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CELLETS – Microcrystalline Cellulose Pellets. The safe and easy way to multi-particulate dosage forms

CELLETS – Microcrystalline Cellulose Pellets – are predestined for multi-particulate dosage forms. Multi-particulates have striking advantages compared to monolithic dosage forms, such as:

  • low variability of gastric emptying
  • lower dependency on nutrition state
  • low risk of localized high drug concentrations in the GI
  • reduced risk of sudden dose dumping
  • lower intra- and inter-individual variability
  • high control on time and place of drug delivery

This means firstly higher safety and secondly better compliance for your patients, and added-value for your products.

However, historically the way to successful formulation of multiparticulate dosage forms was bumpy. But: Cellets with their unique features are now offering streamlined formulation and processing opportunities, making formulator’s life easier, and your patient’s lives safer.

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    Processing advantages

    The specific manufacturing process of Cellets provides mechanically extremely stable cores. Low friability and solubility facilitate the layering process and improve the yield while the extreme hardness of the core makes Cellets a perfect carrier for later tableting.
    Cellets 100 provide the same core quality in sphericity and stability as coarse fractions and therefore grant comparable content uniformity and constant release profiles.

    pellets blue spoon

    Content uniformity and controlled release with CELLETS

    The homogeneous distribution of APIs in multiparticulate dosage forms make high demands on core material characteristics

    • narrow particle size distribution
    • even and dense surface
    • perfect sphericity
    • low friability
    • inertness

    Altogether, this means higher safety and better compliance for your patients, and added-value for your products.

    Neutral spheres made of Microcrystalline Cellulose

    As an inert odorless and tasteless excipient MCC is extremely versatile.
    Cellets are made from certified MCC and pure water

    TypeParticle size distribution
    (≥ 85 %)    		learn more
    Cellets 100100-200 µm
    (150/80)    		more information
    Cellets 200200-355 µm
    (80/50)    		more information
    Cellets 350350-500 µm
    (50/35)    		more information
    Cellets 500500-710 µm
    (35/25)    		more information
    Cellets 700700-1000 µm
    (25/18)    		more information
    Cellets 10001000-1400 µm
    (18/13)    		more information

    Method: Cellets Standard. Special sizes on demand.

    Cellets are powerful weapon in our arsenal to help our clients target and achieve the release profile their product requires. For an inert substrate, we always recommend Cellets as they are unmatched in their mechanical stability, sphericity, and tight particle size distributions. Eliminating one variable is always an advantage.

    Great pellets for easy-to-use in coating layer process and excellent carriers for MUPS formulations. Our people recommend micropellets indicated for low dosing of highly potency API. Uniform spherical shape and structure makes them becoming an easy tool in formulation science.

    The drug layering process can exert a lot of mechanical stress onto the starter beads, therefore it is important to work with highly robust materials.

    Cellets® are made of 100% high quality MCC and offer a robust and secure solution for our customer’s layering process.

    The advantages at a glance of CELLETS – microcrystalline cellulose spheres

    • Micropellets (100 µm to 200 µm) for highly active low dosage API
    • Perfect tool for combinatory and controlled release products
    • Wide range of particle size fractions with uniform spherical shape and structure
    • Narrow particle size distribution within each fraction
    • Cellets are made under GMP conditions with MCC from certified suppliers
    • Quality analyzed according to Ph.Eur., USP/NF and JPE
    • Formulation of sensitive actives due to the inertness of MCC
    • Cellets are almost water in-soluble
    • High abrasion resistance improves and simplifies the coating process
    • Ideal for capsules
    • Cellets show excellent compactibility due to the high plasticity
    • Higher payload permits smaller capsule sizes
    pellets and capsule

    CELLETS: Technical specification

    Characters

    Cellets 100 – Cellets 1000Test Method
    AppearanceWhite, nearly white or beige, hard and almost spherical particlesCellets Standard
    SolubilityInsoluble in water, ethanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l)Ph.Eur.
    OdorOdorlessPh.Eur., JPE

