Search Results (139)

Background/Objectives: Silodosin (SLD) is a selective α1A-adrenoceptor antagonist used in the treatment of benign prostatic hyperplasia. Bioequivalence failures have been reported for hard capsule formulations, largely due to the effect of disintegrant excipients, making soft capsules a promising alternative dosage form. This study investigated the stability of SLD soft capsules stored in two different packaging materials, PVC/PVDC and AquaBa^®. Methods: Storage temperatures at 25 °C/60%, 30 °C/65% RH, 30 °C/75% RH, and 40 °C/75% RH, and sampling were performed according to the International Council for Harmonisation (ICH) stability conditions. Assays were performed by HPLC and UV, and mass detection. Results: Degradation analysis revealed that temperature played a critical role in SLD degradation and the formation of its primary degradation products, dehydrosilodosin and impurity 1. Conclusions: AquaBa^® demonstrated superior protective properties compared to PVC/PVDC, preserving SLD content above 95% for over 12 months under 25 °C and 30 °C conditions while limiting the formation of degradation products. Nevertheless, impurity 1 exceeded its ICH Q3B (R2) specification limit (0.3%) after six months under all conditions tested, suggesting a critical interaction between SLD and excipients such as Capryol^® 90. Kinetic modeling confirmed first-order degradation kinetics for both dehydrosilodosin and impurity 1, with a faster degradation rate observed in PVC/PVDC blisters. These findings highlight the critical role of packaging in pharmaceutical stability. While AquaBa^® emerges as the preferred option for SLD soft capsules, formulation optimization remains necessary to limit impurity formation, extend shelf life, and ensure regulatory compliance. Full article

Corn husk-derived cellulose (CHC) was incorporated into gelatin–cassava starch (CS) capsule formulations to evaluate its effectiveness as a sustainable reinforcing agent. The addition of CHC enhanced the structural cohesion of the films and improved their resistance to storage-related temperature–humidity stress, while maintaining desirable flexibility. Consistent with this, the films retained mechanical performance and appearance under ICH-aligned storage conditions, indicating better endurance during storage and processing. Disintegration performance remained within pharmacopeial requirements in both acidic and neutral media, confirming the suitability of the capsules for oral delivery applications. Surface assessment revealed more uniform morphology and fewer irregularities in the capsule matrix when CHC was present, suggesting strong compatibility among the cellulose, gelatin, and starch components. Collectively, these findings demonstrate that CHC is an effective plant-based reinforcement capable of strengthening gelatin capsules without compromising functional performance. The use of corn husk, an abundant agricultural residue, also highlights a sustainable pathway for the development of halal-compliant capsule shells and contributes to the broader advancement of eco-friendly biopolymer systems in pharmaceutical applications. Full article

Egg parasitoids, such as Telenomus remus (Hymenoptera: Scelionidae), face significant challenges after release, as their pupae are exposed to various mortality factors that reduce the efficiency of biological control programs. Therefore, this study aimed to evaluate a honey-solid diet that can feed adults still inside the capsules without sticking the wasps on its surface, enabling parasitoid storage and later field release. Three independent bioassays were performed, each with 20 completely randomized replications. The first bioassay evaluated the acceptance of a solid feed—honey soaked in cotton thread—compared to the traditional form—honey droplets. In the second bioassay, the storage periods after emergence of adults in capsules with honey-solid food were analyzed at 2, 4, 6, and 8 days post-emergence, and the third bioassay studied the efficacy of different release densities of fed adults under field conditions. Parasitoids fed on the honey-solid diet exhibited a 13.3% reduction in parasitism compared to honey droplets. However, the sticky, viscous nature of honey can lead to parasitoids becoming glued, potentially leading to their death. T. remus feeding on the honey-solid diet resulted in low mortality inside the capsules, living up to six days with only 22.2% reduction in parasitism capacity, making it a viable alternative to release and transport fed adult parasitoids, with an increase of around 30% in the released density of parasitoids compared with the parasitoids fed on honey droplets. This flexibility of releasing T. remus up to six days after emergence provided valuable knowledge to establish T. remus as a biocontrol agent. Furthermore, the highest tested parasitoid density of 20,000 parasitoids per hectare obtained the highest parasitism of Spodoptera frugiperda (Lepidoptera: Noctuidae) eggs. However, future studies are still required with higher releasing densities and less expensive methods of mass rearing the parasitoid for those higher densities to be economically viable. Full article

