background.
* Instrumental Method :
* A light ray is passed
* The light gets scattered into the
Product

* The instrument images all the
undissolved particles in the product ..

20. CLARITY TEST

« Light & Dark Background.

21. LEAKAGE TEST.

« Take 10 opthalmic ointments

« Wipe it well at both the ends

* It should be sealed

« Keep it in hot air oven for 60 degree celsius for
8 hours

« If there is no leakage the opthalmic
preparation passes the fest..

22. LEAKAGE TEST..

« For all opthalmic products ...

23. METAL PARTICES IN OPTHALMIC
PRODUCTS.

. 10 g of 10 ml of opthalmic preparation is
taken in a petri dish

. Then it is heated at 85 degree celsius for 2
hours

. Then cool at room temperature to solidify

. Slightly invert the petridishes in he stage o a
suitable microscope

5. Observe he metallic compounds in it .

25. ASSAY & pH

* The sample is titrated against the standard.
° pH:
« The ph of the opthalmic preparation should
be equal to that of the lachrymal secretions..
+ OPTIMUM PH: 7.4
The pH is tested usind the ph paper or ph
meter

26. pH METER.

27. VISCOSITY

* In the preparation of Ophthalmics various
thickening agents are used...
+ OPTIMAL VISCOSITY : 15 - 25 Centipoise

¢ They are added to increase the ocular contact
time.

« And to reduce the surface tension

* Viscosity is measured by Brookfield’s
viscometer & Rolling ball viscometer..

28. BROOKFIELD'S VISCO

29. STABILITY

+ Stability study can be done by 2
methods..

+ Accelerated stability study.
« Freeze thaw method.

31. SUMMARY

The total summary of ophthalmics includes
1)Definition & its types

2)Ideal properties of
the ophthalmic products

3)Formulation
4)Preparation

5)Sterility testing
And packaging & evaluation...

32. DEFINITION

Ophthalmic prep are sterile &
specified dosage forms designed to be
instilled onto the external or internal
surface of the eye witha help ofa
ophthalmic device.

34. IDEAL PROPERTIES OF
OPHTHALMIC PREPARATIONS.

Viscosity Tonicity

Ophthalmic Products
should be isotonic with
the lachrymal secretion

It depends on the

type of
preparation.

35. IDEAL PROPERTIES

Sterility

Tears have a

¡ Ex:
. lua Preservative .
Preparation : is added tid Benzalkonium

should posses q chloride,
this pH Polysorbate

36. STERILITY TESTING
Different Methods

Methods of stenlizahon/ disinfection

r r =
ree Chemical Physio
—— ——— Liquid chemical
Sunlight Heat Vibration Radiation Filtration
f Nonminiing Earthenware pre
at Aldehydes
pom PE we Lo pr Phases
fered glass Halogens
sn Fr Pa | CNenbrane wen meta
gig tod Surface actwe agents
Hot au oven: Dyer
Indea red
‘Gaseous
Formaldehyde
Ethylene onde

Plasma

37. FORMULATION OF
OPHTHALMIC PRODUCTS

* Basically a ophthalmic preparation should
contain

« Tonicity modifier -Dextrose & Nacl &Kcl

* surfactants - polyethylene sorbitane mono
oleate (0.1-0.5%) sorbitane mono oleate
(0.05-0.25%)

* Antioxidants - Ascorbic acid - 0.02-1

Sodium bisulphite- 0.1-0,15

38. FORMULATION

* Solubilizing agent: Alcohol
Glycerine
Polyethylene glycol
Lecithin
* Buffers : Acetates
Citrates
Phosphates

Chelating agent : EDTA, Citric acid & Tartaric
acid.

39. FORMULATION OF EYE DROP

Prepare the vehicle containing the preservative.

0

Then add antioxidant , surfactant , tonicity modifier
buffer
y
Add the active ingredient
Y
Vehicle is made up to the volume.
y

Then it is clarified using sintered glass filter then
sealed

40. EYE OINTMENT

Ointment base is sterilized by heat

Remove the foreign matter when it is molten
It is placed in Steam jacketed kettle
Previously sterilized active ingredient is added
The above all are carried in aseptic condition

Then it is passed through a previously
sterilized colloid mill to attain uniformity.

41. CONTACT LENSES

Soft contact lenses: made up of hydrophilic
transparent plastic“ hydroxy ethyl
methacrylate”

It contains 30 -80% of water.

It is of 2 types

Daily wear

Extended wear..