You are on page 1of 24

Pharmaceutics

practical 4
Solid Dosage form

Procedures and methods for solid dosage form preparation in


laboratory for pharmacy students level 4

Dr. Mohammed A.Malik Al-Qassim


2019
Pharmaceutics practical 4

Contents
Laboratory No (1) .................................................................................. 2
Introduction ( What is Solid dosage form? ) ............................................... 2
Experiment No (2) .................................................................................. 4
Experiment Of : preparation of dusting powder ........................................... 4
Experiment No (3) .................................................................................. 6
Experiment Of : preparation of oral rehydration powder ............................... 6
Experiment No (4) .................................................................................. 8
Experiment Of : Preparation of effervescent Granulation............................... 8
Experiment No (5) ................................................................................ 10
Experiment Of : preparation of powder by granulation method .................... 10
Experiment No (6) ................................................................................ 12
Experiment Of : preparation of Tablet manually ......................................... 12
Experiment No (7) ................................................................................ 15
Experiment Of : preparation of Lozenges tablets ....................................... 15
Experiment No (8) ................................................................................ 17
Experiment Of : filling and polishing Capsules .......................................... 17
Experiment No (9) ................................................................................ 19
Experiment Of : filling and polishing Capsules .......................................... 19
Experiment No (10) .............................................................................. 21
Experiment Of : Density of solid preparation ............................................ 21
measure Angle of repose for powder dosage form ..................................... 21
References : ........................................................................................ 23

1
Pharmaceutics practical 4

Laboratory No (1)
Introduction ( What is Solid dosage form? )
Objectives of Experiment :

Students will be study of :


1- Knowledge Solid dosage form ( definition , Advantage, types )
2- Study of powders and its properties as a main source for more drugs
dosage form.
3- Study of type of powders.
Terms & Definitions :

Solid dosage form : is a common shape of most drugs, usually dry and regular
very small size of particles, may be essential.

Powder : is a pharmaceutical powder is a mixture of finely divided drugs of


chemicals in a dry form meant for internal or external use..

Advantage of solid dosage form:

- More chemical stability than other dosage form.


- Fast absorbent.
- Suitable for all groups of patient.
- Rapid solubility.

Types of solid dosage form :

1- Powders.
2- Tablets.
3- Chewable tablets.

Properties of powders :

1- Simplest particles to doses on desirable.


2- Can be administrator large dose without dangerous.
3- Easy to administrator in different times.
4- Less cost in preparation, usually don’t need machine.
Type of powder in prepared :
1- Divided powder : that can be packaging in ( packets ) to facilitate doses
knowledge.
2- Undivided powder : that packaging as one bulk in one container without
2
Pharmaceutics practical 4

divided in parts.
Important instruction :

1) Student must be wear lab-coat .


2) Student must be approach experiment with other students ( group )
3) Each group give simple name for them. e.s : ( Alpha, Beta , gamma, omega)
pharma group.
4) Student must be carefully approach all experiment.
5) Student must be note and follow teacher explain.
6) Student must be write report for each experiment & give to doctor in final
course.
7) Student must be keep laboratory clean.
8) Student must be give suitable container ( clean, good, size, shape).
9) Student must be print a label contain information about product :
( trade name , generic name, content, uses, group name) size suite with
container with beautiful design.
Good luck ,,,,, Dr. Mohammed Abdolmalik Al-Qassim

3
Pharmaceutics practical 4

Experiment No (2)
Experiment Of : preparation of dusting powder
Objectives of Experiment :
Students will be study of :
1- Training to approaching preparation of dusting powder.
2- Training to how can be give softness of powder.
3- Training to work in group.
Terms & Definitions :
Dusting powder : is a very fine, light powder for external use.
Medical uses of dusting powder :
1- Used as an insecticide.
2- Toiletry.
3- Antiseptic.
Principle of Experiment :
By mortar and pestles the ingredient are grinded in one way, and with sieve No
95-120 can be achieved on softness powders

Preparation of Talc Power:

Rx:

- Talc powder ………………………….. 500 gm.


