Microemulsions for pharmaceutical compositions
AssigneeWyeth
InventorsKristine M. Brophy, Jeffery J. Seyer, Peter Ramsey, Christopher Roper, Andrew Durber
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Abstract
The invention provides microemulsion pharmaceutical compositions comprising pharmaceutical actives which are hydrotropes that facilitate formation of microemulsions. The invention further provides methods of making the compositions and utilization of the compositions in liquid fill soft shell capsules including capsules having shells of non-animal derived materials (e.g. non-ADRM).
Claims23
A pharmaceutical composition for liquid filling soft shell capsules comprising, based on total weight of the composition:
- from about 15% w/w to about 50% w/w hydrotropic pharmaceutical active:
- from about 10% w/w to about 65% w/w oil;
- and
- water, wherein at least a portion of the hydrotropic pharmaceutical active is in a salt form.
A pharmaceutical composition for liquid filling soft shell capsules comprising, based on total weight of the composition:
- from about 15% to about 50% by wt ibuprofen;
- from about 15% to about 65% w/w medium chain triglycerides and
- water, wherein a first portion of the ibuprofen is potassium ibuprofen and second portion of the ibuprofen is un-ionized and the molar ratio of the potassium ibuprofen first portion to the un-ionized ibuprofen second portion is about 0.3 to 0.4.
A method of making a pharmaceutical composition for liquid filling soft shell capsules comprising:
- obtaining a hydrotropic pharmaceutical active having at least a portion of the hydrotropic pharmaceutical active in a salt form;
- obtaining water;
- obtaining an oil;
- and
- mixing the pharmaceutical agent with the water and the oil.
A pharmaceutical composition for liquid filling a hard shell non-ADRM capsule comprising, based on total weight of the composition:
- from about 15% w/w to about 50% w/w hydrotropic pharmaceutical active;
- from about 10% w/w to about 65% w/w oil;
- and
- water, wherein at least a portion of the hydrotropic pharmaceutical active is in a salt form.
A pharmaceutical composition for liquid filling a soft shell capsules comprising based on total weight of the composition:
- from about 15% w/w to about 50% w/w hydrotropic pharmaceutical active
- from about 10% w/w to about 65% w/w oil;
- a non-ionic surfactant;
- and
- a crystallization inhibitor.
Dependencies are inferred from the claim text.