1. The Pharmaceutical Industry
2. 6 Amino Penicillinic Acid
3. Ascorbic Acid (Vitamin-C) From Lemon
4. A S P I R I N
5. Dettol Like Antiseptic Lotion
6. Dextrose 5%
7. Glucose Saline
8. I.V. Fluid
9. Ibuprofen
10. Injectables For Pharmaceuticals
11. Liquid Glucose (Honey) From Potato (Mat Dextrose)
12. Paracetamol
13. Sorbitol
14. Tablets, Capsules, Syrups, Lotions Etc.
15. Trimethoprime
16. Directory Section    
A. Suppliers Of Plant And Machinery  
B. Suppliers Of Raw Materials

^ Top

INJECTABLES FOR PHARMACEUTICALS

INTRODUCTION

In 1865 Billroth for the first time reported that injections of contaminated stored distilled water produced fever in dogs. Later Burden -Sanderson in 1876 reported a fever-producing substance from putrefying meat and named it pyrogen. It is now well established that (1) many species of both gram +ve and gram -ve bacillus (bacteria) synthesized pyrogen, (2) Those produced by the gram negative bacteria are more potent and are known as endotoxins which are protein lipolysaccharides with molecular weights between 20000 and 30000 dilutions. Specific and potent effect of endotoxins is the ability to induce fever after parenteral administration that even a one thousand of microgram if given infravenously produces fever in rabbit which is the species used for the pharmacopial bioassay of pyrogen. Even when bacterias are killed during sterilization, those pyrogens which cause heat, strike resulting in fever in patients who adequately receive them parenterally. The pyrogen molecules are too big to be absorbed by the oral route and are therefore ineffective when taken orally.

Glass ampoules are special thin walled tubular glass containers to hold vaccines, serums and other medicated solutions, solvents etc. These may be obtained as either plain or the constricted type. The constricted style is preferred because of the greater satisfaction obtained by a physician when the solution is withdrawn by a syringe. The ampoule is broken at the point of constriction on the neck. This prevents the loss of solution, permits the use of a short needle and also the removal of all the solution.

Ampoules are manufactured from special thin walled glass tubes. Coloured ampoules especially the amber ones, are manufactured from amber coloured glass tubes. Several sizes and shapes of ampoules are required for different uses and trades. Most of these variable factors of size, shape etc. of ampoules have been standardized by the Indian Standard Institution in their specification No. 489-1254.

PARENTAL PRODUCTS (INJECTABLES)

In the chronicles of parenteral products, earlier some British and French surgeons began 'subcutaneous' administration in the mid-nineteenth century and by 1860 this mode of administration of drugs got established to a certain extent subsequently dawned the realisation that the injection ought to be free from the living microbes and suitable devices must be evolved to push the solution into the tissues. The last one hundred years have pushed ahead the knowledge of parenteral therapy in a big way so much so that on an average 25% of all drugs administered in the hospitals these days are in the injectable forms.

PROPERTIES & CHARACTERISTICS OF INJECTION (DISTILLED WATER)

Injections are sterile solution, emulsions or suspension packed in containers which will maintain sterility, and are intended for parenteral administration, or for use in radiography.

Official injections are classified in four distinct classes as follows (a) solutions of medicaments suitable for injection, (b) dry solids which, on addition of suitable solvents, yield solution conforming in all respects to the requirements for injection (c) solids which are suspended in a suitable fluid medium and which are not to be used for intravenous intrathecal, intracisternal or peridural injection, and (d) dry solids which on addition of the suitable vehicle, yield preparation conforming to the requirements for sterile suspension.

CHARACTERISTICS OF INJECTABLES

Injectables must possess the following characteristics:

1. Freedom from living microbes;
2. Freedom from microbial products viz. toxins, pyrogens etc;
3. Freedom from physical contaminants viz. particulate matter, fibres etc.; and
4. Matching synthetic qualities with respect to body fluids.

USES AND APPLICATION

Water for injection is generally used as the vehicle for aqueous injections.

BIS SPECIFICATION

IS	:	489 - 1973
		Part - I
		Glass ampoules for liquid injections.

IS	:	1070 - 1977
		Water for general laboratory use distilled water.
		For oxytocin injection no BIS is available.
		BUREAU OF INDIAN STANDARDS,
		9, B.S. Zafar Marg,
		New Delhi - 110 002.

MARKET SURVEY

India has witnessed phenomenal expansion in her pharmaceutical industry after the achievement of independence. This was as a result of economic planning and now our country is self-sufficient in medicines and medicinal equipment. Moreover, a bulk amount of medicines are being exported to a number of foreign countries. The importance of distilled water ampoules is very significant in the application of certain drugs into the body of a diseased person.

Distilled water is used along with powdered drugs which is to be emulsified prior to injection. Therefore, the market of distilled water ampoules is directly proportional to the production and comsumption of these drugs. The following data on pencillin and stryptomycin will indicate the growth and consumption of these medicines and thus the consumption of distilled water ampoules, because these drugs are the largest consumers of injection water ampoules.

