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PubMed1996

Optimal particle size for beta 2 agonist and anticholinergic aerosols in patients with severe airflow obstruction.

BACKGROUND: The optimal particle size of a beta 2 agonist or anticholinergic aerosol in patients with severe airflow obstruction is unknown. METHODS: Seven stable patients with a mean forced expiratory volume in one second (FEV1) of 37.9% of the predicted value inhaled three types of monodisperse salbutamol and ipratropium bromide aerosols with particle sizes of 1.5 microns, 2.8 microns, and 5 microns, respectively, and a placebo aerosol. The volunteers inhaled 20 micrograms salbutamol and 8 micrograms ipratropium bromide, after which lung function changes were determined and analysed with repeated measurements analysis of variance (ANOVA). RESULTS: Greater improvements in FEV1, specific airway conductance (sGaw) and maximum expiratory flow at 75%/50% of the forced vital capacity (MEF75/50) were induced by the 2.8 microns aerosol than by the other particle sizes. CONCLUSIONS: In patients with severe airflow obstruction the particle size of choice for a beta 2 agonist or anticholinergic aerosol should be approximately 3 microns.

Adrenergic beta-Agonists↗

PubMed2004

Impact of excipient particle size on measurement of active pharmaceutical ingredient absorbance in mixtures using frequency domain photon migration.

A system of dual-component powder mixtures, varying in excipient particle size and concentration of active pharmaceutical ingredient (API), is analyzed using frequency domain photon migration (FDPM) techniques. The results show that the FDPM-measured absorption coefficient increases linearly with increasing API concentration whereas the isotropic scattering coefficient shows no sensitivity to changes in API concentration. It is further seen that the absorption coefficient of blends, owing to the API, is not only linearly dependent on its concentration, but that this relationship is furthermore related to the excipient particle size. Finally, a comparison between near-infrared absorbance and FDPM-measured isotropic scattering as a function of reciprocal particle size is made to highlight FDPM as a powerful particle sizing tool without need for calibration. Overall, this study presents FDPM as a comprehensive method for detection of API concentration independent of excipient particle size.

Absorption↗

PubMed1998

Near-infrared mass median particle size determination of lactose monohydrate, evaluating several chemometric approaches.

The influence of particle size on near-infra red (NIR) spectra is typically considered a 'nuisance factor' which many scatter correction methods attempt to eliminate, e.g., multiplicative scatter correction. However, particle size is a key issue in the formulation of many pharmaceutical products and has a profound effect on the behaviour of both raw materials and drug substances during formulation. NIR has already been demonstrated as a potential alternative particle sizing technique to current accepted methodology. This investigation assessed several chemometric approaches that model this information, using lactose monohydrate as the raw material. A variety of modelling techniques were applied to both zero order and second derivative spectra namely multiple linear regression, partial least squares, principal component regression and artificial neural networks. One further data transformation evaluated was polar coordinates, although no statistical data were generated. Typically, cross-validation root mean square errors of calibration and cross-validation root mean square errors of prediction of approximately 5 microns were calculated for all of the modelling techniques. These values are comparable to those associated with the reference technique (laser diffractometry). Correlation coefficients of approximately 0.98 for all techniques were also calculated. The predictive abilities for models generated using second derivative spectra were found to be comparable to those obtained using zero order spectra.

Data Interpretation, Statistical↗

PubMed1980

Effect of particle size upon digestible cell wall and rate of in vitro digestion of alfalfa and orchard grass forages.

Alfalfa and orchardgrass forages chopped through a 13-mm screen were larger in particle size than were rumen ingesta samples from sheep fed the same forages. Samples of the chopped forages were ground through 1-, 4-, 8-, and 12-mm screens; particle sizes of the 8- and 12-mm ground forages were not significantly different from those of rumen ingesta samples or chopped forages. The 1- and 4-mm ground forages were significantly smaller in particle size than the 8- and 12-mm ground forages, rumen ingesta and chopped forage. Alfalfa contained less cell wall at the beginning of in vivo digestion, more cell wall residue at the end of digestion and less potentially digestible cell wall than did orchardgrass. The cell wall of alfalfa was 44% digestible, whereas that of orchardgrass was 61% digestible; particle size did not affect the amount of digestible fiber. Alfalfa ground through 1- and 4-mm screen openings had digestion rate constants that were about twice those of the 8- and 12-mm granulations (.10 less than P less than .20). Particle size did not affect rate constants of orchardgrass. These data suggest that in vitro kinetic studies based on examination of finely ground forages (1) may not reflect in vivo conditions, and (2) may depend upon the type of forage. Differences between legumes and grasses in (1) amount of digestible fiber and (2) digestion rate constants and the interaction of the above two factors with particle size and passage rate have important implications for digestibility of forage fiber.

