Seminar On COARSE DISPERSION S & FINE DISPERSIONS :

1 Seminar On COARSE DISPERSION S & FINE DISPERSIONS BY N.NISHANTH KUMAR

Contents: :
2 Contents: Dispersion Coarse dispersion Fine dispersion Suspensions Emulsions Micro Emulsions Multiple Emulsions Conclusion Reference

Dispersion :
3 Dispersion A dispersion is defined as a heterogeneous system in which the internal or dispersed phase is uniformly dispersed in the external phase or dispersing medium. It may be kept in a state of dispersion for prolonged periods with the aid of suitable dispersing agents.

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4 Types of Dispersion: Coarse dispersion Fine dispersion Molecular dispersion Colloidal dispersion

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5 Coarse dispersion Suspensions Emulsions Fine dispersion Micro emulsions Multiple emulsion

Suspensions: :
6 Suspensions: Suspensions are the biphasic liquid dosage form of medicament in which the finely divided solid particles ranging from 0.5-5.0 microns are dispersed in a liquid or semisolid vehicle. The solid particles act as disperse in a liquid vehicle acts as the continuous phase. Suspensions are generally take orally or by parenteral route. They are also used for the external applications.

Advantages :- :
7 Advantages :- Stability Ease of administration In soluble drugs can be formulated in the form of suspension. Mask the taste: By adding flavors,sweetners. Ex. chloramphenicol palmitate

Disadvantages:- :

8 Disadvantages:- Dose precision is not achieved . So not suitable for potent drugs. The product is capable to undergo oxidation and hydrolysis. Sedimentation Flocculation

Classification of Suspensions :
9 Classification of Suspensions Suspensions are classified into four main classes those are Oral Suspensions Parenteral Suspensions Ophthalmic Suspensions Suspensions for external use

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10 Formulation of Suspensions Flocculating agents Suspending agents / Thickening agents Wetting agents Dispersing agents Preservatives Organoleptic additives

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11

Theories of suspensions :
12 Theories of suspensions Theory of Brownian movement: Brownian movement of particles prevents sedimentation. In general particles are not in a state of Brownian movement in suspensions, due to larger particle size & higher viscosity of the medium. Brownian movement can be observed, if the size of the particles is about 2 to 5 m, provided densities of the particles & viscosity of the medium are favorable.

Theory of sedimentation: :
13 Theory of sedimentation: Rate of sedimentation = d2 (1- 2) 18 Where, d= diameter of the particles, cm 1=density of the dispersed phase, g/cm3 2=density of the dispersion medium, g/cm3 = viscosity of the dispersion medium, poise g= acceleration due to gravity (980.7 cm/sec2)

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14 Stability of suspensions: A stable suspension can be redisperse homogenously with moderate shaking & can be easily poured throughout its shelf life. The most stable pharmaceutical suspensions are flocculated i.e. the suspended particles are bonded together physically to form a loose, semi-rigid structure. The non-flocculated suspensions can be made stable by decreasing the particle size of the suspended material or by increasing the density & viscosity of the vehicle.

Evaluation of suspensions: :
15 Evaluation of suspensions: The following methods are commonly used for evaluating the physical stability of suspension. Sedimentation method Rheological method Electrokinetic method Micrometric method

Emulsions :
16 Emulsions Def : An emulsion is a biphasic liquid preparation containing two immiscible liquids , one of which is dispersed as minute globules into the other. Classification Oil-in-water type (o/w) Water-in-oil type (w/o) Micro Emulsions Multiple Emulsions

Advantages: :
17 Advantages: Medicines having an unpleasant taste & odour can be made more palatable for oral administration in the form of an emulsion. Emulsion provides against drugs which are prone to oxidation or hydrolysis. Various external preparations such as creams, lotion & foam aerosols are formulated in emulsion.

Preparation of Emulsions: :
18 Preparation of Emulsions: Dry gum method Wet gum method Bottle method Other methods

Identification of type of emulsions :

19 Identification of type of emulsions Dilution test Dye test Conductivity test Fluorescent test

Stability of Emulsions :
20 Stability of Emulsions Creaming Cracking Phase Inversion

MICRO EMULSION :
21 MICRO EMULSION These emulsions are clear transparent solutions. They are appear to represent a state intermediate between thermodynamically unstable emulsions. They contain droplets of oil in water phase (o/w) or droplets of water in oil (w/o) with diameters of about 10 to 200 nm & the volume fraction of the dispersed phase varies from 0.2 to 0.8

Classification :
22 Classification Micro emulsions Micellar Solutions Conventional Emulsions (or) Macro emulsions

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23 Micellar Micro emulsion Emulsion Solution (10-200nm) (>1000nm) (2-5nm)

Advantages of Micro Emulsions :

24 Advantages of Micro Emulsions Micro Emulsions are thermodynamically stable system and the stability allows self-emulsification of the system whose properties are not dependent on the process followed. Micro Emulsions act as super solvents of drug. They can solubilize hydrophilic and lipophilic drugs including drugs that are relatively insoluble in both aqueous and hydrophobic solvents.

