CHAPTER ONE
1.1 INTRODUCTION: Pharmaceutical Laboratory deals with the production of various drugs. The drug may be produced in liquid form, solid form or powdery form. It can be used orally or by applying it to the external part of the body. The laboratory scientist always carry out different analysis on the raw materials and the finished products whether the finished products comply with the specification (standard) or not.
1.2 BACKGROUND: This report was based on different types of drugs that is being produced in the laboratory and some analysis that are being carried out on the drugs (finished products) to ascertain that the drugs can be released for selling, during the period of my Student Industrial Work Experience Scheme (SIWES) under the supervision of the laboratory scientist of De Shalom Pharmaceutical Lab. Nig. Ltd. Ilesha.
1.3 OBJECTIVES OF SIWES: The innovative scheme (SIWES) is initiated by the federal government and supervised/coordinated by ITF. More so, it has a policy documentation number 1 of 1973, which establish the scheme, and includes the following objectives: Preparation of the student for industrial work situation that they are likely to meet
after graduation.
It gives student the practical knowledge of theoretical studies they have learnt in
school.
1.4 RELEVANCE OF SIWES TO BIOCHEMISTRY: The relevance of siwes to student cannot be over emphasized as ITF has a strong vision backing the initiation of SIWES. Therefore, as a biochemistry student, I have acquired a lot of benefits during the course of my SIWES which are listed below: 1. SIWES has helped me in apply the theoretical principles I have learnt in school to real
2. It has given me the privilege to see and operate some equipment and apparatus that
3. SIWES has helped in building good and formidable human relations in an industrial
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CHAPTER TWO
2.1 DESCRIPTION OF THE ESTABLISHMENT: De Shalom Pharmaceutical Lab. Nig. Ltd. Is a drug manufacturing company located at KM 4, Iloko Ijesha Road,Ilesha, Osun State, Nigeria. The company was incorporated in the year 1998 in Nigeria. The company is 100% indigenous to Nigeria and fully owned by Nigerian. The company is manufacturing Oral Liquid Drugs, External Liquid Drugs, Tablet Drugs and Flavoured Drinks.
To eradicate the rate at which people are suffering and dying of minor and major
diseases.
To boost the activities of some cells like White Blood Cell (Immune Cells), Red
RECEPTION/ADMIN OFFICE
PRODUCTION ROOM
TABLET ROOM
EQUIPMENT
CHEMICAL
MICRO
LAB
LAB
BIOLOGY
LAB
RAW MATERIALS STORE: All raw materials that are being used
for the manufacture of drugs are stored in this room at appropriate temperature. This section contain two sub sections. They are; 1. REJECTED MATERIALS ROOM: Rejected raw materials are stored in this room.
2. DISPENSING ROOM: Weighing of raw materials are done in this room, after which the weighed raw materials are being transferred to the mixing room.
3. EXTERNAL PRODUCT LINE: Drugs that are used for external part of
STORE: All drugs that are being produced in the production department of the
company were stored in this room.
3.1 WATER TREATMENT: The source of water that is being using in De Shalom Pharmaceutical Lab. is bore hole. The water is treated in order to get rid of some microorganism and metals like magnesium ion (Mg2+), Calcium ion (Ca2+) etc. METHOD: The water is pumped from the bore hole into a 1,500Litre surface tank.
addition of 6% De Shalom chlorine solution to the water that has been pumped
into the surface tank. This is done to make the water microbial free and to introduce
oxidation.
Add of 100g sodium bicarbonate (Na2CO3) to soften the water and to shift the pH
The water is allowed to pass through sand bed filtration. There are two types of sand bed filtration, they are;
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The water is transferred into the holding tank of 10,000L and then pass through
5micron
2micron
2micron
1micron
0.5micron
deionizer The water is passed through the deionizer (an ion exchange resin i.e Na+ and K+
exchange resin) which remove all ions except Na+ and K+.
