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. The powder is greasy to Pharmaceutical tablets comprising clopidogrel bisulfate and a lubricant selected from zinc stearate, stearic acid, and sodium stearyl fumarate. 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. Magnesium stearate. Magnesium stearate (MgSt) is a frequently used lubricant in tablet manufacturing due to its excellent properties . Magnesium stearate is capable For the tablet formulations the following ingredients were used and provided by different producers: ra-nitidine hydrochloride, titan dioxide (Merck Darm-stadt, Germany), magnesium stearate and ethanol 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 TABLUBE TM MAGNESIUM STEARATE. The lubricity of magnesium stearate in a formulation can be increased with either the concentration or the duration of mixing. Ariyasu A, et al. Its applications exploit its softness, insolubility in many solvents, and low toxicity. Lubricants are agents added in small quantities to tablet and capsule formulations to improve certain processing characteristics. 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. 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. NITIKA is the pioneer in the manufacturing of TABLUBE TM since last about fifteen years. Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. 9. Peroxide content of the Crospovidone played an important role in controlling the impurity in the formulation. It helps to keep blood sugar and blood pressure at the right levels. M. 480 Mannitol. However, their key func- Tablet lubricant. U.S. Pat. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. 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. C36H70MgO4 or Mg(C18H35O2)2. These granules were lubricated with mixture of talc and magnesium stearate (2:1). 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. Differences in chemical composition: Commercial Magnesium Stearate actually consists of a mixture of several different fatty acids. Source: AIChE. Common minerals like talc or silica, and fats, e.g. As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. Magnesium citrate is a form of magnesium thats bound with citric acid. TLDR. Magnesium stearate (Mg (C18H3502)2 or octadecanoic acid) is a solid, white powder at room temperature. 1. Magnesium stearate (MgSt) is a common lubricant used in tablet formulations to facilitate tablet manufacturing by reducing ejection force. 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. 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 stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. TABLUBE (Magnesium Stearate USP/NF/BP/EP/JP/ As per USDMF No.18912 a. E DM No. The major uses of magnesium stearate are as a lubricant, anti-adhesion agent, and glidant in the manufacturing of pharmaceuticals tablets and capsules. Magnesium stearate reduces not only the lower punch ejection force by about 70% but also tablet tensile strength. Octadecanoic acid, magnesium salt. Mallinckrodts Magnesium Stearate Monohydrate High purity Well-defined crystalline state Consistent physical properties US6914141B2 - Clopidogrel bisulfate tablet formulation - Google Patents Clopidogrel bisulfate tablet formulation Download PDF Info Publication number US6914141B2. As a result, the use of magnesium stearate as a lubricant may lead to longer disintegration times. 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. volume, mixing intensity and time on tablet properties of dierent formulations using magnesium stearate as a lubricant (Kushner and Moore 2010; Ragnarsson et al. U.S. Pat. The most commonly used lubricant is magnesium stearate. The present invention relates to solid pharmaceutical formulations which comprise an active ingredient drug substance, a carrier and magnesium stearate. The most commonly used lubricant is magnesium stearate. This invention comprises a new formulation which solves the stability problems of a thieno pyridine derivative, anthitrombotic clopidogrel bisulphate compositions. It is not as effective as magnesium stearate, the minimum effective stearic acid concentration is about 1%, and it reduces the lower punch ejection force by no more than 30%. 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 ]. MAGNESIUM STEARATE. General description. PDF. 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. Magnesium stearate is a lubricant, and the most common ingre-dient used in tablet formulations. 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. Description. Tablet or capsule opaquant. 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. (2016). The lubricating effect was evaluated as the maximum ejection force (EJF/A) and 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. It is hydrophobic, and there are many reports in the literature concerning its adverse effect on dissolution rates. 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 In tablet film coatings, Magnesium stearate is used to reduce tack and improve the moisture resistance of coatings. 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 PDF. Lubricants, such as magnesium stearate and sodium stearyl fumarate, were also used to improve owability of cohesive powders without signicantly aecting the ta- Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour Magnesium distearate. Magnesium is required for energy production, oxidative phosphorylation, and glycolysis. Delay effect of magnesium stearate on tablet dissolution in acidic medium. 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. Tablet polishing agent. 