Patent Application
20150352568
Wurster coating of multi-particulates with polymer suspensions and solutions is widespread in the pharmaceutical industry. Several formulations for polymer coatings of aqueous dispersions and organic solvent based polymer systems require glidants such as talc, stearates, silica compounds, calcium compounds, and many other materials to be suspended into the polymer solutions to cut down on polymer tackiness and reduce agglomeration. These glidants can aggregate or may not be available as a fine enough particle to suspend indefinitely and so can fall out of solution during the process, causing spray gun plugging and line plugging. Plugging of the spray gun and lines normally requires shutdown of the machine for cleaning, which delays the coating process and increases the production costs. Adding glidant to a suspension or solution reduces the rate of polymer application by the very nature of the formulation, which typically requires the same amount of glidant to be in suspension as polymer. For a given application rate only half is polymer, leading to extended processing times and inefficient coating processes.
In the typical spray application where glidant is included in the suspension or solution, the glidant is necessarily coated with polymer as it is sprayed on to the substrate particle, reducing its ability to spread on to the substrate and is less effective in reducing aggregation.
Therefore, there is a need for an improved Wurster coating machine and process, which eliminates the problems in the prior art.
Accordingly, a primary objective of the present invention is the provision of a Wurster accelerator having a powder applicator with improved performance.
Another objective of the present invention is the provision of a Wurster accelerator which applies dry powder without plugging a spray gun or associated lines.
A further objective of the present invention is the provision of a Wurster coating machine which applies dry powder to the particles in the fluid bed without agglomeration or aggregation.
Still another objective of the present invention is the provision of a Wurster accelerator with a dry powder line connected to the accelerator sleeve to deliver dry powder to the particles in the fluid bed.
Yet another objective of the present invention is the provision of a process for coating particulate material with dry powder using a Wurster accelerator.
A further objective of the invention is to reduce suspension or solution preparation time and complexity in a Wurster coating processor.
A further objective is the provision of a Wurster dry powder coating process wherein the glidant it removed from the suspension or solution and applied as a dry substance, thereby increasing its efficient use and efficacy in reducing aggregation, compared to glidant that is in suspension and therefore coated with polymer as it is applied in the spray.
A further objective is the provision of a Wurster dry powder coating process which allows higher amounts of polymer in suspension or solution by eliminating the glidants in the suspensions or solutions.
A further objective is the provision of a Wurster dry powder coating process which applies polymer at a faster rate to the substrate due to the higher amount of polymer in the suspension or solution.
A further objective is the provision of a Wurster dry powder coating process which applies polymer at a faster rate due to the greater efficiency and efficacy of applying the glidant as a dry powder to reduce aggregation.
Another objective of the invention is to remove the suspended solids (inactive excipients such as talc, disintegrant such as crospovidone, nutritional additives such as probiotics, API's such as Fexofenidine and any material) from the suspension or solution, thereby removing sedimentation and clogging in the lines and spray gun of a Wurster coater.
Another objective (same as p. 1 re provision of a Wurster . . . ) which applies disintegrants as a dry powder directly to the substrate without the disintegrant being hydrated.
Another objective of the present invention is the provision of a Wurster processor with improved sprayability, reduced process time, and reduced solution instability of certain pharmaceutical and other polymers containing insoluble solids and or soluble solids.
Still another objective of the present invention is the provision of a Wurster coating apparatus which applies solids without needing to suspend or solubilize the solids so as to improve the process, reduce time and avoid instability of the solids with water or other solvents.
These and other objectives will become apparent from the following description of the invention.
The invention utilizes the Wurster accelerator spray gun system to apply dry, finely divided solid substances during a Wurster process by replacing the original accelerator diverter sleeve compressed air supply with a vacuum generating eductor thereby causing powder to be entrained into the diverter air flow and distributed via the plurality of (radial) holes of the diverter sleeve. By applying the powder in a dry form to the particles circulating in the fluid bed of the processor, agglomeration and/or aggregation is eliminated or minimized.
This modified Wurster invention can apply any finely divided, dry solid substance including but not limited to chemicals and polymers and active pharmaceutical ingredients (API's) and inactive substances often known as excipients, and/or any combination of these.
The invention uniformly distributes the finely divided powder due to accelerator design, including an air diverter sleeve, as described in Applicant's U.S. Pat. Nos. 6,685,775, 6,736,897 and 6,773,747, each and all incorporated herein by reference.
The invention also precisely controls powder feed rate due to the eductor/feeder arrangement, described in Applicant's published U.S. Patent Application No. 2010/0031881, incorporated herein by reference.
The invention applies finely divided powders without interfering with spray pattern or droplet distribution in any way, and without interfering with the normal product movement within the Wurster apparatus in any way.
The invention can be used with organic solvent systems, inorganic solvent systems and aqueous solvent systems and any combination thereof, such as hydro-alcoholic or hydro-acetonic systems.
The modified Wurster invention prevents agglomeration or aggregation of a substrate due to the characteristics of the spray liquid by applying a dry glidant.
The invention also prevents agglomeration or aggregation due to the use of high spray rates by applying a glidant in a dry form.
The invention also prevents agglomeration or aggregation due to the use of high polymer content in the sprayed liquid by applying a glidant in a dry form.
The invention allows the use of high polymer content in the sprayed liquid by applying a glidant in a dry form.
