Abstract: Disclosed are compositions and methods for treating a patient with a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins, wherein the pharmaceutical composition is in the form of an emulsified nasal spray comprising: a macrocyclic permeation enhancer, a liquid carrier comprising water, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins; wherein the macrocyclic permeation enhancer is a Hsieh enhancer emulsified in the liquid carrier.

Abstract: The present invention provides pharmaceutical compositions for intranasal delivery of a benzodiazepine. The composition may contain a therapeutically effective amount of a benzodiazepine or a pharmaceutically acceptable salt thereof, and a permeation enhancer. The permeation enhancer may be propylene glycol or a Hsieh permeation enhancer. The present compositions have excellent bioavailability. After administration of the present compositions, therapeutically effective plasma levels of the benzodiazepine may be achieved rapidly. The present pharmaceutical composition may be used to treat a patient suffering from anxiety, epilepsy, insomnia, agitation, seizures, muscular disorders, alcohol dependence, and drug withdrawal.

Abstract: Disclosed are compositions and methods for treating a patient with a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins, wherein the pharmaceutical composition is in the form of an emulsified nasal spray comprising: a macrocyclic permeation enhancer, a liquid carrier comprising water, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins; wherein the macrocyclic permeation enhancer is a Hsieh enhancer emulsified in the liquid carrier.

Abstract: Compositions and methods for intranasal delivery of antigens for immunization of a mammal are disclosed. Antigens include peptides, proteins, peptidomimetics, DNA, RNA, carbohydrates and phospholipids. The compositions contain at least one antigen and a permeation enhancer. The permeation enhancer can be a macrocyclic permeation enhancer, such as a Hsieh enhancer.

Abstract: A pharmaceutical compositions in the form of an emulsion and containing a continuous liquid phase, for example, an aqueous phase, liquid droplets dispersed in the continuous phase, a pharmaceutically active compound, a Hseih enhancer, and a hydrocolloid emulsifying agent and in which, for example, the active compound is dissolved in the aqueous phase or in the liquid droplets, and the use of such composition to treat a condition in a patient, for example, diabetes.

Abstract: Pharmaceutical compositions for nasal administration to humans, or to warm-blooded animals, comprise: (A) a therapeutically effective amount of insulin; (B) a permeation enhancer; and (C) a liquid carrier; the compositions being further comprised of, or characterized by, any, or each, of: (D) a combination of non-ionic surfactants; wherein the combination of non-ionic surfactants comprises: (i) at least one fatty acid ester of a sugar or sugar alcohol and (ii) at least one pegylated fatty acid ester of a sugar or sugar alcohol; (E) an acidic pH, but no greater than a pH of 4.5; and (F) an osmolality of <200 mOsmol/Kg H2O.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.

Abstract: The present invention provides a preparation of a therapeutically effective amount of insulin with a concentration of A21 desamido insulin greater than about 2% (w/w).

Abstract: Compositions and methods for intranasal delivery of antigens for immunization of a mammal are disclosed. Antigens include, peptides, proteins, peptidomimetics, DNA, RNA, carbohydrates and phospholipids. The compositions contain at least one antigen and a permeation enhancer.

Abstract: Disclosed are compositions and methods for treating a patient with a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins, wherein the pharmaceutical composition is in the form of an emulsified nasal spray comprising: a macrocyclic permeation enhancer, a liquid carrier comprising water, and a therapeutically effective amount of the pharmaceutically active agent; wherein the macrocyclic permeation enhancer is a Hsieh enhancer emulsified in the liquid carrier; and wherein the Hsieh enhancer has the following structure: wherein X and Y are oxygen, sulfur or an imino group of the structure or ?N—R with the proviso that when Y is the imino group, X is an imino group, and when Y is sulfur, X is sulfur or an imino group; A is a group having the structure and the remaining variables are defined herein.

Abstract: Compositions and methods for treating a patient with insulin that combines insulin, a permeation enhancer, and a carrier that maintains an acidic pH, are disclosed.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.

Abstract: Compositions and methods for treating a patient with insulin that combines insulin, a permeation enhancer, and a carrier that maintains an acidic pH, are disclosed.

Abstract: Disclosed are compositions and methods for treating a patient with a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins, wherein the pharmaceutical composition is in the form of an emulsified nasal spray comprising: a macrocyclic permeation enhancer, a liquid carrier comprising water, and a therapeutically effective amount of a pharmaceutically active agent other than insulin selected from the group consisting of peptides, peptidomimetics, and proteins; wherein the macrocyclic permeation enhancer is a Hsieh enhancer emulsified in the liquid carrier; and wherein the Hsieh enhancer has the following structure: wherein X and Y are oxygen, sulfur or an imino group of the structure or ?N—R with the proviso that when Y is the imino group, X is an imino group, and when Y is sulfur, X is sulfur or an imino group, A is a group having the structure wherein X and Y are defined above, m and n are integers having a value from 1 to 20 a

Abstract: The present invention provides a method for achieving a therapeutically effective plasma levels of insulin by administering at least two doses of pharmaceutical formulation of insulin sequentially into the same nostril. The administration of the second dose in the same nostril gives substantially higher plasma levels of insulin when compared with sequential administration in two different nostrils. Without being limited to any specific physiological mechanism, it is believed that the first dose of insulin acts as a loading dose. This loading dose is required to achieve the subsequent plasma levels of insulin that are observed with subsequent doses. The Cmax of plasma insulin achieved by the methods and formulations of the present invention is at least about 70 microU/ml when plasma insulin is measured from about 0 to about 45 minutes after administration of a second dose. The AUC achieved is at least about 1800 microU/(ml*min).

Abstract: A pharmaceutical composition comprising: (A) a continuous liquid phase; (B) liquid droplets dispersed in said continuous phase; (C) a pharmaceutically-active compound; (D) an enhancer as described in U.S. Pat. No. 5,023,252; and (E) a hydrocolloid emulsifying agent; including, for example, a composition in which the liquid phase comprises an aqueous solution of insulin and the liquid droplets comprise a solution of the enhancer and a solvent therefore; and the use of the composition to treat a condition for example diabetes in a patient by applying to the membrane of the patient the composition.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.

Abstract: A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.