BioHale® Trehalose Dihydrate

DFE Pharma offers a wide range of milled and sieved lactose products, including the Pharmatose® and Lactochem® brands. Varying degrees of particle sizes can be offered to allow pharmaceutical companies to choose the grade best fitting their formulation needs. Milled lactose compacts well due t...

SuperTab® 11SD is a highly consistent, spray-dried monohydrate lactose enabling efficient tableting by offering free flow properties. It is designed to combine the high compactibility of finely milled lactose with good flow properties of spherical spray-dried particles. For those formulators that requi...

SuperTab® 21AN is a highly consistent anhydrous lactose with excellent compaction and re-compaction. Its low moisture content makes SuperTab® 21AN a popular choice in formulating with moisture sensitive API’s. For those formulators that require additional compaction and/or flow DFE Pharma offers SuperT...

SuperTab® 30GR is a highly consistent, agglomerated monohydrate lactose processed utilising a unique production technology. The granule structure (containing small primary particle sizes), as a result of fluid bed processing, provides optimal flow / compaction ratio allowing easy direct compression pr...

SuperTab® 40LL is a co-processed excipient combining anhydrous lactose with lactitol. SuperTab® 40LL combines all required functionalities into one single excipient. It redefines the limits of direct compression, making it the excipient of choice for mini-tablet and/or other challenging formulations. qq...

BioHale® Sucrose is a non-reducing crystalline disaccharide made up of glucose and fructose. Sucrose is commonly used in the biopharmaceutical industry to stabilize proteins, lipids, and carbohydrates during the formulation process. The utility and function is driven by its unique chemical and physical pro...

Lactohale® 200 is milled lactose produced with a tightly controlled mean particle size. The size of the particles of Lactohale® 200 can be controlled and but also varied by gentle milling. This means that different D50's can be produced depending on the degree of milling to match the cust...

Lactohale® 300 is a very fine and micronised lactose with a D50 below 5 microns. Lactohale® 300 is applied to Dry Powder Inhalation formulation to improve the drug deposition or optimize the flow properties of their formulation. In addition, Lactohale® 300 can be blended with several coarse lactose gra...

Respitose® SV014 is a sieved inhalation-grade lactose grade with excellent flow properties and very large lactose crystals. It’s optimal flow properties provides opportunities for application in reservoir devices or to maintain the required flow and content uniformity in high dose inhalation formulatio...

Pharmatose® 100M is a highly consistent monohydrate lactose. It’s a pure white, crystalline lactose that is sieved to varying particle sizes, allowing pharmaceutical companies to choose the grade that best fits their formulation needs. This type of lactose is typically used for sachets and capsul...

Primellose® is DFE Pharma’s product brand name for croscarmellose sodium and It is suitable for various tablet and capsule formulations. Primellose® is effective in combination with both insoluble and soluble filler-binders at concentrations of 2%w/w - 6%w/w. Primellose® is effecti...

Primojel® sodium starch glycolate is a superdisintegrant suitable for various tablet and capsule formulations. In higher concentrations, Primojel® can act as a dissolution enhancing agent. Primojel® is highly effective when used intragranular and/or extragranular in dry/wet granulation processes.

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The new ‘Closer to the Formulator’ (C2F) center offers DFE Pharma’s excipient expertise to help pharmaceutical companies achieve ‘first-time right’ formulations

DFE Pharma is a global leader in excipient products and services for usage in the pharmaceutical, biopharmaceutical, and nutraceutical industries. We strive to develop, produce and supply the highest quality functional excipients for oral solid dose, inhalation, and parenteral formulations. Our products play essential roles as fillers, binders, disintegrants, and stabilizing agents in formulations. 

They enable the active ingredients to be dosed and released into the patients' system in a predictable, accurate, and effective manner. With over a century of experience, we are driven by our purpose your medicines, our solutions. Moving to a healthier world. 

DFE Pharma is proud to announce that we have been awarded a Gold Medal by EcoVadis for our sustainability achievements. This prestigious recognition places us in the top 5% of companies globally, highlighting our commitment to environmental and social responsibility.

Assessing nitrosamines in drug products has become one of the top challenges for formulators in the pharmaceutical industry.

During drug product risk evaluation, excipients play a crucial role. Although the risk of nitrosamine presence is low, some excipients contain trace amounts of nitrites. Under specific conditions, these traces can lead to nitrosamine formation within the drug product.

Different studies reveal varying nitrite levels among different excipients and even within the same type from different suppliers. Comparing excipient types and suppliers is essential for risk mitigation during production.

Excipients are a crucial component of the pharmaceutical product formulation, and the industry is constantly having to adapt to changes in demand and technology innovations

As pharmaceutical production moves from batch-wise to continuous manufacturing, individual processing steps, such as blending of the active pharmaceutical ingredient (API) with excipients, have to be re-designed to continuous operations.

Whilst the cost and quality benefits of CM are well documented, successful implementation relies on an in-depth understanding of how raw materials and their mixtures – including excipients – behave in continuous processes. This whitepaper will outline some of the key learnings from DFE Pharma’s excipients in CM processes variability experiments, before setting out DFE Pharma’s Stretch Batch Approach and how it can work in practice.
Ultimately, it will demonstrate why DFE Pharma is fast becoming the pharma industry’s preferred global partner in the robust development of continuous tablet manufacturing processes.

DFE Pharma's Norten Hardenberg plant, located in Germany, is dedicated to the production of anhydrous lactose. An investment for the future, featuring a new state-of-the-art production line, like for like process, high-end control to ensure batch homogeneity.