Gummy formulations are defined as gradually or slowly released solid oral dosage forms. Risperidone is an atypical antipsychotic medication used to treat schizophrenia and autism-related irritability. This study presents the development of visually appealing, patient-tailored medicated gummies that act as a novel pharmaceutical form of Risperidone for pediatrics. In this study, two gummy bases were used, one containing Glucomannan and the other containing Gelatin as a gelling agent, where these gummy bases were loaded with coated Risperidone pellets with a controlled release layer. The final products were evaluated for their pH, viscosity, content uniformity, drug content, and dissolution profile. Both formulas showed proper rheology and met content and weight uniformity standards. The release rates for F1 and F2 in the acidic media were 25% and 11%, respectively, after 2 h. At the same time, a full-release profile for Risperidone was noticed in both formulae at pH 6.8 where the release lasts for 24 h. It can be concluded that the chewable semi-solid dosages (gummies) filled with coated pellets are suitable for pediatric patients since pediatrics have drug-related problems which can be solved using high gastro-resistance coated pellets, which also shows a proper release profile for the drug.

A pediatric dosage form for crizotinib (Xalkori) was commercialized using quality-by-design principles in a material-sparing fashion. The dosage form consists of spherical multiparticulates (microspheres or pellets) that are coated and encapsulated in capsules for opening. The crizotinib (Xalkori)-coated pellet product is approved in the US for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) and unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. The product is also approved in the US for adult patients with non-small cell lung cancer (NSCLC) who are unable to swallow intact capsules. The lipid multiparticulate is composed of a lipid matrix, a dissolution enhancer, and an active pharmaceutical ingredient (API). The API, which remains crystalline, is embedded within the microsphere at a 60% drug loading in the uncoated lipid multiparticulate to enable dose flexibility. The melt spray congealing technique using a rotary atomizer is used to manufacture the lipid multiparticulate. Following melt spray congealing, a barrier coating is applied via fluid bed coating. Due to their particle size and content uniformity, this dosage form provides the dosing flexibility and swallowability needed for the pediatric population. The required pediatric dose is achieved by opening the capsules and combining doses of different encapsulated dose strengths, followed by administration of the multiparticulates directly to the mouth. The encapsulation process was optimized through equipment modifications and by using a design of experiments approach to understand the operating space. A limited number of development batches produced using commercial-scale equipment were leveraged to design, understand, and verify the manufacturing process space. The quality by design and material-sparing approach taken to design the melt spray congeal and encapsulation manufacturing processes resulted in a pediatric product with exceptional content uniformity (a 95% confidence and 99% probability of passing USP <905> content uniformity testing for future batches).

OBJECTIVE: This paper investigates the critical role of material thickness in freeze-dried pellets for enhancing the storage stability of encapsulated bacteria. Freeze dried material of varying thicknesses obtained from different annealing durations is quantified using Scanning Electron Microscopy (SEM) and X-ray microtomography (μCT), the material thickness is then correlated to the storage stability of the encapsulated cells.
METHODS: A formulation comprising of sucrose, maltodextrin, and probiotic cells is quenched in liquid nitrogen to form pellets. The pellets undergo different durations of annealing before undergoing freeze-drying. The material thickness is quantified using SEM and μCT. Storage stability in both oxygen-rich and oxygen-poor environments is evaluated by measuring CFU counts and correlated with the pellet structure.
RESULTS: The varying annealing protocols produce a range of material thicknesses, with more extensive annealing resulting in thicker materials. Storage stability exhibits a positive correlation with material thickness, indicating improved stability with thicker materials. Non-annealed pellets exhibit structural irregularities and inconsistent storage stability, highlighting the impracticality of avoiding annealing in the freeze-drying process.
CONCLUSIONS: Extensive annealing not only enhances the storage stability of probiotic products but also provides greater control over the freeze-drying process, ensuring homogeneous and reproducible products. This study underscores the importance of material thickness in freeze-dried pellets for optimizing storage stability for probiotic formulations, and emphasize the necessity of annealing as a critical step in freeze-drying quenched pellets to achieve desired structural and stability outcomes.

