Co-processed excipients Ludiflash (BASF, Ludwigshafen, Germany), Pharmaburst 500 (SPI Pharma, Wilmington, DE, USA), Ultraburst (SPI Pharma, Wilmington, DE, USA), and F-Melt type C (Fuji Chemical Industries Co., Ltd., Toyama, Japan) were kindly gifted by their manufacturers. Crospovidone–Polyplasdone XL-10 (Ashland, Schaffhausen, Switzerland), croscarmellose sodium–Primellose (DFE Pharma, Goch, Germany), and sodium starch glycolate–Primojel (DFE Pharma, Goch, Germany) were used as superdisintegrants. Microcrystalline cellulose–Vivapur PH-101 (JRS Pharma, Rosenberg, Germany) and Vivapur PH-102 (JRS Pharma, Rosenberg, Germany), D-mannitol–Pearlitol 100SD (Roquette, Lestrem, France), and spray-dried lactose–Supertab 14SD (DFE Pharma, Goch, Germany) were used as fillers. Silicon dioxide–Aerosil 200 (Evonik, Essen, Germany), sodium stearyl fumarate–Pruv (JRS Pharma, Rosenberg, Germany), calcium silicate–Rxcipients FM 1000 (Evonik, Havre de Grace, MD, USA), and magnesium aluminometasilicate–Neusilin US2 (Fuji Chemical Industries Co., Ltd., Toyama, Japan) were used to improve lubrication, flow, and compressibility of the tablet mass. Pregelatinized hydroxypropyl pea starch–Lycoat RS 720® (Roquette, Lestrem, France) and poly(vinyl alcohol)–PVA–Poval 4-88 (Kuraray, Tokyo, Japan) were used as film-forming polymers. Sorbitol–Polysor® (Roquette, Lestrem, France) was used as a plasticizer. Sucralose–Emprove (Merck, Darmstadt, Germany) was used as a sweetener. Menthol (Fagron, Krakow, Poland); citric acid (Chempur, Piekary Slaskie, Poland); bitter masking FLV PDR (Kerry Ingredients and Flavo, Mozzo, Italy); and mint, orange, lemon, strawberry, milk, and honey flavors (Firmenich, Genas, France) were used to mask the taste and smell of RRE.
Pearlitol 100 sd
Manufactured by Roquette
Sourced in Gabon, France, Germany, Panama, United States
About the product
Pearlitol® 100 SD is a specialty excipient produced by Roquette. It is a co-processed mannitol-based excipient designed for use in the pharmaceutical and nutraceutical industries. The product is intended to provide specific functionalities in the formulation and manufacturing of solid dosage forms.
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Lab products found in correlation
Cab o sil m 5p fumed silicon dioxide, by Cabot (27 mentions)
Fmc ac di sol, by FMC Biopolymer (12 mentions)
Magnesium stearate, by Thermo Fisher Scientific (10 mentions)
Comil u5, by Quadro (6 mentions)
Salicylic acid, by Merck Group (3 mentions)
Ac di sol, by FMC Biopolymer (3 mentions)
Pearlitol 300dc, by Roquette (2 mentions)
Mannit q, by Mitsubishi (2 mentions)
Pearlitol 200 sd, by Roquette (2 mentions)
Supertab 14 sd, by DFE Pharma (2 mentions)
Aspirin, by Euro Chemo-Pharma (2 mentions)
Lithium chloride and sodium chloride solutions, by METER Group (2 mentions)
Orthophosphoric acid, by Merck Group (2 mentions)
Aqualab 4tev, by METER Group (2 mentions)
Tumbler 15l, by SHOWA KAGAKU KIKAI (2 mentions)
Compact tableting machine, by Kikusui Seisakusho (2 mentions)
Fd 5s, by POWREX (2 mentions)
Splenda, by Tate and Lyle of Decatur (2 mentions)
Hyqual, by Mallinckrodt (2 mentions)
Fast flo 316, by Foremost Bara (2 mentions)
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Product FAQ
43 protocols using «pearlitol 100 sd»
1
Formulation and Evaluation of Rapidly Disintegrating Tablets
2
Moisture-Sensitive Drug Formulations with Co-Processed HPMC-Mannitol
