APIs, Excipients and cGMP Polymeric Milling Media
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Purolite has been manufacturing and selling to the generic pharmaceutical market for over three decades. Generics are off-patent drugs that are bioequivalent to branded medications in terms of dosage, strength, quality, form, effect, intended use, side effects, and route of administration. The generic market in the US alone will approach $200 billion by 2024 and is having a positive impact on lowering the cost of health care. Our resins are used in drug formulations as active pharmaceutical ingredients (APIs) or excipients.
The production of all pharmaceutical products must adhere to strict guidelines. Purolite pharmaceutical resins meet the demands of the American (USP), European (Ph.Eur.), British (BP) and Japanese (JP) pharmacopeias. Drug Master Files (DMFs) are held for each, single, listed API pharmaceutical product manufactured in Purolite’s facilities. We provide support to allow rapid filing and approval by the FDA.
Active Pharmaceutical Ingredients
Purolite markets two APIs with registered DMFs to large pharmaceutical companies: Cholestyramine and Sodium Polystyrene Sulfonate. Cholestyramine is taken orally to reduce blood cholesterol, while sodium polystyrene sulfonate, is taken to control blood potassium to prevent hypokalemia. Purolite provides value to these mature markets in many ways including the stability of supply. We continue to invest in the expansion and maintenance of four cleanroom operations as well as analytical and quality-related systems.
Purolite excipients can be used in drug formulations as taste-masking agents, drug carriers and tablet disintegrants. The excipients are often used in off-patented products as well as for new formulations.
In addition to their application as active pharmaceutical ingredients, excipients, ion exchange resins and polymeric adsorbents can be used in a wide variety of pharmaceutical applications including extraction and purification of enzymes, hormones, alkaloids, viruses, antibiotics, and treatment of fermentation products. Ion exchange copolymer beads are also used in nanoparticle milling of pharmaceutical products.
PuroMill™ cGMP Polymeric Milling Media enables the preparation of high-purity nanoparticle sized pharmaceuticals (< 100 nm) for small molecule to improve bioavailability. PuroMill™ advanced polymeric milling media reduces the particle size of compounds and molecules to the nanoscale, improving the overall characteristics of the client’s formulation. The media is clean, safe and scalable to optimize milling processes, and is available in two purity grades to address the needs of process requirements.
PuroMill low-density polymeric media significantly reduces contamination due to low extractables and leachables, as well as particles developed due to attrition, while curtailing the risk of hydraulic packing. Use for high shear milling with conventional or novel equipment for creating nanoparticles. It is also used for biological cell disruption in biopharmaceutical applications.
High Purity Water
High purity ion exchange resins are used in extraction and purification processes or for the production of water for injectables. These resins meet the requirements of both the US Food and Drug Administration (FDA) and the European Union.
Calcium Polystyrene Sulfonate | Potassium Control
Cationic pharmaceutical compounds uptake
Cholestyramine | Cholesterol Control
Pharmaceutical Milling Media
Polacrilex | Taste Control | Drug Carrier
Polacrilin Potassium | Tablet Disintegrant
Sodium Polystyrene Sulfonate | Potassium Control