Certainly, there have been sweeping changes in bulk drug exports. India is now perhaps the largest manufacturer in the world of drugs like ethambutol, methyldopa and ibuprofen. Indeed, Indian bulk drugs are eagerly sought after in Hamburg and London, principal centres of the global pharmaceutical trade, since they are marginally cheaper than other competing countries' products. This is partly because of the rupee's depreciation against other foreign currencies. Also many manufacturers have consciously tried to keep prices down in order to gain a foothold in new markets.

MANUFACTURERS

1.M/S. ANOCO PHARMACEUTICALS (INDIA) PVT. LTD.,

BRAHMAPURA, P.O. M.I.T,

MUZAFFARPUR - 842 003,

BIHAR.

2.M/S. GLINDIA LTD.,

DR. ANNIE BESANT ROAD,

WORLI,

MUMBAI - 400 025.

3.INDIAN NATIONAL DRUG COMPANY PRIVATE LTD.,

5/2, BELAGHATA MAIN ROAD,

CALCUTTA - 700 085. (W.B.)

MANUFACTURING PROCESS

Water for injection is prepared by a simple process called multiple stage evaporation. The raw water is first treated with Kmno4 solution in order to remove the odor and microorganism present in the water. Next comes the main step of the process distillation in 3 repeated times.

Distillation is a method of separation of substances which differ appreciably in their vapour pressures. There are various types of distillation methods using different equipments in the pharmaceutical industry. Fractional distillation is highly effective in the point of view of purity of the separated liquid. The raw water is heated in the reboiler to get vapourised. This vapour is condensed in a condenser and transfered to the reboiler of the next distillation unit. This repeated distillation makes highly pure water.

If saline water for injection is to be made required quantity of pure Nacl is added prior to filling and sealing in ampoules. Sodium chloride injection water contains 0.9% weight per volume of sodium chloride.

FILLING OF AMPOULES

As supplied by the manufacturer, ampoules for liquids are usually sealed to exclude dust, having previously been washed and dried. For use, the ampoule is filled above the neck and the sealed end broken off, care being taken to prevent glass spicules from falling inside. The length of neck remaining should be sufficient to provide adequate leverage when the completed ampoule is opened. Preliminary sterilization is not essential if the contents are to be subjected to a final heating process after sealing, but if the contents are thermolabile, the empty ampoules must be sterilized before filling them.

In order that the ampoules may be dry, it is best to sterilize them in a hot air oven, but if they are to be used for aqueous liquids, they can be sterilized by autoclaving provided that they are well drained. For small batches, filling is usually carried out under a screen using a syringe, while for slightly larger batches a burette fitted with a hypodermic needle covered by a hood can be used. The necks may then conveniently be sealed with a twin jet burner. On a large scale, of course, automatic filling, sealing, labelling, machines are employed.

PROCESS FLOW CHART

FLOW DIAGRAM FOR PREPARATION OF INJECTABLES

MANUFACTURING PROCESS FOR OXYTOCIN INJECTION (PITUITARY)

Mamolian Posterior lobe is collected and cleaned by washing with sterile water. Then put in the deep freezer for store. Now posterior lobe is put in the extraction tank. Extraction is started by ethyl alcohol or acid digestion methods. Extraction is continued at 600C-700C to 12 hours. After 12 hours of extraction check the extract, how much oxytocin is come out, in the extract. When maximum amount of oxytocin comes out indicates the extraction is completed.

Now the extract is diluted and filtered through the filter press to get clear transparent extract. Now pack it into ampules. Store it and sale in the market.

Production depends on the quality of the posterior lobe.

INJECTABLE FOR PHARMACEUTICALS

RATED PLANT CAPACITY	=	100.00 LITRES/DAY
	=	30000.00 LITRES/ANNUM
		INJECTABLE FOR PHARMACEUTICALS

LAND & BUILDING

1.	TOTAL LAND REQUIRED 550 SQ. YARDS	Rs.3,30,000.00
2.	BUILDING	Rs.5,80,000.00
	TOTAL	Rs.9,10,000.00

LIST OF PLANT & MACHINERY

1. 1. FOR DISTILLED WATER AMPOULES. DISTILLED WATER STILL CAP. 25.00 LTRS/HR.
2. DISTILLED WATER STORAGE TANKS MADE OF 16 GAUGE 18/8, AISA-316 S.S WELDED) EQUIPPED WITH GAUGE.
3. ULTRA VIOLET LAMP FOR TESTING PURPOSES.
4. AMPOULE WASHING MACHINE.
5. AMPOULE FILLING AND SEALING MACHINE
6. PACKING EQUIPMENT TO ARRANGE AMPOULES INTO PACKETS OF 50 EACH.
7. MISCELLANEOUS EQUIPMENTS INCLUDING LAB EQUIPMENTS.
8. SCREEN FILTERS MADE UP OF SINTERED GLASS/PORCELAIN/S.SS FOR CLARIFICATION PURPOSES.
9. AUTOCLAVE/HOT OVEN FOR STERILIZATION PURPOSES.
10. FILTER.
11. MISCELLANEOUS.
12. IN OXYTOCIN SECTION. EXTRACTOR OR S.S. GLASS LINED VESSEL
13. FILTRATION UNIT.
14. DEEP FREEZER.
15. STERILIZER (LIKE U.V. LIGHT LAMINATED AIR FLOW SECTION).
16. BABY BOILER 200 KG/HR STEAM PRODUCTION CAPACITY.
17. AIR CONDITIONERS.

