1.

INTRODUCTION

1.1 History:-
Medicamen Biotech Ltd is a widely held public limited Indian company
and one of the leading pharmaceutical formulation company providing
best quality medicines at a low cost both to domestic and international
market. We are committed to produce and provide wide of best quality
medicines both generic and branded at a cheaper price.
Medicamen was initiated in Dec. 1993 as a distributor and trader of
medicines manufacturing on loan license basis. The distribution activities
were spread manifold over a wide market expending beyond the domestic
market musty CIS countries The wide distribution network with demand
for low cost medicines prompted the promoters to go for own production
of medicine.
The liberalized industrial policy of the Indian government has also
encouraged the promoter towards manufacturing. As a consequence
medicament commissioned its state of the art ultra modern
pharmaceutical manufacturing plant at the industrial area of Bhiwadi.

1.2 Location:-
Medicamen Biotech Ltd. is situated near Jaipur – Delhi highway at
Bhiwadi, Alwar. It just 90 km away from Alwar head quarter North side
at Alwar and just 60 km away from international airport of Delhi.
The corporate office of the company is located at the heart of Delhi where
the relationship/ interface & corporate activities such as marketing,
purchases, finance, and other activities are controlled. The only
manufacturing facility of the company at Bhiwadi is constructed on a
sprawling 2, 10,000 Sq. ft land with constructed area of 90,000 Sq. ft.
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The manufacturing facility is divided into different block for Smooth
Functioning and to comply with the international norms: It has Beta-
Lactum, Non Beta- Lactum Block, ORS Block, Utilities Block and store
and quality control block.

1.3 Status of company:-

ISO 9001:2000 Certification:-
Medicamen recognizes quality to be the prime driver in pharmaceutical
industry and committed to adhere to international standards. The
company was granted ISO 9001:2000 with improved version valid till 12
June 2006.

WHO GMP:-
Medicamen has recognized the importance of WHO-GMP certification
for manufacturing medicines for export market and complied with
its requirement and obtained the certification on 19-11-1998 which
has been subsequently renewed after every two years. Beside WHO
GMP the company has faced a number of inspections from various
international agencies and by implementing the observation of these
agencies; medicamen has acquired distinction amongst the
companies of its size. To name, medicamen’s plant is approved in
Brazil, Uganda, Zimbabwe, Nigeria, Ghana, Yemen and Tanzania.

Membership:-
It has always been the policy of the company to have membership of
leading associations/organizations to have active interface with the
industry vis a vis government policies and the active legal and technical

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environment. Currently medicamen is the active member of the following
association/organizations
• Confederation of Indian industry
• Federation of Indian chambers of commerce and industry
• Indian drug manufactures associations
• Federation of Indian export organizations
• CHEMEXIL
• PHARMMAXIL
• Indian trade promotion organization
• Indian institute of management studies
• Rajasthan pharmaceutical manufactures association
• Bhiwadi manufactures association
• Sh. B.K. Gupta, managing director is active member in various
specialized comities of FICCI, such as biotechnology committee,
taxation committee etc.

Export market:-
Medicamen had a mere turnover of Rs. 3 crores during 1996-97 but now
it is about to touch Rs. 50 crores with the constant growth in export
market. The company has grown from strength to strength and has the
distinction of getting “IRYAT SHREE” gold trophy from the ministry of
commerce, Govt. of India for 2 consecutive year of excellence in export
performance.

Joint Venture with Pharmadanica, Denmark:-

To strengthen its overseas operation Medicamen had entered into
strategic joint venture with Pharmadanica, Denmark in November 2002.
Our partners have the active marketing & logistic operation in 75
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countries throughout the world. They have participated both in equity
shares of the company and provide soft loan. The co-operation is going
on very well and we are working full-fledged in developing new products
and fixed dose packs for anti-malarial, anti-TB and HIV products for the
world market. We are targeting WHO Geneva approval in the near future
followed by approval in UK MHRA. European registration and then
finally US-FDA. The company is planning to be a major player in
generics in international market with the help of its partners.

