Granulation Time Research Articles

Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation.

High shear wet granulation is commonly applied technique for commercial manufacturing of tablets. Granulation process for tablets manufacturing is generally optimized by hit and trial which involves preparation of granules under different processing parameters, compression of granules and evaluation of the resultant tablets; and adjustment is made in granulation process on the basis of characteristics of tablets. Objective of the study was to optimize the process of high shear wet granulation and prediction of characteristics of tablets on the basis of properties of granules. Atenolol granules were prepared by high shear wet granulation method, using aqueous solution of polyvinyl pyrrolidone (PVP k-30) as binder. Concentration of binder solution and granulation time were taken as process variables, both studied at three levels. Different combinations of process variables were determined by Design Expert software. Granules were evaluated for different parameters on the basis of SeDeM-ODT (Sediment Delivery Model-Oro Dispersible Tablets) expert system. Granules from all the trials were compressed using round (10.5 mm) flat faced punches at compression weight of 250 mg/tablet. Tablets were evaluated of different quality control parameters as per USP. Results showed that both the process variables had positive effect on mechanical strength of tablets and negative effect on disintegration and dissolution rate. Granule prepared with highest level of binder concentration (15%) and highest granulation time (60 sec) resulted in tablets with highest crushing strength (11.8 kg), specific crushing strength (0.328 kg/mm2), tensile strength (0.208 kg/mm2), lowest value of friability (0.19%) and highest disintegration time (10.9 min), as predicted from granules characteristics on the basis of SeDeM-ODT expert system. Drug release from Trial-13 (processed under highest level of both process parameters) was also lower than rest of the trials. It is concluded from the study that quality characteristics of tablets can be predicted from granules characteristics using SeDeM-ODT expert system. Furthermore, SeDeM-ODT expert system can also be used for optimization of the process of high shear wet granulation.

Investigation on the granulation behavior of iron ore fine in a horizontal high-shear granulator

High-shear granulation is widely used in many particulate industries for its good capability to improve the size, strength and composition uniformity of powder substances. This work conducted an experimental study to investigate the granulation behavior of iron ore fine in a horizontal high-shear granulator, such as granules size distribution, granules growth rate, and permeability of the granules bed. The results show that the granule size and permeability of packed granules bed increase gradually with increasing the granulation time, and the growth of granules can be divided into three stages: the rapid growth stage, the slow growth stage and the relatively stable stage. Both the higher rotational speed and larger number of impellers increase the kinetic energy and collision frequency of the particles, which causes the increase of average granule size, growth rate and permeability of granules packed bed. On the other hand, the shear damage effect of the impellers on the granules is also enhanced with the increase of rotational speed and impeller number, resulting in significant granule size segregation.

Direct sludge granulation by applying mycelial pellets in continuous-flow aerobic membrane bioreactor: Performance, granulation process and mechanism

This study provides a sustainable manner for direct cultivation of aerobic granular sludge (AGS) by addition of mycelial pellets (MPs) into continuous-flow aerobic MBR. The results showed that the granulation time in MPs-MBR was shortened by at least 65 days, accounting for enhanced mean size of granules (0.68–0.76 mm), increased mixed liquor suspended solids (MLSS) concentration (12.8 g/L) and improved settling ability (78.1 mL/g), in comparison with that of 0.23–0.28 mm, 9.8 g/L and 102.1 mL/g in control MBR. MPs-MBR demonstrated significant advantages in terms of COD reduction (97.0–99.1%), NH4+-N reduction (100%) and TN reduction (32.27–42.33%). MPs, extracellular polymeric substances (EPS) and filamentous bacteria acted as inducible nucleus, crosslinking matter and supporting skeleton, respectively, in favor of promoting the formation and stabilization of AGS with a four-layered structure. The relevant mechanism was underlined by rheological analysis, indicating that MPs addition enhanced non-Newtonian flow characteristics and network structure of sludge.