The water is then exposed to ultra violet sterilizer so as to screen and to kill any
Water source
Sand bed
5micron filter
10000L
Storage tank
0.5micronfilter
3.2 PRODUCTION OF DRUGS PRODUCTION OF PEACETONE SYRUP (SHALOM BLOOD TONIC): MATERIALS: Hot water (95oC - 100oC), Sugar, Carboxy Methyl Cellulose (CMC), Xanthangum, MethylParaben, Propyl Paraben, 95% Ethanol, Glycerine, Ferric Ammonium Citrate, Cold Water (Treated water), Mixer, Bowl and Thermometer. PROCEDURE: Pour part of the sugar into the mixer. Add hot water and switch on the mixer. Add Carboxy Methyl Cellulose and Xanthan gum one after the other. Leave it for some minutes to gel out (i.e to form syrup). Dissolve methyl and propyl paraben in ethanol. Pour the solution into the syrup in the mixer gently. Add glycerine. Dissolve the remaining sugar and ferric ammonium citrate in a container containing hot water. Pour the solution into the mixer. Add rhasberry and fill the mixer to the desire level with cold water. Leave it for some minutes to form homogenous mixture. Transfer it to the holding tank.
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PRODUCTION OF VITAMIN C SYRUP: MATERIALS: Hot water (65oC - 70oC), Sugar, Soda-Ash, CMC, Methyl Propyl Paraben, 95% Ethanol, Glycerine, Sorbitl, Salt, Dextrose Powder, Ascorbic Acid, Pineapple Flavour, Ethylene Diamine Tetra Acetic Acid (EDTA), Metabisulphite, Concentrated Hydro Chloric Acid (HCl), Colourant, Thermometer, Bowls and Mixer. PROCEDURE: Pour sugar into the mixer and add soda ash. Transfer hot water into the mixer and switch on the mixer. Add CMC and leave the mixture to form gel. Add Conc. HCl to the syrup formed follow by glycerine. Dissolve salt, sorbitol, dextrose powder, EDTA and metabisulphite in a bowl Containing hot water (65oC 70oC) and pour the solution into the mixer containing syrup. Also, dissolve ascorbic acid in a separate bowl containing hot water and pour the solution into the mixer as well. Pour methyl propyl paraben solution (methyl propyl paraben that has been dissolved in 95% ethanol) into the mixer. Add pineapple flavour and colorant one after the other. Make up the solution in the mixer to the desire level with hot water and leave for some minutes to homogenize.
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Transfer the mixture into the holding tank. NOTE: The temperature of the hot water used should not exceed 70oC during the production of the Syrup and the temperature must be reduced to 60oC before the addition of ascorbic acid.
PRODUCTION OF MIST POT CITRATE: MATERIALS: Hot water (90oC 100oC), Potassium Citrate, Citric Acid, Sorbitol, Methyl Paraben, Chloroform, Lemon flavour, Colorant, Thermometer, Bowl and Mixer. PROCEDURE: Pour hot water into the mixer and switch on the mixer. Add potassium citrate, citric acid, sorbitol solution, methyl paraben Solution (methyl paraben that has been dissolved in hot water), chloroform, lemon flavour and colorant one after the other. Fill up the mixer to the level of interest and leave for some minutes to homogenize. Transfer it into an holding tank and leave it for about three days to improve its colour before packaging.
PRODUCTION OF SHALOM COF SYRUP: MATERIALS: Treated Water (i.e cold water), CMC, Xanthan Gum, Aspartame, Methyl
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Propyl Paraben, 95% Ethanol, Sorbitol, Ammonium Chloride, Ammonium Bicarbonate, Chlorpheniramine, Sodium Citrate, Liquorise Block, Peppermint oil, Dextrose Powder, bowl and mixer. PROCEDURE: Transfer treated water into the mixer and switch on the mixer. Add CMC, xanthan gum and aspartame. Leave it for some minutes to form gel. Pour methyl propyl paraben solution into the mixer. Dissolve sorbitol, chlopheniramine, ammonium bicarbonate, ammonium chloride and sodium citrate in a bowl containing cold water. Pour the solution into the mixer. Dissolve dextrose powder in cold water. Pour the solution into the mixer as well. Pour liquorise block solution and add peppermint oil. Use cold water to make up the mixture to the quantity desired. Leave for some minutes to homogenize. Transfer it into an holding tank.
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PRODUCTION OF PARACETAMOL SYRUP: MATERIALS: Hot water (95oC 100oC), CMC, Sugar, Methyl Propyl Paraben, 95% Ethanol, Glycerine, Sorbitol, Paracetamol Powder, Colorant, Rhasberry, Cold Water, Thermometer, Bowl and mixer. PROCEDURE: Pour sugar into the mixer and transfer hot water into it. Switch on the mixer and add CMC. Leave for some minutes to gel out. Dissolve the remaining sugar and the sorbitol in a separate bowl containing cold water and pour the solution into the mixer. Add glycerine. Dissolve methyl propyl paraben and paracetamol powder in 95% ethanol in a separate bowl and pour the solution into the mixer as well. Add rhasberry and colorant. Fill the mixer with cold water to the desire litre. Leave for some minutes to homogenize. Transfer it into an holding tank.
