Residual Moisture Content Research Articles

Drying of Seabuckthorn (Hippophae rhamnoides L.) Berry: Impact of Dehydration Methods on Kinetics and Quality

Convective hot air drying and freeze drying were investigated as potential dehydration processes to obtain powders of seabuckthorn fruit pulp. Halved seabuckthorn fruits were placed in a hot air dryer and dried at 1 m/s and at 50 or 60°C or freeze dried at less than 30 mTorr and at 20 or 50°C shelf plate temperature. An initial characterization of the seabuckthorn pulp (moisture, pH, soluble solid content, vitamins C and E, total phenolics, and carotenoids) was performed. Water loss, total phenolic compounds, total carotenoids, and vitamin C were determined at different processing times. Vitamin E was determined before and at the end of drying. Freeze-drying kinetics were faster than air drying, probably due to lower moisture diffusion in the compact, sugary, and oily structure of the air-dried tissue. The temperature had an important impact on hot air–drying and freeze-drying kinetics. Drying method and processing times affected the remaining phenolic, carotenoid, and vitamin contents of seabuckthorn berries. Freeze drying was revealed as a superior method to obtain seabuckthorn powders because of the lower residual moisture content, the ease of grinding, as well as the better nutritional retention.

Optimization of the Secondary Drying Step in Freeze Drying Using TDLAS Technology

The secondary drying phase in freeze drying is mostly developed on a trial-and-error basis due to the lack of appropriate noninvasive process analyzers. This study describes for the first time the application of Tunable Diode Laser Absorption Spectroscopy, a spectroscopic and noninvasive sensor for monitoring secondary drying in laboratory-scale freeze drying with the overall purpose of targeting intermediate moisture contents in the product. Bovine serum albumin/sucrose mixtures were used as a model system to imitate high concentrated antibody formulations. First, the rate of water desorption during secondary drying at constant product temperatures (-22 °C, -10 °C, and 0 °C) was investigated for three different shelf temperatures. Residual moisture contents of sampled vials were determined by Karl Fischer titration. An equilibration step was implemented to ensure homogeneous distribution of moisture (within 1%) in all vials. The residual moisture revealed a linear relationship to the water desorption rate for different temperatures, allowing the evaluation of an anchor point from noninvasive flow rate measurements without removal of samples from the freeze dryer. The accuracy of mass flow integration from this anchor point was found to be about 0.5%. In a second step, the concept was successfully tested in a confirmation experiment. Here, good agreement was found for the initial moisture content (anchor point) and the subsequent monitoring and targeting of intermediate moisture contents. The present approach for monitoring secondary drying indicated great potential to find wider application in sterile operations on production scale in pharmaceutical freeze drying.

Evaluation of domestic washing in Japan using life cycle assessment (LCA)

AbstractChanging lifestyles and family structures have changed consumer domestic washing behaviour in our country, with growing use of washer‐dryers and changing detergent preferences, including use of concentrated detergents. In particular, there has also been an increase in the number of combined washer‐dryers, which both save space and reduce the housework burden. However, power consumption for drying is extremely high compared to that for washing. This study reveals the drying performance of sweat‐absorbent, quick‐drying clothing in domestic washing, and uses the life cycle assessment method to evaluate washing and drying with heat‐pump washer‐dryers compared with the conventional washer‐dryer. In this study, it was assumed that drying was used on 99 days per year, based on the mean number of 99 days per year with rainfall in Tokyo. Both types of washer‐dryer showed high CO2eq emission levels for usage, with the highest levels for power consumption during drying. Compared with the conventional washer‐dryer, the heat‐pump washer‐dryer was able to reduce CO2eq emissions significantly through power savings and used less water as well, although it did require the use of larger amounts of detergent. However, the largest portion of CO2eq emissions was attributable to the drying process, and the use of sweat‐absorbent, quick‐drying clothing enabled these emissions to be reduced by approximately 10%. The residual moisture content of clothing after washing and spin‐drying, which significantly affects the amount of CO2eq emissions generated at the drying stage, depended on spin‐drying times and the proportion of polyester fibres in the clothing.

