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Product Name: Pramipexole
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(S)-Pramipexole enantiomer. s disease (PD) and restless legs syndrome (RLS). It is also sometimes used off-label as a treatment for cluster headache and to counteract the problems with sexual dysfunction experienced by some u sers of the selective serotonin reuptake inhibitor (SSRI) antidepressants.
Brief Introduction of Active Pharmaceutical Ingredients Pramipexole:
1. Pramipexole (Mirapex, Mirapexin, Sifrol) is a dopamine agonist of the non-ergoline class indicated for treating Parkinson's disease (PD) and restless legs syndrome (RLS).
2. Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.
3. Only immediate-release pramipexole (Mirapex) is approved to treat either Parkinson symptoms or RLS. Extended-release pramipexole (Mirapex ER) is approved only to treat Parkinson symptoms.
Medical Application of Active Pharmaceutical Ingredients Pramipexole:
1. Pramipexole is used to treat symptoms of Parkinson's disease (stiffness, tremors, muscle spasms, and poor muscle control). Pramipexole is also used to treat restless legs syndrome (RLS).
2. Pramipexole also possesses low/insignificant affinity (500–10,000 nM) for the 5-HT1A, 5-HT1B, 5-HT1D, and α2-adrenergic receptors. It has negligible affinity (>10,000 nM) for the D1, D5, 5-HT2, α1-adrenergic, beta-adrenergic, H1, and mACh receptors. All sites assayed were done using human tissues.
3. While pramipexole is used clinically (see below), its D3-preferring receptor binding profile has made it a popular tool compound for preclinical research. For example, pramipexole has been used (in combination with D2- and or D3-preferring antagonists) to discover the role of D3 receptor function in rodent models and tasks for neuropsychiatric disorders.
4. Of note, it appears that pramipexole, in addition to having effects on dopamine D3 receptors, may also affect mitochondrial function via a mechanism that remains less understood. A pharmacological approach to separate dopaminergic from non-dopaminergic (e.g. mitochondrial) effects of pramipexole has been to study the effects of the R-stereoisomer of pramipexole (which has much lower affinity to the dopamine receptors when compared to the S-isomer) side-by-side with the effects of the S-isomer.
5. Bipolar Depression:
In a single controlled study of twenty one patients, pramipexole was found to be highly effective in the treatment of bipolar depression. Treatment was initiated at 0.125 mg three times a day and increased at a rate of 0.125 mg three times a day to a limit of 4.5 mg daily until the patients' condition satisfactorily responded to the medication or they could not abide the side effects. The final average dosage was 1.7 ± 0.9 mg daily. The incidence of hypomania in the treatment group was no greater than in the control group, although the size of the study is too small to determine risks for manic switch.
6. Unipolar Depression:
In one controlled study, pramipexole was shown to be efficacious in the treatment of unipolar depression.
Technical Test Sheet of Active Pharmaceutical Ingredients Pramipexole:
White or off-white powder
Chemical purity (HPLC)
Optical purity(Chiral HPLC)
Loss on drying
Residue on ignition
Analysis according to Factory Standards , Conform
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