Title:
MELATONIN-CONTAINING GRANULES
Document Type and Number:
WIPO Patent Application WO/2021/117792
Kind Code:
A1
Abstract:
[Problem] To provide granules for improving difficulty in sleep onset that target sleep disorders associated with neurodevelopmental disorders in infancy, ensure safety to young children, make it possible to obtain a sufficient effect, are used in a manner elaborated with due consideration to safety and effect, and are easy for infants and young children to swallow. [Solution] Granules for improving difficulty in sleep onset that contain melatonin as an active ingredient and that are produced by a method including: a granulation step in which orally soluble core particles and melatonin are mixed in the presence of a binder and melatonin base particles are obtained; and a drying step in which the melatonin base particles obtained in the granulation step are dried. The granules are characterized by targeting difficulty in sleep onset accompanying neurodevelopmental disorders in infancy, and in that a dose thereof equivalent to 1-4 mg of melatonin is administered orally once a day prior to bedtime.
Inventors:
YOTSUYA OSAMU (JP)
ABURADA TAKAKO (JP)
SATO MASANOBU (JP)
OKABE TOSHIO (JP)
ABURADA TAKAKO (JP)
SATO MASANOBU (JP)
OKABE TOSHIO (JP)
Application Number:
PCT/JP2020/045944
Publication Date:
June 17, 2021
Filing Date:
December 09, 2020
Export Citation:
Assignee:
NOBELPHARMA CO LTD (JP)
International Classes:
A61K31/4045; A61K9/16; A61K47/26; A61K47/38
Domestic Patent References:
| WO2001072285A1 | 2001-10-04 |
Foreign References:
| EP3127536A1 | 2017-02-08 | |||
| JP2007269783A | 2007-10-18 |
Other References:
FILALI, S. ET AL.: "Formulation, stability testing, and analytical characterization of melatonin-based preparation for clinical trial", JOURNAL OF PHARMACEUTICAL ANALYSIS, vol. 7, no. i ssue 4, 2017, pages 237 - 243, XP055835111
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