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

摘要

The present invention relates to the technical fields of the science and technology of the long-acting dosage forms with a drug. The present invention treats one dosage type low temperature, is used for the long-acting of a medicament contg, is wherein including a calcium sulfate and/or calcium carbonate with equivalent physical and chemical activity, a collagen and at least one drug, preferably a calcium sulphate dihydrate or a calcium salt. The dosage form it is a kind of for long-acting method by kind plus be used in and (also referred to as extend or postpone, EMA, 2014) there is an adjustment mechanism in type composition. In more detail, the present invention relates to the one dosage type low temperature for the composition for including a kind of mixture for including or, (i) by a calcium sulfate and/or a calcium carbonate, a preferably calcium sulphate dihydrate, or one calcium salt composition, its with equivalent physical and chemical activity, a (ii) collagen and (iii), at least one drug or the active component used for drug. In the context of the present invention, term drug is understood in the active component meaning used for drug. In dosage form of the invention, individual component, such as one is controlled or extended or delayed mode in discharge, via decomposing or a molten liquefied process occurs, be present between collagen and calcium salt in composition or adjusting its ratio and dynamics by ratio set in dosage form. Drug is released due to ratio set, in the preparation between collagen and calcium salt. Advantageously, this adjustment mechanism simplifies preparation, experimental research and the industrial production with long-acting dosage forms. The present invention has been applied successfully to various drugs, it is described below shown in.