- Starch powder ………………………. 250 gm
- Zinc oxide ……….. up to …………………………1000gm.

Each groups prepare 20 gm only.

Talc powder used as protective, absorbents, antiseptic

Tools Materials
1- Sieve 95 – 120. 1- Talc powder
2- Balance 2- Zinc powder
3- Mortar & pestle 3- Starch powder
4- Funnel.
5- Square paper
Procedures :
1- Good washing all tools with water and dry them with clean paper.
2- Weighing all ingredients.
3- Put each one of ingredient in mortar, reduction of particle size to softness

4
Pharmaceutics practical 4

by grind them by pestle and pressure hand with stir in one way.
4- To insure small range of particle pass powder through sieve 95 then sieve
120, use finger to pressure & move powder on sieve pores
5- Packaging in suitable container and labeling.
6- Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
7- Good washing all tools and pinch.
Results :
You will produce pharmaceutical powder used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask.

5
Pharmaceutics practical 4

Experiment No (3)
Experiment Of : preparation of oral rehydration powder
Objectives of Experiment :
Students will be study of :
1. Training to approaching preparation of oral rehydration powder.
2. Training to how can be give pharmaceutical product to medicine propos.
3. Training to work in group.
Terms & Definitions :
oral rehydration powder: is a pharmaceutical powder, fine and light powder for
internal use
medical uses of oral rehydration powder :
1- To replacement of body fluid.
2- To prevent dryness to diarrhea patients.
Principle of Experiment :
By mortar and pestles the ingredient are grinded in one way, and with sieve No 30
– 40 can be achieved on softness powders.

Formula of oral rehydration powder:

Rx:

Sodium chloride ……………………… 2.6 gm


Glucose …………………………………… 13.5 gm
Potassium chloride …………………. 1.5 gm
Tri sodium citrate …………………… 2.9 gm

Tools Materials
1. Sieve 30 – 40. 1. Sodium chloride
2. Balance 2. Glucose
3. Mortar & pestle 3. Potassium chloride
4. Funnel. 4. Tri sodium citrate
5. Square paper
Procedures :
1. Good washing all tools with water and dry them with clean paper.
2. Weighing all ingredients.
3. Put each one of ingredient in mortar, reduction of particle size to softness
by grind them by pestle and pressure hand with stir in one way.
4. To insure small range of particle pass powder through sieve 30 then sieve
40, use finger to pressure & move powder on sieve pores
6
Pharmaceutics practical 4

5. Packaging in suitable container and labeling.


6. Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
7. Good washing all tools and pinch.
Results :
You will produce pharmaceutical powder used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves.
Notes :
1- Glucose facilitates the absorption of sodium ( and hence water abs.)
2- Sodium and potassium electolye to replacement lossess of these essential
ions during diarrhea.
3- Citrate corrects the acidosis.

7
Pharmaceutics practical 4

Experiment No (4)
Experiment Of : Preparation of effervescent Granulation
Objectives of Experiment :
Students will be study of :
1. Training to approaching Preparation of effervescent Granulation in
laboratory.
2. Training to how can be taking chemical substances to Preparation of
effervescent Granulation.
3. Training to work in group.
Terms & Definitions :
Granulation : is a process in which primary powder particles are made to adhere
to from larger, multi-particle entities called granules.
Why granulation?
- To prevent segregation of the constituents of the powder mix.
- Important to control the particle size distribution.
- To improve the flow properties of the mix.
- To improve the compaction characteristics of the mix.
- The granulation of toxic materials will reduce the hazard associated with
the toxic dust granulation.
Principle of Experiment :

By wetting ingredient with suitable wetting agent as water or cohol, then divide
adhere mass to granules with sieve 12.
Preparation of Antiacidic effervescent granules:
Rx:
Sodium bicarbonate ………………. 510 gm
Citric acid ………………………………. 180 gm
Tartaric acid ………………………….. 270 gm
Sucrose …………………………………. 50 gm
Alcohol …………………………………. Drops as a wetting agent
Prepare 50 gm of medicine that used as anti-acid and spasmolytic of gastric pain.
Tools Materials
1. Sieve 12. 1. Sodium bicarbonate
2. Balance 2. Citric acid
3. Mortar & pestle 3. Tartaric acid
4. Funnel. 4. Sucrose
5. Square paper 5. Alcohol
8
Pharmaceutics practical 4

