Industrial Training

At

DEY’S“Care You Can trust”

Dey’s Medical Stores (Mfg) Pvt. Ltd.

62 Bondel Road, Kolkata-700019

West Bengal.

Training from 1st July to 30th July 2009.

Report submitted in partial fulfillment of the requirement for the degree of bachelor of pharmacy

By

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ACKNOWLEDGEMENT

The industrial training work is undertaken as a part of the curriculum of

the bachelor of pharmacy (B.Pharm) course of department of pharmaceutical

science of Dibrugarh University, Assam.

The accomplishment of this work require the help and effort of many

people and the work is indifferent. I am grateful to Dr. A. Bhattacharyya the

head of the department of Pharmaceutical science of Didrugarh University for

givin me the opportunity to undergo the industrial training at Dey’s Medical

Stores (Mfg) pvt. Ltd.

It has been a pleasure to undergo training at Dey’s. In spite of its short

duration (01.07.09-30.07.90), the practical experience of industrial work

environment will be a valuable asset to me and will go a long way in enhancing

my prospects in the pharmaceutical field.

I want to convey my sincere thanks specially to Mr. Deepak Banik for his

helping hand in every step here and also to each and every personal of Dey’s

for helping me the formulation industry in a better way. I want to specially

thank the supervisors and in-charges and support.

I express my deep gratitude to the below named persons for their

support and valuable information.

1. Mr. Tapash Benerjee (Personal Manager)2. Mr. Santanu Roy & Mr. Sanjay Dutt (In-charge tablet dept.) 3. Mr. Arijit Dutta (In charge capsule)4. Mr. Saradindu Mondal (Supervisor capsule)5. Mr. Subhankar Biswas (In-charge liquid)6. Mr. Amarnath Roy (In-charge I-tone)7. (In-charge Q.C.)8. Mrs. Sikha Roy (Librarian)

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SOMETHING ABOUT THE COMPANY

Dey’s Medical Stores (Mfg) Pvt. Ltd. Is a private company dealing with the

production of many pharmaceutical products. It was established in 1958. It has

four manufacturing units-three at Kolkata, W.B and other one at Naini,

Allahabad, Uttar Pradesh.

The beginning of Dey’s is fascinating. In 1941, Late Mr.B.N.Dey, the then

Managing Director of this organization, from a mere urge to serve the society,

started a small retail medical store in Kolkata through his unique character

comprising high capabilities with honesty. Soon he was able to gain the

confidence of the medical profession including the stalwarts in the field. During

the 2nd world was, when the supply of essential drugs was uncertain and

much hampered, Dey’s come forward in the field of agency to ensure and

maintain a steady supply of left Saving drugs and appliances to the medical

profession and also to the ailing people of the country.

In 1957 Dey’s took sold step in establish a manufacturing units in the city

of Kolkata its own indigenous know how various dosage forms of drugs-

capsules, tablets, granules, powders, oral liquid, drops etc of all the important

categories of medicines-antibiotics, antiasthma ties, antihypertensive, ant

dysentery, anti-inflammatory. In the year 1971 Dey’s opened a second

manufacturing company at Naini, Allahabad, in the state of Uttar Pradesh.

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CONTENT

1. Tablet......................................................................................................5

2. Capsule……………………………………………………………………………………………….10

3. Liquid ( I & II)……………………………………………………………………………………….14

4. Quality Control…………………………………………………………………………………….18

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TABLETS

Tablets may be defined as solid pharmaceutical dosage form containing

drug substances with or without suitable diluents and prepared by either

compression or moulding methods.

The compressed tablet has a number of advantages as a dosage form. It

enables an accurate dosage of medicament to be administed simply.

Tableting Methods

Dry Granulation Wet Granulation

General Procedure For Production Of Non β-αActum Tablets :

It is devided into two

I. Wet Granulation MethodII. Dry Granulation Method

WET GRANULATION METHOD:-

Weighing of materials

Dissolution in solvent (water of organic solvent)

Addition of binding material

Mixing in steam jacketed vessel till formation of dough

Drying in tray dryer

Granulation

Addition of excipients

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Mixing in planetary mixer

Compression

Coating

Packing, striping or blistering

Packing

DRY GRANULATION METHOD:-

Weighing of materials

Addition of fillers & binders

Sifting and granulation for proper mixing

Mixing in planetary mixer

Compression

Coating

Packing, striping or blistering

Packaging

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QUALITY CONTROL

VACCUM LEAD TEST

ADDITION OF EXCIPIENTS

QUALITY CONTROL

VACCUM LEAD TEST

DURING ONE WEEK OF TRAINING FOLLOWING TABLETSWERE PROCESSED

PRODUCT PROCEDURE DRUG USE

solacid w.G(wet granulation)

Dried aluminiumhydroxid

e gel I.P, Mg. trisilicate I.P, Mg(OH)2 I.P,

simethicone I.P

Antacid, Ant flatulent,

Adsorbent.

