Ophthalmic Preparations

STORAGE/LABELING

Revitalife ophthalmic preparations should be stored at either room or refrigerated temperatures and should not be frozen.

STABILITY
Revitalife Ophthalmic Solution beyond used date is not later than 7 days under refrigeration and 4 days in room temperature, when stored at refrigerated temperatures, for products prepared from ingredients in solid form.

References:
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Revitalife Ophthalmic Preparations (eye preparations) are sterile and liquid preparations that may contain one or more active pharmaceutical ingredient(s) intended for application to the conjunctiva, the conjunctival sac or the eyelids. The following are subclassification of our ophthalmic preparation:

Intravitreal solution for injection
Intravitreal solution for injection of substances dissolved in a vehicle solution is a common tool used to assess retinal function. Intravitreal Injections are now standard treatment for various ocular conditions such as age-related macular degeneration, diabetic retinopathy and retinal vein occlusions.
Eye Drops
Principally absorbed through the cornea and absorption through conjunctival mucosa also occurs, giving rise to systemic effects.
Eye Ointments
Ointments allow a prolonged contact time; therefore, less frequent applications are required (good for night use).

REVITALIFE OPTHALMIC PREPARATION CHARACTERISTICS

Clarity- Revitalife Ophthalmic Solutions is free from foreign particles, which is generally accomplished by filtration. The filtration achieved clarity of the solution.

Tonicity– Lacrimal fluid has an isotonicity value equivalent to that of a 0.9% sodium chloride solution. However, the eye can tolerate a value as low as 0.6% and as high as 1.8% sodium chloride equivalency. Several of our ophthalmic solutions will be hypertonic by the nature of the high concentration required of the drug substance. Some will be hypotonic and will require the addition of a substance to attain the proper tonicity range. Sodium chloride, boric acid, and dextrose are commonly used. Three hundred mOsm/L is ideal with 200-600 mOsm/L acceptable which is the range of our ophthalmic products.

pH and Buffering– Revitalife ophthalmic solutions are buffered at the pH of maximum stability for the drug(s) they contain. The buffers are included to minimize any change in pH during the storage life of the drug.

Sterility– Revitalife ophthalmic solutions are sterile. Sterility is achieved through sterile filtration using a sterile membrane filter of 0.45 or 0.2 micron pore size and filtering into a sterile container.

Preservation– Revitalife ophthalmic solutions are prepared in multiple use containers. The selected preservative is compatible with the active drug as well as all the other excipients in the product.

REVITALIFE OPTHALMIC PREPARATION CHARACTERISTICS

a. Intravitreal injections:

Bevacizumab
Triamcinolone acetonide (Kenalog)
Ganciclovir
Foscarnet
Cidofovir
Fomvirsen
Methotrexate
Vancomycin
Ceftazidime
Amikacin
Amphotericin B
Voriconazole
Dexamethasone
Voriconazole intrastromal injection

b. Eye drops:

Vancomycin ED
Tacrolimus ED
Cefazolin ED
CEFTAZIDIME ED
CHLORHEXIDINE ED
Cyclosporine ED
Fluconazole ED
Methyl prednisolone ED
Mitomycin ED
Fortified tobramycin ED
Gentamicin ED
Amikacin
Linezolid ED
Colistin ED
Imepenim-cilastin ED
Amphotericin ED
Voriconazole ED

c. Eye ointment

Tacrolimus EO
Amphotericin B EO

Packaging of Revitalife ophthalmic solutions is appropriately done in sterile dropper bottles or individual doses can be placed in sterile syringes, without needles.