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25 This is due to existence of micro domains of different polarity within the same single-phase solution. Because of thermodynamic stability, micro emulsions are easy to prepare and require no significant energy contribution during preparation. Micro emulsions have low viscosity compared to other emulsions.

Disadvantages of Micro Emulsion :

26 Disadvantages of Micro Emulsion Micro emulsion stability is influenced by environmental parameters such as temperature and pH. These parameters change upon micro emulsion delivery to patients. Limited solubilizing capacity for high-melting substances

Important Characteristics of Micro-Emulsions :

27 Important Characteristics of Micro-Emulsions Particle size < 200 nm Thermodynamically stable Optically clear Surface area increased High solubilizing capabilities

Micro Emulsion Structure :

28 Micro Emulsion Structure

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29 Characteristics of Micro Emulsions: Particle size < 200 nm Thermodynamically stable Optically clear Surface area increased High solubilizing capabilities

Hypothetical Phase Regions of Micro emulsion :

30 Hypothetical Phase Regions of Micro emulsion

Characterization of Micro emulsions :

31 Characterization of Micro emulsions Phase Behavior Studies Scattering Techniques for Micro emulsions Characterization Nuclear Magnetic Resonance Studies Viscosity Measurements Predicting Micro emulsion Type

Applications: :
32 Applications: Micro Emulsions have industrial applications, one of them being the synthesis of polymers. Water-in-oil Micro Emulsions for some dry cleaning processes. Floor polishers and cleaners. Personal care products. Pesticide formulations.

Multiple Emulsions :
33 Multiple Emulsions These are the Emulsion systems in which the dispersed phase contain smaller droplets that have the same compositions the external phase. This is made possible by double emulsification hence the systems are called as Double emulsion these are two types; Oil-in-water-in-oil (O/W/O) Water-in-oil-in water (W/O/W)

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34 Principles of liquid surfactant membrane Emulsion When a W/O emulsion is dispersed in an outer aqueous phase, a three phase system is produced in which the two miscible aqueous phases are separated by organic phase. This organic phase is called liquid membrane. The organic phase is composed of a hydrocarbon solvent, emulsifiers and various additives. The composition of the organic membrane must satisfy two primary requirements. It must have the ability to form a stable emulsion. It must have negligible effect on drug activity.

Methods of preparation :

35 Methods of preparation Multiple emulsion systems can be formed by the re-emulsification of a primary emulsion or they can be produced when an emulsion inverts from one type to another, for example W/O to O/W. Two step Emulsification (Double Emulsification) Phase inversion technique

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36 Two step Emulsification (double Emulsification)

Phase Inversion technique :

37 Phase Inversion technique

Invitro characterization :
38 Invitro characterization Average globule size & size distribution Number of globules Rheological evaluation Zeta potential Potent drug entrapment Percent drug entrapment In vitro drug release Invitro stability studies

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39 Average globule size & size distribution The optical microscopy method using calibrated ocular & stage micrometer can be utilized for globule size determinations of both multiple emulsion droplets of internal dispersed phase. Multiple emulsion as coarse (>3m diameter) as fine (1-3m diameter) & Micro multiple emulsion (<1m diameter) NMR self-diffusion methods are adopted to multiple emulsion characterization Using this technique droplet size distribution for the water in the starting w/o emulsion &the water in the multiple emulsion can be evaluated.

Number of globules :
40 Number of globules Number of globules per cubic mm can be measured using the haemocytometer cell. The emulsion is diluted, a countable number of the cell & counted. The globules in five groups of 16 small squares (total 80 small squares) are counted. The total number of globules in per cubic mm are calculated by using the formula. No. of globules *Dilution*4000 No. of of globules/mm3= ----------------------------------- No. of small squares counted

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41 Zeta potential:- The zeta potential & surface charge can be calculated using Smoluchowskis equation from the mobility & elecrophoretic velocity of dispersed globules using the zetapotentiometer.

