AU2007302320A1 — Active ingredient containing stabilised solid medicinal forms and method for the production thereof

USPTO Abstract

A solid medicament dosage form (A), containing drug(s) (I) and water-soluble desiccant(s) (II) selected from trimagnesium dicitrate (TMDC) and/or calcium chloride, has a loss on drying at 120[deg] C for 30 minutes of at most 6% and a relative equilibrium moisture content (measured at 25[deg] C) of 25% or less (preferably 10% or less). Independent claims are included for: (1) a solid medicament dosage form (A), containing moisture-sensitive drug(s) (I'), 5-95 wt. % TMDC and optionally further auxiliaries; (2) the production of (A) or (A'), by (a) blending (I) and (II), (b) optionally dry-granulating the mixture, (c) compressing or encapsulating to give the solid dosage form (A)/(A') and (d) optionally packaging in sealed manner, the ratio of (I) to (II) and the processing conditions being adjusted so that (I) has loss on drying and moisture content properties as specified for (A); (3) a method for increasing the chemical stability of moisture-sensitive drugs (I'), involving mixing (I') with TMDC; and (4) the use of TMDC (i) for stabilizing moisture-sensitive drugs (I'), (ii) for protecting (I') against hydrolysis or (iii) as desiccant in solid dosage forms.