Dear Colleagues;
As is well known, rare diseases are chronic conditions affecting small patient populations. Since the R&D processes for medications used in treating these diseases are quite challenging, time-consuming, and costly, and because their market supply often remains low, demand for their R&D and manufacturing is limited; hence, these drugs are termed “Orphan Drugs”.
While reminding you that we can easily prepare such medications in our laboratories when prescribed by physicians for patients facing difficulties accessing them, I would like to emphasize once again that extemporaneous (compounding) production is of vital importance in this regard for public health.
Due to the unavailability of potassium-containing medications, I am once again sharing with you my article written on 10.11.2013.
PREPARATION OF EFFERVESCENT GRANULES IN POTASSIUM DEFICIENCY
Known under the brand names Kalinor and Pot-k effervescent tablet in our country, Kalinor in Germany, and Kalioral in Austria, this medication containing potassium bicarbonate and potassium citrate—which we occasionally face difficulties in sourcing—is, as we all know, utilized in the prophylaxis and treatment of hypokalemia, the management of digitalis toxicity, and as prophylactic therapy to prevent the recurrence of kidney stones.
In this article, we will examine this preparation manufactured and marketed using the EFFERVESCENT FORMULA technique.
First, let us recall together the notes from the course that our generation called GALENICAL PHARMACY during our school years, now referred to as PHARMACEUTICAL TECHNOLOGY in modern terminology;
Granulated sacchures (medicated sugars) are solid preparations in the form of more or less calibrated particles. These are sugar matrices in which active pharmaceutical ingredients are dispersed. Granule sizes range from 100 to 3000 microns.
Granulation is the process of bringing fine powder particles together into agglomerates of the desired size.
Effervescent granules are prepared starting from a mixture of an acid (citric, tartaric) and sodium bicarbonate. Agglomeration of powders is achieved with heat (it occurs as a result of compacting the powdered substance under heat without melting). The warm mass is granulated and dried under a stream of warm air at 30-50 0C.
In effervescent granules, as in other granular formulations, losses occur during procedures such as pulverization, mixing, sieving, and drying carried out during operations.
Consequently, when working according to a specified formula, the practical mass obtained is always less than the theoretical mass. If it is desired to prepare the exact quantity of the specified formula, the formulation should be calculated with a certain margin of expansion.
Water and alcohol are used as humectant (wetting) liquids.
Returning to our formula;
Each effervescent tablet contains the equivalent of 1.56 g Potassium:
Potassium bicarbonate 2000 mg
Potassium citrate 2170 mg
Citric acid (anhydrous) 2057 mg
In addition, sugar or sodium saccharin may be used as a sweetener, and lemon flavor as an aromatizing agent.
Preparation of the formula;
Potassium bicarbonate and potassium citrate are mixed in a mortar, citric acid is added, and the mixture is homogenized. Continue mixing while adding alcohol drop by drop. If desired, sweetening and flavoring agents should be incorporated at this stage before the addition of alcohol. Once the mass starts granulating with a semolina-like consistency, stop adding alcohol. The mass is passed through a sieve (1.6 mm mesh size) and dried in a forced-air drying oven at 50 0C. After passing the dried granules through a sieve with a 1.1 mm aperture size, we can place them into an airtight and moisture-proof container, label it properly, and dispense it to the patient. 08.10.2022
Wishing you healthy days.
Spec. Pharm. Ahmet Nezihi Pekcan
Source:
Majistral Makaleler I – Ahmet Nezihi Pekcan
