Respira Therapeutics, Inc.

Xeris Pharmaceuticals, Inc.

The University of New Mexico

Martin J Donovan

Hugh Smyth

Robert Curtis

Zhen Xu

Revati Shreeniwas

Dan Deaton

James Hannon

Aileen Gibbons

Jeffry G Weers

Adaani Frost

Alain Romero

Pravin L Soni

Steven J Prestrelski

Michael A Sandoval

Stephen Lermer

Hugh D C Smyth

Hugh D Smyth

Jacques Pappo

Wendy Hu

Parthiban Selvam

Robert M Curtis

Novel dry powder compositions comprising and methods relating thereto are provided. The dry powder compositions comprise PDE5 inhibitors, such as vardenafil, or pharmaceutically acceptable salts or esters thereof. The dry powder compositions may optionally include an carrier/excipient. The concentration of active agent may be at least about 2% by weight. Methods of aerosolizing the dry powder compositions and using them to treat various diseases are also disclosed.

PDE5 inhibitor powder formulations and methods relating thereto

Provided herein are methods for treating pulmonary hypertension. The methods include administering to a subject in need thereof an effective amount of a vasodilator, wherein the vasodilator is administered to the subject via inhalation pro re nata using a portable inhaler. In some embodiments, the vasodilator is a PDE5 inhibitor. Pharmaceutical compositions for pro re nata administration of vasodilators are also described.

Methods and compositions for treatment of pulmonary hypertension and other lung disorders

The present invention concerns the use of aprotic polar solvents, water, and an ionization stabilizing agent to prepare device compatible stable therapeutic formulations by dissolving a therapeutic agent (active ingredient) in an aprotic polar solvent system that can then be used with various devices (e.g., pumps, infusion sets) for administration of the formulation. In certain embodiments, the invention is directed to formulations comprising one or more therapeutic agents, as well as methods of making such formulations, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system, such as a DMSO/water admixture, comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

Stable therapeutic compositions in aprotic polar solvents and methods of manufacturing the same

Certain embodiments are directed to a formulation of a therapeutic agent, as well as a method of making such a formulation, comprising at least one therapeutic agent dissolved in an aprotic polar solvent system comprising at least one ionization stabilizing excipient in a concentration sufficient to impart physical and chemical stability to the therapeutic agent.

Methods for producing stable therapeutic glucagon formulations in aprotic polar solvents

A dry powder inhaler includes a powder storage element configured to hold a powdered medicament and an inlet channel receives powdered medicament from the powder storage element that is entrained in an airflow. The inlet channel has a first diameter and defines an opening. The inhaler includes a dispersion chamber that receives the airflow and the powdered medicament from the opening. The dispersion chamber has a second diameter. The inhaler includes an actuator housed within the dispersion chamber. The actuator oscillates within the dispersion chamber when exposed to the airflow to deaggregate the powdered medicament entrained by the airflow passing through the dispersion chamber. A ratio between the first diameter and the second diameter is between about 0.40 and 0.60 such that an audible sound is produced as the actuator oscillates. The inhaler includes an outlet channel through which the airflow and powdered medicament exit the inhaler.

Powder dispersion methods and devices

This disclosure includes syringes, kits containing the same, and related methods. Some syringes are pre-loaded with paste and have a syringe body defining a reservoir having an internal first transverse dimension, a paste disposed within the reservoir, the paste having a solids concentration of greater than 50 mg/mL, a needle defining a lumen having an internal second transverse dimension that is smaller than the first transverse dimension, the needle configured to be in fluid communication with the reservoir to allow intracutaneous delivery of the paste, and a plunger and/or piston disposed within the reservoir and configured to be moved to dispense paste from the reservoir through the lumen. Some syringes include a fitting (e.g. Luer fitting) disposed on the syringe body and in fluid communication with the reservoir and a sealing cap disposed on the Luer fitting to seal the reservoir.

Syringes, kits, and methods for intracutaneous and/or subcutaneous injection of pastes

Methods for treatment of pulmonary hypertension

Powder inhaler, system and methods

Methods for producing stable therapeutic formulations in aprotic polar solvents

Growing community of inventors

El Paso, TX, United States of America

Martin J Donovan