Summary : New patent application covering a novel amphiphilic excipient obtained with materials of natural origin with large applicability for specific delivery of bioactive agents in therapy and preventive medicine.

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The present patent application refers to an original composition useful for sustained or/and targeted delivery of large range of active principles.

The novel ingredient exhibits properties completely different from existing materials in the field of pharmaceutical formulation.

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Obtained by simple physical co-processing of a polymer containing carboxyl groups with a lipid, the complex is able to control the release of various active principles when formulated as tablets, pellets, microspheres, etc. The special features of the complex come from a good ratio and repartition of hydrophilic/hydrophobic segments which allow good stabilization of the drug, a gradual fluids penetration and a slow release of contained drug from the dosage form.

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The proposed composition (complex) exhibits multiple advantages:

• The starting materials are GRAS (safe, non-toxic) and accepted by regulatory agencies;

• Abundant source of polymers (mainly starch or other natural polysaccharides)

• Low cost of lipids which are used for complex preparation

• Simple manufacturing (without chemical modifications) by a standard procedure: co-spray drying of the polymer caring carboxyl groups and the lipid from an aqueous suspension.

• Short period of product development and easy regulatory path.

• The proposed complex/ingredient represents a simple alternative to control the release of drugs which are difficult to formulate (i.e. zwitterions, charged molecules, bioactives with solubility which varies on the pH, poor water soluble drugs, etc.). Current approaches consist in the usage of multiple inactive excipients and multiple steps manufacturing processes. The compositions containing the proposed complex can be obtained by simple mixing with the active molecules.

• The complex will be able to provide a drug release independent of pH variation.