Pengembangan Formula Bentuk Suspensi

PENGEMBANGAN
FORMULA
BENTUK
SUSPENSI
Nurus Sobah, M.Farm.Klin., Apt.

Learning Objective
– Describe definition, characteristics, type of suspension

– Describe the stability problems of suspension
– Describe the aspects of suspension stability
– Ability to solve the stabilty problems
Suspension Suspension
Ai
r
EMULGATOR
Suspensions are dispersions of an

insoluble drug or other substance in Continous Phase
an aqueous or nonaqueous continuous
phase.
Characteristics of an Acceptable Suspension
1. Suspended material should not settle too rapidly.
2. Particles that settle to the bottom of the container should not

form a hard mass (cake) but should be easily re-dispersed on
shaking
3. The suspension should not be too viscous to pour freely from a

bottle or to flow through a needle
4. The average of particle size should be 0,1 – 100 µm

Advantages of Suspension
1. Taste masking
2. Suitable for children or people who have difficulity

in swallowing tablets/ capsules
3. More easily absorbed (than tablets or capsules)
4. More suitable for topical use

Disadvantages of Suspension
1. Stabilty ↓ (crystal growht, degradation)
2. Homogenity ↓ (physical stabilty  caking)
3. Dose accuracy ↓ (than solution)

Type of Supension
Oral Topical Ear Drop
Opthalm
Injection
ic
Stability of Suspension (1)
1. Physical Stability
the particle do not aggregated and in which they remain Seldom Realize
uniformly distributed throughout the dispersion
If the particle do settle, they should be easily

resuspended by a moderate amount of agitation
2. Thermodinamically Stability
The large surface area of the particles that result from the comminution is
associated with a surface free energy that makes the system
thermodinamically unstable.
Stability of Suspension (2)
The aim in the formulation of suspensions is to achieve

partial or controlled flocculation.
Aspects of Suspension Stability (1)
1.Surface Free Energy
ΔG : Surface Free Energy

ΔA : Total Surface Area
Flocculated : to form light, fluffy conglomerates that are

held together by weak van der Waals force.
Agglomerates : the particles may adhere by stronger force
make a compacted cake
Caking : occurs by the growth and fusing together of
crystal in precipitates to produce a solid aggregates.
Aspects of Suspension Stability (2)
2. Zeta Potential (ζ)
a. Changes in ζ on addition og flocculating agents, surfactans and othe additives can be used
to predict the
stability of system.
b. Flocculation can therefore be controlled by use of ionic spesies with a charge opposite to
the charge of
the particles dispersed in the medium.
Settling in Suspension (1)
1. Theory of Sedimentation
Suspension that contain dispersed particles in concentration of 5%,

10% or higher, the particles exhibit hindered settling
Stability can be obtained by diluting the suspension about 0,5% - 2%

of dispersed phase.
1.Effect of Brownian Movements
Brownian Movements counteracts

sedimentation of particles having a
diameter about 2 – 5 µm
1. Sedimentation of Flocculated Particles
The floc tend to fall together
Deffloculated suspension  the larger particles settle more rapidly than the smaller particles and the
supernatan remains turbid for a considerably longer period of time.
Sedimentation Parameters:
F: Sedimentation volume
Vu : Volume of the sediment
Vo : The original volume of suspension before settling
F can have values ranging from less than 1 to greater than 1

A more useful parameters fo flocculation is β (degree
of flocculation)
Controlled Flocculation (1)
1. The addition of electrolyte or ionic surfactants that

reduce the zeta potential, and hence VR, to give a
satisfactory secondary minimum in which flocs
may be formed.
2. In the absence of charge on the particles

flocculation may be controlled using non-ionic
polymeric material including naturally occurring
gums (e.g. tragacanth) and cellulose polymers
(e.g. sodium carboxymethylcellose)
Controlled Flocculation (2)
The ideal suspending agent for controlling

flocculation should:
– be readily and uniformly incorporated in the formulation

– be readily dissolved or dispersed in water without resort to
special
techniques
– ensure the formation of a loosely packed system which does
not
cake
– not influence the dissolution rate or absorption rate of the
drug
Formulation of Suspension
1. Wetting Agent  surfaktan, gliserin, PG
2. Elektrolit  mengurangi barier elektrik
3. Surfaktan  menghasilkan flokulasi dar partikel yang

