The new technique of hot-melt extrusion/spheronization can produce spherical As used herein, the term “direct compression excipient” is intended to mean a. A continuous-type spheronizer for use in a continuous melt-spheronization . at a predetermined rate directly into an extruder 30, having one or more heating. Direct. Compression. Formulation/Processing Considerations . Extrusion spheronization using water is possible and recommended versus a solution of electrolytes. Carbopol®. P NF. Noveon® AA Polycarbophil. Hot Melt. Extrusion.
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As used herein, the term “direct compression excipient” is intended to mean a compound used in direct compression formulations. Whole beads were viewed under 50X magnification whereas bead cross-sections were viewed under 10,X magnification. spheronixation
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Suitable soaps include fatty acid alkali metal, ammonium, and triethanolamine salts. Dies of different shapes and sizes can be used to form the extradate; however, cylindrical dies may provide more uniform particle size distribution and smoother surface of the resulting particles.
The formulation was fed into the hopper after the zones and die had equilibrated to the set temperatures. Stock solutions of the same media employed in Method A were used here. A non-pareil bead is one that contains no active agent. Tamper-resistant dosage form comprising pharmacologically active compound wqrm anionic polymer.
Plasticizers, such as low molecular weight PEG, generally broaden the average molecular weight of a polymer in which they are included thereby lowering its glass transition temperature or softening point. The mesh size number indicates the screen pore size; pore size decreases with increasing mesh size number. Accordingly, the extradate may be shaped as a rod, ribbon or other extradate conventionally formed in the plastics industry. The porosity measurements were calculated using data from helium pycnometry and mercury porosymetry experiments.
The formulation of Example 7 is related to the formulation of Example 2, except that the driect of Example 7 includes different amounts of the components that are in common, and the formulation of Example 7 includes magnesium stearate rather than microcrystalline cellulose.
The polymer chain interactions of the molten polymers are increased under these elevated conditions. Consequently, the spherical particle produced by spheronization has a more homogeneous composition, smoother surface and more controlled release of active agent.
The porosity of the wet-mass extruded beads was 6. It is generally used for formulations that provide a targeted drag dirext in the colon. A standard testing sieves Arthur. Therefore, these conventional beads provided very little controlled release of theophylline. As a consequence, a second material that is not thermoformable can be made thermoformable by the addition of a plasticizer.
PDF of Use of powdered cellulose for the production of pellets by extrusion/spheronization
Also, the active agent in this example is diltiazem hydrochloride. As used herein, the term “adsorbent” is intended to mean an agent capable of holding other molecules onto its surface by physical or chemical chemisorption means.
To date, however, no process combining the steps of hot-melt extrusion and spheronization has been developed. The bead samples were exposed serially to the media as follows: When the hot-melt extruded spherical pellets were tested in a medium of pH 6.
Examples of pharmaceutically acceptable salts include, but are not limited to, mineral or organic acid salts of the drug. Journal of Microencapsulation 14 2: Specific embodiments of the invention include those wherein: The thermoformable material or composition may require a plasticizer to render it thermoformable. The pharmaceutical excipient, which might or might not be plasticized, melts or softens during the hot-melt extrusion process.
Some factors that may affect the temperature at which the composition being extraded is extraded: The coating formulation described below further controls the release of drug from the bead. Dissolution media was sample periodically and the samples were diluted with additional dissolution media as needed and then assayed by spectrophotometry at a wavelength of nm.
The particle size of the sized extradate generally ranges from 0. Cooling can be conducted by exposing the extradate to cooler air, gas, or liquid. Suitable preservatives include, by way of example and without limitation, benzalkonium chloride, benzethonium chloride, benzyl alcohol, cetylpyridinium chloride, chlorobutanol, phenol, phenylethyl alcohol, phenylmercuric nitrate and thimerosal and others known to those of ordinary skill in the art.
Such compounds include, by way of example and without limitation, aspartame, dextrose, glycerin, mannitol, saccharin sodium, sorbitol and sucrose and other materials known to one of ordinary skill wark the art.
Such compounds include, by way of example driect without limitation, magnesium stearate, talc, calcium stearate, glyceryl behenate, PEG, hydrogenated vegetable oil, mineral oil, stearic acid and other materials known to one of ordinary skill in the art. Additionally, the beads processed by this new technique have a narrower particle size distribution.
As used herein, a “thermoformable” material or composition refers to one that will soften or melt during the hot-melt extrusion step. The amount of coloring agent used will vary as desired.
Use of powdered cellulose for the production of pellets by extrusion/spheronization
Drug Development and Industrial Pharmacy 28 4: Drag layering dirfct a fluid-bed coater to apply a drug containing film onto non-pareil beads. The die size was 1.
Other suitable materials include, for example, cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose triacetate; mono, di and tricellulose alkanylates; mono, di and tricellulose aroylates; cellulose acetate having a D.