PHARMACEUTICAL UNIT

(TABLET, CAPSULES, SYRUPS, OINTMENTS,

LOTION, NEBULIZER)
[EIRI/EDPR/3929] J.C.: 2051

INTRODUCTION

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.
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. 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.

Many dynamic scientific, social and economic factors affect the pharmaceutical
industry. Some pharmaceutical companies operate in both national and
multinational markets. Therefore, their activities are subject to legislation, regulation
and policies relating to drug development and approval, manufacturing and quality
control, marketing and sales (Spilker 1994).

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Academic, government and industry scientists, practising physicians and
pharmacists, as well as the public, influence the pharmaceutical industry. Health
care providers (e.g., physicians, dentists, nurses, pharmacists and veterinarians) in
hospitals, clinics, pharmacies and private practice may prescribe drugs or
recommend how they should be dispensed. Government regulations and health care
policies on pharmaceuticals are influenced by the public, advocacy groups and
private interests. These complex factors interact to influence the discovery and
development, manufacturing, marketing and sales of drugs.

The pharmaceutical industry is largely driven by scientific discovery and

development, in conjunction with toxicological and clinical experience (see figure
below). Major differences exist between large organizations which engage in a broad
range of drug discovery and development, manufacturing and quality control,
marketing and sales and smaller organizations which focus on a specific aspect.
Most multinational pharmaceutical companies are involved in all these activities;
however, they may specialize in one aspect based upon local market factors.
Academic, public and private organizations perform scientific research to discover
and develop new drugs. The biotechnology industry is becoming a major contributor
to innovative pharmaceutical research. Often, collaborative agreements between
research organizations and large pharmaceutical companies are formed to explore
the potential of new drug substances.

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Drug development in the pharmaceutical industry

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 CONTENTS

INTRODUCTION
DRUG DEVELOPMENT IN THE PHARMACEUTICAL INDUSTRY
PROJECT LOCATION
CLIMATE
MAP
TRANSPORTATION
BUS
RAIL
AUTO-RICKSHAW
TAXI/CAB
AIR
MAJOR CATEGORIES OF PHARMACEUTICAL AGENTS
MARKET POSITION
PHARMA SEGMENTS
COMPETITIVE LANDSCAPE
PHARMACEUTICAL MARKET RESTRAINTS AND DRIVERS
THE CHANGING GEOGRAPHY OF PHARMA MARKETS
KEY SEGMENTS IN THE PHARMACEUTICAL MARKET
COMPETITIVE LANDSCAPE & TOP PHARMACEUTICAL COMPANIES
IN THE OVERALL MARKET, TOP PHARMACEUTICAL COMPANIES INCLUDE:
INDUSTRY DEVELOPMENTS:
MARKET SIZE
INVESTMENTS
GOVERNMENT INITIATIVES
ROAD AHEAD
INCREASING INVESTMENTS IN THE SECTOR
DETAILED EXPORT DATA OF PHARMA PRODUCT PHARMACEUTICAL
REQUIREMENT FOR WHO/FDA APPROVAL
GOOD PRACTICES FOR DRUG MANUFACTURING
EU REGULATIONS
US REGULATIONS
OTHER COUNTRIES
SANITATION AND HYGIENE GMPS

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PERSONNEL
PERSONAL HYGIENE
PREMISES
EQUIPMENT
MATERIALS
WASTE DISPOSAL
STANDARD OPERATING PROCEDURES AND RECORDS:
GOOD PRODUCTION PRACTICES
MANUFACTURER OF PHARMACEUTICAL PRODUCTS
FORMULATIONS OF TABLETS
TABLETS:
1. TABLETS FOR FATIGUE & GENERAL TONIC
2. ANTI ASTHMATIC:-
3. COLCHICINE TABLETS
4. TABLETS FOR INFLUENZA AND COMMON COLD:-
5. ANTI ALLERGIC TABLETS :
6. MULTI VITAMIN TABLETS, 500 MG EACH TABLET CONTAINS
7. ENTERO VIOFORM TABLETS:
8. TABLETS FOR COMMON COLD:
9. TABLETS FOR MENOAPUSE SYNDROMS:
10. STIMULATING TABLETS:
11. ANACIN TABLETS:
12. IRON TABLETS:
13. CAPSULES:
MULTI VITAMIN CAPSULES:-
14. ANTI INFLAMMATORY ANTIPYRETIC AND ANALYGERIC:
15. BROAD SPECTRUM ANIT-BIOTIC CASPULES:
16. IRON WITH VITAMIN CAPSULES:-
17. ANTI ANNEMIA CAPSULES:
18. CHLORAMPHENICOL CAPSULES:
19. HEAMATINIC CAPSULES:-
20. UROBIOTIC CAPSULES:
INJECTIONS FORMULATIONS
TERRAMYCIN 1 M :-
AMPICILLIN INJECTION :-
SULPHACETAMIDE EYE-DROP :-
SULPHACETAMIDE EYE-DROP EACH ML CONTAINS:-
BETENSOL-N-EYE/EAR DROPS CONTAINS:-