This article examines the effects of different storage conditions on selected physicochemical properties of three types of agro-biomass pellets: sunflower husks, wheat straw and hemp hurds, and wood pellets. The tests were carried out in a climatic chamber, which allows simulation of real storage conditions, i.e. conditions with high air humidity and variable (±) ambient air temperatures. The results showed higher degradability of agro-biomass pellets compared to woody biomass. The pellets degraded to a less extent at varying  ± temperatures than at high humidity (90% RH). After complete moisture saturation, durability decreases for agro-pellets by an average of 9%, while after freezing and defreezing for sunflower husk pellets and woody pellets durability decreases by 2%, and for hemp hurd pellets by 11%. In contrast, strength-by-dropping index for agro-pellets decreased by 20% after being in the environment (30 °C and 90%RH) and 15% under varying temperature conditions. No change in the energy parameters of all pellets in the dry matter was noted. On the other hand, an increase in the moisture content of pellets when they are stored under different environmental conditions results in a decrease in calorific value.

Residual lignocellulosic biomass (RLB) is a valuable resource that can help address environmental issues by serving as an alternative to fossil fuels and as a raw material for producing various value-added molecules. To gain a comprehensive understanding of the use of lignocellulosic waste in South America, a review was conducted over the last 4 years. The review focused on energy generation, biofuel production, obtaining platform molecules (such as ethanol, hydroxymethylfurfural, furfural, and levulinic acid), and other materials of interest. The review found that Brazil, Colombia, and Ecuador had the most RLB sources, with sugarcane, oil palm, and rice crop residues being the most prominent. In South America, RLB is used to produce biogas, syngas, hydrogen, bio-oil, biodiesel, torrefied biomass, pellets, and biomass briquettes. The most studied and produced value-added molecule was ethanol, followed by furfural, hydroxymethylfurfural, and levulinic acid. Other applications of interest that have been developed with RLB include obtaining activated carbon and nanomaterials. Significant progress has been made in South America in utilizing RLB, and some countries have been more proactive in regulating its use. However, there is still much to learn about the potential of RLB in each country. This review provides an updated perspective on the typification and valorization of residual biomass in South America and discusses the level of research and technology being applied in the region. This information can be helpful for future research on RLB in South America.

UNASSIGNED: The anthropause during the recent COVID-19 pandemic provided a unique opportunity to examine the impact of human activity on seabirds. Lockdowns in Peru prevented people from visiting coastal areas, thereby reducing garbage disposal on beaches and the movement of microplastics into the ocean. This cessation of activities likely led to a temporary decrease in plastic pollution in coastal regions. We aimed to investigate this phenomenon in inshore-feeding neotropic cormorants (Nannopterum brasilianus) along the Circuito de Playas Costa Verde (CPCV), situated on the coastal strip of Lima, Peru (∼ 11 million people).
UNASSIGNED: We collected and analyzed fresh pellets along the CPCV before (over 11 months) and during the pandemic lockdowns (over 8 months).
UNASSIGNED: Our findings revealed a significant reduction in the occurrence of plastic in pellets during the pandemic period (% Oc = 2.47, n = 647 pellets) compared to pre-pandemic conditions (% Oc = 7.13, n = 800 pellets). The most common plastic debris item found in the pellets was threadlike microplastic. Additionally, our study highlights the direct correlation between human presence on beaches and the quantity of microplastics (mainly threadlike) found in cormorant pellets. We suggest that the reintroduction of these materials into the sea, previously accumulated on the coast, is likely facilitated by the movement and activity of beachgoers toward the ocean.

The bitter drug, warfarin, has a narrow therapeutic index (NTI) and is used in paediatrics and geriatrics. The aim of this feasibility study was to formulate the taste-masked warfarin-containing pellets to be applicable for dose personalisation and to improve patient compliance, as well as to investigate the effect of the core type (PharSQ® Spheres M, CELPHERE™ CP-507, and NaCl) on the warfarin release from the Kollicoat® Smartseal taste-masking-coated pellets. The cores were successfully drug-loaded and coated in a fluid-bed coater with a Wurster insert. An increase in particle size and particle size distribution was observed by optical microscopy. In saliva-simulated pH, at the Kollicoat® Smartseal level of 2 mg/cm2, none of the pellets demonstrated drug release, confirming their efficient taste-masking. However, in a stomach-simulated pH, a faster drug release was observed from PharSQ® Spheres M- and CELPHERE™ CP-507-coated pellets in comparison with NaCl cores. Additional experiments allowed us to explain the slower drug release from NaCl-containing pellets because of the salting-out effect. Despite the successful taste masking, the drug release from pellets was relatively slow (not more than 91% per 60 min), allowing for further formulation improvements.

