Dear Colleagues;
I wanted to continue the UNGUENTUM CONTRA FISSURAS (ointment for fissures) series that I published last week with a formula that is frequently prescribed today.
HYDROPHILIC DILTIAZEM HYDROCHLORIDE CREAM 2% (NRF 5.7.)
Rp
Diltiazem hydrochloride ……………… 2.0 g
Basiscreme DAC ………………….to 100.0 g
If we examine this formulation, which is quite commonly prepared in pharmacies in Germany and used for acute and chronic anal fissures;
We should remember from our university years that hydrophilic simply means water-loving, water-attracting, or behaving like water. In this formula, we will prepare together the formulation containing 2% Diltiazem hydrochloride active substance in a hydrophilic ointment base (which the Germans call Basiscreme DAC).
Although it is unfortunately very difficult to find Diltiazem hydrochloride as a pure active pharmaceutical ingredient in our country, it is possible to prepare the formulation by utilizing finished products from various companies.
Diltiazem hydrochloride is a medication from the calcium antagonist class (antagonism = counteracting effect, weakening or eliminating the effect of something) that exerts a vascular and smooth muscle relaxant effect, and is therefore primarily used systemically in the treatment of coronary heart disease.
In acute and chronic anal fissures, spasm develops following defecation due to the contraction of the sphincter (the muscle that controls the anus, surrounding the anus where the large intestine opens outward), and severe pain lasting up to several hours may occur. In this pain-induced spasm, diltiazem relaxes vascular and sphincter smooth muscles and increases blood circulation, thereby promoting healing. Preparations showing a similar effect include nitroglycerin, isosorbide dinitrate, and nifedipine. In diltiazem formulation applications, it provides superiority over other vasodilators since the incidence and severity of the ‘nitrate-type headache’ side effect seen with nitroglycerin due to vasodilation are milder.
If we come to the formula of Basiscreme DAC, which is a hydrophilic vehicle (base);
DAC is the abbreviation for the German Drug Codex. In other words, it refers to the basic cream with hydrophilic properties included in the German Drug Codex.
Basiscreme DAC
Glycerol monostearate 60 …………………………. 4.0 g
Cetyl alcohol ………………………………………….6.0 g
Medium-chain triglycerides …………………………..7.5 g
White petrolatum …………………………………… 25.5 g
Macrogol-20-glycerol monostearate ……………. 7.0 g
Propylene glycol ……………………………………. 10.0 g
Purified water ……………………………….40.0 g
Dear Colleagues, I expressed the formula with the synonyms as they appear in the German Drug Codex. You can easily obtain the auxiliary vehicle excipients in this formula from the relevant companies. While reminding you that WeiBes Vaselin in German is White Petrolatum (White Soft Paraffin) and Gereinigtes Wasser is Purified Water, I would like to mention Mittelkettige Triglyceride, which I want to emphasize in this formula. Mittelkettige Triglyceride, known in German as medium-chain triglycerides, is a white fatty mass obtained by cold pressing from the dried solid parts of the fruits of the COCUS NUCIFERA L. (PALMAE) plant, which we all know very well. I think we will remember it better if I say that this oil, which is a source of medium-chain triglycerides, is called COCONUT OIL. Known as a pleasant-smelling natural cosmetic product, coconut oil is used topically primarily for hair loss, as well as for countless skin problems (eczema, psoriasis, skin wounds and scars, dermatitis, etc.).
Basic cream is an important hydrophilic base that can also be used comfortably during pregnancy and lactation.
Preparation of basic cream:
Glyceryl monostearate, cetyl alcohol, coconut oil (obtained by cold pressing), and white petrolatum (lipophilic mixture) are heated in a water bath set to approximately 60 degrees.
On the other hand, macrogol-20-glycerol monostearate, propylene glycol, and purified water are mixed and dissolved in another Erlenmeyer flask in a water bath, again at 60 degrees. (hydrophilic mixture)
This prepared mixture (hydrophilic) is added to the first (lipophilic) mixture while stirring at a constant speed and cooled down to 30 degrees.
The prepared basic cream is levigated and mixed in a mortar with the calculated amount of diltiazem hydrochloride that has been softened with a small amount of liquid paraffin.
Directions for use:
It is applied with the help of a finger cot after defecation, in the morning and evening, by gently rubbing an amount no larger than a pea into the rectum (provided that it is not applied too deeply inside the anus). It should not be used in pregnant and lactating women.
It should be stored in 50 g ointment jars protected from heat and light in airtight containers for a maximum of 3 months.
Wishing you a good week…
Specialist Pharmacist Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