Bio-carrier–enhanced aerobic granulation: Effects on the extracellular polymeric substances production and microorganism community

In this study, the strengthening effect of bio-carrier inoculation in the process of aerobic granulation and its influence on the microbial secretion of extracellular polymeric substances (EPS) has been systematically explored, to further understand and perfect the rapid granulation mechanism. Complete granulation was achieved within 15 days, and the granule morphology realized in a reactor inoculated with the bio-carrier (R1) was better than that in the control group (R2), in which complete granulation was not achieved during the entire operation period. However, AGS gradually disintegrated after the 20th day because of the strong shearing force, the crushed AGS enhanced granulation, however did not ensure stability. The average EPS content in R1 20 mg﹒gVSS−1 higher than that in R2, and the protein (PN) content changes around 41.23–82.56 mg﹒gVSS−1 during the granulation process. This indicates that the bio-carrier stimulates microorganisms to secrete more EPS, and PN may have a greater effect on the aggregation of microorganisms. The results showed that the addition of the bio-carrier shortened the AGS granulation time, and increased the EPS content, and the broken AGS played an auxiliary role as the nucleus for floc attachment.

Development, optimization and characterization of chewable tablet containing synergistic combination of magnesium orotate dihydrate with cholecalciferol and menaquinone-7 for management of hyperglycemia and its pharmacokinetic study.

The objective of the present research is to develop and optimize a chewable tablet containing synergistic combination of magnesium orotate dihydrate (MOD), cholecalciferol (CHOL) and menaquinone-7 (MK-7) as per product development guidelines of ICH Q8 (R2). The effects of critical variables on quality attributes of chewable tablets were evaluated using 30 runs based design of experiment (DoE) after risk assessment. Optimized formulation was found to be the one that was prepared with moderate granulation time of 7.23 min and contained 14 mg/tablet binder, 31 mg/tablet disintegrant and 11.377 mg/tablet lubricant. Prepared tablets were evaluated for prescribed pharmacopoeial and regulatory quality checks. Optimized formulation was found to have very low disintegration time of 6.06 min and 87.39% dissolution of MOD within 15 min in acidic media (0.1 N HCl), which ensure that the developed formulation behaves as a solution following oral administration. Stability studies under accelerated conditions revealed that the developed formulation can retain its quality characteristics throughout its shelf life. Pharmacokinetics study of chewable tablets in male Wistar rats shows that the time to reach maximum plasma or serum concentration (Tmax) was 3 h for MOD and 6 h for both CHOL and MK-7. Maximum plasma or serum concentration (Cmax) of MOD, CHOL and MK-7 was found to be 7.233 ± 1.159, 8.182 ± 0.783 and 8.331 ± 0.863 μg/mL [mean ± standard deviation (SD)], respectively. The area under the curve (AUC 0-t) for MOD, CHOL and MK-7 was 80.692 ± 11.197, 124.325 ± 17.101 and 126.568 ± 12.064 μg.mL.h-1 (mean ± SD), respectively. Comparison of pharmacokinetic data of chewable tablets with a mixture of pure drugs proves that the developed formulation can efficiently deliver all the three nutrients in blood and is capable to elicit desired pharmacological response.

Valorization of apatite mining flotation residues by the manufacture of artificial aggregates

Mining residues are usually stockpiled because of their understudied physico-chemical properties and of their abundance, which make their valorization challenging. In this work, a cold-bonding granulation apparatus was built in order to transform a mining residue sludge from an apatite ore, into artificial aggregates suitable for use in civil engineering. A 25 rpm rotation speed, 15° angle relative to horizontal, and an ideal feeding amount of the granulation drum, as such as the liquid (supernatant) distribution method, were preliminary determined. Effects of rotation speed, liquid content, and granulation time were then studied to evaluate the best combination for appropriate aggregate size distribution. Box-Behnken experimental designs were used to investigate the evolution of compressive strength of the individual aggregates when Portland cement is added to the mix, and when granulation time varies, around the critical liquid content of 14% of total weight. Thus, the possible parameters combinations which allow a maximization of compressive strength without exclusively increasing cement content, were determined and used to confirm the Box-Behnken predictions. Spherical aggregates were thus manufactured, with diameters mainly comprised between 5 and 40 mm, and compressive strength comparable to those of commercialized aggregates, up to 7 MPa and to 3 MPa for aggregates with diameters respectively below and above 10 mm. Paths for greater consolidation as prior homogenization, use of humid cure conditions, and use of other additives emerge from literature and from the results presented.

Efficacy and safety of an artificial dermal graft for the reconstruction of exenterated sockets: a preliminary report.

