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Pharmaceutics III, Department of Pharmaceutics
KINGDOM OF SAUDI ARABIA
UNIVERSITYPRINCE SATTAM BIN ABDULAZIZ
COLLEGE OF PHARMACY
LABORATORY MANUAL
PHARMACEUTICS IIIPHT-322
LEVEL VILab Co-ordinator
Dr. Shahid Jamil
Email:- [email protected]
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Pharmaceutics III, Department of Pharmaceutics
Contents Page
no Remarks Topics Exp-
No Week
Powder and granulesIntroduction1
Introduction 2
Preparation of absorbable dusting powder
13
Pulverization by Intervention24
Determination of angle of repose of given powders
35
Determine the bulk density, porosity
of 10 gm of the supplied powders A
and B. Provided that the true
densities of powders are 2.75 and
3.18 respectively. Tabulate your
results.
46
Determine the percent
compressibility of 10 gm of
magnesium sulphate powder by
calculating the tapped and bulk
density. Tabulate your results
57
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Pharmaceutics III, Department of Pharmaceutics
Send 20 gm of effervescent granules
containing
20% of - Magnesium sulfate (Mg
SO4), - Magnesium carbonate
( MgCO3 - or magnesium oxide
(MgO)
68
Send 20 gm of effervescent granules
Sod. Citro-tartrate containing 25% of
this mixture.
79
TabletsTo prepare and compress 30 tablets each contains 0.9 g sodium chloride by direct compression method.
810
To prepare and compress 20, tablets
each contains sodium bicarbonate
911
CapsuleDetermination of the capsule fill
weight
1012
Suppositories To prepare six Glycerin
Suppository B.P.
1113
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Pharmaceutics III, Department of Pharmaceutics
Note 2: Lab record must be checked on or before next experiment. (Late submission means losing 1 grade/day) Note 3: Final Lab exam (10) + viva/ synopsis/ other activities/ (5)
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Pharmaceutics III, Department of Pharmaceutics
Powder and granules
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Pharmaceutics III, Department of Pharmaceutics
Experiment 1
AIM: Preparation of absorbable dusting powder Rx
Corn starch 98 g
Light magnesium oxide 2 g
Send 20 g
Sig.: to be used U.D.
Procedure :
1- Pulverize starch and magnesium oxide to fine powders, and
pass through a 90-mesh sieve.
2- Triturate the two powders (starch over magnesium oxide) in
a mortar with pestle method
use : As lubricant for surgical gloves.
Calculation :
Because of mechanical losses during preparation, you have
to calculate for 25% excess so , instead of preparing 20 g , you will
prepare 25 g , the total amounts in the prescription is 100 g , so,
multiply each ingredient by a factor of (25/100).
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report Name of Experiment:Date: Student Name: ID#:
1.AIM:
2. Theory/Principle:
3. Equipments:
4. Materials:
5. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
6 .Observations & Results:
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Pharmaceutics III, Department of Pharmaceutics
EXPERIMENT 2
AIM: Pulverization by Intervention
It is the reduction of particle size with the aid of a second agent
which can be readily removed from the pulverized product
Procedure :
1. Weigh 1g of camphor crystal
2. It is readily triturated when a few drops of alcohol or other
volatile solvent is added.
3. The pulverized camphor is readily recovered as the solvent
evaporates.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:Date: Student Name: ID#:
1.AIM:
2. Theory/Principle:
3. Equipments:
4. Materials:
5. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
6 .Observations & Results:
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Pharmaceutics III, Department of Pharmaceutics
Flow of powdersOne of the properties which are of great concern to
pharmacists is the extent to which free flow will occur.
Many pharmaceutical processes require free flowing powders. Such
requirements include the following:
1- The control of weight in both capsules and tablets is dependent
upon the reproducibility of powder flow into fixed volumes re-
ceptacles.
2- Powders that are too fluid are difficult to hand pack into
capsules.
