Flavoring Systems for Pharmaceutical Compositions and Methods of Making Such Compositions

A liquid pharmaceutical composition comprising:

• (a) a flavoring system, said flavoring system comprising one or more sweetening agents and two or more flavored ingredients selected from the group consisting of a menthol flavored ingredient, a peppermint flavored ingredient, a vanilla flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof;
• (b) one or more pharmaceutically active agents, said one or more pharmaceutically active agents being selected from the group consisting of ritonavir or derivatives thereof, lopinavir or derivatives thereof, and mixtures thereof;
• and
• (c) a solvent system, said solvent system comprising two or more solubilizing agents selected from the group consisting of water, alkyl alcohols, alkylene glycols, and mixtures thereof.

A method for making a liquid pharmaceutical composition, said method comprising:

• (1) charging a vessel with at least a portion of a solvent system, said solvent system comprising two or more solubilizing agents selected from the group consisting of water, alkyl alcohols, alkylene glycols, and mixtures thereof;
• (2) dissolving one or more pharmaceutically active agents selected from the group consisting of lopinavir or derivatives thereof, ritonavir or derivatives thereof, and mixtures thereof, in at least a portion of the solvent system in the vessel;
• and
• (3) combining in the vessel
• (i) one or more liquid sweetening agents,
• (ii) two or more flavor modifiers selected from the group consisting of sodium citrate, sodium chloride, citric acid, and mixtures thereof,
• (iii) two or more flavored ingredients selected from the group consisting of a peppermint flavored ingredient, a vanilla flavored ingredient, a menthol flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof, and
• (iv) any remaining portion of the solvent system.

A liquid pharmaceutical composition comprising:

• (1) a solvent system, said solvent system comprising three or more solubilizing agents selected from the group consisting of water, alkyl alcohols, alkylene glycols, and mixtures thereof;
• (2) a flavoring system, said flavoring system comprising
• (i) one or more sweetening agents selected from the group consisting of:
• glycerin, monoammonium glycyrrhizinate, acesulfame potassium, high fructose corn syrup, saccharin sodium and mixtures thereof;
• (ii) three or more flavored ingredients selected from the group consisting of a peppermint flavored ingredient, a vanilla flavored ingredient, a menthol flavored ingredient, a cotton candy flavored ingredient, and mixtures thereof;
• and
• (iii) three or more flavor modifiers selected from the group consisting of sodium citrate, sodium chloride, citric acid, and mixtures thereof;
• and
• (3) one or more pharmaceutically active agents selected from the group consisting of lopinavir or derivatives thereof, ritonavir or derivatives thereof, and mixtures thereof, and made by a process comprising steps of:
• (a) charging a vessel with at least a portion of the solvent system;
• (b) dissolving the one or more pharmaceutically active agents in the at least a portion of the solvent system in the vessel;
• and
• (c) combining in the vessel the at least a portion of the solvent system containing the one or more dissolved pharmaceutically active agents, the flavor modifiers, the sweetening agents, the flavored ingredients and any remaining portion of the solvent system.