Method of making particles for use in a pharmaceutical composition
AssigneeVectura Limited
InventorsJohn Nicholas Staniforth, David Alexander Vodden Morton, Rosella Musa
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Abstract
A method for making composite excipient particles for use in a pharmaceutical composition comprises a milling step in which particles of an excipient material are milled in the presence of an additive material. The product particles are of small size and the milling requires relatively low input of time and energy. The composite particles are suitable for use in inhalable pharmaceutical compositions.
Claims31
A method for making composite excipient particles for use in a pharmaceutical composition, the method comprising a milling step in which particles of an excipient material are milled in the presence of an additive material prior to adding active ingredient, wherein the milling step applies a force sufficient to break coarse excipient particles of mass median aerodynamic diameter (MMAD) greater than 100 μm down to fine particles of MMAD not more than 50 μm and involves mechanofusion, ultracentrifugal milling, jet milling, homogenisation, bead milling, media milling, hybridization, air jet milling, pin milling, hammer milling or knife milling;
- wherein the milling step results in the additive material being applied to the surfaces of the excipient particles;
- and wherein the composite particles comprise not more than 60% additive material by weight.
Dependencies are inferred from the claim text.