EPHEDRINE [CODE NO 3696]
Ephedrine is a medication and stimulant. It is often used to prevent low blood pressure during spinal anesthesia. It has also been used for asthma, narcolepsy, and obesity but is not the preferred treatment. It is of unclear benefit in nasal congestion. It can be taken by mouth or by injection into a muscle, vein, or just under the skin. Onset with intravenous use is fast, while injection into a muscle can take 20 minutes, and by mouth can take an hour for effect. When given by injection it lasts about an hour and when taken by mouth it can last up to four hours.
Common side effects include trouble sleeping, anxiety, headache, hallucinations, high blood pressure, fast heart rate, loss of appetite, and inability to urinate. Serious side effects include stroke, heart attack, and abuse. While likely safe in pregnancy, its use in this population is poorly studied. Use during breastfeeding is not recommended. Ephedrine works by increasing the activity of the α and β adrenergic receptors.
Ephedrine was first isolated in 1885 and came into commercial use in 1926. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system. It is available as a generic medication. The wholesale cost in the developing world is about US$0.69–1.35 per dose. In the United States it is not very expensive. It can normally be found in plants of the Ephedra type. Dietary supplements containing ephedrine are illegal in the United States, with the exception of those used in traditional Chinese medicine, where its presence is noted by má huáng.
COST ESTIMATION
Plant Capacity 450 Kg/Day
Land & Building (1500 sq.mt.) Rs. 2.18 Cr
Plant & Machinery Rs. 1.60 Cr
Working Capital for 2 Months Rs. 1.92 Cr
Total Capital Investment Rs. 5.92 Cr
Rate of Return 35%
Break Even Point 50%
INTRODUCTION
PROPERTIES OF EPHEDRINE
PROPERTIES OF EPHEDRINE HYDROCHLORIDE
CLASSIFICATION (FORMS):-
NOMENCLATURE
GRADES:-
MECHANISM OF ACTION
COMPOUNDS WITH DECREASING Α-RECEPTOR AFFINITY
MEDICAL USE
OTHER USES
USES AND APPLICATIONS
CHEMISTRY AND NOMENCLATURE OF EPHEDRINE
CONTRAINDICATION AND ADVEISE EFFECTS OF EPHEDRINE
ADVERSE EFFECTS
OVERVIEW OF INDIAN PHARMACEUTICAL INDUSTRY
IMPORT DATA OF EPHEDRINE
EXPORT DATA OF EPHEDRINE
MARKET POSITION OF API (ACTIVE PHARME INGREDIENT)
INDIA API MARKET TRADE (%), FY 2016
SHARE OF INDIA IN GLOBAL API MARKET (%), FY 2016
SHARE OF INDIA IN GLOBAL API MARKET
INDIAN API DOMESTIC CONSUMPTION MARKET FUTURE OUTLOOK
INDIAN API DOMESTIC CONSUMPTION MARKET (BILLION US$),
FY 2015-FY 2022
MAJOR APIS IN THE INDIAN API MARKET
MAJOR APIS IN THE INDIAN API MARKET
DRIVERS
RISING HEALTHCARE EXPENDITURE
HEALTHCARE EXPENDITURE (US$ PER HEAD), 2012-2016
INCREASING DISPOSABLE INCOMES
PERSONAL DISPOSABLE INCOME (TRILLION US$), 2012-2016
GROWING GERIATRIC POPULATION
INDIAN POPULATION - 60 YEARS OR ABOVE (MILLION), 2015 & 2030
INCREASING INCIDENCES OF CHRONIC DISEASES
CARDIOVASCULAR DISEASES
DIABETES
INDIA - NUMBER OF PEOPLE WITH DIABETES (MILLION), 2015 & 2040
PATENT EXPIRY OF BLOCKBUSTER DRUGS
LIST OF BLOCKBUSTER DRUGS LOSING PATENT (2016-2022)
INCREASED CONSUMPTION OF GENERIC DRUGS
INVENTION OF NEW GENERATION OF APIS
CHALLENGES
OVER DEPENDENCE ON CHINA FOR IMPORTS
API IMPORT FROM CHINA (BILLION US$), FY 2012 TO FY 2015
THE REASONS FOR LOW MANUFACTURING COST OF API IN CHINA ARE:
GLOBAL MARKET POSITION OF EPHEDRINE
PROCESS OF MANUFACTURE
MANUFACTURING PROCESS:-
REACTION WITH ACTIVELY FERMENTING GLUCOSE SOLUTION:-
CONDENSATION WITH METHYLAMINE:-
REDUCTION TO PRODUCE 1-EPHEDRINE:-
CONVERSION TO EPHEDRINE HYDROCHLORIDE:-
PACKING AND FORWARDING:-
PROCESS FLOW SHEET FOR THE MANUFACTURE OF EPHEDRINE HYDROCHLORIDE (KETOL)
OTHER METHODS:
PREPARATION OF PROPIONYL CHLORIDE AND PROPIOPHENONE
EPHEDRONE [Α-METHYLAMINOETHYL PHENYL KETONE]
DL -EPHEDRINE HYDROCHLORIDE
SYNTHESIS
ANOTHER METHOD:
DL -EPHEDRINE HYDROCHLORIDE
METHOD FOR MANUFACTURING EPHEDRINE OR PSEUDOEPHEDURINE
METHYLAMINE SOLUTION PREPARING THESE SOLVENTS, THERE ARE
TWO WAYS:
MANUFACTURING PROCESS OF PS ENDS EPHEDRIVE HCL
THE PROCESSING STAGES ARE AS FOLLOWS:-
STAGE-1
STAGE-2
STAGE-3
STAGE-4
PROCESS FLOW DIAGRAM
INNOVATION TWO STAGE PROCESS FOR THE MANUFACTURE OF EPHEDRINE
STAGE 1
STAGE 2
EPHEDRINE AND ITS SALTS ISOLATION AND PROPERTIES
EXPERIMENTAL
EXTRACTION
PREPARATION OF EPHEDRINE HCL BY FRACTIONAL CRYSTALLIZATION
SEPARATION OF THE OXALATES BY DIFFERENCE OF SOLUBILITY
PREPARATION OF PURE EPHEDRINE BASE
PROPERTIES OF PURE EPHEDRINE
PSEUDOEPHEDRINE
ACTION OF HCL UPON EPHEDRINE. PREPARATION OF PSEUDOEPHEDRINE
THE MODELING AND 3D STRUCTURES OF EPHEDRINE HYDROCHLORIDE
RAMAN SPECTRUM OF EPHEDRINE HYDROCHLORIDE
PLANT LAYOUT
SUPPLIERS OF RAW MATERIALS
SUPPLIERS OF PLANT & MACHINERY
APPENDIX – A:
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)
