2007. Only a very small amount of Magnesium Stearate needs to be used in any formulation, it commonly ranges between 0.25 to 5% of your total blend. Introduction of the high-speed tableting machine requires the use of higher concentrations of formulations and the lubrication time should be balanced in terms of the adverse effects of the used lubricant. A higher level and longer mixing time reduce the drug dissolution. Magnesium stearate is an additive that is most frequently used as a lubricant. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour Group . Another object of the invention is to form a new formulation It is hydrophobic, and there are many reports in the literature concerning its adverse effect on dissolution rates. Effect of Magnesium Stearate attributes on tablet lubrtication. Typically, stearic acid must be used at higher levels in order to achieve similar ejection forces. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. 200C (lit.) Three factors have been determined to be mainly responsible for this variation: 1. Typical excipient levels used in immediate-release formulations range between 0.255% w/w [ 6 ]. Abstract. Magnesium stearate, the magnesium salt of stearic acid, is an additive, a flow agent used in pharmaceutical or supplement capsules and tablets. Laboratory Chemical Safety Summary (LCSS) Datasheet. MAGNESIUM STEARATE. The present invention relates to solid pharmaceutical formulations which comprise an active ingredient drug substance, a carrier and magnesium stearate. Disintegration Time with LUBRI-PREZ Compared to Other Products in the Market. DOI: 10.1016/j.ijpharm.2016.07.034 CFR: Code of federal regulations title 21. Uses of Magnesium Stearate. Effect of Magnesium Stearate attributes on tablet lubrtication. Lactose, a sugar commonly found in dairy products, gives the tablet most of its volume. Melting Point. TABLUBE TM MAGNESIUM STEARATE. Find Magnesium Finally, the amount and the mixing time of Magnesium stearate in the formulation are critical variables. More Scientific Information: The commercial grade of stearic acid used to produce the Stearate salts contains fatty acids that range from 12 carbon atoms (C12, lauric) to C22 (behenic) and the major components are C18 (stearic) and C16 (palmitic) acids. dissolution rate. Advantages of Sodium stearyl fumarate over Magnesium stearate The use of MgSt in tablet formulation is known to potentially deteriorate tabletability of plastic powders and slow down drug dissolution. The invention also relates to the use of magnesium stearate to inhibit or reduce chemical reaction or degradation of an active ingredient substance in the presence of a carrier. 1-17. Evaluated effects of two different concentrations of magnesium stearate on dissolution properties of ranitidine hydrochloride coated tablet formulations labeled to contain 150 mg indicated differences in drug release from analyzed ran itidine hydro chloride formulations and could cause differences in therapeutic response. It is a FDA-approved inactive ingredient commonly used in the pharmaceutical industry as a lubricant and release agent in the manufacture of tablet, capsule, and powder dosage forms. No. TABLUBE (Magnesium Stearate USP/NF/BP/EP/JP/ As per USDMF No.18912 a. E DM No. Lubripharm Sodium Stearyl Fumarate (SSF) is a tablet lubricant for use in traditional and orally disintegrating tablets, effervescent formulas, or in formulas where the active is incompatible with magnesium stearate. AEROSIL [91-99] 1. The use of Magnesium Stearate is further complicated by significant batch to batch variation of lubrication properties. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. 033414) is one of the oldest and most widely used lubricants for tablet, capsules and other solid dosage forms. Appearance. It also has lubricant properties. Used in tablet formulations to reduce friction during tablet compression. Magnesium stearate. Magnesium stearate is the chemical compound with the formula Mg(C 18H 35O 2) 2. It is a soap, consisting of salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg 2+ ). Magnesium stearate is a white, water-insoluble powder. It is thus unusual that Plavix tablets do not contain magnesium stearate as the lubricant, but instead contain hydrogenated castor oil and polyethylene glycol as lubricants. Replacing magnesium stearate with an equal amount of calcium stearate in the formulation would be expected to _____ the dissolution rate of xy1000 from the tablets. Lubricants, such as magnesium stearate and sodium stearyl fumarate, were also used to improve owability of cohesive powders without signicantly aecting the ta- Description. It is primarily used as a lubricant in capsule and tablet manufacture at concentration between 0.25 0.5% w/w. Calcium stearate, magnesium stearate, Sterotex, Talc, and Sterowet etc. Most lubricants are used in concentration 1% w/w. Mineral oil. Researchers opine that tablets without magnesium stearate have a 90 percent absorption rate, while those formulated with magnesium stearate show a 25 30 percent absorption capacity. Differences in chemical composition: Commercial Magnesium Stearate actually consists of a mixture of several different fatty acids. 