Domestic Marketing:-
The domestic ethical marketing was introduced during the year 2001 but
was at very nascent stage, but keeping in view the importance of ethical
business. The company has taken vigorous steps to penetrate into ethical
market. The company has appointed franchises throughout India and the
ethical market is slowly and steadily in the growth path.
Currently the company has a range of around 40 branded products in the
market and has established its network in the status of Delhi, Rajasthan,
Uttar Pradesh, Bihar, west Bengal, Orissa, Andhra Pradesh, Tamilnadu,
Kerala, Maharashtra, and J. & K., and is now in the process of covering
remaining territories.
Medicament also has a formalized under-license manufacturing
arrangement with its partner, Pharmadanica A/S Denmark to promote to
ethical market. The response from the market for the product range
packaging standard has been very encouraging.

Institutional Marketing:-
Institutional marketing has been one of the core business areas of the
company since inception. By virtue of its long list of WHO COPP

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approval, respectable turnover, market standing of large range of
products, the institutional business has been growing substantially every
year. The company has been participating in almost all national level
tenders and selected state level tenders.

Contract Manufacturing:-
For the better utilization of idle manufacturing facilities the company has
initiated contract manufacturing for come reputed pharmaceutical
companies in India. The company is currently contract manufacturing for
M/S Torrent Pharma Ltd and M/S Menarini Rounaq Pharma Ltd.
(affiliated to M/S A. Menarini,Italy). It was also contract manufacturing
some reputed brand of M/S Ranbaxy Laboratory Ltd. For more than six
years.

New Ventures:-
The company has an ambitious plan to establish a new formulation unit in
tax free zone to support its domestic business and the plant is likely to
come up in the financial year 2008-2009.

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 2. FACTORY PREMISIS (SCHEDULE ‘M’)

2.1 Requirements of Factory Premises:-

(A) Location and surroundings: - The Factory shall be situated in a

place which shall not be adjacent to on open sewage, drain, public lavatory
or any factory which produces a disagreeable of obnoxious odor or fumes
or large quantities of soot, dust or smoke. The factory shall be located in
sanitary place, remote from filthy surroundings.

(B) Buildings: - The buildings used for the factory shall be

consummated so as to permit of production under hygienic conditions. The
walls of the room in which manufacturing operations are carried out shall,
up to a height of six feet from the floor, be smooth, water-proof and must be
capable of being kept clean. The flooring shall be smooth, even and
washable and shall be such as not to permit of retention or accumulation of
dust.

(C) Water Supply: - The water used in manufacturing shall be pure

and of drinkable quality, free from pathogenic micro-organisms.

(D) Disposal of waste: - Waste water and other residues from the
laboratory which might be prejudicial to the workers or to public health
shall be disposed of after suitable treatment to render them harmless.
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(E) Health, clothing and sanitary requirement of the staff: - All
workers shall free from contagious or obnoxious disease. Their clothing
shall consist of a white or coloured uniform suitable to the nature of work
and the climate, and shall be clean.. Adequate facilities for personal
cleanliness, such as clean towels, soap and hand scrubbing brushes shall be
provided separately for each section.

(F) Medical services: - The manufacturing shall provide :

1. Adequate facilities for the first aid.
2. Medical inspection of the workers.
3. Facilities for vaccination and inoculation against the enteric or any
other epidemic group of diseases.
4. Adequate precautions for safeguarding the head of the workers.

(G) Working benches: - shall be provided for the carrying out

operations such as filling, labeling, packing etc.

(H) In factories where operations involving the use of containers, such

as bottles, vials, jars ampoules, are conducted, there shall be adequate
arrangements separated from the manufacturing operations for washing,
cleaning and drying such containers with suitable equipment for the
purpose . Sterilizing facilities where necessary should also be provided.

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 2.2 Requirements of Plant and Equipments:-

(A) The following equipment’s are recommended for the manufacture

of syrups, elixirs and solutions:-
1. Mixing and storage tanks
2. Portable mixer
3. Filter press or other suitable filtering equipment, such as meta filter
or sparkled filter
4. Vacuum or gravity filter

5. Water still or Deionizer

An area of 30 square meters is recommended for the basis
installations.

(B) Equipment for the manufacture of pills and compressed tablets

including hypodermic tablets:-
For operations the tablet production department shall be divided into
three distinct and separate sections:
(a) Granulating section
(b) Tableting section
(c) Coating section

The following equipments are recommended in each of the three sections.

