Polyethylene glycol matrix pellets for greasy, oily or sticky drug substances
AssigneeAstraZeneca AB
InventorsChrister Karlsson, Per Johan Lundberg, Adam Rosinski, Malin Söderbom
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Abstract
A drug delivery system for oral administration in solid dry form of greasy/oily/sticky substance(s) and pharmaceutically active substance(s) or pharmaceutically active substance(s) which itself/themselves is/are greasy/oily/sticky) characterized by having a plurality of solid, polymeric matrix beads comprising considerable amounts of greasy/oily/sticky substances and having fast release characteristics and a process for the preparation of such solid, polymeric matrix beads comprising greasy/oily/sticky substances.
Claims15
A dry, solid, fast release drug delivery composition which comprises:
- (i) a component consisting essentially of at least one pharmaceutically active substance selected from the group consisting of thrombin inhibiting peptide drugs, alendronate, and almokalant, the composition comprising from 15 wt % to 70 wt % of the component, and
- (ii) a polymeric matrix wherein the sole matrix forming material is a polyethylene glycol or a mixture of polyethylene glycols, wherein the polyethylene glycol or the mixture is solid at ambient temperature,
- said composition being in the form of a plurality of beads and having fast release characteristics defined by in-vitro dissolution test release within 30 minutes of not less than 60% w/w of the component (i).
The drug delivery composition according to any one of the preceding claims wherein the polymeric matrix beads have a particle size of 0.1-10 mm.
A process for the preparation of a dry, solid, fast release drug delivery composition which comprises:
- (i) a component consisting essentially of at least one pharmaceutically active substance selected from the group consist of thrombin inhibiting peptide drugs, alendronate, and almokalant, the composition comprising from 15 wt % to 70 wt % of the component, and
- (ii) a polymeric matrix wherein the sole matrix forming material is a polyethylene glycol or a mixture of polyethylene glycols,
- wherein the process consists essentially of the steps of:
- a) transforming a polyethylene glycol or a mixture of polyethylene glycols from a solid state to a liquid state, the polyethylene glycol or the mixture of polyethylene glycols being solid at ambient temperature;
- b) adding the at least one pharmaceutically active substance;
- c) preparing an emulsion/suspension of the mixture of the components used in step (a) and the components added in step (b);
- and
- d) transforming suitable aliquots/droplets of the emulsion/suspension to form a plurality of beads in the solid state,
- said beads forming the composition and having fast release defined by in-vitro dissolution test release within 30 minutes of not less than 60% w/w of the component (i).
Dependencies are inferred from the claim text.