Abstract: 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.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: 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, Raynaud'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.

Abstract: 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.

Abstract: 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.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: 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.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one ester of a sugar or sugar derivative; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid; with the proviso that the pre-formulation does not further comprise a liquid crystal hardener. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: 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.

Abstract: The present invention relates to pre-formulations comprising: a) at least one di-acyl lipid; b) at least one phospholipid; c) at least one biocompatible, organic solvent; d) an alkyl ammonium EDTA salt; and e) at least one somatostatin receptor agonist; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: 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.

Abstract: The present invention relates to an injectable pre-formulation comprising a low viscosity mixture of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one oxygen containing organic solvent; d) at least one 5HT3 antagonist; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. Such compositions may additionally comprise polar solvents and/or further active agents such as opioid agonists and/or antagonists. Methods of treatment, particularly for management of nausea and vomiting such as for post-operative nausea and vomiting and/or therapy induced nausea and vomiting are provided, as well as corresponding uses of the compositions. Administration devices comprising the formulations and kits comprising the devices are also provided.

Abstract: The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one ester of a sugar or sugar derivative; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid; with the proviso that the pre-formulation does not further comprise a liquid crystal hardener. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents.

Abstract: The present invention provides a method for forming a dispersion comprising non-lamellar amphiphile particles having improved phase behavior, particle size distribution and/or storage stability, said method comprising forming a dispersion of lamellar and optionally non-lamellar particles comprising at least one structuring agent in a polar solvent, heating said particles to an elevated temperature, followed by cooling, wherein said heating is to a temperature and for a period sufficient to provide, after cooling, a measurable improvement in phase behavior, particle size distribution and/or storage stability.

Abstract: The present invention relates to particulate compositions comprising at least 50% of dioleoyl phosphatidyl ethanolamine (DOPE) and 1 to 50% of Polysorbate 80 (P80). All parts are by weight relative to the sum of the weights of a+b and the compositions comprise non-lamellar particles or form non-lamellar particles when contacted with an aqueous fluid. The compositions have advantageous stability and low toxicity and the invention also relates to pharmaceutical compositions thereof.

Abstract: The present invention relates to particulate compositions comprising at least 50% of dioleoyl phosphatidyl ethanolamine (DOPE) and 1 to 50% of Polysorbate 80 (P80). All parts are by weight relative to the sum of the weights of a+b and the compositions comprise non-lamellar particles or form non-lamellar particles when contacted with an aqueous fluid. The compositions have advantageous stability and low toxicity and the invention also relates to pharmaceutical compositions thereof.

Abstract: The invention provides a composition suitable for administration to a mammalian, particularly human, subject wherein the composition comprises an active agent and an amphilic component (containing at least one amphiphile) wherein at least a portion of the amphiphilic component is an ether-linked lipid and wherein the composition includes a non-lamellar phase, preferably in the form of particles, or forms a non-lamellar phase on contact with an aqueous liquid. The aqueous liquid may be a body fluid. The invention also provides pharmaceutical and cosmetic formulations comprising the compositions and methods for their formation.