I have two essays to complete i was wondering if you could help me with them.
One is organic chemistry, the other is microbiology ?
I have posted the exact questions below.
The role of stereochemistry in API [url removed, login to view] what i have so far for you to work on.
The Role of Stereochemistry in the Production of Active Pharmaceuticle Ingredients
Optical Activity was first discovered in 1915 in 1815 at the Collège de France by the physicist Jean-Baptiste Biot. However it has only been since the late 1980’s when Everhardus Jacobus Ariens revisited Louis Pasteur’s discoverey of the existance of dextro and levo isomers in 1848, that stereochemistry has gained prime importance in the pharmaceutical industry. Where he asked a crutial question ” why we in some cases have to give doses to the patient where half of the content has no effect or the opposite effect?” The inactive enantiomer present in a racemic compounds can be known to not only cause adverse side-effects but can cause no effect or opposite effects on a patient.
This forced the reglatory authorities to re-assess the safety and efficacy requirements for the production of Active Pharmaceutical Ingredients (API’s) as in the synthesis of compounds the molecular structure is directly related pharmacological activity.1 It was once the case that the pharmacology and tocicology screening was carried out on a racemic only. Its seperation was considered difficult, however since Ariens question, the topic became more than an acedemic consideration and each entaniomer of a compound is now required by the Federal Drug Administration (FDA) to be assessed individually.2
This review focuses on the prediction of entaniomers with empasis on their optical activity, biological and pharmacological effects and the importance of there characteristics in the development of pharmaceutical products . The review will explore techniques for identification, characterization and seperation
Stereoisomers are different compounds that have the same molecular formula but differ in there three dimentional arrangement of atoms. It is a huge challange to distinguish between pairs of isomers. Only a plane polarised beam of light can be used to to detect their veriance. When an optically active substance is passed through polarized light or polarimeter, the plane rotates, depending on the direction and degree of rotation, characteristic differences of isomers can be demonstrated. If a plane of polarized light rotates the plane clockwize, the enantiomer is said to be dextrorotary, and laevorotatory if vice-verse. The degree of rotation is dependent on the concentration of the solution, the path length of the beam through the solution, the temperature and the wavelength of the light used.
The existance of different enantiomers of the same molecular formula exists due to the molecules chirality-, this is the way in which the molecules bond to the carbon structure, and when view in a three dimentional way is not superimposable on their mirror image. For example we know that chloroiodomethanesulfonic acid is not superimpossible and therefore can produce two different entaniomers. See Fig 1.
In some instances, a mixture of two entaniomers in equal ratios within a drug can appear to be achiral or optically inactive, however in fact when seperated each enantiomer can be found to exactly cancel each other by opossite rotation. This is known as an Racemic modification, which has been frequently used in practice before seperation was possible.3
The micro question :(basically EU GMP annex 1 vrs annex 9)
You work for a company that currently manufactures
liquid oral dosage forms. The
company is considering moving into multi-dose formu
lations for intravenous
administration. You have been asked to prepare a br
iefing note outlining the pros and
cons of this proposal of not more than 4 pages in l
ength. Areas you have been asked
to cover in this brief include but are not limited