Abuse resistant formula
AssigneeEmplicure AB
InventorsSusanne Bredenberg, Anna Dahlgren, Anders Sågström, Håkan Engqvist
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Abstract
There is provided a sustained-release pharmaceutical composition comprising a solid, continuous network comprising an excipient with a high mechanical strength, which network also comprises pores, within which pores is interspersed a mixture of an active ingredient and a film-forming agent, characterized in that said pores are formed during the production of the composition. Compositions of the invention find particularly utility as abuse-resistant formulations comprising opioid analgesics that may be employed in the treatment of chronic pain.
Claims24
A sustained-release pharmaceutical composition comprising a solid, continuous porous network of an inorganic excipient selected from the group consisting of aluminates, silicates, geopolymeric materials, and combinations thereof, said network also comprising secondary pores within which is interspersed a mixture of an active ingredient and an enteric coating material, wherein the secondary pores are formed by physically and/or chemically bonding together the surfaces of particles of the inorganic excipient in the presence of said mixture, and wherein said composition has a mechanical strength of about 1 kgF/cm2 or greater.
A process for the preparation of a sustained-release pharmaceutical composition comprising:
- mixing together an inorganic excipient and an active ingredient, said inorganic excipient being selected from the group consisting of aluminates, silicates, geopolymeric materials, and combinations thereof;
- and
- adding an enteric coating material along with, or in, a liquid, so providing a wet granulate, and thereby forming a solid, continuous porous network of the inorganic excipient and forming secondary pores in said network, wherein said active ingredient and said enteric coating material are dispersed within said secondary pores.
Dependencies are inferred from the claim text.