3- Dusting powders must be free flowing to facilitate
delivery. Through the sifter caps and spreading applied to the
body.
4- Poorly flowing cohesive powders are also difficult to blend
uniformly.
The majority of powders are not free flowing unless
specially treated to make them more flow able.
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Pharmaceutics III, Department of Pharmaceutics
Factors affecting Powder Flow ability:
1- Particle size: - Frictional and cohesive forces (resistance to
flow.) are increased as the particle size is reduced
.2- Density and porosity: - Particles with density and low porosity
tend to posses free flowing properties.
3- Particle shape and surface texture:-Rough irregular particles
presents more points of contact than smooth spherical particles
and less free flowing.
4- Particle size distribution: - larger amount of fines can inhibit
poor Flowing.
5- Moisture: - Drying the powders will reduce the cohesiveness.
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Pharmaceutics III, Department of Pharmaceutics
EXPERIMENT (3)
AIM:- DETERMINATION OF ANGLE OF REPOSE OF POWDERS
In this procedure we will measure the flow characteristic of
some powders of pharmaceutical interest. And study the effect of
glidents on the flow characteristics of various powders.
PROCEDURE:-
1- A quantity of powder is allowed to flow through a funnel ,
whose tip is adjusted at 2 cm form a horizontal surface
beneath , so that the apex of the heap just touch the lower tip of
the funnel .
2- Mark the base of heap.
3- Remove the powder.
4- Measure the diameter of the formed circle ( take the average of
two diameters )
5- Repeat the process three times and calculate the average
diameter (d ) , and the radius r = d / 2 .
6- The height of the heap ( the distance between the horizontal
surface and the lower tip of the funnel is called ( h ) 14
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Pharmaceutics III, Department of Pharmaceutics
Tan the angle of repose ( Ø ) = h / r , get Ø , and tabulate your results.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report Name of Experiment:Date: Student Name: ID#:
1.AIM:
2. Theory/Principle:
3. Equipments:
4. Materials:
5. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
6 .Observations & Results:
Table (1)
Powder Height (h) Radius (r) h/r Remark
Sodium chloride crystalline
Lactose 2 % Talc
Sodium chloride crystalline + 2% Talc
Lactose + 2% Talc
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Pharmaceutics III, Department of Pharmaceutics
Relationship between angle of repose and powder flowAngle of Repose (θ) Flow
<25 Excellent25–30 Good30–40 Passable >40 Poor
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Pharmaceutics III, Department of Pharmaceutics
Density and Porosity of Powders
Density of Powder:Density is define as weight per unit volume
1- True density of the material itself
2- Bulk density: was determined from the bulk volume
and the weight of a dry powder in a graduated cylinder.
The bulk density is sometimes given for both loosely
packed powder and tightly packed powder.
The method of measuring bulk density
It involves introducing a known weight of the
material into a graduated cylinder and compacting the
powder by a standardized procedure.
3- Tapped density: Tapped volume is measured by weighing
certain amount of particles and carefully introduces it
into a 100cc graduate cylinder. The cylinder is dropped
into a hard surface until a constant volume was obtained.
From the used weight and the obtained volume the tapped
density was calculated. Tapped density provides
information on how closely the particles in the powder
have packed together as a result of tapping or
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Pharmaceutics III, Department of Pharmaceutics
compression.
Porosity: Porosity is defined as the ratio of the total volume of space
between the particles to the bulk volume of the packing.
The porosity of powder is given by:
Vb is the bulk volume and Vt is the true volume of the
powder. Porosity is frequently expressed in percent (%)
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Pharmaceutics III, Department of Pharmaceutics
Example; A Sample of calcium oxide powder with a true density
of 3.03 gm / cc and weighing 131 gm was found to have a bulk
volume of 82.0 cc when placed in a 100 ml graduated cylinder.
Calculate the porosity.
