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Copyright of Farmacia is the property of Societatea de Stiinte Farmaceutice Romania and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Investigation on natural sources from plants, animals, and microorganisms that produce gums and mucilages goes on increasing day by day to check their pharmaceutical applications. Different mucilages have been studied for their pharmaceutical effects but the use of date palm (Phoenix dactylifera L.) mucilage as a pharmaceutical excipient is still under the cover. The aim of this study was therefore to evaluate and compare the flow property and binding ability of crude, purified, modified (hydrolyzed and grafted), green synthesized nanoparticles (Zinc oxide (ZnO), cuperic oxide (CuO), silver (Ag), and gold (Au)) of date palm mucilage with hydroxy propyl methyl cellulose (HPMC) and commercially available paracetamol tablets. Previously purified mucilage (with 58.4% yield) was subjected to modification (i.e., acidic, basic, and enzymatic), grafting (polyacrylamide), and green synthesis of nanoparticles. Flow properties of powdered (granular) crude, purified, modified, and nanoparticles were studied and compared with flow properties of HPMC and paracetamol tablet granules. Tablets were made using granules of all types of date palm mucilage (discussed above), HPMC, and granules of paracetamol tablets to study and compare weight uniformity, hardness, friability, dissolution rate, and disintegration time. When 100 mg/kg of mucilage sample was given to mice no oral toxicity was found. The results obtained during this study were within the acceptable ranges given in pharmacopeias. The pseudoplastic flow behavior, hygroscopic nature, increased solubility, and swelling index across the increase in temperature, hardness of the tablets, friability, and drug release behavior were found better than HPMC and the binders used in commercially available paracetamol, hence making the date palm mucilage (crude, purified, and modified) an excellent excipient to be used in pharmaceutical dosage forms. [ABSTRACT FROM AUTHOR]

An excipient intended for direct compression in pharmaceutical tableting must show important features of flowability and compactibility. This study investigated pregelatinised sago starch as an excipient for direct compression tablets. Pregelatinised sago starch was prepared and characterised. Its powder bulk properties and performance in the tablet formulations with paracetamol as a model drug were compared against two commercial, directly compressible excipients, namely Avicel® PH 101 and Spress® B820. The results showed that pregelatinisation did not affect the chemical structure of sago starch, but its degree of crystallinity reduced, and X-ray diffraction pattern changed from C-type to A-type. Powder bulk properties of pregelatinised sago starch and Spress® B820 were comparable, exhibiting better flowability but lower compactibility than Avicel® PH 101. In the formulation of paracetamol tablets, pregelatinised sago starch and Spress® B820 performed equally well, followed by Avicel® PH 101 as indicated in Formulations 3, 2 and 1, respectively. [ABSTRACT FROM AUTHOR]

The work evaluates the stability of amorphous and co-amorphous olanzapine (OLZ) in tablets manufactured by direct compression. The flowability and the compressibility of amorphous and co-amorphous OLZ with saccharin (SAC) and the properties of the tablets obtained were measured and compared to those of tablets made with crystalline OLZ. The flowability of the amorphous and mostly of the co-amorphous OLZ powders decreased in comparison with the crystalline OLZ due to the higher cohesiveness of the former materials. The stability of the amorphous and co-amorphous OLZ prior to and after tableting was monitored by XRPD, FTIR, and NIR spectroscopies. Tablets presented long-lasting amorphous OLZ with enhanced water solubility, but the release rate of the drug decreased in comparison with tablets containing crystalline OLZ. In physical mixtures made of crystalline OLZ and SAC, an extent of amorphization of approximately 20% was accomplished through the application of compaction pressures and dwell times of 155 MPa and 5 min, respectively. The work highlighted the stability of amorphous and co-amorphous OLZ during tableting and the positive effect of compaction pressure on the formation of co-amorphous OLZ, providing an expedited amorphization technique, given that the process development-associated hurdles were overcome. [ABSTRACT FROM AUTHOR]

Misoprostol is a synthetic prostaglandin E1 derivative that has been used to treat duodenal and gastric ulcers, and to prevent ulcers caused by nonsteroidal anti‐inflammatory drugs in many countries. Misoprostol can also be used for medical abortion. This study aimed to investigate the pharmacokinetic profiles of misoprostol tablets (test product) by comparing them with Cytotec (200 μg) (reference product). To assess the bioequivalence between test and reference products, a two‐sequence, two‐period crossover study was conducted with 48 healthy Chinese subjects enrolled under fasting conditions. A validated liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) assay was used to determine the concentration of misoprostol acid in plasma. A mixed model analysis of variance was used to calculate the bioequivalence of pharmacokinetic (PK) parameters. The point estimate of geometric mean ratios with 90% confidence intervals for the maximum observed concentration (Cmax) and the area under the concentration‐time curve (AUC0‐t) for misoprostol acid in reference and test products were 107.8% and 106.5%, respectively (range 80%–125%). Additionally, none of the secondary PK parameters presented significant differences. No severe or more than moderate adverse events were detected in the 48 subjects. However, one subject discontinued the treatment due to drug‐related gastrointestinal reactions. All adverse events were mild with rates of 19.2% and 22.9% after the administration test and reference products, respectively. Overall, the bioequivalence between the two misoprostol products was demonstrated in fasting conditions, and all subjects tolerated both treatments. [ABSTRACT FROM AUTHOR]

Moisture-activated dry granulation (MADG) is an eco-friendly granulation method that uses a small amount of water and insoluble excipients to absorb moisture. MADG is expected to improve productivity and reduce costs. Erythritol, an excipient used for preparing orally disintegrating tablets (ODTs), has poor tabletability and is difficult to form into tablets by conventional methods, such as high-shear granulation (HSG) and direct compression. In this study, we optimized the manufacturing conditions for ODTs to improve the tabletability of erythritol using MADG. The disintegration time of tablets made using the MADG method was approximately one-tenth that of those made using the HSG method, and the hardness was approximately 1.4 times higher. Moreover, MADG could delay disintegration and improve tabletability. We further attempted to optimize the manufacturing conditions using MADG, particularly in terms of the amount of water used. The disintegration time increased as the amount of added water increased. Moreover, water absorption tests revealed that capillary wetting decreased as the amount of water added increased, but the initial wetting did not change. These results suggested that the disintegration time was prolonged because of the increase in granule density and decrease in capillary wetting with the increase in the amount of added water. The hardness of the tablets increased because of the easy deformation of the granules after the addition of up to 3% water; however, when more than 3% water was added, the hardness decreased because of the aggregation of the granules with the excess water. Finally, two-dimensional maps of the effect of the amount of added water and water activity indicated that tablets with a hardness of ≥80 N and a disintegration time of ≤15 s could be produced by adjusting the amount of added water to within the range of 2.2–3.3% and water activity to 0.3–0.53. These results indicate that MADG can improve the tabletability of erythritol and be used for the granulation of ODTs. Tablets with appropriate hardness and disintegration properties can be produced by adjusting the water content to approximately 2.7% and the water activity to approximately 0.4 when producing ODTs with MADG. [ABSTRACT FROM AUTHOR]

