DISSOLUTION OF TABLETS

AIM: To predict invivo drugs release i.e. to predict the amount of active ingredient that is
absorb in the blood stream of human being and also to assess batch to batch consisting of solid
oral dosage form

MATERIALS: Dissolution tester, dissolution jar paddle type, basket type, buffer solution,
0.1Hcl solution.

INTRODUCTION: Drug dissolution testing is routinely used to provide critical invivo drug
release information for quality control purpose. Main objectives of developing introduction are
the established dissolution testing for human bio-equivalence studies. This analytical data from
dissolution testing are sufficient in many cases to establish safety and efficient of drug products .

DEFINITION: Dissolution tester is used to determine the amount of active ingredient that is
present in blood stream which can be determined by using a SPECTROPHOTOMETER
machine in order to dissolve into solution after some necessary activities.
 A single tablet is allowed to sink to the bottom of the jar for the paddle but for the
basket
apparatus, a single tablet is placed in a small wire mesh or net
 The bottom of the shaft is connected to a variable speed motor
 The basket or paddle is immersed in a dissolution medium contained in a 100ml jar
 The jar is cylindrical with hemispherical bottom flask in maintained at 37°c to 50°c by a
constant temperature bath
 The motor is adjusted to turn at specified speed at about 50 revolution per minute
1(RPM) for
one hour (1hr)
 After the rime has reach, the sample of the fluid are withdraw to determine the amount
of the
drugs in solution
 The sample is filtered with the aid of filter paper inside a conical flask
 The filtrate is pipette of standard specification of mix into a 100mls that button flask
that 13
half filled with a medium e.g. 0.1m HCL, water
 After the mixture, the solution is re-filled with the desired medium to the marked point

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 CHAPTER THREE.
3.0 ACTIVITIES IN CHEMICAL LABORATORY AND FUNCTIONS OF SOME
MACHINES
3.1 TABLET DISINTEGRATION
AIM: To determined the required under a given set of condition for a group tablet to the
disintegrate into particles
APPARATUS 600ml of water disintegrate flask, disc and 1000mls beakers
INTRODUCTION
For a drug to be absorbed from a solid dosage form,after oral administration, it must be
in solution and the first important step toward this condition is usually the breaking down of
tablet in order to determine the time taken for each drugs to dissolve into particles, the process
is known as DISINTEGRATION OF DRUGS
DEFINITION: Disintegration machine is used to determine the time taken for each drug such as
human drug and veterinary drugs to disintegrate into particles in the body of human beings and
animals.
PROCEDURE: Disintegration tester consist of a basket Rask holding 6 plastic tubes, open at the
topend and the bottom enclosed with net to allowed the free movement of the disintegrate
drugs down into the beaker, when the drugs is put into the basket Rask.
1. The basket is immersed in a bath of suitable liquid held the temperature of 37°c.
2. The testing fluid is usually at 37°c
3. The start button is pressed and also the time taken in (minutes and seconds)
RESULT: For most uncoated tablet, the British pharmacopeia (BP) required that the tablet
disintegrated should be 15 minutes for human beings and 60 minutes or 1 hour for veterinary
drugs, which is the specification. This provides a simple and useful of monitoring and controlling
the quality of tablets.

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  Add drug sample to the sample plate and reweigh in the Mettler balance and record the
weight
 Add the weight of the sample plate and drug after adding it to the sample plate and
record the weight
 Put the drug sample inside the laboratory ovum for 60minute
 Remove the drug sample and reweigh the sample

It thus calculated below for the percentage of water present

Initial value – Final value × 100

Drug sample

3.8 CONCLUSION
In conclusion, student industrial works experience sceme (SIWES) is a very serious and
important training . It expose student to the practical aspect of their course, the SIWES
program give me the viable knowledge of my profession that I can work in any
laboratory with success
3.9 RECOMMENDATION
It is necessary fo the federal ministry of health to regard the maintenance of
laboratory equipment as an integral of health. I f this is done, it will expose student
practically in all their acquired theoretically.