Background/Objectives: Vitamin D (VD) is a fat-soluble vitamin essential for bone health, and calcium and phosphorus absorption. Recently, new interesting functions are reported such as neuroprotective activity, regulatory roles in the immune system, and protective effects in cancer patients. However, the lipophilic nature of VD represents a limitation, as it is associated with low solubility and poor absorption; additionally, VD exhibits poor stability. Methods: Two nanoliposomes containing VD, conventional (LP-VD) and conjugated with D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS, LPT-VD), were developed. The physical and chemical stability during the storage and gastrointestinal stability, the dissolution profile, the cytotoxicity and the Caco-2 cellular uptake were investigated. Nanoliposomes were fully characterized determining sizes, PdI, Zeta potential, encapsulation efficiency and recovery and they were lyophilized to improve stability. Subsequently, the freeze-dried liposomes were encapsulated in hard gelatin capsules to mimic an oral dosage form, and they were subjected to dissolution test. Results: LP-VD exhibited an average size of 85.50 ± 5.70 nm, a PdI of 0.24 ± 0.06, and a ZP of −20.90 ± 4.37 mV. LPT-VD showed an average size of 61.70 ± 3.90 nm, a PdI of 0.26 ± 0.02, and a ZP of −9.45 ± 2.99 mV. The EE% values were 95.76 ± 1.26% and 97.54 ± 3.24% for LP-VD and LPT-VD, respectively. Both nanoliposomes solubilized 2 mg/mL of VD and improved both its storage stability and stability in aqueous and gastrointestinal environment. The freeze-dried products guarantee constant chemical-physical parameters for 28 days at 25 °C. VD dissolution profile was improved. Conclusions: Nanoliposomes, in particular LPT-VD, showed the best results in terms of chemical stability, dissolution profile, and Caco-2 cellular uptake, confirming the stabilization, bioenhancer properties and P-gp inhibition capabilities of TPGS. Full article

(1) Background: Chronic enteropathy (CE) in canines is associated with persistent microbiome dysbiosis, and conventional therapies (e.g., special diets, antimicrobials, and immunosuppressive drugs) are sometimes ineffective. Currently, fecal microbiota transplantation (FMT) has proven successful in treating CE in canines via invasive methods (e.g., enemas or endoscopy) or via oral frozen liquid capsules, which must be stored at −80 °C. However, due to the invasiveness of the administration methods and the storage constraints of the liquid capsules, FMT is not widely used in veterinary clinical practice. (2) Methods: The case of a four-year-old Siberian Husky with a three-year history of CE following canine parvovirus infection received lyophilized FMT capsules for thirty days. Stool samples were collected for metagenomic sequencing and quantification of fecal short-chain fatty acids (SCFAs), both pre- and post-FMT. Blood samples were analyzed using complete blood count (CBC) and biochemical testing. Ultrasound was used to assess the wall thickness of the stomach, duodenum, jejunum, and colon. (3) Results: Post-FMT, improvements in clinical outcomes were observed: fecal scores improved from 6 (unformed stools with mucus) to 2 (formed stool), and body weight increased by 8.3% (from 24.2 kg to 26.2 kg). Abnormal CBC and biochemical parameters were restored to reference ranges, including hematocrit (from 60.6% to 55.7%), hemoglobin (from 208 g/L to 190 g/L), creatinine (from 167 μmol/L to 121 μmol/L), and urea (from 11.9 mmol/L to 7.1 mmol/L). Ultrasound results showed that colonic wall thickness decreased from 0.23 ± 0.03 cm (pathological) to 0.18 ± 0.01 cm (physiological). Metagenomic analysis revealed that microbial richness (operational taxonomic units (OTUs) from 151 to 183) and diversity (Shannon and Simpson indices from 3.16 to 4.8 and from 0.87 to 0.94, respectively) all increased. The microbiota composition of the recipient exhibited a decline in the relative abundance of Firmicutes, falling from 99.84% to 35.62%, concomitant with an increase in Actinobacteria (from 0.08% to 4.78%), indicating a convergence toward a donor-like profile. Fecal SCFAs analysis revealed a 251.4% increase in propionate (from 0.0833 to 0.2929 mg/g) and elevated acetate (from 0.4425 to 0.4676 mg/g). These changes are functionally linked to enriched propanoate metabolism (Z = 0.89) in KEGG pathways. (4) Conclusions: Oral lyophilized FMT capsules resolved clinical signs of CE, enhanced microbial diversity and richness, and restored donor-like abundances of gut microbiota, particularly SCFA-producing taxa. Microbial restructuring increased microbial metabolite output, notably SCFA concentrations, and enriched functional metabolic pathways. Importantly, lyophilized FMT overcomes storage limitations and administration barriers, demonstrating its high clinical viability for treating canine CE. Full article

