Evaluation of Different Particle Size Reduction Techniques in Application of Formulation Preparation (original) (raw)
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The AAPS Journal, 2004
The concepts of particle engineering and dosage form design have become dominant themes in pharmaceutical manufacturing. This trend is not simply a reflection of the development of new, more sophisticated manufacturing methods of particles or dispersed systems but also recognition of the importance of quality control even in more traditional manufacturing processes. However, the diversity of particle treatments, methods of particle size analysis, expression and interpretation of data, and process applications results in complicated and sometimes confusing criteria for selection, adoption, or relevance of the available techniques.
European Journal of Pharmaceutics and Biopharmaceutics, 2013
It has been previously described that when a sample's particle size is determined using different sizing techniques, the results can differ considerably. The purpose of this study was to review several in-process techniques for particle size determination (Spatial Filtering Velocimetry, Focused Beam Reflectance Measurements, Photometric Stereo Imaging, and the Eyecon Ò technology) and compare them to well-known and widespread off-line reference methods (laser diffraction and sieve analysis). To start with, a theoretical explanation of the working mechanism behind each sizing technique is presented, and a comparison between them is established. Secondly, six batches of granules and pellets (i.e., spherical particles) having different sizes were measured using these techniques. The obtained size distributions and related D 10 , D 50 , and D 90 values were compared using the laser diffraction wet dispersion method as reference technique. As expected, each technique provided different size distributions with different D values. These dissimilarities were examined and explained considering the measurement principles behind each sizing technique. The particle property measured by each particle size analyzer (particle size or chord length) and how it is measured as well as the way in which size information is derived and calculated from this measured property and how results are presented (e.g., volume or mass distributions) are essential for the interpretation of the particle size data.
A comprehensive review of particle size analysis techniques
AkiNik Publications, 2024
In this review, we will discuss particle size analysis as it relates to specific pharmaceutical applications and regulatory aspects, fundamental principles, measurement techniques, and instrumentation types. We will cover the different types of measurement techniques that are commonly used in the pharmaceutical industry. This analysis is highly informative and will have a positive impact on the pharmaceutical field. Readers will gain a lot of knowledge from this review. Particle size is a critical process parameter in pharmaceutical production, as it can greatly affect the physical and chemical properties of drug substances and dosage forms. Particle size distribution (PSD) is one of the most important parameters to check when evaluating a new drug. Size reduction is a vital unit operation that is extensively used in pharmaceutical manufacturing. This process involves reducing large solid unit masses into small unit masses, coarse particles, or fine particles. Size reduction is also known as comminution, diminution, or pulverization.
Particle Size Analysis in Pharmaceutics: Principles, Methods and Applications
Pharmaceutical …, 2007
Abstract Physicochemical and biopharmaceutical properties of drug substances and dosage forms can be highly affected by the particle size, a critical process parameter in pharmaceutical production. The fundamental issue with particle size analysis is the variety of equivalent particle diameters generated by different methods, which is largely ascribable to the particle shape and particle dispersion mechanism involved. Thus, to enable selection of the most appropriate or optimal sizing technique, cross-correlation between different techniques may be required. This review offers an in-depth discussion on particle size analysis pertaining to specific pharmaceutical applications and regulatory aspects, fundamental principles and terminology, instrumentation types, data presentation and interpretation, in-line and process analytical technology. For illustration purposes, special consideration is given to the analysis of aerosols using time-of-flight and cascade impactor measurements, which is supported by a computational analysis conducted for this review.
Recent Advances in Particle Characterization and its Application in Pharmaceutical Industry
International Journal of Pharma Research and Health Sciences, 2020
Particle size characterization is a area of analytical chemistry which is required in a great number of industries where the product's end-use is affected by particle size distribution. The Particles can be in the form of solids, liquids, or gases or an aggregation of molecules as in the case of micelles. Particularly In some instances, especially in the area of pharmaceuticals finished forms, analyses are done to ensure the absence of particulate matter in the product. Particle size characterization helps in monitoring the environment accurately for particulate matter as well as particle size distributions, concentrations for full assessment of health hazard substances. The growing interest in particle size characterization and analysis, especially among analytical chemistry researchers, the subject is mainly emphasized on the application. The number of techniques available for particle size analysis is confounding. More than 250 methods have been reported by the analytical researchers for understanding and assessing the particle size. Because of the broad scope of this area in terms of techniques and analytical approaches, products, and size ranges major technique areas have been discussed. which have received the most attention in recent years: radiation scattering and chromatographic techniques. The new and growing areas are rapidly becoming techniques of choice especially for the rapid analysis of submicrometer particles.
