Dear colleagues;
As you may recall from the Unguentum Contra Fissuras (ointment against fissures) series I previously published, we reviewed the HYDROPHILE DILTIAZEM HYDROCHLORIDE CREAM 2% (NRF 5.7.) formula, which is frequently prescribed today.
This time, again, we will discuss a formulation for acute and chronic anal fissure that relieves pain caused by the contraction of the sphincter (the muscle controlling the anus, surrounding the anal opening where the large intestine exits) after defecation, by relaxing vascular and sphincter smooth muscles, thereby increasing blood circulation and promoting healing.
HYDROPHILE ISOSORBIDE DINITRATE RECTAL CREAM 1% (NRF 5.9.)
Isosorbide dinitrate 40% (DILUTED)* ……………. 2.5 g
Basiscreme DAC ………………………………………………… ad 100.0 g
Isosorbide dinitrate 40% in the formula contains lactose monohydrate. Isosorbide dinitrate acts by relaxing vascular smooth muscle. It provides vasodilation in peripheral arteries and veins, especially in terminal vascular branches. In spasms that develop due to pain in anal fissures, isosorbide dinitrate 40% relaxes vascular and sphincter smooth muscles, thereby increasing blood flow and promoting healing. Preparations showing similar effects include nitroglycerin, diltiazem, and nifedipine.
As for the formula of Basiscreme DAC, which is a hydrophilic vehicle base;
DAC is the abbreviation for the German Pharmaceutical Codex (Deutscher Arzneimittel-Codex). In other words, it refers to the hydrophilic basic cream included in the German Pharmaceutical 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 have stated the formula using the synonyms found in the German Pharmaceutical Codex. You can easily obtain the excipients in this formula from the relevant suppliers. While reminding you that in German WeiBes Vaselin (Weißes Vaselin) is White petrolatum and Gereinigtes Wasser is Purified water, I would like to touch upon Mittelkettige Triglyceride, which I want to emphasize in this formula. Referred to as medium-chain triglycerides in German, Mittelkettige Triglyceride is a white fatty mass obtained by cold pressing the dry solid parts of the fruit of COCUS NUCIFERA L. (PALMAE), a plant we all know very well. If I say that this oil, which is a source of medium-chain triglycerides, is known as COCONUT OIL, I think we will recall it better. Known as a pleasant-smelling natural cosmetic product, coconut oil is known to be used locally primarily for hair loss, as well as for numerous skin conditions (eczema, psoriasis, skin lesions and scars, dermatitis, etc.).
Basic cream is an important hydrophilic vehicle that can be safely used during pregnancy and lactation.
Preparation of the basic cream:
Glyceryl monostearate, cetyl alcohol, coconut oil (obtained by cold press), and white petrolatum (lipophilic phase) are heated in a water bath set to approximately 60 degrees Celsius.
Meanwhile, Macrogol-20-glycerol monostearate, propylene glycol, and purified water are mixed and dissolved in another Erlenmeyer flask, also in a water bath at 60 degrees Celsius (hydrophilic phase).
This prepared hydrophilic phase is added to the initial (lipophilic) phase while stirring at a constant speed, and cooled down to 30 degrees Celsius.
Preparation of the formula:
The prepared basic cream is mixed in a mortar with the calculated isosorbide dinitrate, which has been levigated and softened with a small amount of liquid paraffin.
Directions for use:
Applied once daily after defecation for 3 to 6 days, by gently rubbing an amount no larger than the size of a chickpea into the rectum (without inserting too deeply into the anus) using a finger cot. It should not be used in pregnancy and lactation.
It should be stored in airtight ointment jars protected from heat and light for a maximum of 1 year.
Wishing you a great week…
Specialist Pharmacist Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657
http://www.majistralformul.com/
