Instrumentation of an Automatic Capsule-Filling Machine

Small, L.E.; Augsburger, Larry L.

doi:10.1002/jps.2600660412

Cited by 29 publications

(8 citation statements)

References 4 publications

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“…This explains the residual axial pressure detected for this material. This effect has been noted previously by other workers (Cole & May 1975;Small & Augsburger 1977), who referred to it as retention force. The residual radial pressure is lower than that for lactose and the ejection pressure is undetectable, being less than the residual axial pressure.…”

Section: Plsupporting

confidence: 81%

Studies on Powder Plug Formation Using a Simulated Capsule Filling Machine

Britten

Barnett

Armstrong

1996

Journal of Pharmacy and Pharmacology

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Using an apparatus which simulates the action of a Macofar 13‐2 dosating‐type capsule‐filling machine, the variation in plug weight and density with changing machine parameters has been studied. The piston ejection speed has no effect on plug properties. However increase in compression speed leads to a less consolidated powder plug and hence reduced plug weight. Application of higher pressures reduces plug weight changes, but would be expected to affect release characteristics. Comparison of axial and radial pressures generated by plugs of Starch 1500 and lubricated lactose show significant differences which can be explained by the different consolidation and elastic properties of the two solids.

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Section: Plsupporting

confidence: 81%

Studies on Powder Plug Formation Using a Simulated Capsule Filling Machine

Britten

Barnett

Armstrong

1996

Journal of Pharmacy and Pharmacology

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“…The machine was instrumented by the Metropolitan Computing Corporation (West Orange, NJ) as described by Davar and colleagues, 14 and provided with digitized data acquisition.…”

Section: Hk Gkf-400mentioning

confidence: 99%

“…A previously instrumented Zanasi LZ-64 (IMA North America Inc, Fairfield, CT) was reinstrumented in a manner similar to that described by Small 14 and Botzolakis, 15 except that the data acquisition process was completely digitized. The necessary hardware and software for data acquisition were acquired from National Instruments (Austin, TX).…”

Section: Zanasi Lz-64mentioning

confidence: 99%

Comparison of the formulation requirements of dosator and dosing disc automatic capsule filling machines

Heda¹,

Muteba

Augsburger

2002

AAPS J

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The overall objective of this study was to provide 'semi-quantitative' or 'rigorous' definitions of the fluidity, lubricity and compactibility requirements of formulation for representative dosator and dosing disc capsule filling machines. To that end, model formulations were developed for those properties using Carr's compressibility index, ejection force, and plug breaking force at a specified compression force to gauge fluidity, lubricity, and compactibility, respectively. These formulations were each encapsulated on an Hofliger-Karg GKF-400 dosing disc machine and a Zanasi LZ-64 dosator machine. Each machine was instrumented to measure plug compression and ejection forces. The encapsulation process was evaluated for %CV of fill-weight, ejection force, plug breaking force and the dissolution of marker drugs incorporated in the formulations. The f 2 metric was used to compare dissolution profiles. The results suggest: (1) formulations should meet different flow criteria for successful encapsulation on the two machines, (2) a relatively lower level of lubricant may be sufficient for the dosing disc machine, (3) a higher degree of formulation compactibility is needed for the dosator machine, and (4) transferring formulations between these machine types (same class, different subclass per FDA's SUPAC-IR/MR Manufacturing Equipment Addendum) could be challenging. In certain cases dissolution profiles for the same formulation filled on the two machines with equivalent compression force were different based on f 2 < 50. Overall, the results of this study suggest a range of formulation characteristics appropriate for transferring formulations between these two types of machines.

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“…The size 1 tamping pins of this machine have been instrumented in the manner previously described 17,20,21,33 for HK dosing disc machines with 350 strain gages (Vishay Intertechnology, Malvern, PA) to measure the tamping and ejection forces (EF). The data acquisition procedure was fully digitalized.…”

Section: Dosing Disc Machine: Instrumentationmentioning

confidence: 99%

“…The research instrumentation of automated capsule filling machines [14][15][16][17][18][19][20][21][22][23][24] , which enables the measurement of force-displacements relationships during plug formation and ejection, has made possible the measurement of plug pre-compression, compression force and ejection force which can be correlated to physicochemical and mechanical attributes of capsule formulations. Examples include evaluation of lubrication requirements of a dosator-type automatic filling machine 22 , the effect of MS on plug breaking strength and dissolution from capsules 23 , the relationship between plug development and tamping pressure at different filling stations of a dosing disc automatic filling machine 20,24 and the systematic comparison of the formulation requirements of dosator and dosing disc automatic capsule filling machines 17 .…”

Section: Introductionmentioning

confidence: 99%

To investigate the influence of machine operating variables on formulations derived from lactose types in capsule filling: part 2

Moolchandani

Augsburger

Gupta

et al. 2015

Drug Development and Industrial Pharmacy

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This study is the second in a series that examines the characterizing and selection of suitable grades of lactose for capsule formulation development. Based upon the previous study, four grades were selected for further study. The effects of drug load and operational variables on formulations derived from these four lactose types were evaluated for physicochemical and mechanical attributes of plugs and their capsules on an instrumented dosing-disc capsule filling machine (H&H KFM/3) using acetaminophen as a model, highly soluble and poorly compressible drug. The results obtained were as follows: (1) flowability reduced upon increasing drug load; (2) powder bed height (PBH) and compression force (CF) had positive significant effect on plug weight (p < 0.05); (3) ejection force was positively and significantly correlated with increasing speed and CF (p < 0.05); (4) AL capsule plugs had the highest plug crushing force which was followed by DCL15; (5) the crushing strength of plugs made from DCL11 increased with increasing acetaminophen concentration; (6) higher CF had a significant negative impact on acetaminophen release at 15 min time point (p < 0.05); (7) at 10% and 40% drug load, formulations containing AL showed the quickest drug release; and (8) increased drug load had a significant negative impact on the release rate at 15 and 45 min time points (p < 0.05). Overall, the results from this study provides information on risk based assessment of filler selection based on drug load and the range of machine operating variables which will help in defining criteria for meeting key quality attributes for capsule formulation development.

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Instrumentation of an Automatic Capsule-Filling Machine

Cited by 29 publications

References 4 publications

Studies on Powder Plug Formation Using a Simulated Capsule Filling Machine

Studies on Powder Plug Formation Using a Simulated Capsule Filling Machine

Comparison of the formulation requirements of dosator and dosing disc automatic capsule filling machines

To investigate the influence of machine operating variables on formulations derived from lactose types in capsule filling: part 2

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