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 COMPOUNDED OPTHALMIC PREPARATIONS
a. Intravitreal injections:
- Triamcinolone acetonide (Kenalog)
- Amphotericin B
- 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
- 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.
Revitalife ophthalmic preparations should be stored at either room or refrigerated temperatures and should not be frozen.
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.
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