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Gels are an excellent formulation for several routes of administration. They are useful as liquid formulations in oral, topical, vaginal, and rectal administration. Gels can be clear formulations when all of the particles completely dissolve in the dispersing medium. But this doesn't occur in all gels, and some are therefore turbid. Clear gels are preferred by patients. Gels are made using substances (called gelling agents) that undergo a high degree of crosslinking or association when hydrated and dispersed in the dispersing medium, or when dissolved in the dispersing medium. This cross-linking or association of the dispersed phase will alter the viscosity of the dispersing medium. The movement of the dispersing medium is restricted by the dispersed phase, and the viscosity is increased. If the gel contains small discrete particles, the gel is called a two-phase system. If the gel does not appear to have discrete particles, it is called as a one-phase system. Two-phase systems are thixotropic, e.g., they are semisolid on standing but liquefy when shaken. If the particle size in a two-phase system is large, the gel is referred to as a magma. Examples of two-phase systems include Aluminum Hydroxide Gel and Bentonite Magma. Single-phase systems contain linear or branched polymer macromolecules that dissolve in water and have no apparent boundary with the dispensing medium. These macromolecules are classed as natural polymers (i.e., tragacanth), semisynthetic cellulose derivatives (i.e., methylcellulose), or synthetic polymers (i.e., Carbomer polymers). Single-phase gels made from synthetic or natural macromolecules are called mucilages.
Common Gelling Agents
There are many gelling agents. Some of the common ones are acacia, alginic acid, bentonite, Carbopols® (now known as carbomers), carboxymethylcellulose. ethylcellulose, gelatin, hydroxyethylcellulose, hydroxypropyl cellulose, magnesium aluminum silicate (Veegum®), methylcellulose, poloxamers (Pluronics®), polyvinyl alcohol, sodium alginate, tragacanth, and xanthan gum. Though each gelling agent has some unique properties, there are some generalizations that can be made. 1. If the gelling agent is added to the dispersing medium in a haphazard manner, there is a tendency for the agent to "clump." The outer molecules of the gelling agent contact the medium first and hydrate forming a surface layer that is more difficult for the medium to penetrate. The clumps will ultimately hydrate, but it will take more time. A much more efficient manner is to sieve the agents onto the surface of the medium a little at a time as the medium is stirring. Using glycerin as a wetting agent will sometimes minimize clump formation.
very good clarity. Carbopol® 4. Most gelling agents require 24-48 hours to completely hydrate and reach maximum viscosity and clarity.5 Carbomer polymers are best introduced into water by slowly sprinkling a sieved powder into the vortex created by rapid stirring. Produces low viscosity gels. 5.2. 30. Only Carbopol® 934P. 7. Same properties as 934. Some examples of this group of gelling agents are Polymer Name Carbopol® 910 Carbopol® 934 Carbopol® 934P Carbopol® 940 Viscosity* Properties 3. This should prevent clumping. As a group. 6.0). Forms clear gels with water. Carbomer is a generic name for a family of polymers known as Carbopol®.400 40. It is easier to add the active drug before the gel is formed if the drug doesn't interfere with the gel formation.5% solution. Carbopols® were first used in the mid 1950s.000 .000 . They will also swell in aqueous solution of that pH as much as 1000 times their original volume. and topicals.11. and form acidic aqueous solutions (pH around 3. Methylcellulose and poloxamers have better solubility in cold water while bentonite. gelatin.000 941 * 0. but intended for pharmaceutical formulations. Carbomers. sustained-release formulations.400 29. 4.000 Effective in thick formulations such as emulsions. and sodium carboxymethylcellulose are recommended for oral administration.000 centipoise (cps). methylcellulose. Once all of the powder has been . very good clarity in water or hydroalcoholic topical gels. Some gelling agents are more soluble in cold water than in hot water. They thicken at higher pHs (around 5 or 6).500 39. 3. Forms clear gels with hydroalcoholic systems. pH 7. they are dry powders with high bulk densities. and alginic acid gels are made with tepid water. and sodium carboxymethylcellulose are more soluble in hot water. Their solutions range in viscosity from 0 to 80.7. suspensions. tragacanth.000 Effective in low concentrations and will provide a low viscosity formulation. Some gelling agents (carbomers) require a "neutralizer" or a pH adjusting chemical to create the gel after the gelling agent has been wetted in the dispersing medium.000 60. "P" = highly purified product Effective in thick formulations. transdermals. Gelling agents are used in concentrations of 0.400 39.5% up to 10% depending on the agent. hydroxypropylmethylcellulose.