The volume of the particles is 131.3 gm / 3.203 gm / cc = 41. 0 cc
The volume of void space = 82.0 - 41 = 41 cc.
The porosity = 82-41 = 41 = 0.5 or 50 %
82
Problem (I)Calculate the porosity of a sample of A having density of 4
gm/ cc when 75 gm of the powder was placed in graduated
cylinder, the A was found to have bulk volume of 62 cc.
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Pharmaceutics III, Department of Pharmaceutics
Experiment (4)Determine the bulk density, porosity of 10 gm of the supplied
powders A and B. Provided that the true densities of powders are
2.75 and 3.18 respectively. Tabulate your results.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report Name of Experiment:Date: Student Name: ID#:
1.AIM:
2. Theory/Principle:
3. Equipments:
4. Materials:
5. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
6 .Observations & Results:
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Pharmaceutics III, Department of Pharmaceutics
Determination of Compressibility of Powder:Powders used for tabulating should possess good compressibility
percent less than 22 % considered to have good flow ability.
The compressibility percent (c) was calculated according to
the following equation
Where Pt and PB are the tapped and bulk densities respectively
Experiment (5)
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Pharmaceutics III, Department of Pharmaceutics
Determine the percent compressibility of 10 gm of magnesium
sulphate powder by calculating the tapped and bulk density.
Tabulate your results
Granules
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Pharmaceutics III, Department of Pharmaceutics
Granulation is a method for, improving the flow ability of
powder drugs. It include the converting the powder of the drug into
agglomerates of smaller particles (free flowing coarse powder) to
be administered as such or to be tabulated or encapsulated.
Granulation also allows the addition of flavoring and coloring
agents and produces an easily handled, attractive, palatable product.
Granules can be prepared in different forms:
1.Non- effervescent granules that contain in addition to the drug
other additives such as sugar, lactose, starch .... etc. All
ingredients are moistened and made as a wetted mass with a
granulating agent such water, starch mucilage, gelatin and sucrose
solutions or dilutions of alcohols. The mass is then pressed through
a sieve of appropriate size and the resulting granules dried. The
granules should be uniform in size as possible.
2. Effervescent granules
That effervesce on addition to water, and usually contain mixture
of citric, tartaric acids with bicarbonate soda and usually some
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Pharmaceutics III, Department of Pharmaceutics
medicaments and occasionally sugar. They are dissolved in water
for purposes of administration and taken during effervescence or
immediately thereafter.
3- Coated granules
That may be coated with film of polymeric material in order to
control the release of the drug after swallowing.
Effervescent granules:
The effervescent granules are popular in use due to the pleasant
taste of carbonated solution and to psychological effect.
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Pharmaceutics III, Department of Pharmaceutics
A mixture of acids will be used because tartaric acid produces a
chalky friable granules and citric acid is too sticky to be
manipulated. It is desired that citric acid and tartaric acid are to be
used in the ratio of 1:2 respectively.
Rx
Citric acid 1
Tartaric acid 2
Sodium bicarbonate 3.4
6.4
For preparation of effervescent granules, citric acid should be
powdered just prior to use. Sodium bicarbonate should be
powdered and dry. Other ingredients should be dried to 100°C until
they cease to loss weight. All ingredients should be passes through
sieve No. 60. The effervescent mixtures of this kind react very
rapidly when added to water and in many cases part of the draught
is lost due the violence of the effervescence.
Method of Manufacture;
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Pharmaceutics III, Department of Pharmaceutics
The preparation of effervescent granules on either small or large
scale. More or less the same general procedures which are:
1- Preparing formula
2- Mixing the ingredients
3- Moistening and granulating
4- Drying the moist granules ate 50-60 °C
5- Packing and storing.
6- The amount of medicinal agent should be determined
according to the dose desired. The usual procedure for
the physician is to prescribe a teaspoonful dose or
multiple of that amount A heaping teaspoonful of an
effervescent salt weighs 5 gm. If the dose of the
medicament is 0.5 gm, then the finished product
should contain 4.5 of the effervescent salt mixture to
each teaspoonful.
