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Filler and Filler-Binder Solutions an Unwavering Commitment to Enabling Life-Saving Pharmaceuticals Fillers and Filler-Binders: a Balancing Act

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Filler and Filler-Binder Solutions an Unwavering Commitment to Enabling Life-Saving Pharmaceuticals Fillers and Filler-Binders: a Balancing Act FILLER AND FILLER-BINDER SOLUTIONS AN UNWAVERING COMMITMENT TO ENABLING LIFE-SAVING PHARMACEUTICALS FILLERS AND FILLER-BINDERS: A BALANCING ACT The ideal formulation delivers a defect-free dosage form in the widest range of manufacturing conditions Enable effective drug manufacturing possible, which is obtained by balancing the brittle, plastic and elastic behavior exhibited by the deformation of the excipients and API under compaction. and enhance patient compliance Plastic behavior • Fewer surfaces generated during compaction, which makes ingredients sensitive to lubrication with our expansive range of reliable • Higher mechanical strength • Higher propensity to cap, higher sensitivity to turret speed fillers and filler-binders. Compressive forces Plastic behavior Final dosage forms come in all shapes and sizes, and our focus is providing formulators and Elastic recovery manufacturers with flexible, high-quality ingredients that enable cost-effective production. No matter your formulation, dosage or process constraints, Roquette offers a diverse range of adaptable filler and filler-binder products and the technical expertise to ensure the right excipient solution is selected. Our commitment to consistency is what sets us apart. Each of our excipients is manufactured Fragmentation behavior under Roquette quality control systems, ensuring consistent product performance for optimum • Fragmentation under compression generates new surfaces fresh of lubricants, making ingredients productivity. From laboratory to industrial scale production, rely on Roquette to help solve your insensitive to lubrication process and formulation challenges with flexible filler and filler-binder solutions. • Lower mechanical strength • Lower propensity to cap, lower sensitivity to turret speed Brittle / Fragmentation Compressive forces behavior Elastic recovery Elastic behavior • No new bonds formed between particles during compaction • No mechanical strength • Highest capping propensity, insensitive to turret speed Compressive forces Elastic behavior Elastic recovery OPTIMIZED FOR YOUR PROCESS FILLER-BINDERS FOR YOUR DESIRED TABLET PROPERTIES Our manufacturing technologies allow us to offer various grades within our filler and filler-binder product families that can be differentiated by particle size, density, surface area or moisture content. This diversity allows our customer to formulate and manufacture all types of solid dosage forms with any process (wet or dry granulation, The combination of organoleptic and tableting properties of our filler-binder range unleashes your formulation direct compression) ensuring uniformity and stability, and optimal organoleptic properties. Below is an overview capabilities, and facilitates solid dose manufacturing in the form of chewables, suckables, swallowables, of the key features of our various products. effervescents, and orally dispersible tablets (ODT). Designed specifically for compressed dosage forms 700 ® ® ® ® like tablets and capsules, our range LYCATAB® C 24 NEOSORB P KLEPTOSE DC Dextrose and GLUCIDEX exhibit filler MICROCEL Wheat starch GLUCIDEX® D 12 delivers a solution to your compaction challenges by 600 NEOSORB® XTAB 200 S XYLISORB® P PEARLITOL® functionality with the addition of being a NEOSORB® XTAB 300 S 20 LYCATAB® C Dextrose anhydrous enhancing tabletability and reducing friability. NEOSORB® P650 carbohydrate source. Of various botanical 500 Pea starch Dextrose monohydrate PEARLITOL® 100SD SweetPearl® MICROCEL® origin to help alleviate patient-intolerance PEARLITOL® Flash 16 ® STARLAC® KLEPTOSE DC exhibits multi-functionality, helping 400 issues, our Native starch excipients SweetPearl® P300DC to improve solubility, dissolution speed, and taste XYLISORB® XTAB 240 12 provide affordable filler functionality with ® masking. 300 XYLISORB XTAB 400 the addition of disintegration properties. MICROCEL® MC102 Hardness (N) 8 ® 200 Ranging from the high hygroscopicity PEARLITOL FLASH ensures ODT formulation with 4 ® a fast disintegration time. Contrary to other ODT of NEOSORB , to no hygroscopicity of 100 Weight variation at equilibrium (%) variation Weight PEARLITOL®, our filler product range excipients, the disintegration time is independent of 0 compression force. 