Dry seed longevity varies considerably among species, but little is known about its relation with the climate and the molecular mechanisms that determine seed lifespan. Salicaceae species, with more than 620 species worldwide, are known to produce short-lived seeds, making them particularly good models to explore ageing processes in the glassy state rather than under accelerated ageing. We compared seed lifespan for 13 species of Salix and Populus across a broad geographical range (up to 2200 m a.s.l.). High-quality seeds were obtained by optimizing collection time (just before capsule dehiscence) and post-harvest handling (i.e., the use of negative pressure to remove seed hairs). At optimal moisture contents (MCs) between 6 and 9%, most species seeds demonstrated minimal decreases in viability after storage at −20 °C or in liquid nitrogen for 3 years. Dry room (15% RH, 15 °C) storage differentiated between species’ seed lifespans (P₅₀s) of c. 150 to >1200 d. Unlike Salix, Populus species from warm wet environments tended to produce longer-lived seeds in dry storage. Based on transcriptome data on Populus davidiana (longer-lived) and Populus euphratica (shorter-lived), we revealed high correlations between late seed maturation genes, such as 60% of HSP and 67% of LEA genes showed higher expression in P. davidiana seeds, while 70% of WRKY transcription factors showed significantly higher expression in P. euphratica seeds. For these two species, genes related to oxidative stress might be the most important contributor to different seed longevity in the dry glassy state. Full article

Background/Objectives: Oral delivery of biologics offers advantages for patient access and adherence compared to injection, but suffers from low bioavailability due to mucosal barriers and drug degradation in the gastrointestinal tract. We previously developed an oral self-pressurized aerosol (OSPRAE) capsule that uses effervescent excipients to generate CO₂ gas, building internal pressure to eject powdered drug at high velocity across intestinal mucosa. Methods: Here, we developed two key design improvements: (i) an enteric covering to protect the capsule delivery orifice in gastric fluids and (ii) reduced humidity content of capsules to extend shelf-life. Results: Enteric-covered capsules prevented drug release in simulated gastric fluid and then enabled rapid release upon transfer to simulated intestinal fluid. Burst pressure for enteric-covered capsules was ~3–4 times higher than non-covered capsules. After storage for up to three days, the capsules’ effervescent excipients pre-reacted, making them unable to achieve high pressure during subsequent use. To address this limitation, we prepared capsules under reduced humidity conditions, which inhibited pre-reaction of effervescent excipients during storage, and a polyurethane coating to improve water uptake into the capsule to drive the effervescence reaction in intestinal fluid. Conclusions: These design improvements enable improved functionality of OSPRAE capsules for continued translation in pre-clinical and future clinical development. Full article

Background/Objectives: This study investigates the impact of high humidity (25 °C, 75% relative humidity) on gelatin and hydroxypropyl methylcellulose (HPMC) capsules used in dry powder inhalers (DPIs), focusing on moisture dynamics, structural responses, and mechanical performance, with an emphasis on understanding how different capsule types respond to prolonged exposure to humid conditions. Methods: Capsules were exposed to controlled humidity conditions, and moisture uptake was measured via thermal analysis. Visual observations of silica bead color changes were performed to assess moisture absorption, while surface wettability was measured using the sessile drop method. Hardness testing, mechanical deformation, and puncture tests were performed to evaluate structural and mechanical changes. Positron annihilation lifetime spectroscopy (PALS) was used to analyze free volume expansion. Results: HPMC capsules exhibited rapid moisture uptake, attributed to their lower equilibrium moisture content and ability to rearrange dynamically, preventing brittleness. In contrast, gelatin capsules showed slower moisture absorption but reached higher equilibrium levels, resulting in plasticization and softening. Mechanical testing showed that HPMC capsules retained structural integrity with minimal deformation, while gelatin capsules became softer and exhibited reduced puncture resistance. Structural analysis revealed greater free volume expansion in HPMC capsules, consistent with their amorphous nature, compared with gelatin’s semi-crystalline matrix. Conclusions: HPMC capsules demonstrated superior humidity resilience, making them more suitable for protecting moisture-sensitive active pharmaceutical ingredients (APIs) in DPI formulations. These findings underline the importance of appropriate storage conditions, as outlined in the Summary of Product Characteristics, to ensure optimal capsule performance throughout patient use. Full article