Two methods for the preparation of effervescent granules are
Fusion method
Wet methods.
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Pharmaceutics III, Department of Pharmaceutics
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Pharmaceutics III, Department of Pharmaceutics
Wet Method:
1- Finely powder all of the ingredients and pass each separately,
thorough sieve No. 60.
2- Mix the powder homogenously in a porcelain dish
2- The mixture of the powdered materials is massed with 95%
alcohol until dough is obtained.
3- The so-produced mass is granulated in a likewise manner as
described above.
Evaluation of the granules:
The quality control tests of effervescent granules is carried out to
Determine
I- Effect of methods of preparations
II- Effect of granules Size
I -Effect of methods of preparations
1- An accurately weighed 0.25 gm of the granules and the transfer
into a dry clean measuring cylinder (100 ml capacity).
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Pharmaceutics III, Department of Pharmaceutics
2- Add 5 ml of distilled water to the granules and record the
following:
a-The time lapsed before effervescence is recorded.
b- The volume of the produced C02
c-The time required until effervescence ceases.
d- The clarity of the solution after effervescence
completely ceases.
e- The Evaluation tests are better carried out on the
granules prepared by the two methods (Fusion
and Wet methods) and the results are tabulated
for comparison .
II- Effect of granules Size
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Pharmaceutics III, Department of Pharmaceutics
1- Prepare 50 gm of effervescent granules (adopt the general
procedure of moist granulation technique ) and the passed
through
a- Sieve No. 10 (2000 µm)
b- Sieve No. 20 (840 µm)
c- Sieve No. 40 (420 µm)
The pervious quality control testes are carried out and the result are
tabulated in the fallowing table:
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Pharmaceutics III, Department of Pharmaceutics
Experimental Work
(1) Uricosuric Effervescent granules
(Non-medicated Granules)
Send 20 gm of effervescent granules containing
20% of -
- Magnesium sulfate (Mg SO4),
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Pharmaceutics III, Department of Pharmaceutics
- Magnesium carbonate ( MgC03)
- or magnesium oxide (Mg 0)
Experiment No:6
RX
Sodium bicarbonate 510 gm
Citric acid 180 gm
Tartaric acid 270 gm
Sucrose 150 gm
Send 20 gm
Calculations
Calculate for 25
Procedure:
1- All the ingredients are finely powdered and passed through
sieve No. 60.
2- Magnesium sulfate must be exsiccated by heating in a clean
dry porcelain dish on direct-flame till completely dry.
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Pharmaceutics III, Department of Pharmaceutics
3- The powders are mixed homogenously, massed with 95%
ethanol. The produced dough is passed through a sieve No.
10.
4- The resultant granules are dried in hot air oven at 40 °C for
4 hours.
Practical Lab Report Name of Experiment:Date: Student Name: ID#:
1.AIM:
2. Theory/Principle:
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Pharmaceutics III, Department of Pharmaceutics
3. Equipments:
4. Materials:
5. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
6. Observations:
Evaluation of the granules:
Quality control tests
Label :
Uses :
Magnesium sulfate granules:
7. Results:
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Pharmaceutics III, Department of Pharmaceutics
Experiment No:7
Send 20 gm of effervescent granules Sod. Citrotartriate ot
containing 25% of this mixture:
Rx
Zinc Oxide 10 gm
Starch Solution Qs
Fiat : (3%) Granules
Send 20-gm
Practical Lab Report
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Pharmaceutics III, Department of Pharmaceutics
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipment:
3. Materials:
4. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
5.Observations:
Quality control tests
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Pharmaceutics III, Department of Pharmaceutics
6.Label and Uses:
7.Results:
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Pharmaceutics III, Department of Pharmaceutics
Tablets
A compressed tablet is unit dosage form prepared by
compression under several hundred kilograms of pressure per
square centimeter, granulated medicinal or powdered substances
into a, discoid shape by means of dies. Tablets usually consist of
several materials in addition to the medicament that they convey
to the patient. These components have different functions.
