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EX-Featured Excipient Capsule and Tablet Lubricants

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tablet capsule lubricants
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  Featured Excipient: Capsule and Tablet Lubricants  Capsule/tablet lubricants are included in formulations to assist in the mechanical handling of  powders prior to and during the encapsulation process. They can aid in eliminating electrostatic forces that make handling some powders difficult during compounding. In the case of tablets, they also reduce wear and friction in the equipment during the tableting operation. Some of the lubricants also aid in enhancing the flow properties of the powders during mixing. Since the lubricants are generally lipophilic, they may retard the disintegration/dissolution rates of the dosage form so they are generally only used in very small amounts (0.25-1%). 1  Some of the selected physicochemical characteristics of these lubricants are shown in Table 1. Official capsule/tablet lubricants include calcium stearate, glyceryl behenate, magnesium stearate, mineral oil (light), polyethylene glycol, sodium stearyl fumarate, stearic acid, stearic acid  purified, talc, vegetable oil (hydrogenated Type I) and zinc stearate. Calcium stearate (C 36 H 70 CaO 4 , MW 607, calcium distearate, stearic acid-calcium salt) is a compound of calcium with a mixture of solid organic acids obtained from fats and consists primarily of calcium stearate and calcium palmitate; it contains the equivalent of 9.0 to 10.5% of calcium oxide. It is used in concentrations up to 1.0% w/w and has good antiadherent and lubricant properties but poor glidant properties. It is also used as an emulsifier, stabilizing agent and suspending agent. It occurs as a fine, white to yellowish white-colored, bulky powder with a slight, characteristic odor; it is unctuous and free from grittiness. It is practically insoluble in 95% ethanol, ether and water. 2  Glyceryl palmitostearate (glycerin palmitostearate) is a mixture of mono-, di- and tri-glycerides of C 16  and C 18  fatty acids. It is not a USP/NF ingredient. It is used in concentrations of 0.5 to 5% w/w as a tablet lubricant and in a concentration range of 10 to 50% as a matrix for sustained release tablets. It occurs as a fine, white powder with a faint odor. It is freely soluble in chloroform and dichloromethane; practically insoluble in 95% ethanol, mineral oil and water. It should be stored at temperatures less than 35°C, preferably at 5-15°C in an airtight container, protected from light and moisture. Glyceryl palmitostearate is incompatible with ketoprofen and naproxen. 3   rs prior to and The Basics of Compunding & Featured Excipient   Glyceryl behenate (C 69 H 134 O 6 , MW 1060) occurs as a fine, white powder with a faint odor. It is soluble, when heated, in chloroform and dichloromethane but is practically insoluble in 95% ethanol, hexane, mineral oil and water. 3,4  Magnesium stearate (C 36 H 70 MgO 4 , MW 591.34, magnesium octadecanoate) is a compound of magnesium with a mixture of solid organic acids and consists chiefly of variable proportions of magnesium stearate and magnesium palmitate (C 32 H 62 MgO 4 ). It is widely used as a tablet and capsule lubricant in concentrations between 0.25 and 5.0% and in cosmetics and foods. It occurs as a fine, white, precipitated or milled, impalpable powder with a low bulk density. It has a faint odor of stearic acid and a characteristic taste; it is greasy to the touch and adheres to the skin. It is practically insoluble in ethanol, ether and water and slightly soluble in warm 95% ethanol. It is listed as incompatible with strong acids, alkalis and irons salts and cannot be used in products containing aspirin, some vitamins and most alkaloidal salts. It should not be mixed with strong oxidizing materials. High purity magnesium stearate has a melting range between 126 and 130°C. 5  Light mineral oil is a mixture of liquid hydrocarbons obtained from petroleum; it may contain a suitable stabilizer. It has a lower specific gravity than mineral oil. It is used as an emollient, solvent, tablet/capsule lubricant, therapeutic agent and oleaginous vehicle. It is described as a transparent, colorless liquid, free from fluorescence in daylight. It is practically tasteless and odorless when cold but has a faint odor when heated. It is soluble in chloroform, ether and the hydrocarbons, is sparingly soluble in 95% ethanol and practically insoluble in water. It can be sterilized by dry heat and should be stored in an airtight container in a cool, dry place and protected from light. It is listed as incompatible with strong oxidizing agents. Light mineral oil is combustible and should not be handled or stored near heat, sparks or flame. 