Detailed Project Report (DPR) on colchicine and thiocolchicine

Detailed Project Report (DPR) on colchicine and thiocolchicine
Code #3641
Original
India
Countries
Translation provided by Google AI

Industry Overview

Colchicine is a toxic natural product and secondary metabolite most commonly used in the treatment of gout. It was originally extracted from plants of the genus Colchicum, particularly Colchicum autumnale, also known as autumn crocus or meadow saffron. Beyond gout, colchicine has applications in conditions including familial Mediterranean fever, pericarditis, and Behçet's disease.

The medicinal history of colchicine dates back centuries. Colchicum autumnale was described for rheumatism and swelling in the Ebers Papyrus, dating to approximately 1500 B.C. Its use in gout was later documented by Pedanius Dioscorides in De Materia Medica during the first century AD. Colchicum corms were subsequently used by physicians including Avicenna and Ambroise Paré and were listed in the London Pharmacopoeia of 1618. Colchicine was first isolated in 1820 by P.S. Pelletier and J.B. Caventou, while P.L. Geiger purified and named the active ingredient colchicine in 1833.

Colchicine's anti-inflammatory effects are associated with its ability to bind to tubulin. In the United States, the FDA approved colchicine as a stand-alone drug in 2009 for specified indications, including acute gout flares and familial Mediterranean fever, following earlier use in combination products.

Cost Estimation

Particulars Cost / Value
Plant Capacity 6 Kg/Day
Land & Building (1.5 Acre) Rs. 3.39 Cr
Plant & Machinery Rs. 1.75 Cr
Working Capital for 1 Month Rs. 3.76 Cr
Total Capital Investment Rs. 9.42 Cr
Rate of Return 36%
Break Even Point 42%

