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CPS
CPS™ Pelletization Technology
This innovative CPS ™ Pelletization Technology is a direct fluid bed pelletization technology, originally invented by Glatt GmbH in Binzen, Germany, in 2000.
Its special features are characterized by a modified fluid bed rotor system with a conical shaped rotating disc plus additional devices for directed movement of coated particles. To start processing, no inert starting beads are required.
Spraying of various liquids (organic and inorganic) as well as dry powder is also possible. By means of rolling particles movement, CPS™ Pelletization Technology clearly defines the densification of particles.
Description of the pelletization process: After intensive mixing of various excipients (preferably MCC, dicalcium-phosphate, methacrylic polymers, disintegrants, solubilizers, e.g. Tween 80, and others) and active pharmaceutical ingredient (API) in a modified fluid bed, the mixture is wetted with pharmaceutical grade water.
In the CPS™ Pelletization Technology process, drug concentrations can vary from low dose (<1%) to high dose (up to about 90%), depending on the core pellet for coating. Using selected excipients for the coating process, a modified release pellet matrix can be generated that get by without a further functional coating step, thus saving precious manufacturing time. In addition, depending on process time and quantity of sprayed liquid, a wide range of mean particle size between about 100 µm to 1400 µm can be obtained. Moreover, a narrow particle size distribution with a deviation of ±100 µm can be reached, accounting for the great homogeneity of the processed API matrix.
When applying Glatt Pharmaceutical Services’ proprietary CPS™ Pelletization Technology, coated products results in great uniformity and homogneity of the matrix of coated pellets. For illustration see raster electron microscopy pictures below, starting clockwise from top left - white bars indicate sizes of 460 µm, 71 µm, 75 µm, and 160 µm, respectively - taken from pellets of a coated water soluble API with a drug loading of 75%..
Outstanding product characteristics are feasable resulting in:
- spherical and smooth pellet surfaces
- high density and loading of drug substance
- low porosity of pellets
- low attrition and friability
- dust free surfaces
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| 75% Potency, CPS™ Process |
Examples of the performance of coated APIs
1) Low dose API – formulation A
Sieve analysis – Pelletization by CPS™ – drying (no sieving)
Target PSD: d50 = 650µm, d90 > 500 µm, d10 > 800 µm
Formulation A
2) Low dose API – Drug release at different particle sizes (PSD)
CPS™ pellets (API, Avicel + Eudragit L 30 D, DBS) – PSD: d50 = 650 µm, d10 > 800 µm, d90 > 500 µm vs.
CPS™ pellets (API, Avicel + Eudragit L 30 D, DBS) – PSD: d50 = 800 µm, d10 > 950 µm, d90 > 500 µm vs.
originator drug product
Dissolution profile of formulation A, versus
branded product, in 500 ml phosphate buffer pH 6.8 at 37
CPS™ vs. MicroPx™
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Difference in particle size capability
- MicroPx = 50 – 500 µm
- CPS = 100 – 1400 µm
- Different formulation concepts possible,
API & excipient flexibility
- Different density ranges
- Typically CPS > MicroPx
- Different processes
- MicroPx = continuous
- CPS = batch
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