Download Opthalmic products types of additives

Ophthalmic products
definition
requirements
types of additives
Definition of ophthalmic products
Definition
Ophthalmic preparations (eye preparations) are
sterile, liquid, semi-solid, or solid preparations
that may contain one or more active
pharmaceutical ingredients or drugs used for
application to the conjunctiva, the conjunctival
sac or the eyelids.
Types of preparations
1-liquid form : this preparation mostly contains
aqueous vehicle , like eye drops and lotion .
2- semi-solid form: like ointments,gels and creams
that based on aqueous and oil to applied to the margin
of the eyelid and conjunctival sac.
3- solid form : drugs in pellet or flake forms , it is put in
conjunctival sac for modified releasing time ( prolonged
time)
Types of preparations
The newest dosage forms for ophthalmic drug delivery are: gels,
ocular inserts , intravitreal injections and implants.
The most commonly employed ophthalmic dosage forms are
solutions, suspensions, and ointments.
Requirements
1- foreign particles
2- viscosity
3- Tonicity
4-PH of preparation
5- sterility
6- surface activity
Requirements
1- foreign particles : all ophthalmic products should be
clear and free from foreign particles ,
Ophthalmic solutions should be clarified very carefully by
passing through bacterial proof filters such as membrane
filters.
The particle size of eye suspension should be in an ultrafine
state of subdivision to minimize irritation , its range from 10
nm- 100nm
A separate filter should be used for different ophthalmic
products in order to avoid the contamination .
Requirements
2- viscosity:
In order to prolong the contact time of the drug in the eye , various
thickening agents are added in ophthalmic preparations.
Polyvinyl alcohol (1-4%), polyethylene glycol , methyl cellulose ,
carboxy methyl cellulose are some of the commonly used thickening
agents. These agents improve the viscosity of the preparation.
An ideal thickening agents should be possess the following properties:
1- it should be easy to filter.
2- it should be easy to sterilize.
3- it should be compatible with other ingredients.
Requirements
3- Tonicity:
Ophthalmic products should be isotonic with lachrymal
secretions to avoid discomfort and irritations.
NaCl, there are certain isotonic vehicles which are used to
prepare ophthalmic products like 1.9% boric acid , sodium
acid phosphate buffer.
It has been observed that eye can tolerate a range of tonicity
from (0.5 to 2%)
Requirements
4- ph of the preparation :
ph plays an important role in therapeutic activity , solubility,
stability and comfort to the patient
Tears have a ph about 7.4 , eye can tolerate solution having
wide range of ph provided they are not strongly buffered .
.
Requirements
5- sterility :
ophthalmic preparations must be sterile when prepared
pseudomonas aeroginosa Is very common gram negative
generally found to be present in bacteria which is
ophthalmic products . It may cause serious
infections of cornea . It can cause complete loss of eye sight in
24-48 hours .
To maintain sterility in multi dose container , containing
ophthalmic products , a suitable preservative is added . The
preservative should be non-toxic , non-irritant
compatible with medicaments . The ophthalmic products are
generally sterilized by autoclaving
Requirements
6- Surface activity : vehicles used in ophthalmic
have good wetting ability to penetrate preparations must
cornea and other tissues .
Certain surfactants or wetting agents added which are found
suitable for ophthalmic products .
It should not cause any damage to the tissue of eye .
Benzalkonium chloride , polysorbate 20 , polysoabate 80 ,
dioctyl sulpho succinate etc, are some of the surfactants
which are commonly used.
Types of Additives
1- Antioxidants : especially sodium bisulfate or metabisulfate and
also, ascorbic acid or acetylcysteine .
It is used for prevention oxidation of drug and inhibit free radical
matters.
2- surfactants : surfactant are often used to stabilize more
hydrophobic drugs.
Nonionic surfactants, are used most often since they generally less
irritating than ionic surfactants. Polysorbate 80 is used in
preparation of ophthalmic emulsions. Polyoxyl 40 stearate and
polyethylene glycol has been used to solubilize a drug in an
anhydrous ointment.
Cationic surfactants, are used gradually in the eye solution but almost
invariable as an antimicrobial preservative.
Types of Additives
3- preservative : Benzalkonium chloride as a preservative
is used in large quantities in commercial eye solution and
suspension, preservative Should be use in multi ophthalmic
dose but in single dose they arent demand .
Done by :
Ali-Alghamdi
Mohammed Ali Saleh Al-ghamdi
Abdullah basheik
Turki Al-Anani
Fahad A.AL-mutairi
Rakan khalaf