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SALIENT FEATURES OF FORMULATIONS OF DPHTHALMIC PREPARATIONS:-
OXYTOCIN INJECTION:-
OXYTOCIN -B VETC :-
MANUFACTURING PROCESS OF INJECTIONS
FILLING OF AMPOULES
FORMULATIONS OF SYRUPS
SYRUPS:
ANTI ALLERGIC COUGH SYRUP:
EDIATRIC SYRUP OF PARACETAMOL:
VICKS FORMULA 44 COUGH MIXTURE
PARACETAMOL - VITAMINIC SYRUP
MULTIVITIMAN SYRUP
COUGH SYRUP
LIQUIDS:
1. GENERAL TONIC (MULTI VITAMIN)
2. SODIUM GLYCEROPHOSPHATE
3. VITAMIN B COMPLEX WITH DIGESTIVE ENZYMES:
TONIC LIQUID:
PALATABLE POTASSIUM SUPPLEMENT:
LOTION:
1. EYE LOTION:
2. SKIN LOTION (FOR SPOT & PIMPLES)
3. ANTI ALLERGIC LOTION (CALAMINE LOTION)
PASTES:-
TERRAMYCIN DENTAL PASTE:
BEPARINE CREAM:
ANTISEPTIC CREAM:
ANTI FUNGAL SKIN OINTMENT:
BURNOL OINTMENT:
FORMULATION OF OINTMENT BASES:
WASHABLE OINTMENT BASE (USED AS SCALP OINTMENT BASE)
GREASE LESS BASE: (USED IN MAKING SKIN OINTMENT)
MANUFACTURING PROCESS (TABLETS)
BASIC MANUFACTURING PROCESS IN THE PHARMACEUTICAL INDUSTRY
FERMENTATION
DIAGRAM OF A FERMENTATION PROCESS
SOLVENTS USED IN THE PHARMACEUTICAL INDUSTRY
CHEMICAL SYNTHESIS

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DIAGRAM OF AN ORGANIC SYNTHESIS PROCESS
DIAGRAM OF A CHEMICAL REACTOR IN ORGANIC SYNTHESIS
EXAMPLES OF STEROIDAL AND NON-STEROIDAL OESTROGEN STRUCTURE
TYPICAL ORAL CONTRACEPTIVE TABLET MANUFACTURING PROCESS FLOW
PHARMACEUTICAL MANUFACTURING OF DOSAGE-FORM PRODUCTS
WORK & SAFETY AT SITES
FERMENTATION PROCESS
CHEMICAL SYNTHESIS
BIOLOGICAL AND NATURAL EXTRACTION
PHARMACEUTICAL MANUFACTURING OF DOSAGE-FORM PRODUCTS
PHARMACEUTICAL UNIT OPERATIONS
WEIGHING AND DISPENSING
CHARGING AND DISCHARGING SOLIDS AND LIQUIDS
LIQUID SEPARATIONS
TRANSFERRING LIQUIDS
FILTRATION
A SPARKLER FILTER
COMPOUNDING
GRANULATION
A HIGH STEAM GRANULATOR
DRYING
A ROTARY VACUUM DRYER
A VACUUM SHELF DRYER
MILLING
BLENDING
COMPRESSION
SOLID DOSAGE-FORM MANUFACTURING
TABLET PRESS WITH LOAD HOPPER AND SPIRAL DUST PICKUPS
FOR PRODUCT RECOVERY
A TABLET COATING MACHINE
DIAGRAM OF A STERILE LIQUID MANUFACTURING FACILITY
CAPSULE & TABLETS
CAPSULE
LARGE CAPSULE
AVERAGE SIZE CAPSULES
SMALL CAPSULES
CAPSULE SIZE AND FILL WEIGHT
CAPSULE SIZE CHART

