Description

Technical Parameters

Tesofensine 0.5mg 100 tablets/bottle Core Description *

Pharmaceutical -grade formulation | Tesofensine (triple monoamine reuptake inhibitor )

Chemical name : (1R)-1-(3,4-dichlorophenyl)-3-[2-(dimethylamino)ethyl]-4-methyl-7,8-dihydro-1H-pyrano[3,4-e]indol-5(3H,4H,6H)-one

CAS number : 402856-42-2

Molecular formula : C₂₄H₂₉Cl₂N₃O₂

Molecular weight : 462.42

Specifications : 0.5mg/tablet, 100 tablets/bottle

Dosage form : Film-coated tablets

Appearance : White or off-white tablets with a dividing line

Core Effects

Tisofensine is a novel triple monoamine reuptake inhibitor ( MARI) that is widely used in the treatment of obesity, metabolic syndrome management, and appetite control due to its unique mechanism of action and significant weight loss effect .

✅ Triple Action Mechanism :

Inhibition of norepinephrine reuptake : Enhanced energy expenditure and fat oxidation

Inhibiting dopamine reuptake : Regulating reward pathways and reducing appetite

Inhibits serotonin reuptake : Increases satiety and reduces food intake

✅ Significant weight loss effect :

Clinical studies show an average weight loss of 10-12% in 6 months

Waist circumference significantly reduced : Visceral fat decreased significantly

Improved metabolic indicators : Optimized blood sugar and blood lipid levels

✅ Long-lasting properties :

Long half-life : approximately 8 days, allowing once-daily dosing

Stable blood drug concentration : avoid peak and valley fluctuations, and reduce side effects

Sustained effect after discontinuation of medication : Weight loss can be maintained after discontinuation of medication

✅ Advantages :

Once a day : High medication compliance

Multiple benefits : Lose weight while improving metabolic health

Good safety profile : Clinical studies have shown good tolerance

End Product Preparation Guidelines

1. Tablet preparation (0.5 mg/tablet) :

Example recipe (for 1000 tablets):

Tesofensine raw material: 0.5g

Microcrystalline cellulose: 80.0g

Lactose: 50.0g

Cross-linked carboxymethyl cellulose sodium: 8.0g

Magnesium stearate: 2.0g

Preparation process :

Raw material pretreatment : micronization (D90≤10μm)

Equal amount incremental mixing : gradually mix with diluent

Wet granulation : granulate with appropriate amount of purified water and dry in fluid bed at 50°C

Granulation : 20 mesh sieve granules, add flow aids and lubricants

Tableting : 6mm round die, 8-10kN pressure tableting

Film coating : Gastro-soluble film coating to improve stability and palatability

Quality Control :

Content uniformity : RSD≤3% (UV-HPLC detection)

Dissolution rate : ≥85% in 30 minutes (paddle method, 50 rpm)

Related substances : Single impurity ≤ 0.5%, total impurities ≤ 1.0%

2. Preparation Notes :

Moisture-proof treatment : The raw material is easy to absorb moisture, so the ambient humidity needs to be controlled

Light protection : Light sensitive, need to be handled and packaged away from light

Stability : Accelerated test for 6 months meets the standards

Usage Protocol

1. Obesity treatment :

Starting dose : 0.25 mg once daily

Target dose : 0.5 mg once daily

Recommended treatment course : at least 6 months, can be extended to 12 months depending on the effect

2. Dosage adjustment plan :

Initial phase (weeks 1-2): 0.25 mg/day

Maintenance phase (week 3 onwards): 0.5 mg/day

Maximum dose : no more than 0.5 mg/day

3. Recommended timing for use :

Take at a fixed time : Take it every morning to avoid affecting sleep

Can be taken before or after meals : food does not affect absorption

Avoid taking at night : May affect sleep quality

4. Use in special populations :

Hepatic insufficiency : Mild to moderate, no adjustment required; use with caution in severe cases

Renal insufficiency : Mild to moderate, no adjustment required; use with caution in severe cases

Elderly : No dosage adjustment required

Children : Safety not established for children under 18 years of age

5. Lifestyle Compatibility :

Dietary control : It is recommended to reduce daily calorie intake by 500 kcal

Exercise Recommendation : At least 150 minutes of moderate-intensity exercise per week

Behavioral intervention : combined with dietary records and behavioral modification

Why choose Tesofensine ?

Triple mechanism of action : targeting multiple appetite regulation pathways

Significant weight loss effect : Clinical studies confirm effectiveness

Long-lasting convenience : once a day, high compliance

Quality Assurance :

GMP -compliant production : Content uniformity testing for each batch

Stability test : Accelerated test for 6 months meets the standards

Third-party laboratory report (COA) is included with the goods

Professional Packaging :

Moisture-proof bottle : 100 tablets/bottle, built-in desiccant

Light- proof : Brown glass bottle or aluminum-plastic blister

Child safety cap : prevent children from accidentally swallowing

Conclusion

Tesofensine tablets are a new option for obesity treatment and weight management , particularly suitable for obese patients who have not responded well to diet and exercise . The recommended dose is 0.5mg/day for at least 6 months .

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