Granulation techniques pdf

Emerging Paradigms in Pharmaceutical Wet Granulation. Abstract Granulation transforms the shape, size, surface, and density of powders to improve their physicochemical properties and handling. Focusing primarily on pharmaceutical wet granulation, this … Expand. Granularity in Materials Science. Granulation is a size-enlargement process by which small particles are bonded, by means of various techniques, in coherent and stable masses granules , in which the original particles are still … Expand.

Preparation of seeded granules to improve mechanical properties and various drug loading for pharmaceutical application. Abstract The present work explores the pharmaceutical application of a novel seeded granulation to develop properties-improved, high drug-loaded, and sustained-release tablets using … Expand.

Medicine, Materials Science. Journal of pharmaceutical sciences. Freeze granulation and spray drying of mixed granules of Al2O3. Powder Technology. Abstract This paper proposes a comparative study of two techniques of granulation of a submicronic alumina powder with high binder content slurries, by spray drying and freeze granulation for the … Expand. An investigation on the dissolution qualities of foam granulated products.

Abstract The worldwide home care industry makes widespread use of granulated laundry powders which must be highly soluble and dissolve rapidly to induce an effective wash cycle. The morphology of … Expand. Fluid bed granulation as an innovative process to produce dry redispersible nanocapsules: Influence of cationic coating of particles.

Abstract The application of nanocarrier aqueous suspensions as drug delivery systems offers an important challenge for formulators: their reduced physicochemical stability during storage. Here, a … Expand. Melt granulation of pharmaceutical powders: a comparison of high-shear mixer and fluidised bed processes.

To browse Academia. Log in with Facebook Log in with Google. Remember me on this computer. Enter the email address you signed up with and we'll email you a reset link. Need an account? Click here to sign up. Download Free PDF. Granulation techniques and technologies: recent progresses. Elena Vinnik.

A short summary of this paper. Shanmugam, BioImpacts, , 5 1 , doi: Granulation process transforms fine powders into free-flowing, dust- free granules that are easy to compress. Nevertheless, granulation poses numerous challenges due to high Article Type: quality requirement of the formed granules in terms Mini-review of content uniformity and physicochemical properties Article History: such as granule size, bulk density, porosity, hardness, Received: 08 Dec.

Granulation process Accepted: 27 Dec. The type of process selection requires thorough knowledge of physicochemical Keywords: properties of the drug, excipients, required flow and release properties, to name a few. Among Granulation technique and currently available technologies, spray drying, roller compaction, high shear mixing, and fluid technology; bed granulation are worth of note. Like any other scientific field, pharmaceutical granulation Pneumatic dry granulation; Reverse wet granulation; technology also continues to change, and arrival of novel and innovative technologies are inevitable.

Steam granulation; This review focuses on the recent progress in the granulation techniques and technologies such Moisture-activated dry as pneumatic dry granulation, reverse wet granulation, steam granulation, moisture-activated granulation; dry granulation, thermal adhesion granulation, freeze granulation, and foamed binder or Thermal adhesion granu- foam granulation. This review gives an overview of these with a short description about each lation development along with its significance and limitations.

Introduction so that it occupies less volume per unit weight for better Granulation, a technique of particle enlargement by storage and shipment, to facilitate metering or volumetric agglomeration, is one of the most significant unit dispensing, to reduce dust during granulation process to operations in the production of pharmaceutical dosage reduce toxic exposure and process-related hazards, and to forms, mostly tablets and capsules. Generally, granulation improved flow, narrow particle size distribution for content commences after initial dry mixing of the necessary uniformity and volumetric dispensing, sufficient fines to powder ingredients along with the active pharmaceutical fill void spaces between granules for better compaction ingredient API , so that a uniform distribution of each and compression characteristics, and adequate moisture ingredient throughout the powder mixture is achieved.

Non-commercial uses of the work are permitted, provided the original work is properly cited. Shanmugam bridges, sintering, chemical reaction, crystallization and Recent progress in dry granulation deposition of colloidal particles.

The two different types are by utilizing high viscous binders. The series of mechanisms illustrated in the schematic diagram Fig. There has not by which granules are formed from the powder particles been much progress in the dry granulation technique encompass wetting and nucleation, coalescence or growth, and technology in comparison to wet granulation, except consolidation, and attrition or breakage.

The granulation technique summarized in Table 1. Pneumatic dry granulation PDG , an innovative dry 1. Among these two techniques, wet granulation is mild compaction force by roller compactor to produce a the most widespread granulation technique used despite compacted mass comprising a mixture of fine particles and the fact that it involves multiple unit processes such as granules.

Pharmaceutical granulation represented as Fig. Also, this to give the reader a glimpse of the latest techniques and technology enables the use of high drug loads of up to technologies with regard to pharmaceutical granulation.

