Manufacturing Process With Chemical Reactions and Mass Balance For 6 Pharmaceutical Drugs
Manufacturing Process With Chemical Reactions and Mass Balance For 6 Pharmaceutical Drugs
Manufacturing Process With Chemical Reactions and Mass Balance For 6 Pharmaceutical Drugs
Introduction
Pharmaceutical Drugs are defined as chemical substances used for treating, curing and preventing different types of
diseases. Commonly referred as medicines or medication, pharmaceutical drugs are used in the medical diagnosis,
treatment, prevention or curing disease. The product has very high specific demand as API bulk drugs products are
especially used to relieve pain, swelling (inflammation) and joint stiffness caused by arthritis. It is essential that API bulk
drug products are safe, effective and of good quality, and are prescribed and used rationally.
The pharmaceutical industry is an important component of health care systems throughout the world; it is comprised
of many public and private organizations that discover, develop, manufacture and market medicines for human
and animal health (Gennaro 1990). The pharmaceutical industry is based primarily upon the scientific research and
development (R&D) of medicines that prevent or treat diseases and disorders. Drug substances exhibit a wide range
of pharmacological activity and toxicological properties (Hardman, Gilman and Limbird 1996; Reynolds 1989). Modern
scientific and technological advances are accelerating the discovery and development of innovative pharmaceuticals
with improved therapeutic activity and reduced side effects. Molecular biologists, medicinal chemists and pharmacists
are improving the benefits of drugs through increased potency and specificity. These advances create new concerns
for protecting the health and safety of workers within the pharmaceutical industry (Agius 1989; Naumann et al. 1996;
Sargent and Kirk 1988; Teichman, Fallon and Brandt-Rauf 1988).
Correspondence: Dr. Ashok K Rathoure, Eco Group of Companies, Surat (GJ) India.
How to cite this article: Rathoure AK, Aggarwal SG. Manufacturing process with Chemical Reactions and mass Balance for 6
Pharmaceutical Drugs. J Durg Dis Dev 2017; 1(1): 54-64.
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Rathoure AK et al. J. Durg. Dis. Dev. 2017; 1(1)
Diclofenac Sodium treat a headache that has already begun. It will not prevent
headaches or reduce the number of attacks.
Diclofenac is used to relieve pain, swelling (inflammation)
and joint stiffness caused by arthritis. Reducing these Manufacturing Process
symptoms helps you do more of your normal daily activities.
2, 6-Dichlorophenol is reacted with MMCA, Aniline
This medication is known as a nonsteroidal anti-inflammatory
and Chloro Acetyl Chloride and AlCl3 to yield (2, 6 -
drug (NSAID). Diclofenac is used to treat mild to moderate
Dichlorophenol) Indolinone is hydrolyzed using isopropyl
pain, or signs and symptoms of osteoarthritis or rheumatoid
alcohol and sodium hydroxide to give crude Diclofenac
arthritis. The Cataflam brand of this medicine is also used
Sodium. This on purification using deminerlised water
to treat menstrual cramps. Diclofenac powder (Cambia) is
and isopropyl alcohol gives the pure Diclofenac Sodium.
used to treat a migraine headache attack. Cambia will only
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Water: 4200 kgs REACTOR Distillation KCl Powder (by-product): 1371 kgs
KCl Solution: 5571.16 kgs (24.61%)
Waste water: 4200 kgs
Aniline: 1711.65 kgs Methanol Recovered: 3213 kgs
Sodium methoxide: 3975.44 kgs (25%) REACTOR Distillation Distillation residue: 89.23 kgs
Loss: 267.75 kgs
Methanol Recovered: 588.95 kgs
Water: 1600 kgs REACTOR Sodium Glycolate: 1803.67 kgs
Waste water: 1268.72 kgs
2,6 DCDPA: 4380.35 kgs 2,6 Di Chloro Di ethyl Amine: 4380.35 kgs Water: 1564 kgs
Toluene (F): 132.2 kgs
Toluene (R): 2189.8 kgs REACTOR HCl Gas: 671.61 kgs Scrubber 30% HCl: 2238 kgs
Chloro Acetyl Chloride: 2080 kgs
Soda ash: 29.25 kgs Distillation Toluene recovered: 2189.8 kgs
Sulphuric acid: 29.25 kgs Distillation residue: 58.05 kgs kgs
Water: 3600 kgs Loss: 133.17 kgs
Waste Water: 3600 kgs
Water: 7500 kgs FILTERATION & WASHING Wash Water: 7500 kgs
Aluminum Chloride: 2454.5 kgs GLASS LINED REACTOR HCl gas: 671.59 kgs Scrubber HCl (30%): 2238 kgs
VACUM DRYER
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DRYER
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Manufacturing Process for Clotrimazole layer by water finally distill out Toluene to get Crude Clt CL.
Clt CL (Ortho Chloro Tritryl Chloride) and Imidazole is heated Crude Clt CL purified in Acetone and Activated charcoal
in Toluene in presence of Triethyl Amine, wash organics and pure product is isolated by filtration.
DRYER
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SPARKLER
DRYER
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Manufacturing of Di Hydralazene Sulphate base. This is converted into acetate by treating with
dilute Acetic Acid. The resulting solution is filtered where
Dihydrallazine Sulphate is also known as nepresol sulphate the crude Dihydrallazine Sulphate is precipitated with
or 1-4, dihydrazino-phthalazine sulphate is manufactured by Sulphuric Acid. The crude Sulphate is dissolved in hot
the condensation of phthalodinitrile (phthalic acid dinitrile) water, treated with activated Carbon and filtered and the
with hydrazine hydrate in the presence of acetic acid glacial clear filtrate cooled to get pure crystals of Dihydrallazine
in methyl alcohol. The base is then converted into the Sulphate. The residue after recovery of Methanol from
soluble acetate and precipitated as sulphate containing the methanolic mother liquors is discarded or treatment
two molecules of water of crystallization. Phthalodinitrile is in effluent treatment plant. Gases generated from the 2nd
reacted with Hydrazine Hydrate in Methanol with catalytic stage will be Scrubbed Off in Scrubber.
quantity of Acetic Acid at 65 - 700 C to get Azinothalazine
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DRYER
H3C N
O
OH
HO .HCl + POCl3 + CH3 C CH3 + Diglyme
OH
Acetone ( 58)
Pyridoxine
Hydro Chloride (205.64)
CH3
O
CH3
O
+ POCl3 + H2O + Diglyme
CH2OH
H3C . HCl
N
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TD
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