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42 Formula : 4 = ------------------*103 E =zeta potential , =viscosity of the dispersion medium, =Migration velocity (cm/s), =dielectric constant of the dispersion medium, E=potential gradient.

Stability of Multiple Emulsions :

43 Stability of Multiple Emulsions Leakage of the contents from the inner aqueous phase Expulsion of internal droplets in external phase Flocculation of internal aqueous phase & multiple emulsion droplets Phase separation

Methods to stabilize the Multiple emulsions :

44 Methods to stabilize the Multiple emulsions Liquid crystal stabilized multiple emulsion Stabilization in presence of electrolytes EX:Ascorbic acid, Acetic Acid, Oleic Acid Stabilization by forming polymeric gel Ex: Poly acrilamide gel Phase-inversion stabilization of w/o/w emulsion Making the inner aqueous phase hypertonic prevents phase separation

Applications :
45 Applications Controlled & sustained drug delivery Drug targeting Vaccine adjuvant Immobilization of enzyme Food & cosmetics applications Protective action

Conclusion :
46 Conclusion To date Emulsions, Suspensions have been shown to be able to protect labile drug, control drug release, increase drug solubility, increase bioavailability and reduce patient variability. Besides this, research papers shows higher percentage of surfactant (much higher than CMC level) used for the formation of micro emulsion, irrespective of different routes of administration, but there is a lack of toxicological evaluation of the prepared micro emulsion, which can be a broad research area in future

Reference :

47 Reference Revised & Expanded Edited by Herbert A Lieberman. Martin M Rieger and Gilbert S .Banker C.V.S Subramanyam. pharmaceutical production and management James swarbrick. Encyclopedia of pharmaceutical technology 3rd addition vol.3 Introduction to pharmaceutics.Ashok K Guptha Pharmaceutical Dosage forms Disperse Systems. 2nd edition Volume II.

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seminor on Accelerated Stability Testing of dosage forms A measure of how a pharmaceutical product maintains its quality attributes over time By : A.Shirisha M.Pharm Pharmaceutics,

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Contents Introduction Types of Stability studies Arrhenius equation Steps involved in prediction of shelf life Addition of Overages Conclusion References

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Stability of a pharmaceutical preparation is the capability of a formulation in a specific container-closure system to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications throughout its shelf life. The time during which the product retains the same properties and characteristics that it possessed at the time of manufacture. Stability testing is used to: Provide evidence as to how the quality of the drug product varies with time. Establish shelf life for the drug product. Determine recommended storage conditions. Determine container closure system suitability. Introduction

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Why Stability studies are necessary ? Chemical degradation of the product leads to lowering of the concentration of the drug in the dosage form. Toxic products may be formed , due to chemical degradation of the active ingredient. Advantages of Stability studies Assurance to the patient Economic considerations Legal requirement

Stability protocol :
Stability protocol

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According to ICH guidelines, The ambient study for drug product must be continued for a sufficient period of time beyond 12 months to cover the shelf life of the product. Intermediate storage condition data are required when a significant change occurs prior to completion of study under the accelerated storage condition. The accelerated storage condition must be >15 C above the ambient storage conditions.

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Testing Frequency: For Long term testing, during first year sampling should be done every three months, during second year, sampling should be done every six months and after two years, sampling should be done once a year. Accelerated testing should be done atleast six months and it suggests sampling points of 0, 3, 6 months.

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Accelerated Stability Studies Accelerated Stability Studies Stability study to predict the shelf life of the product, by accelerating the rate of decomposition, preferably by increasing the temperature of reaction conditions. With the advancement in branch of kinetics, shelf life of a dosage form can be predicted within months based on accelerated stability reports Preparations are subjected to high stresses during stability testing. Common high stresses include : Temperature Humidity Light

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Arrhenius equation It explains the effect of temperature on rate of a reaction. According to Arrhenius, for every 10 rise in temperature, the speed of reaction increases about 2-3 times. k = A e -Ea / RT Arrhenius factor Energy of activation Ideal gas constant Log k = log A Ea / 2.303 RT Arrhenius factor is the frequency of molecular collisions occuring between the molecules.

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Estimation of k value The reaction is conducted at several temperatures. Concentration of reactants is determined. Appropriate graphs are drawn for the kinetic data. Data is processed for all the orders. The order of the reaction is identified. From the slopes of the lines, k values are calculated for all temperatures.

