This week, in line with the requests from you, I would like to talk about Alcohol Borique solution.
Our colleagues complain about the SSI (Social Security Institution) deductions they face regarding the preparation of this compounded formula. While writing my thoughts about these deductions in this article, I want to emphasize that this is merely my own interpretation. I believe that by the end of this article, we will all see that our colleagues working at the SSI also act according to their own interpretations.
First of all, what is a PHARMACOPOEIA? Let us recall.
Official books that establish the necessary standards and specifications of active pharmaceutical ingredients and drugs so that they can be administered to living organisms for therapeutic and preventive purposes are called PHARMACOPOEIA. It is derived from the Greek words Pharmakon (drug/medicine) and Poiein (to make/prepare). Pharmacopoeias are official directives and regulatory codes prepared by the scientific authorities commissioned by each government.
PHARMACOPOEIAS ARE AN INSTRUMENT OF MUTUAL AGREEMENT BETWEEN THE JUDGE, THE PHYSICIAN, AND THE PHARMACIST.
In the past, the term CODEX, meaning code of law, was used for these books. Since this name carried too general a meaning, it was globally abandoned, and the name Pharmacopoeia was adopted.
This means that in case of any dispute, there is only one primary reference book to consult: the pharmacopoeia. Everything else beyond this is nothing more than interpretation.
Let us look at how ALCOHOL (ETHANOL) is defined in our Pharmacopoeia:
TP.1974 ETHANOLUM (Pages 235-237)
ETHANOLUM – ETHANOL
Ethanol is a mixture of ethyl alcohol and water. It should contain not less than 95.0% v/v and not more than 96.8% v/v, not less than 92.5% w/w and not more than 95.0% w/w of C2H6O.
ETHANOLUM ABSOLUTUM – ABSOLUTE ETHANOL
C2H6O Absolute ethanol should contain not less than 99.0% w/w of C2H6O.
ETHANOLUM DILUTUM – DILUTE ETHANOL
Dilute Ethanol is a mixture of ethyl alcohol and water. It should contain not less than 69.1% v/v and not more than 71.0% v/v, not less than 61.5% w/w and not more than 63.5% w/w of C2H6O.
If we look at the definition of Boric Acid in our pharmacopoeia;
ACIDUM BORICUM TP. 1974 (Pages 16-17)
Soluble in 25 parts of water,
3 parts of boiling water,
16 parts of ethanol (95%) R, and
5 parts of glycerol (85%) R.
Action and use: Antiseptic.
Dear colleagues, after looking at the definitions of Ethyl alcohol and Boric acid in our Pharmacopoeia, returning to our topic:
Ethyl alcohol possesses bactericidal, fungicidal, virucidal, and mycobactericidal activities.
The concentration of the alcohol used in this formula is critical for its antimicrobial effectiveness.
While ethyl alcohol is effective at concentrations between 60-90%, a 70% concentration (vol/vol) exhibits optimal efficacy for skin antisepsis. Conversely, when the concentration falls below 50%, it largely loses its activity.
Alcohol exerts its action by precipitating proteins and dissolving lipids. Since protein denaturation requires the presence of a certain amount of water, the antimicrobial efficacy of absolute (96%) alcohol is weak.
To summarize now:
1- 70-degree alcohol efficacy is very clearly stated in the English description found on the hand sanitizer page: “70-degree alcohol is the most antiseptic ratio and kills 99.9% of bacteria in one minute”:
Alcohol rub sanitizers containing at least 70% alcohol (mainly ethyl alcohol) kill 99.9% of the bacteria on hands 30 seconds after application and 99.99% to 99.999% in one minute.
reference: http://en.wikipedia.org/wiki/Hand_sanitizer
2- The solubility of boric acid in water increases as the temperature increases, as seen below; therefore, using 70-degree alcohol instead of 96-degree alcohol will also increase the solubility of boric acid in alcohol. It will dissolve when gently heated (25-30 degrees Celsius):
Solubility of boric acid in 100 ml of pure water
2.52 g/100 ml (0°C)
4.72 g/100 ml (20°C)
5.70 g /100 ml (25°C)
19.10 g/100 ml (80°C)
27.53 g/100 ml (100°C)
In conclusion, if the formula is prescribed externally for fungal/ear infections, it is widely accepted by scientific circles that preparations compounded with 70-degree alcohol will be more effective.
Preparation: 70-degree alcohol is prepared, then boric acid is added and heated up to 25-30 degrees Celsius on a magnetic stirrer. The reaction is irreversible.
IN CONCLUSION; EVEN THOUGH 70% ALCOHOL SOLUTIONS ARE SCIENTIFICALLY IDEAL FOR COMPOUNDING THE FORMULA;
When a prescription comes to our pharmacies, such as 3% BORIC ALCOHOL solution, unless the alcohol grade to be used is specified by the physician, how fair is it for our colleagues to suffer payment deductions as a result of using 96% Ethanol—which is what is understood by default when ‘alcohol’ is stated in OUR PHARMACOPOEIA?
It is clear that a formula prepared with 96% Alcohol will not cause harm to the patient, although its efficacy may be debatable.
From this point of view, remembering the fact that the pharmacist does not have the right to modify the prescribed formula, we must not forget that a pharmacist cannot be expected to take the initiative to unilaterally use 70% alcohol.
In the meantime, to prevent our colleagues from suffering any financial loss due to reimbursement deductions, I believe that warning the prescribing physician on such prescriptions to specify the desired alcohol grade will resolve the issue.
References:
Classification of Disinfectants and Antiseptics (Ankem Journal 4, no 3)
DAS (Disinfection, Antisepsis, Sterilization Association Publications)
Istanbul University Cerrahpaşa Faculty of Medicine, Continuing Medical Education Activities Symposium Series No: 6
and with the contributions of my esteemed colleague Specialist Pharmacist & Pharmaceutical Chemist Anooshirvan Miandji
Spec. Pharm. Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
