Solid porous unitary form comprising micro-particles and/or nano-particles, and its preparation

A solid, porous unitary form comprising a combination of a primary unitary form which disintegrates in aqueous medium and a secondary unitary form having controlled dissolution and controlled release of an active principle, said secondary unitary form comprising a particulate system having a diameter up to 2 mm, said solid, porous unitary form being obtained by A) forming a paste by mixing

• i) particles having a diameter up to 2 mm containing a predetermined quantity of at least one active principle;
• ii) at least one thickening or binding agent, wherein the thickening or binding agent is selected from the group consisting of a polypeptide, a high polymer capable of giving colloidal solutions, a cellulose derivative, and a water dispersible starch derivative;
• and/or extender, wherein the extender is selected from the group consisting of a lactose, glycine, sorbitol, mannitol, glucose, maltodextrin, an oxide, a carbonate, a phosphate, micro-crystalline cellulose and mixtures thereof;
• iii) at least one stabilizing agent to prevent settling and/or rising to the surface of the particles having a diameter up to 2 mm wherein the stabilizing agent is selected from the group consisting of an oxide, salts, and sugars;
• iv) optionally at least one other active principle or mixture of particles having a diameter up to 2 mm containing an active principle;
• and
• v) water,
• and B) lyophilizing said paste to obtain the solid, porous unitary form.

A process for the preparation of a solid, porous unitary form wherein the solid porous unitary form comprises a combination of a primary unitary form which disintegrates in aqueous medium and a secondary unitary form, the secondary unitary form having controlled dissolution and controlled release of an active principle contained in the secondary unitary form, said process comprising forming a paste comprising

• i) particles of the secondary unitary form, the particles having a diameter up to 2 mm and containing a predetermined quantity of one or more active principles;
• ii) at least one thickening or binding agent and/or extender;
• iii) one or more stabilizing agents to prevent settling and/or rising to the surface of the particles having a diameter up to 2 mm;
• iv) optionally one or more other active principles or mixtures of particles having a diameter up to 2 mm containing an active principle;
• and
• v) water in an amount sufficient to adjust the viscosity of the paste such that the paste is sufficiently fluid to allow regular division and the paste is sufficiently viscous to avoid sedimentation of the particles,
• and lyophilizing the paste to obtain the solid porous unitary form comprising the combination of the primary unitary form and the secondary unitary form.