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Estimation of energy of activation A graph can be drawn by taking log k on y-axis and reciprocal temperature (1/T) on x-axis. A straight line is obtained, the slope of the line is negative and the magnitude is Ea / 2.303 R. The intercept corresponds to log A All the constants in the Arrhenius equation can be obtained from the graph. Activation energy is the minimum energy that a molecule should possess so that the molecular collisions produce the product.

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Steps involved in Accelerated Stability Testing Steps involved in prediction of shelf life

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The Preparation is stored at different elevated temperatures, to accelerate the degradation Samples are withdrawn at different time intervals The Order of the reaction is determined by plotting the appropriate function of concentration against time and linear relationship is determined Straight line in a graph permits the estimation of k value from the slope Similarly graphs are drawn for different elevated temperatures. K value for each temperature are calculated. By using Arrhenius relationship, Log k values are plotted against reciprocal of absolute temperature, energy of activation can be calculated.

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Extrapolate the straight line to room temperature (k25) or refrigerated temperature and read the log k value on y-axis. Substitute the k value in the appropriate equation to get the shelf life of the product.

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Arrhenius plot for predicting the rate constant at ambient temperature(25C).

Overview of storage conditions and storage period for solid, semisolid, and liquid dosage forms :
Overview of storage conditions and storage period for solid, semisolid, and liquid dosage forms

Bracketing system for Dosage forms :

Bracketing system for Dosage forms

Packaging material:in selecting packaging material, the following has to be considerd :

Packaging material:in selecting packaging material, the following has to be considerd Packaging materials permeable to water vapor result in a falsification of the results for semisolid and liquid dosage forms if varying degrees of weight loss occur that leads to differences in the active ingredient concentration or ion strength. The use of inert standard packaging materials that are impermeable to water vapor is important precondition for stress tests that are evaluated in terms of reaction kinetics, and on the results on which stability predictions are to be tested.

Most of the stress tests are carried out in standard packaging material.The following standard packaging materials are used: :
Most of the stress tests are carried out in standard packaging material.The following standard packaging materials are used: Solid dosage forms: 50-mL glass container with twist-off closure polypropylene tube Semisolid dosage forms: Standard tube, small volumetric flask, Aluminum tube, inert internal lacquering Liquid dosage forms: 25mL volumetric flask with ground-glass stopper However, furture investigations for the selection of the final packaging are necessary.

Selection of packaging material for solid dosage forms. :

Selection of packaging material for solid dosage forms. On the basis of the results of the stress tests for solid dosage forms, the sensitivity to moisture can be determined and suitable packaging materials can be selected. As a rule, no interactions are to be expected. If the final packaging material has been selected and samples packed in the final packaging material are available, the investigation of photostability should be performed. Photostability :The samples with and without container are irradiated with a Xenon lamp for 24 hours.

Selection of packaging material for semisolid dosage forms. :

Selection of packaging material for semisolid dosage forms. Packaging: Aluminum tube internally lacquered, plastic tubes. Problems: Corrosion , permeation, sorption. Tests packaging material dosage form: To test for corrosion ,the filled metal tubes are stored horizontally upright and inverted at 400C, for 3 months and are then investigated. To test for permeation and sorption the filled plastic tubes are stored for 3 months at 500C, 400C, 300C/70%. If the final packaging material has been selected, the investigations on the photostability are performed.

Selection of packaging material for liquid dosage forms :

Selection of packaging material for liquid dosage forms Packaging ampoule, injection vial with rubber stopper, glass bottle or plastic bottle with screw closure. Problems: leakage. To test for

permeation, and leakage, the finale formulation solution is filled in the container, and for desorption placebo solution is used. The samples are stored vertically and inverted under 500C, 400C, 300C/70% for up to 12 weeks. Tested intervals: 0, 1, 2, 3 months. If the final packaging material has been selected the investigations on the photostability are performed.

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Accelerated Stability Testing in Emulsions An emulsion is stored at elevated temperature. This decreases viscosity of the continuous phase. If the emulsion withstands this stress it is assumed to be stable at normal conditions of storage. Centrifugation Method: Creaming and flocculation are slow processes. Centrifugation accelerates rate of creaming and flocculation in emulsions. The emulsion is subjected to different centrifugal speeds and separation of phases is observed at different time periods. Bad emulsion separates oil instantly. Good emulsion does not exhibit detectable separation of oil phase until certain time period.

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Accelerated tests for Suspensions Cake formation is accelerated by centrifugation. High speed centrifugation is hence not preferred, low speed centrifugation is used to study the physical stability. A Freeze-Thaw cycling technique is one of the stress testing . This cycling treatment promotes particle growth and has primary importance for changes in absolute particle size, particle size distribution and crystal habit.