Development of a lyophilized plasmid/LPEI polyplex formulation with long-term stability—A step closer from promising technology to application

Cationic polymer/DNA complexes are limited by their instability in aqueous suspensions and usually have to be freshly prepared prior to administration. Thus, the development of isotonic lyophilized polyplex formulations with long-term stability is a desirable goal. Polyplexes based on 22 kDa linear polyethylenimine were prepared using a micro-mixer method. Freeze-thawing and lyophilization were performed on a pilot scale freeze-drier. Several excipients (trehalose, sucrose, lactosucrose, dextran, hydroxypropylbetadex or povidone and combinations thereof) at varying concentrations were evaluated for their stabilizing potential against freezing and dehydration induced stresses. For stability testing the lyophilized samples were stored for 6 weeks at 2–8 °C, 20 °C and 40 °C, respectively. Polyplex samples were characterized for particle size, zeta potential, their in vitro transfection efficiency and metabolic activity in Neuro2A cells. In addition, liquid samples were investigated for turbidity and number of sub-visible particles and solid samples were analyzed for residual moisture content, glass transition temperature and sample morphology. L-histidine buffer pH 6.0 was selected as effective buffer. In isotonic formulations with 14% lactosucrose, 10% hydroxypropylbetadex/6.5% sucrose or 10% povidone/6.3% sucrose, particle size was < 170 nm for all formulations and did not change after storage for 6 weeks at 40 °C. Polyplexes formulated with lactosucrose or hydroxypropylbetadex/sucrose showed high transfection efficiencies and cellular metabolic activities. Absence of large aggregates was indicated by turbidity and subvisible particle number measurements. The current standard limits for particulate contamination for small volume parenterals were met for all formulations. All samples were amorphous with low residual moisture levels (< 1.3%) and high glass transition temperatures (> 90 °C).

Short- and Long-Term Stability of Lyophilised Melatonin-Loaded Lecithin/Chitosan Nanoparticles

The aim of this study was to establish a freeze-drying process for melatonin-loaded lecithin/chitosan nanoparticles (NPs) to preserve their chemical and physical stability for a longer time period that what is possible in an aqueous suspension. Glucose and trehalose were investigated as potential excipients during freeze-drying of NP suspensions. Lecithin/chitosan NPs were characterised by mean diameter and zeta potential, ranging between 117.4 and 328.5 nm and 6.7 and 30.2 mV, respectively, depending on the lecithin type and chitosan content in the preparation. Melatonin loadings were up to 7.1%. For all lecithin/chitosan NPs, no notable differences in the mean particle size, size distribution, zeta potential or melatonin content were observed before or immediately after the lyophilisation process or after 7 months of storage at 4 °C. The residual moisture contents of lyophilisates with glucose and trehalose immediately after the lyophilisation process varied between 4.0-4.8% and 2.4-3.0%, respectively. All lecithin/chitosan NPs had a fully amorphous nature after the freeze-drying process, as indicated by modulated differential scanning calorimetry. NP lyophilisates with glucose had a low glass transition temperature (ca. 5 °C), confirming that lyophilisation with glucose as a cryoprotectant was not appropriate. All lyophilisates with trehalose had a glass transition temperature above the room temperature, allowing formation of the cake without a collapse of the structure, which was capable of preserving its characteristics and appearance following 7 months of storage at 4 °C.

Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers

The aim of the present study was to examine the possibilities/advantages of using recently introduced in-line spectroscopic process analyzers (Raman, NIR and plasma emission spectroscopy), within well-designed experiments, for the optimization of a pharmaceutical formulation and its freeze-drying process. The formulation under investigation was a mannitol (crystalline bulking agent)–sucrose (lyo- and cryoprotector) excipient system. The effects of two formulation variables (mannitol/sucrose ratio and amount of NaCl) and three process variables (freezing rate, annealing temperature and secondary drying temperature) upon several critical process and product responses (onset and duration of ice crystallization, onset and duration of mannitol crystallization, duration of primary drying, residual moisture content and amount of mannitol hemi-hydrate in end product) were examined using a design of experiments (DOE) methodology. A 2-level fractional factorial design (25−1=16 experiments+3 center points=19 experiments) was employed. All experiments were monitored in-line using Raman, NIR and plasma emission spectroscopy, which supply continuous process and product information during freeze-drying. Off-line X-ray powder diffraction analysis and Karl-Fisher titration were performed to determine the morphology and residual moisture content of the end product, respectively.In first instance, the results showed that – besides the previous described findings in De Beer et al., Anal. Chem. 81 (2009) 7639–7649 – Raman and NIR spectroscopy are able to monitor the product behavior throughout the complete annealing step during freeze-drying. The DOE approach allowed predicting the optimum combination of process and formulation parameters leading to the desired responses. Applying a mannitol/sucrose ratio of 4, without adding NaCl and processing the formulation without an annealing step, using a freezing rate of 0.9°C/min and a secondary drying temperature of 40°C resulted in efficient freeze-drying supplying end products with a residual moisture content below 2% and a mannitol hemi-hydrate content below 20%. Finally, using Monte Carlo simulations it became possible to determine how varying the factor settings around their optimum still leads to fulfilled response criteria, herewith having an idea about the probability to exceed the acceptable response limits. This multi-dimensional combination and interaction of input variables (factor ranges) leading to acceptable response criteria with an acceptable probability reflects the process design space.

Optimization of Process Parameters for Spray Drying of Fermented Soy Milk

Generally used as an inexpensive source of high-quality protein with many other health-promoting properties, soy milk offers an interesting alternative when fermented. Fermentation with lactic acid bacteria brings about the value addition to soy milk, making a nutritious probiotic food product. Dehydration helps to achieve longer shelf life and easier transportation and storage, enabling wider distribution of the product. The present work pertains to optimization of process parameters for spray drying of fermented soy milk using response surface methodology (RSM). The process parameters studied include inlet air temperature, aspirator speed (air flow rate), feed flow rate, and atomization pressure. The experiments were designed using the central composite design tool. Residual moisture content was found to be low at higher inlet air temperature, lower feed flow rate, higher atomization pressure, and higher air flow rate. Porosity reduced with increased atomization pressure. Higher product yield was obtained at high air flow rate and low feed flow rate. The increase in the atomization pressure increases the cohesiveness between particles, resulting in reduced flowability. An increase in the inlet air temperature greatly reduces the viability and the isoflavone aglycone content in the product. Protein denaturation during the process was found to reduce the product solubility.

Exergetic Analysis of Textile Convective Drying with Stenters by Subsystem Models: Part 2—Parametric Study on Exergy Analysis

In this study, the effects of exhaust air humidity ratio, the residual moisture content of fabric outlet, and the temperature of the drying air on the exergy destruction and efficiency of stenters were investigated. The exergy efficiencies of the direct gas heated stenter (DGHS) and hot oil heated stenter (HOHS) were calculated to be varying from 8.5 to 17.5% and from 6.8 to 14.0%, depending on the exhaust air humidity ratio, respectively. The increase in the drying air temperature led to an increase in the exergy efficiency, especially in the constant rate and second rate period of the drying. On the other hand, the application of the gradual temperature method caused the highest total exergy efficiency due to the highest drying rates in the first chambers where considerably high air temperatures were set. Overdrying resulted in the higher irreversibility due to the increase in the fuel consumption in the falling rate period of drying. Thus, the exergy efficiency decreased drastically.

Strength Characteristics of Shallow Gassy Sand in the Hangzhou Bay

F Abstract—In view of geological origin, formation of the shallow gas reservoir of the Hangzhou Bay, northern Zhejiang Province, eastern China, and original occurrence characteristics of the gassy sand are analyzed. Generally, gassy sand in scale gas reservoirs is in the state of residual moisture content and the approximate scope of initial matric suction of sand ranges about from 0kPa to100kPa. Results based on GDS triaxial tests show that the classical shear strength formulas of unsaturated soil can not effectively describe basic strength characteristics of gassy sand; the relationship between apparent cohesion and matric suction of gassy sand agrees well with the power function, which can reasonably be used to describe the strength of gassy sand. In the stress path of gas release, shear strength of gassy sand will increase and experimental results show the formula proposed in this paper can effectively predict the strength increment. When saturated strength indexes of the sand are used in engineering design, moderate reduction should be considered. Keywords—Gassy sand, Gas release, Occurrence characteristics, strength