Copyright of Chinese Journal of Inorganic Analytical Chemistry / Zhongguo Wuji Fenxi Huaxue is the property of Beijing Research Institute of Mining & Metallurgy Technology Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Orodispersible tablets (ODTs) are pharmaceutical formulations used to obtain fast therapeutic effects, usually recommended for geriatric and pediatric patients due to their improved compliance, bioavailability, ease of administration, and good palatability. This study aimed to develop ODTs with cannabidiol (CBD) phytocannabinoid extracted from Cannabis sativa used in the treatment of Lennox–Gastaut and Dravet syndromes. The tablets were obtained using an eccentric tableting machine and 9 mm punches. To develop CBD ODTs, the following parameters were varied: the Poloxamer 407 concentration (0 and 10%), the type of co-processed excipient (Prosolv® ODT G2—PODTG2 and Prosolv® EasyTab sp—PETsp), and the type of superdisintegrant (Croscarmellose—CCS, and Soy Polysaccharides—Emcosoy®—EMCS), resulting in eleven formulations (O1–O11). The following dependent parameters were evaluated: friability, disintegration time, crushing strength, and the CBD dissolution at 1, 3, 5, 10, 15, and 30 min. The dependent parameters were verified according to European Pharmacopoeia (Ph. Eur.) requirements. All the tablets obtained were in accordance with quality requirements in terms of friability (less than 1%), and disintegration time (less than 180 s). The crushing strength was between 19 N and 80 N. Regarding the dissolution test, only four formulations exhibited an amount of CBD released higher than 80% at 30 min. Taking into consideration the results obtained and using the Modde 13.1 software, an optimal formulation was developed (O12), which respected the quality criteria chosen (friability 0.23%, crushing strength of 37 N, a disintegration time of 27 s, and the target amount of CBD released in 30 min of 99.3 ± 6%). [ABSTRACT FROM AUTHOR]

This study developed a nanosensor for the detection and determination of favipiravir, a presumed drug that has potential therapeutic efficacy in treating COVID‐19 patients, from tablets and serum samples. This nanosensor was obtained by adding the optimum amount of diamond nanoparticles into carbon paste. For the determination of favipiravir adsorptive stripping differential pulse (AdSDPV) and adsorptive stripping square wave voltammetry (AdSSWV) were used. Limit of detection values were found as 4.83×10−9 M and 2.44×10−7 M for bulk and 5.18×10−8 M and 4.38×10−8 M for serum samples using AdSDPV and AdSSWV, respectively. Recovery studies made of the tablet and serum produced satisfactory results. [ABSTRACT FROM AUTHOR]

Active pharmaceutical ingredients (API) and excipients are often classified as 'brittle' or 'ductile' based on their yield pressure determined through the Heckel analysis. Such a brittle/ductile classification is often correlated to some measure of elasticity, die-wall stresses, and brittle fracture propensities from studies performed with a handful of model excipients. This subsequently gives rise to the presumption that all ductile materials behave similarly to microcrystalline cellulose (MCC) and that all brittle materials to lactose, mannitol, or dicalcium phosphate. Such a 'one-size-fits-all' approach can subsequently lead to inaccurate classification of APIs, which often behave very differently than these model excipients. This study compares the commonly reported mechanical metrics of two proprietary APIs and two classical model excipients. We demonstrate that materials classified as 'ductile' by Heckel's 'standards' may behave very differently than MCC and in some cases may even have a propensity for brittle failure. Our data highlight the complexity of APIs and the need to evaluate a set of mechanical metrics, instead of binary assignments of ductility or brittleness based on quantities that do not fully capture the tableting process, to truly optimize a tablet formulation as part of the overall target product profile. [ABSTRACT FROM AUTHOR]

Pharmaceutical tablet productions by direct compaction (DC) are more environmentally sustainable than wet granulation (WG) owed to DC's lower energy consumption. For drug particles with poor flowability, however, the environmental benefits of DC become questionable because DC of such drugs requires either pre-compaction treatment, increased excipients' proportion in the tablets, or using excipients with unfavorable sustainability profiles. Using ibuprofen (IBU) as the model drug with poor flowability, we performed cradle-to-gate life cycle assessment (LCA) using ReCiPe 2016 method to characterize the environmental impacts of DC and WG tablet productions. Material and energy flow data from laboratory-scale (1 and 2.2 kg IBU) and simulated pilot-scale (25 kg IBU) productions were utilized in the LCA. Despite the increased proportion of excipients with less-than-ideal sustainability profile in DC tablets, the environmental impacts of DC tablet production remained smaller than WG tablet production across different production scales, as the impacts were governed by process-level energy consumption. The impacts of DC and WG tablet productions, nevertheless, became closer in magnitude with increasing production scale attributed to superior improvements in the energy requirement and yield of WG tablets. Thus, the environmental beneftis of DC tablets over WG tablets was diminished for drugs with poor flowability. [Display omitted] • Environmental impact of tablet production is centered on human/ecosystem toxicity. • Environmental impact of tablet production is ruled by process-level energy usage. • DC tablet has less environmental impact than WG tablet for poorly flowable drugs. • Environmental impacts of DC and WG tablets become more comparable at larger scales. [ABSTRACT FROM AUTHOR]

PT. ABC (Company) is one of the companies engaged in pharmaceutical sector, more precisely in the manufacture of medicines in the type of tablets, caplets, capsules, syrup, ovules, injections, and so on. Optimal control of raw material supplies is very important for the company in order that the production process can run properly. The Economic Order Quantity (EOQ) method is a basic method of inventory control, which aims to fmd the minimum point between the ordering cost and the holding cost. The purpose of this study is to examine the control of the inventory of some raw materials in PT. ABC by using the EOQ method. In this study, data collection is conducted by using survey and observational methods with a quantitative descriptive approach. Then, the data is analyzed by using the EOQ method and Total Inventory Cost formulas. The results obtained from this study indicate a Total Inventory Cost of Rp 267,459,634 with an efficiency of 15,02%. [ABSTRACT FROM AUTHOR]