TOTAL Rs. 7,16,000.00

FIXED CAPITAL

1.	LAND & BUILDING	Rs.9,10,000.00
2.	PLANT & MACHINERY	Rs.7,16,000.00
3.	OTHER FIXED ASSETS	Rs.1,95,000.00
	TOTAL	Rs.18,21,000.00

LIST OF RAW MATERIALS

1. FOR DISTILLED WATER AMPOULES. PORTABLE WATER 15,000 LITRES.
2. POTASSIUM PERMANGANATE 15 KG.
3. GLASS AMPOULES 3,75,000 NOS (5 ML).
4. GLASS AMPOULES 1,25,000 NOS (10 ML).
5. CARD BOARD CARTONS FOR AMPOULE PACKING 1000 CARTONS.
6. LIDOCAINE 180 GM. TERAMYCIN AMPOULES AND VIALS.
7. GLASS AMPOULES 2 ML 25,000 NOS.
8. GLASS VIALS (10 ML). 12,500 NOS.
9. GLASS VIAL (30 ML). 6,250 NOS.
10. PACKAGING MATERIAL VIZ. CARDBOARD CARTON ETC.
11. MISCELLANEOUS.
12. AMPICILLIN DRY POWDER 500 MG. 125.00 GM
13. GLASS VIAL 5000 NOS.
14. MISCELLANEOUS.
15. EYE DROPS (FOR BETNESOL-N EYE DROPS) (3 ML). BETAMETHASONE SODIUM PHOSPHATE 75 GM.
16. NEOMYCIN SULPHATE. 375 GM.
17. GLASS EYE DROPS VIALS. 25,000 NOS (3 ML).
18. MISCELLANEOUS.
19. FOR SULPHACETAMINE EYE DROPS (20% 10 ML). SULPHACETAMINE 50 KG.
20. GLASS EYE DROPS VIALS 25,000 NOS (10 ML).
21. MISCELLANEOUS.
22. IN OXYTOCIN SECTION (PITUITARY INJECTION) POSTERIOR LOBE 12 KG.
23. ETHYL ALCOHOL 57 LTRS.
24. ACETONE 22 LTRS.
25. LDO 66 LTRS.
26. FILTER AIDS.
27. AMPOULES 25000 NOS (1 ML).
28. MISCELLANEOUS.
29. FOR VETENARY USE. POSTERIOR PITUITARY USE 24 KG.
30. ETHYL ALCOHOL 114 LTRS.
31. ACETONE 44 LTRS.
32. LDO 132 LTRS.
33. FILTER AIDS.
34. AMPOULES 50,000 NOS (1 ML)
35. MISCELLANEOUS.

TOTAL Rs. 1,62,124.50

WORKING CAPITAL REQUIREMENT/MONTH

TOTAL

1.	RAW MATERIAL	Rs.1,62,124.50
2.	SALARY & WAGES	Rs.93,750.00
3.	UTILITIES & OVERHEADS	Rs.91,500.00
Rs.3,47,374.50

TOTAL CAPITAL INVESTMENT

TOTAL FIXED CAPITAL	Rs.18,21,000.00
TOTAL WORKING CAPITAL FOR 3 MONTHS	Rs.10,42,123.50
TOTAL	Rs.28,63,123.50

TURN OVER/ANNUM

1. 30,000 NOS VIELS AMPICILLIN DRY POWDER (250 MG).
2. 30,000 NOS VIELS AMPICILLIN DRY POWDER (500 MG).
3. 3,00,000 NOS BETNESOL-N EYE DROP (3 ML).
4. 3,00,000 NOS SULPHACETAMIDA 20% EYE DROP (10 ML).
5. 3,00,000 NOS AMPOULES (1 ML) OXYTOCIN (HUMAN USE).
6. 6,00,000 NOS AMPOULES (1 ML). OXYTOCIN (VETENARY USE).

TOTAL Rs. 57,22,500.00

PROFIT	=	RECEIPTS - COST OF PRODUCTION
	=	57,22,500.00 - 47,77,693.76
	=	9,44,806.24
PROFIT SALES RATIO	=	Profit/Sales x 100
	=	16.51 %
RATE OF RETURN	=	Operating profit / T.C.I x 100
	=	33.00 %
BREAK EVEN POINT	=	61.33 %

For Comprehensive and exhaustive informations on

"INJECTABLES FOR PHARMACEUTICALS",

"MARKET SURVEY CUM DETAILED TECHNO ECONOMIC FEASIBILITTY REPORT" is available with NIIR.

National institute of industrial Research

106-E, Kamla Nagar, P.B. No. 2162, Delhi - 110 007 (INDIA)

PHONES: 23843955, 23845654, 23845886, (Mob.) 9811043595

FAX: 91-11-23841561 E-MAIL: niir@vsnl.com

WEBSITE: http://www.niir.org

^ Top