Design and Use of a Laboratory Extruder for Pharmaceutical Granulations

Goodhart, Frank W.; Draper, J. Ronald; Ninger, Fred C.

doi:10.1002/jps.2600620127

Cited by 21 publications

(5 citation statements)

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“…The extrusion operation can be considered to be a specialized wet granulation technique, [10] as well as an integral part of the overall spheronization process. The production of spheroids by extrusion-spheronization is widely used in the manufacture of controlled release as well as immediate release dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Influence of operational variables in multi-particulate delayed release systems for colon-targeted drug delivery of celecoxib using extrusion spheronization

Sinha¹,

Aggarwal²,

Srivastava³

et al. 2010

Asian J Pharm

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T he present research was aimed to formulate and evaluate pH and time-dependent multiparticulate systems for colon-targeted drug delivery of celecoxib (CXB) with maximum drug absorption, reduced peak plasma fluctuations, and minimum potential side effects. Multiple unit delayed release systems of the drug in MCC (Avicel ® PH-102) grade were prepared using polymethacrylate polymers (Eudragit ® L-100 and RSPO) as a granulating binder by the extrusionspheronization technique and characterized for their shape, size, size distribution, friability, density, and moisture content. In vitro release studies were performed in 0.1N HCl, for first 2 h then further performed in phosphate buffer (pH 6.8) for 24 h. The resulting pellets were prepared by extrusion spheronization using different grades of polymethacrylate polymers as a granulating binder, showing a substantial decrease in drug release in initial 5 h (16.28-16.7%) and releasing most of the drug in 12-24 h. The geometric and arithmetic mean diameter ranged from (490 to 780 µm) and (636 to 734 µm), respectively. The minimum to maximum range for circularity, elongation and rectangle were found to be (0.847±0.009 to 0.965±0.078), (1.036±0.057 to 1.185±0.023), and (0.724±0.041 to 0.791±0.047) respectively showing the proper shape and size of the pellets. The content of CXB in the prepared pellets was observed between 98.70 and 99.47% justifying the uniform drug distribution. The in vitro dissolution studies showed that the retardant effect in initial 5 h and most of the drug release in 24 h depended on the ratio and concentration of different grades of methacrylate polymers used in the formulation. CXB-loaded MUPS prepared by the extrusion-spheronization technique using polymethacrylate polymers showed immense potential for colon-specific drug delivery of the drug.

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Section: Introductionmentioning

confidence: 99%

Influence of operational variables in multi-particulate delayed release systems for colon-targeted drug delivery of celecoxib using extrusion spheronization

Sinha¹,

Aggarwal²,

Srivastava³

et al. 2010

Asian J Pharm

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“…High-shear wet granulation by twin screw extrusion machinery is an emerging continuous manufacturing technology for solid oral dosage forms [1][2][3][4][5][6][7][8][9][10][11][12][13][14] which is receiving considerable attention by the pharmaceutical industry. The technology has the capacity to produce a well-mixed granular product of excipients and active ingredients with high consistency in a relatively short span of time (in the order of seconds).…”

Section: Introductionmentioning

confidence: 99%

Foam granulation: new developments in pharmaceutical solid oral dosage forms using twin screw extrusion machinery

Thompson

Weatherley

Pukadyil

et al. 2011

Drug Development and Industrial Pharmacy

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This paper investigates foam granulation in a twin screw extruder as a new continuous wet granulation technique for pharmaceutical powder drug formulations. Foamed aqueous binder has a reportedly lower soak-to-spread ratio than drop or spray liquid addition in batch granulation. This work demonstrates a twin screw extruder configuration for foam granulation and subsequently compares the new approach against liquid injection in the granulation of α-lactose monohydrate with a methylcellulose binder. Trials were conducted at high powder output rates (20-40 kg/h) and high screw speeds (220-320 RPM) with two screw configurations. Process stability improved with the new technique allowing granulation with less binder. The extruded mass maintained a low exit temperature, being insensitive to operating conditions unlike the liquid injection approach, where temperatures rose significantly as flow rate increased. The particle size distribution by foam granulation reflected a more uniformly wetted mass with larger granule growth noted even for conditions where dry powder exited by liquid injection. Other factors were found similar between the two binder delivery methods such as consumed mechanical energy, as well as fracture strength and compressibility of produced granules.

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“…Twin‐screw extrusion machinery is the most flexible in terms of use, offering a vast multitude of configurable variables with regard to barrel layout, screw design, and the placement of auxiliary units like feeders and pumps. In comparison, single‐screw variants of an extruder have received much less attention for wet granulation due to their relatively poor mixing capabilities 3. Like other known continuous techniques for granulation, a learning curve should be expected as more extrusion machinery is commissioned for pharmaceutical processes like tablet manufacture.…”

Section: Introductionmentioning

confidence: 99%