(a) Granulating section:-
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1. Disintegrator
2. Powder mixer
3. Mass mixer
4. Granulator
5. Ovens, thermostatically controlled

(b) Tableting section:-

1. Tablet machine, single punch or rotary
2. Pill machine
3. Punch and dies storage cabinet
4. Tablet counter

(c) Coating section:-

1. Jacked kettle, steam, gas or electrically heated for preparing solution

2. Coating pan
3. Polishing pan

(d) The following equipment’s are recommended for filling of hard

gelatin Capsules:-

1. Mixing and blending equipment.

2. Capsule counters.

3.3 Manufacturing Area:-

1. Storage equipment for container
2. Water still

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 3. Mixing and preparation tanks or other containers
4. Filtering equipment such as filter process or sintered glass funnel
5. Autoclave
6. Hot air sterilizer
7. Benches for filling and sealing
8. Filling and sealing unit
9. Bacteriological filters such as seitz filter candles or sintered glass
filters.
10. Filling and sealing unit
11. Inspection table
12.Leak testing equipment
13.Labeling and packing benches

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 3. BETA - LACTUM BLOCK

3.1 Production Section:-

The term good manufacturing practices (GMP). I will understand, however
people having good theoretical knowledge of pharmaceutical principle and
adequate relevant experience in manufacturing generally compliance to
GMP.
In medicament biotech specially observed in appreciated the following
general aspect are
1. All equipment are utilized are of standard qualification.
The manufacturing process are regularly reviewed and revalidated.
2. Efficient clinic system and transfer from shift to shift use.
3. Equipments are arranged regularly.

There are four sections in production in beta - lactum block:

1. Tablet section
2. Dry syrup section
3. Syrup section

3.1.1 Tablet Section:-

• Tablet Production Area:-
1. Fabrication area
2. Compression area
3. acking area

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• Equipment available in fabrication area:-
 Electronic balance
 Mechanical sifter
 Double cone blender

• Machine available in compression area:-

 Double side rotatory tablet compression machine

• Machine available in packing area:-

 Strip packing machine
 Blister packing machine
 Tablet counter machine

• Mechanical sifter:-
In this moment is used to separate different fraction fraction at particular
size by using sieves of different no. (Siever no.
0,12,14,16,18,20,22,24,30,40,60,80,100,120.)

• Multi mill granulator:-

In has eight curser in diameter, which crushes the lump, formed during
mixing. Its motion is oscillating type and out come is 22 kg per hour.
Screen no. used in multimill. (Screen no. 2mm,2.5mm, 3.0mm, 3.5mm.)

12
 • Double cone blender:-

Figure 1: Double cone blender

Double cone blender is an electrically operated double cone shaped pan

rotating around its central axis. It is used for blending of screened granules
with lubricants and disintegrates.
Filling capacity of double cone blender = 250 kg,
Rotating speed = 10 rpm,
Motor Horse power = 5 H.P

3.1.2 Dry Syrup Section:-.

Dry syrup production area:-
1. Fabrication
2. Dry Syrup filling/sealing area
3. Labeling or final packing area

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• Fabrication area available equipment:-
 Shifter
 Multimill granulator
 Double cone blender

• Dry syrup filling/ sealing area available machine:-

 Dry syrup bottle cleaning machine
 Dry syrup filling machine
 Bottle sealing machine

• Dry syrup packing area available machine:-

 Semi automatic labeling machine.

• Dry Syrup filling machine:-

Semi automatic dry syrup filling machine capacity = 60 bottle/min.
Dry syrup powder filling capacity =1gm – 40 gm/bottle

3.1.3 Liquid Section:-

• Liquid section is divided in different area:-

 Fabrication Area
 Formulation area
 Bottle washing/ drying area
 Liquid filling/sealing area
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 Packing area

• Fabrication area available equipment:-

 Shifter
 Multi mill
 Double cone blender

• Formulation area available equipment:-

 Heating SS tank
 Manufacturing SS tank
 Collided mill
 Liquid transfer pump
 Bottle washing/drying machine

• Liquid filling/sealing area available machine:-

 Eight head liquid filling machine
 Cap holding/ cap sealing machine
 Induction cap sealing machine

• Packing area available machine:-

 Semi automatic labeling machine

Heating SS tank:-
There tank that are using for storing of prepared liquid in constant temp is
capacity is 1000 liter.
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Manufacturing tank:-
There is a 1600 liter capacity syrup preparation tank.

Colloidal mill:-

Figure 3: Colloidal Mill

This is used for particle size reduction.

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 4. NON - BETA - LACTUM BLOCK

Non-beta lactum block are two type of dosage form are manufacture.