Mangosteen fruit has been widely consumed and used as a source of antioxidants, either in the form of fresh fruit or processed products. However, mangosteen peel only becomes industrial waste due to its bitter taste, low content solubility, and poor stability. Therefore, this study aimed to design mangosteen peel extract microcapsules (MPEMs) and tablets to overcome the challenges. The fluidized bed spray-drying method was used to develop MPEM, with hydroxypropyl methylcellulose (HPMC) as the core mixture and polyvinyl alcohol (PVA) as the coating agent. The obtained MPEM was spherical with a hollow surface and had a size of 411.2 µm. The flow rate and compressibility of MPEM increased significantly after granulation. A formula containing 5% w/w polyvinyl pyrrolidone K30 (PVP K30) as a binder had the best tablet characteristics, with a hardness of 87.8 ± 1.398 N, friability of 0.94%, and disintegration time of 25.75 ± 0.676 min. Microencapsulation of mangosteen peel extract maintains the stability of its compound (total phenolic and α-mangosteen) and its antioxidant activity (IC50) during the manufacturing process and a month of storage at IVB zone conditions. According to the findings, the microencapsulation is an effective technique for improving the solubility and antioxidant stability of mangosteen peel extract during manufacture and storage. [ABSTRACT FROM AUTHOR]

Direct compression (DC) attracts increasing attention for tablet manufacturing; however, its application in medicinal plant tablets is still extremely limited. In this work, eight kinds of the Gardeniae fructus water extract powder (GF)-based composite particles (CPs) were prepared with different cohesive surface engineering materials, including dextran, inulin, hypromellose, and povidone, alone or in combination with mannitol and colloidal silica. Their physical properties and compacting parameters were characterized comprehensively. All the CPs showed marked improvement in tabletability, which is about 2–4 times higher than that of GF and physical mixtures (PMs). Specifically, the CPs showed a 7.45–26.48 times higher hardness (Ha) value and a 1.26–2.74 times higher cohesiveness (Co) value than PMs. In addition, all the CPs (angle of repose being from 34.27° to 38.46°) showed better flowability than PMs (35.49° to 53.53°) and GF (51.86°). These results demonstrated that (i) fluid-bed coating was not a simple process of superposition and transmission of the physical properties of raw materials; and (ii) all the surface engineering materials studied could improve the DC properties of problematic GF to some degree. As a whole, through the design of fluid-bed coating CPs, qualified tablets with high GF loadings (up to 93%) were produced via DC. [ABSTRACT FROM AUTHOR]

The two main components of starch — amylose and amylopectin, are responsible for its interaction with moisture. This study investigated how moisture sorption properties of the starches with different amylose-amylopectin ratio impacted tablet properties including drug stability. The starch samples were equilibrated to 33, 53, and 75% relative humidity (RH) and then assessed for tabletability, compactibility, and yield pressure. Effect of humidity on viscoelastic recovery was also evaluated. Tabletability and compactibility of high-amylose starch were better than that of high-amylopectin starch at 33 and 53% RH. However, at 75% RH, the reverse was observed. In terms of yield pressure, high-amylose starch had lower yield pressure than high-amylopectin starch. High-amylose starch tablets also exhibited lower extent of viscoelastic recovery than high-amylopectin starch tablets. The variations in the tableting properties were found to be related to relative locality of the sorbed moisture. Degradation of acetylsalicylic acid in high-amylose starch tablets at 75% RH, 40°C was less than the tablets with high-amylopectin starch. This observation could be attributed to the greater amount of water molecules binding sites in high-amylose starch. Furthermore, most of the sorbed moisture of high-amylose starch was internally absorbed moisture, therefore limiting the availability of diffusible sorbed moisture for degradation reaction. Findings from this study could provide better insights on the influence of amylose-amylopectin ratio on tableting properties and stability of moisture-sensitive drugs. This is of particular importance as starch is a common excipient in solid dosage forms. [ABSTRACT FROM AUTHOR]

Copyright of Inzynieria Mineralna is the property of Polskie Towarzystwo Przerobki Kopalin and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Istradefylline as a selective adenosine A2A-receptor antagonist is clinically used to treat Parkinson's disease and improve dyskinesia in its early stages. However, its crystal form, as an important factor in the efficacy of the drug, is rarely studied. Herein, three kinds of crystal forms of istradefylline prepared from ethanol (form I), methanol (form II), and acetonitrile (form III) are reported by use of a crystal engineering strategy. These three crystal forms were characterized and made into tablets for dissolution testing. Both the solubility and the dissolution rates were also determined. The dissolution rate of form I and form III is significantly higher than form II at pH 1.2 (87.1%, 58.2%, and 87.7% for form I, form II, and form III, respectively), pH 4.5 (88.1%, 58.9%, and 87.1% for form I, form II, and form III, respectively) and pH 6.8 (87.5%, 58.2%, and 86.0% for form I, form II, and form III, respectively) at 60 min. Considering the prepared solution and the proper dissolution profile, form I is anticipated to possess promising absorption for bioavailability. [ABSTRACT FROM AUTHOR]

The individualization of pharmacotherapy including the age and health condition of the patient is a recent trend determining directions of pharmaceutical technology development. Groups of patients that especially need individualization of the therapy include children of different age and elderly with different health condition. Both of them still misses appropriately designed forms of the drugs. One of the dosage forms that enables wide modifications and broad application, convenient for a numerous groups of patients, are minitablets. Minitablets are a solid dosage form of the drug with a diameter from 1 to 3 mm and a mass ranging from several to several dozens of milligrams. They can be administered orally as a conventional and modified release dosage forms, particularly as sustained or enteral release forms. Orodispersible minitablets suitable for children and people with swallowing disorders are also under development. Numerous studies proved that they are convenient even for newborns, infants and toddlers. What is more, they can be much safer alternative for the liquid dosage forms such as syrups or drops. Fast disintegration of such minitablets causes that they can be mixed with soft foods or liquids, including milk and enteral feeding formulas. They can be put directly in the oral cavity or administered with spoon, bottle, or transferred to the stomach or intestines with feeding tubes. Minitablets intended for the oral administration can be applied as an individual dosage units or as a multicompartment dosage form enclosed in a capsule, sachet or administered with a special dispenser. This allows individual dose adjustment within a very wide range. The aim of this study is to present, based on the literature review, the current directions of development of minitablets as a drug form, especially beneficial in pediatric and geriatric patients. This paper also describes methods of minitablets production, compendial requirements regarding quality control of the minitablets, and possibilities of their administration to the patients concerning their age and physiological conditions.