Role of continuous moisture profile monitoring by inline NIR spectroscopy during fluid bed granulation of an Enalapril formulation

Background: Granulation and tableting are closely related process steps in the supply chain of pharmaceutical products. Even today, these steps are still optimized independently by trial and error. On the framework of a process analytical technology approach, these processes were evaluated in an integrated approach. Enalapril maleate is a low-dose drug substance with poor granulating and tableting behavior. In order to verify how granulation influences tableting properties, different granulation experiments were performed. Methods: Granulation experiments with fast spraying rate and fast drying as well as fast spraying rate and slow drying, and also combinations of both were run. The obtained granules were then promptly compressed into tablets in a rotary press and subjected to hardness testing. The progress of spraying and drying was controlled by a continuous near-infrared spectroscopic measuring setup. This study confirms that the tablet characteristics. Result/Conclusion: after compression of the granules in comparison to placebo granules are dependent not only on the residual moisture content of the granules but also on the moisture profiles during the entire fluid bed granulation process.

Colour responses from wood, thermally modified in superheated steam and pressurized steam atmospheres

In this study, two different methods were used to produce thermally modified wood. One was carried out in a typical kiln drying chamber using superheated steam (SS) and the other used pressurized steam in an autoclave cylinder (PS). Overall, both processes followed the same principles and the wood was not treated with any chemicals. Two wood species were studied, Scots pine (Pinus sylvestris) and Norway spruce (Picea abies). Treatments in the autoclave were carried out under pressure using temperatures of 160°C, 170°C and 180°C. Temperatures of 190°C and 212°C were used in treatments in the chamber at normal air pressure. The colour was measured using L*C*H colour space. Results for both species showed that similar L* (lightness) can be reached at lower (20–30°C) temperatures using PS compared with SS treatment. The hue angle of PS-treated wood was smaller than that of SS-treated wood. No significant difference in C* (chroma) was detected. The difference in E value between PS- and SS-treated wood was smaller for Norway spruce than for Scots pine. The residual moisture content was about 10% higher in wood treated by the PS process compared with the SS process.

Formulation and in vitro evaluation of highly dispersive insulin dry powder formulations for lung administration

The aim of this work was to develop highly dispersible and dry formulations of insulin for use in dry powder inhalers (DPIs) using high-pressure homogenisation (HPH) and spray-drying. Several formulations were evaluated, including formulations spray-dried without excipients and formulations coated with lipids. A physiological lipid composition based on a mixture of cholesterol and phospholipids was used to form the coating film around micronised drug particles. The production technique and excipients were chosen in order to limit the degradation of the active ingredient. The resulting powders exhibited a size and shape suitable for the deep lung deposition of drugs, and good aerodynamic features were obtained for the different formulations tested, with fine particle fractions between 46% and 63% vs. 11% for raw insulin powder. The presence of a lipid coating of up to 30% (w/w) did not significantly affect the aerodynamic behaviour, and the coated formulations also exhibited a decreased residual moisture content of between 2.3% and 3.7% vs. 4.8% for raw insulin, which should improve the long-term stability of the protein formulations. No degradation of the insulin molecule occurred during the HPH/spray-drying process, as it was shown using an HPLC method (insulin content between 98.4% and 100.5%), and the content in high molecular weight proteins, assessed using a gel filtration method, stayed below 0.4%.