Solid dosage form Liquid dosage form

Tablet Capsule Dry Syrup Suspension Syrup

4.1 Production of Solid Dosage Form:-

4.1.1 Tablet Section:-
Fabrication area
 Compression area
 Coating area
 Packing area

• Tablet compression area available machine:-

 Onside rotatory machine 16 station
 Double side rotatory machine 20,35,45 station

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Tablet coating area available equipment:-
 Coating Pan
 Solution manufacturing tank
 Polishing Pan

Tablet packing area:-

 Blister packing machine
 Strip packaging machine

Fabrication Area Machine:-

Fluidized Bed Dryer (FBD):-
This dryer provides more efficient drying than hot air oven – it consist of
two ports, one is movable port in which granules to be dried are placed and
covering part has a material holding cloth and a sanction above the cloth.
After the attaching both portions hot and pressurizes air up lifts the granules
and dried efficiently. The sanction take out the humid airs which by passing
through heating coils re circulated.

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 Figure 4: Fluidized Bed Dryer

RMG (Rapid Mass Granulator):-

This mixer provides more efficient granule than planetary mixer.
Capacity the mixing material : 250 kg.
Rotating speed : 1428-2856 rpm.
Rotating speed in granulator : 50-60 rpm.
Motor power : 50 H.P. in mixer motor.

Tablet Compression Machine (number of machine 4):-

Tablets are made by compressing a formulation containing a drug or drug
with excipient on stamping machine called presses.
1. One side rotatory machine
2. Double side rotatory machine

Table 3: Comparison of Machines.

One side double side

rotatory machine rotator Machine
No. of station 16 20,35,45
Type of tolling 1 2
Max.operating 10 tones 6.5 tones
Pressure.
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 Die size 8mm-12.5 mm 8m-12.5 mm

Coating pan:-
The standard coating pan system consist of a circular matter pan mounted
some what angularity on a stand. There are five coating pan in this block
consisting a Aquarius shaped steel body that is used for sugar and film
coating, enteric coating. It consisting of a air pipe through which hot air
comes for drying for coating material filling capacity of each pan is 12kg, 40
kg, 60kg, for film coating 25 kg for sugar coating. This pan rotates on three
speeds in a slightly titled position.

Filling capacity:-
1. Small pan 12kg
2. Medium pan 40kg
3. Large pan 60kg

Figure 5: Coating Pan

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Type of coating:-
1. Sugar coating
2. Filling coating
3. Enteric coating

Polishing Pan:-
It is cylindrically shaped pan having an inner lining of wax and slightly
rough cloth and is used for polishing of coating material. It rotates in a
slightly inclined position at a speed 20rpm. Its filing capacity is 20 kg.

Process Adopted for Tableting:-

Tablet manufacturing process involves following steps:-
1. Preparation of granules for compression , it include
(a) weighing the ingredients
(b) mixing the powdered ingredients and excipients
(c) Converting the mixed ingredients into granules.
2. Compression of granule into tablet
3. Coating of tablets

Preparation of Granules:-
(a) Weighing of the ingredients:-
The appropriate quantities of raw material are weighed using a balance of
high quality.
(b) Mixing of the powdered ingredients and excipients:-

21
Appropriate quantities of raw material mixed in a mass mixer in accordance
with GMP for blending of free flowing material with components of uniform
size and density.
(c) Converting the mixed ingredient into granules:-Granulating agent is
added in a mixed material; generally starch past is added to form a raw
material appropriate for granulation. Two method are used for granulation
1. Wet granulation: Dumped mass formed by mixing of drug material with
liquid placed in material for making granules which than dried in tray dryer
or fluidized bed dryer. Their dried granules are than screened by shifter.
2. Dry granulation: For dry granulation evaporating solutions are used
mixing of raw material is than placed into the roll compactor, through which
we get slug which than crushed and screened by shifter.

Compression of granules into tablet:-

Granules obtained from shifter are blended with lubricants and disintegration
agent in double cone blender. This blended material transferred into the
hopped of the tablet compression machine, which passes into dies through
bed shoe where this granule are compressed between upper and lower
punches and then collected in a double line drum.