Animal Feed↗

PubMed1999

Measurement of the cumulative particle size distribution of microcrystalline cellulose using near infrared reflectance spectroscopy.

The cumulative particle size distribution of microcrystalline cellulose, a widely used pharmaceutical excipient, was determined using near infrared (NIR) reflectance spectroscopy. Forward angle laser light scattering measurements were used to provide reference particle size values corresponding to different quantiles and then used to calibrate the NIR data. Two different chemometric methods, three wavelength multiple linear regression and principal components regression (three components), were compared. For each method, calibration equations were produced at each of eleven quantiles (5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 95%). NIR predicted cumulative frequency particle-size distributions were calculated for each of the calibration samples (n = 34) and for an independent test set (n = 23). The NIR procedure was able to predict those obtained via forward angle laser light scattering.

Cellulose↗

PubMed1998

Assessment of particle size distributions of health-relevant aerosol exposures of primary lead smelter workers.

Experiments were conducted at a primary lead smelter to investigate the particle size distributions of lead-containing aerosol to which workers were exposed, using personal inhalable dust spectrometers (PIDS) in specific smelter process areas. A total of 46 PIDS samples were evaluated, taken from the ore storage/mill, sinter plant, blast furnace and dross furnace process areas. Continuous particle size distributions were derived from the raw PIDS data employing a recently-developed optimisation routine, enabling determination of the percentages of inhalable, thoracic and respirable aerosol (in terms of lead content) as fractions of total lead aerosol. In addition, the mass ratios thoracic/inhalable and respirable/inhalable were also determined. Although the parameters of the measured particle size distributions ranged widely, some clear trends emerged. Firstly, the aerosols were coarser than had been expected based on measurements of previously reported workplace particle size distributions. This is thought to be due to the fact that the PIDS collects larger particles more efficiently than other instruments which have been used for such measurements. Secondly, there were significant differences in particle size distribution between process areas, in particular that the aerosol in the blast furnace area was generally finer than in the sinter plant. Such results may be used to support the results of workplace studies (reported elsewhere) into the differences between exposures to inhalable and 'total' aerosol as measured using different sampling instruments, especially when they are used together with knowledge of the physical processes governing the performances of such instruments.

Analysis of Variance↗

PubMed2006

Influence of particle size on the distributions of liposomes to atherosclerotic lesions in mice.

In order to confirm the efficacy of liposomes as a drug carrier for atherosclerotic therapy, the influence of particle size on the distribution of liposomes to atherosclerotic lesions in mice was investigated. In brief, liposomes of three different particle sizes (500, 200, and 70 nm) were prepared, and the uptake of liposomes by the macrophages and foam cells in vitro and the biodistributions of liposomes administered intravenously to atherogenic mice in vivo were examined. The uptake by the macrophages and foam cells increased with the increase in particle size. Although the elimination rate from the blood circulation and the hepatic and splenic distribution increased with the increase in particle size in atherogenic mice, the aortic distribution was independent of the particle size. The aortic distribution of 200 nm liposomes was the highest in comparison with the other sizes. Surprisingly, the aortic distribution of liposomes in vivo did not correspond with the uptake by macrophages and foam cells in vitro. These results suggest that there is an optimal size for the distribution of liposomes to atherosclerotic lesions.

Animals↗

PubMed2001

Reduced HDL particle size as an additional feature of the atherogenic dyslipidemia of abdominal obesity.