Chemical mapping by Raman spectroscopy is widely used in the pharmaceutical industry to characterise the distribution of components within pharmaceutical tablets; however, current methods do not go beyond examining an exposed surface area of a sample. There are known limitations with estimating domain size and shape statistics from 2D chemical images as the values obtained will depend on where the domain is sectioned, potentially under‐ or overestimating its true value. The combination of Raman spectroscopic mapping and serial sectioning has been recently explored as an alternative method to obtain a depth profile of a sample; however, to date, this has involved instrumentation capable of automated Raman mapping with subsequent sample sectioning. A key requirement for Raman mapping is producing an optically flat surface, and this becomes increasingly challenging for larger surface areas required for the examination of a pharmaceutical tablet. Here, we describe 3D imaging of a tablet matrix by combining Raman mapping with independent sample sectioning to provide appropriate lateral and axial resolution. The approach was first validated by analysing a spherical object of known size and shape and comparing the 3D domain size statistics calculated from the reconstructed image to its absolute values. The method was then applied to a three‐component model system, simulating a pharmaceutical tablet, to determine the capability and applicability of the method for solid dosage formulations. The study demonstrated that relative differences in the size, shape and distribution of domains can be quantified enabling an enhanced understanding of the spatial arrangement of each component within the formulation and the effect of each processing condition on the final drug product. By visualising the 3D structure of a tablet matrix with demonstrable accuracy and precision using materials of known dimensions, new capabilities to enhance tablet manufacturing methods are now available. [ABSTRACT FROM AUTHOR]

Background and objective: AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule formulation of AMG 986 relative to the tablet formulation in 12 healthy subjects. Methods: In a two-period, two-way crossover design, eligible subjects were randomized 1:1 to tablet/capsule or capsule/tablet treatment sequences; each treatment sequence lasted for approximately 6 days and comprised six subjects. Results: Following a single oral dose of AMG 986, the geometric mean maximum observed concentration (Cmax) values were 9670 ng/mL and 6920 ng/mL and the geometric mean area under the curve from time zero to 120 h (AUC0–120h) values were 68,000 ng*h/mL and 59,900 ng*h/mL for the tablet and capsule, respectively. The geometric least squares means (90% confidence interval [90% CI]) for the ratios of capsule/tablet were 0.88 (90% CI 0.81–0.96) and 0.72 (90% CI 0.57–0.91) for AUC0–120h and Cmax, respectively. AMG 986 had an acceptable safety profile; all adverse events were grade 1 or 2 in severity. Conclusion: There was a modest 12% decrease in AUC0–120h and a 28% decrease in Cmax with the AMG 986 capsule versus the tablet. These differences are not considered to be clinically relevant, suggesting the capsule formulation can be used in subsequent clinical studies of AMG 986. [ABSTRACT FROM AUTHOR]

The dissolution profile is of great importance in drug delivery and is affected by the manufacturing method. Thus, it is important to study the influence of the thermal process on drug release in emerging technologies such as 3D printing-fused deposition modeling (FDM). For this purpose, the characteristics of 3D printed tablets were compared to those of tablets prepared by other thermal methods such as hot-melt extrusion (HME) and non-thermal methods such as physical mixture (PM). Theophylline was used as a drug model and blends of ethyl cellulose (EC) and hydroxypropyl cellulose (HPC) were used as a matrix former. The solid state of the drug in all formulations was investigated by differential scanning calorimetry, X-ray powder diffraction, and Fourier-transformed infrared spectroscopy. All studied tablets had the same weight and surface area/volume (SA/V). Dissolution data showed that, for some formulations, printed tablets interestingly had a faster release profile despite having the highest hardness values (>550 N) compared to HME and PM tablets. Porosity investigations showed that 100% infill printed tablets had the highest porosity (~20%) compared to HME (<10%) and PM tablets (≤11%). True density records were the lowest in printed tablets (~1.22 g/m3) compared to tablets made from both HME and PM methods (~1.26 g/m3), reflecting the possible increase in polymer specific volume while printing. This increase in the volume of polymer network may accelerate water and drug diffusion from/within the matrix. Thus, it is a misconception that the 3D printing process will always retard drug release based on increased tablet hardness. Hardness, porosity, density, solid-state of the drug, SA/V, weight, and formulation components are all factors contributing to the release profile where the total balance can either slow down or accelerate the release profile. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to print a thermolabile drug-containing tablet using the fused deposition modeling (FDM) technique and analyze its mechanical, pharmaceutical and environmental feasibility using a variety of tests. Design/methodology/approach: Ascorbic acid (Vitamin C) is the thermally-sensitive drug impregnated into polyvinyl alcohol excipient using ethanol-water mixture and printed by an FDM printer by varying three parameters without using any external stabilizing agent. Afterward, Taguchi analysis has been performed on these parameters to recognize the significant factors and interactions. Besides this, a regression model has been obtained based on the dissolution data. Various thermo-mechanical and pharmaceutical tests have been carried out to confirm the feasibility. Finally, a life cycle assessment (LCA) analysis has been carried out to compare it with the existing tableting method by considering the environmental impacts. Findings: The dissolution profile was found to follow the Korsmeyer-Peppas model, where the drug release occurred both by dissolution and erosion. Further, the infill percent has been found as the most significant parameter. The characterization tests and imaging outputs proved the fidelity of this attempt. Finally, the three-dimensional printed method was found to be more environmentally sustainable than the existing conventional tableting process. Originality/value: LCA on a printed tablet is a one-of-a-kind attempt. Thus, this research attempt delivered another approach to print personalized tablets at a temperature lower than prescribed temperatures with required release behavior and can contribute toward the quest of sustainable personalized medication. [ABSTRACT FROM AUTHOR]