4.2 Production of Liquid Section:-

• Liquid section is divided in different area
 Bottle washing area / drying area
 Fabrication area ( formulation chamber)
 Liquid filling / sealing area
 Labeling /packing area
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• Formulation area available equipment:-
 Heating S.S. tank

 Mixing S.S. tank

 Manufacturing S.S. tank

 Liquid transfer pump

 Colloidal mill

• Filling area available machine:-

 Liquid four head filling machine
 Baby liquid filling machine
 Sealing machine
• Packaging area:- Automatic labeling machine

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 5. INPROCESS QUALITY CONTROL TEST

5.1 Tablet:-
(1) Hardness (Limit N.M.T 1.0%):-
Tablets require a certain amount of strength, or hardness to withstand
mechanical shocks of handling in manufacturer, packaging and shipping. In
addition, tablets should be able to withstand reasonable abuse when in the
hands of consumer.
The following devices are commonly used by analyst to find out the
hardness of tablet.
Monsanto Hardness Tester:-
The

Monsanto chemical company limited had designed spring, pressure device to

test the hardness a tablet. It has a graduated scale which gives the reading in
Kg/sq Cm
Pfizer Tablet Hardness Tester:-
It is bases on the principle of ordinary pliers. Pfizer tablet hardness tester is
a pliers fitted with a pressure dial.

(2) Friability (Limit NMT 1.0%):-

24
The crushing strength test may not be the best measure of potential tablet
behavior during handling packaging.

Figure 9: Friability Apparatus

(3) Weight Variation:-

A tablet must contain a proper amount of drug, for testing weight
variation a sample of 20 tablets. Taken hourly and random weighted on
electronic and physical balance. The tablet must having acceptable
average weight.

Table 9: Limits for weight Variation as per IP’85

AVERAGE WEIGHT PERCENT
OF TABLET AGE
DEVIATI
ON
1. 80 Mg or less 10%
2. More than 80 Mg and 7.5%
less than 250 Mg
3. 250 Mg or more 5%

25
(4) Thickness and diameter of tablet:-
Instrument Use - Vernier caliper scale

(5) Disintegration time:-

This is time in which breakdown of tablet in GIT occurs. To test D.T.
there is disintegration test apparatus is used that is stated as per
pharmacopoeia. A starch past is employed as disintegration agent which
may standards for D.T.

D.T. of various type tablets:-

 D.T. for uncoated tablet = 15 minute

D.T. for coated tablet:-

 Film coated = 30 minute
 Other coated = 60 minute

D.T. for enteric coated tablet:-

 No sign of disintegration in 0.1 N HCL for 2 hour and disintegrate in
phosphate buffer pH 6.8 in 1 hour.
 D.T. for soluble tablet = 3minute
 D.T. for effervescent tablet = 5 minute

26
 Figure 10: Disintegration Apparatus

(6) Leakage test:-

• For this purpose leaker test apparatus is used

 Strip pack-Maintain Vacuum at 250 mm for 30 sec.

 Blister pack-Maintain Vacuum at 180 mm for 30 sec.

(7) Checked the common defect of tablet:-

 Capping & lamination

 Picking & sticking

 Chipping

5.2 Dry Syrup:-

• Test performed for dry syrup:-

 Weight variation
 Average weight
 Sealing checking test
 Leaker test

5.3 Liquid:-
• Test performed for dry syrup:-

 Average weight
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 Uniformity of weight/volume
 Inspection for foreign particles
 Bottle leakage test

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 6. QUALITY CONTROL LABORATORY

The maintain the quality of product in last or finished product called quality
control (Q.C.), ensures product stability keeping the compliance to GMP
going and assures that the product will retain all their claims till they are
consumed.
• Q.C department is divide in following area:-
 Instrumental lab
 Chemical lab
 Microbiology lab

• Instrumental lab:-
Equipment available in Instrument Lab:-
 Polari meter
 Digital PH meter
 Dissolution rate apparatus [6 basket is used at a time]
 Inflorescence light apparatus
 Karl fisher universal titrator
 Flame photometry
 U.V/visible spectrometer
 Refractrometer
 Karl fisher titrator
 HPLC-2 {one is manual & one is automatic}
 Fourier transform infrared spectrophotometer

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• Chemical lab:-
 Disintegration test apparatus
 Friability apparatus
 Action shacking machine
 Centrifuge machine
 Magnetic stirrer
 Melting point apparatus
 Sonicator
 Bulk density apparatus
 Single distillation still [ for HPLC water]

• Microbiological lab:-
Equipment available
 Auto clave
 Refrigerator
 B.O.D
 Laminar air flow
 Incubator
 Cubic colony counter
 Antibiotic zone reader
 Membrane filter assembly
 Kimark stand
 Vacuum pump
 Hot air oven
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  Fumicator
 Temperature tester

Procedure of quality control:-

1. Raw material analysis:-

After receiving raw material in store division. Q.C. dept is called for
sampling for testing its quality & purity as per pharmacopoeia. If the raw
material stood in its Q.C. passes the raw material for production for
inspections two samples from each of the tablet, capsule, liquid section are
selected, one is meant for testing and another is for storage.

