A Recent Progresses and Manufacturing Techniques in Pharmaceutical Powders and Granulation (original) (raw)
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Advanced Granulation Techniques for Pharmaceutical Formulations Overview
2013
INTRODUCTION Active pharmaceutical compounds (drugs) are used for the treatment of a disease or for prophylactic purpose. An Active Pharmaceutical ingredient may exist in solid, liquid or semisolid form. They are rarely prescribed to the patients as such i.e. without adding excipients, since the desired effect may not be obtained. Earlier, it was thought that excipients are inert in nature but, in recent time it is well known that excipients can greatly modify the intended effect of a drug. The API and excipients are suitably processed in pharmaceutical industry to convert them into dosage forms such as tablet, capsule, suspension, solution, ABSTRACT The Present study was focus on different techniques adopted while formulating solid dosage forms like tablets, Capsules and Granules etc. The ideal characteristics of granules include uniformity, good flow and compatibility. Nowadays the agglomeration process used in pharmaceutical industry for granulation. Based on the characteristics, suitable excipients were selected for the formulation of dosage forms. Physiological properties like bulk density, tapped density, hausners ratio and compressibility index have to evaluated and optimized for good pharmaceutical formulations. Apart from Physiological properties we have to consider evaluation parameters of finished products such as disintegration time and In-vitro release studies. Here we are mainly focusing on different types of granulation technique.
Pharmaceutical granulation processes, mechanism and the use of binders
Pharmaceutical …, 2008
The user has requested enhancement of the downloaded file. All in-text references underlined in blue are linked to publications on ResearchGate, letting you access and read them immediately. Cantor et al. flow better and are usually more compactible than the original powders. Granulation also permits handling of powders without loss of blend quality, since after blending particles are locked in-place within granules in a form of ordered mix.
Asian Journal of Pharmaceutics, 2014
I n the present investigation, suitability of a cost-effective and convenient granulation technique that is, moisture activated dry granulation (MADG) process for high drug loading in tablet formulation was studied. In this work, effect of the amount of water on flow properties of granules as well as an effect of mixing time on surface morphology of granules was studied. Paracetamol (PCM) immediate release granules were prepared using conventional excipients such as polyvinylpyrrolidone K-30, Kollidon VA 64 (as binders), and simple equipments by MADG technique. The prepared granules were evaluated for flow properties and tablets were compressed using optimized granule formulation. The prepared granules possessed good flow properties that is, angle of repose was 32.11 and percent compressibility index was 19.44. Tablets disintegrated in 2.08 min and 89% of the drug was released within 30 min. All the results were comparable with PCM tablets prepared by wet granulation method. Therefore, from the above studies it was concluded that MADG process may be effectively adopted by using Kollidon VA 64 as a binder in tablet formulations where high drug loading is to be achieved, where all the parameters of the formulation can be obtained within specified limits using this simple, convenient, less time consuming, economical, and efficient method of granulation.
Improved Tablet Production by Modified Granulation Techniques - A Review
Tablets are one of the oral solid dosage forms most widely used by the pharmaceutical manufacturers, physicians and patients due to the convenience in manufacturing, administration and suitability for delivery of most of the active ingredients. Tablets are manufactured by different methods such as wet granulation, dry granulation and direct compression. Granulation is defined as the size enlargement process in which fine and smaller particles are aggregated to form strong and stable particles called granules. Present article mainly focuses on advanced granulation techniques such as moisture activated dry granulation, thermal adhesion granulation, foam binder granulation etc.
OPTIMIZATION OF GRANULATION TECHNIQUES FOR DEVELOPMENT OF TABLET DOSAGE FORM
The purpose of this study was to optimize the best granulation techniques for development of tablet dosage form. The present study explains comparative study of different wet granulation techniques including Planetary mixer granulation, Rapid mixer granulation, Fluid bed granulation with Direct compression method. Similar formulations were used to evaluate Planetary mixer granulation, Rapid mixer granulation and Fluid bed granulation method. The granules prepared by different techniques were evaluated for particle size distribution, porosity, spherisity, bulk density, flow property and compressibility, compatibility and tablet properties of Diclofenac sodium tablet. The fluid bed granulation technique had superior flow properties, compressibility, compactibility measured by Kawakita, Hekel, Walker and Leuenberger equation. The granules prepared by Fluid bed granulation showed better tablet properties (weight uniformity, hardness, friability and disintegration, drug content, dissolution) and accelerated stability study compared to other granulation techniques so finally, it was concluded that Diclofenac sodium tablets prepared by using fluid bed granulation which meets the required specification compared to other wet granulation techniques and direct compression method. Key words: Granulation technique, Flowability, compressibility, compactibility, Diclofenac sodium tablet.