PRODUCTION OF MIST MAG (NON SYRUP): MATERIALS: Treated water, Sodium Bicarbonate, Magnesium Trisilicate, Light14
Magnesium Carbonate, Sorbitol, Methyl Propyl Paraben, 95% Ethanol, Peppermint Oil, chloroform and mixer. PROCEDURE: Transfer cold water into the mixer and switch the mixer on. Add sodium bicarbonate, magnesium trisilicate and light magnesiumcarbonate. Add sorbitol solution, methyl propyl paraben solution. Also, add peppermint oil and chloroform. Make it up to the desire level with cold water. Transfer into an holding tank.
PRODUCTION OF SHALOM MAG (WITH SUGAR): MATERIALS: Hot Water, Sugar, CMC, Mist Mag (without peppermint oil and chloroform), Peppermint Oil, Cold Water and Mixer. PROCEDURE: Pour sugar into the mixer and transfer hot water into it. Add CMC and switch on the mixer. Leave it for some minutes to form gel. Transfer the mist mag that has just been prepared in another mixer into the mixer containing syrup. Add peppermint oil.
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Make the mixture up to the expected litres with cold water. Leave for some minutes to mix properly. Transfer to an holding tank.
PRODUCTION OF SHALOM MAG (NON SUGAR): MATERIALS: Cold Water, CMC, Mist Mag (without peppermint oil and chloroform), Peppermint Oil, Chloroform and Mixer. PROCEDURE: Transfer cold water into the mixer. Switch on the mixer and add CMC. Leave it for some minutes to gel out. Transfer the mist mag that has just been prepared in another mixer into the mixer containing syrup. Add peppermint oil and chloroform. Make the mixture up to the expected litres with cold water. Leave for some minutes to mix properly. Transfer it into an holding tank.
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PRODUCTION OF MIST KAOLINE SUSPENSION (ANTI - DIARRHOEA): MATERIALS: Treated Water, Sodium Bicarbonate, Magnesium Trisilicate, Light Kaolin, Peppermint Oil, Chloroform and Mixer. PROCEDURE: Transfer cold water into the mixer and switch on the mixer. Add sodium bicarbonate, light kaolin, magnesium trisilicate, chloroform and peppermint oil one after the other. Fill up the mixer to the level desired with cold water. Leave for some minutes to homogenize. Transfer the mixture into the holding tank.
PRODUCTION OF GENTIAN VIOLET PAINT (G.V.) IN SPIRIT: MATERIALS: Crystal Violet (in spirit), 95% Ethanol, Mixer. PROCEDURE: Pour 95% ethanol into the mixer. Pour crystal violet into the mixer and switch on the mixer. Leave for some minutes to homogenize. Transfer into the holding tank.
PRODUCTION OF GENTIAN VIOLET IN WATER: MATERIALS: Crystal Violet (in water), Hot Water, Thermometer and Mixer.
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PROCEDURE: Pour hot water into the mixer. Pour crystal violet into the mixer and switch the mixer on. Leave for some minutes to homogenize. Transfer into the holding tank.
PRODUCTION OF METHYLATED SPIRIT: MATERIALS: Methanol, Isoproylene and Mixer. PROCEDURE: Pour methanol and isoproylene into the mixer one after the other. Switch on the mixer and leave for some minutes to mix properly.
PRODUCTION OF HYDROGEN PEROXIDE (H2O2): MATERIALS: Stabilizer (mixture of benzoic acid and methanol), Concentrated Hydrogen Peroxide, Phosphoric Acid, Cold Water and mixer. PROCEDURE: Pour cold water into the mixer. Add conc. hydrogen peroxide to the water gently. Add phosphoric acid and stabilizer. Make it up to the desired litres by adding cold water. Switch on the mixer and leave for some minutes to homogenize. NOTE: H2O2 is highly reactive, so, care must be taken during its preparation.
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Taste
Odour
pH
Acidity
Chloride
Oxidizable Substance
Conductivity
Specific Gravity
Flow Rate
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Fill the pycnometer with the liquid to be weighed and note that the liquid
W3 = W2
W1
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Pipette 25ml of the homogenized solution and get your stop watch ready.
Simultaneously release the liquid by allowing it to flow and start your stop watch at
Repeat the process three times and then calculate the average flow time.
