A DOSAGE FORM COMPRISING A CALCIUM SALT, COLLAGEN AND A DRUG AND RELATED USE IN A METHOD OF CONTROLLED RELEASE ENDOWED WITH A REGULATORY MECHANISM OF DRUG RELEASE INSIDE THE COMPOSITION
The invention relates to the technical field of the science and technology of dosage forms with controlled release of a drug. The present invention regards a dosage form for the controlled release of a drug present therein comprising a calcium sulphate and/or calcium carbonate, preferably a calcium sulphate dihydrate, or a calcium salt with equivalent physical and chemical activity, a collagen and at least one drug. Said dosage form is advantageously used in a method of controlled release (also referred to as prolonged or delayed, EMA, 2014) endowed with a regulatory mechanism inside the specific composition. In greater detail, the invention relates to a dosage form consisting in a composition that comprises a mixture which comprises or, alternatively, consists of (i) a calcium sulphate and/or a calcium carbonate, preferably a calcium sulphate dihydrate, or a calcium salt with equivalent physical and chemical activity, (ii) a collagen and (iii) at least one drug or an active ingredient for pharmaceutical use. In the context of the present invention, the term drug is understood in the sense of active ingredient for pharmaceutical use. In the dosage form of the present invention, the release of the individual components, for example in a controlled or prolonged or delayed mode, takes place via a process of dissolution or solubilisation, the rate and kinetics of which are regulated by the ratio set between the collagen and the calcium salt present in the composition or in the dosage form. The drug is released thanks to the ratio set, at the time of preparation, between the collagen and the calcium salt. Advantageously, this regulatory mechanism simplifies the preparation, experimental study and industrial production of the dosage forms with controlled release. The present invention has been successfully applied to various drugs, as shown in the description that follows.Linvention concerne le domaine technique de la science et de la technologie des formes pharmaceutique