a stable water soluble gel is formed. and carboxymethylcellulose) are commonly used.added. The compounds' ability to hydrate is reduced by the addition of salts. Common Traits The most difficult task is to introduce the compounds into solvents without or clumping. A "neutralizer" is added to increase the pH and cause the dispersion to thicken and gel. The powder is dispersed with high shear in about 1/3 of the required amount of water at 80°C to 90°C. alcohol (70%). and each one has their unique properties. hydroxyethylcellulose. hydroxyethylcellulose Makes thinner gels Compatible with water and alcohol (30%) . the solution will have a low pH. The viscosity of the gel can be further manipulated by propylene glycol and glycerin (to increase viscosity) or by adding electrolytes (to decrease viscosity). potassium hydroxide. Some derivatives are more sensitive to divalent and trivalent inorganic salts. and propylene glycol (50%) Hydrates and swells in hot water. If the inorganic bases are used to neutralize the solution. hydration. the stirring speed should be reduced to decrease the possibility of entrapping air bubbles in the formulation. Some neutralizing agents are sodium hydroxide. hydroxypropylmethylcellulose. There are some commonalties in these compounds. As mentioned. Once it is dispersed. If triethanolamine is used. CMC has its ideal viscosity at pH 7-9. The cellulose derivatives (methylcellulose. the viscosity dramatically decreases below pH 4 and above pH 10. the rest of the water (as cold water or ice water) is added with moderate stirring. Maximum clarity. the gel can tolerate high alcohol concentrations. and triethanolamine. hydroxypropylcellulose. There are some compounding techniques that can be used to minimize this problem: o sift the powders into the vortex of the rapidly stirring solvent o levigate the powder with a water miscible nonsolvent such as absolute alcohol or propylene glycol o use a blender to homogeneously mix the powder and solvent All of the derivatives except carboxymethylcellulose (CMC) maintain their viscosity over a wide pH range (3-11). when the carbomer is dispersed. and viscosity will be obtained if the gel is cooled to 0-10°C for about a hour. Unique Traits methylcellulose 1500 cps Makes thinner gels with high tolerance for added drugs and salts Compatible with water.
waxy granules that form clear liquids when dispersed in cold water or cooled to 0-10°C overnight. but are gels at room or body temperature. After all of the powder is added and hydrated (about 8 . "PLO gel" is made by combining a Pluronic® F-127 gel and a lecithin/isopropyl palmitate syrup. Pluronic® F-127 is often combined with a lecithin and isopropyl palmitate solution to make what is called a "PLO gel. water soluble drugs are dissolved in the Pluronic® gel or oil soluble drugs are dissolved in the lecithin .9 Compatible with water and alcohol Disperse in cold water to hydrate and swell. and then heat to about 60°C. Maximum stability at pH 7 .12 hours) Forms an occlusive dressing when lightly applied to the skin and allowed to dry hydroxypropylcellulose Makes thinner gels with high tolerance for added drugs and salts Compatible with alcohols and glycols Hydrates and swells in water or hydroalcoholic solution. the formulation can be stirred or shaken. The two components are made and stored separately. alcohol (80%) Disperse in cool water Good gelling agent for time released formulations carboxymethylcellulose Generally used as the sodium salt Makes thicker gels but less tolerance than hydroxypropylmethylcellulose. Hydrates and swells in cool water (about 8 . The powder is sprinkled in portions into water or hydroalcoholic solution without stirring and allowed to thoroughly wet. hydroxypropylmethylcellulose Makes thicker gels but lower tolerance for positively charged ions Compatible with water. Poloxamer copolymers are white. When it is time to compound a formulation." This is a slight misnomer.12 hours). This means they are liquids at cool (refrigerator) temperature.2 hours. since the final product is actually an emulsion. The confusion comes from using a gel as one of the ingredients for the emulsion. They will form thermoreversible gels in concentration ranging from 15% to 50%. Poloxamer (Pluronics®) are copolymers of polyoxyethylene and polyoxypropylene. Maximum gelling in 1 . Good gelling agent if 15% or more of an organic solvent is needed to dissolve the active drug.
syrup.edu/labs/gels/videos. The mixture is forced between the two syringes and the shear caused by the passing the mixture through the adapter will create the "PLO gel. each of the components can be put into a syringe and the two syringes are connected by a adapter.unc." http://pharmlabs. If a small quantity of formulation is to be made.htm#lechitin .
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