Hauszeitschrift engl. 17/02

innovativ
L . B . B o h l e M a g a z i n e f o r C u s t o m e r s The way to increase efficiency
Continuous granulating and drying
The impressive performance of
the new BCG system:
• 24-hour operation
• Increase in dissolution rate by
changing porosity
• High active concentration
enabling smaller tablets
In this issue:
BCG was developed in close cooperation with the September 2002
Rheinische Friedrich-Wilhelms-Universität of Bonn fully implement economic evaluations and makesuggestions on the effectiveness of contemplatedmeasures. This has shown that older systems, based Dear Readers,
on current standards of GMP-directed documentation,are frequently no longer satisfactorily qualifiable. Looking back at INTERPACK 2002 we see that the Measures to modify overall measurement and control well-known Düsseldorf exhibition, contrary to the techniques to modernize an old set-up proves some current trend, continues its successful upward climb. times to be too costly, as mechanical components The Bohle team also noted a lively turnout and there- possess a defined life span. Moreover, up-dating and fore had every reason to thank our visitors. The many reinstallation of equipment cause the necessity of new positive comments, above all regarding the three novelties presented by us, attest to the fact that we areon the right path. In some cases, a cost comparison between an oldmachine, including necessary adjustments and a new We have already thoroughly introduced two of these installation with the most modern technology and designs in earlier editions of Bohle innovativ. For validation, resulted in only a slight difference. No example: No. 13 - September 2000 featured the difference in cost was noted when considering the Bohle Coater BFC 200, whose design caused great required time for re-commissioning. On various occa- enthusiasm in Düsseldorf. Also, No. 14 – April 2001 sions, even conversions were not economically justifi- provided information about the Bohle Containment able, because new machines, equipped with modern System BCS immediately after its development was controls and software, which can be validated, are no complete and it was ready for marketing. We also longer able to integrate with old equipment. The Bohle gained a great deal of attention in Düsseldorf with this team is happy to be available to you for appropriate system. Today, continuous granulation is the centre of our information. On pages three and four you will findall that you will need to know about the technology ofBCG 10, its capabilities and applications. In order to meet your requests for adequate documen-tation and qualification of all machines and systems, we are currently expanding our administration build-ings in Ennigerloh. Also, towards the end of this year,we will provide another one thousand square meter ofoffice area for our Engineering Department. I would like to call your attention to an interestingtopic with which we have been intensely occupied Trade fairs and exhibitions 2002
the past several months by customer request. Manycompanies are planning to shift existing capacities With more than three quarters of sales coming from to another plant. In some cases we could success- exports, stronger efforts to contact and meet with ourinternational clientele are necessary. Trade fairs andexhibitions offer a welcome opportunity for thispurpose. In this issue we would like toexpress our special thanks For the remaining part of the year, you will be able to longterm works as editor of“Bohle Innovativ“.
Our BCG 10
The continuous way to substantial granules
The current dominant granulating method is the wet or binder granulation, because of the increased
lipophily of modern actives. With BCG 10, our company has included a new method for granule distribution
in its program, which links a continuous mode of operation with higher efficiency.
Developed in cooperation with the Department of Pharmaceutical Technology at the University of Bonn,
this method has a vastly different functional principle compared to other known granulation methods and
impresses because of its simplicity. The only thing in common with them is the division of process steps
with regards to weighing, granulating, drying and sifting.
The Technology:
gas (for example nitrogen) at the start of the glass tubeand therefore increase drying efficiency. By means of The dosing of the powdered ingredients and thus a double valve lock the dry product then arrives in a the actual weighing is implemented by using one or sieve, type BTS 100, and is milled into the desired more gravimetric screw-feeders. A specially adapted planetary roller extruder subsequently carries out thegranulation. It mixes the powdered ingredients with the One of the measurements used in determining thequality of pharmaceutical granules is their porosity, since this can influence tablet formation and tabletproperties such as disintegration time and speed ofrelease. However, when using classical methods,this parameter can only be varied within very narrowconfines and depends mainly upon the process andmaterials. The BCG 10 on the other hand allowsnitrogen or any other gas to be added during thegranulation phase and intensely mixed with the wetgranulate mass. Upon reaching the drying phase, thegas bubbles suddenly expand and can lead to a moderate increase in porosity, which with certain mix-tures can significantly change tablet formation and granulation fluid and rolls them onto the entire extru-sion length into a homogenous strand.
