Academic literature on the topic 'Wet Granulation Method'

The work presents a comparison of methods of granulating waste – tannery shavings – from the leather industry. This waste is often used for the production of leather composites, but it creates a number of problems in transport and storage. It seems that granulation of this waste together with mineral additives needed in their further processing is a solution. However, the traditional method of granulation involving the gradual moistening of a loose deposit on a moving surface of the granulator does not give the desired results for the granulation of material with such unusual physical properties. Therefore, new methods have been proposed to eliminate the disadvantages and limitations of traditional granulation. The methods proposed differ in the way the binder liquid and mineral material are applied. They consist in soaking the shavings with binding liquid beforehand, removing excess liquid, and then granulating the wet pulp with the addition of selected fine-grained mineral material. Analysis of the results was based on a comparison of the granulometric compositions and compressive strength of the agglomerates obtained.

Introduction. The stage of wet granulation is often used in the technology of solids. The method of wet granulation in a mixer-granulator with high shear force can be regarded as the most complicated method of its implementation from the engineering and technological point of view. The mixer-granulator has two mixers located in mutually perpendicular planes. Using an impeller, dry components are mixed, and the chopper, turning on when spraying a humidifier, ensures the formation of granules. By setting different chopper rotational speed, granules of different sizes can be obtained. This granulator has the following advantages: it provides a high product yield (≥ 99 %), takes up small workspaces, and the closed design ensures environmental protection.Aim. The aim of the research is to scale the granulation process, on the example of the solids production technology, using the wet granulation stage - in a mixer-granulator with high shear force.Materials and methods. Dry extract «N» and auxiliary substances were used as a pharmaceutical substance: lactose monohydrate, microcrystalline cellulose (MCC) (MICROCEL® MC-102), potato starch, povidone (Plasdone™ K-29/32), calcium stearate. Granulate under scaling conditions was produced in a mixer-granulator with high shear force. Technological properties of dry extract «N» and granulate were determined by the methods described in National pharmacopeia XIV.Results and discussion. On the basis of experimental studies, it was found that the resulting granulate, both when obtained under laboratory conditions and under scaling conditions, has good flowability, and also has a homogeneous fractional composition. The presence of a grinder in the mixer-granulator made it possible to obtain a more uniform fractional composition of the granulate. A 10-fold increase in loading did not affect the composition of the granulate. When scaling the pelletizing process, a risk analysis was carried out, factors influencing the technological process were identified and structured. It turned out that the most important stages are mixing and the actual granulation. To obtain a homogeneous mixture, additional equipment was used - a mixer.Conclusion. As a result of scaling up the granulation process, the parameters of wet granulation in the mixer-granulator (optimal loading, impeller and grinder rotation frequency), technological properties of the resulting granulate, and risks affecting the technological process were selected. were evaluated and a causal diagram (Ishikawa diagram) was drawn.

