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Question

Posted on: January 25 2017

Preparation atropine 0.01% eye drops

I would like to prescribe atropine 0.01% as an ophthalmologist, as a magisterial preparation with a one-month usage mine. I notice that the original atropine 1% has a pH of 4.8. I wondered if this should just be used as a standard artificial tear (Optive) (pH: 7), which already contains a preservative instead of a more complex magistal preparation with the addition of benzalkonium chloride.

Answer

To meet your demand for a simple method of preparing a 0.01% solution I would like to refer to the following text, which I have taken from a scientific article that studied the stability of an atropine solution:  

CONCLUSION

A concentrated atropine sulfate solution 2 mg/mL can be pre-pared easily and economically from pharmaceutical-grade powder in isotonic saline solution and packaged in sealed Polypropylene Syringes. Our results show that this concentrated atropine sulfate solution was stable for 28 days when stored at 35 °c and exposed to light, for 364 days when stored at 23 °C and exposed to light, or for 364 days when stored at 5 °C and protected from light. This infor-mation allows pre lled syringes, with an acceptable shelf life, to be prepared in a quick and economical manner for immediate use.  

To avoid the instability problems, which can be caused by a too high PH (7) I would suggest if excipient do not   use artificial tears (optive)   But of physiological serum (PH = 5.5). Short at the optimal pH for atropine = 4.6 à 4.8.

So the pharmacist takes a sterilized collyrevial and brings in the vial   under the best possible hygienic conditions (found in the TMF under   https://www.tmf-ftm.be/nl_NL/web/pharmacist/ftm/b/bii/bii7/bii7a) an ampoule Physiological serum. On the other hand, he takes a bottle of Isopto-atropine 1% (Cnk 1075043). With a sterile syringe and sterile needle, it sucks a minimum amount and brings 100 mg of the Isopto-atropine to 1% in the collyrevial. The vial of ISOPTC-Atropine and   The prepared collyrevial are both immediately closed and the prepared solution is gently mixed.  

The eye dropper bottle is provided with the necessary mandatory labelling. Since the eyedrop contains no Conserveermidddel, the usage is limited to 14 days.   The mentioned reference refers to the shelf life of injections and these are only opened once. . The customer stores the bottle in the refrigerator.

He is advised to take hygienic preys when instating the solution.  

The vial of Isopto-Atropine is best kept by the pharmacist, who places it in his refrigerator. He can use it later for the renewal of this regulation. This depends on the duration of the therapy.