RECIPE: Diltiazem is used in a concentration of 2% in a fatty cream or in a gel. The fat base is preferable. This offers NL. An additional protection for the anale mucosa. It is also easier to apply. The gel has the disadvantage of being potentially irritating to the anale mucous membrane. At this time, there is no speciality with topically diltiazem on the market. A preparation is therefore necessary. Unlike other scientific references, the therapeutic Magijet Formularium (TMF) does not contain any formula with diltiazem. The following are a few general remarks concerning Magistral preparations based on Diltiazem before giving an overview of the different formulas. Diltiazole hydrochloride is slightly sensitive. Preparations should be made outside the direct influence of light. This molecule is very well soluble in water. It is by consequence unnecessary to dissolve diltiazemhydrochloride for mixing with the ointment base in water. Dissolving in the aqueous phase of the base will take place spontaneously. In Belgium, Diltiazem has recently been available as a raw material with a certificate of analysis. Previously, the preparation had to be performed on the basis of tablets with immediate exemption. Search work yielded us the following formulas:
Diltiazem 2% lipophilic Cream:
| Diltiazemhydrochloride | 2g |
| water-containing petroleum jelly with sorbitansesquioleate | 98g |
This preparation is delivered in a tube.
Diltiazemhydrochloridevaselinecrème 2% LNA:
Diltiazemhydrochloride Vaseline cetomacrogolcrème FNA 98g
Vaseline Cetomacrogol Cream FNA, for 100 g:
| Etomacrogolwas, emulsifying | 15g |
| Liquid Paraffin | , 5g |
| Propylene glycol | 10g |
| White Petroleum jelly | 22, 5g |
| Purified Water | 40g |
Method of preparation of the base: Heat the cetomacrogol wax, the liquid paraffin and the white petroleum jelly to about 70 °C. Mix the propylene glycol with the distilled water and heat the mixture to about 70 °C. The propylene glycol water mixture in the melted mass. Homogenize to cool down. Fill in the evaporated water by adding distilled water to the desired weight. Deliver the preparation in a tube.
Diltiazem 2% Gel:
| Diltiazemhydrochloride | 2g |
| Propylene glycol | 10ml |
| Hydroxyethylcellulose | 4g |
| Aqua Conservans.... QS Ad | 100ML |
Preparation mode: Moisten the diltiazem with propylene glycol. Add hydroxyethylcellulose and mix well. Under gentle stirring, add the water that was heated up to 70 °C in the preceding condition. Deliver the preparation in a tube.
AUTHOR:
APR. Valérie Schaus Center for Pharmaceutical Information, CWOA – APB. Valerie.schaus@apb.be
Acquired with approval from Pharmaceutical magazine for Belgium, December 2013.
The full article can be found in the appendix