Objective: The main objective of this study is comparative study of natural and synthetic superdisintegrants in orodispersible Metformin tablet by using direct compression method and wet granulation method.
 Method: Orodispersible Metformin tablet were prepared by wet granulation method and direct compression method by using different synthetic and natural superdisintegrants. Orodispersible tablets (ODTs) have received more interest in the pharmaceutical industry for their easy to use and self medication. ODTs overcome the problem of dysphagia (difficulty in swallowing) in the all group age of patients and advantage particularly for the paediatric and geriatric patients. Metformin hydrochloride (Hcl) is an orally administered antihyperglycemic agent, used in the management of non-insulin dependent (type-2) diabetes mellitus. Metformin orodispersible tablet is prepared by using two methods i.e. direct compression method and wet granulation method. Both methods are applied to prepare Orodispersible Metformin tablet. Orodispersible tablet of Metformin was prepared by using superdisintegrants from both natural and synthetic origin. In natural superdisintegrants we used the mucilage of Fenugreek and Lepidium sativum. In synthetic superdisintegrants we used crospovidone and sodium starch glycolate.
 Conclusion: In direct compression and wet granulation method final blend and granules were evaluated the flow properties like bulk density, tapped density, compressibility index, hausner’s ratio and angle of repose. The values of precompression parameter evaluated were found to be within the prescribed limit and indicated good flow properties. The data obtained from the post compression methods was studied. Other parameters such as wetting time, water absorption ratio were also evaluated. The formulation (F5) containing 10% crospovidone prepared by wet granulation method was found the optimize formulation.
 Keywords: Metformin Hcl, Orodispersible tablets, Superdisintegrants, Direct Compression, and Wet granulation
 Objective: The main objective of this study is comparative study of natural and synthetic superdisintegrants in orodispersible Metformin tablet by using direct compression method and wet granulation method.
 Method: Orodispersible Metformin tablet were prepared by wet granulation method and direct compression method by using different synthetic and natural superdisintegrants. Orodispersible tablets (ODTs) have received more interest in the pharmaceutical industry for their easy to use and self medication. ODTs overcome the problem of dysphagia (difficulty in swallowing) in the all group age of patients and advantage particularly for the paediatric and geriatric patients. Metformin hydrochloride (Hcl) is an orally administered antihyperglycemic agent, used in the management of non-insulin dependent (type-2) diabetes mellitus. Metformin orodispersible tablet is prepared by using two methods i.e. direct compression method and wet granulation method. Both methods are applied to prepare Orodispersible Metformin tablet. Orodispersible tablet of Metformin was prepared by using superdisintegrants from both natural and synthetic origin. In natural superdisintegrants we used the mucilage of Fenugreek and Lepidium sativum. In synthetic superdisintegrants we used crospovidone and sodium starch glycolate.
 Conclusion: In direct compression and wet granulation method final blend and granules were evaluated the flow properties like bulk density, tapped density, compressibility index, hausner’s ratio and angle of repose. The values of precompression parameter evaluated were found to be within the prescribed limit and indicated good flow properties. The data obtained from the post compression methods was studied. Other parameters such as wetting time, water absorption ratio were also evaluated. The formulation (F5) containing 10% crospovidone prepared by wet granulation method was found the optimize formulation.
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The manufacturing of solid pharmaceutical dosage forms composed of cocrystals requires numerous processes during which there is risk of dissociation into parent molecules. Resonant acoustic wet granulation (RAG) was devised in an effort to complete theophylline–citric acid (THPCIT) cocrystal formation during the granulation process, thereby reducing the number of operations. In addition, the influence of granulation liquid was investigated. A mixture of anhydrous THP (drug), anhydrous CIT (coformer), and hydroxypropyl cellulose (granulating agent) was processed by RAG with water or ethanol as a granulation liquid. The purposes were to (i) form granules using RAG as a breakthrough method; (ii) accomplish the cocrystallization during the integrated unit operation; and (iii) characterize the final solid product (i.e., tablet). The RAG procedure achieved complete cocrystal formation (>99%) and adequately sized granules (d50: >250 μm). The granulation using water (GW) facilitated formation of cocrystal hydrate which were then transformed into anhydrous cocrystal after drying, while the granulation using ethanol (GE) resulted in the formation of anhydrous cocrystal before and after drying. The dissolution of the highly dense GW tablet, which was compressed from granules including fine powder due to the dehydration, was slower than that of the GE tablet.

This paper presents the results of research on the granulation process of leather industry waste, i.e., tanning shavings. It is economically justified to granulate this waste together with mineral additives that are useful in the processes of their further processing. Unfortunately, the granulation of raw, unsorted shavings does not obtain desired results due to their unusual properties. In this study, the possibilities of agglomeration of this waste were examined by a new method consisting of the production and then the granulation of wet pulp. During granulation, no additional binding liquid is added to the granulated bed. As part of this work, the specific surface of granulated shavings, the granulometric composition of the obtained agglomerates, and their strength parameters were determined. The use of a vibrating disc granulator, the addition of a water glass solution (in the pulp), dolomite, and gypsum made it possible to obtain durable, mechanically stable granules.

Tablets are one of the most commonly used solid dosage forms of medicine in the pharmaceutical industry. The granulation process commonly used in making tablets is the wet granulation process. The operation method includes mixing the active ingredients and excipients, adding a binder liquid, forming granules, drying and sieving. The methods used in this research are literature research, journal reviews, and analysis of relevant papers carried out during the 2015-2023 period. The aim of this literature study is to determine the process, advantages, limitations and application of wet granulation in the pharmaceutical industry. Based on the results of a literature study, tablet production using the wet granulation method was proven to be an effective technique and is widely used for the production of tablet formulations.

