Wednesday, January 23, 2013

Sulfamethazine: FDA Statement

This original ANADA submitted under section 512(b) of the Federal Food, Drug, and  Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that  SMZ-MED 454 Soluble Powder, when used under its proposed conditions of use, is safe and  effective for its labeled  indications.

Read the full FDA statement and also the information about sulfamethazine possible side effects.

Tuesday, January 22, 2013

Simultaneous Estimation Of Cinitapride And Pantoprazole Sodium By Rp-Hplc In Their Marketed Formulation: Abstract

A reversed-phase-liquid chromatographic (RP-HPLC) method was developed for the  determination of Cinitapride and Pantoprazole Sodium in their marketed formulation. A reversed-phase C- 18 column (250 mm × 4.60 mm i.d., particle size 5 µm) with mobile phase consisting of acetonitrile : water :
Triethylamine (80:20:0.05)  was used. The flow rate was 1.2 ml/ min and effluents were monitored at 260 nm.


 
The retention times of Cinitapride and Pantoprazole Sodium were found to be 5.26 ± 0.10 min and 1.72  ± 0.10 min, respectively. The method was validated in terms of linearity, range, accuracy, precision, limit of  detection (LOD) and limit of quantitation (LOQ). The method showed good linearity in the range of 12-28  µgm/ml for Cinitapride and 24-56 µgm/ml for Pantoprazole Sodium. The % recoveries of Cinitapride and  Pantoprazole Sodium were found to be between 99.52 - 99.85% and 99.38 – 99.74 % respectively.  The
percentage RSD for the method precision was found to be less than 2%. The proposed method was  successfully applied to the estimation of Cinitapride and Pantoprazole Sodium in combined capsule dosage  forms.

Read the full article: sphinxsai.com

Saturday, January 19, 2013

Voacamine Abstract: Antimalarial drug extracted from Peschiera fuchsiaefolia

In our previous studies, voacamine, a bisindolic alkaloid extracted from Peschiera fuchsiaefolia, was examined for its possible capability of  enhancing the cytotoxic  effect of doxorubicin (DOX) on multidrug resistant (MDR) human osteosarcoma  cells (U-2 OS-R). Voacamine induced in resistant cells a significant increase of drug  retention and intranuclear location which became comparable to those observed   in the parental sensitive  counterparts (U-2 OS-WT). In the present study, the cell  survival analysis and the electron microscopic observations confirmed the evident   cytotoxicity of DOX on MDR cells after pre-treatment with the plant extract.  

Moreover, an increase of the reactivity of P-glycoprotein (P-gp) with the  monoclonal antibody UIC2, which recognizes an epitope of the drug transporter in  its functional conformation, was revealed, demonstrating that voacamine is a substrate of P-gp, thus acting as a competitive antagonist of the cytotoxic agent. 

Moreover, to investigate if the enhancement of the cytotoxic effect induced by  voacamine could be due to an apoptotic process, we carried out the analysis of  cell morphology after Hoechst staining and the quantification of apoptosis by   Annexin V-FITC assay. These evaluations showed a very low rate of apoptosis in U-2   OS-R cells treated with voacamine and DOX given in association. In addition, the  combined treatment induced ultrastructural modifications suggestive of  autophagic cell death. In particular, transmission electron microscopy  observations revealed the presence of numerous lysosomes and the formation of a  large number of autophagosomes containing residual digested material. 

In conclusion, these findings seem to indicate that voacamine is capable of 
enhancing the cytotoxic effect of DOX on MDR cells by favouring a lethal   autophagic process.

No conclusion  about the side effects of voacamine have been released. Check the Voacamine Side Effects tracking page for any drug alerts about this product.