Technology Overview
Bugu-SleepTM – Natural Ingredients for Sleep.
Bugu-SleepTM (hereinafter Bugu-STM) is a patented botanic extract for sleep improvement and exclusively refined manufacturing process. This natural sleep aid aims to regulate the gut-brain axis—the communication between the brain and the intestines. By changing the gut microbiota composition, Bugu-STM can improve physical constitution, facilitate sleep, and reduce stress and anxiety. The ingredients are suitable for people who have irregular sleep schedules, caffeine-induced sleep disturbances, or insomnia linked to high blood pressure. The materials used are all food raw materials registered in the "List of Raw Materials Available for Food" of the Ministry of Health and Welfare (MOHW) of Taiwan. The manufacturing and quality comply with ISO22000 and domestic HACCP food hygiene management regulations, and have passed animal and human safety assessments.
Features & Specifications
Features
- Patented formula (US11701399B2, TWI823041B, JP7287937B2, CN114173798B, EP4110363A1)
- Exclusively refined manufacturing process
- Efficacy evaluation
Animal experiments have shown that Bugu-STM can shorten the time to fall asleep, maintain longer sleep time, increase deep sleep time (NREM) and reduce awake times. It is suitable for sleep disturbances caused by:
- abnormal work and rest/jet lag (circadian rhythm disruption)
- caffeine
- high blood pressure
- Human studies of 8-week Bugu-STM administration show it can:
- ameliorate difficulty in falling asleep
- maintain a longer sleep time
- improve sleep efficiency
- reduce physical tension and anxiety stress levels
- Safety assessment
- After 28 days of repeated dose toxicology tests on animals, the no-obvious adverse effect dose (NOAEL) was 2,500 mg/kg, which is equivalent to 150 times the recommended daily dose.
- Clinical studies have shown that after 8-week Bugu-STM administration, there are no serious adverse reactions as current clinical drugs, such as dizziness and lack of energy the next day, and it will not affect daily activities.
- Mechanism of action studies
- regulating neurotransmitter dopamine through analysis of animal genomics
- modulating gut microbiome through next-generation sequencing of animal feces
- reducing intestinal permeability (leaky gut) and restoring the expression of intestinal cell tight junction protein
Specifications
- Through text mining and omics data analysis by AI technology, an insomnia disease module is established to accelerate the identification of potential materials. After gut-brain axis-related efficacy validation, a patented API (Bugu-STM) is developed.
Applications & Benefits
- promotes sleep quality
- relieves insomnia caused by irregular work schedules, such as shift work and jet lag
- mitigates sleep disturbances from high blood pressure
- aids in relieving sleep disturbances due to high caffeine intake
One-Stop Biomedical Services
 ITRI Web_One-Stop Services_LINK 800x337.jpg)
- Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
- Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
- Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
- Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
- Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.