Tuesday, September 5, 2023

The Local Small Scale Production of Eye Drops

That’s the title of a World Health Organization publication for medical personnel working in rural areas and third world countries.  An anonymous reader posted the link in a comment to the Dealing with Pink Eye article published earlier this month.  This 83-page document provides information on how to manufacture several eye drop solutions.  It includes all the details about creating a sterile laboratory in austere conditions as well as exact formulas for producing the eye drops. 

Most of the formulas contained therein aren’t really relevant to us.  It’s unlikely that we’ll be able to obtain the ingredients.  But there are two good formulas that merit posting on this blog.  They are easy and use supplies you should already have on hand.

Povidone Iodine Eye Drops 0.5% v/V

  • 5.0 ml Povidone Iodine solution 10%
  • 100 ml Sodium chloride solution 0.9% (normal saline)

METHOD

  • Complete production record sheet (discussed earlier in the 83-page WHO document, address below)
  • Mix 5.0 ml of povidone iodine 10% solution, making it up to 100 ml with sterile sodium chloride 0.9% solution from an intravenous solution pack. 
  • Transfer into a sterile beaker and dispense into the bottles which should, as normally, have been PRE-STERILIZED.
  • Seal bottles, as usual, with PRE-STERILIZED caps and pipettes, using a hand press. 

STERILIZATION

  • Not required, if prepared as above, as povidone iodine is a strong antiseptic with a wide antimicrobial spectrum. 

SHELF-LIFE AND STORAGE

  • If kept in refrigerator (2-8°C):  6 months.
  • If kept at ambient temperatures, prepare freshly each month.
  • Once opened, use within 1 month. 

LABEL

“Povidone iodine eye drops 0.5%, Topical antimicrobial eye drop, Manufactured on (date).”[1]

Also from the WHO document:  

“This is a disinfectant which has for years been used on a large scale in the prophylaxis and treatment of infections, particularly before surgery.  In ophthalmology, it has been used both pre-operatively (1.5% solution recommended by the manufacturer) and in the treatment of conjunctivitis and keratoconjunctivitis (0.5% eye drops).  Its use as a topical antimicrobial preparation has been shown to cause no local adverse reactions, apart from the possible occasional case of allergy to the iodine component.  There is also some evidence that 0.5% drops, in a single application, may be used as an effective prophylaxis against conjunctivitis in the newborn caused by Neisseria gonorrhoeae.”[2]

Lidocaine Eye Drops 4% m/V

  • 4000 mg lidocaine hydrochloride
  • 0.5 ml stock solution benzalkonium chloride
  • Distilled water to total of 100 ml.

METHOD

  • Complete production record sheet.
  • Weigh lidocaine HCl and dissolve in distilled water in measuring cylinder. 
  • Measure out benzalkonium stock solution, add contents of measuring cylinder and make up to volume with freshly distilled water.
  • Filter by whichever method is available. 
  • Transfer filtrate into beaker and dispense in 5-10 ml portions into PRE-STERILIZED bottles.
  • Seal bottles with PRE-STERILIZED caps and pipettes, using a hand press. 
  • View and label after sterilization and cooling are complete. 

STERILIZATION

  • Autoclaving at 121-124°C for 15 minutes at 200 kPa (15 psi or 1 atmosphere above atmospheric pressure).

SHELF LIFE AND STORAGE

  • Use within 6 months from date of sterilization.
  • Store in cool, dry and dark place.
  • Once opened, use within 1 month. 

LABEL

“Lidocaine eye drops 4%, Topical Anesthetic, Manufactured on (date).”

Note:  This drop is an alternative to tetracaine.[3]


Remember, you are not a doctor.  You will not be using these drops to treat anybody.  You are just gathering information and materials so that you can give a doctor what he needs to be able to care for you family. 

Links to related posts:

Benzalkonium chloride

Lidocaine

Pink Eye

Povidone Iodine

References:

https://apps.who.int/iris/bitstream/handle/10665/60981/WHO_PBL_90.20.pdf?sequence=1&isAllowed=y



[1] World Health Organization, Local small scale preparation of eye drops, p 33, https://apps.who.int/iris/bitstream/handle/10665/60981/WHO_PBL_90.20.pdf?sequence=1&isAllowed=y (accessed 22 September 2021).

[2] World Health Organization, Local small scale preparation of eye drops, p 51, https://apps.who.int/iris/bitstream/handle/10665/60981/WHO_PBL_90.20.pdf?sequence=1&isAllowed=y (accessed 22 September 2021).

[3] World Health Organization, Local small scale preparation of eye drops, p 27, https://apps.who.int/iris/bitstream/handle/10665/60981/WHO_PBL_90.20.pdf?sequence=1&isAllowed=y (accessed 22 September 2021).

 

 28 september 2021

2 comments:

  1. I am old enough that when I had pink-eye at age 5, the doctor recommended that my eye be wiped with a mixture of baking soda and water. Mom used a washcloth and the mixture was very watery. My eye stayed closed and the “matter” was wiped away several times a day. Oh, and I had to wear sunglasses, which I thought was cool. Of course, there was much hand-washing and I had to stay away from my siblings. Nobody else got it and it cleared up quickly as I remember.

    ReplyDelete
  2. Interesting #2 solution same ingredients as Bactine which says do not get in eyes. Been using Bactine.in place of other antiseptics. Lidocaine definitely a gentle pain reliever. They have upped the amount lidocaine in the recipe sometime in the last 10years. But still only the 2 ingredients.

    ReplyDelete