A liquid water base ibuprofen composition for oral administration is described, the ibuprofen being maintained in suspension by a combination of primary suspending agents and being taste masked by primary taste masking agents, the composition also containing a buffer acid to adjust the pH of the composition to between 1.5 and up to about 3.5 and to provide a buffer capacity within the range of 0.03 to 0.05 between the initial pH and a pH which is 1.0 pH unit higher than the initial pH.
The unpleasant taste of water-soluble ibuprofen salts in aqueous solution is masked by incorporating in the solution a taste-masking amount of an alkali metal bicarbonate, alkali metal monohydrogen phosphate or alkali metal tribasic citrate. Preferably, the taste-masking compound is an alkali metal bicarbonate, especially sodium bicarbonate.
A suspension of a sparingly water-soluble acidic drug, especially, a nonsteroidal anti-inflammatory analgesic agent, which is stable for a prolonged period of time and is highly dissolvable, and a process for simply and easily producing the suspension. This suspension has a pH value of 2 to 5 and comprises a sparingly water-soluble acidic drug whose average particle size ranges from 1 to 15 .mu.m, a polyglycerol fatty acid ester, a water-soluble polyhydric alcohol and water, optionally, together with an inorganic powder having an average particle size of 1 to 15 .mu.m. This process is characterized by carrying out pulverization and dispersion of a sparingly water-soluble acid drug, a polyglycerol fatty acid ester, a water-soluble polyhydric alcohol and water by means of a pulverizer comprising a main shaft adapted to rotate in a casing and a plurality of layshafts adapted to revolve in relationship interlocked with the rotation of the main shaft, each of the layshafts being fitted with a multiplicity of annular griding media.
An ibuprofen composition yielding an aqueous preparation having a pH of less than 7 on the addition of water to said composition which comprises one or more medicaments including an ibuprofen medicament which forms an ibuprofen active ingredient having a melting point less than 100.degree. C., when combined with water to give an aqueous preparation having a pH of less than 7 and a phospholipid material intimately mixed with the ibuprofen medicament. The phospholipid material is capable of forming an aqueous preparation comprising an emulsion or dispersion comprising an aqueous phase substantially free of said ibuprofen active ingredient and a discrete phase consisting essentially of said phospholipid material and insoluble pharmacologically active ingredient including said ibuprofen active ingredient on the addition of water to said composition. The invention also provides aqueous drink preparations (especially heated emulsions) produced thereform and a process to prepare said aqueous drink preparations.
A process for dispersing a particulate solid substance in a continuos aqueous phase comprising the steps of: providing a comminution reactor; providing a particulate solid substance comprising a weak acid functional group, having effective pK.sub.a1 >1 and less than 1% by weight aqueous solubility at pH=pK.sub.a1 ; providing an aqueous solution consisting essentially of water or a mixture of water with water-miscible solvent, at pH less than the greater of 7 and pK.sub.a1 +2; providing a buffering salt of a weak acid, where the weak acid associated with this buffering salt has pK.sub.a2 and where providing milling media; combining said particulate solid substance, said aqueous solution, said buffering salt, and said milling media in said comminution reactor to produce a multiphase mixture; and milling said mixture to produce a reduced particle size slurry of said particulate solid substance is disclosed.
