A solid composition package of valsartan and sacubitril

Abstract

A solid composition package comprising: a solid composition comprising: (a) amorphous valsartan disodium granules comprising at least one filler, at least one disintegrant, at least one lubricant and at least one glidant; (b) crystalline form B sacubitril monosodium granules comprising at least one filler, at least one disintegrant, at least one lubricant and at least one glidant; and (c) at least one extragranular excipient selected from fillers, binders, glidants and lubricants; wherein the solid composition is packaged in Alu / Alu blister packaging and / or a HOPE bottle with desiccant. A process comprising: (i) preparing a valsartan disodium blend (ii) dry granulating the valsartan disodium blend to form granules; (iii) preparing a sacubitril monosodium blend (iv) dry granulating the sacubitril monosodium blend to form granules; (v) mixing the granules with extragranular excipients (vi) compressing the mixture (vii) coating (viii) packaging.

Images