This work summarizes select methodology of twin-screw melt granulation (TSMG) and process analytical technology that were used in the successful scaling-up and commercial transfer of high drug load (80.5% w/w) immediate release fevipiprant tablets. The unique and compelling learnings from this industry work are (1) insights into Novartis AG's commercial scale transfer using TSMG and (2) rapid, nondestructive NIR methodology as a PAT tool for RTR testing. No prior literature combines these two aspects at the level of detail we present/disclose. Scaling up of TSMG was guided by specific energy values obtained for the 27 mm (pilot scale) and 50 mm (commercial scale) twin-screw extruders (TSE). Proven acceptable ranges (PARs) were confirmed by varying the critical process parameters (CPPs) for granulation (screw speed) and tableting (dwell time and crushing strength) at three process levels (upper, target, and lower). An at-line NIR method was developed and validated for real-time release testing (RTRT). The combination of CPPs were selected to have the same effect on critical quality attributes (CQAs), that is, lower (–) and upper (+) process level challenged tablet aspect/appearance and dissolution, respectively. TSMG was performed using a 50 mm extruder at constant feed rate. Compression of the six final blends (∼300 kg) showed no impact of varied granulation and compression process conditions on both CQAs. A near-infrared spectroscopy method was validated to determine content uniformity, assay, identity, and to predict CQAs on uncoated tablets in preparation for a real RTRT of future batches. [ABSTRACT FROM AUTHOR]

Amorphous solid dispersions (ASDs) are a proven method of improving the solubility and bioavailability of poorly soluble compounds. Immediate release tablets are frequently used as final dosage form for ASDs. Increasing tableting process throughput during clinical development requires using larger, faster tablet presses which subject materials to higher strain rate. Many pharmaceutical materials show strain rate sensitivity, i.e., yield pressure sensitivity to compression speed. Currently, there is only scattered information available in scientific literature on how ASDs behave under different tablet compression speeds. The purpose of this study was to examine spray-dried ASDs' sensitivity to strain rate under compression in a comprehensive study. We also investigated the drivers for such a strain sensitive behavior. A set of sample spray-dried powders, selected for their range of properties, were compressed using a simulated Korsch XL100 profile at 3 and 30 RPM and V-profile at 0.1 and 300 mm/s on a Phoenix compaction simulator. The sample set included samples with varying API content (0–50% w/w), stabilizing polymer (HPMC, HPMC-AS, PVP-VA), particle size, and bulk densities, produced on spray driers from lab to commercial scale. We identified that all ASD samples showed plastic flow and deformation behavior and form robust compacts at slow compression speeds. At high speed, tablet defects occurred. The strain rate sensitivity observed in this study was comparable or slightly superior to that observed for microcrystalline cellulose, known to be a mildly strain rate–sensitive material. We showed that compression speed is a critical process parameter for ASD-containing tablets. [ABSTRACT FROM AUTHOR]

In this study, the possibility of the industrial application of terahertz (THz) imaging technology was verified. It was applied to the inspection of voids in multistack semiconductors that require safe inspection and to the high-resolution detection and inspection of foreign substances in tablets in the pharmaceutical field. To acquire a high-resolution THz image, a resonant slit probe operating in the THz region was designed, and a high-speed scanning system was established. For the inspection of a multistack semiconductor, a lateral scan method was proposed, and voids with a diameter of 0.5 mm in the multistack semiconductor were detected. In addition, the proposed probe even enables the distinguishment of the positions of voids in the multistack semiconductor. For pharmaceutical inspection, we investigated the application of THz imaging to detect mixed foreign objects frequently occurring in the tablet manufacturing process. For metals, plastics, and rubber, which are the most frequently mixed materials in the tablet manufacturing process, the foreign objects were identified in tablets using a transmission THz system. The measured THz image was compared with the conventional X-ray test result to confirm the potential of THz inspection. In the X-ray image, only metal and some polymer foreign objects were detected. In contrast, in the THz image, although the materials could not be distinguished, most foreign substances were detected. Consequently, the THz imaging test was verified as a possible new tool in fields where X-ray or existing tests are not possible. [ABSTRACT FROM AUTHOR]

Copyright of Farmacia is the property of Societatea de Stiinte Farmaceutice Romania and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

We use terahertz (THz) time-domain spectroscopy (TDS) to assess the crystalline state of indomethacin (IM) when loaded in smartFilms®. We found that smartFilms favour the amorphous IM (A-IM) for low loading concentrations. For higher concentrations, IM recrystallizes in its α - crystalline form and the amount of A-IM in the smartFilms reduces. Both, α - and A-IM are preferred over the more common γ - crystalline form, as they exhibit better water solubility, which can increase the oral bioavailability of the drug. [ABSTRACT FROM AUTHOR]

Background: In the medical and pharmaceutical fields, man has made successful use of natural origin things for millennia. Natural medications and excipients have piqued the interest of the entire globe today. Obtained from plant polymers have flashed a lot of attention in current decades because of their various pharmacological applications, such as gelling agents in gels as well as in, cosmo products, tablets, oral fluids, suspensions, and bases in a suppository. Objectives: Polymers are biocompatible, inexpensive, readily existing, and they are chosen over semisynthetic and artificial excipients. However, they have some drawbacks, including microbial contamination, lot to lot variation, reduced viscosity throughout storage, inappropriate mechanical properties, low strew and uninhibited rate of hydration. Materials and Methods: The thiolesterification technique, which uses thioglycolic acid (TGA) in the presence of a catalytic quantity of hydrochloric acid, was used to modify xanthan gum chemically. Microwave irradiated thiolated xanthan gum was also made by irradiating thiolated xanthan gum with a 750W frequency after it had been microwave irradiated. Modified and crude xanthan gum was used to make the sustained release tablet of Lornoxicam. Pre-compression and post-compression tests were performed on compressed tablets. Results: FT-IR, DSC, and X-ray diffraction investigations all show that grafting was successful. Additional peaks were identified in thiolated Xanthan gum and microwave irradiated gum, which were not present in pure Xanthan gum, according to FT-IR research. The presence of the SH stretch of the thiol group may be seen in the bands closer to 2568.00 cm-1 and 2584.70 cm-1. Modified xanthan gum had a high swelling index. When compared to tablets made from crude xanthan gum, an in-vitro release study utilizing a pH 6.8 phosphate buffer indicated a sustain release of Lornoxicam from modified xanthan gum. Conclusion: Chemically modified xanthan gum sustains the drug over a prolonged period and could be a promising carrier in oral delivery to enhance anti-nociceptive and anti-inflammatory efficiency. [ABSTRACT FROM AUTHOR]

