Appeal No. 98-2247 2
Application No. 08/108,822
THE INVENTION
The invention is directed to a method of preparing a pharmaceutical composition
wherein a salt form of an organic acid sterol derivative in an amount sufficient to form a
closed vesicle is mixed with an aqueous phase and agitated until the vesicles are formed.
The mixture is essentially free of organic solvent. Other features of the claimed subject
matter are set forth in the following illustrative claim.
THE CLAIMS
Claims 129 is illustrative of appellants’ invention and is reproduced below.
129. A method for preparing a pharmaceutical composition which comprises liposomes
having bilayers comprising a lipid which consists essentially of a salt form of an organic
acid sterol derivative capable of forming closed bilayers, the method comprising:
(I) mixing an amount of the salt form of the organic acid sterol derivative sufficient
to form closed vesicles with an aqueous phase so as to form a mixture comprising the
aqueous phase and the sterol derivative, wherein the mixture is essentially free of organic
solvent; and
(ii) agitating the mixture until vesicles are formed,
wherein when the sterol derivative is negatively charged at neutral pH the mixture
is substantially free of multivalent cations or when the derivative is positively charged at
neutral pH the mixture is substantially free of multivalent anions.
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