Compounding of Gels/ Jellies – PST05208 Pharmaceutics Theory and Compounding

NTA Level 5 • Semester 2 • PST05208

Compounding of Gels/ Jellies

Pharmaceutics Theory and Compounding • Source Session/Topic 10
Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability.

Session 10: Compounding of Gels/ Jellies

Total Session Time: 120 Minutes

Prerequisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

 Give overview of gels

 Describe procedures for preparing gels

 Prepare gels

 Label prepared gels

 Dispense prepared gels into suitable containers and closure

Resources Needed:

• Flip charts, marker pens, and masking tape
• Black/white board, chalk and whiteboard markers
• LCD projector and computer
• Figure 10.1: Gels jars and tube

SESSION OVERVIEW

Activity/

Step Time Content

Method

1 05 Minutes Presentation Introduction, Learning Tasks

Presentation

2

25 Minutes Buzzing Introduction to Gels

3 10 Minutes Presentation Procedures for Preparing Gels

Presentation

4 Preparing Gels

35 Minutes Demonstration

Presentation

5

25 Minutes Demonstration Labeling of Prepared Gels

Presentation Dispensing of Prepared Gels into Suitable Containers

6

10 Minutes Brainstorming and Closure

7 05 Minutes Presentation Key Points

8 05 Minutes Presentation Evaluation

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SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing.

STEP 2: Introduction to Gels (25 minutes)

Activity: Buzzing (5 minutes)

ASK students to pair up and buzz on the following question for 2 minutes

• What are Gels?

ALLOW few pairs to respond and let other pairs to add on points not mentioned

WRITE their response on the flip chart/board

CLARIFY and SUMMARIZE by using the content below

• Gels are transparent (or translucent) semi-solid or solid preparations of either suspensions made

up of small inorganic particles or large organic molecules interpenetrated by a liquid

• Are semisolid systems consisting of dispersion of small or large molecules in an aqueous liquid

vehicle rendered jelly-like through addition of a gelling agent

• Movement of dispersing system is restricted by interlacing network of particles or solvated

macromolecules of dispersed phase

• Gels are made using substances (called gelling agents) that undergo a high degree of cross-

linking or association when hydrated and dispersed in the dispersing medium or when dissolved

in the dispersing medium

• Cross-linking or association of dispersed phase alters the viscosity of the dispersing medium
• Hence the movement of dispersing medium is restricted by the dispersed phase
• Two-phase System Gel

o Is when the gel contains a network of small discrete particles

• One or Single-phase System Gel

o When gels appear to have no discrete particles,

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o Macromolecules are uniformly distributed throughout the liquid, usually organics

o No apparent boundaries between dispersed macromolecules and the liquid

o Two-phase system gels are thixotropic

Gel mass consists of floccules of small distinct particles

Usually involve inorganics

Semisolid on standing but liquefy on shaking

If the particles in the two-phase systems are large

• The gel is called a Magma or Milk

Composition of gels is:

o Gelling agents

o Water

o Co-solvents

o Preservatives

o Stabilizers

• One-phase gels are made from synthetic or natural organic macromolecules distributed uniformly

throughout a liquid without any boundary between dispersed and dispersing phases (e.g.

tragacanth, cellulose, methylcellulose)

• If made from natural gum, single-phase gels are called Mucilages
• Some Gelling Agents

o Acacia, tragacanth, Methylcellulose,

o Alginic acid, Bentonite, Carbopol®,

o Carboxymethylcellulose (CMC),

o Gelatin, Hydroxypropyl cellulose,

o Magnesium Aluminium Silicate (Veegum®) etc

• Characteristic Properties of gels are:often non-greasy, smooth, elegant, produce cooling effect on

application and easily washable from skin

STEP 3: Procedures for Preparing Gels (10 minutes)

• Specific method depends on gelling agent

o e.g. gelatin gels

o By dispersing gelatin in hot water followed by cooling OR

o By wetting gelatin with organic liquid e.g. Propylene glycol, followed by addition of hot water

and cooling

• Example of a gel formulation:
• Methylcellulose and Carbomer Gel Base

o Methylcellulose, 4000cps 1.0%

o Carbomer 934 0.35%

o 1N Sodium Hydroxide Solution qs to pH 7

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o Propylene glycol 16.7%

o Methyl paraben 0.015%

o Purified water, qs 100

o Disperse the methylcellulose in a portion of hot (80-90°C) water

o Cool to room temperature, and disperse the Carbomer 934 in the gel using a bladed stirrer.

o Adjust the pH of the dispersion to 7.0 by adding sufficient 1N Sodium hydroxide solution.

o Dissolve the methylparaben in the propylene glycol. Mix the methylcellulose, Carbopol 934

and propylene glycol fractions using caution to avoid incorporating air.

STEP 4: Preparing of gels (35 minutes)

Activity: Demonstration (45 minutes)

DIVIDE students in small manageable groups.