Procedures :
1. Good washing all tools with water and dry them with clean paper.
2. Weighing all ingredients.
3. Put all ingredient in mortar, reduction of particle size to softness by grind
them by pestle and pressure hand with stir in one way.
4. Wet with 1-2 drops of alcohol to give wet adhesive mass.
5. To produce small particle wet granules pass (wet adhesive mass) through
sieve 12, use finger to pressure & move it on sieve pores
6. Wait for 10 minutes til dry.
7. Packaging in suitable container and labeling.
8. Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
9. Good washing all tools and pinch.
Results :
You will produce pharmaceutical powders used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask.

9
Pharmaceutics practical 4

Experiment No (5)
Experiment Of : preparation of powder by granulation method
Objectives of Experiment :
Students will be study of :
1. Training to approaching preparation of powder by granulation method in
laboratory.
2. Training to how can be taking chemical substances to preparation of
powder by granulation method.
3. Training to work in group.
Terms & Definitions :
Granulation : is a process in which primary powder particles are made to adhere
to from larger, multi-particle entities called granules.
Why granulation?
- To prevent segregation of the constituents of the powder mix.
- Important to control the particle size distribution.
- To improve the flow properties of the mix.
- To improve the compaction characteristics of the mix.
The granulation of toxic materials will reduce the hazard associated with the toxic
dust granulation.
Principle of Experiment :
By wetting ingredient with suitable wetting agent as water or cohol, then divide
adhere mass to granules with sieve 12 then grind granules to fine powder
characterized with regular shape of particles .
Preparation of aspirin granules fort:
Rx:
Di-magnesium tri-silicate ………………. 40%
Magnesium carbonate ……………………30 %
sodium carbonate ……………………….… 30 %
Prepare 50 gm of medicine that used as ingesting agent .
Tools Materials
1. Sieve 12. 1. Di-magnesium tri-silicate
2. Balance 2. Magnesium carbonate
3. Mortar & pestle 3. sodium carbonate
4. Funnel.
5. Square paper

10
Pharmaceutics practical 4

Procedures :
1. Good washing all tools with water and dry them with clean paper.
2. Weighing all ingredients.
3. Put all ingredient in mortar, reduction of particle size to softness by grind
them by pestle and pressure hand with stir in one way.
4. Wet with 1-2 drops of alcohol to give wet adhesive mass.
5. To produce small particle wet granules pass (wet adhesive mass) through
sieve 12, use finger to pressure & move it on sieve pores
6. Wait for 10 minutes til dry.
7. Grind well with mortar and pestle til change to fine powder.
8. Packaging in suitable container and labeling.
9. Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
10.Good washing all tools and pinch.
Results :
You will produce pharmaceutical powders used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask

11
Pharmaceutics practical 4

Experiment No (6)
Experiment Of : preparation of Tablet manually
Objectives of Experiment :
Students will be study of :
1. Training to approaching preparation of Tablet manually in laboratory.
2. Training to how can be taking chemical substances to preparation of
Tablet manually proposes.
3. Training to work in group.
Terms & Definitions :
Tablets : are solid pharmaceutical dosage forms containing drug substances with
or without suitable diluents.
Ingredients used in tablet formulation :
- Drugs, active agent with some of the following additive agents:
Agents Use of agents
1. Fillers, diluent Make a reasonably sized tablet
2. Binders Bind powders together in wet granulation and
compression
3. Disintegrate Promote breakup tablet and release drug
4. Lubricants Reduce the friction during tablet pass in machine
5. Glidants Reduce friction inside tablet and improve the flow
6. Anti-adherants Prevent adherence of the granules on punch face and
dies
7. Dissolution Enhance and retardant
8. Wetting agent Adhere mass forming
9. Anti-oxidant Prevent chemical oxidation to product
10.Preservatives Remain product stable during store
11.Coloring agent Give appearance
12.Flavoring agent Give taste and odor
13.Coated agent Cover tablet against GIT factors
Some substance have some properties and working in multi functions and
proposes. e.i. ( starch )
Tableting procedures by machine :
- three stages FCE (filling, compression, ejection)
Tableting procedures manually :
- five stages PFPDE(prepare, filling, pressure, drying, ejection)
Compare between FCE & PFPDE
12
Pharmaceutics practical 4

