Vinblastine Sulfate

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Vinblastine Sulfate API

 

Haorui supplies high quality Vinblastine Sulfate API produced by our GMP facility that has been successfully inspected by the FDA. We offer competitive prices and support our products with reliable technical and regulatory services. Vinblastine Sulfate API is available from R&D to commercial quantities. Please contact us for more details.

The following information is provided for general information purposes ONLY.

Vinblastine Sulfate Description

Vinblastine Sulfate for Injection USP is vincaleukoblastine, sulfate (1:1) (salt). It is the salt of an alkaloid extracted from Vinca rosea Linn., a common flowering herb known as the periwinkle (more properly known as Catharanthus roseus G. Don). Previously, the generic name was vincaleukoblastine, abbreviated VLB. It is a stathmokinetic oncolytic agent. When treated in vitro with this preparation, growing cells are arrested in metaphase.

Chemical and physical evidence indicates that vinblastine sulfate has the molecular formula C46H58O9N4H2SO4 and that it is a dimeric alkaloid containing both indole and dihydroindole moieties.

The structural formula is as follows:

Vinblastine Sulfate structural formula illustration

M.W.= 909.07

Vinblastine sulfate is a white to off-white powder. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. It is insoluble in benzene, ether, and naphtha.

The clinical formulation is supplied in a sterile form for intravenous use only. Vials of Vinblastine Sulfate for Injection USP contain 10 mg (0.011 mmol) of vinblastine sulfate, in the form of a white, amorphous, solid lyophilized plug, without excipients. After reconstitution with sodium chloride solution, the pH of the resulting solution lies in the range of 3.5 to 5.

Vinblastine Sulfate Pharmacology

Vinblastine interferes with metabolic pathways of amino acids leading from glutamic acid to the citric acid cycle and urea. Vinblastine has an effect on cell energy production required for mitosis and interferes with nucleic acid synthesis.

Vinblastine Sulfate Pharmacokinetics

Absorption

Rapidly absorbed 15 to 30 min following IV triphasic serum decay pattern.

Distribution

Undergoes rapid distribution (from blood to tissue) and extensive tissue binding.

Metabolism

Metabolized by the hepatic P450 3A cytochromes. The metabolite, deacetyl vinblastine, is more active than parent drug.

Elimination

Major route of excretion is the biliary system (liver). Terminal t is 24.8 h.

Special Populations

Hepatic Function Impairment

Toxicity may be enhanced. A dose reduction is recommended. In patients with a direct serum bilirubin value more than 3 mg/dL, a 50% dose reduction is recommended.

Pregnancy

Category D . Information is very limited.

Vinblastine Sulfate Indications and Usage

Adult

Hodgkin disease, non-Hodgkin lymphoma, mycosis fungoides, advanced testicular carcinoma, Kaposi sarcoma, choriocarcinoma, breast cancer.

Children

Hodgkin disease, non-Hodgkin lymphoma, mycosis fungoides, Letterer-Siwe disease, choriocarcinoma.

Unlabeled Uses

Non-small cell lung carcinoma, bladder cancer, cervical cancer, refractory idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia.

Vinblastine Sulfate Clinical Trials 1 Vinblastine Sulfate Clinical Trials 2
Vinblastine Sulfate Clinical Trials 3 Vinblastine Sulfate Clinical Trials 4
Vinblastine Sulfate Patents 1 Vinblastine Sulfate Patents 2
Vinblastine Sulfate Patents 3 Vinblastine Sulfate Patents 4
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