Cellets - Microcrystalline Cellulose Pellets (MCC) - excipient

Cellets - Microcrystalline Cellulose Pellets

Successful formulation of new actives demand safe application and high quality excipients. Cellets – Microcrystalline Cellulose Pellets – are versatile starter cores for multiparticular dosage forms.

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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.

Content uniformity and controlled release

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 cores

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

Type	Particle size distribution (≥ 85 %)	learn more
Cellets 100	100-200 µm (150/80)	more information
Cellets 200	200-355 µm (80/50)	more information
Cellets 350	350-500 µm (50/35)	more information
Cellets 500	500-710 µm (35/25)	more information
Cellets 700	700-1000 µm (25/18)	more information
Cellets 1000	1000-1400 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.

Glatt Air Techniques

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.

Pharmatrans Sanaq

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.

HARKE GROUP

The advantages at a glance of Cellets – microcrystalline cellulose pellets

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

Technical information and Spezifications

Characters

	Cellets 100 – Cellets 1000	Test Method
Appearance	White, nearly white or beige, hard and almost spherical particles	Cellets Standard
Solubility	Insoluble in water, ehtanol, acetone and toluene, diluted in acids Ph.Eur. and sodium hydroxide solution (50 g/l)	Ph.Eur.
Odor	Odorless	Ph.Eur., JPE

Physical parameters

	Cellets 100	Cellets 200	Cellets 350	Cellets 500	Cellets 700	Cellets 1000	Test method
Particle size distribution (≥ 85 %)	100-200 µm	200-355 µm	350-500 µm	500-710 µm	700-1000 µm	1000-1400 µm	Cellets Standard

	Cellets 100 – Cellets 1000	Test 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)	≥ 0.90	Cellets Standard
Friability (%)	0	Cellets Standard
Swelling index (ml/g)	≤ 2	Cellets Standard

Chemical parameters

	Cellets 100 – Cellets 1000	Test Method
Identification infrared absorption	passed	Ph.Eur., USP/NF, JP
Identification zinc chloride test	passed	Ph.Eur., USP/NF, JP, JPE
Degree of polymerization	≤ 350	Ph.Eur., USP/NF, JP
pH value	5.0 – 7.5	Ph.Eur., USP/NF, JP, JPE
Conductivity (µS/cm)	≤ 75	Ph.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)	≤ 10	JP, JPE
Sulfated ash / Residue on ignition [%] determined on 1 g)	≤ 0.1	Ph.Eur., USP/NF
Sulfated ash / Residue on ignition [%] determined on 2 g)	≤ 0.1	JP, 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 1000	Test Method
Total aerobic microbial count	≤ 1,000 CFU/g	Ph.Eur., USP/NF, JP, JPE
Fungi / moulds and yeasts	≤ 100 CFU/g	Ph.Eur., USP/NF, JP, JPE
E. coli Ps. aerugin. St. aureus	absence in 1 g sample	Ph.Eur., USP/NF, JP, JPE
Salmonella species	absence in 10 g sample	Ph.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.