FCE PFPDE
Work speed Fast Slowly
Cost Less cost Mediate cost
Efficiency High quality Low quality
Produce amount Large number of tab Small number of tab
Power source Electricity – technology Pharmacist, employee
operative
Tableting methods:
1- Dry methods : direct compression, with dry granulation
2- Wet methods : powders wetted and granulated then tableted.
After tableting; sometimes problems are appeared as the following :
Problem Discuses
Capping Partial or complete separation of the top or bottom of
tablet from the main body of tablet
Lamination Separation of a tablet into two or more distinct layer
Picking Removal of a tablet's surface material by a punch
Sticking Adhesion of tablet material to a die wall
Mottling An equal color distribution on tablet

Principle of Experiment :
Prepare the powder by wetting method, then put in drill of the mold, drying and
finally ejection
Aspirin tablet preparation :
Rx:
Acetyl salicylic …………… 500 gm. ( active agent )
Starch ………………………... 90 gm.( diluent , lubricant , blinder)
Talc …………………………… 10 gm. ( glidnat, anti- adherant)
Alcohol …………………… few drops to forming adhesion mass
Prepare only 70 gm of drug
Tools Materials
1. Drilled Mold 1. Acetyl salicylic
2. Balance 2. Starch
3. Mortar & pestle 3. Talc
4. Funnel. 4. Wetting agent ( alcohol)
Procedures :
1. Good washing all tools with water and dry them with clean paper.
13
Pharmaceutics practical 4

2. Weighing all ingredients.


3. Put all ingredient in mortar, reduction of particle size to softness by grind
them by pestle and pressure hand with stir in one way.
4. Wet with 1-2 drops of alcohol to give wet adhesive mass.
5. Put adhesive mass in drill of mold by spoon.
6. Wait for 10 minutes til dry.
7. Grind well with mortar and pestle til change to fine powder.
8. Packaging in suitable container and labeling.
9. Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
10.Good washing all tools and pinch.
Results :
You will produce pharmaceutical tablets used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask

14
Pharmaceutics practical 4

Experiment No (7)
Experiment Of : preparation of Lozenges tablets
Objectives of Experiment :
Students will be study of :
1. Training to approaching preparation of Lozenges tablets in laboratory.
2. Training to how can be taking chemical substances to preparation of
chewable tablets proposes.
3. Training to work in group.
Terms & Definitions :
Lozenges tablet : They are tablets that absorbent in mouth, and are designed for
administration to patients e.g. vitamin products.
Principle of Experiment :
Putting powders of active agent in hot high viscosity sweet liquid then cooled and
poured into ready molds.
Herbal Throat Lozenges tablet preparation :
Rx:
Sucarose ( sugar ) …………………… 600 gm ( flavouring agent, blinder, dillunt)
Honey ……………………………………. 40 gm ( = = = =
Ginger root ( powder) ……………. 40 gm ( active agent)
Cloves flowers ………………………. 10 gm ( active agent)
Ascorbic acid …………………………. 10 ml ( active agent)
Distelled water ………………………. 300 ml ( wetting agent)
Prepare 100 gm of preparation
Lozenges tablets used for relief pain of throat or mouth inflammatory.
Tools Materials
1. Beaker 250 ml 1. Sucrose.
2. Magnetic hot stir 2. Honey.
3. Balance 3. Ginger root.
4. Spoon 4. Cloves flowers.
5. Square or circle mold 5. Ascorbic acid.
6. Sandwich paper 6. Distilled water
7. Glycerin
Procedures :
1. Good washing all tools with water and dry them with clean paper.
2. Weighing all ingredients.
3. Put all ingredient in beaker 250 ml.
4. On magnetic hot stirrer 70 – 90 C for 20 minutes or (on hot plate with
stirring) .
15
Pharmaceutics practical 4

