Administration form comprising an acid-labile active compound
AssigneeAltana Pharma AG
InventorsRudolf Linder, Rango Dietrich
Life of this patent
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Abstract
An administration form for acid-labile active compounds are described. The administration forms have no enteric layers and are suitable for oral administration.
Claims40
An oral administration form for an acid-labile active compound comprising an acid-labile active compound and a pharmaceutical auxiliary,
- wherein the auxiliary is not suitable for formation of an enteric layer,
- wherein the acid-labile active compound is a member selected from the group consisting of an acid-labile proton pump inhibitor, a salt of an acid-labile proton pump inhibitor with a base, and a hydrate of a salt of an acid-labile proton pump inhibitor with a base, and
- wherein the active compound is present in the form of a plurality of individual compound units, the units having a particle size less than 200 μm.
An enteric-coating-free oral administration form for an acid-labile active compound comprising a pharmaceutical auxiliary and a plurality of individual active compound units,
- wherein the acid-labile active compound is a member selected from the group consisting of an acid-labile proton pump inhibitor, a salt of an acid-labile proton pump inhibitor with a base, and a hydrate of a salt of an acid-labile proton pump inhibitor with a base, and
- wherein the acid-labile active compound in the individual active compound units is surrounded by a mixture of at least one sterol and at least one polymer, by at least one fatty alcohol or by a mixture of at least one fatty alcohol and at least one polymer and/or at least one sterol.
A method for overcoming a need for an enteric layer in preparing a stable oral administration form for an acid-labile active compound which is a member selected from the group consisting of an acid-labile proton pump inhibitor, a salt of an acid-labile proton pump inhibitor with a base, and a hydrate of a salt of an acid-labile proton pump inhibitor with a base,
- which comprises surrounding a plurality of individual units of the acid-labile active compound by a) a mixture of at least one sterol and at least one polymer, b) at least one fatty alcohol, or c) a mixture of at least one fatty alcohol and at least one polymer and/or at least one sterol.
An active compound unit comprising an acid-labile active compound, wherein the acid-labile active compound is a proton pump inhibitor and is surrounded by a mixture of at least one sterol and at least one polymer, by at least one fatty alcohol or by a mixture of at least one fatty alcohol and at least one polymer and/or at least one sterol.
A composition comprising a spray-dried suspension of an acid-labile proton pump inhibitor in a solution of at least one sterol and at least one polymer in a suitable solvent.
A composition comprising a spray-congealed suspension of an acid-labile proton pump inhibitor in a solution of at least one fatty alcohol or a mixture of at least one fatty alcohol and at least one polymer and/or sterol in the fatty alcohol.
A pharmaceutically acceptable composition comprising an effective amount of a) an acid-labile proton pump inhibitor together with b) a sterol and c) a polymer, and which is a spray-dried suspension of (a) in a suitable-solvent solution of the sterol and the polymer.
A pharmaceutically acceptable composition comprising an effective amount of a) an acid-labile proton pump inhibitor together with b) a fatty alcohol or c) a mixture of a fatty alcohol, a polymer and/or a sterol, and which is a spray-congealed suspension of (a) in the fatty alcohol or in a solution of the polymer and/or sterol in the fatty alcohol.
Dependencies are inferred from the claim text.