Dear Colleagues;
As we all know, this medication containing POTASSIUM BICARBONATE and POTASSIUM CITRATE—known under the brand names KALİNOR and POT-K EFFERVESCENT TABLET in our country, KALİNOR in Germany, and KALİORAL in Austria, and which we occasionally experience difficulties in procuring—is used in patients for the prophylaxis and treatment of hypokalemia, the management of digitalis toxicity, and in prophylactic treatment to prevent the recurrence of kidney stones.
We will examine this preparation manufactured and marketed using the EFFERVESCENT FORMULA technique.
First; if you wish, let us all recall the notes from the course our age group called GALENICAL PHARMACY during our school years, which is now included in the new terminology as PHARMACEUTICAL TECHNOLOGY;
Granulated sacchures (medicated sugars) are solid preparations in the form of more or less calibrated particles. These are sugar structures 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. The agglomeration (clustering) of powders is carried out using heat (it occurs as a result of compacting the substance in powder form under heat without melting). The hot mass is converted into granules and dried under a hot air stream at 30-50 °C.
In effervescent granules, just as in other granule formulas, losses occur during processes such as pulverization, mixing, sieving, and drying carried out during compounding.
As a result, when working according to a given formula, the practical mass obtained is always less than the theoretical mass. If the given formula is to be prepared in the exact final amount, the formula must be calculated with a certain excess allowance.
Water and alcohol are used as humectant liquids (wetting agents).
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 and sodium saccharin can be used as sweeteners, and lemon flavoring can be used as a flavoring agent.
Preparation of the formula;
Potassium bicarbonate and potassium citrate are mixed in a mortar, citric acid is added, and the mixture is homogenized. Mixing is continued by adding alcohol drop by drop. (If desired, sweeteners and flavoring agents should be added at this stage prior to the addition of alcohol.) When the mass begins to granulate like semolina, the addition of alcohol should be discontinued. The mass is passed through a sieve (1.6 mm mesh size) and dried in an air-flow drying cabinet at 50 °C. We can pass the dried granules through a sieve with a 1.1 mm aperture, place them in an airtight and moisture-proof container, label them appropriately, and dispense them to the patient.
Wishing you a good week,
Spec. Pharm. Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