5. Wait to Cooling with continuo stir til density of mixture increase.


6. During cooling prepare mold or oily paper by using glycerin on paper.
7. Pour mixture in mold slowly to obtain regular tablet. Or ( by spoon pour
small amount on oily paper ( sandwich paper with glycerin).
8. When product cooling, Put little of softens sugar on tablet
9. Packaging in suitable container and labeling.
10.Keep container in dry place, protect them against humidity, air oxidation
and loss of volatile ingredients.
11.Good washing all tools and pinch
Results :
You will produce pharmaceutical sweet tablets used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask

16
Pharmaceutics practical 4

Experiment No (8)
Experiment Of : filling and polishing Capsules
Objectives of Experiment :
Students will be study of :
1. Training to approaching filling and polishing Capsules manually.
2. Training to how can be taking chemical substances to filling and
polishing Capsules proposes.
Terms & Definitions :
Capsule : is a unit dosage form in which drug or drugs with or without excipients
are enclosed in a hard or soft water-soluble shell or a container of
gelatin or of any other suitable substance. It is intended for oral
administration.
Capsules types : 1- hard capsule 2- soft capsule
Capsules size : look the following table :

Capsule No
000 00 0 1 2 3 4 5
Capacity
accommodate 950 600 450 300 250 200 150 100
in (mg)

Capsule's content : may be solid, liquid or paste. Capsules may contain one or
more medicament with or without excipients. If quantity of the
drugs is insufficient to fill the capsule, then diluent is used to
increase the bulk. After mixing the drug with diluent, appropriate
size of a capsule is selected for filling.

Storing of capsules : capsules should be stored in cool place with controlled


humidity. At higher temperatures, due to loss of moisture, the
capsules become brittle and tend to crack. In humid atmosphere
the capsules absorb moisture and lose their shape.

17
Pharmaceutics practical 4

Principle of Experiment :
Emptying trade drugs capsules and refilling them, then close and polishing.
Tools Materials
1. Watch dish 1. Trade drugs capsules
2. Zip-closed 2. salt
3. Balance
4. Sieve 10
5. Paper
Procedures :
1. Open trade drug capsules about 10 – 15 cap.
2. Emptying into watch dish.
3. Keep capsules ( body & cover ) side.
4. Refilling body of capsule manually by collecting up down.
5. Close body of capsule with cover.
6. Weight it each one one and write the weight in your note.
7. Capsules have some powders and fingers work, so need to polish with salt.
8. Put capsules and some salts in zip-close and move right left and shake for
30 seconds.
9. Pour zip-close content in sieve 10 .
10.Put capsules in suitable dry glass container and labeling good.
Results :
You will produce pharmaceutical capsules used in medicine propose.
Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask

18
Pharmaceutics practical 4

Experiment No (9)
Experiment Of : filling and polishing Capsules
Objectives of Experiment :
Students will be study of :
1. Training to approaching filling and polishing Capsules manually.
2. Training to how can be taking chemical substances to filling and
polishing Capsules proposes.
3. Training to work in group.
Terms & Definitions :
Capsule : is a unit dosage form in which drug or drugs with or without excipients
are enclosed in a hard or soft water-soluble shell or a container of
gelatin or of any other suitable substance. It is intended for oral
administration.
Principle of Experiment :
Emptying trade drugs capsules and refilling them, then close and polishing.
Tools Materials
1. Watch dish 1. Trade drugs capsules
2. Zip-closed 2. Salt
3. Balance
4. Sieve 10
5. Paper

Procedures :
1. Open trade drug capsules about 10 – 15 cap.
2. Emptying into watch dish.
3. Keep capsules ( body & cover ) side.
4. Refilling body of capsule manually by collecting up down.
5. Close body of capsule with cover.
6. Weight it each one one and write the weight in your note.
7. Capsules have some powders and fingers work, so need to polish with salt.
8. Put capsules and some salts in zip-close and move right left and shake for
30 seconds.
9. Pour zip-close content in sieve 10 .
10.Put capsules in suitable dry glass container and labeling good.

