557-04-0. 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%. Magnesium stearate reduces not only the lower punch ejection force by about 70% but also tablet tensile strength. Magnesium stearate. Magnesium stearate is the most common ingredient used in tablet formulations. 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. One of the most common excipients is Magnesium Stearate or the Stearic Acid. NITIKA is the pioneer in the manufacturing of TABLUBE TM since last about fifteen years. 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. Zinc stearate. C36H70MgO4 or Mg(C18H35O2)2. Titanium dioxide. 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. Magnesium distearate. It is hydrophobic, and there are many reports in the literature concerning its adverse effect on dissolution rates. Peroxide content of the Crospovidone played an important role in controlling the impurity in the formulation. Magnesium stearate is a more effective lubricant than stearic acid. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. 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]. Companies call magnesium stearate a “flow agent.”. Typically, stearic acid must be used at higher levels in order to achieve similar ejection forces. These granules were lubricated with mixture of talc and magnesium stearate (2:1). Stearic acid. AEROSIL [91-99] 1. Used to render a coating opaque. TABLUBE (Magnesium Stearate USP/NF/BP/EP/JP/ As per USDMF No.18912 a. E DM No. In this regard, the substance is also useful because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets; magnesium stearate is the most commonly used lubricant for tablets. However, it might cause lower wettability and slower disintegration... 033414) is one of the oldest and most widely used lubricants for tablet, capsules and other solid dosage forms. A publication by Rutgers University, entitled “Effects of Magnesium Stearate on Tablet Properties,” reports that tablets containing 1% magnesium stearate have the least dose deviation, the most uniformity in composition, and maintain the highest ... Excipients used in the formulation of tablets. Effect of Magnesium Stearate attributes on tablet lubrtication. Magnesium stearate; lubrication; ejection force; dissolution; tensile strength; solid-state NMR; compaction Introduction Magnesium stearate (MgSt) is a pharmaceutical excipient com-monly used in solid oral dosage forms, with over half of the tablet formulations on the market using it as a lubricant. 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. Magnesium citrate is a form of magnesium that’s bound with citric acid. The use of Magnesium Stearate is further complicated by significant batch to batch variation of lubrication properties. As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. It also has lubricant properties. In this study, the mechanism underlying the delay caused by Mg-St was investigated with model metformin hydrochloride (HCl) tablets containi … 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. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. 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 … U.S. Pat. The major uses of magnesium stearate are as a lubricant, anti-adhesion agent, and glidant in the manufacturing of pharmaceuticals tablets and capsules. Tablet lubricant. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour The present invention relates to solid pharmaceutical formulations which comprise an active ingredient drug substance, a carrier and magnesium stearate. Pharmaceutical applications: cosmetics, foods and pharmaceutical formulations. 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; This product is a white, delicate and relaxing powder with a large specific volume (1g of magnesium stearate has a volume of 10-15ml). Questions 10-14 refer to the following tablet formulation for a new drug. No. Ariyasu A, et al. The amount and the mixing time of magnesium stearate in the formulation are critical variables. 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 … 4,847,265, in examples 1 and 2, shows the use of magnesium stearate as the lubricant. In tablet film coatings, Magnesium stearate is used to reduce tack and improve the moisture resistance of coatings. A higher level and longer mixing time reduce the drug dissolution. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. 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. TABLUBE TM – MAGNESIUM STEARATE. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. 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. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour Group . This study demonstrates the use of hydrophilic interaction liquid chromatography with a nano quantity analyte detector for the retention, separation and detection of magnesium from magnesium stearate in tablet formulations for a drug product formulation blend containing a hydrochloride salt of a weakly basic compound as the active ingredient. Tablet polishing agent. ... Calcium stearate, magnesium stearate, Sterotex, Talc, and Sterowet etc. Stearic acid is the second most important lubricant. 