Direct compression grade HPMC (HPMC DC; METHOCEL™ DC2 K4M, HPMC 2208, 4000 mPa.s grade, Colorcon, Harleysville, PA, USA) was used as received. Co-processed HPMC-mannitol, prepared at a 70:30 ratio (H 70 M 30 -CP) and 50:50 ratio (H 50 M 50 -CP) were kind gifts from Roquette, France. These co-processed excipients were prepared using a spray-drying tower, where mannitol syrup was sprayed onto fluidized HPMC particles (Benecel™ K4M CR, Ashland, Wilmington, DE, USA) and simultaneously dried. As references for comparison, physical mixtures of HPMC DC and spray-dried mannitol (PEARLITOL ® 100 SD, Roquette, Lestrem, France) at different ratios were prepared. The ratio of HPMC and mannitol was varied at 70:30 and 50:50 to obtain H 70 M 30 -PM and H 50 M 50 -PM physical mixtures, respectively. Physical mixtures were prepared by blending HPMC and mannitol at the respective ratios in a tumble blender (Turbula ® , WAB, Basel, Switzerland) at 42 rpm for 10 min. Aspirin (Euro Chemo-Pharma, Perai, Malaysia) was used as the model moisture-sensitive drug as its degradation products and mechanism of degradation in the solid state have been well characterized [35, (link)50, (link)53] (link). Magnesium stearate (MgSt; Productos Metalest, Zaragoza, Spain) was the tableting lubricant. Lithium chloride and sodium chloride solutions (Meter Group, Pullman, WA, USA) were used for the calibration of the water activity meter (Aqualab 4TEV, Meter Group, Pullman, WA, USA). Salicylic acid (Sigma-Aldrich, Burlington, MA, USA) was used to prepare calibration standards for the quantification of Aspirin degradation products by high-performance liquid chromatography (HPLC). Acetonitrile (J.T. Baker, Phillipsburg, NJ, USA), ortho-phosphoric acid (Sigma-Aldrich, Buchs, Switzerland), and purified water (Advantage A10, MilliQ, Burlington, MA, USA) were used to prepare the mobile phase for HPLC analyses. Dichloromethane (Merck, Darmstadt, Germany) and isopropyl alcohol (Avantor Performance Materials, Alberta, Canada) were used for particle sizing by laser diffractometry.
3
Spray-Dried HPMC-Mannitol Co-Processed Excipients
Direct compression grade HPMC (HPMC DC; METHOCEL™ DC2 K4M, HPMC 2208, 4000 mPa.s grade, Colorcon, Harleysville, PA, USA) was used as received. Co-processed HPMC–mannitol, prepared at a 70:30 ratio (H70M30–CP) and 50:50 ratio (H50M50–CP) were kind gifts from Roquette, France. These co-processed excipients were prepared using a spray-drying tower, where mannitol syrup was sprayed onto fluidized HPMC particles (Benecel™ K4M CR, Ashland, Wilmington, DE, USA) and simultaneously dried. As references for comparison, physical mixtures of HPMC DC and spray-dried mannitol (PEARLITOL® 100 SD, Roquette, Lestrem, France) at different ratios were prepared. The ratio of HPMC and mannitol was varied at 70:30 and 50:50 to obtain H70M30–PM and H50M50–PM physical mixtures, respectively. Physical mixtures were prepared by blending HPMC and mannitol at the respective ratios in a tumble blender (Turbula®, WAB, Basel, Switzerland) at 42 rpm for 10 min. Aspirin (Euro Chemo-Pharma, Perai, Malaysia) was used as the model moisture-sensitive drug as its degradation products and mechanism of degradation in the solid state have been well characterized [35 (link),50 (link),53 (link)]. Magnesium stearate (MgSt; Productos Metalest, Zaragoza, Spain) was the tableting lubricant.
Lithium chloride and sodium chloride solutions (Meter Group, Pullman, WA, USA) were used for the calibration of the water activity meter (Aqualab 4TEV, Meter Group, Pullman, WA, USA). Salicylic acid (Sigma-Aldrich, Burlington, MA, USA) was used to prepare calibration standards for the quantification of Aspirin degradation products by high-performance liquid chromatography (HPLC). Acetonitrile (J.T. Baker, Phillipsburg, NJ, USA), ortho-phosphoric acid (Sigma-Aldrich, Buchs, Switzerland), and purified water (Advantage A10, MilliQ, Burlington, MA, USA) were used to prepare the mobile phase for HPLC analyses. Dichloromethane (Merck, Darmstadt, Germany) and isopropyl alcohol (Avantor Performance Materials, Alberta, Canada) were used for particle sizing by laser diffractometry.
