Homogeneous preformulations containing high concentrations of steroids, for producing low-dose solid and semi-solid pharmaceutical preparations

US6290931A · kind A · utility

Assignee

• Jenapharm GmbH & Co. KG · DE

Inventors

• Detlef Grawe · Kleinromstedt, DE
• Peter Hoesel · Jena, DE
• Peter Moellmann · Jena, DE
• Carsten Timpe · Bad Birnbach, DE
• Michael Dittgen · Apolda, DE
• Klaus Matthey · Jena, DE

Key dates

• Filing date: Jun 10, 1999
• Grant date: Sep 18, 2001
• Expiry date: Jun 10, 2019

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61K31/575
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A homogeneous steroid-containing preformulation for production of solid and semi-solid pharmaceutical preparations containing a uniform constant dosage of at least one steroid in a range from 0.001 to 1 percent by weight is described. This steroid-containing preformulation contains of from 0.001 to 50 percent by weight of the at least one steroid. The homogeneous steroid-containing preformulation is made by a method including dissolving the at least one steroid in a solvent to form a dispersant; dispersing an adjuvant consisting of adjuvant particles in the dispersant in a mass ratio of the adjuvant to the at least one steroid of 1:1 to 1000:1 to form a suspension; and creating a spray-mist of the suspension so as to evaporate and remove the solvent from the suspension and thus to form a dried particulate which includes steroid-containing particles. The droplets in the spray mist have a droplet diameter greater than a mean diameter of the adjuvant particles. The maximum particle size of the dried particulate forming the steroid-containing preformulation is increased by less than 30 percent in comparison to an average particle size of the adjuvant particles.