DIRECT WARM SPHERONIZATION PDF

Zulkisar It is possible the psheronization will impart some particularly advantageous physical properties to the osmotic device of the invention. More particularly, the invention concerns a process wherein a hot-melt extruded solid substrate, such as a pellet, is spheronized. The release profiles for the formulation of Example 7 are dirsct in FIG. The dosage form of the invention can also include oils, for example, fixed oils, such as peanut oil, sesame oil, cottonseed oil, corn oil and olive oil; fatty acids, such as oleic acid, stearic acid and isotearic acid; and fatty acid esters, such as ethyl oleate, isopropyl myristate, fatty acid glycerides and acetylated fatty acid glycerides. Spheronizwtion addition, content uniformity of the layered beads is often a problem.

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Brataur As used herein, a polyol is a polyhydroxylated compound or polymer and includes, by way of example and without limitation, mannitol, xylitol, and sorbitol. At the 5-hour time point, which direcct one hour after exposure to pH 6. 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. 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.

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. There was a problem providing the content you requested 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.

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.

LIDL URC-L PDF 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. Extending the spheronization time will eliminate the occurrence of the dimple. TOP Related Posts.

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DIRECT WARM SPHERONIZATION PDF

Tukazahn A multi- zone extruder was used and the temperature of the respective zones were set as indicated below. 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 sirect pH less than 7. The process of the invention can directt used to prepare controlled release beads comprising essentially any one or more active agents. The formulation of Example 13 is only somewhat related to the formulation of Example 2.

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Whole beads were viewed under 50X magnification whereas bead cross-sections were viewed under 10,X magnification. 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.

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Dikinos Essentially any known extrasion die can be used. When the wet-mass granulated spheres were direect in a dissolution medium of pH 7. Under these conditions, theophylline was completely released from the wet-mass granulated beads after 4 hours, which behavior is similar to that observed in the USP apparatus 2 at a pH of less than 7. Method of manufacturing fine particles suitable for orally disintegrating pharmaceutical dosage forms.

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The elevated temperatures and high pressures utilized in hot-melt extrusion reduced the free volume of the resulting exudates. There was a problem providing the content you requested One aspect of the invention provides a spheronized particle made according to a process comprising the steps of: Powdered cellulose as excipient for extrusion-spheronization pellets of a cohesive hydrophobic drug. The disadvantage of this method is the difficulty of calculating the amount of drug spheronizatikn since coating solution is lost onto the coating apparatus. Essentially any known extrasion die can be used. All references made to these examples are for the purposes of illustration. For example, an extrusion die with a round cross- section will form a cylindrical extradate, whereas, warn extrusion die with a flat-lip will form a ribbon or sheet-shaped extradate. The hot-melt extruded spheres displayed an initial burst in drag release, due to theophylline on or near to the bead surface, but drug release was zero-order after the initial burst.

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