FINASTERIDE IMPURITY, ITS IDENTIFICATION, CHARACTERIZEATION and USES

FINASTERIDE IMPURITY, ITS IDENTIFICATION, CHARACTERIZEATION and USES

FINASTERIDE IMPURITY, ITS IDENTIFICATION, CHARACTERIZEATION and USES

During the production of drugs, there is always the possibility of formation of impurities. Just like any manufacturing process, quality control is important. More so in drug processing as this has to do with health and wellbeing of people. People turn to drugs to get better. We do not want failure in the manufacturing process to end up being a health hazard. This is why Identification of impurities is important.

It is therefore important for impurities to be profiled so as to detect and identify organic or inorganic impurities in mass produced drugs and pharmaceutical formulations. Drug analysis is very important especially due to the increasing demand for pure drugs. If any problems are identified, it is important to give details of impurities and solutions. Modern analytical chemistry should be used when providing solutions.

The synthesis process of Finasteride

The enzyme steroid 5α-reductase has been approved as a drug treating prostatic hyperplasia. Finasteride is a potent inhibitor of this enzyme. It is therefore necessary to look out for this impurity if this enzyme is to perform as it should during treatment. The original method used to detect finasteride at pictogram level in human plasma by isotope-dilution gas chromatography mass spectrometry. Finasteride was synthetized with a high ratio of trideuteration. Samples were injected in the GC-MS instrument and there was a minimum detection of finasteride. The new invention provides a short circuit that has a high yield despite its simplicity and low cost synthesis of finasteride.

Characterization of finasteride

The pure polymorphic forms I, II, and III of finasteride were prepared and their purity was confirmed by FTIR, differential scanning calorimetry, and X-ray powder diffraction measurements. The preparation experiments demonstrated process of dissolving some finasteride solvates results in not only the formation of polymorphic forms I and II, but also in obtaining the pure form III. The 13C cross-polarization magic angle spinning (CP-MAS) and the 15N CP-MAS spectra can distinguish all three polymorphic forms of finasteride. Additionally, the data point to the presence of only one molecule in crystallographic asymmetric unit of polymorphic forms I and III and two molecules in the form II. The application of electronic circular dichroism (ECD) and vibrational circular dichroism (VCD) spectroscopy for finasteride polymorphic forms shows that the three polymorphs could be distinguished by the characteristic shapes of their VCD spectra in the spectral range 1520–1440 cm–1. The ECD spectral patterns of all these forms, however, are almost indistinguishable because of their close similarity.

Uses of finasteride

  • Finasteride is important for shrinking enlarged prostate. It is sometimes taken alone or in combination with other drugs. Use of finasteride reduces possibilities of going for surgery.
  • Finasteride reduces symptoms accompanying enlarged prostrate. It reduces the urge to urinate, promotes better urine flow and reduces the feeling of a full bladder even after urination.
  • Finasteride reduces the hormone DHT that is responsible for the growth of prostate.

Cons of finasteride

  • Women and children should not come into contact with this drug. This is especially so for pregnant women. If the tablet is broken, a pregnant woman or one that is expecting to get pregnant should not touch it.
  • This drug should be taken continuously at the same time. It therefore requires one to be very keen if it is to work.

 

 

 

 

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