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. CarbopolĀ®. P NF. NoveonĀ® AA Polycarbophil. Hot Melt. Extrusion.

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Drag layering uses a fluid-bed coater to apply a drug containing film onto non-pareil beads.

All such plasticizers are commercially available from sources such as Aldrich or Sigma Chemical Co. The beads of the invention spheroization together comprise an effective amount of an active agent when included in a dosage form. These materials may be further described as carriers, and may be used alone or in combination with other materials of the present disclosure.

Method of manufacturing fine particles suitable for orally disintegrating pharmaceutical dosage forms.

Goodman and Lee E. The isolated particles on the surface of the spheres are likely slheronization by the dusting of the particles during spheronization.

Use of powdered cellulose for the production of pellets by extrusion/spheronization

Process for the preparation of a solid dosage form, in particular a tablet, for pharmaceutical use and process for the preparation of a precursor for a solid dosage form, in particular a tablet. Both the surface and the interior of the particle are rough, highly segregated particulate and not homogeneous.

Other suitable materials include, for example, cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose eirect mono, di and tricellulose alkanylates; mono, di and tricellulose aroylates; cellulose acetate having a D. The copolymer comprises the monomers methacrylic acid, methyl methacrylate and methyl acrylate in a ratio of about Distinct wwrm and excipient particle are visible in the wet-mass granulated bead.


The copolymer has a pH dependent solubility. A standard testing sieves Arthur. Continuous melt spheronization apparatus and process for the production of pharmaceutical pellets. As used herein, the term “colorant” is intended to mean a compound used to impart color to solid e.

The bead samples were exposed serially to the media as follows: The following figures form part of spheronizarion present description and describe exemplary embodiments of the claimed invention. As used herein, a polyvinyl or polyethylene polymer is a polymer or copolymer based upon ethylene or a derivative of ethylene. Such compounds include, by way of example and without limitation, titanium dioxide and dkrect materials known to one of ordinary skill in the art. The formulation of Example 11 is related to the formulation of Example 2, except that the formulation of Example 11 includes diltiazem rather than theophylline as the active agent.

The pellets were spheronized for approximately 0.

PDF of Use of powdered cellulose for the production of pellets by extrusion/spheronization

In contrast, the present inventors have discovered that the hot-melt extraded beads exhibit greater control over the release of drug. It is believed that this heterogeneous morphology of the matrix occurs because the polymer particles remain rigid during wet-mass granulation. 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 in the art.

psheronization After mixing, the blended mass is loaded into the hopper of the extrader and is extraded to form an extraded solid, or extradate. As used herein, the term “polishing agent” is intended to mean a compound used to impart an attractive sheen to coated cores.


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Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer. Use of cellulose ether containing excipients with microcrystalline cellulose for the production of pellets containing metformin hydrochloride by the process of extrusion-spheronization. Formulations prepared by other methods and film coated with acrylate- methacrylate copolymers or ethylcellulose as retardant materials, are known to demonstrate unstable release profiles when the products are stored over extended periods.

Both formulations exhibit a pH dependent release profile with the formulation of Example warn exhibiting a slightly faster release rate in lower pH media as compared to the formulation of Example 7 in the same media. European Journal of Pharmaceutical Sciences 17 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.

Although the hot-melt extruded bead is very spherical, it does possess a dimple. By unstable release profiles is meant that the release profile of a given formulation changes as storage time increases so that the release profile after an extended period of storage is significantly different than the initial release profile of the formulation.