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. Due to its hydrophobic nature, magnesium stearate also affects the ingress of water into the tablet matrix. As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. It is primarily used as a lubricant in capsule and tablet manufacture at concentration between 0.25 – 0.5% w/w. Synonyms. 37. 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 Magnesium stearate (Mg (C18H3502)2 or octadecanoic acid) is a solid, white powder at room temperature. 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. Its applications exploit its softness, insolubility in many solvents, and low toxicity. Search through a list of Tablet Chewable finished formulations (FDFs) using Stearic acid magnesium & MAGNESIUM STEARATE as a pharmaceutical grade excipient and find corresponding application numbers, supplier and manufacturer details, etc. It is a versatile component and can be used as a flow agent, lubricant etc. Source: AIChE. 1. Typically 5–10% for loose powders. Used in tablet formulations to reduce friction during tablet compression. (Dave 2008) 1-17. Molecular Formula. It is made up of two important components; magnesium and stearic acid. Magnesium stearate, the magnesium salt of stearic acid, is an additive, a flow agent used in pharmaceutical or supplement capsules and tablets. Both are nutritional substances and are naturally found in a variety of foods. It has good adhesion. TLDR. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. Abstract. Magnesium Stearate Home > Magnesium Stearate. 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. TLDR. After achieving a homogenous blend of pow-dered ingredients, a small amount of magnesium stearate is added to enable In spite of its popularity as an effective lubricant, it has been repeatedly recognized that there is significant 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. of lubricant in each formulation and determine its effect on compressibility and ejection force. Whilst it’s main purpose is as a lubricant, it does have other benefits in a formulation such as an emulsifier, binder, anticaking, thickening and antifoaming agent. 9. The three companies announce that they will be … 2007. Magnesium stearate is a lubricant, and the most common ingre-dient used in tablet formulations. It is also used in certain food applications and nutraceutical formulations. 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 (MgSt) is the most commonly used pharmaceutical excipient and is present in over half the tablet formulations on the market. 2. Its role is as an excipient (inactive ingredient) and the main function in … 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. The results show that lubrication by magnesium stearate led to decrease in σ 0 and increase in TBI 0. Magnesium Stearate is surprisingly creamy when handled—it has a wonderful, rich slip when rubbed between the fingers. Disintegration Time with LUBRI-PREZ Compared to Other Products in the Market. PDF. 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. Overlubrication, due to the use of high concentration or excessive mixing can result in reduced compactibility of the blend and/or rate of drug release from the tablets. For nutraceutical tablet manufacturing, it is the lubricant of choice. 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. 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 ]. Rowe et al., eds. ... Calibration standards consisted of tablets of the same formulation as Product A, but without the API. 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. This acid is found naturally in citrus fruits and gives them their tart, sour flavor. In this study, stearic acid was used at 0.5% and magnesium stearate was used at 0.25%. The use of sodium Stearyl Fumarate instead of magnesium stearate provided better release pattern. Find Magnesium … Magnesium stearate is commonly utilized as a lubricant in pharmaceutical formulations to avoid the excipient blend from the formulation contents from sticking to the manufacturing equipment. Finally, the amount and the mixing time of Magnesium stearate in the formulation are critical variables. coverage depend on the mixing time of the tablet mass with Magnesium Stearate because of its laminar structure 3. Disintegration Time with LUBRI-PREZ Compared to Other Products in the Market. sustained-release tablet formulations,(11) as a carrier in dry powder inhalers,(12,13) and as a diluent in rapidly dispersing oral dosage ... 20mm. Your solution. magnesium stearate, which serves as a lubricant were a part of the formulations. Stearic acid is saturated fat, while magnesium is an essential mineral. Ludiflash due to polyvinyl acetate content increased disintegration time & therefore alters the release of the A.P.I. Tablet or capsule opaquant. Magnesium citrate. PDF. binder in tablets (think of how you might use eggs as a binder to mix with flour during baking). It has also been used in topical medical devices to enhance the performance of barrier creams. This invention comprises a new formulation which solves the stability problems of a thieno pyridine derivative, anthitrombotic clopidogrel bisulphate compositions. Magnesium stearate (MgSt) is a frequently used lubricant in tablet manufacturing due to its excellent properties . Some lubricants, like SSF, are less hy-drophobic than Magnesium Stearate and minimize the negative impact on wettability. Water-insoluble Lubricant. 