The purpose of this study is to report our experience with the use of artificial dermis grafts for orbital socket reconstruction following orbital exenteration (OE). A retrospective study was conducted in our ocular oncology centre from May 2018 to June 2020 in patients undergoing OE for orbital malignancies in whom an artificial dermis device (Integra® template, 2 layers) was used for reconstruction. Data recorded included demographics, previous and adjuvant treatments, aetiologies, surgical procedure, surgical reconstruction, complications and follow-up. The main outcome measure was the time between OE and the full granulation of the cavity. Ten patients (mean age, 71.3 years [43-92]) were included. Tumours originated from the conjunctiva (n = 5, 50%), eyelid (n = 3, 30%) and orbit (n = 2, 20%). Nine patients underwent total OE, and one required enlarged OE. Orbital reconstruction was performed using an artificial dermis alone (n = 9, 90%) or combined with regional flaps (n = 1, 10%). The mean granulation time was 3.3 weeks (2-4). Three (30%) patients received adjuvant radiotherapy 1 month post-surgery. The mean time to spontaneous epithelialization was 9.4 weeks (6-12). Preoperative and postoperative radiotherapy was not associated with a delayed epithelialization of the socket (p = 0.463 and p = 0.236, respectively). One (10%) and 2 (20%) patients experienced postoperative socket infection and an ethmoidal fistula, respectively. The mean follow-up was 11.6 months (6-16). Using artificial dermis grafts alone or with regional flaps appears to be a viable surgical procedure for orbital socket reconstruction. They reduce surgical morbidity and hospital stay. Preoperative and postoperative radiotherapy does not seem to delay socket healing.

Influence of ferric iron dosing on aerobic granular sludge: granule formation, nutrient removal and microbial community

AbstractBACKGROUNDThree lab‐scale sequencing batch reactors were used to investigate the effects of Fe3+ on aerobic granular sludge (AGS) formation, nutrient removal, and microbial community.RESULTSThe addition of 6 and 12 mg Fe3+ L−1 could not shorten the granulation time. However, compared to the reactor without Fe3+ addition (average sludge volume index at 30 min (SVI30) 70.8 mL g−1; stable average particle size 548 μm), the addition of 12 mg Fe3+ L−1 helped improve the physical properties of AGS (average SVI30 57.0 mL g−1; stable average particle size 1067 μm). Furthermore, with 12 mg Fe3+ L−1 addition (Fe3+ to PO43−‐P molar ratio = 1.33), effective removal of NH4+‐N (≤0.5 mg L−1) and PO43−‐P (<1 mg L−1) was achieved. The addition of Fe3+ reduced the microbial diversity and specific activity of heterotrophic bacteria, but promoted the growth of nitrite‐oxidizing bacteria. The growth of particle size not only increased the active biomass ratio and microbial diversity, but alleviated the inhibition effect of Fe3+ on the specific heterotrophic bacteria activity.CONCLUSIONThe addition of Fe3+ had both negative and positive effects on the formation and stability of AGS. The results will help enrich the understanding of AGS application in nutrient removal and especially that of phosphorus. © 2020 Society of Chemical Industry

Formulation and Optimization of Immediate Release Cajanus Cajan Starch-Based Tablets Containing Metronidazole

Starch is found almost in all organs of plants as a carbohydrate reserve. It is considered one of the most commonly used pharmaceutical additives, mainly in tablet dosage forms; it used as a tablet binder when incorporated through the wet granulation process or as a disintegrant. Cajanus cajan has a high level of carbohydrate, which makes it another potential choice as a source for starch. This study aims to investigate and optimize the effect of Cajanus cajan starch concentrations as well as wet massing granulation time on physicochemical properties of metronidazole tablets. The hardness, friability percentage, and disintegration time of prepared tablets were determined, and the central composite design was employed in the optimization process. Then the tablets of optimized batch were compared against those tablets in which maize starch and sodium starch glycolate were used instead of Cajanus cajan starch. The results indicated that metronidazole tablets containing the upper level of starch paste (Cajanus cajan and/or maize starch paste) exhibited better percentage friability, hardness, and disintegration time than those formulated with lower levels and those without starch paste. The study showed that experimental design is a useful technique for optimizing Cajanus cajan starch-based tablets, which enabled a better understanding of how different variables could affect the responses. In addition, the study demonstrated that incorporation of Cajanus cajan starch in tablets formulation led to improvement of its physical properties compared to the formulations of maize starch and sodium starch glycolate respectively.