Schematic diagram of dry granulation and two different techniques. Schematic diagram of tablet compression techniques slugging. Alternatively, the drug was mixed etc.

The resulted wet granules were milled after drying. The granules produced by this process were found to have good Recent progress in wet granulation flow and handling characteristics like those produced with Wet granulation is the widely used technique and the wet granulation process.

In addition, tablets formed from granules are produced by wet massing of the excipients and these granules eroded more uniformly during dissolution API with granulation liquid with or without binder.

The testing as compared to usual wet granulation technique. Wet granulation has witnessed Controlled breakage was proposed to be the predominant various technical and technological innovations such as granule formation mechanisms in reverse wet granulation steam granulation, moisture-activated dry granulation or technique.

The significance acts as a wetting agent and enable adequate wetting of the and limitations of the recent wet granulation techniques drug substance during granulation. It also increases the and technologies are summarized in Table 1.

These Reverse wet granulation improved granule characteristics result in even erosion of Reverse wet granulation or reverse-phase wet granulation tablets during dissolution. This technique could be suitable for poorly water-soluble drugs because of the intimate association between a drug and the polymer.

Usability of currently available equipment such as high speed mixer is another merit of this technique. However, this technique produced granules with a greater mass mean diameter and lower intragranular porosity when compared to the conventional wet granulation at lower binder concentrations.

Steam, at its pure form is transparent gas, and provides a higher diffusion rate into the powder and a more favorable thermal balance during the drying step. After condensation of the steam, water Fig. Schematic diagram of pneumatic dry granulation forms a hot thin film on the powder particles, requiring Fig.

Schematic diagram of conventional wet granulation Fig. It does not require an and evaporates more easily. This no involvement of organic solvents. However, this method terminology. Some authors believe that dry granulation requires high energy inputs for steam generation. Besides, involves the use of a roller compaction or a slugging step this process is not suitable for all binders and is sensitive to followed by milling to obtain granules. The granules produced by this process technique did not use either of those steps.

The two steps of this this technique include wide applicability, time efficiency MADG are presented in Fig.

Agglomeration takes place and less energy input, and involvement of few process when the granulating fluid water activates the binder. However, Once the agglomeration is achieved, moisture-absorbing this technique could not be used for the preparation of material such as microcrystalline cellulose, silicon dioxide, granules that require high drug load and for moisture etc. A high-shear mixer coupled with a sprayer would the powder mixture, leading to relatively dry granule be a suitable equipment for the MADG process.

An ideal mixture. During this moisture redistribution process, some machine should be equipped with efficient impellers, of the agglomerates remain intact in size without change, blades, and choppers to allow good mass movement and while some larger agglomerates may break leading to more proper mixing of the granulation mass.

Granules of required particles size can 2. It provides granules with good flow properties and binding capacity to During agglomeration, drug is blended with diluents and binder in the powder form, to obtain a uniform mixture. The binder Here liquid binders are added as aqueous foam. It has several benefits over spray wet granulation such as it facilitates the binding of the drug and excipients as they requires less binder than spray granulation, requires less move in a circular motion forced by the mixer blades.

The water to wet granulate. The rate of addition of foam is process does not results in larger lumps formation as the amount of water used in this process is very small as greater than rate of addition of sprayed liquids, no compared to the other conventional wet granulation detrimental effects on granulate, tablet, or in vitro drug dissolution properties, no plugging problems since use of techniques.

In moisture spray nozzles is eliminated, no over wetting. When they come into contact, thebed, reduce manufacturing time, less binder required for moisture absorbents pick up moisture from the moist Immediate Release IR and Controlled Release CR formulations.

Foam granulation technique involves addition agglomerates, resulting in moisture redistribution within the mixture. When this happens, the entire mixture becomes of liquid binders as aqueous foam. The advantages of foamed binder addition conventional binder addition relatively dry.

While some of the moisture is removed from the wet agglomerates, some of these agglomerates remain method includes, almost intact and some usually the larger particles may 1 No spray nozzle is used break up. This process results in granulation with more 2 Improve process robustness uniform particle size distribution. Time efficient 3.

Very few variables involved in the process 4. Suitable for continuous processing 5. This enables flexible modification of drug loading, disintegration time and tablet hardness. It is compatible with other technologies, such as sustained release, fast release, coating etc.

It is suitable for heat labile and moisture sensitive drugs. The PDG Technology produces porous granules with excellent compressibility and flowability characteristics. The pneumatic dry granulation process can granulate virtually any pharmaceutical solid dosage ingredient. The granulated material has exceptionally good flowability and compressibility properties. PDG Technology has been used with superior results in developing fast-release, controlled- release, fixed-dose, and orally disintegrating tablets.

The technology is applicable to practically any solid dosage pharmaceutical product. Formulation teams will usually target a 1.