37. The amount and the mixing time of magnesium stearate in the formulation are critical variables. Octadecanoic acid, magnesium salt. sustained-release tablet formulations,(11) as a carrier in dry powder inhalers,(12,13) and as a diluent in rapidly dispersing oral dosage 20mm. It was observed that the Magnesium Stearate with a designed PSD is controlling the drug release profile of Metformin hydrochloride Tablets, which can replace the use of excess quantity of Magnesium Stearate or addition of a rate controlling polymer like hydroxy propyl methyl cellulose in the formulation design. Whilst its main purpose is as a lubricant, it does have other benefits in a formulation such as an emulsifier, binder, anticaking, thickening and antifoaming agent. 1979). U.S. Pat. TLDR. Claims that it decreases absorption in the digestive tract and may even be unsafe for human consumption have been made by various individuals and companies, stirring up uncertainty Magnesium stearate (Mg (C18H3502)2 or octadecanoic acid) is a solid, white powder at room temperature. Lubricants, such as magnesium stearate, may or may not promote granule flow, depending on the level at which they are used higher levels tending to impede flow. For nutraceutical tablet manufacturing, it is the lubricant of choice. Magnesium stearate is a more effective lubricant than stearic acid. 2007. MAGNESIUM STEARATE WITH TABLET DISSOLUTION AND LUBRICATION Magnesium stearate (MgSt) is the most commonly used pharmaceutical excipient and is present in over half the tablet formulations on the market. The irregularity of the shapes of commercially available magnesium stearates compared to pure magnesium stearate relates to their reduced lubricant effects (Miller & York, 1985). Calibration standards consisted of tablets of the same formulation as Product A, but without the API. As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. 12 %; each formulation contained: metformin HCl 500 mg, colloidal silicon dioxide 0.55 %, magnesium stearate 0.55 %; microcrystalline cellulose - quantity sufficient to 900 mg Preparation of matrix tablets by melt granulation Hot melt granulation technique was used to prepare the drug-wax matrix formulations. volume, mixing intensity and time on tablet properties of dierent formulations using magnesium stearate as a lubricant (Kushner and Moore 2010; Ragnarsson et al. Magnesium stearate is widely used in the production of dietary supplement and pharmaceutical tablets, capsules and powders as well as many food products, including a variety of confectionery, spices and baking ingredients. Compatibility investigation was performed between magnesium stearate and acidic drug compounds (ibuprofen, indomethacin and valproic acid) and acidic pharmaceutical excipients (lactic acid and citric acid) using differential scanning calorimetry (DSC). on PharmaCompass. Typically 510% for loose powders. Once the raw materials of a vitamin product formulation have been mixed up it is very important to maintain the mix consistency, otherwise the nutrients going into the capsule will not be able to meet the label claims of what is in the capsule. The The three companies announce that they will be Magnesium Stearate is surprisingly creamy when handledit has a wonderful, rich slip when rubbed between the fingers. The most commonly used lubricant is magnesium stearate. PDF. 2. Magnesium stearate reduces not only the lower punch ejection force by about 70% but also tablet tensile strength. Pharmaceutical tablets comprising clopidogrel bisulfate and a lubricant selected from zinc stearate, stearic acid, and sodium stearyl fumarate. White fine powder. Magnesium stearate (MgSt) is a frequently used lubricant in tablet manufacturing due to its excellent properties . Magnesium stearate is hydrophobic in nature, over Lubrication leads to create hydrophobic layer, this cause dissolution, Dt, tablet harness issue. A method of inhibiting or reducing chemical degradation of an anti-muscarinic active ingredient in a powder formulation comprising carrier particles and the anti-muscarinic active ingredient, the method comprising: coating a surface of the carrier particles with magnesium stearate in preparation of the powder formulation; wherein: the anti-muscarinic Res Rev J Chem. Stearic acid typically ranges between 0.5 [percent]10 percent of the tablet weight, while magnesium stearate typically represents 0.25 [percent]1.5 percent of the tablet weight. This fact not only eases the manufacturing process, but it also eases ingestion1. Calcium stearate. Partners DFE Pharma, Hosokawa Micron and Harro Hfliger describe their unique multidisciplinary study into lactose-based DPI formulations including magnesium stearate, whose findings will give generic players a head-start in the development process so that they can tap into this rapidly growing market. One of the most common excipients is Magnesium Stearate or the Stearic Acid. The major uses of magnesium stearate are as a lubricant, anti-adhesion agent, and glidant in the manufacturing of pharmaceuticals tablets and capsules. It is a versatile component and can be used as a flow agent, lubricant etc. The results show that lubrication by magnesium stearate led to decrease in 0 and increase in TBI 0. It is useful in formulations or processes where lubricants are likely to cause problems, such as the potential to slow down dissolution or produce weak tablets, for instance, when magnesium stearate is selected. Stearic acid is the second most important lubricant. It helps to keep blood sugar and blood pressure at the right levels. Both are nutritional substances and are naturally found in a variety