Abstract: The invention relates to pre-formulations comprising: i) a lipid mixture comprising: a) at least one of a mono-, di-, or tri-acyl lipid and/or a tocopherol; b) optionally, at least one phospholipid; and c) at least one biocompatible, organic solvent; and ii) an alkyl ammonium EDTA salt; wherein the pre-formulation has a water content in the range of 0 to 1.0 wt %. 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.

Abstract: The present invention relates to pre-formulations comprising low viscosity, non-liquid crystalline, mixtures of: a) at least one neutral diacyl lipid and/or at least one tocopherol; b) at least one phospholipid; c) at least one biocompatible, oxygen containing, low viscosity organic solvent; wherein at least one bioactive agent is dissolved or dispersed in the low viscosity mixture and wherein the pre-formulation forms, or is capable of forming, at least one liquid crystalline phase structure upon contact with an aqueous fluid. The preformulations are suitable for generating parenteral, non-parenteral and topical depot compositions for sustained release of active agents. The invention additionally relates to a method of delivery of an active agent comprising administration of a preformulation of the invention, a method of treatment comprising administration of a preformulation of the invention and the use of a preformulation of the invention in a method for the manufacture of a medicament.

Abstract: A composition suitable for restoring bone tissue in a human or animal body, which comprises a solid, preferably particulate, calcium phosphate as a biocompatible bone tissue substitute material distributed in a lamellar liquid crystalline phase comprising at least one phospholipid and water or other aqueous liquid as a bioacceptable carrier therefor, said lamellar crystalline phase being pre-formed or being formed in situ in said body in the presence of said water or other aqueous liquid, e.g., body fluid.