Blood System Agents Pregabalin Pharmaceutical raw material Lyrica 148553-50-8
CAS No: 148553-50-8
Application: Anti-Epileptic Drug Pharmaceutical Intermediates
Appearance: White or Almost White Crystalline Powder
Function: Blood System Agents
Grade Standard: Pharmaceutical Grade
Pregabalin is an anticonvulsant drug used for neuropathic pain and as an adjunct therapy for partial seizures with or without secondary generalization in adults.It has also been found effective for generalized anxiety disorder,it was designed as a more potent successor to gabapentin
Pregabalin also known as β-isobutyl-γ-Aminobutyric acid (β-isobutyl-GABA) and sold under the brand name Lyrica is a medication primarily used for epilepsy, neuropathic pain, and fibromyalgia.Its use for epilepsy is as an add-on therapy for partial seizures with or without secondary generalization in adults.It is also considered useful for generalized anxiety disorder.
Pregabalin is a derivative of the naturally occurring inhibitory neurotransmitter γ-Aminobutyric acid (GABA) and classified as a depressant by the Drug Enforcement Agency.It is a neurotransmitter modulator that has analgesic, anticonvulsant, anxiolytic, and sleep-modulating properties. Pregabalin is a potent gabapentinoid and a close structural analogue of GABOB (β-hydroxy-GABA), baclofen (β-(4-chlorophenyl)-GABA), and phenibut (β-phenyl-GABA)
Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.
LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a
clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a
polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with
methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive
Pregabalin is indicated for:
1.Treatment of neuropathic pain from diabetic neuropathy or post herpetic neuralgia. There is not enough data to state that it should be used in all neuropathic pain.
2.Adjunctive therapy in adults with partial seizures with or without secondary generalization
4.Generalized anxiety disorder
Usually physicians will start the patient on a low dose of pregabalin and increase it gradually, depending on the patient's evaluation. Its therapeutic effect appears after 1 week of use and is similar in effectiveness to lorazepam, alprazolam and venlafaxine but pregabalin has demonstrated superiority by producing more consistent therapeutic effects for psychic and somatic anxiety symptoms. Long-term trials have shown continued effectiveness without the development of tolerance and additionally unlike benzodiazepines it does not disrupt sleep architecture and produces less severe cognitive and psychomotor impairment; it also has a low potential for abuse and dependence and may be preferred over the benzodiazepines for these reasons.
|Appearance||A white to off white powder||White powder|
|Identification||Meets the requirement||Complies|
|IR: similar to Reference Substance||Complies|
|Loss on drying||≤0.5%||0.21%|
|Related Substances||Any single impurity ≤0.1%||0.05%|
|Total impurity ≤0.8%||0.10%|
|Purity By HPLC R-isomer||≤0.15%||0.10|
|Residue on ignition||≤0.1%||0.05%|
|Residual solvents||Isopropyl alcohol ≤5000ppm||150ppm|
|Ethyl Acetate ≤5000ppm||250ppm|
|Conclusion||Analyse according to Factory Standard , Conform|