Composite method to quantify powder flow as a screening method in early tablet or capsule formulation development

Taylor, Michael K.; Ginsburg, Jeri; Hickey, Anthony; Gheyas, Ferdous

doi:10.1208/pt010318

Cited by 64 publications

(33 citation statements)

References 7 publications

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“…The final filtrate of both reactions was analyzed for a PEG content using periodate titration method (11). Charring temperature of a conjugate was determined by Herculus drop technique using thistle tube.…”

Section: Evaluation Of Cellulose-peg Conjugatementioning

confidence: 99%

Synthesis of MCC–PEG Conjugate and Its Evaluation as a Superdisintegrant

Bhalekar¹,

Desale²,

Madgulkar³

2010

AAPS PharmSciTech

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Abstract. PEGylated conjugate of microcrystalline cellulose (MCC) was synthesized by reacting MCC with polyethylene glycol (PEG) 200 in the presence of catalyst at elevated temperature. Conjugation between MCC and PEG was confirmed by FT-IR and 1 H NMR studies. The conjugate showed 61% PEG content increase in molecular weight determined by mass spectroscopy. PEGylation did not improve solubility of cellulose significantly. The physico-chemical properties of conjugate were compared against MCC. This conjugate was evaluated for water vapor uptake isotherms, maximum water saturation, water penetration rate, disintegration time, superdisintegration power, and dissolution study. After comparing its results with that of commercial superdisintegrants, it can be concluded that MCC-PEG conjugate can prove to be a good superdisintegrant.

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Section: Evaluation Of Cellulose-peg Conjugatementioning

confidence: 99%

Synthesis of MCC–PEG Conjugate and Its Evaluation as a Superdisintegrant

Bhalekar¹,

Desale²,

Madgulkar³

2010

AAPS PharmSciTech

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“…13,17 The flow of powders is influenced by various factors including interparticle forces, surface irregularities, moisture, particle size, density, and particle shape. The use of any single flow test cannot account for all these factors 18 and a combination of flow tests is recommended. Some of the commonly used tests include use of Carr index, flow rate, shear analysis, and critical orifice diameter.…”

Section: Powder Characteristics and Capsule Fillingmentioning

confidence: 99%

Investigation of various factors affecting encapsulation on the In-Cap automatic capsule-filling machine

et al. 2004

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The purpose of this study was to determine the factors that influence fill weight and weight variability of capsules produced on the In-Cap and to assess any differences in terms of capsule defects between gelatin and HPMC (Quali-V) shells. The In-Cap is an automatic tamping type capsule-filling machine and the low output of ~3000 capsules/hour makes it ideal for early formulation development and phase I/IIa clinical supplies manufacture. Four commonly used excipients (Avicel PH101, Avicel PH302, A-Tab, and Prosolv HD90) and a poorly flowing drug blend were encapsulated at various pin settings and powder bed heights. The average fill weight and coefficient of weight variation were determined. The percentage of defective capsules formed during encapsulation was calculated. Results of the study showed that pin setting was critical for controlling the fill weight and the weight variation. The order of pin setting with pin 1 (closer to the powder chute) set to a relatively higher position and pin 4 (before ejection) set to a lower position was found to give higher fill weights with relatively lower weight variability. The powder bed height influenced the fill weight for poorly flowing powders. The capsule machine speed did not appear to significantly influence the fill weight. The fill weight and weight variation were found to depend on the flow property of the material. A large percentage of defective capsules was obtained using HPMC shell size #00. Some of the commonly observed defects included split caps and improperly closed filled capsules. In general, appropriate selection of pin settings and bed height can reduce the weight variability seen, especially with poorly flowing high-dose formulations.

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“…12 Aerosolization and dispersion properties of powders in a DPI formulation are dependent on the flow properties of the powder particles, which, in turn, are affected by particle surface morphology, size, surface charge, surface roughness, and forces of interaction among the powders. 4,13,14 Thus, the drug dispersion from lactose carriers is a complex interplay of various variables. The physical characterization of lactose carriers used in DPI formulations has been intensively investigated and the readers are referred to the comprehensive articles demonstrated by Hickey et al 15,16 for further information.…”

Section: Introductionmentioning

confidence: 99%