The granulating unit (Fig. 1) consists of a cooledcentral spindle (2), the single actively driven elementand a cooled barrel (3) plus three to seven planetaryspindles. These rotate due to their special gear teeth,similarly to planetary gears, and roll out the granulatemass around the central spindle and the barrel. The process heat is transferred directly at the place oforigin, enabling excellent temperature control.
The extruded mass subsequently arrives in a rotatingglass tube (Fig. 2), where it is cut into short pieces and is dried by means of microwaves in a vacuum. The residual moisture in the drying product can be in-fluenced by the irradiated microwave energy and thetime it remains in the drying room. The latter can becontrolled to a great extent by the filt angle of theentire system. It is also possible to dose a stripping Editor:
L.B. Bohle
Maschinen und Verfahren GmbH
Industriestraße 18
D-59320 Ennigerloh
Telephone: 0 25 24 / 93 23-0
High concentration of active ingredients
Application also suitable for food
Based on current knowledge, the main strength of This method is not only suitable for the manufacture the granulation unit lies in the excellent temperature of granulates used pharmaceutically. Applications for control and high dispersion attainment. With this the food sector are thinkable, or have already been method it is even possible to granulate rather poorly implemented. One of these realized granulations was wetable materials with extremely low binder con- in the processing of tea dust into free-flowing granules.
centrations. Thus, Ibuprofen granulate, for example, In addition to the fine-cut leaves, the starting mate- could be manufactured with a concentration of active rial also contained smaller twigs and other woody ingredients of up to 96%. The resulting tablets were elements. The granulation required an addition of of excellent technological qualitiy and after adding approximately 25% water, but could be dried to a the external phase still had an Ibuprofen content of residual moisture of 3.9%. Result: a good free-flowing over 92%. General market products typically contain granule, in which no individual components could 45-65% of active ingredients. Tablets produced with be detected. The brewing of this “tea“ made for an BCG 10 are smaller and lighter. They require corres- pondingly lower costs for raw material and storage.
They also cause fewer swallowing difficulties for Other possible applications are the processing of patients, which can benefit a therapy.
flavors in liquid and powder form for free-flowinggranules by coating them onto carrier materials usingthe low thermal charge during processing or themanufacture of homogenous mixtures of every kind.
Feasibility of a granulation depends only on a certainminimum amount of the lubricating additives. Usually,this is water. However, fats, waxes or other lubricantscan be used. Frequently, such additions are notnecessary in the food sector, as the basic mixtureusually contains this property.
A BCG 10 with a throughput of 1-15 kg per hour is available to you for tests in our technical laboratory.
It is entirely feasible to have machine sizes with out-puts of up to several tons per hour.
Figure 3: The average time the product remains in thegranulator is controlled by the number of planetaryspindles and the dosing rate of the powder. All valuesin minutes. (Explanation see text) In extrusion systems, the holding time distribution isfrequently used as the measure of the mixing per- formance. This mirrors the dwell time and distributionof the powder quantity which is added at a specifictime. The diagram shows the average dwell time, i.e.
L. B. Bohle LLC
the amount of time could be detected for up to halfof an added indicator for a product (blue line). The width of the distribution curve is shown as red line. It isobvious that both parameters can be controlled within a wide spectrum by the number of planetary spindlesused, and the dosing rate of the powder.

Source: http://www.drescher.com.ar/active/htm/novedades/bohle_Innovativ/nr_17_sept_2002_engl.pdf