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FOAM
GRANULATION
PRESENTED BY
Long Island University
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Content:
Introduction Why Do We Need Granulation? Mechanism of Foam Granulation Benefits Applications Conclusion Personal opinion References
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INTRODUCTION
Definition:
In addition to active ingredients, formulations are complex
mixtures of diluents, binders, disintegrants, surface active agents, glidants, lubricants, colorants, coating substances, surfactants and many other raw materials that impart different properties to the final solid dosage product.
(granules). Granulation is required to impart improved technical properties to a substance, to prevent sintering (adhesion) and increase friability, to make it possible to use small portions of a material, and to facilitate loading and transporting.
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GRANULAR MATERIALS
A granular material is a collection of distinct macroscopic particles,
such as sand in an hourglass or peanuts in a container.
repulsive forces between particles that are non-zero only when there is a contact between particles. tremendous amount of complex behavior, much of which has not yet been satisfactorily explained. They behave differently than solids, liquids, and gases which has led many to characterize granular materials as a new form of matter. then the large scale state of the system depends on the angle of the plane.
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Contin.
For large angles the granular material flows like a non-Newtonian
liquid. For small angles the granular material will behave like a solid and remain stationary.
the preparation history, and the transition between the phases is a manifestation of the glass transition. granular materials interesting are inelastic collisions and the unimportance of temperature.
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Foam Granulation
In 2003, The Dow Chemical Company (Midland,
MI) introduced foam technology for delivering aqueous binder systems in high-shear and fluidbed wet granulation applications. solution tank and high-shear granulator to introduce the binder as a foam rather than spraying or pouring in binder onto a moving powder bed.
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Foam Generator
What was the motivation to develop a new granulation technology versus conventional granulation techniques ?
The significant problem in the spray granulation is the uniform
distribution of the liquid/binder combination evenly throughout a moving powder bed. It may appear to be uniform when spraying, but it doesn't always happen. preferentially grab the water in the granulating liquid and sometimes this would interfere with its uniform distribution enlargement
Foam granulation uses less liquid to achieve the same extent of size Reduces drying and manufacturing time in the granulation stage due
to lower liquid requirements
Faster addition rates, and improved process control Selection of nozzle can be eliminated
Long Island University 11/8/2011 99
Contin.
Simplified scale up can be achieved by reducing the number of
variables.
mechanical properties of granules and tablets made by foam granulation and spray granulation for three high drug load formulation. pore size when using foam or spray granulation, but there were differences in the mechanical properties of the tablets.
plasticity of granules was higher when foam granulation was used, possibly due to improved surface coverage of the liquid binder on the brittle drug particles.
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there may be difficulty in scaling up a process because of over-wetting and the number of nozzle systems that may need to be used. Foam technology has been proven to scale very easily for both immediate release and matrix controlled-release products.
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Contin.
The technology also uses less water per granulation,
which means less drying time and less impact on the environment.
These issues include areas of concentrated over wetting The technology seems to provide a better and a wider
endpoint in which to granulate to even with some very difficult actives that we work with, including natural ingredients in the nutritional supplement industry.
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For foam delivery, the nuclei formation is influenced by the foam The experiments show that the narrowest nuclei size distribution is
obtained by granulating with high-quality foam and intensive powder mixing conditions. intensively agitated powder. The interactions of foam quality and the powder flow pattern are discussed and two distinct wetting and nucleation mechanisms are proposed under bumping flow, a low-quality foam tends to induce localised wetting and nucleation. The wetting and nucleation is foam drainage controlled. Under roping flow, foam will be dispersed by the motion of the agitated powder. The wetting and nucleation is mechanical dispersion controlled.
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4. FFL-316 (24.5%)
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The foam system achieved common endpoint torque in 40% less time than the spray addition method. The foam method also required 40% less water for the granulation step. 11/8/2011 1515
Here, Two trials for the foam system yielded quite similar particle size distributions. Even more important, the foam addition method yielded significantly lower levels of particles smaller than 140 mesh (105 microns).
It strongly suggests that the very rapid and thorough particle wetting by the foam allows small particles to adhere to larger particles in the early stages of granulation, Long Island University 11/8/2011 1616
Physical properties were quite similar for the foam and spray systems. Physical property testing generally showed tablet crushing strengths within one standard deviation of each other. Tablet thicknesses were also very similar. 11/8/2011 1717
Applications
The Use of Starch 1500 as a Binder and Disintegrant in foam
Granulation
The choice of where to add the starch excipient depends greatly on the
Dry Addition
The cold water soluble fraction of Starch 1500 provides unique benefits for
the granulation process. The main advantage is that it can be dry blended with other ingredients and granulation can be accomplished by the addition of water. slurries. The approach is similar to using fully pregelatinized starches,
Island University LongThis simplifies the process by eliminating the need to prepare binder 1818 11/8/2011
Conclusion
Foam granulation gives excellent stability and a broader
operating window than standard liquid injection.
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Personal Opinion
This new technology allows for fast, simple and cost
effective granulation and could minimize issue associated with conventional process. cost foam generator, the manufacturing process uses less water than traditional wet granulation process. process so that it can reduce the nozzle difficulties.
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References
P. Sheskey et al., "Foam Technology: The Development of
a Novel Technique for the Delivery of Aqueous Binder Systems in High-Shear and Fluid-Bed Wet-Granulation Applications," poster presented at AAPS Annual Meeting and Exposition, Salt Lake City, UT, Oct. 26-30, 2003.
References
M. Bardin, P.C. Knigh and J.P.K. Seville, Powder
Technol., 140, 169175 (2004). 30(8), 831845 (2004).
C.M. Keary and P.J. Sheskey, Drug Dev. Ind. Pharm., T. Hlinak, Am. Pharm. Rev., 3(4), 3336 (2000). M. Yasumura and K. Ashihara, Pharm. Technol. Japan,
12(9), 12791289 (1996).
E. Russo, Pharm. Technol., 8(11), 4656 (1984). K. Ashihara and M. Yasumura, Kagaku Kogaku, 60(3),
180182 (1996).
Keary and D. Clark, 11/8/2011 poster presented at 2222 the 2006 Annual Meeting and Exposition of the
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