Reduced plasma HDL cholesterol concentration has been associated with an increased risk of coronary heart disease. However, a low HDL cholesterol concentration is usually not observed as an isolated disorder because this condition is often accompanied by additional metabolic alterations. The objective of this study was to document the relevance of assessing HDL particle size as another feature of the atherogenic dyslipidemia found among subjects with visceral obesity and insulin resistance. For that purpose, an average HDL particle size was computed by calculating an integrated HDL particle size using nondenaturing 4-30% gradient gel electrophoresis. Potential associations between this average HDL particle size versus morphometric and metabolic features of visceral obesity were examined in a sample of 238 men. Results of this study indicated that HDL particle size was a significant correlate of several features of an atherogenic dyslipidemic profile such as increased plasma TG, decreased HDL cholesterol, high apolipoprotein B, elevated cholesterol/HDL cholesterol ratio, and small LDL particles as well as increased levels of visceral adipose tissue (AT) (0.33 < or = absolute value of r < or = 0.61, P < 0.0001). Thus, men with large HDL particles had a more favorable plasma lipoprotein-lipid profile compared with those with smaller HDL particles. Furthermore, men with large HDL particles were also characterized by reduced overall adiposity and lower levels of visceral AT as well as reduced insulinemic-glycemic responses to an oral glucose load. In conclusion, small HDL particle size appears to represent another feature of the high TG- low HDL cholesterol dyslipidemia found in viscerally obese subjects characterized by hyperinsulinemia.

Abdomen↗

PubMed1984

Particle size analysis of latex suspensions and microemulsions by photon correlation spectroscopy.

The particle size in microemulsions and other highly dispersed systems was determined by means of photon correlation spectroscopy (PCS). As PCS cannot be applied to highly concentrated dispersed phases, the measurement accuracy was tested for its dependence on the particle concentration using latex suspensions. The data obtained by clipping and scaling were compared. The particle size determination was expected to provide information about the influence of the structure of the surfactant system on microemulsions, using a homologous alcohol series as cosurfactant and potassium oleate as surfactant. In this system the region of solubilization is characteristically divided from the region of microemulsification by a zone of instability. Furthermore, there are distinct differences in mean particle sizes between microemulsions (9-30 nm) and micellar solutions (4-6 nm).

Alcohols↗

PubMed1981

The effect of the particle size of an inert additive on the surface roughness of a film-coated tablet.

The effect of the particle size of a model inert additive--a dolomite, commercially available in a wide range of grades with varying particle sizes--on the surface roughness of a coated tablet has been studied using a stylus surface roughness measuring instrument. With all grades with a maximum particle size below 10-15 microns there was only a marginal increase in roughness on the addition of the material at low concentrations with a marked increase at concentrations in excess of 20-30% v/v. With the largest particle size material (mean size 18 microns) there was a marked increase in surface roughness at low concentrations with a decrease at higher concentrations. The different trends were due to the influence of the inherent roughness of the tablet substrate used. The results illustrate the potential of this accurate, rapid, simple and non-destructive technique in the optimization of film formulations during product development.

Particle Size↗

PubMed1996

Low-density lipoprotein particle size distribution in end-stage renal disease treated with hemodialysis or peritoneal dialysis.

Dyslipidemia accompanies end-stage renal disease (ESRD) and contributes to the high incidence of cardiovascular disease in patients on chronic dialysis treatment. The lipid abnormalities of elevated triglyceride level and reduced high-density lipoprotein cholesterol level that occur in ESRD are associated in the normal population with an altered distribution of low-density lipoprotein (LDL) particle size, a pattern associated with increased risk of coronary heart disease. To assess the effect of ESRD on LDL particle size distribution, we examined plasma lipid levels and LDL particle size in 43 subjects on chronic hemodialysis, 23 subjects on continuous ambulatory peritoneal dialysis, and 30 control subjects with normal renal function. Of subjects on continuous ambulatory peritoneal dialysis, 48% had small LDL particle size compared with 23% of subjects on hemodialysis and 7% of control subjects. Subjects on both forms of dialysis also had higher triglyceride levels and lower high-density lipoprotein cholesterol levels that correlated with LDL particle size. We conclude that altered LDL particle size forms an important component of the metabolic abnormalities that contribute to the increased cardiovascular risk found in ESRD.