Advanced Powder Technology, 2011
Understanding the relationship between high shear wet granulation processing parameters and the characteristics of intermediate and final products is crucial in the ability to apply quality by design (QbD) and process analytical technologies (PAT) to secondary pharmaceutical processes. This research examined a high shear wet granulation process and subsequent manufacturing of a tablet containing a biopharmaceutics classification system (BCS) class II drug, gliclazide (low solubility, high permeability). Previous studies have concentrated on either granulation or tabletting but not both together; this work brings together the analysis as a single large multivariate process. The design of experiment (DoE) was performed according to an L9 Taguchi method with three replications, in total; thirty-six runs were performed. A full statistical analysis relating both granule and tablet properties to selected process parameters were carried out. The research illustrates that mapping a highly multivariate process is possible. Statistically significant critical process parameters were identified for granule hardness, granule density and granule particle size. These granule properties were also identified as contributing to the dissolution release characteristics. Dissolution modeling and prediction was achieved within the DoE structure. Process noise was identified and measured across the entire production and specifically with respect to the milling process.
2015
Wet granulation is the agglomeration of particles using a liquid binder to form granules. The process is extensively used in the pharmaceutical industry to manufacture tablets, as granulation minimizes segregation, dust, and improves flowability. Granule uniformity is important in pharmaceutical manufacturing, as the tablet must contain a uniform distribution of excipients in the product in order to comply with United States Food and Drug Administration (FDA) regulations. The research presented in this thesis focuses on the influence of formulation and process parameters on granule formation. Sugar spheres were initially used to study segregation during the dry mixing phase of high shear granulation. The effect of formulation, specifically the effect of any hygroscopic components, was studied through drop penetration measurements using heterogeneous powder beds of varying hygroscopicity. The results were compared to theoretical models in the literature and led to improvements in the models through the introduction of a semi-empirical parameter. The effects of both process parameters and formulation were then combined in a final study. The conclusions from this research provide guidance for the selection of process parameters to promote the formation of optimal granule nuclei which can then grow into final granules with specific properties and provide information on the effect of formulation that can be used in development.
Pharmaceutical Processing – A Review on Wet Granulation Technology
Granulation of a powder or mixture of powder is done in order to improve flow, uniformity of contents, better compressibility, improve density and to aid pharmaceutical dosing of the actives. The review article updates about the latest developments in technologies behind most commonly used wet granulation process. Article deals with in depth basic information about granule growth mechanisms during granulation. The article also provides an insight to the in-process variables and factors influencing the granulation end point and its determination when a high shear mixer granulator of laboratory or commercial scale is utilized for industrial production.
International Journal of Pharmaceutics, 2009
The purpose of this study was to establish a relationship between the material properties of an active pharmaceutical ingredient (API) and its behavior during high-shear wet granulation. Using several actives and excipients as material probes, the influence of aqueous solubility, wettability, water holding capacity, mean and width of the particle size distribution, and surface area was examined. The effect of these variables on the processibility and performance of the granulations was evaluated by monitoring such responses as granule growth, compactability and flow changes upon wet granulation. The prominent findings from this study include: (a) controlled growth is highest in readily wettable APIs with low surface area, (b) uncontrolled growth is high in APIs of high solubility and low water holding capacity, (c) polydisperse granulations are produced from APIs of high contact angle and surface area, (d) improvement in compactability is high in APIs with large surface area and broader size distributions and (e) flow enhancement as a result of wet granulation is highest in APIs of large size distributions. These results are physically interpreted in this manuscript based on the prevailing wet granulation theories. Findings from this study are useful in mapping a new material to predict its performance in a high-shear wet granulation process.
Powder Technology and Pharmaceutical Development: Particle Size and Particle Adhesion
KONA Powder and Particle Journal, 2013
Both the FDA (U.S. Food and Drug Administration) and ICH (International Conference on Harmonisation) have urged the incorporation of Quality by Design (QbD) 1) into the manufacture of pharmaceutical products 2). The performance of many pharmaceutical manufacturing processes and the performance of some pharmaceutical products requires a knowledge of powder properties. Under the principles of QbD it is possible to adjust processes to account for variations in powder properties. These adjustments, in turn , require knowledge of the relation between powder properties and manufacturing performance. This relation between powder properties and performance is often not well understood; thus, the required information is not collected. In this paper, particle-particle and particle-surface interactions are considered to be a source of product variability. As particle size effects are intertwined with particle adhesion effects this topic is also considered. From the discussion below, it can be seen that the surface chemistry of particles can vary due to mechanical treatment, crystallization solvent, and surface contamination. Variations in surface chemistry affect interparticle adhesion and thus may lead to process or product performance changes. Issues concerning the role of interparticle adhesion that are related to tableting and dry powder inhalers are discussed in some detail. It is clear that a deeper understanding of the powder state and the establishment of appropriate analytical tools will be required to fully implement QbD. Improvements in par ticle sizing technologies, improvements powder sampling procedures and measurements of particle surface properties will be required. It is hoped that this paper will stimulate thought on this issue.