Background: Tragacanth, a natural gum, is frequently used as stabilizer for colloidal systems and as a binder in tablets. Materials from natural sources are in increasing demand to solve the current global environmental problems arising from synthesis involving petroleum-based substances. Objectives: In this context, we improved functionality of tragacanth through crosslinking and extended its application for directly compressed fast dissolving systems. Fast dissolving formulations upon settling on the tongue disintegrate promptly and release the medicament, thus making it especially suitable for paediatrics, geriatrics, bedbound, or incapacitated patients. Materials and Methods: Cross-linked tragacanth (CLT) was explored as a potent disintegrant and compared with sodium starch glycolate and Crospovidone for its effect on compressibility and release of metoclopramide hydrochloride from tablets made by direct compression and sublimation method. Formulations made using CLT were optimized for swelling capacity, absorption efficiency, and moisture sorption capacity. Results: The most appropriate controls for linkage of tragacanth were 1:0.4 proportion of tragacanth: Epichlorohydrin, at 105°C temperature for 45 min of reaction. Prepared formulations showed desired disintegration and wetting time. Formulations made using camphor showed porosity because of sublimation and favored rapid disintegration. Based on the drug release study, it is confirmed that formulation with 4% CLT and 20% camphor prepared by sublimation process exhibited highest drug release, i. e. 99.23% within 15 min. Conclusion: This study demonstrates the novel applicability of tragacanth as an effective natural superdisintegrant after cross-linking and provides a sustainable alternative to synthetic superdisintegrants while formulating the fast-disintegrating tablets. [ABSTRACT FROM AUTHOR]

Objectives: The objective of present study was to improve dissolution rate with tableting properties of BCS class II drug Etodolac, by melt granulation and sublimation techniques. Materials and Methods: The granules of etodolac were formulated using Gelucire 50/13. The surface adsorbent Aerosil 200 was utilized. Both melt granulation and surface adsorption method in conjunction with sublimating agent were used to formulate tablets of Etodolac. Etodolac: Gelucire 50/13: Aerosil200 was used in different ratio for melt granulation technique to improve dissolution and tableting properties. Results: Solubility study of melt granules were carried out in different ratio. 1:2:1 ratio showed 25 fold increases in solubility of Etodolac. This 1:2:1 (A4) ratio was selected to designate the tablets along with super disintegrant and sublimating agents. Precompression and postcompression parameters results were satisfactory for etodolac tablets. XRD and DSC study showed that Etodolac crystallinity was completely disappeared in A4 melt granules. In vitro drug release of formulation F4 and F8 containing crosscarmallose sodium and menthol were found to be 94.64% and 98.14% drug release at the end of 24 and 20 min respectively. The dissolution statistics like MDT, %DE and DP10 for optimized formulation F8 exhibited 8.90 min, 28.25% and 55.45% respectively. Conclusion: The melt granulation technique is useful to improve dissolution of Etodolac ideally, along with superior tableting properties. [ABSTRACT FROM AUTHOR]

The moisture content of pharmaceutical powder is a key parameter contributing to tablet sticking during the tableting process. This study investigates powder moisture behavior during the compaction phase of the tableting process. Finite element analysis software COMSOL Multiphysics® 5.6 was used to simulate the compaction microcrystalline cellulose (VIVAPUR PH101) powder and predict temperature and moisture content distributions, as well as their evolution over time, during a single compaction. To validate the simulation, a near-infrared sensor and a thermal infrared camera were used to measure tablet surface temperature and surface moisture, respectively, just after ejection. The partial least squares regression (PLS) method was used to predict the surface moisture content of the ejected tablet. Thermal infrared camera images of the ejected tablet showed powder bed temperature increasing during compaction and a gradual rise in tablet temperature along with tableting runs. Simulation results showed that moisture evaporate from the compacted powder bed to the surrounding environment. The predicted surface moisture content of ejected tablets after compaction was higher compared to that of loose powder and decreased gradually as tableting runs increased. These observations suggest that the moisture evaporating from the powder bed accumulates at the interface between the punch and tablet surface. Evaporated water molecules can be physiosorbed on the punch surface and cause a capillary condensation locally at the punch and tablet interface during dwell time. Locally formed capillary bridge may induce a capillary force between tablet surface particles and the punch surface and cause the sticking.

The crystallization of peptides offers a sustainable and inexpensive alternative to the purification process. In this study, diglycine was crystallised in porous silica, showing the porous templates’ positive yet discriminating effect. The diglycine induction time was reduced by five-fold and three-fold upon crystallising in the presence of silica with pore sizes of 6 nm and 10 nm, respectively. The diglycine induction time had a direct relationship with the silica pore size. The stable form (α-form) of diglycine was crystallised in the presence of porous silica, with the diglycine crystals obtained associated with the silica particles. Further, we studied the mechanical properties of diglycine tablets for their tabletability, compactability, and compressibility. The mechanical properties of the diglycine tablets were similar to those of pure MCC, even with the presence of diglycine crystals in the tablets. The diffusion studies of the tablets using the dialysis membrane presented an extended release of diglycine through the dialysis membrane, confirming that the peptide crystal can be used for oral formulation. Hence, the crystallization of peptides preserved their mechanical and pharmacological properties. More data on different peptides can help us produce oral formulation peptides faster than usual.