Although all of them furnish bulk or volume to the tablets, they
are usually classified according to the principle function in the
tablet. Therefore. The word diluent "or" bulking agent applies only
to those substances that usually make up the major portion of the
tablet. Substances that bind powders together and make then
cohesive are the "binders".
Tablet Ingredients :
Materials that help the tablet to break up and dissolve to
release the medicament are the disintegrates . In order for
granules to flow from a hopper on the tablet press to the die and
for consistent and uniformly fill, substances called "glidants" are
added to the formula. Once the tablet has been compressed, it 44
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Pharmaceutics III, Department of Pharmaceutics
will not release from the die unless a "Lubricant' is present in
sufficient amount. Sometimes the compressed tablet leaves a
film on the Punches and "anti-adhesives" are needed to prevent
this. The last three substances frequently have interrelated
properties. Ingredients sometimes added but not essential for tab
letting are dyes, flavors, sweetness, adsorbents, and buffers.
Compressed tablets
A compressed table is a unit dosage form _prepared by
compressing medicinal substance in a powder or granular form
under several hundred kilograms of force per square centimeter into
the required shape by means of punches and dies. There are
approximately 360 official tablets.
Tablets usually consist of several materials in addition to the
drug called excipient s
These excipients are classified according to their principle
function they exert in the tablets.
I- Diluenis , Bulking agents, Fillers:
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Pharmaceutics III, Department of Pharmaceutics
These are substances inert and stable used to increase the
volume of the tablet.
Soluble: eg Lactose, sucrose, mannitot sorbitoL
Insoluble: eg Calcium sulfate, dicalcium phosphate ,
tricalcium phosphate starch calcium
carbonate .
2- Binders or Adhesives-
These are substances that bind all the powder together to make them
as cohesive paste. Binders may be added in a dry or in solution form.
Binders are either polysaccharides polymeric materials.
Examples of binder used - Acacia mucilage 10-20% -Tragacanth mucilage 10-20%
- Gelatin solutions 3-10%- Starch mucilage 5-10%
- Glucose syrup 25-50%-67%
Cellulose derivatives 3-10%
3- Disintegratents:
These are materials that help tablet break up into small particles 46
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Pharmaceutics III, Department of Pharmaceutics
in the gastrointestinal tract.
Examples :
Starch, alginates, cellulose derivatives, and lactose
Disintegrates added into tablets in two portions.
- One half is added to the powdered components before
the wet granulation process
- Second half added to the finished granulation just prior
to compression.
5- Lubricants
- These are agents that reduce the friction between the tablet
edges and die wall during the ejection cycle. They are usually
added at the very last step before compression. They present on
the granules surfaces and in between them and the Parts of the
tablet press.
- Example: Magnesium stearate, stearic acid, talc.
6-Glid ants are Materials that improve the flow characteristics of
granulation. Example:- Talc
7-Anti- adherents: 47
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Pharmaceutics III, Department of Pharmaceutics
Are materials used to prevent tablet sticking to the faces of
ft punches and die walls. Example: Talc.
8- Other table components
These are coloring agents, flavors, sweeteners and
adsorbents. etc.
Manufacture of compressed tablets
For tablets manufacture fine powders are the basis of most
formula. But they do not flow easily and are difficult to feed
into the die and they will not easily binder under
compression. If however, this fine powder is converted into
granules by granulation (pretreatment).
Granulation is the process the fine powders are converted to
granules using either Wet granulation or Dry granulation
that improve flow ability of powder to ensure a uniform fill
of the die cavity.
Experiment No:8Direct Compression:
1-Sodium chloride tablets
Aim: To prepare and compress 30 tablets each contains 0.9 g 48
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Pharmaceutics III, Department of Pharmaceutics
sodium chloride by direct compression method .