Content Index

  • INTRODUCTION
  • FDA APPROVAL
  • SOURCES OF COLCHICINE
  • SOURCES OF COLCHICINE
  • COLCHICUM AUTUMNALE
  • COLCHICUM LUTEUM
  • IPHEGENIA INDICA
  • GLORIOSA SUPERBA
  • PROPERTIES OF THIOCOLCHICINE
  • THIOCOLCHICINE
  • PROPERTIES & FUNCTION OF COLCHICINE
  • FORMULA C22H25NO6
  • CAS NAME COLCHICINE
  • FUNCTION OF COLCHICINE
  • EXPLANATION
  • COMPOSITION, CLASSIFICATION AND LABELLING OF THIOCOLCHICINE
  • PHYSICAL HAZARDS
  • HEALTH HAZARDS
  • REPRODUCTIVE TOXICITY
  • GERM CELL MUTAGENCICITY
  • CARCINOGENCITY
  • SPECIFIC TARGET ORGAN TOXICITY-SINGLE
  • SPECIFIC TARGET ORGAN TOXICITY-REPEATED
  • SPECIFIC CONCENTRATION LIMITS
  • ENVIRONMENTAL HAZARDS
  • LABELLING
  • HAZARD PICTOGRAM
  • HAZARD STATEMENT
  • PRECAUTIONARY STATEMENTS
  • ADDITIONAL TEXT
  • ADDITIONAL TEXT
  • LABELLING
  • RISK PHRASES
  • SAFETY PHRASES
  • USES AND APPLICATION OF THIOCOLCHICINE
  • PHARMACEUTICAL INTERMEDIATE
  • USES AND APPLICATION OF COLCHICINE
  • MEDICAL USES
  • GOUT
  • OTHER
  • CONTRAINDICATIONS
  • ADVERSE EFFECTS
  • TOXICITY
  • MECHANISM OF ACTION
  • CHEMICAL STRUCTURE OF COLCHINOIDS
  • MARKET SURVEY
  • EXPORT DATA OF COLCHICINE
  • IMPORT DATA OF COLCHICINE
  • OVERVIEW OF PHYTOCHEMICALS
  • ON THE BASIS OF FORM, MARKET IS SEGMENTED INTO
  • ON THE BASIS OF FUNCTIONALITY, MARKET IS SEGMENTED INTO
  • ON THE BASIS OF APPLICATION, MARKET IS SEGMENTED INTO
  • SOME OF THE KEY PLAYERS IDENTIFIED IN THE GLOBAL PHYTOCHEMICALS MARKET INCLUDE
  • BASED ON THE APPLICATION, THE PHYTOCHEMICAL API MARKET IS SEGMENTED INTO THE FOLLOWING
  • PRESENT MANUFACTURERS/SUPPLIERS OF COLCHICINE & THIOCOLCHICINE
  • PHARMACOLOGICAL USE OF COLCHINOIDS
  • DRUGS WITH COLCHICINE
  • DRUGS WITH COLCHICINE DERIVATIVES
  • OCCURANCE AND PROPAGATION OF G SUPERBA
  • BOTANICAL DESCRIPTION
  • PROPAGATION
  • MEDICINAL APPLICATION
  • AND ETHANOPHARMACOLOGY OF G. SUPERBA
  • ETHANOPHARMACOLOGY
  • MANUFACTURING PROCESS
  • OF COLCHICINE AND THIOCALCHICINE
  • PROCESS FLOW DIAGRAM OF COLCHICINE EXTRACTION
  • MANUFACTURE OF THIOCOLCHICINE
  • PROCESS FLOW DIAGRAM FOR THE MANUFACTURE OF THIOCOLCHICINE
  • METHOD OF EXTRACTION AND ISOLATION OF ALKALOIDS
  • ALL THESE FIVE STEPS SHALL BE DISCUSSED INDIVIDUALLY AS UNDER
  • SAMPLE PREPARATION
  • LIBERATION OF FREE ALKALOIDAL BASE
  • EXTRACTION OF ALKALOIDAL BASE
  • PURIFICATION OF ALKALOIDAL EXTRACT
  • FRACTIONATION OF CRUDE ALKALOIDS
  • QUANTIFICATION OF COLCHICINE IN VARIOUS PARTS OF GLORIOSA SUPERBA BY HPLC
  • MATERIALS AND METHODS
  • EXTRACTION PROTOCOLS
  • TABLE PEAK AREA OBTAINED FOR COLCHICINE EXTRACTED FROM DIFFERENT PLANT PARTS OF GLORIOSASUPERBAUSING DIFFERENT METHODS
  • CONCENTRATION COMPARISON
  • CONCLUSION
  • ESTIMATION OF COLCHICINE IN TUBERS OF GLORIOSA SUPERBA L
  • MATERIALS AND METHODS
  • TABLE COLCHICINE CONTENT IN WILD AND CULTIVATED TUBERS OF GLORIOSA SUPERBA FROM DIFFERENT AGRO CLIMATIC ZONES OF ODISHA.
  • FIGURE- COLCHICINE CONTENT IN WILD AND CULTIVATED TUBERS OF GLORIOSA SUPERBA FROM DIFFERENT AGRO CLIMATIC ZONES OF ODISHA.
  • FIGURE - TLC PLATES SHOWING COLCHICINE BANDS OF STANDARD AND TEST SAMPLES
  • FIGURE- TUBERS OF GLORIOSA SUPERBA FROM DIFFERENT AGROCLIMATIC ZONES
  • FIGURE- HPLC CHROMATOGRAM OF STANDARD COLCHICINE. COLCHICINE PEAK AT THE RETENTION TIME 1.2 MIN DETECTED AT A WAVELENGTH OF 350 NM.
  • FIGURE.. HPLC CHROMATOGRAM OF COLCHICINE IN CULTIVATED TUBERS OF ‘NORTH CENTRAL PLATEAU’ MAYURBHANJ (NCP-M).
  • FIGURE-HPLC CHROMATOGRAM OF COLCHICINE IN CULTIVATED TUBERS OF ‘NORTH CENTRAL PLATEAU’ KEONJHAR (NCP-K).
  • FIGURE- HPLC CHROMATOGRAM OF COLCHICINE IN CULTIVATED TUBERS OF ‘EAST SOUTH EASTERN COASTAL PLAIN(GANJAM)( ESECP-G)
  • FIGURE- HPLC CHROMATOGRAM OF COLCHICINE IN CULTIVATED TUBERS OF ‘WESTERN CENTRAL TABLE LAND, BARGARH ( WCTL-B).
  • COLCHICINE DERIVATIVES AND THEIR PROCESSES
  • BIOACTIVITY OF COLCHICINE AND ITS DERIVATIVES
  • MATERIAL SAFETY DATA SHEET OF COLCHICINE
  • COMPOSITION, INFORMATION ON INGREDIENTS
  • HAZARDS IDENTIFICATION
  • FIRST AID MEASURES
  • FIRE FIGHTING MEASURES
  • ACCIDENTAL RELEASE MEASURES
  • HANDLING AND STORAGE
  • EXPOSURE CONTROLS, PERSONAL PROTECTION
  • PHYSICAL AND CHEMICAL PROPERTIES
  • STABILITY AND REACTIVITY
  • SUPPLIERS OF RAW MATERIALS
  • GLORIOSA SUPERBA HERB
  • P TOLUENE SULFONIC ACID
  • OTHER RAW MATERIALS
  • SUPPLIERS OF PLANT AND MACHINERY
  • PULVERIZERS
  • FILTER PRESS
  • EVAPORATORS
  • VACUUM DRYER
  • CRYSTALLIZER
  • CENTRIFUGE
  • BOILERS (BABY)
  • LABORATORY TESTING EQUIPMENT
  • PLANT LAYOUT