    Physical parameters

    Cellets 100Cellets 200Cellets 350Cellets 500Cellets 700Cellets 1000Test method
    Particle size distribution
    (≥ 85 %)    		100-200 µm200-355 µm350-500 µm500-710 µm700-1000 µm1000-1400 µmCellets Standard
    Cellets 100 – Cellets 1000Test Method
    Loss on drying≤ 7.0 %Ph.Eur., USP/NF, JP, JPE
    Bulk density (g/m3)0.80 ± 5 % (for information only)Ph.Eur., USP/NF, JP
    Sphericity degree
    (average)    		≥ 0.90Cellets Standard
    Friability (%)0Cellets Standard
    Swelling index (ml/g)≤ 2Cellets Standard

    Chemical parameters

    Cellets 100 – Cellets 1000Test Method
    Identification infrared absorptionpassedPh.Eur., USP/NF, JP
    Identification zinc chloride testpassedPh.Eur., USP/NF, JP, JPE
    Degree of polymerization≤ 350Ph.Eur., USP/NF, JP
    pH value5.0 – 7.5Ph.Eur., USP/NF, JP, JPE
    Conductivity (µS/cm)≤ 75Ph.Eur., USP/NF, JP, JPE
    Ether soluble substances≤ 0.05 %Ph.Eur., USP/NF, JP, JPE
    Water soluble substances≤ 0.25 %Ph.Eur., USP/NF, JP, JPE
    Heavy metals (ppm)≤ 10JP, JPE
    Sulfated ash / Residue on ignition [%]
    determined on 1 g)    		≤ 0.1Ph.Eur., USP/NF
    Sulfated ash / Residue on ignition [%]
    determined on 2 g)    		≤ 0.1JP, JPE

    Organic solvents in accordance to Ph.Eur., 5.4 and USP <467> (CPMP/ICH/283/95) are not used neither by manufacturing of Cellets® nor by cleaning of equipment.

    Microbiological parameters

    Cellets 100 – Cellets 1000Test Method
    Total aerobic microbial count≤ 1,000 CFU/gPh.Eur., USP/NF, JP, JPE
    Fungi / moulds and yeasts≤ 100 CFU/gPh.Eur., USP/NF, JP, JPE
    E. coli Ps. aerugin. St. aureusabsence in 1 g samplePh.Eur., USP/NF, JP, JPE
    Salmonella speciesabsence in 10 g samplePh.Eur., USP/NF, JP, JPE

    We declare that the starting material of Cellets is exclusively of vegetable origin. A contamination with animal material during manufacturing, storage or shipment in the sealed containers is strictly excluded. Therefore, the product is absolutely unobjectionable in terms of BSE/TSE risk and according to Ph.Eur., 5.2.8 no BSE/TSE certificate has to be issued by the manufacturer/supplier.

    Note: All values are presented only for the purpose of basic reference and not as specifications. Special fractions on demand.

    Formulation Support

    The development of solid dosage forms is one of Glatt Pharmaceutical Services’ specialty, with focus on complex formulations and vast expertise for multiparticulate systems. The development and manufacturing centers with FDA and EU-GMP certification are well equipped for all your requirements. New technologies are in charge for the realization of your product ideas. Also for demanding ingredients.

    • Sites in Germany & USA
    • Strong core competence
    • Solution oriented
    • Flexible setup
    • Full service

    pharmaceuticalservices@glatt.com

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    Order your MCC spheres here

    We are happy to support you with helpful free product samples of Microcrystalline Cellulose spheres (Cellets) for conducting case studies.

    Order your free product sample here

    pellet functionalities

    Documents on spheres, pellets, starter beads

    Get the Cellets brochure here

    + Overview poster: starter beads in process technologies

    Follow a manual added link

    + Granulation: process technologies

    Case Studies & Literature on Cellets

    Find more about Case Studies & Applications on Cellets – Microcrystalline Cellulose Pellets.

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    Benefits and challenges of multilayer high drug-loaded amorphous solid dispersions

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