A/s Alfred Benzon

Helle Bechgaard

Arne M Pedersen

Jens R Jensen

Finn N Christensen

Peter Houmoller

Composition and method for investigating alimentary functions

A pharmaceutical oral controlled release multiple-units formulation in which individual units comprise cross-sectionally substantially homogeneous cores containing particles of a sparingly soluble active substance, the cores being coated with a coating which is substantially resistant to gastric conditions, but which is erodable under the conditions prevailing in the small intestine, in particular an enteric coating which is substantially insoluble at a pH below 7 such as Eudragit.RTM. S (an anionic polymerizate of methacrylic acid and methacrylic acid methyl ester), is prepared by a process comprising comminuting an active substance together with a substance which is readily soluble in intestinal fluids such as an anionic detergent to obtain particles containing the active substance in intimate admixture with the readily soluble substance, combining the resulting particles into cross-sectionally substantially homogeneous cores together with components which accelerate the disintegration of the cores and intestinal fluids such as talc and saccharose, coating the individual cores with an erodable coating, and combining a multiplicity of the coated cores into a capsule or tablet formulation. Such a coating may also be used when the active substance is a substance which exerts an irritating effect on the gastric mucosa and/or is unstable in an acidic environment.

Pharmaceutical multiple-units formulation

A controlled release multiple-units drug dose is described, which comprises a tablet or a capsule enclosing a plurality of subunits, each containing a therapeutically active agent and being enclosed in an insoluble membrane allowing for diffusion of the juices of the gastrointestinal tract, at least some of the subunits being of increased specific weight as compared with the specific weight of the active agent.

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Hellerup, Denmark

Helle Bechgaard