Detailed Project Report (DPR) on ephedrine

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)