TH14841A - Granulation - Google Patents

Abstract

A process for making granules which are precipitated Carrier contains diluents, binders, and may also contain dispersants. In a container separated from the carrier They provide steroids, lubricants, and possibly anti-oxidants, dissolved in organic solvents that may be pre-heated. The resulting solution was put into the substance. Bring in a mixer such as a vacuum mixer. Then continue to mix the mixture to remove the organic solvent from the mixture. The mixture is further mixed to form a granulation. The process also introduces a flow promoting agent, such as colloidal silicon dioxide, into the granulation granules for making a dose unit into a granule. Characteristic granules consisting of a) a carrier containing a diluent and a binder and b) such a film-like carrier coat.The film contains a disogester and lubricant. And has specific characteristics The storage of dezogestrel was 90% at a pressure of 150 mbar and a temperature of 70 ° C for 72 hours.

Claims (8)

1. The process for granulation containing steroids consists of a) dissolving steroids and lubricants in organic solvents in A sufficient amount to form a solution, b) mixing this solution with a carrier containing a diluent and a fixing agent, thus forming a mixture of the solution and the carrier and c) removing the organic solvent from the mixture while Mix the mixture to Make granulation where the steroid is 2. Process according to claim 1, in which the said organic solvent has been eliminated. Out in the vacuum mixer 3. Process according to claim 1 or 2, in which the steroid is a dezogestrel. 4. Process according to one of the claims 1-3, in which the lubricant is stearic acid. 5. The granulation unit for the dosing unit obtained by the process of claim No. 1 showing the characteristic that the granules have a film-coated layer containing stearoid. And lubricants 6. The granules of claim 5 characterized by specific characteristics consisting of dezogestrel and stearic acid. And continue to exhibit specific characteristics by storing dezoges The trail is kept up to 90% at the pressure of 150 mbar and at 70 ° C for 72 hours. 7. The granules of claim No. 5 or No. 6, characterized by specific characteristics, include a) lactose-containing carriers. Polyvinyl pyrolidone and dispersants, and b) such film-based coatings. And the film contains dezogestrel and stearic acid. 8.A tablet showing a specific nature, containing the granulation of any claim. One of Claims No. 5 - 7.