I compound tablet triturates containing hormones for some of my patients. Recently, a patient mentioned that the combination of estrogens and progesterone that I prepared was "too hard" and did not dissolve rapidly. Do you have any suggestions?
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When compounding tablet triturates or other molded forms (suppositories, lozenges, and the like), the vehicle must comprise at least two thirds of the theoretical blank weight of the dose form. Three of the most common tablet triturate molds used allow preparation of approximately 60-, 100-, and 200-mg triturates. A frequently used vehicle consists of lactose and sucrose triturated to fine consistency and with the active ingredient(s) levigated to a paste with a water and alcohol (ethanol 200 proof) mixture. Compounding this dosage form especially relies on secundum artem - the art of pharmaceutical compounding; the pharmacist's "right brain." The proportions of the sugars and the solvents can be varied to prepare a "harder" or softer (friable) triturate as the situation demands. Climate has an effect on the formulation, since a higher proportion of water relative to the alcohol will produce a "harder" tablet triturate which dissolves slowly; in a humid climate, it may be advisable to decrease the proportion of water. Also, replacing 1% of the vehicle with starch will increase the preparation's "hardness." The following is a "starting place" from which to work toward a formulation suitable for the patient, therapy, and climate.Ingredients
Sucrose USP 20%
Lactose hydrous USP 80%
Purified water USP 40%
Alcohol USP (ethanol) 60%