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STEROID-CONTAINING PHARMACEUTICAL DOSAGE UNITS PREPARED BY DRY-MIXING MICRONISED STEROIDAL MATERIAL WITH A BINDER HAVING AN 80 PERCENT BINDING ABILITY AND A DEMIXING POTENTIAL OF LESS THAN 10 PERCENT; PREPARATORY PROCESS
STEROID-CONTAINING PHARMACEUTICAL DOSAGE UNITS PREPARED BY DRY-MIXING MICRONISED STEROIDAL MATERIAL WITH A BINDER HAVING AN 80 PERCENT BINDING ABILITY AND A DEMIXING POTENTIAL OF LESS THAN 10 PERCENT; PREPARATORY PROCESS
Disclosed are dry pharmaceutical preparations containing potent steroidal medicinal agents in combination with an excipient capable of binding the agent to an extent greater than 80% and a having a demixing potential of less than 10% for said agent. Such excipients include spray-dried polyalcohols, granulated alpha -lactose monohydrate, or mixtures thereof. Also disclosed is a process of manufacturing stable tablets containing nearly identical amounts of at least one steroidal medicinal agent present in each tablet in an amount varying from 0.005 to 0.5 percent by weight of the tablet. Also disclosed is a dry mix consisting essentially of 1 to 100 parts, by weight, of at least one medicinal agent uniformly distributed throughout 2000 to 20,000 parts, by weight, of the described excipients. The mixture can be used to make dry dosage forms such as capsules, tablets, powders, and slugged granulates. IMAGE
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