tersuspensi
4. Polimer (senyawa rantai panjang, BM tinggi dan

mengandung gugus aktif di sepanjang gugusnya)  zat
pemflokulasi karena sebagian diadsorbsi pada permukaan
Evaluasi Stabilitas Fisik
1.Evaluasi Laju Sedimentasi
2.Evaluasi Volume Sedimentasi
3.Evaluasi Waktu Redispersi  terdispersi

sempurna dengan pengocokan dalam
waktu maksimal 30 detik
Evaluasi Sifat Fisika
1.Evaluasi Viskositas
Viskositas dapat dinaikkan dengan
penambahan suspendng agent.
2.Evaluasi Kerapatan Partikel (Bobot Jenis)

Kerapatan zat terlarut umumnya lebih
besar darpada pelarutnya. Karena bila
bobot jenis zat terlarut lebih kecil 
partikel akan mengambang dan sulit
didistribusikan dalam medium pendispersi
Procedures (1)
1. Add 180 g of purified water to the mixer and heat to 90 0C
2. Dissolve item 3 and 4 while mixing  see the solubility profile
3. Add and dissolve item 2 while mixing
4. Cool down to approximately 500C – 550C
5. Add and dissolve item 5 while mixing
6. Collect the syrup in a clean stainless steel tank
7. Disperse item 9 in item 6 in a separate stainless steel container
8. Add 40 g of hot purified water (900C) at once while mixing
9. Mix f0r 20 minutes to make a homogeneous smooth mucilage
10. Mix item 7 in 10 g of purified water (250C) in a separate stainless steel container
11. Add item 1 while mixing with stirrer
12. Mix for 25 minutes to make uniform suspension
13. Add sugar syrup and mucilage to the mixer
14. Rinse the container of mucilage with 15 g of purified water and add the rinsings to the mixer
15. Cool to 250C while mixing
16. Add item 1 dispersionto the mixer
17. Rinse the container dispersion with 15 g of purified water and add rinsings to the mixer
18. Check the suspension for uniformity of dispersion
Procedures (2)
19. Add item 8 to the mixer and mix for 10 minutes
20. Dissolve item 10 in 7 g of purified water and add to the mixer
21. Disperse tem 11 in 7 g of puriified water and add to the mixer
22. Add item 12 to the mixer
23. Add cold purified water (250C) to bring the volume up to 1 L
24. Homogenize for 5 minutes at low speed
25. Check the dispersion for uniformity
26. Check the pH
TERIMAKASIH

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PENGEMBANGAN

Nurus Sobah, M.Farm.Klin., Apt.

– Describe definition, characteristics, type of suspension

Suspensions are dispersions of an

1. Suspended material should not settle too rapidly.

2. Particles that settle to the bottom of the container should not

3. The suspension should not be too viscous to pour freely from a

4. The average of particle size should be 0,1 – 100 µm

2. Suitable for children or people who have difficulity

3. More easily absorbed (than tablets or capsules)

4. More suitable for topical use

1. Stabilty ↓ (crystal growht, degradation)

2. Homogenity ↓ (physical stabilty  caking)

3. Dose accuracy ↓ (than solution)

Oral Topical Ear Drop

If the particle do settle, they should be easily

The aim in the formulation of suspensions is to achieve

1.Surface Free Energy

ΔG : Surface Free Energy

Flocculated : to form light, fluffy conglomerates that are

2. Zeta Potential (ζ)

Suspension that contain dispersed particles in concentration of 5%,

Stability can be obtained by diluting the suspension about 0,5% - 2%

1.Effect of Brownian Movements

Brownian Movements counteracts

1. Sedimentation of Flocculated Particles

The floc tend to fall together

F can have values ranging from less than 1 to greater than 1

1. The addition of electrolyte or ionic surfactants that

2. In the absence of charge on the particles

The ideal suspending agent for controlling

– be readily and uniformly incorporated in the formulation

1. Wetting Agent  surfaktan, gliserin, PG

2. Elektrolit  mengurangi barier elektrik

3. Surfaktan  menghasilkan flokulasi dar partikel yang

4. Polimer (senyawa rantai panjang, BM tinggi dan

1.Evaluasi Laju Sedimentasi

2.Evaluasi Volume Sedimentasi

3.Evaluasi Waktu Redispersi  terdispersi

2.Evaluasi Kerapatan Partikel (Bobot Jenis)

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