SOLID FORMS OF THE DRUG COAMORPHIC TYPE: PIOGLITAZONE AND STATINS

Abstract

Solid drug formulations, specifically coamorphs obtained by solvent-assisted or dry milling, are described for drugs such as pioglitazone hydrochloride (PGZ·HCl) and statins (ESTs). Dissolution profile studies are also described. It is well known that for drugs with solubility problems, one of the easiest and cheapest ways to improve this property is to present the amorphous form of the drug in question. In this case, the ESTs rosuvastatin calcium (RSV), fluvastatin sodium (FLV), and atorvastatin calcium (ATV) exhibit problems in their dissolution profiles, as well as in their water solubility. This invention describes the preparation of three coamorphs: PGZ·HCl-RSV; PGZ·HCl-FLV and PGZ·HCl-ATV, where the solubility and dissolution profiles of these coamorphs were evaluated and compared with pure ESTs.It is also described that the coamorphs of the present invention are useful in the treatment of diabetic patients with dyslipidemia problems.