CAS 148553-50-8 1g/Cm3 Pregabalin Powder Treat Epilepsy Neuropathic Pain
Product Name: Pregabalin
||3-(aminomethyl)-5-methyl-hexanoic acid; Pregablin; (3S)-3-(aminomethyl)-5-methyl-hexanoic acid; (R-)-3-isobutyl GABA; 3-isobutyl GABA; CI 1008; CI-1008; 3-(aminomethyl)-5-methyl-(3S)-Hexanoic acid; 3-(aminomethyl)-5-methyl-(S)-Lyrica; PD 144723; PD-144723; Pregabalin [USAN]; TOS-BB-0910; Pregabalin intermediate; (3R)-3-(aminomethyl)-5-methylhexanoic acid; (S)-Pregabalin; (S)(+)-3-Aminomethyl-5-methyl-hecanoic acid
||274°C at 760 mmHg
||0.00153mmHg at 25°C
||White or white crystalline powder
||New antiepileptic drugs. Used in the treatment of peripheral neuropathy, or partial seizures
Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is 1.35.
LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide. 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. 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 ingredients.
||A white to off white powder
||A. Meets the requirement
|B. IR: similar to Reference Substance
|Loss on drying
||Any single impurity ≤0.1%
Total impurity ≤0.8%
|Purity By HPLC R-isomer
|Residue on ignition
||Isopropyl alcohol ≤5000ppm
Ethyl Acetate ≤5000ppm
||Analyse according to Factory Standard , Conform
Pregabalin is useful when added to other treatments, when those other treatments are not controling partial epilepsy. Its use alone is less effective than some other seizure medications. It is unclear how it compares to gabapentin for this use.
The European Federation of Neurological Societies recommends pregabalin as a first line agent for the treatment of pain associated with diabetic neuropathy, post-herpetic neuralgia, and central neuropathic pain. A minority obtain substantial benefit, and a larger number obtain moderate benefit. Other first line agents, including gabapentinand tricyclic antidepressants, are given equal weight as first line agents, and unlike pregabalin, are available as less expensive generics. Pregabalin is not recommended for certain other types of neuropathic pain such as pain that of trigeminal neuralgia or HIV infection and its use in cancer-associated neuropathic pain is controversial.There is no evidence for its use in the prevention of migraines and gabapentin has been found not to be useful. It has been examined for the prevention of post-surgical chronic pain, but its utility for this purpose is controversial.
Therapeutic effects of pregabalin appear after 1 week of use and is similar in effectiveness to 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, in addition, , it has a beneficial effect on sleep and sleep architecture, characterized by the enhancement of slow-wave sleep. and produces less severe cognitive and psychomotor impairment;
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