Effect of calcium addition to aerobic granular sludge systems under high (conventional SBR) and low (simultaneous fill/draw SBR) selection pressure

This paper investigated the effect of calcium addition on the formation and properties of aerobic granules under high (conventional SBR) and low (simultaneous fill/draw SBR) selection pressure. Additionally, the simultaneous removal of carbon, nitrogen, and phosphorus, and the operational stability were assessed. The conventional SBRs showed earlier granule development (20 days) than the simultaneous fill/draw SBRs. The effect of calcium on granulation was more accentuated in conventional SBRs, forming larger granules in a shorter interval of time due to the higher EPS production. Additionally, higher amounts of calcium were found in the EPS matrix, mainly during the formation of granules. The operation regime and the addition of calcium did not affect the removal of carbon, nitrogen, and phosphorus. However, they both influenced the granulation time, settleability characteristics, size, and granule composition.

Comparison between negative pressure and conventional wound dressing for diabetic foot ulcer: A systematic review

Background: Diabetic foot ulcer (DFU) is a common complication of diabetes mellitus (DM), resulting in loss of limb or life. Negative pressure wound therapy (NPWT) is an emerging therapeutic option in the management of DFU. This study aims to compare the efficacy of NPWT to conventional moist wound dressing in the management of DFU.Methods: Literature was searched from online public scientific databases, including PubMed, Google Scholar, ScienceDirect, and Portal Garuda. Our review included clinical trials and analytic studies comparing NPWT and conventional moist dressing to treat DFU published in 2017 or later. Outcome measures include the proportion of wound healing, healing time, ulcer size reduction, granulation time, amputation, infection, and bleeding.Results: We include 11 articles, including eight randomized clinical trials (RCTs), two retrospective analytic studies, and one non-random clinical trial. There was methodological variation between studies on the application of NPWT, outcome measures reported, and length of follow up. Results mostly showed NPWT yielded a higher proportion of complete wound healing, shorter healing time, granulation time, and faster ulcer size reduction rate. However, NPWT was not associated with a reduction of amputation risks.Conclusions: Our review found NPWT was superior in short-term treatment outcomes such as granulation time and wound closure; however, there was no difference in reducing amputation risk between NPWT and conventional moist dressing. Results are inconclusive due to variation in methodologies of included articles.

Melt granulation: A comparison of granules produced via high-shear mixing and twin-screw granulation.

Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear granulator (HSG) (rotation speed of chopper/impeller and granulation time varied). Evaluated granules characteristics were process yield, particle-size distribution (PSD), particle morphology, flowability, porosity, specific surface area (SSA), tabletability, compressibility and binder distribution. Compared to TSG, granules produced from HSG were more spherical in shape with lower porosity, smaller mean particle size and a superior flowability. Granules made by TSG showed a more elongated structure, higher porosity and larger mean particle size with smaller SSA instead. Concerning the compression process of granules, tablets made of TSG granules exhibited a higher tabletability compared to HSG granules, whereas the compressibility remained similar. In the case of the TSG granules, energy-dispersive-X-ray (EDX) measurements of the tablet surface indicated an enhanced homogenous binder distribution. Additionally, the EDX-analyses determined that more binder was available between the individual particles, resulting in a stronger bonding.

Математическая модель процесса гранулообразования дисперсных смесей на основе молочной сыворотки в аппаратах тарельчатого типа

Introduction. In Russia, production of juice, whey, milk, and flavor powders is complicated by the lack of effective manufacturing technologies. Thus, a new technological flow for simultaneous use of moisturizing additives and structured capillary-porous granules remains an urgent task as it would allow combining a polydisperse system with instantiation reliability. The research objective was to create a mathematical model of the process of granulation of dispersed mixtures, as well as scientific substantiation for the new technology of instant polydisperse granular beverage mixes.
 Study objects and methods. The research featured a disk-type granulator with an activator and a polydisperse whey-based mix. The fractional composition of the mix included cranberry pulp (20%), whey (40%), potato starch (5%), powdered sugar (20%), premixes (5%), etc.
 Results and discussion. The research revealed the effect of granulation modes, granulator operation modes, and the phase composition of the initial mix on the profile of the resulting granulated product. The mathematically obtained results were proved experimentally: the model accurately reflected the physical essence of the granulation process of the polydisperse mixes based on local raw materials and whey.
 Conclusion. The study provided methods for regulating the process of granulation of polydisperse whey-based mixes n in disktype granulators. The article introduces a mathematical model of the process based on the hypothesis of the stochastic nature of the processes. The granulation process was described as a combination of seven states depending on the granular composition and granulation time.