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. 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. Magnesium stearate (MgSt) is the most commonly used pharmaceutical excipient and is present in over half the tablet formulations on the market. 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. Stearic acid is saturated fat, while magnesium is an essential mineral. White fine powder. Three factors have been determined to be mainly responsible for this variation: 1. Another object of the invention is to form a new formulation Magnesium stearate is a magnesium salt combined with stearic acid. 033414) is one of the oldest and most widely used lubricants for tablet, capsules and other solid dosage forms. Mineral oil. 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. Calcium stearate, magnesium stearate, Sterotex, Talc, and Sterowet etc. Some lubricants, like SSF, are less hy-drophobic than Magnesium Stearate and minimize the negative impact on wettability. One of the most common excipients is Magnesium Stearate or the Stearic Acid. 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. Magnesium octadecanoate. 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. DOI: 10.1016/j.ijpharm.2016.07.034 CFR: Code of federal regulations title 21. 2016;5(2):143-54. 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. Magnesium Stearate is surprisingly creamy when handledit has a wonderful, rich slip when rubbed between the fingers. Your solution. In this study, stearic acid was used at 0.5% and magnesium stearate was used at 0.25%. 1979). 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. 1-17. on PharmaCompass. 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. AEROSIL [91-99] 1. 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 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. 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. Its role is as an excipient (inactive ingredient) and the main function in Molecular Weight. (canceled) 18. Melting Point. 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. No. 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 Home > Magnesium Stearate. dissolution rate. The adverse effect of this product on tablet hardness is less than that of magnesium stearate. Abstract. The use of Magnesium Stearate is further complicated by significant batch to batch variation of lubrication properties. 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. Since it is less hydrophobic than magnesium stearate it provides better stability. 4,847,265, in examples 1 and 2, shows the use of magnesium stearate as the lubricant. 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). It has good adhesion. The use of sodium Stearyl Fumarate instead of magnesium stearate provided better release pattern. Magnesium Stearate is the salt of magnesium and stearic acid. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour Group . The use of MgSt in tablet formulation is known to potentially deteriorate tabletability of plastic powders and slow down drug dissolution. In this study, the mechanism underlying the delay caused by Mg-St was investigated with model metformin hydrochloride (HCl) tablets containi Advantages of Sodium stearyl fumarate over Magnesium stearate Magnesium Stearate is the most popular excipient used in pharmaceutical industry. No. coverage depend on the mixing time of the tablet mass with Magnesium Stearate because of its laminar structure 3. Companies call magnesium stearate a flow agent.. Magnesium is an essential mineral that it is often missing from the human diet despite the many places it is found. 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. Pharmaceutical applications: cosmetics, foods and pharmaceutical formulations. 2007. The results show that lubrication by magnesium stearate led to decrease in 0 and increase in TBI 0. Calibration standards consisted of tablets of the same formulation as Product A, but without the API. Magnesium Stearate cannot be used in products containing aspirin, some vitamins and most alkaloidal salts. 37. 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. Calcium stearate. Find Magnesium The amount and the mixing time of magnesium stearate in the formulation are critical variables. Lactose, a sugar commonly found in dairy products, gives the tablet most of its volume. 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. 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. Due to its hydrophobic nature, magnesium stearate also affects the ingress of water into the tablet matrix. 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. 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. It is also used in certain food applications and nutraceutical formulations. Appearance. LIST OF FIGURES 1.1 Chemical structure of DCPM 1 It is made up of two important components; magnesium and stearic acid. Stearic acid. of lubricant in each formulation and determine its effect on compressibility and ejection force. Both are nutritional substances and are naturally found in a variety of foods. Zinc 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). Most lubricants are used in concentration 1% w/w. One of the most common capsule and tablet filling agents in use today, magnesium stearate has recently been the source of a great debate in the supplement world. Its main job is to keep the ingredients in a capsule from sticking together. Used in tablet formulations to reduce friction during tablet compression. sustained-release tablet formulations,(11) as a carrier in dry powder inhalers,(12,13) and as a diluent in rapidly dispersing oral dosage 20mm. Finally, the amount and the mixing time of Magnesium stearate in the formulation are critical variables. The uniformity was also checked. Titanium dioxide. 