Treatment of chronic cough, breathlessness and dyspnea
a technology for breathing and dyspnea and cough, applied in the field of treating chronic cough, breathlessness or dyspnea, can solve the problems of imbalance between, chronic cough severely affecting the quality of life of patients, etc., and achieve the effects of reducing morbidity and mortality, reducing the incidence of acute exacerbation of ipf related to deterioration of lung function, and reducing respiratory difficulties
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example 1
[0243]A 30 mg, 60 mg or 180 mg extended release (ER) nalbuphine tablet was prepared as follows: Nalbuphine HCl, mannitol, xanthan gum, locust bean gum and calcium sulfate dihydrate were added to a high shear mixer and dried mix at low speed. A granulating solution (water for injection or purified water) was introduced into the mixer at low speed. The wet granulation was granulated at high speed and dried in a fluid bed processor. The dried granules were milled and sized using a conventional mill. The milled granulation was transferred into a diffusion (tumble) mixer. Hydroxypropylcellulose and, when applicable, fumaric acid (180 mg formulations only) were added to the diffusion mixer and blended. Thereafter, magnesium stearate was added to the diffusion mixer and blended. The final blend was compressed using a rotary tablet press. Tablets may be coated with a non-functional Opadry white coating.
TABLE 130 mg, 60 mg, 120 mg and 180 mg Extended Release Nalbuphine TabletIngredientmg / tab...
example 2
[0245]A double-blind, randomized, placebo-controlled, 2-period crossover safety and efficacy study in Idiopathic Pulmonary Fibrosis subjects with nalbuphine HCl ER tablets for the treatment of cough, breathlessness and dyspnea will be undertaken according to the following protocol.
[0246]The study consists of two 3-week treatment periods separated by a washout period of 2 weeks (FIG. 1). In the first treatment period, patients are randomized in a 1:1 ratio to nalbuphine ER tablets to a target dose of 162 mg twice daily (BID) (Equivalent Amount of Nalbuphine Free Base) or placebo tablets BID.
[0247]The primary objectives are evaluating the effects of nalbuphine HCl ER tablets on (1) the percent change in the daytime cough frequency and (2) as well as safety and tolerability. Daytime is defined as period of time the subject is awake in the 24 hours after the digital cough monitor is applied for use. Assessments are done using objective digital cough monitoring.
[0248]Participants
[0249]To...
embodiments
[0341]1. A method of treating idiopathic pulmonary fibrosis (IPF) cough, breathlessness or dyspnea comprising administering an effective amount of nalbuphine or a pharmaceutically acceptable salt or ester thereof to a patient in need of such treatment.[0342]2. The method of embodiment 1, wherein prior to said treatment the patient's daytime cough severity is at least 4 on the Cough Severity Numerical Rating scale.[0343]3. The method of embodiment 1, wherein prior to said treatment the patient's daytime average cough count is at least 15 per hour measured using a cough count monitor device.[0344]4. The method of embodiment 1, wherein the IPF cough is chronic cough.[0345]5. The method of embodiment 1, wherein the IPF cough is refractory chronic cough.[0346]6. The method of embodiment 1, wherein the IPF cough is refractory to treatment with an antitussive agent selected from gefapixant, serlopitant, and orvepitant.[0347]7. The method of embodiment 1, wherein the IPF cough, breathlessne...
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Abstract
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