PREPARE equipment and materials needed for demonstration

POSITION students so that everyone can see and hear

REVIEW steps of preparing pastes with students

REFER students to the official formula of preparing Ichthammol gel IP In the

Tanzania Pharmaceutical Handbook

DEMONSTRATE the procedure of preparing ointments according to the instruction under

the official formula in the Tanzania Pharmaceutical Handbook (Mitte 50g)

ALLOW one student from each group to do a return demonstration and let others comment

on it

CLARIFY and SUMMARIZE Using the content below

INFORM the students that “every student will practice in the skills laboratory under

supervision until is competent”

• Official formula given for Ichthammol gel PCx

Ichthammol……………………………………………………….. 1.0g

Tragacanth, in powder……………………………………………… 2.5g

Alcohol 90%……………………………………………………………… 5.0g

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Glycerin……………………………………………………………… 1.0g

Purified water q.s………………………………………………………… 50.0g

Mitte 50.0g for Allen Mbogo

• Thus, amount of official formula = 100g
• Total amount required = 50g
• Amount of each ingredient (x) =?
• FACTOR= Required amount

Official amount

= 50g

100g

= 0.5

Then, amount of each ingredient can be obtain as summarised in the table below:

Formula Official amount Factors Required amount

Ichthammol 1.0g 0.5g

Tragacanth, in powder 2.5g 0.5 1.25g

Alcohol 90% 5.0g 2.5g

Glycerol 1.0g 0.5g

Purified water q.s 50.0g 25g

Procedure:

• Prepare Ichthammol solution:

o According to solubility,

o 1g Ichthammol 10ml water

• Formula for Ichthammol solution:

o Ichthammol 1.0g

o Glycerol 1.0g

o Water 10ml

Weigh empty beaker (preferably plastic) and weigh1.0g of Ichthammol and 1.0g of glycerol directly

into beaker. Add about 10ml of water then stir until obtaining solution.

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• Prepare mucilage:

o Calculate amount of water

o Final weight of jelly – other ingredients.

-50g – (1.0g+2.5g+5.0g+1.0g)

Ichthammol Tragacanth Alcohol Glycerol

(Approximate Conversion)

=50g – 9.5g =40.5g – 40g =40ml water used in preparation

10ml water has been used for Ichthammol solution

40ml – 10ml=30ml: Amount of water can be used for mucilage.
• Formula for mucilage

o Tragacanth 2.5gm

o Alcohol (90%) 5.0mL

o Water 30mL

• Weigh2.5g of Tragacanth and measure 5.0ml of alcoholand

30ml of water.

o Place alcohol first in mortar and add Tragacanth onto alcohol then disperses by pestle.

o After obtaining uniform dispersion, add water as quickly as possible at once then mix well.

NB: Alcohol should be placed first otherwise may lead lump formation

• Combine:

o Add Ichthammol solution into the mucilage in portion triturate frequently scraping off the

material from the side soft hemortar and the pest leuntil obtaining completely uniform

mixture

• Adjust final weight:

o Weigh the empty dispensing container, then transfer jellies into the container.

o Make the required weight by rinsing the mortar and pestle with a small amount of water.

o When the weight is made up, mix the contents well by stirring rod

o Make sure that the product is uniform

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STEP 5: Labeling of Prepared Gels (25 minutes)

• As for other external semisolids or otherwise stated

Activity: Demonstration (10 minutes)

DIVIDE students in small manageable groups.

PREPARE equipment and materials needed for demonstration

POSITION students so that everyone can see and hear

REVIEW steps of writing a label

REFER students to the important things required to appear on the label.

DEMONSTRATE on how to write a good label

ALLOW one student from each group to do a return demonstration and let others comment

on it

CLARIFY and SUMMARIZE by using the content below

INFORM the students that “every student will practice in the skills laboratory under

supervision until is competent”

• Example of labels:

For External Use Only

ICHTHAMMOL GEL IP

50g

Spread the medicine in a thin layer and then apply to the affected part every twelve

hours for seven days

The name of the dispenser and the name and address of the dispensing Institution

Preparation date

Expiry date

Keep Out of Reach of Children

Keep away from heat

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STEP 6: Dispensing of Prepared Gels into Suitable Containers and

Closure. (10 minutes)

Activity: Brainstorming (5 minutes)

Ask students to brainstorm on the following question:

• What are suitable containers and closure for gels?

ALLOW few students to respond?

WRITE their responses on the flip chart/ board

CLARIFY and SUMMARISE by using the content below

• Containers containing gels should be well filled to minimise evaporation of water
• Well closed and stored in a cool place to prevent drying out
• Collapsible tubes should be used for packing the sterile products such as catheter

Figure 10.1: Gels jars and tube

Source: Pharmaceutical Compounding and Dispensing (2008).

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STEP 7: Key Points (5 minutes)

• Gels are transparent (or translucent) semi-solid or solid preparations of either suspensions made

up of small inorganic particles or large organic molecules interpenetrated by a liquid

• Procedures for preparing gels include: by dispersing gelatin in hot water followed by cooling OR

by wetting gelatin with organic liquid e.g. Propylene glycol, followed by addition of hot water

and cooling

• Suitable containers and closure for creams are: containers containing gels should be well filled to

minimise evaporation of water, well closed and stored in a cool place to prevent drying out and

collapsible tubes should be used for packing the sterile products such as catheter

STEP 8: Evaluation (5 minutes)

• What are gels?
• What are procedures for preparing gels?
• What are suitable containers and closure for gels?

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References

Britain, R. P. S. o. G. (1994). The Pharmaceutical Codex (12 ed.). London: London Pharmaceutical

Press.

Winfield, J. A. R., I. Smith. (2009). Pharmaceutical Practice (4th ed.)British

Wolverton, SE. Comprehensive Dermatologic Drug Therapy. WB Saunders. 2001. pp 563-572.New

York

Singh Malik, D; Mital, N; Kaur, G (2016). "Topical drug delivery systems: a patent review". Expert

opinion on therapeutic patents. 26 (2): 213–28. Sudan

Senya, S. S., Mwasha, C. Y. S., Muyinga, A. M., Amiri, R. I., & Mauga, E. A. S. K. (2011). Tanzania

Pharmaceutical Handbook (2nd ed.). Dar es salaam.

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