This review presents information obtained over the past 10 years on the methods to control the widespread worldwide phytopathogen Pectobacterium carotovorum subsp. carotovorum (Pcc). This bacterium is among the ten most dangerous phytopathogens; it affects a wide range of cultivated plants: vegetables, ornamental and medicinal crops, both during vegetation and during the storage of fruits. Symptoms of Pcc damage include the wilting of plants, blackening of vessels on leaves, stems and petioles. At the flowering stage, the stem core gradually wilts and, starting from the root, the stem breaks and the plant dies. Pcc is a rod-shaped, non-capsule and endospore-forming facultative anaerobic Gram-negative bacterium with peritrichous flagellation. Pcc synthesizes bacteriocins—carocins. The main virulence factors of Pcc are the synthesis of N-acyl-homoserine lactone (AHL) and plant cell wall-degrading enzymes (PCWDEs) (pectinases, polygalacturonases, cellulases, and proteases). Diagnostic methods for this phytopathogen include polymerase chain reaction (PCR), loop-mediated isothermal amplification (LAMP), multilocus genotyping of strain-specific genes and detection of unique volatile organic compounds (VOCs). The main methods to control this microorganism include the use of various chemicals (acids, phenols, esters, salts, gases), plant extracts (from grasses, shrubs, trees, and algae), antagonistic bacteria (Bacillus, Pseudomonas, Streptomyces, and lactic acid bacteria), viruses (including a mixture of bacteriophages), and nanomaterials based on metals and chitosan. Full article

The fruit of Momordica cochinchinensis Spreng., commonly known as Gac fruit, contains arils rich in carotenoids and unsaturated fatty acids, making it suitable for use as a natural colorant, flavor enhancer, and dietary supplement. This study examined Gac oil extracted from locally cultivated Gac fruit in Taiwan and evaluated the impact of different encapsulation methods and press through packaging (PTP) packaging on its oxidative stability during storage. The Gac oil was found to contain exceptionally high levels of β-carotene (up to 6047.52 ± 16.15 ppm) and lycopene (3192.84 ± 20.21 ppm). Among the tested formulations, soft capsules demonstrated lower peroxide value (PV) and better retention of carotenoids, including lycopene β-carotene compared to hard capsules. Furthermore, capsules stored in PTP packaging exhibited enhanced protection against oxidation. Overall, soft capsules combined with PTP packaging provided the most effective approach for maintaining the nutritional quality and oxidative stability of Gac oil during storage. Full article

The growing demand for natural preservatives in the food industry has highlighted the importance of essential oils (EOs), despite their limitations related to volatility and oxidative instability. This study addresses these challenges by developing pectin-based microcapsules for encapsulating lemon essential oil (LEO) using ultrasound-assisted ionotropic gelation. The EO, extracted from Citrus limon (Eureka variety), exhibited a high limonene content (56.18%) and demonstrated significant antioxidant (DPPH IC50: 28.43 ± 0.14 µg/mL; ABTS IC50: 35.01 ± 0.11 µg/mL) and antifungal activities, particularly against A. niger and Botrytis spp. Encapsulation efficiency improved to 82.3% with ultrasound pretreatment, and SEM imaging confirmed spherical, uniform capsules. When applied to fresh-cut apples, LEO-loaded capsules significantly reduced browning (browning score: 1.2 ± 0.3 vs. 2.8 ± 0.2 in control), microbial load (4.9 ± 0.2 vs. 6.5 ± 0.4 log CFU/g), and weight loss (4.2% vs. 6.4%) after 10 days of storage at 4 °C. These results underscore the potential of ultrasound-enhanced pectin encapsulation for improving EO stability and efficacy in food preservation systems. Full article

Background: The personalization of medication through 3D printing enables the development of capsular devices (CDs) tailored to patient-specific needs. This study aimed to evaluate the stability and in vivo performance of 3D-printed polyvinyl alcohol (PVA) CDs with 0.4 and 0.9 mm width wall thicknesses (WT) compared to traditional hard gelatin capsules (HGCs). Methods: Capsules were tested for swelling, erosion, adhesion, water sorption, and in vitro disintegration. Additionally, the release of the model drug (losartan potassium) from CDs was evaluated. In vivo capsule opening times were assessed in dogs using X-ray imaging. Stability studies were conducted under natural (25 ± 2 °C, 60 ± 5% RH) and accelerated (40 ± 2 °C, 75 ± 5% RH) storage conditions. Results: CDs with 0.4 mm WT (CD–0–0.4) exhibited higher swelling and erosion, lower adhesion, and faster disintegration, leading to a more immediate drug release, comparable to HGCs. A strong correlation was found between in vitro and in vivo disintegration behavior. Water sorption tests revealed lower moisture affinity for PVA CDs compared to HGC. Stability studies showed that CD–0–0.4 retained its physical and chemical properties. Instead, CDs with 0.9 mm WT (CD–0–0.9) were sensitive to storage, particularly under accelerated aging, which affected their integrity and release profile. Conclusions: These findings highlight the potential of PVA-CDs, especially the 0.4 mm design, as a promising and stable alternative for compounding pharmacy applications, offering an effective platform for personalized oral drug delivery. Full article