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  Also for veterinary drugs, after individual weight of 10 bolus, 10 bolus is re-
weight again at once and the reading is recorded
 To calculate the average weight is as follows

Average weight = Total number of 27 tablet weight at once

27
 Weight variation for tablet is measure in mg, while for bolus is measure in gm
 The tablet pass the (USP) test if it is no more that the difference of two (2) are
outside the percentage limit
3.6 DISINTEGRATION TEST
AIMS: To determine the rate at which the drug dissolve in the Gastric Intestinal Tract (GIT) of
human body.
APPARATUS: Disintegration machine, water-bath
PROCEDURE:

 The water is heated at 37°c i.e the normal temperature of the body
 The drug is introduced into the disintegration machine containing water-bath
 The drug is dissolved with varying time to each other
 The time is recorded for each batch of drugs

NOTE: Some drugs don’t need the disintegration test e.g Ascorbic which it is
disintegration start from mouth

3.7 MOISTURE CONTENT ANALYSIS

AIMS: To determine the percentage of water content in the different drug.
APPARATUS: Drug sample, Mettler balance, Sample plate, Laboratory ovum
PROCEDURE:
 Weigh the same plate inside Mettler balance and record the weight

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  The solution is taken to the spectrophotometer to determine the absorbance and
transmission of the wavelength
 The test tolerance is expressed as a percentage potency absorbance of sample

3.3 FRIABILITY TEST

AIM: To determine mechanical strength of tablets. To determine the ability to withstand
stress upon exposure to mechanical shock
MATERIALS: A friabilator machine, petri-dish, weighing balance, recording materials
e.g Bro and notebooks
INTRODUCTION: When some formulated raw materials are composed into very hard
tablets, it tends to cap or lose their crown portion, such tablet breaks to powders or chip
or fragment.
They do not only lack elegances and consumer acceptance but also spill in the area of
manufacturing
A friability testing apparatus stimulate the conditions that the products will be when
exposed during the production
PROCEDURE: Friabilator consists of a plastic chamber for placing the tablets, which is
attached to a horizontal wills mode of a transparent synthetic polymer with polished
internal surface.
 After the sampling of the tablet from the machine and checked the weight to ten
(10) tablet of each side (three time each), compiled with the compressing weight
 20 tablets of each side is weight with the aid of weight weighing machine and the
outcome is recorded as the initial weight
 The tablet is put into the plastic chamber which has two sides as the drugs is
been sample (Left and Right) to revolve round at 100 times
 After 100 times of the revolving, the tablet is later reweighed again and it is
recorded as the final weight. The tablet are subjected to combine the effect of
abrasion and shock, the tablet drops at distance of 6 inches of each revolving

The compressed tablet that lose should not above 1% as the specification or considered
acceptable
The calculation can be done as follows

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 CHAPTER TWO
2.1 VARIOUS DEPARTMENT IN TUYIL PHARMACEUTICAL AND THEIR FUNCTIONS
The products area is broadly divided into two sections namely:

 The human section

 The veterinary section
The following department is present in both sections
G.M.P DEPARTMENT (good manufacturing practice) they ensure that, manufacturing process
are clearly ensure consistency and compliance with specification
They also ensure instruction and procedure are written in clear language and a good
documentation practices
2.2 QUALITY CONTROL DEPARTMENT
They are involves in setting up prosedures intended to ensure that a manufactured
products adhere to a defined set of quality criteria or meet requirement
2.3 PRODUCTION DEPARTMENT
The department are involved in the transformation of raw materials into finished products
production department takes raw material and fashion into input for consumers use
2.4 ADMINISTRATION DEPARTMENT
Consist of the performance or management of operation and thus making or
implementing the major decision in the establishment. The basic function of personnel
department related to the administrative as well as human resources , are also involved in
organization people and resources efficiently so as to direct activities in the company
2.5 PERSONNEL DEPARTMENT
Management, work, hiring suitable candidates performance, evaluation and motivation of the
sales