Field studies with the large-stemmed plant Artemisia dubia (A. dubia) have been carried out at the Vėžaičiai Branch of LAMMC since 2018. According to three years of experimental results, annual dry matter (DM) yield varied from 7.94 to 10.14 t ha-1. Growing conditions, nitrogen application level, and harvesting time had statistically significant impacts on A. dubia productivity. The most important tasks of this article were to investigate and determine the factors influencing A. dubia plant biomass productivity and the evaluation of technological, power, and environmental parameters of plant biomass utilization for energy conversion and the production of high-quality solid biofuel pellets. For the experiments, six variants of A. dubia samples were used, which were grown in 2021. Plants were cut three times and two fertilization options were used: (1) no fertilization and (2) fertilization with 180 kg ha-1 of nitrogen fertilizer. These harvested plants were chopped, milled, and pressed into pellets. The physical-mechanical characteristics (moisture content, density, and strength) of the A. dubia pellets were investigated. During this study, it was found that the density in the dry mass (DM) of the pellets ranged from 1119.86 to 1192.44 kg m-3. The pellet moisture content ranged from 8.80 to 10.49%. After testing pellet strength, it was found that the pellets which were made from plant biomass PK-1-1 (first harvest without N fertilization) were the most resistant to compression, and they withstood 560.36 N of pressure. The dry fuel lower heating value (LHV) of the pellets was sufficiently high and was very close to that of the pine sawdust pellets; it varied from 17.46 ± 0.25 MJ kg-1 to 18.14 ± 0.28 MJ kg-1. The ash content of the burned pellets ranged from 3.62 ± 0.02% to 6.47 ± 0.09%. Emissions of harmful pollutants-CO2, CO, NOx, and unburnt hydrocarbons (CxHy)-did not exceed the maximum permissible levels. Summarizing the results for the investigated properties of the combustion and emissions of the A. dubia pellets, it can be concluded that this biofuel can be used for the production of pressed biofuel, and it is characterized by sufficiently high quality, efficient combustion, and permissible emissions to the environment.

Background and Objectives: The enteric form of omeprazole is one of the most commonly prescribed medications. Similarly to Europe, Kazakhstan relies on the localization of pharmaceutical drug production as one of its primary strategies to ensure that its population has access to affordable and good-quality medicines. This study comprehensively describes the technologically available development of bioequivalent delayed-release omeprazole. Materials and Methods: Various regimes and technological parameters were tested on laboratory- and production-scale equipment to establish a technical process where a functional and gastro-protective layer is essential. According to the ICH guidance on stability testing and Kazakhstan local rules, stability studies were conducted under conditions appropriate for climate zone II. The comparison of the rate and extent of absorption with subsequent assessment of the bioequivalence of the generic and reference drugs after a single dose of each drug at a dose of 40 mg was performed. Results: The quantitative and qualitative composition and technology of producing a new generic enteric form of omeprazole in capsules were developed and implemented at the manufacturing site of solid forms. Dissolution profiles in media with pH 1.2 and 6.8 were proven. During the accelerated six-month and long-term twelve-month studies, the developed formulation in both packaging materials at each control point passed the average weight and mass uniformity test, dissolution test, acid-resistance stage test, buffer stage test, impurity assay, and microbiological purity test and met all the specification criteria. A bioequivalence study in 24 healthy volunteers compared against the innovative drug showed the bioequivalency of the new generic system. The obtained values from the test and reference products were 1321 ± 249.0 ng/mL and 1274 ± 233 ng/mL for Cmax, 4521 ± 841 ng·h /mL and 4371 ± 695 ng·h /mL for AUC0-t, and 4636 ± 814 ng·h /mL and 4502 ± 640 ng·h /mL for AUC0-∞. Conclusions: Using affordable technologies, a bioequivalent generic delayed-release formulation of 20 and 40 mg omeprazole has been developed.

Liquid formulations are mostly used in the paediatric population. However, with certain active pharmaceutical ingredients (APIs), it is very difficult to guarantee quality and stability; this is the case, for example, with omeprazole. Omeprazole is used as a model drug due to the lack of a paediatric formulation meeting gastro-resistance requirements, which remains a challenge today. In this experimental study, the development of enteric polymer-coated pellets is proposed. It is proposed to use aqueous coating dispersions without the use of organic solvents, which are commonly used in fluidised bed coatings. To do this, the design of experiments method is used as a statistical tool for experiment creation and the subsequent analysis of the responses. In particular, this study uses a randomised full factorial design. The mean weight increases of the protective layer and the enteric coating are chosen as factors. Each factor is assigned two levels. Therefore, the design of the used experiments is a 22 + 1 central point. Overall, the obtained pellets can be an alternative to the compounding formulas of omeprazole that are currently used in the paediatric population, which do not meet the gastro-resistance specifications necessary to guarantee the therapeutic efficacy of this active ingredient.