Norita - Pharmaceutical Engineering 5 - Assignment 4

Norita Pharmaceutical Engineering 5
1. Explain the theory and sedimentation behavior of flocculated and deflocculated suspension and the relevance with pharmaceutical suspension dosage form. Theory of Fluccolated and Deflocculated Suspension Flocculation is the formation of light, fluffy groups of particles held together by Van Der Waals forces. The basic concern in developing a suitable suspension is to adequately control the rate of settling and ease of redispersion, as well as, the prevention of caking the particles as a dense mass at the bottom of the container. The best approach is to achieve a controlled flocculation of the particles, where they appear as floccules or like tufts of wool with a loose fibrous structure. These particles settle rapidly, forming a loose adhering system with a large sediment height. Deflocculation is the absence of association which occurs when repulsive forces between particles predominate. If repulsion forces prevail, the particles separate or deflocculate. Particles in these systems settle very slowly in stages, but ultimately form a dense sediment which is considerably more compact than the corresponding sediment of a flocculated system and more difficult to resuspend. Particle motion in the suspension is due to Brownian motion, convection currents, and sedimentation. When the particles settle, a dense mass is formed since there is no association between deflocculated particles. Downward movement due to gravity and the lateral motion due to Brownian movement facilitates tight packing of larger particles with the smaller particles filling the void spaces. Particles at the bottom of the cake are gradually pressed together by the weight of the ones above. In order to stabilize deflocculated systems, it is necessary to add a suspending and gelling agent to retard settling and agglomeration of the particles by functioning as an energy barrier. Sedimentation Behavior of Flocculated and Deflocculated Suspension Flocculated Suspensions In flocculated suspension, loose aggregates will cause increase in sedimentation rate due to increase in size of sedimenting particles. Hence, flocculated suspensions sediment more rapidly. Here, the sedimentation depends not only on the size of the flocs but also on the porosity of flocs. In flocculated suspension the loose structure of the rapidly sedimenting flocs tends to preserve in the sediment, which contains an appreciable amount of entrapped liquid. The volume of final sediment is thus relatively large and is easily redispersed by agitation.

Deflocculated suspensions In deflocculated suspension, individual particles are settling, so rate of sedimentation is slow which prevents entrapping of liquid medium which makes it difficult to redisperse by agitation which called cracking. In deflocculated suspension larger particles settle fast and smaller remain in supernatant liquid so supernatant appears cloudy whereby in flocculated suspension, even the smallest particles are involved in flocs, so the supernatant does not appear cloudy. Comparative Properties of Flocculated and Deflocculated Suspension Flocculated Suspension Particles form loose aggregates Rate of sedimentation is high, so it formed rapidly The sediment eventually becomes very loosely packed and easy to disperse, so as to reform the original suspension The suspension is somewhat unslightly, due to rapid sedimentation and the presence of an obvious, clear supernatant region. The suspension has a pleasing appearance because uniform dispersion of particles Deflocculated Suspension Particle exist in a suspension as separate entities Rate of sedimentation is slow, so it formed slowly The sediment eventually becomes very closely packed and hard cake is reformed so hard to redisperse
2. Advantage and disadvantage of flocculated and deflocculated system in pharmaceutical preparation. Flocculation Advantages Flocculation removes contaminants and loose, airborne particles from water or other solutions. It is very simple and is produced when flocculants are added to a solution and the particles bond together. Flocculation can be done in a lab or in the Disadvantages Flocculation only occurs in liquids and cannot be used on metals or other substances. Not all flocculants can be used with the same solutions or under the same conditions. The suspension is somewhat unslightly,

