Modified-release tiopronin compositions, kits and methods for treating cystinuria and related disorders
AssigneeAltibio, Inc.
InventorsPatrick Reichenberger, Artem Zykovich
Life of this patent
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Abstract
The present invention provides methods, compositions, devices, and kits for treating cystinuria or related disorders, in which tiopronin is administered to a patient according to a modified-release strategy that releases tiopronin in critically-spaced, repeated pulses over time, to provide lower peak plasma levels but consistently higher urine levels of the drug for binding cystine. In particular, use of the present modified-release formulations and systems reduce side effects of tiopronin, thereby increasing patient compliance and quality of life, as well as achieving efficacy with less frequent administrations and/or lower total dosages.
Claims21
A method of treating cystinuria in a subject in need thereof comprising administering a pharmaceutical composition comprising:
- a therapeutically effective amount of tiopronin;
- and
- a pharmaceutically acceptable modified-release component for releasing the tiopronin in repeated pulses,
- wherein the tiopronin is released in repeated pulses-every two to six hours for about 12 to about 24 hours,
- wherein a first fraction of the tiopronin is released at a first time point and a second fraction of the tiopronin is released at a second time point about two to about six hours after said first time point,
- wherein the first fraction is released in 1 second to 30 minutes and the second fraction is released in 1 second to 30 minutes.
A method of treating Cystinuria in a subject comprising administering a therapeutically effective amount of tiopronin to achieve an extended duration therapeutic effect in the subject,
- said composition comprising tiopronin, in a first treatment dose, and a pharmaceutically acceptable modified-release component that releases distinct fractions of the tiopronin in repeated pulses over time at intervals of two to six hours, wherein each distinct fraction releases in 1 second to 30 minutes;
- wherein dosing is repeated to provide an average total daily dose of 15 mg/kg or less;
- and
- wherein said first treatment dose achieves the extended duration therapeutic effect in reducing urinary cystine concentration effectively below about 250 mg/L for at least about an 8-hour duration of effect to about 14-hour duration of effect.
Dependencies are inferred from the claim text.