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Accelerated Tests for moisture absorption In this method, products are placed in an environment of high relative humidity and controlled temperature. Their physical and chemical stabilities are assessed. The results will indicate whether the product is susceptible to moisture and also whether the container needs to provide a high degree of protection.

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Limitations Stability predictions based on Arrhenius equation are valid only when the break down depends on temperature. The energy of activation obtained in the study should be between 10 to 30 kcal/mole. When degradation is due to Microbial contamination Photochemical reactions When the product looses its physical integrity at higher temperatures. When the order changes at elevated temperatures. In case of disperse systems, when temperature is elevated viscosity is decreased and this may introduce errors in the prediction of stability.

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Excess amount of the drug can be added to the preparation to maintain 100% of the labelled amount during the shelf life of the product. Overages are calculated from the accelerated stability studies and added to the preparation at the time of manufacture. They should be within the limits compatible with the therapeutic requirement. Addition of overages doubles the shelf life of the product. Overages are added in multi vitamin preparations Addition of Overages

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110% 100% 90% 1 Year 1 Year 2 years

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Conclusion Conclusion Knowledge of stability of a formulation is very important for three primary reasons: A Pharmaceutical product must appear fresh, elegant and professional for as long as it remains on the shelf. Since some products are dispensed in multiple dose containers, uniformity of dose of the active ingredient over time must be ensured . The active ingredient must be available to the patient through out the expected shelf life of the preparation. A breakdown in the physical system can lead to non availability or of the medication to the patient.

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References : Patrick J.Sinko , Martins Physical Pharmacy and Pharmaceutical Sciences. Theory and practice of Industrial Pharmacy - Lachman International Stability Testing Drug stabilityCartensen C.V.S Subrahmanyam www.google.com

EVALUATION OF EMULSION STABILITY The primary objective of studying stability emulsion is to predict its shelf life under normal storage conditions. The final evaluation of the product for its shelf life must be done in the container in which it is packed because : The ingredients may interact with the container, Some material may leach out from the container

Loss of water and volatile ingredients may occur through the container or closures. The problem of stability assessment under normal conditions is that they last long periods of time. To shorten the time many types of stress tests conditions are used to provide a basis for prediction of the stability of an emulsion. These can provide valuable information but one must be aware of the risk that changes occurring under stress conditions may not necessarily take place under normal storage conditions. Stress conditions normally employed for stability studies are (a) Time stress , (b) thermal stress ,(c) Centrifugation: Thermal stress: The instability of emulsion at higher temperature may include phenomenon such as temperature dependent solubility, degradation reactions occurring only at higher temperature temperature induced phase changes and altered rheological behavior structural deformation and reformation It is considered reasonable to use the time for destabilization at 40o C multiplied by 4 to give an estimate of shelf life at room temperature. 1. Aging and temperature: In this method the sample of emulsion is stored at various temperatures and parameters like viscosity, %ge of phase separation, particle size , zeta potential , rheolgical parameters , electrical conductivity are monitored . The normal effect of aging an emulsion at elevated temp. is acceleration of the rate of coalescence or creaming. and this is usually coupled with changes in viscosity. Thee are many ways of running such aging tests : The two most common procedures are : To age one sample of the emulsion at different temperatures ; for instance 4oC, room temp. 35o C , 43oC, for 2,4,and 6 weeks. Freeze thaw cycle test: To age the same sample and cycle the temperature many times between two extreme value:. Such a test is completed after 4-5 days. A correlation can be established between the two tests. Then the cycling test allows the prediction of stability of the tested emulsion and saves a lot of time. Phase inversion temperature : It is the temperature at which the emulsion inverts. This method is useful for assessing stability of o/w emulsions.

