• Document: The binding performance of DFE Pharma Starch
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The binding performance of DFE Pharma Starch MCC Starch Lactose Inhalation Superdisintegrants We are DFE Pharma We are the global leader in excipient solutions. We develop, produce • Leading in expertise and market excipients for oral solid We are here to help you create dose and dry powder inhalation pharmaceutical products that set the formulations. Our customers are new standard. pharmaceutical companies, operating globally, regionally and locally. • Leading in supply We are here to ensure you can always The pursuit of excipient excellence produce your products. No matter what Excipient excellence is a pursuit that happens. will never be fully achieved. What is excellent today will be outdated • Leading in time to market tomorrow. That’s why to us the pursuit We are here to help you grow by of excipient excellence is a way of life. minimising the time to market. A source of inspiration. Excipient excellence is what guides us on our way We invite you to join us in our pursuit of to developing and producing the best excipient excellence. possible excipient solutions for our customers. Today, tomorrow, always. Pursuit ‘the act of striving towards an ideal with strong determination.’ 3 Starch Your Starch by DFE Pharma Starches have a proven track record as effective excipients. Together with our solid experience with excipients, we provide this natural ­product in our excipients product portfolio. Which means you can also use starch’s binding performance. Brought to you by DFE Pharma. Starch and starch derivatives are widely used excipients pharmaceutical companies have successfully in the pharmaceutical industry and are frequently used formulated their solid oral dosage forms using our native in oral solid dosage forms such as tablets, capsules or and pregelatinised starch products. sachets. Our in-house knowledge of starch enables us to provide high-level support and innovative solutions to DFE Pharma offers three reliable pharmaceutical-grade specific customer challenges. Our production process starch products: and your pharmaceutical end product are important • Solani Amylum: native potato starch ­factors that determine the appropriate type of starch to • Prejel PA5 PH: fully pregelatinised potato starch be used in the formulation. For many years numerous • SuperStarch® 200: partly pregelatinised starch 4 Solani Amylum Native potato starch Description Specification Solani Amylum is a purified potato starch in the form of a white and free flowing powder. Solani Amylum complies Moisture content < 20% with USP–NF, Ph. Eur. and JP monographs for native pH 6.0 - 8.0 (potato) starch (Figure 1, top). Oxidising substances < 0.002% Potato starch is a widely accepted raw material within the Sulphur dioxide < 5 ppm pharmaceutical market. In comparison to other starches it Iron < 10 ppm has a low protein and fat content. Potato starch is also Total aerobic mesophilic count < 1000 cfu/g gluten free and Solani Amylum can be provided with a Yeasts and moulds < 100 cfu/g GMO-free statement. E. coli (1g) Absent

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