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. Description. Due to its hydrophobic nature, magnesium stearate also affects the ingress of water into the tablet matrix. Questions 10-14 refer to the following tablet formulation for a new drug. TLDR. Magnesium stearate is a more effective lubricant than stearic acid. Synonyms. Lactose is physically a 200C (lit.) Magnesium stearate is the most common ingredient used in tablet formulations. magnesium stearate is Magnesium stearate is primarily used in pharmaceutical formulations as a lubricant in tablet manufacture at concentration up to 1%. The Magnesium Stearate Synpro Stearates $ 0.00. magnesium stearate, which serves as a lubricant were a part of the formulations. vegetable stearin, magnesium stearate or stearic acid are the most frequently used lubricants in tablets or hard gelatin capsules. Magnesium stearate occurs as a very fine, light white, impalpable powder of low bulk density, having characteristic taste and odour Water-insoluble Lubricant. Effect of Magnesium Stearate attributes on tablet lubrtication. Rapid quantitative analysis of magnesium stearate in tablets using laser-induced breakdown spectroscopy. It should be noted that the amounts of stearic acid and magnesium stearate typically used in a tablet is relatively minute. Disintegration Time with LUBRI-PREZ Compared to Other Products in the Market. 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 acid is found naturally in citrus fruits and gives them their tart, sour flavor. It also has lubricant properties. 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. May be used alone or with a colorant. 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%. Disintegration Time with LUBRI-PREZ Compared to Other Products in the Market. After achieving a homogenous blend of pow-dered ingredients, a small amount of magnesium stearate is added to enable 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. Typically, stearic acid must be used at higher levels in order to achieve similar ejection forces. It is a versatile component and can be used as a flow agent, lubricant etc. Ludiflash due to polyvinyl acetate content increased disintegration time & therefore alters the release of the A.P.I. Magnesium stearate (Mg-St) is a common lubricant used for solid pharmaceutical formulations and is known for its property to cause delay of tablet dissolution. Molecular Formula. 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]. 1. binder in tablets (think of how you might use eggs as a binder to mix with flour during baking). 37. Uses of Magnesium Stearate. The object of the present invention is to use a new lubricant other than magnesium stearate which cause degradation in thieno[3,2-c] pyridine derivatives. Typical excipient levels used in immediate-release formulations range between 0.255% w/w [ 6 ]. Typically 510% for loose powders. Excipient compatibility testing would help in magnesium stearate, Primary amine selecting right excipient. specific tablet formulation. It has also been used in topical medical devices to enhance the performance of barrier creams. Laboratory Chemical Safety Summary (LCSS) Datasheet. Magnesium stearate, the magnesium salt of stearic acid, is an additive, a flow agent used in pharmaceutical or supplement capsules and tablets. 2007. 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. Effect of Magnesium Stearate attributes on tablet lubrtication. 557-04-0. The use of MgSt in tablet formulation is known to potentially deteriorate tabletability of plastic powders and slow down drug dissolution. Magnesium stearate is hydrophobic in nature, over Lubrication leads to create hydrophobic layer, this cause dissolution, Dt, tablet harness issue. For nutraceutical tablet manufacturing, it is the lubricant of choice. Magnesium stearate being highly hydrophobic could sig-nificantly impact dissolution especial-ly when used at high concentrations and blended extensively with the API. Magnesium citrate. It is primarily used as a lubricant in capsule and tablet manufacture at concentration between 0.25 0.5% w/w. 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. Used to render a coating opaque. C36H70MgO4. 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. This fact not only eases the manufacturing process, but it also eases ingestion1. 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. A higher level and longer mixing time reduce the drug dissolution. Lubricant: magnesium stearate 0.7% w/w for Pearlitol 400 DC and Pearlitol 500 DC; magnesium stearate 1% w/w for Pearlitol 300 DC. 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. For creamy cosmetics and binding powders for pressing youll need to use it at higher rates. 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. (Dave 2008) Stearic acid is the second most important lubricant. Magnesium stearate is an additive that is most frequently used as a lubricant. 20 30 40 50 60 70 minutes Tablet formulation: Compap 0900 plus 0.5, or 2 % lubricant, 10 min blending time, and compressed at Rowe et al., eds. 2. The three companies announce that they will be 4,847,265, in examples 1 and 2, shows the use of magnesium stearate as the lubricant. 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). 591.24 g/mol.