0 10 20 30 40 50 60 70 80 90 100 helps alleviate variable stability and 0 0 5 10 15 20 25 30 Relative humidity (%) process constraints. STARLAC®* is more than just a lactose and starch Compression force (kN) Figure 1: Dynamic vapor sorption plot at 20°C of designated filler/filler-binder offering. combination. The co-processing delivers superior tablet performance (disintegration, low friability) and Figure 3: Filler-binder excipient compactability, as measured using Korsch® XP1 with 13mm robustness (low lubricant sensitivity and constant diameter concave punches at 20 tablet/min rate. PATIENT-FOCUSED FORMULATIONS tabletability over time). Ideal for capsule filling, ourLYCATAB ® C range delivers consistent performance for customers seeking fast disintegration with the addition of excellent compressibility. Our polyol fillers offer sugary sweetness without 7 the drawbacks. Possessing a low caloric and low Brittle 6 XYLISORB® XTAB 240 insulinemic index, these excipients tackle the Crumbly 5 SweetPearl® 300 DC growing concern of health-conscious patients. According to NF EN ISO 5492 NEOSORB® XTAB 300 S Crumbly: low level, e.g. corn muffin 4 ® Brittle: high level, e.g. peanut brittle PEARLITOL SD 200 OPTIMIZED FOR YOUR PRODUCTIVITY Short: low level, e.g. shortbread 3 ® Melting: very low level, e.g. ice cream PEARLITOL 400 DC For “tasty” dosage forms, the unique organoleptic Crusty: high level, e.g. French bread crust properties of XYLISORB® combine sweetness Pasty: moderate level, e.g. flour paste 2 NEOSORB® XTAB 200 S PEARLITOL® 200 SD and a cooling effect. 1 XYLISORB® XTAB 400 DC SweetPearl® P 300 DC Pasty 0 Short 600 PEARLITOL® is the all-in-one excipient: a unique Crusty Melting The compactability of these products has been combination of solubility, sweetness, chemical and 500 physical stability that makes it fit with any formulation optimized using processes like: ® 400 or dosage form. • hot melt extrusion (PEARLITOL DC) spray drying (PEARLITOL® SD, • 300 ® ® NEOSORB XTAB S) With its intrinsically high density, SweetPearl allows ® Figure 2: A ternary plot representing the various terms and definitions relating to sensory 200 formulators to pursue smaller dosage forms for ease • granulation (XYLISORB XTAB, hardness (N) Tablet analysis, as dictated by NF EN ISO 5492. SweetPearl® P DC) of intake. As Figure 2 shows, polyols range offers you 100 to design your product sensorial profile to target any in order to provide consistent performance, batch after batch, to maximize productivity. 0 patient population. 40,500 101,250 162,000 Tableting speed (tablets/hr) Figure 4: As one example, PEARLITOL® 200 SD shows consistent superior hardness independent of turret speed. *StarLac® is a product co-marketed by Meggle and Roquette. FILLER AND FILLER-BINDER SOLUTION OFFERING Native LYCATAB® C NEOSORB® XYLISORB® PEARLITOL® KLEPTOSE® starches Dextrose GLUCIDEX® StarLac® SweetPearl® ® MICROCEL® range range range PEARLITOL FLASH DC range Potato, wheat, Monohydrate, Maltodextrin dry Microcristalline Pregel starch Lactose starch Sorbitol Xylitol/binder Maltitol Mannitol Mannitol/starch Betacyclodextrin maize, pea anhydrous glucose syrup cellulose Main Fragmentation/ Fragmentation/ Elastic Plastic/elastic Fragmentation Plastic Plastic Fragmentation Plastic Fragmentation Plastic Plastic Deformation elastic elastic Filler X X X X X X X X Filler/binder X X X X X X X X X X X >50% Solubility Insoluble Partially soluble 1000 (viscosity is a Partially soluble 2250 1600 1500 170 Partially soluble 18.5 Insoluble limiting factor) Self- Yes Yes No No Yes No No No No Yes No No disintegrating Maillard No No Yes Yes Yes No No No No No No No reaction Hygroscopicity High Medium Slight Medium Slight High Medium Very low No Slight Medium Medium Moisture 12% 5-7% 8% 4% 5% 0.5% 0.5% 0.1% 0.1% 2% 12% 5% content Organoleptic Neutral Neutral Sweet Sweet Neutral Sweet Sweet Sweet Sweet Sweet Neutral Neutral FILLER AND FILLER-BINDER SOLUTIONS NATIVE STARCHES PEA STARCH MAIZE EXTRA WHITE MAIZE WHEAT WHEAT POTATO POTATO POWDERED 400 L NF STARCH B MAIZE STARCH STARCH 5% STARCH TB STARCH 5% STARCH STARCH 8% NF CORN CORN STARCH SUPRA NP STARCH BACTERIO Product Oxidized corn Pea starch Corn starch Corn starch Corn starch Wheat starch Wheat starch Potato starch Potato starch Corn starch description starch Color / for White to off White to off White to off White to off White to off White to off uniform tablet White White White White white white white white white white color Particle size 5–45 5–25 5–25 5–25 2–40 2–40 15–100 15–100 5–25 5–25 (µm) Moisture content 14% 12% 12% 5% max 12% 5% max 19% 8% max 12% 12% 1 ® Registered trademark(s) of Roquette Freres, Blanver Farmoquimica Ltda. or Itacel Farmoquimica Ltda. The information contained in this document is to the best of our knowledge true and accurate but all instructions, recommendations or suggestions are made without any guarantee. Since the conditions of use are beyond our control, we disclaim any liability for loss and/or damage suffered from use of these data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with these data or suggestions infringes any patent. No part of this document may be reproduced by any process without our prior written permission. FILLER AND FILLER-BINDER SOLUTIONS
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