Lithium chloride and sodium chloride solutions (Meter Group, Pullman, WA, USA) were used for the calibration of the water activity meter (Aqualab 4TEV, Meter Group, Pullman, WA, USA). Salicylic acid (Sigma-Aldrich, Burlington, MA, USA) was used to prepare calibration standards for the quantification of Aspirin degradation products by high-performance liquid chromatography (HPLC). Acetonitrile (J.T. Baker, Phillipsburg, NJ, USA), ortho-phosphoric acid (Sigma-Aldrich, Buchs, Switzerland), and purified water (Advantage A10, MilliQ, Burlington, MA, USA) were used to prepare the mobile phase for HPLC analyses. Dichloromethane (Merck, Darmstadt, Germany) and isopropyl alcohol (Avantor Performance Materials, Alberta, Canada) were used for particle sizing by laser diffractometry.
4
Formulation and Production of Mini-Tablets
Example 10
A batch of standard convex cylindrical 4 mm diameter, approximately 2.5-3 mm thickness tablets was formulated to have approximately 10 mg of Compound 1 per tablet using the amounts of ingredients recited in Table 10.
Intermediate 1, sucralose (commercially available from Tate and Lyle of Decatur, Ill.), sodium lauryl sulfate (SLS, of Fisher Scientific), and colloidal silicon dioxide (Cabot Cab-O-Sil® M-5P Fumed Silicon Dioxide, commercially available from Cabot Corporation of Alpharetta, Ga.) were co-screened through 30 mesh (600 micrometer) screen. Mannitol (Pearlitol® 100 SD commercially available from Roquette America Inc. of Keokuk Iowa), and croscarmellose sodium (FMC Ac-Di-Sol®, commercially available from FMC BioPolymer Corporation of Philadelphia, Pa.), were co-screened through 30 mesh (600 micrometer) screen. Magnesium stearate (commercially available from Fisher Scientific, Pittsburgh, Pa.) was sieved through a 60 mesh (250 micrometer) screen.
The co-screened Intermediate 1, colloidal silicon dioxide, sucralose, and SLS, and 20 wt % of screened magnesium stearate were blended together for 15 minutes at 20-27 rpm in a 4 quart V-blender. The co-screened mannitol and croscarmellose sodium were added to this blend and blended for 7 minutes at 20-27 rpm. The second blended mixture was delumped using a Comil through a 610 micrometer screen. The remaining 80% of the total magnesium stearate was added to the blend in a 4 quart V-blender and blended for 5 minutes at 20-27 rpm forming a compression mixture. The compression mixture was transferred to a Piccola 8-Station tablet press. 4 mm diameter round convex tablets were compressed using 4 mm diameter round standard cup tooling. Each tablet weighed approximately 26.7 mg and had a thickness of ˜2.5 to 3 mm. Each tablet contained approximately 10 mg of Compound 1.
5
Formulation and Compression of Mini-Tablets
Example 11
A batch of standard convex cylindrical 4 mm diameter, approximately 2.5-3.5 mm thickness tablets was formulated to have approximately 10 mg of Compound 1 per tablet using the amounts of ingredients recited in Table 11.
Intermediate 1, sucralose (commercially available from Tate and Lyle of Decatur, Ill.), sodium lauryl sulfate (SLS, of Fisher Scientific), and colloidal silicon dioxide (Cabot Cab-O-Sil® M-5P Fumed Silicon Dioxide, commercially available from Cabot Corporation of Alpharetta, Ga.) were co-screened through 30 mesh (600 micrometer) screen. Mannitol (Pearlitol® 100 SD commercially available from Roquette America Inc. of Keokuk Iowa), and croscarmellose sodium (FMC Ac-Di-Sol®, commercially available from FMC BioPolymer Corporation of Philadelphia, Pa.), were co-screened through 30 mesh (600 micrometer) screen. Magnesium stearate (commercially available from Fisher Scientific, Pittsburgh, Pa.) was sieved through a 60 mesh (250 micrometer) screen.
The co-screened Intermediate 1, colloidal silicon dioxide, sucralose, and SLS, and 20 wt % of screened magnesium stearate were blended together for 15 minutes at 20-27 rpm in a 4 quart V-blender. The co-screened mannitol and croscarmellose sodium were added to this blend and blended for 7 minutes at 20-27 rpm. The second blended mixture was delumped using a Comil through a 610 micrometer screen. The remaining 80% of the total magnesium stearate was added to the blend in a 4 quart V-blender and blended for 5 minutes at 20-27 rpm forming a compression mixture. The compression mixture was transferred to a Piccola 8-Station tablet press. 4 mm diameter round convex tablets were compressed using 4 mm diameter round standard cup tooling. Each tablet weighed approximately 35.7 mg and had a thickness of 2.5-3.5 mm. Each tablet contained approximately 10 mg of Compound 1.
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