The aim. To investigate the polymorphic structure of the API-dapagliflozin propanediol monohydrate and to reveal the absence of an effect of the tabletting process on the polymorphic structure of the API in model compositions of tablets. Materials and methods. Model mixtures of API-dapagliflozin propanediol monohydrate and excipients were studied. The research used the method of designing pharmaco-technological parameters of solid dosage forms, the method of quantum-chemical modelling of the mechanical properties of polymorphic modifications of APIs, the modelling of shear deformation, the nanoindentation method, the Rietveld method for calculating X-ray patterns, X-ray structural analysis of API and selected model compositions of tablets. Results. The polymorphic structure of API-dapagliflozin propanediol monohydrate and its polymorphic structure in selected model compositions of tablets produced by the pressing method were studied and analyzed. An X-ray structural study was carried out, and the qualitative and phase composition of samples and polymorphic modifications of API and model series of tablets were determined. According to the results of the X-ray structural analysis, it was established that there is no polymorphic transition and that the polymorphic structure of API is invariant under the influence of pressing pressure, which ensures the quality of the tablet form. Conclusions. The design of an experimental study was determined based on the application of the QbD concept, design of experiments -- DoE, for designing and ensuring a high-quality technological process -- tabletting of API-dapagliflozin propanediol monohydrate and excipients. To manage a critical technological parameter -- the stability of the polymorphic structure of the API, which guarantees the quality of the tablet form, its bioavailability and bioequivalence, it is necessary to use a set of methods for studying structural changes and polymorphic modifications of the API during the tableting process. According to the results of the X-ray structural study of API and selected model compositions of tablets, it was established that during the process of tabletting under pressure, the structure of the polymorphic modification of dapagliflozin propanediol monohydrate does not change, and no polymorphic transition is observed [ABSTRACT FROM AUTHOR]

Background: Starches have been shown to be important across various disciplines such as the pharmaceutical industries, food industries and also paper industries. Starch is basically a mixture of polymers consisting of α-d-glucose as the monomeric unit. The goal of this study is to modify the native starches which were obtained from Zea mays, Triticumestivum and Oriza sativa through cross-linking (using sucrose and formaldehyde at different concentrations) and also to assess the utilizability of the modified starches as potential excipients [binder] for tableting of paracetamol. Results: Maize and rice starches cross-linked with 2.5% sucrose gave the least percentage moisture content. The batches cross-linked with 40% formaldehyde showed the highest moisture content. The densities (bulk and tapped) of maize wheat and rice starches showed a reduction with the increasing concentration of the cross-linking agent for sucrose, which is the reverse case for formaldehyde. The different concentrations of sucrose and formaldehyde cross-maize, wheat and rice starches had pH values between 4.50 and 5.52. The onset and end set of the glass transition temperatures were varied for all the starches modified with formaldehyde. The melting peak temperatures obtained indicated that the formaldehyde-modified rice starch had significantly lower melting temperature than those of wheat and maize starches. Conclusions: This study reveals that various concentrations of sucrose and formaldehyde had some influence on the properties of the native starches and resulted in the production of new starch motifs with improved or new functionalities suitable for use as drug excipients in tableting. [ABSTRACT FROM AUTHOR]

Finite element analysis (FEA) is a computational method providing numerical solutions and mathematical modeling of complex physical phenomena that evolve during compression tableting of pharmaceutical powders. Since the early 2000s, FEA has been utilized together with various constitutive material models in a quest for a deeper understanding and unraveling of the complex mechanisms that govern powder compression. The objective of the present review paper is to highlight the potential and feasibility of FEA for implementation in pharmaceutical tableting in order to elucidate important aspects of the process, namely: stress and density distributions, temperature evolution, effect of punch shape on tablet formation, effect of friction, and failure of the tablet under stress. The constitutive models and theoretical background governing the above aspects of tablet compression and tablet fracture under diametral loading are also presented. In the last sections, applications of FEA in pharmaceutical tableting are demonstrated by many examples that prove its utilization and point out further potential applications. [ABSTRACT FROM AUTHOR]

Market globalisation, shortened patent lifetimes and the ongoing shift towards personalised medicines exert unprecedented pressure on the pharmaceutical industry. In the push for continuous pharmaceutical manufacturing, processes need to be shown to be agile and robust enough to handle variations with respect to product demands and operating conditions. In this paper we examine the use of operational envelopes to study the trade-off between the design and operational flexibility of the fluid bed dryer at the heart of a tablet manufacturing process. The operating flexibility of this unit is key to the flexibility of the full process and its supply chain. The methodology shows that for the fluid bed dryer case study there is significant effect on flexibility of the process at different drying times with the optimal obtained at 700 s. The flexibility is not affected by the change in volumetric flowrate, but only by the change in temperature. Here the method used a black box model to show how it could be done without access to the full model equation set, as this often needs to be the case in commercial settings. [ABSTRACT FROM AUTHOR]

Corn is an important dietary composition and energy source in ruminant breeding. Different processing methods have different digestibility in ruminants, and the economic benefit of steam flaking is higher. The degree of starch gelatinization can be improved by steam tabletting of corn. Feeding ruminants by steam-flaked corn can change the inner circumstance of the rumen, thereby improving the digestibility of corn by ruminants and improving the production performance of ruminants. The paper reviews the effect of steam-flake corn on rumen environment and production performance of ruminants, to provide reference for the application of steam-flake corn in practical production. [ABSTRACT FROM AUTHOR]

Renewable energy technologies have the great advantage of using inexhaustible, low-polluting resources with an insignificant contribution to climate change. In addition, their use reduces dependence on conventional resources that will be depleted in the not-too-distant future. Solid biofuels are produced from biomass materials, especially wood, and are new fuels that meet the new requirements of using "clean" and regenerative energy. The paper presents a series of experimental research for obtaining biomass tablets using specially designed equipment, which are a viable solution for the recovery of lignocellulosic waste from vineyards and orchards and beyond. [ABSTRACT FROM AUTHOR]

Background: Xanthan gum (XG) is a natural polymer with numerous uses. But its poor tableting and release charact1eristics reduce its usage as a tablet matrix former. Hence, the aim of the study is to improve the quality of XG by blending it with a successful semisynthetic polymer, hypromellose (HPMC). Methods: Extended release (ER) tablets were made using wet granulation technique using XG and HPMC blend. The blend was optimised using Central composite design. Prepared tablets were evaluated for in vitro tableting characteristics and drug release. In vivo absorption studies are carried out in New Zealand white rabbits. Results: Under optimal conditions, the ideal combination of factors was observed in the range of X1: 2.75-4.25 %w/w and X2: 10-20% w/w. At these finest concentrations, the predictable responses, the drug release at 4th hr was 36.31-40.34%, 20th hr was 82.21-91.43% and the hardness of the tablet was 6.6-8.5 kg/Cm2. The drug release of the optimized batch (RANERT 14) showed 90.9% similarity with the standard commercial ER tablets. Further, in vivo pharmacokinetic testing of the same batch showed, bioavailability (88.0 ±2.5%), mean residence time (16.1± 2.85 h) and biological half-life (11.47 ±0.42 h) against pure drug (BA: 65.0 4%; MRT: 5.1± 2.85 h; t1/2: 2.6151 ± 0.54 h). Conclusion: Comparable drug release profiles with the commercial tablets and enhanced pharmacokinetic profile made this combination as successful in achieving extended-release for a period of 24 hr by overcoming the drawbacks associated with XG. [ABSTRACT FROM AUTHOR]