Case-Control Studies↗

PubMed2003

Short-term natural weathering of MSWI bottom ash as a function of particle size.

The chemical and material composition of MSWI bottom ash depends on the particle size; this suggests that the mechanisms and kinetics of natural weathering are also a function of particle size. This paper reports the effects of short-term natural weathering on the leaching of heavy metals (mainly Pb, Cu and Zn) from MSWI bottom ash. Initial concentrations of heavy metals were higher for the smallest particle size fractions, but these levels fell dramatically during the first 50 days of weathering before levelling off. The main differences between size fractions were in the pH and the solubility of calcium and aluminium. For the initial stages of weathering and small size fractions, portlandite solubility seemed to control the pH. In contrast, for fractions bigger than 6 mm, the formation of ettringite was the reaction controlling the pH and the solubility of sulphates, aluminium and calcium.

Carbon↗

PubMed1979

Benoxaprofen, a new anti-inflammatory agent: particle-size effect on dissolution rate and oral absorption in humans.

The particle-size effect of benoxaprofen, a new nonsteroidal anti-inflammatory agent, on the in vitro dissolution rate and oral absorption in humans was evaluated. Ten normal subjects participated in a randomized crossover-designed absorption study with two sieved particle-size formulations: one with crystals larger than 60 mesh (mean equivalent spherical diameter = 640 micron) and the other with crystals smaller than 100 mesh (mean equivalent spherical diameter = 67 micron). Plasma drug concentrations and urinary drug excretion were used to determine the relative absorption of the two formulations. The standard USP procedure was used for the dissolution study. Particle size had a dramatic effect on both the in vitro drug dissolution and its oral absorption in humans. In vitro, the smaller crystals dissolved more rapidly and more efficiently than the larger crystals. In vivo, the smaller crystals produced higher plasma concentrations, more rapid peak concentration attainment, and more drug excreted in the urine.

Anti-Inflammatory Agents↗

PubMed1982

Effect on particle size on the compaction mechanism and tensile strength of tablets.

The effect of particle size variation on tablet tensile strength for spray-dried lactose, Sta-Rx 1500 and Avicel PH-101 was investigated. Decreasing the particle size of spray-dried lactose and Sta-Rx 1500 resulted in stronger compacts whereas the tablet tensile strength of Avicel PH-101 was unaffected by particle size variation. The Heckel relationship, at two different contact times, was used to examine the predominant compaction mechanism. This was independent of the size fractions studied for all three materials. Angle of repose and Hausner ratio measurements indicated a correlation between the internal forces of friction and cohesion of the sized powders and the tensile strength of compacts formed from them.

Hardness↗

PubMed1996

Comparative evaluation of mean particle size of bulk drug powder in pharmaceutical preparations by Fourier-transformed powder diffuse reflectance infrared spectroscopy and dissolution kinetics.

This paper reports a quantitative correlation between specific FT-IR absorption peak intensity of phenytoin (PTH) to its particle size in the bulk as well as in powder blends. Absorption peak intensity in FT-IR spectra of phenytoin (PHT) increased with decrease of mean particle size of the powders. The relationships between the FT-IR absorbance at 1724 cm-1 of PHT and the specific surface area (Sw) obtained by the BET N2 gas absorption method or the reciprocal of mean particle size (D50) obtained by particle counting of SEM photomicrographs of ground samples showed straight lines, indicating that the absorbance followed the equation log (lo/l) = K1/D50 = K2Sw, where lo and l are intensities of the incident and transmitted light, respectively, and K1 and K2 are constants. In binary mixture of powders containing 50% PHT and 50% lactose, the relationship between the absorbance at 1724 cm-1 of PHT powder and Sw of the reciprocal of D50 also gave a linear plot. The dissolution behaviors of the binary mixture samples were measured in pH 1.2 buffer containing 0.1% sodium lauryl sulfate at 37 degrees C. The data from initial rates of dissolution of the binary mixture was utilized to calculate the particle size (Dg) using the Hixon-Crowell equation, and these particle size values were consistent with those obtained from Sw data as well as the absorbance data by the IR spectral method.

