We are the global leader in excipient solutions. We develop, produce and market excipients for oral solid dose and dry powder inhalation formulations. Our customers are pharmaceutical companies, operating globally, regionally and locally. The pursuit of excipient excellence
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Microcrystalline Cellulose (MCC) has a long history in the pharmaceutical industry and has demonstrated its success as a reliable excipient in a wide variety of formulations. By incorporating another excipient category, we have achieved greater synergies and further increased the power of our product portfolio.
We offer our MCC-based products to customers with the same high and consistent DFE Pharma quality you have come to expect from your global leader in pharmaceutical excipients. Microcrystalline cellulose is extensively used as an excipient in the pharmaceutical industry, and is especially important for oral solid dosage forms. Assured continuity and exceptional quality is of paramount importance to us. Your future requirements may differ significantly from today’s norms, but DFE Pharma is ready to evolve with you by continuously investing in improved quality standards and production technologies. Along with this, we make sure that our people are trained and committed to provide you with the technical and commercial support you need. We care for your challenges, now and in the future.
DFE Pharma offers a high-quality range of
• Pharmacel 101
• Pharmacel 102
Pharmacel 101 & 102
Microcrystalline Cellulose is used in a wide variety of oral solid dosage forms, including tablets, capsules, pellets and others. It is one of the most commonly used diluents in drug formulations, and it is made by controlled partial hydrolysis of high purity wood pulp, followed by purification and drying.
DFE Pharma produces two grades of microcrystalline cellulose:Pharmacel 101 and Pharmacel 102, which are ideally suited to the majority of tablet and capsule formulations processed by direct compression or filling, wet granulation, dry granulation or extrusion-spheronisation.Both Pharmacel 101 and Pharmacel 102 possess excellent properties that make them suitable for use in a wide range of formulations.
Pharmacel in tableting
Pharmacel MCC is an ideal excipient for tableting by wet granulation, dry granulation or direct compression. It is very high compactability means that strong tablet can be made at low forces, thus minimizing tablet tooling wear, even when the proportion of active ingredient within the tablet is high. Additionally, tablets made using Pharmacel MCC can be made to disintegrate readily. when a superdisintegrant is used, thus maximizing the potential for drug bioavailability.
When used as a component for wet granulation formulations,Pharmacel 101 promotes excellent distribution of the granulating fluid, thus ensuring even distribution of the granules. Wet granulation with Pharmacel is therefore a robust and reproducible process, and the resulting
tablets show excellent properties. Granule density and compactability can be controlled by the extent of granulation as shown in Figure 1: increasing the granulating fluid increases the granule density and decreases compactability.
Wet granulated formulations containing Pharmatose and Pharmacel in combination with a superdintegratant such as Primojel, are easily optimised to give strong tablets with excellent drug dissolution profiles.
In the example below, tablets were made by conventional wet granulation and drying, followed by compaction with 9mm punches at a force of 10kN.
Pharmacel is an ideal excipient for use in dry granulated formulations. It does not stick to the rollers or ribbons during roller compaction and it can be used in formulations with a high drug dosage. When used in combination with a brittle excipient such as SuperTab 21AN anhydrous lactose, the benefits of high tablet strength and insensitivity to recompaction are combined to give robust dry granulation formulations. A recommended starting point, especially for low dose formulations, is to use approximately 40% Pharmacel 101 and 60% SuperTab 21AN as the basis for tablets to be made by roller compaction.
No other excipient compacts as well as MCC, making Pharmacel 102 the ideal choice for direct compression formulations. Its versatility in direct compression extends even to very high dose actives, where compactability is at a premium.
When used in combination with DFE Pharma’s other direct compression excipients, the formulator has unrivalled possibilities to optimize the joint benefits of excellent flow and compaction together with enhanced disintegration. Robust, rapidly disintegrating DC formulations can be developed with ease.
In the example below, Ibuprofen had a median particle size of approximately 85 micron and was suitable for direct compression. Materials were blended and compressed using 9mm tooling with a compaction force of 10kN.
Pharmacel in Encapsulation
Pharmacel is an inert diluent for hard gelatin capsules. Based on considerations of powder flow, Professor Larry Augsburger concluded a Carr’s Index of 20 – 30% is optimal. Carr’s Index values of Pharmacel 101 and Pharmacel 102 are typically in the range of 22% to 28% making them both very suitable for capsule filling of dry blended formulation.
Reference: Comparison of the Formulation Requirements of Dosator and Dosing Disc Automatic Capsule Filling Machines, Pavan K. Heda, Kapiamba Muteba and Larry L. Augsburger, AAPS Pharm. Sci. 2002; 4 (3) article 17.
Pharmacel in Modified Release formulations
Multiparticulate formulations for extended and delayed release products are the ideal means of consistent drug delivery. The regular gastric emptying profile of multiparticulates means that enteric coated formulations are not susceptible to gastric hold up, while the presence of many small units in the drug delivery system means that the possibility of dose dumping is minimized when compared to single unit systems. Pharmacel is the perfect excipient for multiparticulates made by extrusion – spheronisation. It can yield hard round robust spheres that are ideal for subsequent coating operations. We recommend inclusion of at least 20% Pharmacel in formulations made by extrusion-spheronisation.
Pharmacel 101 complies with the latest editions of the USP-NF, Ph.Eur. and IP. Pharmacel 102 complies with the latest editions of the USP-NF, Ph.Eur. and IP.
Pharmacel is available in 25kg multi-layer polyethylene bags with a polyethylene inner liner.
Keep in original, unopened packing in ambient conditions, protected from humidity and away from strongly odorous materials.
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