Entero-mycetin caplet

w.G chloram phenicol I.P Typhoid

Horn-o Dry granulation(D.G)

Ornidazole I.P,

Ofloxacin I.P,

Infection

Horn-500 W.G Ornidazol I.P

Brotzv D.G Cepha doxyl

Avicel pH101

Cough & Cold

Milk Of Magnesia

W.G Antacid &Laxative

Etformin W.G Metformin hydrochloride I.P

Diabetis

Liz-M W.G Gliclazide Metformin

hydrochloride

Diabetis

Zovax-500 Amoxycillin Trihydrate

Antibiotic

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Tablet Coating:- Tablet coating is a process of application of a coating composition to a moving bed of tablet with a concurrent use of a heated air to facilitate evaporation of the solvent. The distribution of coating is accomplished by the movement of the tablets either perpendicularly (coating pan) or vertical (air suspension coater) to the application of the coating composition.

Tablet coating may be divided into→

-Film coating

-Sugar coating

- Enteric coating

Machine used→

→Name – UNICOTA- 36

→Capacity of pan – 50 kg

→It is an automatic coating machine with 3 coating hozzles (Guns)

→RPM of machine – 6 CPS

→Spraying on timer – 8 sec.

→spraying off timer – 8sec

→Temperature of coating pan – 37.7°C

Composition of coating solution→

Polymer – HPMC, CAP, HPMC Pthalate, Shellac.

Plasticizer – PEG-6000, DBP, DEP

Solvents – Water, Isopropyl Alcohol, Ethyl Alcohol, Acetone, Methyl chloride

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Colouring Agents – Titanium dioxide, Brilliant blue, Erythrosine lake colour, Yellow oxide of Iron

Polishing agent – Talcum, PG

For enteric coating tablets ‘OPAR DYE’ is used along with other materials.

Other machines used or associated with UNICOATA - 36

→3 SPRAYING GUNS

→PERISTALTIC PUMP

→VESSEL CONTAINING COATING SOLUTION FIXED GWITH STIRRER

→AIR INJECTOR

→PRESSURE GAUGE

FIGURE of UNICOTA-36

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CAPSULES

Capsules are solid pharmaceutical doses forms consisting of solids, semisolids and liquid enclosed in a gelatin shell.

Capsules are of two types:

→HARD GELATIN CAPSULES

→SOFT GELATIN CAPSULES

The capsule filling materials may be

→ Dry solid – powder, granules and pellets

→Semisolid – thinotropic mixtures, thermosoftening mixtures, pastes etc.

→Liquid – oily liquid suspension, solutions

TYPES OF CAPSULE PRODUCED IN DEY’S MEDICAL

1. AYURVEDIC CAPSULE2. ALLOPATHY CAPSULE

Size of capsules – there are various types of capsules 000, 00, 1, 2, 3, 4, 5.

Machines required in the production of various capsules:-

1. Granulator,2. Double cone blender,3. Dough mixer,4. Cube blender,5. Impex pulveriser,6. Shifter,7. Automatic blister machine(packing),8. Automatic capsule filling machine(PAM)

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-: Manufacturing Procedure for Capsules:-

WEIGHING → SEIVING → BLENDING & LUBRICATION ← LACTOSE, STARCH,Mg.STEARATE

POLISHING & STORING

STRIP/BLISTER PACING

PACKING

Machines used in different area of production of capsules:

AREA NAME OF MACHINECHARGING AREA 1. Weighing machine

2. Oscillating granulator3. Double cone blender4. Tray drier5. Cube blender

FILLING AREA 1. Semi automatic filling machine - PAM

2. Automatic filling machine – Zenasis

PACKAGING AREA 1. Strip packing machine-Four track-Two track

2. Blister packaging machine-PHARMAPACK 240 CH

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IN PROCESS TESTING, eg:WEIGHT VARIATION TEST

QUALITY CONTROL

ALLOPATHY CAPSULE:

ENTERMYCETIN CAPSULE – Constituents → Chorophenicol

Category → Typhoid

AYURVEDIC CAPSULE: There are 3 in number

1. LIVINA CAPSULE a. ACTIVE INGREDIENTS – Kalmegh,Kakamachi,Sarapunkha,

Guduchi,Haritaki,Katuka,Saptapura

b. EXTRACTS OF THE INGREDIENTS – Bhumium laki, Kakilakshy a Indrayva,

Daruharidra,Kasni

c. LUBRICANTS – DCP,Starch, SiO2, Magnesium stearate,Talcum powder

d. PRESERVATIVES – Sodium benzoate

e. USES – In liver ailments, helps and protects liver from hepatotonic

substances, promotes appatite, clear constipation

f. PROCEDURE :-

Mix all active potential ingredients – Sieve (mesh 60)

