Inspire Pharmaceuticals, Inc.

Christy L Shaffer

Janet L Rideout

Karla M Jacobus

David J Drutz

Richard C Boucher

William Pendergast

Karol La Croix

Richard C Evans

Karol K LaCroix

A method of promoting clearance of retained mucous secretions in the bronchi, bronchioles and small terminal airways of a subject in need of such treatment is disclosed. The method comprises administering to the bronchi of the subject a uridine phosphate such as uridine 5'-triphosphate (UTP), or P.sup.1,P.sup.4 -di(uridine-5') tetraphosphate (U.sub.2 P.sub.4), an analog of UTP, or any other analog, in an amount effective to promote mucociliary clearance and/or cough clearance of retained fluid in the bronchi, bronchioles and small terminal airways. Pharmaceutical formulations and methods of making the same are also disclosed. Methods of administering the same would include: aerosol inhalation, any liquid suspension (including nasal drops or spray), oral form (liquid or pill), injected, intra-operative instillation or suppository form.

Method of treating bronchitis with uridine triphosphate and related

Novel pharmaceutical compositions of uridine 5'-triphosphate (UTP) for use in promoting increased mucociliary clearance of retained mucous secretions of the human airways, middle/inner ears or sinuses are disclosed. Novel Formulation I comprises UTP and aqueous solution having a therapeutic concentration between 5 and 45 mg/mL, a controlled tonicity within the range of 250 to 100 mOsM, a pH between 7.0 and 7.5, and is sterile. The pH-adjusted composition is capable of long-term storage in the refrigerated state with a shelf life of up to 30 months. Formulation I may be delivered therapeutically either in a nebulized form or in a liquid form. Novel Formulation II comprises UTP in an aqueous solution or suspension having a therapeutic concentration approaching the limit of UTP's solubility at ambient temperature. This high concentration allows delivery of a therapeutic amount of UTP in very small volumes (50 to 100 .mu.L) suitable for administration via portable hand-held devices such as metered dose inhalers. Formulation II has extended shelf life without the need for refrigeration after being dispensed to the patient.

Pharmaceutical compositions of uridine triphosphate

A novel formulation of uridine 5'-triphosphate (UTP) for use in promoting increased mucociliary clearance of retained mucous secretions of the human airways, middle/inner ears, or sinuses is disclosed. The composition comprises UTP and aqueous solution having a therapeutic concentration between 5 and 35 mg/mL, which has controlled tonicity within the range of 250 to 1000 mOsM, pH-adjusted, having pH between 7.0 and 7.5; and sterile. The pH-adjusted formulation is capable of long-term storage in the refrigerated state, with a shelf life of up to 30 months if kept refrigerated at 5.degree. C. The formulation is delivered therapeutically either in a nebulized form using any of several commercially available nebulizers (e.g., jet, ultrasonic, etc.), or in liquid form.

Sterilized, isotonic and pH-adjusted pharmaceutical formulation of

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Chapel Hill, NC, United States of America

Christy L Shaffer