US Pharm. 2016;41(6):40-41.

Method of Preparation: Note—This formulation should be prepared according to strict aseptic compounding technique in a laminar airflow hood in a cleanroom or via isolation barrier technology by a compounding pharmacist who is validated in aseptic compounding. This is a low-risk preparation. Note that the handling of biologic fluids must be compliant with federal, state, and local requirements.

Calculate the required quantity of each ingredient for the total amount to be prepared. Aseptically, clean the hood and all equipment to be used in this preparation. Accurately measure each ingredient as indicated. Aseptically, withdraw the required volume of sterile autologous serum and place it in an appropriate container. Aseptically, withdraw the required volume of 0.9% Sodium Chloride Injection, add it to the sterile autologous serum, and mix well. Optionally, filter the mixture through a sterile 0.2-µm low-protein binding filter. Package the mixture into sterile containers and label.

Use: This preparation is used in the treatment of dry eye or disruption of normal tear film, keratoconjunctivitis sicca and persistent epithelial defects, corneal erosions, and neurotrophic keratitis.

Packaging: Package in sterile unit-of-use dropper containers.1

Labeling: Keep out of reach of children. Keep refrigerated. Discard after ____ [time period]. For the eye.

Stability: A beyond-use date based on sterility has been determined to be 31 days when this preparation is stored in the refrigerator and 181 days when it is frozen at –10°C.2 Because there is no active pharmaceutical ingredient in this preparation, maintenance of sterility is important.

Quality Control: Quality-control assessments include weight/volume, physical observation, pH, specific gravity, osmolality, assay, color, clarity, particulate matter, and sterility.

Discussion: For patients with the conditions listed in the Use section who do not achieve symptom relief with the use of commercially manufactured eye drops, autologous serum eye drops (plasma eye drops, serum eye drops) have been shown to be highly effective.3-6

Tears contain fibronectin, growth factors, and vitamins that support the migration, proliferation, and differentiation of the conjunctival and corneal epithelium and then exert optical, antimicrobial, mechanical, and nourishing ocular effects.7

Serum autologous eye drops are nonallergenic and exhibit biomechanical and biochemical properties similar to those of the patient’s own tears.

Serum is the component of the blood that is neither a blood cell (serum does not contain WBCs or RBCs) nor a clotting factor; it is the blood plasma not including the fibrinogens. Serum includes all proteins not used in blood clotting (coagulation) and all of the electrolytes, antibodies, antigens, and hormones and any exogenous substances (e.g., drugs and microorganisms).

0.9% Sodium Chloride Injection contains not less than 95.0% and not more than 105.0% of the labeled amount of sodium chloride in water for injection. It has a pH of 4.5 to 7.0 and contains no added antimicrobial agents. Sodium chloride solutions are chemically and physically stable. Sodium chloride is soluble in water to the extent of 1 g in 2.8 mL water, and it is slightly soluble in alcohol (1 g in 250 mL of 95% ethanol).8

REFERENCES

1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; May 2016.
2. Reed-Kane D, Carlson RA, Kupiec TC, Vu N. Applications and sterility of autologous serum eye drops. IJPC. 2009;13:540-543.
3. Mixon W, Angelle PP, Chang RI. Autologous eye drops for the treatment of dry eye and neurotrophic keratitis. IJPC. 2009;11:506-515.
4. Mixon B, Mixon J, Isbey EK, Sprinkle S. Autologous serum eye drops for severe dry eye syndrome in a patient with chronic graft-versus-host disease: a case report. IJPC. 2014;18:370-377.
5. Liu Y, Hirayama M, Cui X, et al. Effectiveness of autologous serum eye drops combined with punctal plugs for the treatment of Sjögren syndrome-related dry eye. Cornea. 2015;34:1214-1220.
6. Katsakoulas I, Lougovoi C, Paraskevopoulou P, Vougiukas N. Protocol of blood serum eye drops. IJPC. 2015;19:252-260.
7. Geerling G, Maclennan S, Hartwig D. Autologous serum eye drops for ocular surface disorders. Br J Ophthalmol. 2004;88:1467-1474.
8. Maximilien JS. Sodium chloride. In: Rowe RC, Sheskey PJ, Cook WG, Fenton ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. London, England: Pharmaceutical Press; 2012:729-732.

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