The development of robust and scalable tablet manufacturing methods remains a key objective in pharmaceutical technology, especially when dealing with active pharmaceutical ingredients (APIs) and excipients that exhibit suboptimal processing properties. This study evaluated two alternative manufacturing strategies for tablets containing sodium naproxen (20%, API), dolomite (65%, sustainable mineral filler), cellulose (7%), polyvinylpyrrolidone (5%, binder), and magnesium stearate (3%, lubricant). The direct compression method used a vibrating ball mill (SPEX SamplePrep 8000M), while the indirect method employed wet granulation using a pan granulator at different inclination angles. Physical properties of raw materials and granules were assessed, and final tablets were evaluated for mass, thickness, mechanical resistance, abrasiveness, and API content uniformity. Direct compression using vibratory mixing for 5–10 min (DT2, DT3) resulted in average tablet masses close to the target (0.260 g) and improved reproducibility compared to a reference V-type blender. Wet granulation produced tablets with the lowest abrasiveness (<1.0%) and minimal variability in dimensions and API content. The best uniformity (SD < 0.5%) was observed in batch IT2. Overall, vibratory mixing proved capable of achieving tablet quality comparable to that of wet granulation, while requiring fewer processing steps. This highlights its potential as an efficient and scalable alternative in solid dosage manufacturing.

Background/Objectives: The pharmaceutical industry demands stringent regulation of product characteristics and strives to ensure the reproducibility of granules manufactured via the wet granulation process. A systematic model employing the discrete element method (DEM) was developed herein to gain insights into and better control this process. Methods: The model comprehensively simulates particle behavior during granulation by considering the intrinsic properties of the powder material, the specific geometry of the granulation equipment, and various operational conditions, including impeller speed and chopper use. Notably, this approach can simulate dynamic interactions among particles and integrate complex phenomena, such as cohesion, which is crucial for predicting the formation and quality of granules. Results: To further support process optimization, an EDEMpy artificial intelligence (AI) tool was developed as a posttreatment routine to monitor and analyze agglomerate size distributions, proving essential for assessing the efficiency of the granulation process and the quality of resulting granules. The DEM model was evaluated by comparing its output with experimental data collected from a 0.5 L high-shear granulator. The model reproduced the granule growth kinetics observed experimentally, confirming the agreement between the experimental and numerical analyses. Conclusions: This underscores the model’s potential in predicting and controlling granule quality in wet granulation processes, enhancing the precision and efficiency of pharmaceutical manufacturing.

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.

Os métodos termo-analíticos são ferramentas úteis na avaliação da compatibilidade entre fármacos e adjuvantes, com destaque à calorimetria exploratória diferencial. Neste trabalho foram avaliados a compatibilidade e o comportamento térmico entre a isoniazida e adjuvantes tecnológicos primários usualmente empregados em formas farmacêuticas sólidas. A compatibilidade foi examinada por meio da preparação de misturas físicas binárias do tipo fármaco/adjuvante. Foi investigada também a influência da granulação por via úmida e do processo de compactação para as misturas de isoniazida e adjuvantes com função de material de enchimento e carga e deslizante. A isoniazida apresentou um comportamento térmico não encontrado na literatura. Os adjuvantes avaliados foram: ácido esteárico, amido, celulose microcristalina, crospovidona, croscarmelose sódica, dióxido de silício coloidal estearato de magnésio, glicolato de amido sódico, hipromelose, lactose, manitol, polidona e talco. Para as misturas físicas, a maioria dos adjuvantes mostrou-se compatível com o fármaco em questão. Foram verificadas interações com o ácido esteárico, o glicolato de amido sódico, a lactose, o manitol e a povidona. A isoniazida mostrou a formação de uma mistura eutética com o manitol e de interação química com a lactose. A agregação por via úmida e o processo de compactação não mostraram influências adicionais na compatibilidade das misturas avaliadas. Os resultados observados foram confirmados por métodos não-térmicos como difratometria de raios X, espectroscopia de infravermelho e ressonância nuclear magnética.<br>Thermo-analytical methods, and specially Differential Scanning Calorimetry, are useful support for the evaluation of compatibility between drug substances and pharmaceutical excipients. In this work were studied the compatibility and the thermal behavior of isoniazid and pharmaceutical excipients, commonly used for the formulation of solid dosage forms. Colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium croscarmellose, sodium starch glycolate, stearic acid and talc were the excipients employed in these experiments. The compatibility was analyzed testing binary physical drug/excipient admixtures. The effect of wet granulation and compression was also investigated, in this case especially between isoniazid, fillers and lubricant. For almost all excipients no incompatibilities with isoniazid were observed. Interactions were detected when the drug substance was added to stearic acid, sodium starch glycolate, lactose, mannitol and povidone. Isoniazid formed a euthetic mixture with mannitol, whereas a possible chemical reaction occurred between isoniazid and lactose. Wet granulation and compaction of the tested admixtures did not affect the results observed above. These observations were confirmed by non-thermal techniques, such as X-Ray diffractometry, infrared spectroscopy and nuclear magnetic resonance.

