PHARMACEUTICAL DOSAGE FORM COMPRISING A LIQUID OR FLOWABLE CORE COMPOSITION
A pharmaceutical dosage form, comprising a) a liquid or flowable core, b) a shell of a polysaccharide or proteinaceous material completely enclosing said core, the core comprising an active ingredient dissolved in a pharmaceutically acceptable compound of the formula (I) wherein n is an integer from 3 to 5, and wherein the (i) the at least one active ingredient and the compound of the formula (I) account for at least 50% by weight of the composition; and (ii) the water activity aw of the composition is less than 0.4.
1 . A pharmaceutical dosage form, comprising
a) a liquid or flowable composition,
b) a shell of a polysaccharide or proteinaceous material completely enclosing said composition,
the composition comprising at least one dissolved active ingredient and a pharmaceutically acceptable compound of the formula (I)
wherein n is an integer from 3 to 5, and wherein the following conditions are satisfied:
(i) the at least one active ingredient and the compound of the formula (I) account for at least 50% by weight of the composition; and
(ii) the water activity a w of the composition is less than 0.4.
2 . The pharmaceutical dosage form of claim 1 wherein the water activity a w of the composition is 0.3 or less.
3 . The pharmaceutical dosage form of claim 1 , wherein the water activity a w of the composition is 0.15 or less.
4 . The pharmaceutical dosage form of claim 1 , wherein the composition contains up to 12% by weight of water.
5 . The pharmaceutical dosage form of claim 1 , wherein the compound of formula (I) is 1,3-bis-(pyrrolidon-1-yl)-butane.
6 . The pharmaceutical dosage form of claim 1 , wherein the polysaccharide material is alginic acid or sodium alginate.
7 . The pharmaceutical dosage form of claim 1 , wherein the proteinaceous material is gelatine.
8 . The pharmaceutical dosage form of claim 7 wherein the shell is a two-part telescoping capsule.
9 . The pharmaceutical dosage form of claim 7 , wherein the shell is a soft gelatine capsule prepared by the rotary die method.
10 . The pharmaceutical dosage form of claim 1 , wherein the compound of the formula (I) accounts for at least 45% by weight of the composition.
11 . The pharmaceutical dosage form of claim 1 , wherein the composition comprises 0.001 to 50% by weight of active ingredient.
12 . The pharmaceutical dosage form of claim 1 , wherein the active ingredient has a solubility in water at 25° C. of less than 10 mg/100 ml.
13 . The pharmaceutical dosage form of claim 1 , wherein the composition additionally comprises at least one pharmaceutically acceptable surfactant.