→Mix LIVINA extract + distilled water

→ Dryer (1st at 100°c for few hours and then at 60°c)

→Granulation (by passing double zero net Fitz mill

→Dry charge (by adding lubricants)-Filling

→Polishing →Blister packing

g. Capsule colour: Light green- Dark green

h. Size/Fill capacity: 0/0.75 ml

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2. PROSTINA CAPSULE:

a) ACTIVE INGREDIENTS: Vapusha, Pravala (Sea coral), Purified silajit,

Kababchini, Ushira, Chandan oil.

b) LUBRICANTS : DCP, Starch, SiO2, Deprogel,Mg Stearate,Talcum powder

c) USE: In problem of prostrate glands.

d) PROCEDURE : Mix active potential ingredients+lubricants→Sieve(mesh

60)→Filling→Polishing→Polishing→Blister→Packing

e) CAPSULE COLOUR → Orange-Orange

f) SIZE / FILL CAPACITY → 0/0.75 ml

3. TRASINA CAPSULE:

a) ACTIVE INGREDIENTS → Ashwagandha, Tulsi, Purified silajit, Guduchi,

Katuka, Bhringraj

b) LUBRICANTS →Starch, SiO2, Mg Stearate,Talcum powder.

c) PRESERVATIVES →Sodium Benzoate

d) USE→As an adaptogenic formulation recommendedfor management of

diverse types of strain and as an adjuvant therapy in stress induced

diseases.

e) PROCEDURE →Mix active potential ingredients lubricants →Sieve (mesh

60) →Filling→Polishing→Blistering→Packing.

f) CAPSULE COLOUR →Yellow-Dark yellow

g) SIZE/FILL CAPACITY →0/0.75 ml

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LIQUID

Liquid formulation are intended for oral administration and external administration.

Those liquids intended for oral administration or into body cavities should be sufficiently sterile

Liquid department is divided into:

i. LIQUID 1 → ENTEROMYCETIN SYRUP, KARPIN LOTION 1&2.ii. LIQUID 2 →LIVINA SYRUP, HERBODIL SYRUP, KEOKERPIN BODY

OIL(LAVENDER), KEOKARPIN BODY OIL(SANDAL)iii. OTHERS →I-TONE EYE DROP

This department has only one charging room and one storage room for the finished product. Every section has one washing room attached with the packing room which washes the bottle of that particular product.

GENERAL PROCEDURE FOR LIQUID PREPARATION:-

Charging →Filtration →Storage vat →Filling →Capping & Sealing → Labelling → packing.

LIQUID 1:

1. ENTEROMYCETIN SYRUP

This is the main product of liquid 1 section. It is a chloramphenicol oral suspension.This antibiotics is milky white in colour. As chloramphenicol is a drug of choice in typhoid.So thinSyrup is used in typhoid.

PREPARATION PROCEDURE :- Distilled water taken → raised to boiling temperature → Methyl paraben &Propyl paraben is added and stirred continuosly → required amount of sugar is added →add bromopol and sodium benzoate → sieved → kept overnight at room temperature → next day syrup is

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filtered through sparkler filter → filter in charge VAT → chloramphenicol and isopropyl alcohol in stream VAT → clear solution formed at 62°c-65°c → above solution in four containers containing water with stirring → amorphous form of chloramphenicol palminate is formed and is collected → transferred to ball mill and operated for 2 hrs. with little water to make a slurry → slurry sent to quality control for intermediate infrared test → after report add TWEEN 20 → add water and stir for 20-21 hrs. → transfer to mixing VAT in syrup → add ice cream flavours → volume makeup → sent sample to quality control → then for I.R. test → filling → capping → labeling →packing.

2. KARPIN LOTION.

A pack of KARPIN lotion consists of Karpin lotion 1 & Karpin lotion 2.

PROCEDURE FOR PREPARATION OF KARPIN LOTION 1:- In charge VAT add water, sodium thiosulphate + sodium benzoate + sodium hydroxide +cetramide one by one →stir volume make up →filter →storage VAT → sample to quality control(I.R. TEST) →filling →capping → labeling → packing.

PROCEDURE FOR PREPARATION OF KARPIN LOTION 2:- In charge VAT add water + tartaric acid + phenol one by one → volume makeup → filter → storage VAT → sent sample to quality control(I.R.TEST) → filling → capping → labeling → packing.

