Abstract: The present invention relates to a composition for use as a capsule fill comprising (a) fexofenadine hydrohalide; (b) alkali hydroxide, wherein the molar ratio of the alkali hydroxide to fexofenadine is greater than 1.5:1; (c) a solvent, and optionally a solubilizer. This composition is a stable solution, and comprises a sufficiently high concentration of fexofenadine to be useful for manufacture of capsules comprising a pharmaceutically efficacious amount of the fexofenadine for treatment of the symptoms of allergies, hay fever, or urticarial. Further, the present invention relates to a capsule comprising such a fill.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: A non-gelatin encapsulation system for liquid filled soft capsules, by nature of the carrier, the cationic-ionic balance of the carrier and the active ingredients, or the concentration of the active ingredients and excipients, are difficult or impossible to commercially encapsulate in gelatin capsules. In particular, the system is adapted for the encapsulation of highly basic, or alkaline, fills. The system provides for a predominantly starch and gelling carrageenan based shell, which displays high resistance to both concentrated fills and to alkaline fills, in particular, to those fills which contain the salt or salts of weak acids and strong bases.

Abstract: Disclosed are suspensions suitable for encapsulation in gelatin capsules, comprising a solid phase consisting of solid particles having a mean diameter of at least about 149 &mgr;m, and a liquid phase capable of suspending the solid phase, the suspension having a predetermined rheology at a temperature suitable for encapsulation into gelatin capsules.

Abstract: A dosage unit form comprises a biologically active agent, such as a pharmaceutical, nutritional supplement or diagnostic, dissolved or suspended in a carrier liquid encapsulated in a soft elastic gel capsule. The carrier liquid comprises maltitol syrup as a major component. Maltitol syrup may be the only component of the carrier liquid, or may be blended with other liquids and/or excipients.

Abstract: A method is disclosed for increasing the solubility of acetaminophen alone or in combination with antihistamines, antitussives, decongestants, and expectorants to form a clear solution for encapsulation into a softgel. The acetaminophen is solubilized alone or in combination with the above ingredients by mixing with polyethylene glycol, propylene glycol, water, polyvinylpyrrolidone and potassium (or sodium) acetate. This invention increases the solubility of the acetaminophen to obtain the same size softgel for a 325 mg dose as is presently available for a 250 mg dose softgel product. The disclosed solvent system is useful because it provides for a highly concentrated solution of acetaminophen capable of encapsulation in a small enough capsule to permit easy swallowing.

Abstract: Pharmaceutically acceptable solutions of acidic, basic or amphoteric pharmaceutical agents are disclosed. These solutions are suitable for encapsulation in gelatin capsules for subsequent oral administration and include the pharmaceutical agent, an ion species and a solvent system.