Lightweight materials based on wood waste

This paper discusses ways of recycling woodworking waste into light aggregate, optimal compositions of modified binders, as well as the mechanism of cement hydration in the presence of dispersion polymer powders. The methods of obtaining light aggregate based on woodworking waste by granulating in a disc granulator, which is a plate with a tilt angle of 450 and a number of turnovers of 17-19 rpm, are considered. Methods for obtaining granulated aggregate using sawdust of various fractions by the roasting free method are presented, optimal granulation modes are determined, and the main characteristics of the resulting aggregate and concrete based on them are studied. The optimal composition of granulated aggregate on modified cement provides 40 … 60 % of wood processing waste, 60 … 40 % of cement, 25 … 32 % of water and granulation time - 7 … 9 minutes. With this composition, the bulk density of the resulting aggregate corresponds to 850…750 kg/m3, the maximum strength of the granules when compressed in the cylinder is 3.5…4.1 MPa. The optimal content of the polymer additive in the binder is in the range of: mowilith - 0.4…0.7 % and tylose - 0.21…0.13 %. Granulated aggregate on modified aggregate has a frost resistance in the range of F35… F50. The choice of granulated aggregate on modified cement showed the effectiveness of the aggregate for light concretes. The strength characteristics of modified concrete of 25-75 brands were studied. The mechanical properties of modified concrete depending on the average density were studied. Concrete with an average density of 1000 kg/m3 has M25 brand, at 1200 kg/m3 - M35, at 1300 kg/m3 - M50, at 1500 kg/m3 - M75.

Positive effects of zeolite powder on aerobic granulation: Nitrogen and phosphorus removal and insights into the interaction mechanisms

Aerobic granular sludge is considered one of the most promising biological wastewater treatment technologies of the 21st century. However, the long granulation time and poor treatment effect on N and P have severely limited its popularity and large-scale application. In this study, we systematically examine the strengthening effects of zeolite powder on granulation, N and P removal, and their interaction mechanisms. The addition of zeolite powder decreased sludge granulation time to 18 d, and improved average N and P removal rates by 4.48% and 2.22%, respectively. The multi-pore and nutrient-rich environment of the zeolite powder is beneficial for maintaining microbial activity and granular stability. Moreover, its adsorption to N and P enriches their respective removal strains, improving their removal efficiency.

Rapid aerobic granulation using biochar for the treatment of petroleum refinery wastewater

Aerobic granular sludge technology has great potential for the treatment of petroleum refinery wastewater. However, strategies to shorten the granulation time and improvement the stability still need to be developed. In this work, biochar was prepared from waste petroleum activated sludge (biochar-WPS) and used in a sequencing batch reactor for the treatment of petroleum refinery wastewater. Biochar-WPS presented the surface area of 229.77 m2/g, pore volume of 0.28 cm3/g, H/C and O/C atomic ratios of 0.42 and 0.21, respectively. The porous structure and a high degree of hydrophilicity were found to facilitate microbial colonization and adhesion as well as particle aggregation. Application of biochar-WPS resulted in the formation of more substantial and stable aerobic granules (~ 66% of granules > 0.46 mm diameter) 15 days earlier compared with the control. The addition of biochar-WPS enhanced the average removal efficiency of chemical organic demand (~ 3%), oil (~ 4%) and total nitrogen (~ 10%) over the control. Increased microbial richness and diversity were observed within the formed granules and had an increased (~ 4%) proportion of denitrifying bacteria. These results indicate that an aerobic granulation mechanism using biochar-WPS is a feasible option for the treatment of petroleum refinery wastewater.