6  Polyethylene glycol (HOCH 2 (CH 2 OCH 2 ) m CH 2 OH, where m represents the average number of oxyethylene groups) is an addition polymer of ethylene oxide and water. The grades 200-600 are liquids and grades 1000 and above are solids at ambient temperatures. The liquid grades are clear, colorless or slightly yellow-colored liquids with a slight, but characteristic odor and a bitter, slightly  burning taste. The solids are white or off-white in color and range in consistency from pastes to waxy  flakes with a faint, sweet odor. Grades above 6000 are available as free-flowing milled powders. They are used as ointment bases, plasticizers, solvents, suppository bases and tablet/capsule lubricants. They are soluble in water and miscible in all proportions with others in the class. The solid grades are soluble in acetone, dichloromethane, ethanol and methanol; are slightly soluble in aliphatic hydrocarbons and ether, but insoluble in fats, fixed oils and mineral oil. Polyethylene glycols and their aqueous solutions can  be sterilized by autoclaving, filtration or gamma irradiation; sterilization of solid grades by dry heat at 150°C for one hour may induce oxidation, darkening and the formation of acidic degradation products. 7  Sodium stearyl fumarate (C 22 H 39  NaO 4 , MW 390.5) is a fine, white powder with agglomerates of flat, circular-shaped particles. It is used as a lubricant in capsule and tablet formulations at 0.5 to 2.0% w/w concentration. It is reported to be incompatible with chlorhexidine acetate. 8  Stearic acid (C 18 H 36 O 2 , MW 284.47, octadecanoic acid) is a mixture of stearic acid (C 18 H 36 O 2 ) and palmitic acid (C 16 H 32 O 2 ); the content of stearic acid is not less than 40.0% and the sum of the two acids is not less than 90.0%. It is used as an emulsifying agent, solubilizing agent and as a tablet/capsule lubricant. It is described as a hard, white or faintly yellow colored, somewhat glossy, crystalline solid or as a white, or yellowish white, powder. It has a slight odor and taste suggesting tallow. It is listed as incompatible with most metal hydroxides and may be incompatible with oxidizing agents. It will form insoluble stearates with many metals and ointment bases made with it may show evidence of drying out or lumpiness due to such a reaction when compounded with zinc or calcium salts. It is freely soluble in benzene, carbon tetrachloride, chloroform and ether; it is soluble in ethanol, hexane and propylene glycol and practically insoluble in water. 9  Purified stearic acid (C 18 H 36 O 2 , MW 284.47) is manufactured from fats and oils derived from edible sources and is a mixture of stearic acid (C 18 H 36 O 2 ) and palmitic acid (C 16 H 32 O 2 ) which together constitute not less than 96.0% of the total content. The content of the stearic acid portion is not less than 90.0%. It is used solely for external use and is exempt from the requirement that it be prepared from edible sources. It is soluble one part in five parts benzene, six parts carbon tetrachloride, two parts chloroform, 15 parts ethanol, three parts ether and is practically insoluble in water. 9     Talc (powdered talc, purified French chalk, soapstone, steatite) is a purified, hydrated, magnesium silicate, approximating the formula Mg 6 (Si 2 O 5 ) 4 (OH) 4 ; possibly containing small, variable amounts of aluminum silicate and iron. It is used as an anticaking agent, glidant, tablet and capsule diluent and tablet and capsule lubricant. As a lubricant, it is used in a concentration of 1 to 10%. It is a very fine, white to grayish-white colored, odorless, impalpable, unctuous, crystalline powder that adheres readily to the skin, is soft to the touch and is free from grittiness. It is not hygroscopic and is  practically insoluble in dilute acids and alkalis, organic solvents and water. It can be sterilized by heating at 160°C for not less than one hour and can also be sterilized by ethylene oxide or gamma irradiation. It is incompatible with quaternary ammonium compounds. Concerning its use in orally administered  preparations, it is not absorbed systemically and is regarded as essentially a nontoxic material. 10  Vegetable oil, hydrogenated, Type I (Hard fat) has the general structural formula of R  1 COOCH 2 -CH(OOCR  2 )-CH 2 OOCR  3 , where R  1 , R  2  and R  3  are primarily C 15  and C 17 . Commercial  products available include hydrogenated cottonseed oil, hydrogenated palm oil and hydrogenated soybean oil. It is described as a mixture of triglycerides of fatty acids and the two types listed in the USP/NF are characterized by their physical properties. It is used as a lubricant in tablet and capsule formulations at concentrations of 1 to 6%, usually combined with talc. It is also used as a matrix-forming material in lipophilic-based controlled-release formulations and as a controlled release coating. Other uses include the preparation of suppositories, oil-based liquids and semisolid formulations and in the formulation of liquid and semisolid fills for hard-gelatin capsules. It is soluble in chloroform, petroleum spirit and hot propan-2-ol and practically insoluble in water. It is listed as incompatible with strong oxidizing agents. It must be labeled to state that it is Type I. 11  Zinc stearate (C 36 H 70 O 4 Zn, MW 732.33, zinc distearate) is a compound of zinc with a mixture of solid organic acids obtained from fats. It consists primarily of variable proportions of zinc stearate and zinc palmitate and contains the equivalent of 12.5 to 14.0% of zinc oxide. It is used as a tablet and capsule lubricant in concentrations of 0.5 to 1.5%. It is also used in water-repellent ointments, as a dusting powder and as a thickening and opacifying agent in cosmetic and pharmaceutical creams. It occurs as a fine, white, bulky, hydrophobic powder that is free from grittiness and has a faint,

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