Camurus Ab

Camarus Ab

Catalin Nistor

Markus Johnsson

Fredrik Tiberg

Justas Barauskas

Krister Thuresson

Fredrik Joabsson

David Hemmerlin

Johannes Kluge

Priyanga Wickramanayake

The invention relates to pre-formulations comprising: The invention further relates methods of treatment comprising administration of the pre-formulations, to pre-filled administration devices and kits containing the pre-formulations, and to the use of an alkylammonium EDTA salt to reduce the decomposition of the lipid components and/or any active agent contained within the pre-formulation.

Mixtures and formulations

The disclosure provides a glass syringe or a glass cartridge, for parenterally administering, containing a lipid-based pre-formulation suitable for refrigerated storage, wherein the lipid-based pre-formulation includes 20-80 wt % of a diacyl glycerol having a fatty acid composition of at least 98% oleic acid (18:1), as determined in accordance with method C, 2.4.22 (Composition of fatty acids by gas chromatography), European Pharmacopoeia 9.0; 20-80 wt % of a phospholipid; 1-30 wt % of a solvent; and a bioactive agent.

Lipid-controlled release compositions

The present invention relates to compositions forming a low viscosity mixture of: a) 20-50 wt. % of at least one diacyl glycerol; b) 20-54 wt. % of at least one phosphatidyl choline (PC); c) 5-15 wt. % of at least one biocompatible, organic mono-alcoholic solvent; d) 1 to 20 wt. % polar solvent e) 5 to 150 mg/ml of at least one peptide somatostatin receptor agonist comprising pasireotide; f) optionally at least one antioxidant; wherein the ratio of components a:b is in the range 40:60 to 54:46; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. The invention further relates to methods of treatment comprising administration of such compositions, and to pre-filled administration devices and kits containing the formulations.

Somatostatin receptor agonist formulations

The present invention relates to pre-formulations comprising: The invention further relates to methods of treatment comprising administration of such pre-formulations, to pre-filled administration devices and kits containing the formulations, to the use of an alkylammonium EDTA salt to reduce the decomposition of the lipid components and/or any active agent contained within the pre-formulation.

Formulations containing a somatostatin receptor agonist

The present invention relates to compositions forming a low viscosity mixture of: a) 20-80 wt. % of at least one diacyl glycerol and/or a tocopherol; b) 20-80 wt. % of at least one phosphatidyl choline (PC); c) 5-20 wt. % of at least one biocompatible, organic mono-alcoholic solvent; d) up to 20 wt. % polar solvent e) at least one peptide active agent; f) optionally at least one antioxidant; wherein the ratio of components a:b is in the range 40:60 to 54:46; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. The invention further relates to methods of treatment comprising administration of such compositions, and to pre-filled administration devices and kits containing the formulations.

Controlled release peptide formulations

The present invention relates to an injectable pre-formulation comprising: a) at least one of a mono-, di-, or tri-acyl lipid and/or a tocopherol; b) optionally at least one phospholipid; c) at least one biocompatible, organic solvent; and d) at least one prostacyclin analogue or a salt thereof; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with excess aqueous fluid. Such compositions may additionally comprise polar co-solvents. Methods of treatment, particularly for management of pulmonary artery hypertension (PAH), severe PAH, Raynard's disease, ischemia and related conditions are provided, as well as corresponding uses of the compositions. Administration devices comprising the formulations and kits comprising the devices are also provided.

Prostacyclin analogue formulations

The present invention relates to mixtures comprising: i) at least one lipid and/or at least one oil; and ii) an alkyl ammonium EDTA salt; wherein the mixture has a water content in the range of 0 to 1.0 wt %. The invention further relates to mixtures which are pre-formulations, methods of treatment comprising administration of such pre-formulations, to pre-filled administration devices and kits containing the formulations, to the use of an alkylammonium EDTA salt to reduce the decomposition of the lipid components and/or any active agent contained within the pre-formulation, and to alkyl ammonium EDTA salts as described herein.

Mixtures and formulations comprising an alkyl ammonium EDTA salt

The present invention relates to formulation precursors (pre-formulations) for the in situ generation of compositions for the controlled release of the salts of peptide active agents, including somatostatin analogues. The invention also relates to pre-formulations of amphiphilic components and at least one salt of a peptide active agent (e.g., somatostatin analogue) for parenteral application.

Peptide slow-release formulations

The present invention relates to compositions forming a low viscosity mixture of: i) a non-polymeric slow-release matrix ii) at least one biocompatible, (preferably oxygen containing) organic solvent; iii) at least one peptide active agent; and iv) at least one lipid soluble acid. The invention further relates to methods of treatment comprising administration of such compositions, especially in treating diabetes, and to pre-filled administration devices and kits containing the formulations.

Acid containing lipid formulations

The present invention provides a formulation comprising:

Lipid formulations comprising a thiolated antioxidant

The present invention relates to formulations of a lipid based controlled-release matrix, a polyhydroxy component and a bioactive agent. Such formulation are useful in the delivery of the bioactive compounds. The invention also relates to the use of a polyhydroxy component for increasing the solubility of a bioactive compound, especially a peptide in a lipid-based controlled-release matrix.

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Lund, Sweden

Catalin Nistor