field and takes minutes or hours, depending on the quantity of the solution. It can also be stopped or prevented by adding deflocculants to a solution. Rate of sedimentation is high, therefore it form rapidly. due to rapid sedimentation and the presence of an obvious, clear supernatant region. This can be minimized if the volume of sediment is made large. Ideally, volume of sediment should encompass the volume of the suspension.
Deflocculation Advantages T he suspension has a pleasing appearance, since the suspended material remains suspended for a relatively long time. Particles settle independently and separately. Disadvantages Rate of sedimentation is slow, as the sizes of particles are small. The sediment eventually becomes very closely packed, due to weight of upper layers of sedimenting material. Repulsive forces between particles are overcome and a hard cake is formed which is difficult, if not impossible, to redisperse.
3. Explain the electrolytes and zeta potential related with the stability of suspension system. Zeta Potential The zeta potential is defined as the difference in potential between the surface of the tightly bound layer (shear plane) and electro-neutral region of the solution. The potential drops off rapidly at first, followed by more gradual decrease as the distance from the surface increases. This is because the counter ions close to the surface acts as a screen that reduce the electrostatic attraction between the charged surface and those counter ions further away from the surface. Zeta potential has practical application in stability of systems containing dispersed particles since this potential, rather than the Nernst potential, governs the degree of repulsion between the adjacent, similarly charged, dispersed particles. If the zeta potential is reduced below a certain value (which depends on the particular system being used), the attractive forces exceed the repulsive forces, and the particles come together, which called

flocculation. Deflocculation of particles is obtained when the zeta potential is higher than the critical value and the repulsive forces supersede the attractive forces. Electrolytes Electrolytes act by reducing the zeta potential, which brings the particles together to form loosely arranged structures. The flocculating power increases with the valency of the ions. Hence, calcium ions are more powerful than sodium or potassium ions. However, trivalent ions are less commonly used because of their toxicity. When electrolytes are added to a positively charged deflocculated suspension, zeta potential decreases slowly. At certain stage, upon persistent addition, it becomes zero. Beyond that limit, zeta potential becomes negative. As zeta potential decreases, the sedimentation volume increases sharply up to a point. The sedimentation volume reaches its maximum value and remains relatively constant within a certain range of zeta potential, where it changes from low positive potential to low negative potential. When the potential becomes too negative, the sedimentation volume decreases again. An experiment by microscopic examination showed that flocculation increases with the addition electrolytes, and the extent of flocculation coincided with the sedimentation volume. Caking was observed at less than the maximum values of sedimentation volume.
4. Why multiple emulsion system which is water in oil in water and oil in water in oil is used? Multiple emulsions are complex systems in which the drops of the dispersed phase contain smaller droplets that have the same composition as the external phase. Normally consist of a liquid that is miscible, and in most cases identical, with the continuous phase.The most promising use of multiple emulsions is in the area sustained release, drug formulation since the oil layer between the two aqueous phases can behave like a membrane controlling solute release. The main reason why multiple emulsion was used is to deliver the API achieve the target of releasing. Other reason of multiple emulsions were used because the system was: Remarkable degree of biocompatibility Complete biodegradability Hydrophilic as well as hydrophobic drug can be entrapped Protection from the inactivation by the endogenous factors Increase in drug dosing intervals Taste masking of bitter drugs

Water in oil in water (W/O/W) Water-in-oil-in-water (W/O/W) multiple emulsions are emulsion systems where small water droplets are entrapped within larger oil droplets that in turn are dispersed in a continuous water phase. Because of the presence of a reservoir phase inside droplets of another phase that can be used to prolong release of active ingredients. W/O/W emulsion possess many of the advantages of W/O emulsion, but in addition have a low viscosity due to the lower viscosity of the aqueous external phase, which makes them more convenient and useful especially to inject/ W/O/W multiple emulsions may be prepared with two step procedures. W/O/W emulsions able to break and release their inner aqueous phase under shear rate are which compatible with cosmetic applications. A unique property of W/O/W multiple emulsions compared to simple W/O emulsions is the diffusion of water through the oil phase because of unbalanced osmotic pressures between the internal and external aqueous phases. The oil layer acts as a membrane separating these 2 aqueous phases. Polar molecules dissolved in either the internal aqueous phase or the external continuous aqueous phase can pass through the oil layer by diffusion because of the concentration gradient. In the case of water this is driven by osmotic pressure. Oil in water in oil (O/W/O) In O/W/O systems an aqueous phase (hydrophilic) separates internal and externaloil phase. In other words, O/W/O is a system in which water droplets may besurrounded in oil phase, which in true encloses one or more oil droplets. Liquid membrane emulsions of the o/w/o type have been used to separate hydrocarbons where the aqueous phase serves as the membrane and a solvent as the external phase.

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Norita Pharmaceutical Engineering 5