The effects of high shear blending on α-lactose monohydrate

Bridson, Rachel H.; Robbins, Phillip T.; Chen, Y.; Westerman, D.; Gillham, C.R.; Roche, T.C.; Seville, Jonathan

doi:10.1016/j.ijpharm.2007.02.022

Cited by 38 publications

(20 citation statements)

References 22 publications

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“…Based on "active sites," "agglomerates," or alternative hypotheses (22)(23)(24), Aerolizer/ Formulation B would be expected to have a lower FPM than Aerolizer/Formulation A and provide a closer FPM match to the reference product. However, during the formulation screening, a greater FPM of Aerolizer/Formulation B was observed at 60 LPM relative to Aerolizer/Formulation A.…”

Section: Aerolizer With Test Formulationsmentioning

confidence: 99%

Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers

Adams¹,

Lee

Plourde

et al. 2012

AAPS J

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Abstract. The study examined the sensitivity of DPI in vitro performance to formulation and device changes. Rotahaler/Rotacaps was selected as the reference DPI drug product, and Aerolizer was selected as the test device. Since the test device was recognized to have much greater efficiency of dispersion, simple modifications to both formulation and device were made in an effort to provide a closer match to the in vitro performance of the reference product. The modifications included varying the drug and lactose particle sizes and/or lactose fine particle content in the test formulations, as well as lowering the specific resistance of the test device. These modifications were intended to address variables important for drug product performance for a defined experimental design and were not intended to mimic the extensive formulation and device design strategies that are employed in an industrial setting. Formulation and device modifications resulted in a modified test product that approached the reference product in the in vitro performance.

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Section: Aerolizer With Test Formulationsmentioning

confidence: 99%

Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers

Adams¹,

Lee

Plourde

et al. 2012

AAPS J

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show abstract

“…For example, simulation involving from 4,000 to 30,000 particles in high-shear mixers that range in particle diameter from 8 to 200 mm [7,14,36] is far from the practical experimental conditions. In reality, particle size of common excipients, such as lactose, may be in the micron range [9]. Calcium carbonate particles are found in the range of 5-214 µm [19].…”

Section: Number Of Particlesmentioning

confidence: 99%

Using Compartment Modeling to Investigate Mixing Behavior of a Continuous Mixer

2008

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In this paper, the development of a compartment model to simulate mixing within a continuous blender is reported. The main benefit of the method is that it can generate extensive modeling predictions in very short computational time. The model can also be used to explore the effect of sampling parameters on estimated mixing performance, a topic that has been central to pharmaceutical manufacturing for the past 15 years and that remains a central issue in the PAT initiative. However, this method requires more input than conventional particle dynamics methods. Thus, we investigate the effects of modeling parameters on mixing performance to develop general guidance needed to adapt this modeling framework to any continuous process. An experimental technique based on longitudinal sampling is used to examine the content uniformity of the blend along the continuous mixer. The model compares favorably with continuous mixing experiments, capture the effects of feeding rate variability, active product ingredient concentration, and blender processing angle, while effectively capturing and making explicit the effect of sampling parameters such as number of samples and sample size. The modeling approach provides a convenient tool for process design.

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“…Blending API with carrier is a critical stage that determines the blend homogeneity and is the first step to obtain the final quality (14,15). Various blending options are available to the formulator.…”

Section: Introductionmentioning

confidence: 99%

Dry Powder Inhalers: Study of the Parameters Influencing Adhesion and Dispersion of Fluticasone Propionate

Thi

Robins³

et al. 2012

AAPS PharmSciTech

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Abstract. Interactions between particles are dependent on the physicochemical characteristics of the interacting particles but it is also important to consider the manufacturing process. Blending active pharmaceutical ingredient (API) with carrier is a critical stage that determines the blend homogeneity and is the first step towards obtaining the final quality of the powder blend. The aim of this work was to study parameters that influence the interactions between API and carrier in adhesive mixtures used in DPI and their effect on API dispersion. The study was done with fluticasone propionate blended with lactose 'Lactohale 200'. The study was based on the influence of the operating conditions (speed, mixing time, resting steps during mixing), the size of the carrier and the storage conditions on the blend properties and on the API dispersion. The quality of the blends was examined by analysing the API content uniformity. Adhesion characteristics were evaluated by submitting mixtures to a sieving action by air depression with the Alpine air-jet sieve. Aerodynamic evaluation of fine particle fraction (FPF) was obtained using a Twin Stage Impinger; the FPF being defined as the mass percentage of API below 6.4 μm. For good dispersion and therefore good homogeneity of the API in the carrier particles, speed and powder blending time have to be sufficient, but not too long to prevent the appearance of static electricity, which is not favourable to homogeneity and stability. The FPF increases with the decrease in the carrier size. The storage conditions have also to be taken into consideration. Higher humidity favours the adhesion of API on the carrier and decreases the FPF.

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The effects of high shear blending on α-lactose monohydrate

Cited by 38 publications

References 22 publications

Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers

Effects of Device and Formulation on In Vitro Performance of Dry Powder Inhalers

Using Compartment Modeling to Investigate Mixing Behavior of a Continuous Mixer

Dry Powder Inhalers: Study of the Parameters Influencing Adhesion and Dispersion of Fluticasone Propionate

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