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Pharmaceutics III, Department of Pharmaceutics KINGDOM OF SAUDI ARABIA UNIVERSITY PRINCE SATTAM BIN ABDULAZIZ COLLEGE OF PHARMACY LABORATORY MANUAL PHARMACEUTICS III PHT-322 LEVEL VI Lab Co-ordinator Dr. Shahid Jamil 1

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Page 1: psau.edu.sa€¦ · Web viewPowder and granules Introduction 1 Introduction 2 Preparation of absorbable dusting powder 1 3 Pulverization by Intervention 2 4 Determination of angle

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]

1

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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

2

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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

3

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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

5

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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).

6

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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:

7

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Pharmaceutics III, Department of Pharmaceutics

6 .Observations & Results:

8

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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.

9

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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:

10

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Pharmaceutics III, Department of Pharmaceutics

6 .Observations & Results:

11

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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.

12

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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.

13

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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.

15

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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:

16

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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

17

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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

19

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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 (%)

20

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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.

21

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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.

22

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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:

23

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Pharmaceutics III, Department of Pharmaceutics

6 .Observations & Results:

24

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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)

25

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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

26

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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

27

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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.

28

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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;

29

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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.

30

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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).

32

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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

33

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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:

34

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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),

35

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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.

36

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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:

37

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Pharmaceutics III, Department of Pharmaceutics

3. Equipments:

4. Materials:

5. Calculations:

38

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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:

39

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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

40

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Pharmaceutics III, Department of Pharmaceutics

Name of Experiment:

Date:

Student Name: ID#:

1. Principle:

2. Equipment:

3. Materials:

4. Calculations:

41

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Pharmaceutics III, Department of Pharmaceutics

5.Observations:

Quality control tests

42

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Pharmaceutics III, Department of Pharmaceutics

6.Label and Uses:

7.Results:

43

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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:

45

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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.

50

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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:

51

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Pharmaceutics III, Department of Pharmaceutics

5 .Observations & Results:

Description :

Label:

Uses

52

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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.

54

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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.

55

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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:

56

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Pharmaceutics III, Department of Pharmaceutics

5 .Observations & Results:

Description:

57

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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

58

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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.

59

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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

60

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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

61

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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) .

62

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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

63

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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:

64

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Pharmaceutics III, Department of Pharmaceutics

5 .Observations & Results:

6- Label:

65

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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:

66

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Pharmaceutics III, Department of Pharmaceutics

5 .Observations & Results:

6- Label:

67

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Pharmaceutics III, Department of Pharmaceutics

Suppositories

68

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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

69

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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

70

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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

71

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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.

72

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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.

73

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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.

74

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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.

75

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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:

76

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Pharmaceutics III, Department of Pharmaceutics

4. Calculations:

5 .Observations & Results:

6- Label:

77