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TABLETS
PROPERTIES OF TABLETS:
ADVANTAGES OF TABLET:
DISADVANTAGES OF TABLETS:
THE VARIOUS TABLET TYPES ARE DESCRIBED AS FOLLOWS:
COMPRESSED TABLETS
SUGAR-COATED TABLETS
FILM-COATED TABLETS
EFFERVESCENT TABLETS
ENTERIC-COATED TABLETS
CHEWABLE TABLETS
BUCCAL AND SUBLINGUAL TABLETS
LOZENGES OR TROCHES
TABLET TRITURATES
HYPODERMIC TABLETS
DISPENSING TABLETS
GELATIN-COATED TABLETS
MULTIPLE COMPRESSED TABLETS/ MULTI-COMPRESSED TABLETS
COMPRESSION COATED TABLETS
LAYERED TABLETS
INLAY TABLETS
FLOW DIAGRAM OF TABLET MAKING PLANT
MANUFACTURE OF LIQUIDS (SYRUP)
FILTERATION:
BOTTLING:
FLOW DIAGRAM OF MIXING PLANT
CAPSULE FILLING SEALING
FILLING:
SEALING AND LOCKING:
FLOW DIAGRAM OF CAPSULE MAKING PLANT
MANUFACTURE OF LOTION
FLOW DIAGRAM OF LOTION MAKING PLANT
OINTMENT AND PASTE MAKING
FORMULATION:
MELTING:
MIXING:-
FILLING:
FLOW DIAGRAM FOR PASTE & OINTMENT MAKING

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ASSEMBLY OF A NEBULIZER
A NEBULIZER, COMPRISING:
PHARMACEUTICAL LABELING
TYPES OF LABEL
LEGAL REQUIRMENTS OF A MANUFACTURER LABEL
NAME OF THE PREPARATION
BRAND NAME:
STRENGTH
SPECIFICATION
DOSAGE FORM
QUANTITY
INSTRUCTIONS
DO NOT SHAKE THE PATIENT; SHAKE THE BOTTLE WELL BEFORE USE.
PRECAUTIONS
STORAGE CONDITIONS STORE IN A COOL PLACE:
PROTECT FROM LIGHT:
KEEP OUT OF THE REACH OF CHILDREN
FOR EXTERNAL USE ONLY:
INFLAMMABLE:
NOT TO BE TAKEN:
TYPES OF WARNINGS
REGISTRATION NUMBER
BATCH NUMBER
MANUFACTURING DATE
EXPIRY DATE
LICENSE NUMBER
MANUFACTURER INFORMATION
PRICE
BARCODES
DISPENSING LABEL
SUPPLIERS OF PHARMACEUTICAL PLANTS MACHINERY
SUPPLIERS OF RAW MATERIALS
SUPPLIERS OF GELATINE
SUPPLIERS OF FOOD COLOURS
SUPPLIERS OF SODIUM SULPHATE
SUPPLIERS OF PINE OIL
SUPPLIERS OF GLYCERINE
SUPPLIERS OF CAUSTIC SODA

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SUPPLIERS OF METHYLATED SPIRIT
SUPPLIERS OF ASPIRIN
SUPPLIERS OF PARACETAMOL TABLETS (PCM)
SUPPLIERS OF PAPAIN POWDER
SUPPLIERS OF VITAMIN
SUPPLIERS OF THYMOL
MACHINERY PHOTOGRAPHS
OINMENT MANUFACTURING LINE
PRODUCT PHOTOGRAPHS
COMPRESSED TABLETS
SUGAR-COATED TABLETS
FILM-COATED TABLETS
EFFERVESCENT TABLETS
ENTERIC-COATED TABLETS
CHEWABLE TABLETS
BUCCAL AND SUBLINGUAL TABLETS
LOZENGES OR TROCHES
HYPODERMIC TABLETS
GELATIN-COATED TABLETS
COMPRESSION COATED TABLETS
LAYERED TABLETS
INLAY TABLETS

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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)

COST ESTIMATION

Plant Capacity 25,72,000 Nos/Day

Land & Building (5000 sq.mt.) Rs. 4.79 Cr
Plant & Machinery Rs. 20 Cr
Working Capital for 1 Month Rs. 26.69 Cr
Total Capital Investment Rs. 55.02 Cr
Rate of Return 64%
Break Even Point 30%

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