Magnesium stearate

Manufactured by Mallinckrodt

Sourced in United States, India

Magnesium stearate is a fine, white powder used as a lubricant and anti-caking agent in the manufacture of pharmaceutical tablets and capsules. It is a salt of magnesium and stearic acid, a long-chain fatty acid. Magnesium stearate is added to formulations to improve the flow properties of the powder and to prevent ingredients from sticking to manufacturing equipment.

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Lab products found in correlation

Lh 21, by Shin-Etsu Chemical (2 mentions) Colloidal silicon dioxide, by Evonik (2 mentions) Pearlitol r 200 sd, by Roquette (2 mentions) Anhydrous emcompress r, by JRS Pharma (2 mentions) Carbamazepine, by Merck Group (1 mentions) Soluplus, by BASF (1 mentions) Kollidon va64, by BASF (1 mentions) Starch 1500, by Colorcon (1 mentions) Emcompress anhydrous, by JRS Pharma (1 mentions) Sodium chloride (nacl), by Merck Group (1 mentions) Magnesium chloride, by Merck Group (1 mentions) Pearlitol 200sd, by Roquette (1 mentions) Kollidon cl, by BASF (1 mentions) Mefenamic acid, by Merck Group (1 mentions) Eudragit epo, by Evonik (1 mentions) Aerosil, by Evonik (1 mentions) Sodium lauryl sulfate, by BASF (1 mentions) Sodium stearyl fumarate, by JRS Pharma (1 mentions) Glyceryl behenate, by Gattefosse (1 mentions) Low substituted hydroxypropyl cellulose l hpc, by Shin-Etsu Chemical (1 mentions)

22 protocols using magnesium stearate

Capsule Formulation of Compound 2

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Example 5

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 171.0 mg in a hypromellose capsule shell (VcapsPlus®, size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 170 mg of compound 2 per capsule shell.

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 171.0 mg in a gelatin capsule shell (size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 170 mg of compound 2 per capsule shell.

US09981040B2. Capsule formulation (2018-05-29). Eisai R&D Management Co., Ltd. [JP]. Inventors: Yosuke Ueki [JP].

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Formulation of Compound 2 Capsules

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Example 3

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 34.2 mg in a hypromellose capsule shell (VcapsPlus®, size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 34 mg of compound 2 per capsule shell.

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 34.2 mg in a gelatin capsule shell (size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 34 mg of compound 2 per capsule shell.

US09981040B2. Capsule formulation (2018-05-29). Eisai R&D Management Co., Ltd. [JP]. Inventors: Yosuke Ueki [JP].

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Compound 2 Capsule Formulation

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Example 4

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 85.5 mg in a hypromellose capsule shell (VcapsPlus®, size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 85 mg of compound 2 per capsule shell.

Compound 2 (19.88 g), a phosphonooxymethyl derivative of ravuconazole, was mixed with 0.12 g of magnesium stearate (produced by Mallinckrodt) in a vial. The resulting mixture was weighed at 85.5 mg in a gelatin capsule shell (size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 85 mg of compound 2 per capsule shell.

US09981040B2. Capsule formulation (2018-05-29). Eisai R&D Management Co., Ltd. [JP]. Inventors: Yosuke Ueki [JP].

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Compound 2 Capsule Formulation

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Example 11

788 g of compound 2, a phosphonooxymethyl derivative of ravuconazole, 8 g of magnesium oxide (produced by Kyowa Chemical Industry Co., Ltd.) and 4 g of magnesium stearate (produced by Mallinckrodt) were mixed. The resulting mixture was weighed at 174 mg in a hypromellose capsule shell (VcapsPlus®, size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 171 mg of compound 2 per capsule shell.

US09981040B2. Capsule formulation (2018-05-29). Eisai R&D Management Co., Ltd. [JP]. Inventors: Yosuke Ueki [JP].

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Formulation of Carbamazepine Solid Dispersions

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Soluplus (Lot number: 65511368E0) and polyvinylpyrrolidone vinyl acetate copolymer (PVP-VA), that is, Kollidon VA 64 (Lot number: 46581856Po), were procured from BASF SE, Germany. Methocel premium (CR, USA) was procured from Dow Chemicals, Michigan. Carbamazepine (Lot number: SLBB3655V) was purchased from Sigma Aldrich, USA. Magnesium stearate (Lot number: J03970) was procured form Mallinckrodt, USA.

Ullah M., Ullah H., Murtaza G., Mahmood Q, & Hussain I. (2015). Evaluation of Influence of Various Polymers on Dissolution and Phase Behavior of Carbamazepine-Succinic Acid Cocrystal in Matrix Tablets. BioMed Research International, 2015, 870656.