2. In process control:-
There is a real and significant difference between a finished product and the
quality assurance of the manufacturing process.
For control sample size usually taken as-
1. 100 tablets [ 10 packets ]
2. 10 bottles of liquid
3. 10 bottle of powder
4. 100 capsule [ 10 packet]
There are many equipment used in each section for testing during the in
process are-
1. Electronic balance
2. Disintegration test apparatus
3. Friability test apparatus
4. Hardness tester
5. Vernier calipers
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6. Measuring cylinders
Description:-Describe physical property of sample as color, odor, physical
state.
Solubility:-Maximum amount of solute dissolve in minimum quantity of
solvent.
Identification:-Conformation about sample.
Color & color of solution:-Substances give specific color in presence of
reagent specified in I.P.
Limit test:-Quantitative and semi qualitative determination of elements
present in sample.
Loss on drying:-Rare observed water or water of hydration is determined by
specified condition.
Sulphated ash:-Sample dissolves in sulphuric acid and put in to MUFFLE
FURNACE. Determined residue as sulphated ash.
Titration:-Titrand and titrent are used in titration in standardization of
solution.
Assay:-To determine actual quantity of active ingredient present in sample.
Disintegration:-A generally accepted maxim is that for a drug to be readily
available to the body, it must be in solution. For most tablets, the first most
important step towards solution is breakdown of the tablet in to smaller
particles or granules, a process knowledge known as disintegration.

Dissolution:-The original rationale for using tablet disintegration test was

the fact that as the tablet breaks down small particles it offers a greater
surface area to the dissolving media and therefore must be related to the
availability of the drug to the body.

32
Test for water:-This test is done to determined quantity of moisture/water
present in sample. Determined by KARL FISHER titrametric method.

Stability data generation and handling:-

HPLC- In the past few years, stability testing has been revolutionized by too
highly technologic advancement -high pressure liquid chromatography
(HPLC) methodology, and the computer for stability data acquisition,
storage, analysis and reporting.

Method used for checking the quality:-

1. Electrical method:-
It is a titrametric method that can be used for the precise analysis of active
ingredients.
2. Solvent extraction method:-
It is possible to extract acidic, neutral, of basic compounds from organic
solvent on the basis of partial behaviors of their ionized and unionized
species.
3. Spectrophotometric Method:-
This methods is widely used in pharmaceuticals for this material is separated
by the solvent and than its put in the spectrophotometer and observations
taken

4. chromatographic method:-
Now days TLC is replaced by HPLC and rarely used in Medicamen Biotech
Ltd.

Quality assurance control:-

33
The concept of quality control refers to the process of starting to produce a
perfect product by a series of measures requiring an organized effort at
every stage in production.
Quality control ensures product stability keeping the compliance to GMP
going and assures that the product will retain all there claims till they are
consumed.

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 7. BIBLIOGRAPHY

1. Indian Pharmacopoeia, Government of India, Ministy of Health and

Family Welfare, The controller of publication,1996 New Delhi.
2. Lachman Leon, Libberman A Herbert, The Theory and practice of
industrial Pharmacy,1991, Varghese Publishing House, Bombay.
3. Remington’s- The science and practice of pharmacy, international student
edition, 20th ed. 2000 Philadelphia College of Pharmacy and Science,
Philadelphia.
4. Ansel’s Pharmaceutical Dosage forms and Drug Delivery Systems 8th ed.
B.I. Publications Pvt. Ltd. Lippincott Williams and willkins, Philadelphia.
5. Bentley’s textbook of Pharmaceutics 8th ed. Published by all India
Traveler Book Seller, Delhi.
6. Pharmaceutics – The science of Dosage from Design International
Student edition, edited by M.E Aulton, London.
7. Kohli D.P.S and Shah D.H Drug formulations Manual Eastern
Publishers, New Delhi.
8. Sharma P.P ‘How to Practice GMPS’ , Vandana Publications Pvt. Ltd.
New Delhi.
9. United State Pharmacopoeia, 23rd edition.

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