The objective of this study was to evaluate the impact of Particle size distribution by means of sieving of granules for tablet compression through mesh screen and the relationship between this size distribution and physical & chemical properties of tablets (e.g., hardness, thickness, target weight, appearance, friability, disintegration time, dissolution and potency). Optimization of particle size distribution was also carried out for taking the effects of hardness, thickness, target weight, appearance, friability, disintegration time, dissolution and potency into consideration. The physical properties of granules for tablet compression and tablets were found to be significantly affected by this factor. That was mean, the different particle size distribution with different size of mesh screen found to be governed the physical and chemical properties of tablets. So, it can be said that the evaluation parameters such as hardness, thickness, target weight, appearance, friability, disintegration time, dissolution and potency was found to be affected by the particle size distribution. Potency was not affected significantly due to different particle size distribution. Dissolution rate increased with decreasing granule size (over the range 16-20 mesh to 60-80 mesh) and probability of rising sticking problem &poor flow property was observed with decreasing granule size but not strictly proportionally to the corresponding increase in the apparent surface area of the granules. Increasing starch content of granules (varied from 0 to 20 per cent) resulted in an increase in dissolution rate. Increasing precompression pressure (varied from 715 to 5720 Kg/cm 2 ) caused an increase in dissolution rate. This was probably due to fracturing of the harder granules into smaller particles with greater specific surface area or bonding of the softer granules (prepared at lower slugging pressure) during their compression into tablets.
Analytical and Bioanalytical Chemistry, 2011
This work compares the estimation of the particle size distribution of a pharmaceutical powder using nearinfrared spectroscopy (NIRS), powder flowability properties, and components concentration. The estimations were made by considering the former data blocks separately and together using a multi-block approach. The powders were based on a formulation of paracetamol as the pharmaceutical active ingredient. The reference method used to determine particle size distribution was sieving. Partial least squares methods were used to estimate the multivariate regression models, and the results were compared in terms of figures of merit. It was shown that the partial least squares methods gave similar prediction errors. Regarding the data blocks used, the NIRS block was proven the most advantageous to estimate the particle size distribution. The prediction error of the NIRS block was similar to the other data blocks with additional advantages such as less generalization problems and the possibility of its use to predict additional physical and chemical properties with an improvement to analysis time. The multi-block approach produced the worst results but nevertheless allowed a deeper understanding of the individual contributions of the data blocks in the prediction of the particle size distribution.
PQRI recommendations on particle-size analysis of drug substances used in oral dosage forms
Journal of Pharmaceutical Sciences, 2007
This document provides information for the Pharmaceutical Industry and the Federal Drug Administration (FDA) regarding the selection of suitable particle-size analysis techniques, development and validation of particle-size methods, and the establishment of acceptance criteria for the particle size of drug substances used in oral solid-dosage forms. The document is intended for analysts knowledgeable in the techniques necessary to conduct particle-size characterization (a table of acronyms is provided at the end of the document). It is acknowledged that each drug substance, formulation, and manufacturing process is unique and that multiple techniques and instruments are available to the analyst. ß
An overview of size reduction technologies in the field of pharmaceutical manufacturing
Asian Journal of Pharmaceutics, 2008
S ize reduction is a process of reducing large solid unit masses into small unit masses, coarse particles or fine particles. Size reduction process is also termed as comminution or diminution or pulverizations. In addition to the standard adjustments of the milling process (i.e., speed, screen size, design of rotor, load), special techniques of milling may be useful including special atmosphere, temperature control, sonocrystallization, supercritical fluid process. etc. Moreover, some advance technologies of size reduction including Micron Technologies, Gran-U-Lizer™ Technology, Jet-O-Mizer™ and Microfluidics® have been popular. Various application of size reduction concept covers oral delivery of poorly soluble drugs, micronization, nanotechnology (micro-and nano suspensions), etc. This systemic review highlights advantages and disadvantages, mechanisms, theories, techniques, advances, and pharmaceutical applications of size reduction technology.