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Pharmaceutical Excipients Study on Drug Formulation

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Tapioca starch (TS) was purchased from Kaensiri Starch Co., Ltd. (Khon Kaen, Thailand). Acetaminophen (ACT) (K Sciences Center and Medical Ltd., Part., Khon Kaen, Thailand), propranolol hydrochloride (PPN) (Changzhou Yabang Pharmaceutical Co., Ltd., Changzhou, Jiangsu, China), polyvinylpyrrolidone K30 (PVP) (Union Sciences Trading Co., Ltd., Khon Kaen, Thailand), Starch 1500^® (Colorcon Ltd., Dartford, UK), and magnesium stearate (Mallinckrodt Inc., St. Louis, MO, USA) were employed in this study. All other reagents were of analytical grade and used as received.

Siriwachirachai C, & Pongjanyakul T. (2022). Particle Agglomeration of Acid-Modified Tapioca Starches: Characterization and Use as Direct Compression Fillers in Tablets. Pharmaceutics, 14(6), 1245.

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Tablet Formulation Development and Characterization

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Tablet excipients included microcrystalline cellulose (MCC) (Avicel®PH-102, FMC International), mannitol (Pearlitol®200 SD, Roquette), lactose (FastFlo®316, Foremost Farms USA) and dibasic calcium phosphate anhydrous (DCPA) (Anhydrous Emcompress, JRS Pharma) as fillers. The disintegrants croscarmellose sodium (CCS) (FMC International), crospovidone (XPVP) (Kollidon®CL, BASF), low-substituted hydroxypropyl cellulose (L-HPC) (LH-21, Shin-Etsu Chemical Co.) and sodium starch glycolate (SSG) (Primojel®, DFE Pharma) were used in the tablet formulations. Magnesium stearate (Mallinckrodt) was used as a lubricant. Magnesium chloride and sodium chloride (Sigma Aldrich) were used to make saturated salt solutions.

Maclean N., Khadra I., Mann J., Williams H., Abbott A., Mead H, & Markl D. (2021). Investigating the role of excipients on the physical stability of directly compressed tablets. International Journal of Pharmaceutics: X, 4, 100106.

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Mefenamic Acid Formulation Optimization

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Mefenamic acid (MA) was purchased from Sigma Aldrich (Bellefonte PA. USA); Eudragit^® E PO and Aerosil^® was gifted by Evonik (Evonik Industries, Germany); Avicel^® 200 was gifted by FMC Biopolymers (Philadelphia, PA. USA); Polyplasdone^TM crospovidone was gifted by ISP Technologies (ISP Technologies, Inc., Wayne, NJ, USA); Magnesium stearate was purchased from Mallinckrodt (St. Louis, MO, USA). All other chemicals used were of analytical grade.

Alshehri S.M., Park J.B., Alsulays B.B., Tiwari R.V., Almutairy B., Alshetaili A.S., Morott J., Shah S., Kulkarni V., Majumdar S., Martin S.T., Mishra S., Wang L, & Repka M.A. (2015). Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology. Journal of drug delivery science and technology, 27, 18-27.

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Formulation and Compression of AT Matrix Tablets

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Materials AT and KSR were purchased from Provizer Pharma, India; Spray-dried lactose (Sheffield Products, Norwich, NY, U.S.A.); Avicel pH 101 (FMC Corporation Philadelphia, PA, U.S.A.); Emcompress (Stauffer Chemical Company, Westpot, CT, U.S.A.); and Magnesium stearate (Mallinckrodt, St. Louis, MO, U.S.A.).
Preparation of AT Matrix Tablets Different formulae of AT were prepared as illustrated in Table 1. AT was mixed with KSR in a porcelain mortar with a geometric dilution for 5 min, followed by mixing with each of the remaining ingredients (SP.D.L, AV, or EMS) for 10 min. Magnesium stearate was then added and mixed for an additional 5 min. Tablets were directly compressed using Erweka-Apparatebau single punch tablet machine (Erweka-Apparatebau, AR400, GmbH, Germany) with a diameter of 0.28 inch and 200 mg weight using flat-faced punches.

Owayez A.S., Abd El-Ghany G.M, & Abu Hashim I.I. (2017). Potential Use of Polyvinyl Acetate-Polyvinylpyrrolidone Mixture for the Development of Atenolol Sustained Release Matrix Tablets: Optimization of Formulation through in Vitro-in Vivo Assessment Study. Chemical & pharmaceutical bulletin, 65(6).

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Ravuconazole Phosphonooxymethyl Derivative Capsule Formulation

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Example 9

794.4 g of compound 2, a phosphonooxymethyl derivative of ravuconazole, 1.6 g of magnesium oxide (produced by Kyowa Chemical Industry Co., Ltd.) and 4 g of magnesium stearate (produced by Mallinckrodt) were mixed. The resulting mixture was weighed at 172 mg in a hypromellose capsule shell (VcapsPlus®, size 2, produced by CAPSUGEL) to obtain a capsule formulation comprising 171 mg of compound 2 per capsule shell.

US09981040B2. Capsule formulation (2018-05-29). Eisai R&D Management Co., Ltd. [JP]. Inventors: Yosuke Ueki [JP].

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