Rx
Sodium chloride 0.9 g
Notes for preparation:
1- The crystals of sodium chloride are granular and free
Flow able (No need for granulation)
2- Sodium chloride crystals when compressed, bind together,
To produce tablets of good hardness (no need for binding
Agent)
3-Tablets of sodium chloride, being soluble tablets (no need for
disintegrating agent)
4-Sodium chloride when compressed, dose not stick to metal of
punches and dies of tablets machine (no need for lubricant).
Procedure:
1- Screen sodium chloride crystals through a No. 16-22 sieve. This
step is necessary to break down lumps and to produce a uniform
granular powder.49
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Pharmaceutics III, Department of Pharmaceutics
2- Adjust the tablet machine to 1/2 gm size tablet.
3- Fill the sodium chloride into the feeder (hopper) of tablet
machine whose dosing unit has been adjusted for
compressing tablets having weight 0.5 gm. Check on the
weight of the tablets every now and then adjust the machine
accordingly.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipments:
3. Materials:
4. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
5 .Observations & Results:
Description :
Label:
Uses
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Pharmaceutics III, Department of Pharmaceutics
Tablets used in preparation of isotonic solutions
One tablet dissolved in sufficient water for injection and the
volume completed to 100 ml.
Storage:
In well closed container
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Pharmaceutics III, Department of Pharmaceutics
Experiment No: 9
Wet Granulation:
Sodium bicarbonate tablets
Aim: To prepare and compress 20, tablets each contains sodium
bicarbonate
Rx
Sodium bicarbonate 300 mg
Peppermint Oil 0.003 ml
Acacia powder 3%
Acacia mucilage q . s (25%)
Magnesium stearate 0.25% 0.75%
Talc purified.
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Pharmaceutics III, Department of Pharmaceutics
Procedure 1- Acacia mucilage is prepared by dissolving 5gm of powdered acacia
in 10 ml. of water and stirring until the acacia is dissolved then
complete to 20 ml warm water.
2- Sodium bicarbonate mixed with powdered acacia
3- The pervious mixture moistened with the acacia solution.
4- Wet mass is pressed through a sieve 0.84 mm.
5- Granules are dried at temperature not exceeding 60°C and
Sieved to remove powder and small granules.
6- Peppermint oil is added. The oil is dissolved in little alcohol
and sprayed on the dry granules, which are continually turned
over during the process.
7- Finally, lubricants are added and the whole are shaken
In a dry way.
8- Granulation is transferred to the hopper of tablet machine
adjusted for compression of tablets having calculated final
compression weight.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipments:
3. Materials:
4. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
5 .Observations & Results:
Description:
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Pharmaceutics III, Department of Pharmaceutics
Label:
Uses
Used as gastric antacid, in treatment of systemic acidosis. It can be
used locally on the skin in the form of moist paste or solution. In this
form, it is an effective antipruritic.
Storage :
In well closed airtight container in cool place.
Capsules
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Pharmaceutics III, Department of Pharmaceutics
Capsules are shells of gelatin with individual dos medications. They provide
accurate dosage of drugs and mask their bitter taste. When swallowed the
gelatin shell dissolves in the G.I fluid and release its content within 5 minutes.
Capsules are gelatin filled with powdered drug blended with other
ingredients that make up an individual dose. Dry powders,
semisolid, and liquids that do not dissolve gelatin may be
encapsulated.
- Soft Gelatin capsules:
These are formed, filled and sealed in one manufacturing
operation and may contain powders, non-aqueous liquids,
solutions, emulsions, suspensions and pastes .
- Hard gelatin capsules :
The shell is manufactured from gelatin with the addition of
suitable plasticizers, preservatives and coloring agent. Hard
gelatin shells are available in a range of sizes.
