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PACLITAXEL USP
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DOSAGE FORM: Liquid Injection, 30mg/5ml,100mg/16.7ml,260mg/43.4ml and 300mg/50ml

BIOLOGICAL SIGNIFICANCE

It is a diterpenoid compound with anti-tumor activity. It binds specifically to the tubulin subunit of microtubule and appears to antagonize the disassembly of this cytoskeletal protein. Paclitaxel is a mitotic inhibitor used in cancer chemotherapy.

CLINICAL USE

Paclitaxel used for ovarian cancer, breast cancer, lung cancer.

It is also used in the treatment of Kaposi's sarcoma.

It is recommended in NICE guidance of June 2001 that it should be used for non-small cell lung cancer in patients unsuitable for curative treatment, and in first-line and second-line treatment of ovarian cancer.

In September 2001 NICE recommended that paclitaxel should be available for the treatment of advanced breast cancer after the failure of anthracyclic chemotherapy

MODE OF ACTION

Paclitaxel interferes with the normal function of microtubule growth. Whereas drugs like colchicines cause the depolymerization of microtubules, paclitaxel arrests their function by having the opposite effect; it hyper-stabilizes their structure. This destroys the cell's ability to use its cytoskeleton in a flexible manner. Specifically, paclitaxel binds to the ß subunit of tubulin. Tubulin is the "building block" of microtubules, and the binding of paclitaxel locks these building blocks in place. The resulting microtubule/paclitaxel complex does not have the ability to disassemble. This adversely affects cell function because the shortening and lengthening of microtubules (termed dynamic instability) is necessary for their function as a mechanism to transport other cellular components. For example, during mitosis, microtubules position the chromosomes during their replication and subsequent separation into the two daughter-cell nuclei. Further research has indicated that paclitaxel induces programmed cell death (apoptosis) in cancer cells by binding to an apoptosis stopping protein called Bcl-2 (B-cell leukemia 2) and thus arresting its function. Paclitaxel is an effective treatment for aggressive cancers because it adversely affects the process of cell division by preventing this restructuring.

STRUCTURE:

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SPECIFICATIONS
COMPLIES TO USP
PARAMETER LIMIT
ASSAY NLT 90% AND NMT 110%
BACTERIAL ENDOTOXIN NMT 0.67 USP ENDOTOXIN UNITS PER MG OF PACLITAXEL
PH 3.0 – 7.0
STERILITY SHOULD COMPLY USP
   
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