Description

Technical Parameters

Pregabalin (Pregabalin) Raw Material Powder Core Introduction

Pharmaceutical Grade Ingredients | Pregabalin (GABA Analog )

Chemical Name : (S)-3-(Aminomethyl)-5-methylhexanoic acid

CAS number : 148553-50-8

Molecular formula : C₈H₁₇NO₂

Molecular weight : 159.23

Melting point : 186-188°C

Appearance : White crystalline powder

Purity : ≥99% (HPLC)

Core Effects

Pregabalin is a novel calcium channel modulator that is widely used in the treatment of neuropathic pain, adjunctive therapy for epilepsy, and management of generalized anxiety disorder due to its unique anticonvulsant and analgesic properties .

✅ Precision treatment of neuralgia :

Inhibit calcium influx and reduce the release of neurotransmitters such as glutamate and norepinephrine

Diabetic neuropathy : pain improvement rate up to 50-60%

Postherpetic neuralgia : Significantly reduced pain scores

✅ Anti-epileptic auxiliary effect :

Partial epileptic seizures : Adjunctive therapy effectively reduces seizure frequency

Good safety profile : synergistic with traditional anti-epileptic drugs

✅ Anxiety Management :

Generalized Anxiety Disorder : Improving Anxiety Symptoms and Improving Quality of Life

Fast- acting : Symptom improvement can be felt within 1 week

✅ Advantages :

Multiple indications : One drug for multiple treatments, improving drug economy

Linear pharmacokinetics : Dose is proportional to blood concentration, making it easy to adjust

Well -tolerated : Side effects are relatively mild and patient compliance is high

End Product Preparation Guidelines

1. Oral capsule preparation (25mg/capsule, 75mg/capsule, 150mg/capsule) :

Example formulation (1000 tablets of 75mg preparation):

Pregabalin raw material: 75.0g

Microcrystalline cellulose: 50.0g

Lactose: 25.0g

Cross-linked sodium carboxymethyl cellulose: 5.0g

Magnesium stearate: 1.5g

Preparation process :

Raw material pretreatment : micronization (D90≤10μm)

Equal amount incremental mixing : gradually mix with diluent

Capsule filling : Fully automatic capsule filling machine filling

Polishing and dust removal : Capsule polishing machine removes surface powder

Aluminum-plastic packaging : moisture-proof and light-proof packaging

Quality Control :

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

Dissolution rate : ≥80% in 30 minutes (paddle method, 50 rpm)

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

2. Preparation of oral solution (20 mg/ml) :

Recipe example (preparation volume for 100ml):

Pregabalin raw material: 2.0g

Sorbitol: 50.0g

Glycerol: 10.0g

Flavoring agent: appropriate amount

Purified water: add to 100ml

Usage Protocol

1. Neuropathic pain treatment :

Starting dose :

75 mg twice a day

or 150 mg once a day

Dose escalation :

Increase to 300 mg/day after 3-7 days based on efficacy and tolerability

Maximum dose: 600 mg/day, divided into 2-3 doses

Treatment recommendations :

Generally, it is necessary to take it continuously for 2-4 weeks to evaluate the efficacy

Those who are effective can maintain treatment for a long time

2. Adjunctive treatment for epilepsy :

Adult Dose :

Initial: 75 mg twice a day

Maintenance: 150-600 mg/day, divided into 2-3 doses

Children's medication :

Need to calculate according to weight and strictly follow doctor's advice

The starting dose is usually 3.5 mg/kg/day

3. Generalized Anxiety Disorder :

Starting dose : 150 mg/day, divided into 2 doses

Therapeutic dose : 300-600 mg/day

Treatment duration : Usually 4-6 weeks of continuous treatment

4. Use in special populations :

Renal insufficiency :

Creatinine clearance 30-60 ml/min: Maximum dose 300 mg/day

Creatinine clearance 15-30 ml/min: Maximum dose 150 mg/day

Creatinine clearance <15 ml/min: Maximum dose 75 mg/day

Elderly : Adjust dose based on renal function

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

Why choose pregabalin ?

Multiple indications : one drug for multiple treatments including neuralgia, epilepsy, and anxiety

Clear efficacy : Extensive clinical studies have proven its effectiveness

Easy to use : once or twice a day, high compliance

Quality Assurance :

GMP -compliant production , each batch HPLC purity tested (≥99% )

Stability study : Accelerated test for 6 months meets the standard

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

Professional Packaging :

Moisture-proof and light-proof packaging : aluminum foil bag + desiccant

Temperature controlled transport : transported at 15-25°C

Privacy delivery : No sensitive information on the outer packaging

Conclusion

Pregabalin is an important option for the treatment of neurological diseases , particularly suitable for neuropathic pain management, adjunctive treatment of epilepsy, and anxiety symptom control . The recommended dose is 150-600mg/day .

Need a specific preparation plan ?

We provide professional technical guidance to help you prepare end products safely and efficiently!

Need anything, please contact us