Flow Rate = Volume of homogenized sample (in cm3 or ml) Flow time of the sample (in sec.)
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Specification
Result
Complies
Odour Taste Specific Gravity Flow Rate pH Assay of ferric ammonium citrate
Strawberry like Strawberry like 1.122 1.209 1.53 2.53 cm3s-1 6.5 7.9 380 420mg per 10ml
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
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Specification
Result
1.0240 1.1540 1.891 2.613 cm3s-1 4.2 5.2 95 105mg per 5ml
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
Specification
Result
1.040 1.090 cm3s-1 3.5 6.5 1.45mg 1.55mg per 10ml 2.45mg 2.55mg per 10ml
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
Specification
Result
Complies
Odour
Complies
Taste
Complies
1.023 1.153 1.82 2.65 cm3s-1 6.5 7.9 95 105mg per 5ml
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NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
Physicochemical parameter Appearance Odour Taste Specific Gravity Flow Rate pH Assay of paracetamol powder (C8 H9 NO3)
Specification
Result
A clear syrupy liquid Apple like Apple like 1.0780 1.1860 2.280 3.210 cm3s-1 5.1 6.2 120 130mg per 5ml
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
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Specification
Result
A white suspension which sediment very slowly & re- disperse easily
Complies
Odour Taste Specific Gravity Flow Rate pH Assay of magnesium trisilicate Assay of sodium bicarbonate
Peppermint like Peppermint like 1.0370 1.1270 1.204 1.350 cm3s-1 7.5 10.5 1.3 1.7% w/v
Complies
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
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Specification
Result
Complies
Odour Taste Specific Gravity Flow Rate pH Assay of magnesium trisilicate Assay of sodium bicarbonate
Peppermint like Peppermint like 1.130 1.310 1.75 2.85 cm3s-1 7.5 10.5 1.3 1.7% w/v
Complies
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
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Physicochemical parameter Appearance Odour Taste Specific Gravity Flow Rate pH Assay of light kaolin
Specification
Result
Pink suspension Characteristic Sweet peppermint like 1.035 1.313 2.02 3.989 cm3s-1 7.9 9.9 240 260mg per 5ml
NOTE: The batch number, manufacturing date and expiry date of the drug must be
recorded.
the laboratory analyst to know if there is mistake during the production process of the drug.
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ASSAY OF VITAMIN C AIM: To show whether the claim complies with the specification or standard.
REAGENT: Starch mucilage, 1M H2SO4, CO2 free water, 0.05M iodine solution,
Sample.
conical flask.
95ml of boil water (CO2 free water) was added to make it up to 100ml plus
continuous stirring. NOTE: Use immediately after preparation to get accurate result.
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PROCEDURE FOR THE ASSAY OF VITAMIN C 0.05M of iodine solution was poured into the burette to mark.
5ml of the sample was taking and poured into a conical flask.
shaking.
RESULT:
Burette Reading (cm3) Initial Burette Reading (cm3) Final burette Reading (cm3)
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0.008806g
Convert 0.008806g to mg
1g = 1000mg
0.008806g = 8.806mg
100%
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100
= 100.4%
PRECAUTIONS:
Starch mucilage must be used immediately after its preparation to get accurate
result.
Do not waste much time on the practical to avoid oxidation of the active
ingredient.
NOTE: The batch number, manufacturing date and expiry date of the sample must be
recorded.
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Sample.
Take 1ml of the sample (cof syrup) and put it in a conical flask.
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RESULT: Burette Reading (cm3) Initial Burette Reading (cm3) Final Burette Reading (cm3) Titration 0.0 3.7
CALCULATION:
(NH4Cl) i.e
1ml AgNO3
5.349mg
100%
100
= 99%
To avoid drug tolerance which is the reduction or loss of the normal response to
drug. Drug tolerance may be developed when taking a lower quantity of drug than
the prescribed quantity. In such cases, increase dose is required to produce the
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desired effect.
To avoid drug intoxication which is the symptom of poisoning due to ingestion of excess drug than the prescribed quantity.
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5.1
RECOMMENDATION:
I recommend that SIWES programme should continue because it is really a medium that empowers and exposing student to various industrial scheme and also prepare student ahead of the coming challenges as regards his or her field of study. Likewise, I recommend a constant medication for every individual suffering from one disease or the other. Drugs can be taken to increase once shelf life or healthy life.
CONCLUSION: I absolutely submit to the fact that university education without Student Industrial Work Experience Scheme (SIWES) is as worse as not schooling at all.
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