Culex mosquitos are important infectious diseases vectors in temperate and tropical regions of the World, affecting nearly 350 million people in both developed and developing countries. Our approach was to "recycle" the well-established larvicide, and by studying the tablets, pellets and granules as floating or sinking formulations, we found a method to optimise the use of diflubenzuron against Culex pipiens mosquitoes in field conditions. A standard WHO procedure was used to test the larvicide efficacy. The combined efficacy of all floating formulations was 10.7% higher than sinking preparations (p-value =0.002) and that maximised throughout the experiment on days 14 and 21, (p-values 0.012 and 0.008, respectively). All floating formulations kept their efficacies above 70% until day 21 of the experiment, while the mortality of sinking designs dropped significantly after day 14. The lowest efficacy was observed when sinking granules were used and the highest when floating tablets were applied in the canals. Only the floating tablets showed no significant changes in efficacy from day 1 to 21, but then that efficacy drops sharp until day 35. Since the larvae spend most of their time on the surface of the slow-moving waters to breathe, and floating pellets and tablets are made of materials that can serve as food sources, we conclude that these formulations have a higher efficacy, at least in conditions of non- or slow-moving waters. This study shows the importance of a systematic approach to reformulation of old, already proven and environmentally safe larvicides which can control the mosquito populations and their spreading of various pathogens. [ABSTRACT FROM AUTHOR]

While measurement and monitoring of powder/particulate mass flow rate are not essential to the execution of traditional batch pharmaceutical tablet manufacturing, in continuous operation, it is an important additional critical process parameter. It has a key role both in establishing that the process is in a state of control, and as a controlled variable in process control system design. In current continuous tableting line operations, the pharmaceutical community relies on loss-in-weight feeders to monitor and understand upstream powder flow dynamics. However, due to the absence of established sensing technologies for measuring particulate flow rates, the downstream flow of the feeders is monitored and controlled using various indirect strategies. For example, the hopper level of the tablet press is maintained as a controlled process output by adjusting the turret speed of the tablet press, which indirectly controlling the flow rate. This gap in monitoring and control of the critical process flow motivates our investigation of a novel PAT tool, a capacitance-based sensor (ECVT), and its effective integration into the plant-wide control of a direct compaction process. First, the results of stand-alone experimental studies are reported, which confirm that the ECVT sensor can provide real-time measurements of mass flow rate with measurement error within -1.8 ~ 3.3% and with RMSE of 0.1 kg/h over the range of flow rates from 2 to 10 kg/h. The key caveat is that the powder flowability has to be good enough to avoid powder fouling on the transfer line walls. Next, simulation case studies are carried out using a dynamic flowsheet model of a continuous direct compression line implemented in Matlab/Simulink to demonstrate the potential structural and performance advantages in plant-wide process control enabled by mass flow sensing. Finally, experimental studies are performed on a direct compaction pilot plant in which the ECVT sensor is located at the exit of the blender, to confirm that the powder flow can be monitored instantaneously and controlled effectively at the specified setpoint within a plant-wide feedback controller system. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to develop a method for the preparation and characterization of paroxetine (PRX) tablets, obtained by coupling hot-melt extrusion and fused deposition modelling (FDM)-based three-dimensional printing (3DP) technology. The impact of the printing process parameters on the drug stability and on the tablets performance was assessed. Methods: Tablets were obtained by FDM of hot-melt extruded PRX-loaded filaments. Physicochemical, thermal, spectroscopic, diffractometric analysis and in-vitro dissolution tests of the intermediate products and the finished dosage forms were performed. Key findings: The characterization of printed tablets evidenced mass and dimensions uniformity, and consistency of drug content and dissolution profile. The formation of amorphous solid dispersions and interaction of formulation components throughout the manufacturing process were demonstrated. Layer thickness, printing temperature, printing and travelling speeds, and infill were the most impacting process parameters on both the physicochemical properties and the in-vitro performance of the 3D-printed tablets. Conclusions: PRX tablets, meeting compendial limits, were manufactured by 3DP, envisaging their clinical use as individually designed dosage forms. The assessment of the impact of processing parameters on the printed tablets provided insights, which will ultimately allow streamlining of the 3D process set-up for quicker and easier production of patient-centric medicines. [ABSTRACT FROM AUTHOR]

Erythritol has several characteristic physicochemical properties, such as high solubility, low hygroscopicity, low toxicity, and preferred sweetness among patients. However, the raw powder has less compressibility and frequently exhibits tableting failure such as a capping and lamination. In this study, we designed erythritol granules for direct compression using different granulation methods (dry granulation, wet extruding granulation, fluidized bed granulation) and a different binder (e.g., polyvinylpyrrolidone, hypromellose, and sodium carboxymethylcellulose). The tablet using the granules with hypromellose exhibited sufficient tabletability. In addition, we found that granulation using an erythritol dissolving binder solution can increase the erythritol content in the granules and further improve the compressibility and tablet hardness. The resultant erythritol granule was applicable for tableting, even when including less compressible material (acetaminophen and N-acetylglucosamine). [ABSTRACT FROM AUTHOR]

Copyright of Karbala Journal of Pharmaceutical Sciences is the property of Republic of Iraq Ministry of Higher Education & Scientific Research (MOHESR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Following the paradigm shift in the pharmaceutical industry from batch to continuous production, additional instrumentation and revision of control strategies to optimize material flow throughout the downstream processes are required. Tableting manufacturing is one of the most productive in terms of turnover and investment into new sensor technologies is an important decision-making step. This paper proposes a continuous solution to detect changes in material properties, and a control algorithm to aid in minimizing risk at the end-product line. Some of the sub-processes involved in tableting manufacturing perform changes in powder and liquid mixtures, granulation, density, therefore changing flow conditions of the raw material. Using impedance spectroscopy in a continuous sensing and monitoring context, it is possible to perform online identification of generalized (fractional) order parametric models where the coefficients are correlated to changes in material properties. The model parameters are then included in a self-tuning control gain used in ratio control as part of the local process control loop. The solution proposed here is easy to implement and poses a significant added value to the current state of art in pharmaceutical manufacturing technologies. [ABSTRACT FROM AUTHOR]