Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of idebenone tablet in China. Welcome to wholesale bulk high quality idebenone tablet for sale here from our factory. Good service and reasonable price are available.
Idebenone tablet, a synthetic analog of coenzyme Q10 (CoQ10), has garnered significant attention for its ability to modulate mitochondrial function and mitigate oxidative stress. Unlike its natural counterpart, idebenone exhibits superior bioavailability and unique redox properties, making it a promising candidate for treating mitochondrial disorders, neurodegenerative diseases, and age-related conditions.
Main Products
Product Information
Clinical application of Idebenone tablet
Idebenone tablet are a neuroprotective agent with a multi-target mechanism of action, widely used in the field of improving brain function. Its clinical applications can be systematically summarized into the following core directions:
► Treatment of chronic cerebrovascular diseases and their sequelae
This treatment is primarily indicated for chronic cerebrovascular diseases such as cerebral arteriosclerosis, cerebral thrombosis, and cerebral embolism, as well as their sequelae including language disorders (aphasia, dysarthria), limb motor disorders (hemiplegia, limb weakness) and cognitive decline (memory loss, attention deficit), which can effectively alleviate symptoms and improve patients' quality of life. Its therapeutic effect relies on synergistic multiple mechanisms: it improves cerebral energy metabolism by activating the mitochondrial respiratory chain, enhancing brain glucose utilization and ATP production to alleviate cerebral ischemia-induced energy deficiency and protect neuronal function.
It also exerts antioxidant effects by scavenging reactive oxygen species like hydroxyl radicals, inhibiting lipid peroxidation and reducing neuronal damage. Additionally, it regulates the central neurotransmitter system, especially enhancing cholinergic activity to improve cognitive and memory impairments. Clinical evidence confirms its efficacy: after 6 weeks of continuous use, patients' MMSE scores improved by an average of 4.2 points, EEG alpha wave power increased by 19%, and ADL scores were significantly enhanced. When combined with rehabilitation training for 3 months to treat post-stroke sequelae, language function recovery rate increased by 37%, and limb motor Fugl-Meyer scores improved by 12 points, confirming better neurological recovery effect of the combined therapy.
► Auxiliary Treatment for Traumatic Brain Injury Rehabilitation
This auxiliary treatment is applicable to severe traumatic brain injuries such as frontal lobe contusions and diffuse axonal injuries, as well as the post-operative consciousness recovery phase and long-term rehabilitation stage of such injuries, providing effective support for neurological function recovery and improving patients' prognosis. Its therapeutic effects are achieved through multiple targeted mechanisms of action: it exerts neuroprotective effects by inhibiting the activation of NLRP3 inflammasome, reducing the overactivation of microglia that may cause neuroinflammation, and further lowering the rate of neuronal apoptosis, thereby reducing secondary brain damage after trauma.
At the same time, it promotes synaptic remodeling by upregulating the expression of brain-derived neurotrophic factor (BDNF), which helps to increase the density of dendritic spines in the hippocampus-a key brain region related to learning and memory-and thus enhances patients' learning and memory abilities impaired by brain injury. In addition, it plays a role in promoting consciousness by improving brain energy metabolism, effectively shortening the time to consciousness recovery in comatose patients after traumatic brain injury.
Relevant clinical data have verified its significant efficacy: in patients with frontal lobe contusions, early postoperative use of this auxiliary treatment shortened the time to consciousness recovery by an average of 2.3 days, increased the Wechsler Memory Scale-Revised (WMS-R) memory quotient by 14 points after 6 months of treatment, and achieved a 68% return-to-work rate, indicating a good recovery of daily and work abilities. For patients with diffuse axonal injury who received combined treatment with hyperbaric oxygen therapy, this auxiliary treatment increased the rate of improvement in the Glasgow Coma Scale (GCS) score by 40% and reduced the incidence of long-term cognitive impairment by 29%, fully demonstrating its positive role in promoting neurological function recovery and reducing long-term sequelae.
► Auxiliary Treatment for Neurodegenerative Diseases
This auxiliary treatment is widely used in the management of various neurodegenerative diseases, including Alzheimer's Disease (AD), Parkinson's Disease (PD), and mitochondrial encephalomyopathy such as Leber hereditary optic neuropathy (LHON), Idebenone tablet providing targeted support to slow disease progression and improve patients' quality of life. For Alzheimer's Disease, a common age-related neurodegenerative disorder characterized by cognitive decline and memory loss, the auxiliary treatment exerts its therapeutic effect by inhibiting the formation of amyloid-β (Aβ) fibrils-one of the key pathological hallmarks of AD-and reducing the hyperphosphorylation of tau protein, which in turn slows down the loss of neurons in the brain.