Formation and internal microstructure of granules from wetting and non-wetting efavirenz/iron oxide blends

An examination of granulation of non-wetting/wetting powder mixtures is presented. Non-wetting micron-size pharmaceutical active powder was blended with a sub-micron wetting excipient in three different ratios to produce wetting, non-wetting, and marginally-wetting powder blends. Model nuclei were prepared from these blends using binder droplets with viscosity of ca 10, 100 and 1000 mPa·s and further granulated in tumbling drum and high shear granulator. The effects of blend wettability, binder viscosity, granulation time, and shear forces on granule size and microstructure were investigated. Hollow granules were produced at higher binder viscosity of 100 and 1000 mPa·s regardless of blend wettability. Solid granules with a complex internal microstructure were produced at low binder viscosity of 10 mPa·s regardless of blend wettability. Contribution of capillary, viscous and impact forces are considered to explain differences in granule microstructure. Modified Reynolds and Weber numbers are proposed to rationalize formation and stability of shell microstructures.

Diatomite carrier for rapid formation of Aerobic Granular Sludge

Aerobic granular sludge (AGS) is a spherical compact sludge that has a lot of advantages such as great settling ability, high biomass level, good shock resistance and ability to withstand high organic loading rate (OLR) and toxic pollutants. However, it still has a major weakness that influences the low global reputation of AGS which is long granulation time. Therefore, a support material called diatomite which known for its unique characteristic is used in this study to speed up the granulation process in a pilot sequencing batch reactor (SBR) for domestic wastewater treatment. The AGS was cultivated in a pilot bioreactor for 30 days and measured for its characteristic. The result indicates fast granulation with 18 days of AGS formation period. Moreover, SEM images shows the present of diatomite in the inner part of the mature granules and proved its function as a nucleation agent that accelerate the aggregation process. The developed granules demonstrate excellent strength and settleability with strength (IC: 17.42%), SVI of 68 mL/g SS and settling velocity (114 m h−1) respectively.

Impact of additive application on the establishment of fast and stable aerobic granulation.

Aerobic granular sludge (AGS) is a microbial biofilm self-aggregation, which is effective for nutrient and pollutant removal, through the development of dense microbial layers bound together with extracellular polymeric substances (EPSs). However, long start-up times and granule disintegration are still challenges ahead. An array of external additives, including ion chelating agents, sludge-based enhancers, and magnetic influence have been tested to overcome these barriers. The application of such additives may promote enhanced EPS production, neutralization of charges on the bacterial surface, acts as a core-induced agent, or as a bridge to connect EPSs and cell surfaces. Although additives may improve the granule formation without reducing treatment efficiencies, there are still environmental concerns due to the fate and toxicity of discharged excess sludge. This mini-review identifies an array of external additives and their mechanisms to improve granulation properties, and proposes discussion about the technical and economic viability of these additives. KEY POINTS: • Additives reduce granulation time and repair granule disintegration. • Biopolymer-based additives fulfill technical and environmental requirements. • Sludge-based additives are cheap and in line with the resource recovery concept. • The need for environmental-friendly additives for aerobic granular sludge process. • External additives affect granular biomass size distribution.

Fabrication of extended-dissolution divalproex tablets: a green solvent-free granulation technique

Objective: Divalproex sodium (DVS) is a challenging drug owing to its hygroscopicity, bitter taste, and short in vivo half-life. This study aims to produce stable taste masked DVS once daily tablets using solvent free hot melt granulation (HMG) process.Methods: A lab scale high shear mixer granulator employing six meltable lipid binders (compritol®888 ATO, beeswax, gelucire®50/13, precirol® ATO5, stearyl alcohol, and geleol®) was used for the preparation of tablets. Quality control tests were performed on granules and tablets, and Box–Behnken’s design was adopted to investigate the effect of binder concentration, impeller speed, and granulation time on the drug dissolution. Shelf and accelerated stability evaluation, taste assessment, and in vivo pharmacokinetic study were conducted on the selected batches.Results: Results revealed that DVS tablets were successfully prepared, and that the in vitro dissolution of the drug was inversely proportional to the binder concentration. Beeswax and compritol® tablets showed similar dissolution profiles to the marketed product Depakote® 500 ER tablets (F1 < 15 and F2 > 50). The selected batches showed lower moisture content (<2%) and successfully masked the bitter taste compared to uncoated tablets based on a hydrophilic matrix. The in vivo pharmacokinetic study delineated relative bioavailability values for Beeswax and Compritol® tablets of 95.6% and 118%, respectively, compared to the marketed product.Conclusion: The solvent free HMG process can be employed to formulate 24 h extended dissolution DVS tablets with masked bitter taste and high stability, and comparable or higher bioavailability than the marketed product.