of foods. The powder is greasy to 37. Its main job is to keep the ingredients in a capsule from sticking together. PDF. Magnesium stearate being highly hydrophobic could sig-nificantly impact dissolution especial-ly when used at high concentrations and blended extensively with the API. Magnesium Stearate (MgSt) is used in >2,500 pharmaceutical products The most used excipient in top 200 Rx drugs 108 77 61 49 45 40 36 25 22 21 20 20 20 19 19 19 disintegration and dissolution of drug substances in tablets. In this study, stearic acid was used at 0.5% and magnesium stearate was used at 0.25%. However, their key func- General description. The objective of this study was to evaluate the effects of two different concentrations of magnesium stearate on dissolution properties of ranitidine hydrochloride coated tablet formulations labeled to contain 150 mg. The most commonly used lubricant is magnesium stearate. Lubricants and Glidants used in Tablet Formulations are: Magnesium stearate Stearic acid Sodium stearyl fumarate Hydrogenated vegetable oil PEG 4000, 6000 a region of a fast reduction in friction up to 1 %, and a slower friction-reducing effect after 1%. M. 480 Mannitol. Magnesium stearate is capable of forming films on other tablet excipients during prolonged mixing, leading to a prolonged drug liberation time, a decrease in hardness, and an increase in disintegration time. Mallinckrodts Magnesium Stearate Monohydrate High purity Well-defined crystalline state Consistent physical properties C36H70MgO4 or Mg(C18H35O2)2. Magnesium Stearate Home > Magnesium Stearate. It is common manufacturing behavior to add a minimum amount after first achieving a homogenous powder blend of all other ingredients and additionally mixing-in the lubricant for a brief period of time. Rowe et al., eds. The National Center for Biotechnology suggests that taking 2,500 milligrams of magnesium stearate per kilogram of body weight is considered safe. For an adult weighing about 150 pounds, thats 170,000 milligrams per day. When considering the potentially harmful effects of magnesium stearate, its helpful to think about dose dependency. Evaluated effects of two different concentrations of magnesium stearate on dissolution properties of ranitidine hydrochloride coated tablet formulations labeled to contain 150 mg indicated differences in drug release from analyzed ran itidine hydro chloride formulations and could cause differences in therapeutic response. The use of sodium Stearyl Fumarate instead of magnesium stearate provided better release pattern. Some lubricants, like SSF, are less hy-drophobic than Magnesium Stearate and minimize the negative impact on wettability. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. Common minerals like talc or silica, and fats, e.g. binder in tablets (think of how you might use eggs as a binder to mix with flour during baking). As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. Magnesium is a cofactor in more than 300 enzyme systems that regulate diverse biochemical reactions in the body, including protein synthesis, muscle and nerve function, blood glucose control, and blood pressure regulation [ 1-3 ]. Titanium dioxide. Magnesium stearate is the chemical compound with the formula Mg(C 18 H 35 O 2) 2.It is a soap, consisting of salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg 2+).Magnesium stearate is a white, water-insoluble powder. Magnesium Stearate is the salt of magnesium and stearic acid. Magnesium stearate i s a fine, white, prec ipitated or mill ed, impalpabl e po wder of l ow bulk density, having a faint odor of stearic ac id and a character istic taste. In tablet film coatings, Magnesium stearate is used to reduce tack and improve the moisture resistance of coatings. Lubricant is a compound added in tablet formulations primarily to reduce friction between the die wall and granules as the tablet is formed and ejected [1]. Magnesium Stearate cannot be used in products containing aspirin, some vitamins and most alkaloidal salts. US6914141B2 - Clopidogrel bisulfate tablet formulation - Google Patents Clopidogrel bisulfate tablet formulation Download PDF Info Publication number US6914141B2. Excipient compatibility testing would help in magnesium stearate, Primary amine selecting right excipient. May be used alone or with a colorant. Magnesium octadecanoate. Synonyms. Lubricant: magnesium stearate 0.7% w/w for Pearlitol 400 DC and Pearlitol 500 DC; magnesium stearate 1% w/w for Pearlitol 300 DC. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour It is also used in certain food applications and nutraceutical formulations. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. Magnesium Stearate is the most popular excipient used in pharmaceutical industry. No. Its applications exploit its softness, insolubility in many solvents, and low toxicity. Tablet tensile strength () and TBI at zero porosity ( 0 and TBI 0) were obtained from nonlinear regression of data of all powders to evaluate the relationship between brittleness and bonding strength of pore-free tablets. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Due to its hydrophobic nature, magnesium stearate also affects the ingress of water into the tablet matrix. It has good adhesion. Tablet lubricant. The results suggest that dihydrate magnesium stearate exhi bit better lubricity and can be used to minimize sticking i ssues during tableting. Tablet Tensile Strength