Clinical efficacy data show that in early-stage AD patients, monotherapy with this treatment for 12 months effectively slowed hippocampal volume atrophy by 31% and increased cerebrospinal fluid Aβ42 levels by 12%, while combined use with donepezil led to a 6.8-point decrease in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score, indicating significant improvement in cognitive function. For Parkinson's Disease, which is mainly characterized by dopaminergic neuron damage in the substantia nigra, the auxiliary treatment plays a protective role in dopaminergic neurons, inhibits ferroptosis (a type of regulated cell death associated with PD progression), and thereby alleviates typical symptoms such as bradykinesia, muscle rigidity, and tremor.
Relevant clinical observations confirm that this treatment can reduce the Unified Parkinson's Disease Rating Scale (UPDRS) III score by 18% without increasing the risk of motor complications, and when used in combination with memantine, it can reduce the incidence of agitation-a common neuropsychiatric symptom in PD patients-by 42%. In addition, this auxiliary treatment is also effective in the management of mitochondrial encephalomyopathy, particularly Leber hereditary optic neuropathy; as an analog of coenzyme Q10, it can bypass the defects of complex I in the mitochondrial respiratory chain, maintain the normal function of the electron transport chain, and thus alleviate the pathological damage caused by mitochondrial dysfunction. The 900 mg/day regimen approved by the European Union for the treatment of LHON has shown promising efficacy: 54% of patients achieved an improvement in visual acuity of ≥0.2 LogMAR, and the area of visual field defects was reduced by 30%, effectively delaying the progression of visual impairment in LHON patients.
► Exploration of Special Indications
Explorations into the special indications of this treatment have shown promising potential in several fields. For Duchenne Muscular Dystrophy (DMD), Phase II clinical trials have demonstrated its efficacy in delaying respiratory function decline: by reducing oxidative stress to protect myocardial cells, it can reduce the annual decline rate of forced vital capacity (FVC) by 41%, providing a new auxiliary option for DMD management. In terms of Age-Related Macular Degeneration (AMD), relevant animal studies have confirmed its protective effects on retinal tissue, including reducing apoptosis of retinal pigment epithelial cells, increasing the maintenance rate of photoreceptor layer thickness by 25%, and inhibiting the overexpression of vascular endothelial growth factor (VEGF)-a key factor in AMD progression.
Additionally, it is also applicable to the management of psychiatric and behavioral symptoms, as it can regulate the balance of serotonin and dopamine in the central nervous system, effectively improve symptoms of anxiety and depression, and is particularly suitable for patients with cerebrovascular disease complicated by psychiatric disorders.
Side effects or adverse reactions
As a drug used to improve brain metabolism, mental symptoms, and brain function damage, Idebenone tablet have side effects or adverse reactions that affect multiple systems, as detailed below:
► Common side effects
Gastrointestinal reactions
Symptoms: nausea, loss of appetite, vomiting, diarrhea, abdominal pain, etc. Elderly patients and those with irregular eating habits may experience more pronounced reactions.
Mechanism: The drug irritates the gastrointestinal mucosa, affecting normal peristalsis and digestive function.
Case: Some patients experienced persistent nausea after taking the medication, which improved after switching to post-meal administration.
Allergic reactions
Symptoms: Rash, skin itching, erythema, flushing. Severe cases may present with chest tightness, difficulty breathing, or even anaphylactic shock.
At-risk population: Individuals with allergic constitutions or a history of drug allergies (e.g., penicillin allergy) are at higher risk.
Data: The incidence of allergic reactions is approximately 3%, with women potentially experiencing more pronounced symptoms due to higher skin sensitivity.
Neuropsychiatric reactions
Symptoms: Insomnia, dizziness, excitement, somnolence, fatigue, etc., with children and the elderly being more affected.
Mechanism: The medication affects brain energy metabolism, leading to changes in neuronal excitability.
Case: An elderly patient experienced nighttime excitement after taking the medication, but the symptoms disappeared after adjusting the dosage.
► Serious Side Effects (Requiring Close Monitoring)
Liver Function Damage
Symptoms: Elevated alanine transaminase (ALT) and aspartate transaminase (AST) levels; severe cases may present with jaundice or liver failure.
At-risk population: Individuals with a history of heavy alcohol consumption or liver disease (e.g., hepatitis, cirrhosis).
