Abstract: The invention provides a dry, flowable composition in the form of a plurality of particles, each particle comprising, or consisting of, an inert starter core which is coated with at least one coat of an active ingredient composition. The particles are characterized in that the active ingredient composition is substantially free of anti-tacking agents such as talc, and the inert starter core comprises, or consists of, a sugar alcohol wherein the sugar alcohol is mannitol, in particular, a mannitol provided in a direct compression quality. The invention further provides a process for the preparation of the dry, flowable composition, and more specifically a process of coating inert starter cores with an active ingredient coat without the use of anti-tacking agents, such as talc.

Abstract: The invention provides a method for the preparation of effervescent granules wherein the reactive, effervescent components (one acidic and one alkaline CO2-generating component) are brought to reaction with one another under stirring in a vacuum (100-900 mbar) in an evacuable mixing chamber, with said mixing chamber being evacuated to a first vacuum value p1, and then ‘re-evacuated’ to said first vacuum value p1 again, optionally repeatedly, once the pressure has increased to a second vacuum value p2 due to the progressing CO2 formation of the effervescent reaction. The method is carried out in such a way that during at least the effervescent reaction step(s) the stirring speed in the mixing chamber exhibits a Froude number (Fr) of 0.5 or higher, preferably 0.8 or higher, more preferably 0.9 or higher; such as, in the range of 0.50 to 8.00, or 0.80 to 8.00, or 0.90 to 8.00.

Abstract: The invention enables direct oral granules enabling controlled release of magnesium, having both extended-release and non-extended-release fractions. The granules include extended-release particles having a magnesium-containing core and a lipophilic coating, with at least the cores of these extended-release particles having a mandated abrasion resistance which is determined by means of vibration screening over a period of 60 minutes and which allows these cores to be melt-coated, more particularly melt-coated with lipids in a fluidized bed. The invention further provides a method for characterizing the magnesium-containing cores, and also a process for producing the extended-release particles by means of hotmelt coating.

Abstract: The invention provides a method for the preparation of effervescent granules wherein the reactive, effervescent components (one acidic and one alkaline CO2-generating component) are brought to reaction with one another under stirring in a vacuum (100-900 mbar) in an evacuable mixing chamber, with said mixing chamber being evacuated to a first vacuum value p1, and then ‘re-evacuated’ to said first vacuum value p1 again, optionally repeatedly, once the pressure has increased to a second vacuum value p2 due to the progressing CO2 formation of the effervescent reaction. The method is carried out in such a way that during at least the effervescent reaction step(s) the stirring speed in the mixing chamber exhibits a Froude number (Fr) of 0.5 or higher, preferably 0.8 or higher, more preferably 0.9 or higher; such as, in the range of 0.50 to 8.00, or 0.80 to 8.00, or 0.90 to 8.00.

Abstract: The invention relates to a stable medicament for oral administration which comprises (a) a core which contains an active ingredient selected from Omeprazole, Lansoprazole and Pantoprazole, together with customary pharmaceutical adjuvants, (b) an intermediate layer applied onto the core, and (c) a gastric juice-resistant outer layer. The intermediate layer in (b) is formed as a reactive layer in which a gastric juice-resistant polymer layer material partially neutralized with alkali with cation exchange capacity is present. Further, a method for the production of the stable medicament is disclosed.

Abstract: The invention relates to a stable medicament for oral administration which comprises (a) a core which contains an active ingredient selected from Omeprazole, Lansoprazole and Pantoprazole, together with customary pharmaceutical adjuvants, (b) an intermediate layer applied onto the core, and (c) a gastric juice-resistant outer layer. The intermediate layer in (b) is formed as a reactive layer in which a gastric juice-resistant polymer layer material partially neutralized with alkali with cation exchange capacity is present. Further, a method for the production of the stable medicament is disclosed.

Abstract: The invention relates to a stable medicament for oral administration which comprises (a) a core which contains an active ingredient selected from Omeprazole, Lansoprazole and Pantoprazole, together with customary pharmaceutical adjuvants, (b) an intermediate layer applied onto the core, and (c) a gastric juice-resistant outer layer. The intermediate layer in (b) is formed as a reactive layer in which a gastric juice-resistant polymer layer material partially neutralized with alkali with cation exchange capacity is present. Further, a method for the production of the stable medicament is disclosed.

Abstract: The invention relates to a stable medicament for oral administration which comprises (a) a core which contains an active ingredient selected from Omeprazole, Lansoprazole and Pantoprazole, together with customary pharmaceutical adjuvants, (b) an intermediate layer applied onto the core, and (c) a gastric juice-resistant outer layer. The intermediate layer in (b) is formed as a reactive layer in which a gastric juice-resistant polymer layer material partially neutralized with alkali with cation exchange capacity is present. Further, a method for the production of the stable medicament is disclosed.

Abstract: The invention relates to a stable medicament for oral administration which comprises