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2.6 VARIOUS SECTIONS IN TUYIL PHARMACEUTICALS AND THEIR FUNCTIONS
2.6.1 STORE SECTION:
In this section, is namely divided into two major sections as follows:

 Raw materials store section

 Packaging store section
2.6.2 RAW MATERIALS STORE SECTION
This is where all raw materials which is used for production is been stored such as Talcum
powder, magnesium stearate, Tetrazine colorant, methyl paranen, propyl paranen, Gelatin etc.
2.6.3 PACKAGING STORE SECTION
This is where all the packing materials are been kept suc as plastic rubber, of different
size, paking nylon also of different size and also Blister material for blisting.
2.6.4 KITCHEN SECTION
Poduction steps in drugs begin firstly in the kitchen section where some raw materials
for preservation is been formulated together in order to produced starch for paste such as
starch; for blinder, Tetrazine; for colorant gelatin; for hardness of the drugs, methyl paranen;
for preservative, propyl paranen; for preservative are vmix in boil water to produced starch for
paste after some is take to the granulation for the next process
2.6.5 GRANULATING SECTION
The raw materials been formulated together into search for paste is sent into this section
where other ingredient are properly with different set of producing machine such as;

 Mixing Machine: where proper mixture of starch for paste and other ingredient take
place
 Milling Machine: is also another step in which the mixture from mixing machine is
partially transform into granules (i.e partially free from moist)
 Drying Machine: this is another type of producing machine in which the granules is
completely free from moist i.e it completely dried the granules. After that some other
additive or supplements is now added to the granules such as Talcum powders,
magnesium stearate etc.

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There are two types of raw materials they are:

 Active Raw Materials: They are called the outer in the tablet (Act mostly in the body) e.g
chloroquine, phosphate, paracetamol powder, metronidazole, ascorbic acid,
chloropheniramine malate
 Additives: this supports the active ingredients or reactive ingredient be.g starch, lactose,
gelatin, magnesium stearates etc
2.6.6 QUARANTINE SECTION
This is a place where all was materials been transformed into granules from
granulation granulation section is kept to free dust and also from other contamination
materials before been compressed
2.6.7 COMPRESSION SECTION
Compression section are of two sections; they are:
1. Human being drugs compressing section
2. Veterinary drug compressing section
This is where all the granules for both human and veterinary are being compressed into
Tablet, Caplet and Bolus
The operation are to ensure that the weight of the tablet being compressed complies with
the granules weight and also ensure that.

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 Friability= initial – final weight × 100
Initial weight
3.4 HARDNESS TESTER
AIM: To generally measure the tablet crushing strength
MATERIALS: Hardness tester
INTRODUCTION: Tablets required certain amount of strength or hardness and resistance to
friability to withstand or hardness and resistance to friability to withdraw mechanical shakes
of handling in manufacturing, packaging and shipping.
ACTIVITIES:
 Place the tablet in the mouth of hardness tester, placed horizontally of ten
(10) tablet
 Screw the tester until it tighten the tablets till it breaks and the marking point
of the scale is recorded for the ten tablets
 The ten tablets that is recorded is added together and divided by ten
 Hardness tester is measured in kg/cm2
3.5 WEIGHT VARIATION TESTER
AIM: To determine variation weight of each tablet
MATERIALS: Weighing balanced petri-dish, hard glove, calculate
PROCEDURES:

 The formulated raw materials which is compressed into tablet by using 27punches
 The tablets is sample both left and right from the compressing machine and check the
weight if it correspond with the compressing weight by using the standard of 3% and 5%
 Each tablet is weighed one after the other is recorded at each tablet till it reaches 27
tablets, to know the weight of individual punches on the tablet which is compressed
 The 27 tablets is re-weight again at once and the reading is recorded

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