IPS1 - [Granules] - Characteristics And Method Of Granulation

Proverbs 16:3

Granules

These are composed of dry aggregates of powder particles.

Granules

These are also known as COARSE particles.

Coarse Particles

Granules are also known as ____

TRUE

TRUE OR FALSE:

Granules may be swallowed as such, dispersed in food, or dissolved in water.

TRUE

TRUE OR FALSE:

Granules MAY BE compacted into TABLETS OR filled into CAPSULES.

No. 4-12 sieve

Sieve size of GRANULES

No. 12-20 sieve

Sieve size of GRANULES for TABLET FORMULATION

TRUE

TRUE OR FALSE:

Granules are PREFERRED over fine powder particles for tablet and capsule manufacture.

● Compressibility

● Flowability

● Decreased rate of dissolution

● Prevents violent and uncontrollable effervescence

Reasons why granules are used instead of fine powders

● FREE-FLOWING, thus are used in tablet making

● MORE STABLE to the effects of atmospheric humidity

● LESS LIKELY to CAKE or HARDEN upon standing

● MORE easily WETTED

Characteristics of GRANULES

TRUE

TRUE OR FALSE:

Granules are FREE-FLOWING, used in TABLET-making.

TRUE

TRUE OR FALSE:

Granules are MORE stable to the effects of atmospheric humidity.

TRUE

TRUE OR FALSE:

Granules are LESS likely to cake or harden upon standing.

TRUE

TRUE OR FALSE:

Granules are MORE easily wetted.

1. Dry Granulation Method

2. Wet Granulation Method

Methods of Granulation

Dry Granulation Method

[METHODS OF GRANULATION]

This method is also known as DRY FUSION METHOD.

Dry fusion method

[METHODS OF GRANULATION]

Dry Granulation Method is also known as:

Dry Granulation Method

[METHODS OF GRANULATION]

This method is used for drugs that are MOISTURE-SENSITIVE or HEAT LIABLE.

● Moisture sensitive

● Heat liable

[METHODS OF GRANULATION]

Dry Granulation method is used for drugs that are:

Dry Granulation Method

[METHODS OF GRANULATION]

In this method, the water of crystallization from CITRIC ACID serves as the BINDING AGENT.

Citric acid

[METHODS OF GRANULATION]

In this Dry Granulation Method, the water of crystallization from ___ serves as the BINDING AGENT.

Binding agent

[METHODS OF GRANULATION]

In this Dry Granulation Method, the water of crystallization from CITRIC ACID serves as the ___ agent

Dry Granulation Method

[METHODS OF GRANULATION]

In this method, HEATING causes the release of WATER OF CRYSTALLIZATION from the CITRIC ACID.

Heating

[METHODS OF GRANULATION]

In this Dry Granulation Method, ____ causes the release of WATER OF CRYSTALLIZATION from the CITRIC ACID.

Dry Granulation Method

[METHODS OF GRANULATION]

Process includes:

1. MIXING the powders

2. DRYING the powders

3. SIEVING

4. DRYING the granules

1. MIXING the powders

2. DRYING the powders

3. SIEVING

4. DRYING the granules

[METHODS OF GRANULATION]

Process of Dry Granulation Method

Dry Granulation Method

[METHODS OF GRANULATION]

Examples of substances used in this method are aspirin, thiamine, ascorbic acid, and magnesium hydroxide.

● Aspirin

● Thiamine

● Ascorbic acid

● Magnesium hydroxide

[METHODS OF GRANULATION]

Example of substances under DRY GRANULATION method

cohesive properties

[METHODS OF GRANULATION]

In DRY GRANULATION method, one of the constituents, either the active ingredient or the diluent, must have ___ properties

Wet Granulation Method

[METHODS OF GRANULATION]

This method is the WIDELY USED and BEST method of granulation but it is TIME-CONSUMING.

Wet Granulation Method

[METHODS OF GRANULATION]

This method is also known as WET FUSION METHOD.

Wet Fusion Method

[METHODS OF GRANULATION]

Wet Granulation Method is also known as ____

Wet Granulation Method

[METHODS OF GRANULATION]

This method involves the ADDITION of small amounts of LIQUID (water, ethanol, isopropyl alcohol) which acts the BINDING agent.

● Water

● Ethanol

● Isopropyl alcohol

[METHODS OF GRANULATION]

Liquids used in WET GRANULATION method as the binding agents.

Wet Granulation Method

[METHODS OF GRANULATION]

GENERAL process includes:

1. MOISTEN the powder

2. FORM a SOLID mass

3. SCREEN or SIEVE to form granules

4. DRY the granules

1. MOISTEN the powder

2. FORM a SOLID mass

3. SCREEN or SIEVE to form granules

4. DRY the granules

[METHODS OF GRANULATION]

General process of Wet Granulation Method

1. Blending

2. Wet massing

3. Wet screening

4. Drying

5. Dry screening

6. Lubrication

7. Compression

[METHODS OF GRANULATION]

STEPS of Wet Granulation Method

Effervescent Granulated Salts

These are COARSE or VERY COARSE powders containing a soluble medicinal agent in a dry mixture usually composed of:

● Active Pharmaceutical Ingredient (API)

● Alkalinizer: Sodium bicarbonate

● Acidifiers: Citric acid and tartaric acid (ratio 1:2)

● Active Pharmaceutical Ingredient (API)

● Alkalinizer: Sodium bicarbonate

● Acidifiers: Citric acid and tartaric acid (ratio 1:2)

Composition of Effervescent Granulated Salts

Sodium bicarbonate

ALKALINIZER used in Effervescent Granulated Salts

● Citric acid

● Tartaric acid

ACIDIFIERS used in Effervescent Granulated Salts

1 citric acid : 2 tartaric acid

RATIO of citric acid and tartaric acid used in Effervescent Granulated Salts

carbon dioxide

When Effervescent Granulated Salts are mixed with water, acids and base react to liberate ___ resulting in effervescence.

Water (H2O)

The addition of ____ in Effervescent Granulated Salts results in effervescence which mask the undesirable taste of the drug.

Tartaric acid

When this acidifier is used alone, granules CRUMBLE easily and LOSE FIRMNESS.

Citric acid

When this acidifier is used alone, granules become STICKLY and DIFFICULT to granulate.

The granules will LOSE their FIRMNESS and CRUMBLE.

This happens if TARTARIC acid is used alone in making Effervescent Granulated Salts.

Granules become STICKY and DIFFICULT to GRANULATE.

This happens if CITRIC acid is used alone in making Effervescent Granulated Salts.