The pharma industry produces life-saving drugs but some of its byproducts are harmful chemicals. But, green chemistry can help the industry change this perception as per Dr. Bapu Gawde – Founder & Director, Cleanchem Laboratories LLP in this brief interview with PBW.
What are the services offered by Cleanchem to the pharma industry in general?
Cleanchem Laboratories is an independent R&D based company working in the CRAMS space dealing with custom synthesis and supply of impurities as per EP, USP, BP and IP. We are also involved in pharmaceutical & agrochemical intermediates, fragrances & flavouring agents, speciality chemicals & NCEs, drug discovery and metabolites. We initially started out in the field of isolation, characterization and identification of unknown impurities especially process related impurities. Now, we also provide technical consultancy services and undertake projects of pharma R&D departments as well as manufacturing units related to pharma, biotech, specialty chemicals and allied industries.
Could you please elaborate a bit on process related impurities with reference to the pharma industry?
The impurities are the unwanted substances/ chemicals that are present in the APIs or develop during formulation. They are mainly detected during stability studies. The presence of these impurities even in trace amount may influence the efficacy and safety of the medicine. The International Conference on Harmonization (ICH) has formulated certain guidelines regarding the control of impurities which are strictly inspected and recorded by various regulatory authorities like USFDA, European regulatory agencies, FDA (India), etc. The elimination or minimization of these substances in drugs as per the prescribed regulatory limits is of vital importance in the pharmaceutical industry.
How do you isolate and characterize unknown impurities?
Impurities are isolated by various physical, chemical and instrumental techniques based on its physicochemical properties. Prior to its isolation, impurities are enriched in bulk mass or mother liquor by various chemical and physical methods for easy and quick isolation. Liquid impurities can be isolated via atmospheric, fractional or high vacuum distillation. Solid impurities can be separated and purified by recrystallization, column chromatography, preparative HPLC-or flash chromatography. These isolates and purified samples are then subjected to different analytical techniques like mass spectroscopy, FTIR, TGA, 1H-NMR, 13C-NMR, GC, HPLC, etc. Collection and interpretation of all these data help us in profiling the chemical structure, properties and purity of the sample. All this data is eventually used to generate the COA and SER reports.
You had also mentioned about metabolites earlier. What is its significance in dosage regimen design?
Metabolites are chemicals that are formed during various metabolic pathways of biological systems. In this process complex organic compounds are converted into simple molecules (eg. digestion of food and medicinal compounds in biological systems). Metabolism gives us better understanding of drug action and help us in doing further studies like chemical activity, toxicological action, half-life, bioavailability of drugs, etc. Accordingly, we can arrive at the optimum dosage level and cycle for a particular medicine. Studies of metabolic pathways of drugs are very important while doing new drug discovery. This part of research includes theoretical design of scaffold, checking its activity with the help of advanced molecular modeling software, chemical synthesis of best fit molecules for maximum effect, in vivo and in vitro clinical trials, toxicological reports, impurity profiling, bioavailability studies and drug elimination/excretion analysis.
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Pharma Bio World December 2018