Chemical Phenomena↗

PubMed2002

Influence of hydrodynamics and particle size on the absorption of felodipine in labradors.

PURPOSE: To study the influence of GI hydrodynamics and drug particle size on felodipine absorption in the dog. METHODS: Labradors fistulated at midjejunum were used to selectively study the influence of hydrodynamics and particle size on the in vivo dissolution and absorption of the poorly soluble, lipophilic drug felodipine. A combination of infusion and oral administration of either normal saline or a 5% glucose solution was used to maintain "fasted" and establish "fed" state motility patterns, respectively. The absorption characteristics of both a micronized (8 microm) and a coarse fraction (125 micom) of felodipine were subsequently studied under these two motility patterns. RESULTS: A reduction in particle size led up to an approximate 22-fold increase in maximum plasma concentration and up to an approximate 14-fold increase in area under the curve, with a commensurate decrease in the time at which the maximum plasma concentration occurred. Although the absorption of felodipine from the solution and micronized suspension was not influenced by a change in the hydrodynamics, felodipine was absorbed from the coarse suspension almost twice as well in the "fed" state as under "fasted" conditions. CONCLUSIONS: Absorption from coarse suspensions of felodipine was sensitive to luminal hydrodynamics, whereas micronized suspensions were not. However, the particle size seems to have a much more important influence on the bioavailability of felodipine than the hydrodynamics per se.

Administration, Oral↗

PubMed2006

Effect of reinforcement particle size on in vitro behavior of beta-tricalcium phosphate-reinforced high-density polyethylene: a novel orthopedic composite.

Beta-tricalcium phosphate-reinforced high-density polyethylene (beta-TCP/HDPE) is a new biomaterial, which was made to simulate bone composition and study its capacity to act like bony tissues. This material was produced by replacing mineral component and collagen soft tissue of bone with beta-TCP and HDPE, respectively. The biocompatibility of composite samples with different volume fractions of TCP (20, 30, and 40 vol %) and two different particle sizes (80-100 and 120-140 mesh size) was examined in vitro using the osteoblast cell line G-292 by proliferation, alkaline phosphatase (ALP) production, and cell adhesion assays. Cell-material interaction on the surface of the composites was observed by scanning electron microscopy (SEM). The effect of beta-TCP particle size on behavior of the osteoblast cell line was compared between two groups of the composite samples containing smaller and larger reinforcement particle sizes as well as with those of a negative control. In general, results showed that the composite samples containing larger particles supported a higher rate of proliferation and ALP production by osteoblast cells after 3, 7, and 14 days of incubation compared to the composite samples with smaller particle size and control. Furthermore, more cells were attached to the surface of composite samples containing larger particle size when compared to the smaller particle size composites (p<0.05). This number was nearly equal with numbers adhered on negative control [tissue culture polystyrene (TPS)] and significantly higher in comparison with composite control [polyethylene (PE)] (p<0.05). Adhered cells presented a normal morphology by SEM and many of the cells were seen to be undergoing cell division. These findings indicate that beta-TCP/HDPE composites are biocompatible, nontoxic, and in some cases, act to stimulate proliferation of the cells, ALP production, and cell adhesion when compared to the control counterparts. Furthermore, beta-TCP/HDPE samples with larger reinforcement particle size were shown to possess better biological properties.

Bone Substitutes↗

PubMed1985

An initial test of a method for the estimation of real mean particle size from shadowed samples.

During shadowing, a "cap" of metal develops on small particles. This cap increases apparent particle with (measured normal to the shadowing direction) by an extent which cannot be predetermined. The extent of this increase in particle size (here defined as the "cap," X) is estimated in the present method by using opposite (180 degrees sample rotation) bidirectional shadowing. It is argued that the bidirectional cap is the sum of the two unidirectional caps, and therefore that X = 2A - (B + C), where A is the mean bidirectionally shadowed particle size, and B and C are the two mean unidirectionally shadowed particle sizes. As a validation of the method, the mean diameter of air-dried ferritin was estimated and the results appear to confirm the hypothesis (mean diameter by present method, 10.7 +/- 0.2 nm; mean diameter by previous methods, 10.89 nm).

Carbon↗