Tablets are the most widely used solid dosage form in pharmaceutical practice, offering advantages such as precise dosing, stability, and patient convenience. This section explores the various types of tablets, including immediate-release, modified-release, and orally disintegrating tablets, each designed to meet specific therapeutic needs. The composition of tablets, including active ingredients and excipients such as diluents, binders, disintegrants, and lubricants, is discussed in detail. Tablet manufacturing processes, from wet granulation and dry granulation to direct compression, are examined, highlighting the factors influencing the choice of method. Critical quality attributes of tablets, such as hardness, friability, disintegration time, and dissolution rate, are explored along with their testing methods. The principles of tablet press operation and the impact of compression forces on tablet properties are addressed. Coating processes, including film coating and sugar coating, are discussed in relation to their functional and aesthetic benefits. Common tablet defects, their causes, and remedies are outlined to aid in troubleshooting manufacturing issues

Powders and granules are fundamental pharmaceutical forms used both as final dosage forms and as intermediates in the production of other solid dosage forms. This section explores the properties of powders, including particle size, shape, and surface area, and their impact on powder behavior and processing. Various methods of powder production, such as comminution and precipitation, are discussed. The principles of granulation, including wet and dry granulation techniques, are examined in detail, highlighting their role in improving powder flow properties and compressibility. Factors affecting granulation processes, such as binder selection, moisture content, and process parameters, are explored. The concept of particle size distribution and its measurement techniques are addressed. Quality control tests specific to powders and granules, including flow properties, bulk density, and moisture content determination, are detailed. Special considerations for effervescent granules and powder for reconstitution are discussed. The applications of powders and granules in various pharmaceutical dosage forms, including tablets, capsules, and sachets, are highlighted.

Introduction: Pterygium is a degenerative condition of the subconjunctival tissues which proliferate as vascularized granulation tissue to invade the cornea, destroying the supercial layers of the stroma and bowmans membrane, the whole being covered by conjunctival epithelium.The tear lm consists of three layers, the most supercial layer of tear lm is lipid layer produced by meibomian glands. The middle layer is the aqueous layer produced by the main lacrimal gland as well as accessory lacrimal glands of Krause and Wolfring. Aqueous layer constitutes over 90% of the tear lm. The layer closest to the cornea is the mucin layer produced by conjunctival goblet cells. Tear function abnormalities have been proposed as an etiologic factor for pterygium due to observation that a pterygium is exacerbated by dryness and dellen formation. Whether tear dysfunction is a precursor to pterygium growth or pterygium causes tear dysfunction is still not clear. The present study was taken up to study the tear lm changes in patients presenting with pterygium. Materials and methods: The present prospective study was conducted at the Department of Ophthalmology, Chalmeda Anand Rao Institute of Medical Sciences from Jan 2021- July 2022. 75 patients satisfying inclusion and exclusion criteria were included in the study. The eye with pterygium was considered as case and the normal eye of the same patient was considered as controls. The data was recorded for 150 eyes. All patients underwent visual acuity assessment, a detailed slit-lamp examination and ophthalmoscopy to rule out adnexal, anterior segment and posterior segment diseases. Patients were evaluated for tear lm changes using Schirmer's test(with anesthesia),Tear lm breakup time and Tear lm meniscus height. The mean age of the study population was 34.7±4.98 years, with 56% of ma Results: les and 44% of females. Pterygium was present in right eye in 73.33% (n=55) cases and 26.66% (n=20) had it in the left eye. All were on the nasal conjunctiva. Schirmer's test was signicantly lower in eyes with pterygium with P value of &lt;0.001. Tear Film Break Up time and Tear Film meniscus height was signicantly lesser in the eyes with pterygium with P=&lt;0.001. From the present study, we ca Conclusion: n suggest that unstable tear lm is found to a greater extent in eyes with pterygium than in eyes without pterygium. Pterygium is one of the most common ocular surface disorders which results in instability of tear lm indices and thus lead to dysfunctional tear lm and development of dry eye.