The invention allows the use of high spray rates by applying glidant in a dry form.
The invention allows the use of undiluted polymer suspensions and reduces the complexity of suspension or solution preparation.
The Wurster modification of the present invention can be used to apply API's (such as but not limited to: analgesics, antibiotics, antivirals, cardiac drugs, etc.) to produce a chemical, food, pharmaceutical or other product while spraying a solvent and or a binder, and/or while spraying a modified release polymer.
A Wurster accelerator for coating particles is generally designated in the drawings by the reference numeral 10. The Wurster 10 includes a spray gun 12, with a nozzle tip 14.
A cylindrical sleeve or air diverter 16 extends around the spray gun 12 and defines an annular space 18 between the diverter 16 and the gun 12. The diverter 16 includes a plurality of discharge ports 20 at the upper end of the diverter 16. In a preferred embodiment, the ports 20 are angled at approximately 45° relative to the longitudinal axis of the spray gun 12, less preferably at 50°, and much less preferably at 37° and 30°.
A powder feed system is generally designated by the reference numeral 22 in the drawings. The feed system 22 includes a precision load cell metering device with an eductor 24 extending between the device or powder source 26 and the Wurster Accelerator System 10. A powder line 28 connects the eductor 24 to the Wurster Accelerator System 10 so the powder can flow from the powder source 26 to the air diverter 16. A coupler 30 connects the powder line to the Wurster Accelerator System 10 and to the air diverter and thereby creates a path for the powder to enter through a plurality of inlet ports 32 in the base of the air diverter 16. During operation of the Wurster accelerator 10, the powder flows upwardly through the annular space 18 and is discharged through the outlet ports 20 in a direction away from the liquid sprayed by the nozzle tip 14 and onto the particles circulating in the up bed 34 of the Wurster Accelerator System 10.
In a preferred embodiment, the air diverter 16 has between 15 and 55 equally spaced outlet ports 20, most preferably 36 equally spaced outlet ports 20, which can range in diameter from 0.75 mm to 5.00 mm, more preferably 1.00 mm to 3.00 mm, and most preferably 1.2 mm to 2.4 mm, and six equally spaced inlet ports 32 having a diameter of approximately one quarter inch and angled at approximately 35°, as seen in
In operation, the dry powder is applied through the diverter sleeve 16 to the fluidized particles or substrates without agglomeration or aggregation, since the powder is not suspended or dispersed in the liquid spray from the nozzle tip 14.
Utilizing an 18″ straight sided Wurster column, (Wurster Accelerator System, Freund-Vector Corporation) 50 KG of granular potassium chloride was coated with an 18% solids suspension of Eudragit L30 D 55 (Evonik/Degussa). Eudragit L30 D 55 is supplied as a 30% solids suspension and typically diluted to around 15% for use. Dilutions of 15% and 18% were evaluated. The invention allows higher solids content to be used and an 18% dilution was used in Example 1.
During the spray process, using a K Tron KT20 loss in weight powder feeder, talc was injected directly into the spray zone through the 45 degree Wurster Accelerator sleeve on the spray gun. Talc was applied at a rate equivalent to 50% based on the polymer solids being applied, as instructed by the polymer manufacturer's recommendations.
Utilizing an 18″ straight sided Wurster column, (Wurster Accelerator System, Freund-Vector Corporation) 50 KG of granular potassium chloride was coated with a 15% solids suspension of Eudragit L30 D 55 (Evonik/Degussa). For conventional spray coating the manufacturer recommended polymer solids is typically 15%.
In this standard spray approach the glidant (talc) was incorporated (mixed) in the polymer suspension at the same 50% based upon polymer solids rate and sprayed as an admixture with the polymer solids. Coating conditions were held constant as in Example 1.
Maximum spray rate with less than 1% aggregation (agglomeration) of the potassium chloride cores and efficiency of transfer was used as a measure of the difference between the Standard spray process and that of the invention.
In Example 1, spray rates of up to 650 g/min, equivalent to 117 grams of polymer per minute, were accomplished with 0.71% agglomeration during the coating trial. A 10% coating level was achieved in only 73 minutes of spray time at an efficiency of 96.0%.
The talc amount applied was held at a constant 50% to the polymer solids throughout the coating run. No gun or solution line plugging occurred and no solution mixing was required during the trial.
In Example 2 spray rates of 450 g/min or less led to over four times more aggregation, 2.92%, and slightly lower efficiency at 95.1% and ˜33% more time to coat.
Applying talc through the Wurster Accelerator sleeve directly into the spray zone allowed for increased spray rates with reduced agglomeration during the coating process. By removing the solid glidant material out of the spray solution, the need to constantly stir the solution and the potential for line plugging or gun failure during the process was eliminated.
Thus, the invention modifies to an existing Wurster spray system to add solid glidants via a powder feeder in dry form during the Wurster coating process.
The invention has been shown and described above with the preferred embodiments, and it is understood that many modifications, substitutions, and additions may be made which are within the intended spirit and scope of the invention. From the foregoing, it can be seen that the present invention accomplishes at least all of its stated objectives.
This application claims priority under 35 U.S.C. §119 to provisional applications U.S. Ser. No. 62/010,243 filed Jun. 10, 2014, herein incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62010243 | Jun 2014 | US |
