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Excipients used in tablet . Part 2. Hydroxyl propyl methyl cellulose. Hypermellose As a food additive E464 It is a semi synthetic inert polymer has many uses. Uses in pharmaceutical industry. Used in oral tablet and capsule formulations
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Excipients used in tablet Part 2
Hydroxyl propyl methyl cellulose • Hypermellose • As a food additive E464 • It is a semi synthetic inert polymer has many uses
Uses in pharmaceutical industry • Used in oral tablet and capsule formulations • Depending on the grade as controlled release agent to delay the release of a medicinal compound into the digestive tract • Binder • Tablet coatings • Used in ophthalmic solution • Substitute for tear-film • Lubricant • Hypromellose 2% solution has been documented to be used during surgery to aid in corneal protection and during orbital surgery
Other uses • Use in whole grain breads • Substitute for gluten in making all-oat and all-barley breads • It is predicted that whole grain breads made with HPMC will have cholesterol-lowering effects
Colloidal silicone dioxide • Also called anhydrous silica
Uses • Adsorbent • Anticaking agent • Emulsion stabilizer • Glidant • Suspending agent • Disintegrate • Thermal stabilizer • Viscosity increasing agent
Safety • FDA approved for tablets, capsules,suspensions,transdermal preperation and vaginal ovules • Preperations cotain it shouldn’t be used parentrally • It causes granulomas
Titanium dioxide • E171 • It is used as White pigment in film coating tablet
Titanium dioxide and UV light • It is a photocatalyst under ultraviolet (UV) light • Photocatalysis is the acceleration of a photoreaction in the presence of a catalyst • The photocatalytic activity (PCA) depends on the ability of the catalyst to create electron–hole pairs, which generate free radicals (hydroxyl radicals: ·OH) able to undergo secondary reactions
Uses • White pigment because of its brightness and very high refractive index • Sunscreen and UV Absorber • As pigment • A tattoo • Styptic pencils • Sunscreens designed for infants or people with sensitive skin • based on titanium dioxide and/or zinc oxide, as these mineral UV blockers are believed to cause less skin irritation than chemical UV absorber ingredients • The titanium dioxide particles used in sunscreens have to be coated with silica or alumina, because titanium dioxide creates radicals in the photocatalytic reaction • These radicals are carcinogenic and could damage the skin
Styptic pencil • Hemostatic pencil • contains : • Anhydrous aluminum sulfate • potassium alum • Titanium dioxide • Works by causing blood vessels to contract at the site of the wound.
Safety • FDA approved • Titanium dioxide dust, when inhaled, has recently been classified by the International Agency for Research on Cancer (IARC) as an IARC Group 2B carcinogen possibly carcinogenic to humans • Used in skin products has unknown health effects and has a carcinogenic effect on mice • Incompatible with strong oxidizers and strong acids
Talc • Mineral composed of hydrated magnesium silicate with • Uses : • Talc is used in baby powder, an astringent powder used for preventing rashes on the area covered by a diaper • Glidant in food and pharmaceutical industry • Used as an additive for heroin, to expand volume and weight • With intravenous use, it may lead to talcosis, a granulomatous inflammation in the lungs
Safety • FDA considers talc to be generally recognized as safe for use as an anti-caking agent in table salt in concentrations smaller than 2% • inhalation of talc may causes ovarian and lung cancer
Polysorbate 80 • Nonionic surfactant and emulsifier derived from polyethoxylated sorbitan and oleic acid • Other names: • Tween 80 • POE (80) sorbitan monooleate • E433
Pharmaceutical uses • Used as an emulsifier in the manufacture of the popular anti-arrhythmic amiodarone • Used to stabilize aqueous formulations of medications for parenteral administration • It is also used as an excipient in some European and Canadian influenza vaccines
Other uses • Emulsifier in foods, particularly in ice cream • Polysorbate is added to up to 0.5% (v/v) concentration and makes the ice cream smoother and easier to handle, as well as increasing its resistance to melting
Safety • In Europe and America people eat about 0.1 g of polysorbate 80 in foods per day • Influenza vaccines contain 0.000025 g of polysorbate 80 per dose • In general, polysorbate 80 is safe and well-tolerated, although a small number of people are allergic to this substance • May be harmful to people with Crohn's disease • A 1993 study raised concerns that polysorbate 80 might decrease fertility in rats • A 2008 study concluded that there was no observable adverse effects at doses per body weight of up to 1.85 ml/kg·day, which is equivalent to a 70 kg person consuming about 140 g of this substance per day for 21 days
Starch pregelatinized • Starch derivative • Prepared by physically, and chemically treating native starch, thereby changing the properties of the starch and make it flowable and highly compressible • Hygroscopic material
Uses • Diluent • Disintegrant • Binder
Safety • Non toxic non irritant matertial • Approved by FDA
Hydroxy propyl cellulose • Derivative of cellulose with both water solubility and organic solubility
Uses • As a food additive, HPC is used as a thickener, a low level binder and as an emulsion stabiliser • It is used as a topical ophthalmic protectant and lubricant. • In pharmaceuticals it is used as a • Disintegrant • Binder • Lubricant
Safety • Non toxic non irritant matertial • Approved by FDA