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. 591.24 g/mol. Since it is less hydrophobic than magnesium stearate it provides better stability. FORMULATION STUDY OF MALEATE FOR USE IN THE NEW SUSTAINED RELEASE DOSAGE JUNE FABIAN (B Pharm) ... magnesium stearate and talc on tablet hardness 5.4 Analysis of variance for effects of 113 magnesium stearate and talc on T50 TABLE Page x. 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. 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. Mineral oil. 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. Advantages of Sodium stearyl fumarate over Magnesium stearate 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. US6914141B2 - Clopidogrel bisulfate tablet formulation - Google Patents Clopidogrel bisulfate tablet formulation Download PDF Info Publication number US6914141B2. White fine powder. LIST OF FIGURES 1.1 Chemical structure of DCPM 1 Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour 4,847,265, in examples 1 and 2, shows the use of magnesium stearate as the lubricant. No. The aim of this research was to investigate the effects of two different magnesium stearate concentrations on the dissolution properties of ranitidine hydrochloride coated tablet formulations labeled to contain 150 mg. (canceled) 18. magnesium stearate is … Another object of the invention is to form a new formulation … The uniformity was also checked. Differences in chemical composition: Commercial Magnesium Stearate actually consists of a mixture of several different fatty acids. Magnesium stearate in granular form was compared with powdered magnesium stearate as lubricant in 3 directly compressible tablet formulas and one prepared by wet-massing. Description. Occasionally, with high-weight tablets, more uniform weight and improved appearance can be obtained by slowing the machine speed so allowing more time for die-cavity filling. 2016;5(2):143-54. Lubricants, such as magnesium stearate and sodium stearyl fumarate, were also used to improve flowability of cohesive powders without significantly affecting the ta- The most commonly used lubricant is magnesium stearate. Delay effect of magnesium stearate on tablet dissolution in acidic medium. The use of MgSt in tablet formulation is known to potentially deteriorate tabletability of plastic powders and slow down drug dissolution. Lactose, a sugar commonly found in dairy products, gives the tablet most of its volume. 37. However, their key func- 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, that’s 170,000 milligrams per day. When considering the potentially harmful effects of magnesium stearate, it’s helpful to think about “dose dependency.” Appearance. Magnesium Stearate Synpro® Stearates $ 0.00. 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. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Magnesium octadecanoate. Pharmaceutical tablets comprising clopidogrel bisulfate and a lubricant selected from zinc stearate, stearic acid, and sodium stearyl fumarate. volume, mixing intensity and time on tablet properties of different formulations using magnesium stearate as a lubricant (Kushner and Moore 2010; Ragnarsson et al. 1979). 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. Tablet tensile strength (σ) and TBI at zero porosity (σ 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. 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. Melting Point. This fact not only eases the manufacturing process, but it also eases ingestion1. Partners DFE Pharma, Hosokawa Micron and Harro Höfliger 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. Its main job is to keep the ingredients in a capsule from sticking together. Uses of Magnesium Stearate. ... 20 30 40 50 60 70 minutes Tablet formulation: Compap 0900 plus 0.5, or 2 % lubricant, 10 min blending time, and compressed at … 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. Although stearic acid (12 out of 200 tablet formulations), in comparison with magnesium stearate (108 out of 200 tablet formulations), is a less frequently used lubricant, it provides an important alternative option when the use of magnesium stearate is not feasible. on PharmaCompass. The most commonly used lubricant is magnesium stearate. It should be noted that the amounts of stearic acid and magnesium stearate typically used in a tablet is relatively minute. Res Rev J Chem. The powder is greasy to M. 480 Mannitol. The adverse effect of this product on tablet hardness is less than that of magnesium stearate. The irregularity of the shapes of commercially available magnesium stearates compared to pure magnesium stearate relates to their reduced lubricant effects (Miller & York, 1985). dissolution rate. It helps to keep blood sugar and blood pressure at the right levels. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. 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. 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. Magnesium Stearate cannot be used in products containing aspirin, some vitamins and most alkaloidal salts.