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, a polyol is a polyhydroxylated compound or polymer and includes, by way of example and without limitation, mannitol, xylitol, and sorbitol. As used herein, the term “opaquant” is intended to mean a compound used to render a coating opaque. At the 5-hour time point, which direcct one hour after exposure to pH 6.
Use of powdered cellulose for the production of pellets by extrusion/spheronization
Although the composition and average particle size of the beads of FIGS. A multi- xpheronization extruder was used and the temperature of the respective zones were set as indicated below.
Furthermore, the use of solvents is expensive because manufacturers must remove and account for all solvents used, and because they must pay for proper solvent disposal. Effect of microcrystalline cellulose grade and process variables on pellets prepared by extrusion-spheronization. When the hot-melt extruded spherical pellets were spheronkzation in a medium of pH 6. Control of drug release by incorporation of sorbitol or mannitol in microcrystalline-cellulose-based pellets prepared by extrusion-spheronization.
The skilled artisan will, in light of these figures and the description herein, be able to practice the invention without undue experimentation. As used herein, the term “acidifying agent” is intended to mean a compound used to provide an acidic medium for product stability. Soaps and synthetic detergents may be employed as surfactants and as vehicles for detergent compositions.
It should be understood, that compounds used in the art of pharmaceutical formulation generally serve a variety of functions or purposes. Specific embodiments of the invention include those wherein: Dies of different shapes wwrm 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. Exemplary disintegrants include, by way of example and without limitation, starches such as corn starch, potato starch, pre-gelatinized and modified starches thereof, sweeteners, clays, such as bentonite, microcrystalline cellulose e.
It is generally used for formulations that provide a targeted drag delivery in the colon.
A3 Designated state s: To date, however, no process combining the steps of hot-melt extrusion and spheronization has been developed. The glass transition temperature is further reduced upon the addition of a plasticizer.
The wet mass is then extruded without melting of the mass to form a granule that is then spheronized.
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A non-pareil bead is one that contains no active agent. The particle size distribution of beads made according to Examples 1 and 2 was determined by sieving the beads through a series of U. Although the drug was released quickly from these beads, the beads remained intact even after completion of the hour dissolution test because the polymer is not significantly soluble in aqueous media having a pH less than 7.
Such materials can be combined with one or more plasticizers to render them thermoformable. Pellets having an active compound matrix and a polymer coating, and a process for the production of the pellets.
PDF of Use of powdered cellulose for the production of pellets by extrusion/spheronization
Flavors will be present in any amount spyeronization desired by those of ordinary skill in the art. When heat is applied to the mass being spheronized, the temperature will generally be at least degrees above the Tg or melting point of the most abundant thermoformable material spheronzation the particles. These solvents may degrade the active agent in a formulation, and in practice, it is difficult to remove all traces of solvent from a spheronized granule made according to the wet method.
These may also include cinnamon oil, oil of wintergreen, peppermint oils, clove oil, bay oil, anise oil, eucalyptus, thyme oil, cedar leave oil, oil of nutmeg, oil of sage, oil of bitter almonds and cassia oil.
The foregoing will be better understood with reference to the following examples that detail certain procedures for the preparation of formulations according to the present invention.
Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer. This technique is disadvantageous because it employs water or other solvents that require a time-consuming drying step.
Development and evaluation of omeprazole pellets fabricated by sieving-spheronization and extrusion – spheronization process.
Such compounds include, by way of example and without limitation, carnauba wax, white wax and other materials known to one of ordinary skill in the art.
Figure 9 depicts the release profiles for the beads as they are exposed sequentially, in the order indicated, to solutions having pH values of 1. The listed ingredients can be used in the approximate amounts indicated and the extrasion can be conducted in a multi-zone extrader using the approximate temperatures indicated. Although the formulations were identical for beads processed by both techniques, beads displayed significantly different release patterns.
Such compounds include, by way of example and without limitation, powdered and activated charcoal and other materials known to one of ordinary skill in the art. 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 “glidant” is intended to mean agents generally used in tablet or capsule formulations to reduce friction during tablet compression. Extending the spheronization time will eliminate the occurrence of the dimple.