The hard gelatin capsules consists of two closely fitted cylinders each
having a closed and open end .
a-The lower cylinder is called the body or base, b-The upper cylinder called Cap.
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Pharmaceutics III, Department of Pharmaceutics
Method of filling hard gelatin capsules :
With dry materials.
1- P r e p a r i n 2 t h e m a t e r i a l .
All the substances are reduced by trituration to about the same
particle size and then mixed by the process of geometric dilution.
Powders that flow easily and those that creep when triturated may be
filled into capsules more easily if they are wetted with a drop or
two of a liquid. Alcohol is the liquid of choice, but water or
mineral oil might also be used.
2- Choice of an appropriate capsule size.
The capsules, that is convenient to the prescribed dose is selected. Smallest
is selected as the bigger present difficulty in swallowing.
Approximate capacities of hard gelatin capsule shells
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Pharmaceutics III, Department of Pharmaceutics
Filling by hand
Weigh each capsule as it is filled. The cap is removed and the powder is
transferred into the body, then cap is the slipped into its place and weight
tested in compression with an empty one.
Cleanliness
As any trace of moisture can make capsules sticky and cause dry powders to
adhere and leave finger prints. So hands must be clean and dry. This can be
achieved by the following methods:
I- Rub hand with towel before filling of each capsule
2- Use the cap of another capsule as a holder for the base (body)
during filling.
3- Wear finger cots or rubber gloves.
Experiment :10
Determination of the capsule fill weight
To determine the size of the capsules to be used or fill
weight for formulation, the following practical relationship is
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Pharmaceutics III, Department of Pharmaceutics
used:
Fill weight = tapped density of formulation x capsule volume
1- Example (if the size of capsule fit with the standard
capsule size.
A formulation has a theoretical fill weight of `350 mg and a tapped bulk
density of 0.75 g/ml
What size capsule is required?
Volume occupied by fill capsule = 0'35/0.75 = 0.47 ml.
It can be seen from the above table that a size 1 capsule has a volume of 0.48
ml. so it is the required size for the particular formulation.
2 Example (if the size of capsule dose not fit with the standard -capsule
size.
A preliminary mixture has a fill weight of 500 mg and a tapped bulk density
of 0.80 g/ml.
Volume occupied by fill weight = 0.5/0.8 = 0.63 ml.
It can be seen that capsule size 0 can be used (size 0 = 0.67 ml) .
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Pharmaceutics III, Department of Pharmaceutics
The difference 0.67-0.63 =0.04
showed that there is 0.04 ml unoccupied
To solve this problem we can add diluent to the mixture to
improve it performance.
Weight of diluent = 0.04 x 0.8 = 32 mg
32 mg diluent + 500-mg mixture weight = 532 = 0.532 g/0.8 = 0.67 ml
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipments:
3. Materials:
4. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
5 .Observations & Results:
6- Label:
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipments:
3. Materials:
4. Calculations:
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Pharmaceutics III, Department of Pharmaceutics
5 .Observations & Results:
6- Label:
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Pharmaceutics III, Department of Pharmaceutics
Suppositories
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Pharmaceutics III, Department of Pharmaceutics
Suppositories
A suppository is a solid or semisolid mass intended to be inserted
into a body orifice (e.g. the rectum, Vagina, Urethra) to provide
either a local or systemic therapeutic effect. Once inserted, a
suppository either melts at body temperature or dissolves (or
disintegrates) into aqueous secretions of the cavity.
Rectal suppositories are useful when oral administration is
inappropriate, as with infants, debilitated individuals, comatosed
patients, and patients with nausea, vomiting and gastrointestinal
disturbances .Some drugs may cause irritation to the G.I.T. tract.