USE – For application in skin diseases

KARPIN LOTION 1. → For cleaning the affected area

KARPIN LOTION 2. → Therapeutic effect.

Karpin lotion is doubly filtered. 1st through HYFLOW SUPERCEL POWDER (filter aid powder) dissolved in water and then through sparkler filter (2 beded).

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LIQUID 2.

It is mainly ayurvedic section.

The products manufactured here are

1. LIVINA SYRUP, 2. KEOKARPIN BODY OIL (LAVENDER), 3. KEOKARPIN BODY OIL (SANDAL), 4. HERBODIL SYRUP.

1. LIVINA SYRUP

INGREDIENTS: - Kakamachi,Indrayava, Sarapunkha, Kalmegh, Bhumiumlaki,

Guduchi, Harataki, Hakila-Ushya, Saptaparna, Daruharidra, Kasni, Katuka.

ACTIVE INGREDIENTS: - Sodium benzoate, Methyl paraben, Propyl paraben.

ADDITIONAL: - Sugar syrup &alternative sweetners, Sorbitol, sodium saccharine.

USE :- Protects liver from hepatotonic substances, promote appetite, clears

constipation.

2. KEOKARPIN BODY OIL (SANDAL)

INGREDIENTS :- Daruharidra, Haridra, Manjistha, Arjuna

In oil base containing karpoor,camphor, vaishakh, isopropyl alcohol,lanolin,

olive oil, neem oil, arachis oil, light liquid paraffin(for volume make up),

butylated hydroxylated anisole (as preservatives) and sandal(as perfume).

USES :- Herbal body oil.

3. OTHERS → I-TONE EYE DROP:-

It is an unique preparation derived from the ancient ayurveda,rediscovered

through extensive in-house research. In Bhirgutantra Sushtruta & Charaka

samhita succesful treatment of various occular dieseases have been recorded.

Taking lead I-TONE eyedrop has been prepared.It is invaluable in protecting the

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eyes from all pollutants and adverse environment of modern life. It also helps

to maintain the activity of vision and is very useful in treatment of various eye

ailments.

INGREDIENTS :- Aqueous distillate of nimba, shobhanjana, bhringaraj,

punarnava, nirgundi, tulsipatra, satapatri, yamani, haritaki, bibhitaka,

dhatriphala, haridra, karpuram, pudina, satwa, madhu, ela, sweet chandan,

mukta, saindhava, labau.

AS PRESERVATIVES :- Phenyl ethyl alcohol USP, benzalkonium chloride solution

I.P.

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QUALITY CONTROL (QC)

Quality control department is a must for every pharmaceutical industry. There are several aspects of quality control department

1. Q.C. ensures good quality of finished products.2. Q.C. fixes the expiry date of the products.3. Q.C. helps the organisation to discover new drugs.4. Q.C. promotes the drug delivery, production rate etc.5. Q.C. department has the sole authority to reject even finished products,

if it is seen to be not up to the mark.6. Q.C. helps to maintain a consistency in producing good products.

A good Q.C. department helps to increase marketability of drug & the profit of the respective organisation.

Q.C. department generally consists of the following departments:

1. Chemical Laboratory2. Pharmacological Laboratory3. Microbiological Laboratory

CHEMICAL DEPARTMENT:-

Different types of instruments in chemical department are:

1. pH meter2. Dissolution test apparatus 3. Disintegration test apparatus4. Friabilator5. Phase separator apparatus6. TLC apparatus7. HPLC apparatus8. Karl Fischer apparatus9. Automated Karl Fischer apparatus10. I.R. Spectroscope11. Spectrophotometer12. Centrifuge13. Viscometer14. Digital balance with printer.

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Different types of tests done in chemical department are:

1. Dissolution test2. Disintegration test3. Hardness test4. Weight variation test5. HPLC6. TLC7. Titration8. Friability9. Absorbance test10. Solubility test

MICROBIOLOGY LABORATORY:

Instruments which are used in this laboratory are:-

1. Colorimeter.2. Double door autoclave3. Water bath4. Microscope5. Incubator

Following experiments are performed in this laboratory:

1. Antibiotic assay2. Vitamin assay3. Amino assay4. Microbial limit test5. Sterility test6. Spore test

PHARMACOLOGICAL LABORATORY:

In this laboratory the drugs are tested on animals. The tests are:

1. Pyrogen test2. Toxicity test3. Eye irritation test4. Skin irritation test

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Mr. Arijit Dutta (In charge capsule) Mr. Saradindu Mondal (Supervisor capsule) Mr. Subhankar Biswas (In-charge liquid) Mr. Amarnath Roy (In-charge I-tone) (In-charge Q.C.) Mrs. Sikha Roy (Librarian)

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