Lactobacillus spp. and other beneficial bacteria are predominant in the vaginal microbiota and represent an opportunity to correct dysbiosis if administered intravaginally. Since no commercial formulations are available, developing magistral formulations is an option, provided that they ensure viability and therapeutic efficacy. To evaluate their stability and culturability, four magistral formulations containing 10⁹ microorganisms were tested: vaginal capsules, vaginal ointment, gelatinous ovules, and waxy ovules. Certified strains of L. crispatus, L. johnsonii, L. gasseri, Limosilactobacillus reuteri, and Lacticaseibacillus rhamnosus, as well as a combination of the five, were used. The formulations were tested for pharmaco-technical stability using average weight and disintegration tests, as well as evaluation organoleptic. In addition, microbial recovery was evaluated by counting Colony-Forming Units (CFUs). All forms, except the gelatinous ovules, allowed microbial recovery at concentrations from 10⁷ to 10⁹ CFUs, ensuring stability for 60 days. The recovery varied depending on the strains and dosage forms employed, with the most favorable outcomes for vaginal capsules. This highlights the need for standardized strains and excipients in magistral formulations. Further studies are needed to evaluate the viability of other strains of different excipients, vehicles, or different storage; however, capsules have demonstrated efficacy and are an excellent candidate for vaginal use formulations of Lactobacillus spp. Full article

The utilization of gelatin capsule waste (GCW) poses a challenge for the industry. This study investigates its potential as a functional food ingredient by evaluating the physico-chemical, rheological, and techno-functional properties of gelatin capsule waste powder (GCWP). To achieve this, the gelatin capsule waste (GCW) was mixed with maltodextrin at varying ratios (1:1, 1:2, 1:3, 1:4, and 1:5) and subjected to spray drying. The findings highlight maltodextrin’s crucial role in stabilizing the drying process, reducing stickiness, and enhancing handling and storage properties. All the obtained GCWP samples appeared light white and had a slightly sticky texture. The 1:5 (w/w) GCW-to-maltodextrin ratio produced the highest powder recovery with minimal stickiness, indicating enhanced drying efficiency. Increasing maltodextrin reduced gel strength, texture, and foaming properties while raising the glass transition temperature. The FTIR analysis indicated a decline in protein–protein interactions and increased polysaccharide interactions at higher maltodextrin levels. The rheological analysis demonstrated lower elastic and loss moduli with increased maltodextrin, affecting GCWP’s structural behavior. For overall properties, the GCW mixed with maltodextrin at a 1:1 ratio (GCW-1M) is recommended for future applications, particularly for its gelling characteristics. The GCW-1M, being rich in amino acids, demonstrates its potential as a functional food ingredient. However, certain properties, such as gel strength and powder stability (hygroscopicity and stickiness), require further optimization to enhance its industrial applicability as a functional food ingredient. Full article

This study used an embedding technique to prepare microcapsules with tea tree oil as the core material and a composite of β-cyclodextrin and nano-montmorillonite as the wall material. The prepared microcapsules were analyzed for their morphological characteristics, thermal stability, and major components. Additionally, the microcapsules’ effect on the quality of and active substances contained in refrigerated strawberries was investigated. The results revealed that the optimal preparation conditions for the microcapsules were a montmorillonite addition of 2% (m/v), a core-to-wall ratio of 1:12 (m/m), an encapsulation temperature of 70 °C, and an encapsulation time of 90 min. Under these conditions, the microcapsules achieved an encapsulation efficiency of 77.67%. The capsules emitted a noticeable aroma of tea tree oil, and their primary components, specifically terpinen-4-ol, 1,8-cineole, p-cymene, and terpinolene, were consistent with those of tea tree oil. The release rate of the microcapsules at 60 °C and 90 °C was significantly lower than that of liquid tea tree oil (p < 0.05). A suitable treatment with tea tree oil microcapsules preserved the appearance and quality of the strawberries, inhibited spoilage during refrigeration, reduced weight loss, maintained firmness, delayed declines in soluble solid contents and acidity in later storage stages, and enhanced the activity of the superoxide dismutase, catalase, and ascorbate peroxidase. The prepared microcapsules also suppressed increases in anthocyanins and inhibited the further maturation of the stored strawberries. The optimal preservative effect was achieved with the placement of 5.0 g of tea tree oil microcapsules per 1.2 L of storage space. Full article