Preparation:
Suppositories may be prepared by the following three methods:
I- Hand rolling involves molding the supp. With the fingers sifter
the formation of a plastic mass
a. A finely powdered drug is mixed with the grated
base in a mortar and pestle using livigation and
geometric dilution techniques .A small quantity
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Pharmaceutics III, Department of Pharmaceutics
of fixed oil may be added to facilitate the preparation of
the mass.
b. The uniformly mixed semiplastic mass is kneaded
Further and then rolled into a cylinder.
II-Compression: is generally employed when cocoa butter
is used as a base.
III-The fusion method: is the principal way of making
suppositories commercially and is primarily used when
cocoa butter, PEG, an d glycerin-gelatin bases are used.
Examples:
Method for determining displacement value
Using a nominal 2g mould:
Prepare and weigh six suppositories of unmedicated base = ag.
Prepare base containing 30% medicament, fill six moulds and
weigh six suppositories = b g.
Calculate the amount of base c g, and the amount medicament dg.
in the six suppositories c = 70% b and d= 30 % b
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Pharmaceutics III, Department of Pharmaceutics
Therefore tile amount of base displaced by
Dg = a – c g
displacement value (D.V.) = d_
a - c
Example :
Weight of six unmediated suppos. =6.0 g
30 % drug = 7.5 gBase = 70 % of 7.5 = 5.25
Drug = 30 % of 7.5 = 2.25Base displaced by 2.25 g = 6 - 5.25 = 0.75 g
Therefore the displacement value of the drug = 2.25 = 3 0.75
Method for using displacement value
Required: to prepare for 8 suppositories each containing
300 mg drug of displacement value 3 using a normal 2 g mould.
Total amount of drugs required = 8 x 300 mg = 2.4 g
This will displace 2.4 = 0.8 g of base
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Pharmaceutics III, Department of Pharmaceutics
3Therefore amount of base required = 8- 0.8 = 7.2 g
Glycerin Suppositories
Gelatin dissolves in hot water, forming a solution which sets to a
jelly. This fact is used to convert glycerin into solid Corm for use as
suppository. A suitable gelatin jelly is also used as a base for other
medicaments besides glycerin.
A gelatin base is incompatible with many of the substances
prescribed in suppositories, e.g. tannic acid, ferric chloride, gallic
acid and for this and other reasons; it is less frequently used than
cacao butter. Glycerin suppositories containing ichthammol
become insoluble on storage.
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Pharmaceutics III, Department of Pharmaceutics
I. Glycerin Suppository B.P..
R/
Gelatin 14 gGlycerin 70 gWater QS to 100g
This is a suitable base for medicated suppositories
containing solid medicaments or not more than 20 per cent of
semisolid or liquid medicaments. With more than this, the mass
becomes too soft.
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Pharmaceutics III, Department of Pharmaceutics
Experiment NO: 11
RX
Gelatin 14 gGlycerin 70 gWater QS to 100g
Tools:
Mortar and pestle, Porcelain crucible, water-bath, 2 g x 6 mold
Chemicals:
Gelatin 84g, Glycerin 420 g, water 96 ml.
Procedure:
1- Calculate for 6 supp., that is the amount of Gelatin =
6 x 14 = 84 g.
2- Weigh the required amount of gelatin and soak it in enough
water until thoroughly softened.
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Pharmaceutics III, Department of Pharmaceutics
Put the soaked gelatin on the calculated amount of
glycerin previously weighed in a tared crucible and
on a water bath until gelatin dissolves and a constant
weight is obtained. During evaporation the liquid mass
should be only gently stirred, rapid stirring produce air
pubbles which may appear in the finished suppositories.
Remove any skin formed on the surface before pouring.
Pour the mass while still hot, into the holes lubricated
with liquid paraffin, do not let the melted mass to
overflow.
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Pharmaceutics III, Department of Pharmaceutics
Practical Lab Report
Name of Experiment:
Date:
Student Name: ID#:
1. Principle:
2. Equipments:
3. Materials:
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Pharmaceutics III, Department of Pharmaceutics
4. Calculations:
5 .Observations & Results:
6- Label:
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