19
Pharmaceutics practical 4

Results :
You will produce pharmaceutical capsules used in medicine propose.

Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask
See below picture to more clearing about exercise:

1 2 3

4 5 6

20
Pharmaceutics practical 4

Experiment No (10)
Experiment Of : Density of solid preparation
measure Angle of repose for powder dosage form
Objectives of Experiment :
Students will be study of :
1. Training to determine density of solid preparation in laboratory.
2. Training to measure angle of repose for powder dosage form in
laboratory.
3. Training to work in group.
Terms & Definitions :
Density : is determination of mass 1 gm in volume 1 ml, and calculated by
following law :-

Angle of repose: is test to detect regulatory of particles of powders after


granulation method, and calculated by using law :
( )
Principle of Experiment :
For density determine : by weighing solid dosage form on balance then measuring
its volume of tablets and application law .
For angle of repose : by pour powder from limited high and upon gravity acts,
static heap of powder formed, measure diameter and high of heap then
application law.
Any trade tablets for density determine.
Prepare powder preparation from previews experiment to measure AR.
Tools Materials
1. Beaker 250 ml 1. Trade product of tablets
2. Balance 2. Prepared powder.
3. Glass cylinder
4. Large Funnel
5. Burette holder
6. Ruler
7. White Paper
8. Pencil

Procedures :
21
Pharmaceutics practical 4

For density determine :


1. Good washing glass cylinder with water and dry it with clean paper.
2. Fill it with distilled water to 25 ml.
3. Weigh 20 tabs and write no. of weigh = w.
4. Put tabs in cylinder and note increasing of water level above 25 ml.
5. Write the increased volume = v.
6. Apply on law of density and write the result.
For angle of repose measuring :
7. Plug the large funnel on burette holder on high 10 cm from surface of
punch.
8. Put white paper under funnel on the surface of punch.
9. Pour 50 g of powder in funnel slowly and note flowbility in it down to
paper.
10.If particles fine and regular it flow without resistance and not the friction,
and if particles irregular the resistance and the friction happen.
11.Drew diameter around heap of powder and by ruler measure high of heap.
12.Apply on law and calculate then write the result.
13.Good washing all tools and pinch
Results :
You will able to determine density to detection any errors during compression.
And results of AR must be detection of regulatory of particles, see below table:

Precaution :
- Wear lab-coat with link bubble.
- Wear gloves and face mask
See the below picture to more clearing to exercise :

22
Pharmaceutics practical 4

Finally much wishes for all pharmacy students for good future.

References :
1- University of Toronto, Topics in Pharmaceutical Quality and Clinical Laboratory
Medicine Laboratory Manual : faculty of pharmacy.
http://phm.utoronto.ca/pharmlab. 24/8/2019
2- Rola M. Gamil & els. Pharmaceutics in Arabic: Thaqafa for Publishing.2006.
3- Standards of practices for the pharmacy technician,
4- Allen LV, Popovich NG, Ansel HC. Ansel’s Pharmaceutical Dosage Forms and
Drug Delivery Systems.Philadelphia: Lippincott, Williams & Wilkins, 2004.
5- Shrewsbury R. Applied Pharmaceutics in Contemporary Compounding.
Englewood, CO: Morton Publishing, 2001.
6- Thompson J, Davidow L. A Practical Guide to Contemporary Pharmacy
Practice, 3rd ed. Philadelphia: Lippincott, Williams & Wilkins, 2004
-------------------------------------------------------------------------------------------------------------------

Thanks , Dr. Mohammed Abdul Malek Hamood Al-Kassem

23

You might also like