EVALUASI KESTABILAN SUSPENSI

Metode Evaluasi Suspensi

1. Volume Sedimentasi ( F ) F = HU/H0 x 100 % Harga F = > 1 < = yang besar menunjukkan produk yang baik

Sedimentation volumeF = Vsed/Vtot The value of F normally lies between 0 to 1 for any pharmaceutical suspension. The value of F provides a qualitive knowledge about the physical stability of the suspension.

Volume Sedimentasi
F={ volume sedimen Vu }/{ volume awal Vo } Vu Vo Vo

Vu

F=0.5

F=1.0

F=1.5

Degree of flocculation = Ffloc/Fdefloc (Vsed/Vtot)floc =------------------(Vsed/Vtot)defloc

When the total volume of both the flocculated and the deflocculated suspensions are same, as for example, 100 ml in the Figure; the degree of flocculation,

= (Vsed)floc/(Vsed)defloc

2. Kontrol Ukuran Partikel u/ evaluasi adanya agregasi atau pertumbuhan kristal terjadi perubahan ukuran partikel a/ tidak selama penyimpanan 3. Redispersibilitas 4. Penentuan Rheologi selama penyimpanan ada perubahan atau tidak viskositas dan tipe alir 5. Mudah tidaknya suspensi dituang

Instability particle size distribution

Particle size increases with time due to:
1) Temperature fluctuations: - Small particle dissolve more easily 2) Ostwald ripening (or coarsening): - Solubility in the near vicinity of small particles is higher than in the near vicinity of large particles (isothermal process) - Particles also become more spherical

Temperature fluctuations
Usually solubility increases with increasing temperature

Temperature increase

Temperature decrease

Ostwald ripening (1)

Particle 2 Particle 1 mS(a)1 mL(a)1 mL(a)2 mS(a)2

Smaller radius of the curvature of particle 1 is than of particle 2

2g Pressure difference over curved surface (La Places law): Dp = r

pressure in particle 1 > pressure in particle 2
mS(a)1 > mS(a)2 chemical potential, m, increases with increasing pressure

Ostwald ripening (2)

mS(a)1

mL(a)1
x(a)1

mL(a)2
x(a)2

mS(a)2

mS(a)1 > mS(a)2

At equilibrium: mS(a)1 = mL(a)1 en mS(a)2 = mL(a)2

mL(a)1 > mL(a)2

mL (a) + RT ln x(a)1 > mL(a) + RT ln x(a)2

x(a)1 > x(a)2

Packaging and Storage of Suspensions: 1) Should be packaged in wide mouth containers having adequate air space above the liquid. 2) Should be stored in tight containers protected from: freezing and excessive heat & light 3) Label: "Shake Before Use" to ensure uniform distribution of solid particles and thereby uniform and proper dosage.

ASA

SA

SA