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Publication Number
US-8987289-B2
Publication Date
2015-03-24
Expiration Date
Abstract
The present invention relates to methods for treating pruritus with anti-pruritic compositions.
Core Innovation
The invention is directed to oral treatment of prurigo nodularis using nalbuphine or a pharmaceutically acceptable salt or ester thereof. The approach centers on administering an effective amount of nalbuphine and focuses on oral delivery for a subject in need of treatment.
The content addresses nalbuphine and its metabolites in connection with anti-pruritus activity. It states that some nalbuphine metabolites may show anti-pruritic activity, while other metabolites may lack detectable anti-pruritic activity, and it identifies metabolite classes and examples such as nalbuphine glucuronides and hydroxylated nalbuphine metabolites, as well as nornalbuphine and 6-ketonalbuphine.
The content further links dosing and formulation to pharmacokinetic behavior. It describes titration based on metabolite clearance and dialyzability, and it includes pharmacokinetic comparisons between an extended-release oral dosage form and an immediate-release oral solution control, with reported exposure parameters such as Cmax and AUC(0-∞).
Claims Coverage
The independent claim covers one inventive feature: oral treatment of prurigo nodularis with nalbuphine or a pharmaceutically acceptable salt or ester. The dependent claims add five further inventive features relating to administration restrictions, extended-release dosing form, pharmacokinetic constraints, dosage range, and formulation composition.
Oral administration of nalbuphine as an anti-pruritus agent
A method of treating prurigo nodularis by orally administering an effective amount of nalbuphine or a pharmaceutically acceptable salt or ester thereof.
No combination with a second anti-pruritus agent
The method specifies that the anti-pruritus agent is administered without being combined with a second anti-pruritus agent.
Extended-release oral dosage form
The method includes administering the anti-pruritus agent formulated as an extended-release oral dosage form.
Pk release profile with mean Cmax and AUC(0-∞) ranges
The method includes administering a pK release profile in the subject having specified mean Cmax and AUC(0-∞) ranges.
Total daily dosage range and twice-daily dosing
The method specifies administering at a total daily dosage range of about 60 mg to about 180 mg twice daily.
Formulation with nalbuphine hydrochloride and specified excipients
The method is carried out by administering an anti-pruritus agent formulated with nalbuphine hydrochloride and specified excipients including mannitol, hydroxypropyl cellulose, locust bean gum, xanthan gum, calcium sulfate dihydrate, and magnesium stearate.
Overall, the claims coverage centers on oral nalbuphine treatment for prurigo nodularis, with dependent features that further restrict co-administration, specify an extended-release oral dosage form, impose pharmacokinetic range constraints for the pK release profile, define a twice-daily dosage range, and narrow formulation composition via nalbuphine hydrochloride with particular excipients.
Stated Advantages
Documented Applications
Treating prurigo nodularis using oral nalbuphine (or a pharmaceutically acceptable salt or ester).
Treating pruritic conditions including uremic pruritus.
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