Appendix

  • 01. PLANT ECONOMICS
  • 02. LAND & BUILDING
  • 03. PLANT AND MACHINERY
  • 04. OTHER FIXED ASSESTS
  • 05. FIXED CAPITAL
  • 06. RAW MATERIAL
  • 07. SALARY AND WAGES
  • 08. UTILITIES AND OVERHEADS
  • 09. TOTAL WORKING CAPITAL
  • 10. TOTAL CAPITAL INVESTMENT
  • 11. COST OF PRODUCTION
  • 12. TURN OVER/ANNUM
  • 13. BREAK EVEN POINT
  • 14. RESOURCES FOR FINANCE
  • 15. INSTALMENT PAYABLE IN 5 YEARS
  • 16. DEPRECIATION CHART FOR 5 YEARS
  • 17. PROFIT ANALYSIS FOR 5 YEARS
  • 18. PROJECTED BALANCE SHEET FOR (5 YEARS)

Frequently Asked Questions

Colchicine is a naturally derived pharmaceutical compound primarily used to treat gout and certain inflammatory conditions. It is a toxic secondary metabolite historically obtained from plants of the genus Colchicum. The compound has also been associated with treatment of familial Mediterranean fever, pericarditis, and Behçet's disease. Because colchicine has a narrow safety margin and can produce significant toxicity, its manufacture, handling, quality control, and pharmaceutical use require appropriate technical and regulatory controls.

The report identifies several plant sources associated with colchicine and related alkaloids, including Colchicum autumnale, Colchicum luteum, Iphegenia indica, and Gloriosa superba. Plant material can contain different concentrations of target compounds depending on species, plant part, growing conditions, and other factors. Consequently, source selection and analytical characterization are important considerations in projects involving botanical raw materials and the recovery or study of colchicine and related compounds.

Colchicine is used primarily for the management of gout and is also used for certain other inflammatory or hereditary conditions. The report specifically discusses gout, familial Mediterranean fever, pericarditis, and Behçet's disease. Its pharmaceutical applications are linked to its anti-inflammatory mechanism and interaction with tubulin. Actual medical use depends on the indication, formulation, dose, patient characteristics, and applicable prescribing information, so pharmaceutical applications should be evaluated against current regulatory and clinical requirements.

Colchicine is considered toxic because excessive exposure can cause serious adverse effects and potentially severe systemic toxicity. The report includes dedicated sections covering physical hazards, health hazards, reproductive toxicity, germ cell mutagenicity, carcinogenicity, target-organ toxicity, environmental hazards, and safety labelling. These characteristics make controlled handling, appropriate personal protection, exposure management, storage, waste management, and analytical quality control important considerations in industrial and laboratory environments where colchicine or related materials are handled.

Colchicine content in plant material can be evaluated using analytical techniques such as high-performance liquid chromatography (HPLC). The report includes HPLC-based investigations of colchicine in different parts of Gloriosa superba, together with extraction protocols, concentration comparisons, chromatograms, and studies of wild and cultivated tubers from different agroclimatic zones of Odisha. Analytical methods help determine the presence and concentration of target compounds and support raw-material evaluation, research, quality assessment, and process development.

The report identifies equipment categories including pulverizers, filter presses, evaporators, vacuum dryers, crystallizers, centrifuges, boilers, and laboratory testing equipment. Such equipment categories can form part of an industrial process and supporting quality-control infrastructure, depending on the selected process design and product requirements. Equipment selection normally considers raw-material characteristics, process requirements, material compatibility, containment, cleaning, safety, capacity, and applicable pharmaceutical or chemical manufacturing standards.

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