Faster speed of manufacturing compared with wet Wet granulation is also unsuitable for moisture sensitive granulation and heat sensitive drugs, it is more expensive than dry 3. Lower cost of manufacturing compared with wet granulation, it is relatively labour intensive and can take a granulation long time.

There are a large number of process steps and 4. The system is closed offering safety advantages due to each step requires qualification, cleaning, and cleaning low dust levels and potential for sterile production or validation, high material losses can be incurred because of handling of toxic materials the transfer between stages, there is the need for long drying 5. The end products are very stable - shelf life may be times. Scale up is usually an issue, and there are enhanced considerable capital requirements.

PDG Technology solves 6. Little or no waste of material the above problems. PDG Technology granules have 7. Scale-up is straightforward excellent properties compared to wet granulation, dry 8. The granules and tablets produced show fast granulation and direct compression.

At the same time, the disintegration properties, offering the potential for fast granules show both high compressibility and flowability. Release time can be tailored to requirements expensive excipients.

Freeze Granulation Technology: PDG Technology is the key solution to challenges faced by Swedish Ceramic Institute SCI has adopted and developed pharmaceutical companies in development of solid oral an alternative technique that is freeze granulation, which dosage forms.

The technology replaces existing solid enables preservation of the homogeneity from suspension to dosage form development and manufacturing technologies, dry granules by spraying a powder suspension into liquid offering more rapid development and better quality.

In a subsequent freeze-drying the granules are dried by sublimation of the ice without any segregation effects as in the case of conventional drying in air. The result will be spherical, free flowing granules, with optimal homogeneity. Tablets from these granules have excellent hardness and stability.

TOPO granulation requires only a very small quantity of liquid to start the chain reaction. In contrast to other technologies that require e.

As a result, there are no solvent residues in the finished products. Continuous Flow Technology CFT : Continuous Flow CF technology is our second generation granulation technology and is designed especially for high throughput granulation.

The technology does not need any liquid to start the chain reaction. Granulation is carried out in an inclined drum into which powder is fed at one end and granulate removed at the other. The drum is rotated in a way, which is designed to eliminate almost all shear forces. The process results in granules with a surface protected by Figure 4: Freeze granulation inactive components that do not harm sensitive APIs.

CF technology enables us to produce up to 12 tons of granules every day — ideal for products that require large volumes of Melt Extrusion Technology: granules per single dosage form. With no need to add any Melt extrusion technology has proven to be a suitable solvents like acetone, there are no solvent residues in the method for the production of controlled release reservoir finished product.

Sensitive APIs are protected against acids or bases A melt extrusion process for manufacturing matrix drug 2. Granules are less sensitive to humidity and high delivery system was reported by Sprockel and co-workers. Granules form extremely stable products extrusion technology to produce sustained-release pellets. No solvent residues in the final products Another application of hot-melt extrusion was described by Miyagawa, Sato, and coworkers in and They Granulation characterization: studied the controlled release and mechanism of release of Granulation is a process used to prevent segregation of diclofenac.

Chemical properties Melt agglomeration is a process by which the solid fine are equally important due to their impact on specifications particles are bound together into agglomerates, by agitation, of a dosage form such as content uniformity, chemical kneading, and layering, in the presence of a molten binding purity, and in vitro performance. In vivo performance such liquid. Dry agglomerates are obtained as the molten binding as bioequivalence done because it determines whether a liquid solidifies by cooling.

Typical examples of melt pivotal bioequivalency batch passes or fails. Granule Size agglomeration processes are melt pelletization and melt affect the dissolution performance which ultimately affect granulation. During the agglomeration process, a gradual bioequivalence study. Physical characterization can be change in the size and shape of the agglomerates would take performed at molecular, particulate, or bulk macroscopic place.

It is usually not possible to differentiate between levels. Thus granulation is Table No. Different Parameters and Methods for considered a pelletization process when highly spherical Characterization of Granules agglomerates of narrow size distribution are produced. International journal of pharmaceutics, Pharmaceutical products are processed all over the world Dilip M.

Marcel Dekker INC, granulation methods. Which method is chosen depends on New York, Leon Lachman, Herbert A. Liberman, Joseph L. Tablets, properly flow, compresses, eject, and disintegrate. Choosing a method requires thorough investigation of each Nucleation, growth ingredient in the formula, the combination of ingredients, and breakage phenomena in agitated wet granulation processes: a and how they work with each other.

Then the proper review. Powder Technol. A judicial selection of Kristensen HG, Schaefer T. Granulation, a review on wet appropriate technology for carrying out the granulation granulation, Drug Dev. An investigation into the kinetics of liquid distribution and growth in product parameters. In depth knowledge of the processing high shear mixer agglomeration. A systematic Ismat U, Jennifer W. Moisture-activated dry granulation: The one approach should be followed for selecting the suitable pot process.

Pharma Tech Eur 22 3