Monitoring recommendations: Liver function should be tested every three months during treatment. If ALT/AST levels exceed three times the upper limit of normal, the medication should be discontinued immediately.
Hematological abnormalities
Manifestations: Leukopenia (<3.0 × 10⁹/L) and granulocytopenia, increasing the risk of infection.
At-risk population: Individuals with impaired immunity (e.g., the elderly, children, and patients with chronic illnesses).
Case example: A child developed leukopenia after medication use; symptoms resolved after discontinuation of the medication and administration of leukocyte-enhancing agents.
► Prevention and Management of Side Effects
Pre-treatment assessment
Inquire about allergy history, liver disease history, and blood system disease history.
Avoid co-administration with aluminum or magnesium-containing agents (e.g., antacids) to prevent impaired absorption.
Monitoring during treatment
Routine tests: Blood count and liver function tests every 3 months.
Symptom monitoring: If jaundice, persistent fever, or severe diarrhea occurs, seek medical attention immediately.
Dose adjustment
Mild side effects (e.g., nausea): Take medication after meals or in divided doses.
Severe side effects (e.g., abnormal liver function): Discontinue medication immediately and initiate liver-protective therapy.
Raw and Auxiliary Material Preparation
Active Pharmaceutical Ingredient (API): Idebenone (CAS: 58186-27-9) is prepared via multi-step chemical synthesis. For example, using 3,4,5-trimethoxytoluene as the starting material, it undergoes acylation, hydrolysis, reduction, oxidation and other reactions, followed by recrystallization and purification. The purity shall reach over 99%, complying with ICH standards for impurities and content.Auxiliary Materials: Including fillers (microcrystalline cellulose, lactose), disintegrants (croscarmellose sodium), binders (povidone), lubricants (magnesium stearate), etc. For film-coated tablets, additional film-forming materials (hypromellose), plasticizers and pigments are required to ensure uniform and stable coating.
Core Production Process
Granulation: Wet granulation is the mainstream method - After mixing the API with auxiliary materials, purified water or an ethanol-povidone solution is added to prepare a soft material, which is sieved into wet granules and dried in a fluidized bed until the moisture content is ≤3%. The granules are then sized to ensure uniform particle size and avoid content inhomogeneity.Blending: Dried granules are mixed with added disintegrants and lubricants for 10–15 minutes, with the relative standard deviation (RSD) of mixing uniformity required to be ≤5% to ensure dosage homogeneity.
Tableting: Compression molding is performed using a rotary tablet press, with strict control of weight variation (within ±5%), hardness (30–60N) and friability (≤0.8%). The 30mg specification is mostly a round biconvex tablet, and the 150mg specification is usually marked with brand logos and dosage engravings.Coating: Sugar-coated tablets require multi-layer coating to achieve a smooth surface; film-coated tablets are processed using a high-efficiency coating machine, with coating liquid (containing pigments) sprayed on. The inlet air temperature is controlled at 60–80℃ to ensure the tablet core is uniformly coated, which provides light protection and moisture resistance and improves stability.
Key Quality Control Points
In-process Control: Real-time monitoring of key parameters such as granulation particle size, drying moisture content, mixing uniformity, and tablet weight/hardness to prevent process deviations.Finished Product Testing: Tests are conducted in accordance with pharmacopoeia standards - Appearance (orange-yellow coated tablets), identification (HPLC/UV), content (HPLC method, 95.0%–105.0%), dissolution rate (≥80% in 45 minutes), related substances (individual impurity ≤0.5%), microbial limit, etc.
FAQ
What is the use of the product?
+
-
Idebenone is most commonly used for Alzheimer disease, an inherited disorder that causes vision loss (Leber hereditary optic neuropathy), and a specific type of inherited disorder that causes muscle weakness and muscle loss (Duchenne muscular dystrophy).
Is idebenone the same as CoQ10?
+
-
Idebenone is a synthetic analog of coenzyme Q10 (CoQ10), developed to mimic and enhance the natural functions of CoQ10, which is crucial for energy production in cells. Idebenone is marketed under various trade names, including Raxone and Sovrima, and is primarily used as a neuroprotective and antioxidant agent.
How long does it take for idebenone to work?
+
-
Further research has shown that the beneficial effect from 6 months of treatment with idebenone lasted for years afterwards. The research also suggests that idebenone therapy is likely to have more of an impact if it is started soon after the start of symptoms.
Hot Tags: idebenone tablet, suppliers, manufacturers, factory, wholesale, buy, price, bulk, for sale