Basic principle : The HLB of nonionic emulsifier changes with temperature. The higher the temperature, the lower the HLB. In case of ethoxylated nonionics, this decrease of HLB is explained by dehydration of ethoxylate with increase in temperature. Experimental : i. Weigh 200 g of emulsion in a beaker. Adjust heating rate 1o C / min ii. Adjust stirring speed to get a vortex 1 cm deep. iii. Record the temp. when vortex disappears. Conclusion : It has been found that PIT is inversely proportional to the rate of droplet coalescence So if PIT is more , rate of coalescence will be less. So the emulsions must have a PIT as high as possible always higher than the storage temp. ii. Gravitational stress (Centrifufgation) : The shelf life can be predicted rapidly by observing the separation of dispersed phase due to creaming or coalescence when emulsion is exposed to centrifugation. Stokes law shows that creaming is a function of gravity, so increase in gravity accelerates separation. It has been found that centrifugation at 3750 rpm in a 10 cm radius centrifuge for a period of 5 hrs is equivalent to the effect of gravity for about one year. Gravitational stress such as centrifugation may allow phase separation to occur quickly. Ultracentrifugation at high speed (25000 r.p.m.) or more can be expected to cause effects that are not observed during normal aging of an emulsion. It creates three layers a top layer of coagulated oil, an intermediate layer of uncoagulated emulsion and pure aqueous layer. Rapid formation of a clear oily layer is the first clue to abnormal phenomenon taking place during ultracentrifugation. iii. Agitation ; Simple mechanical agitation can contribute to the energy with which two droplets impinge upon each other. Agitation can bring about coalescing of globules and then breaking of emulsion. ( Preparation of butter from milk). Conventional emulsions may deteriorate from gentle rocking on a reciprocating shaker. This is related to impingement of droplets and in part to reduction of viscosity of a normal thixotropic system. PARAMETERS FOR ASSESSING THE EMULSION STABILITY : Physical parameters : The most useful parameters commonly measured to assess the effect of stress conditions on emulsions include :

phase separation Viscosity Electrophoretic properties Particle size number analysis Phase Separation : The rate and extent of phase separation after aging of an emulsion may be observed visually or by measuring the volume of separated phase. The separated phase may be due to coalescence or due to creaming. It is important to differentiate between coalescence and creaming , since the means of correcting these defects are different. A simple means of determining separation due to creaming or coalescence is to withdraw small samples of the emulsion from top and the bottom of the preparation after some period of storage and comparing the composition of the two samples by appropriate analysis of water content , oil content or any other suitable constituent. viscosity : Changes in viscosity during aging can give an idea about shelf life of an emulsion. Viscometers of cone plate type or instruments having co-axial cylinders can be used to measure the viscosity. The viscosity changes in first few days are different for w/o and o/w emulsions As a rule globules in freshly prepared w/o emulsion flocculate quite rapidly. So the viscosity drops quickly and continues to drop for sometime. ( 5-15 days at room temp.) and then remains relatively constant. In o/w emulsions flocculation causes increase in viscosity for some time. After this initial change almost all emulsions show changes in consistency with time , which follow a linear relationship on a log scale. The complete absence of slope ( no change in viscosity with age) is ideal. However , slight increase of viscosity between 0.04 and 400 days.is acceptable. Other emulsions exhibit much more drastic and sudden nonlinear increases in viscosity after two to three months aging. Such behaviour is frequently followed by a drop in viscosity probably associated with phase inversion .C

A ViscosityB

Storage time in days

A = Ideal shelf life B = Typical shelf life. C = Questinable shelf life Electrophoretic properties : Zeta potential : The zeta potential enables the formulator to evaluate the effect of the repulsive forces between globules. It is observed that zeta potential of 50 mV minimum are needed to get satisfactory stability of dispersion. Stability of emulsions can be evaluated through zeta potential measurements. Zeta potential of emulsion is useful for assessing flocculation since electrical charges on particles influence the rate of flocculation If zeta potential comes down with aging, the emulsion is less stable.. Maximum zeta potential is associated with maximum emulsion stability. ii. Electrical conductivity It can also be used to evaluate emulsion stability. The electrical conductivity of o/w or w/o emulsions is determined with the aid of Pt electrodes . Measurements are made on emulsions stored for short time at room temp. or 37o C . Conductivity depends on degree of dispersion. O/w emulsions with fine particles exhibit low resistance. If resistance increases , it is a sign of aggregation and instability. A fine emulsion of water in w/o product doe not conduct current until droplet coagulation i.e. instability occurs. iii. Dielectric constant measurements : An inverse relationship existed between log of rate of increase in dielectric constant and the absolute temperature . This can be used as a prediction test. Particle size, number analysis : Particle size is inversely proportional to the stability. Changes of the average particle size or of the size distribution of droplets are important parameters for evaluating emulsions. Particle analysis can be carried out by microscopic methods. electronic counting devices e.g. coulter counter. Chemical parameters : Autoxidation of polyethylene glycols may occur in emulsions. This can cause formation of undesirable odors, of acidic components and of all types of oxidative by products. The instability of nonionic esters leading to hydrolytic degradation may result in changes in dielectric constant of emulsion.