Antihistamine formulations for soft capsule dosage forms

A pharmaceutical composition for use in soft capsule dosage forms comprising:

• a) loratadine and derivatives thereof in a pharmaceutically effective amount;
• and
• b) a solvent system comprising a mixture of medium chain fatty acids;
• wherein the mixture of medium chain fatty acids is present in an amount of about 89.0% by weight or less of the total composition;
• and wherein said loratadine and derivatives thereof is present in an amount of about 6.3% by weight of the total composition.

A pharmaceutical composition for use in soft capsule dosage forms comprising:

• a) loratadine and derivatives thereof in a pharmaceutically effective amount;
• and
• b) a solvent system comprising a mixture of medium chain fatty acids;
• and further comprising a dispersant;
• and wherein said loratadine and derivatives thereof is present in an amount of about 6.3% by weight of the total composition.

A pharmaceutical composition for use in soft capsule dosage forms consisting essentially of:

• a) loratadine and derivatives thereof present in an amount of about 6.3% by weight of the total composition;
• b) mono- and di-glycerides of medium chain fatty acids present in an amount of about 87% by weight of the total composition;
• c) povidone present in an amount of about 6.3% by weight of the total composition;
• and
• d) polyoxyethylene sorbitan fatty acid ester present in an amount of about 0.8% by weight of the total composition.

A pharmaceutical composition for use in soft gelatin dosage forms consisting essentially of:

• a) decarboalkoxylated loratadine derivative in a pharmaceutically effective amount;
• b) a mixture of mono- and d-glycerides of medium chain fatty acids comprising a mixture of caprylic and capric acid;
• c) povidone;
• and
• d) polyoxyethylene sorbitan fatty acid esters;
• wherein said loratadine derivative is present in an amount of about 6.3% by weight of the total composition.

A soft capsule dosage form comprising a fill composition consisting essentially of:

• a) loratadine and derivatives thereof in a pharmaceutically effective amount;
• b) a mixture of mono- and diglycerides of medium chain fatty acids;
• c) povidone;
• d) polyoxyethylene sorbitan fatty acid ester;
• and
• wherein said loratadine and derivatives thereof is present in an amount of about 6.3% by weight of the total composition, and
• wherein said soft capsule has a capsule size of 5 minim or less.