Epiflex® A new decellularised human skin tissue transplant: manufacture and properties

The manufacture and initial testing of a new human tissue transplant is described. Epiflex(®) is a human acellular dermis transplant that is manufactured from skin recovered from screened consenting donors according to validated and approved methods. The transplant is approved as a drug in Germany. The safety, stability and usability of the transplant are discussed with respect to the results of sterility, residual moisture content and rehydration tests. Histological and confocal laser scanning microscopy experiments and analysis of oxygen and water vapour permeability demonstrate that the native extracellular matrix structure and transport properties of human connective tissue are retained in the transplant. Results from initial clinical investigations suggest that Epiflex(®) can be used successfully in the treatment of burns, hypertrophic scars and as a transplant seeded with autologous dermal fibroblasts for soft-tissue regeneration in settings with wound healing problems following multi-modal treatments for sarcomas of the extremities.

Systematic investigation of the effect of lyophilizate collapse on pharmaceutically relevant proteins I: Stability after freeze‐drying

The objective of this work was to investigate the effect of cake collapse during freeze‐drying on the stability of protein lyophilizates containing a monoclonal IgG1‐antibody or a second pharmaceutically relevant protein, referred to as PA01. In addition, L‐lactic dehydrogenase was investigated because of its well‐documented sensitivity towards freeze‐drying stresses. Collapse was induced by two different means. First, by varying the ratio of the crystalline bulking agent mannitol to the amorphous stabilizer sucrose, different extents of collapsed cakes were generated. Second, formulations were freeze‐dried using an aggressive collapse‐cycle and a conventional freeze‐drying protocol and collapsed and noncollapsed cakes of identical formulation were produced. Lyophilizates were analyzed using a comprehensive set of analytical techniques to monitor protein stability in terms of formation of soluble and insoluble aggregates, the biological activity and the conformational stability. The stability of excipients, namely the glass transition temperature, crystallinity, reconstitution behavior, and the residual moisture content was analyzed as well. In addition, the extent of collapse was quantified using the decrease of the specific surface area (SSA). Collapsed cakes had comparable residual moisture levels to noncollapsed lyophilizates. Reconstitution times were not increased. Protein stability was not relevantly different between collapsed and noncollapsed cakes. © 2009 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 2256–2278, 2010

Studies on electrical properties of wheat bread as a function of moisture content during storage

Bread undergoes several physicochemical changes during storage that results in a rapid loss of freshness. These changes depend on the moisture content present in the bread product and collectively termed as staling. The present work explains how the electrical properties of bread vary with time and moisture content at its crust and crumb. An instrument based on electrical impedance spectroscopy with multichannel electrodes is developed for the present investigations. Detailed studies have been carried out to understand the influence of changes in moisture profile at bread crust and crumb in terms of electrical properties during the storage of 120 h. A linear relationship is observed between the measured impedance and capacitance and residual moisture content in bread at crust during storage. It is observed that the measured Resistance at bread crumb has a nonlinear mathematical relationship with moisture content present at crumb.

Experimental and Numerical Investigation of Spray-Drying Parameters on the Dried Powder Properties of Ginkgo biloba Seeds

The operating parameters for spray drying play a significant role in determining the properties of the dried product. Ginkgo biloba (GB) seeds are a popular food and additive in the food and medicine market; in this study we spray dried these seeds. According to the L1644 orthogonal experimental design, a total of 16 tests was performed in a compact spray dryer. Parameters, i.e., inlet air temperature, air flow rate, outlet air temperature, and feed concentration, were selected as affecting factors. The dried product was evaluated with respect to residual moisture content, color difference, mean particle size, and protein content. The effects of these four parameters on the product properties were investigated. The experimental results showed that operating air temperature, especially the outlet air temperature, significantly affected the residual moisture and protein content in the dried product. High outlet air temperature can reduce the product quality. On the other hand, the mean particle size of GB powder was mainly affected by the feed concentration. Increasing feed concentration increased mean particle size. Color difference of GB seed powder was significantly affected by the inlet and outlet air temperatures and feed concentration. Furthermore, the optimal conditions of GB seed spray drying, i.e., inlet air temperature 190°C, air flow rate 120 m3/h, outlet air temperature 110°C, feed concentration 10%, were obtained from an L1644 orthogonal experiment. At last, correlation equations for GB seed powder properties with operating parameters were obtained using multivariable regression analysis.

Viability of Bifidobacterium Pseudocatenulatum G4 after Spray-Drying and Freeze-Drying

Viability of Bifidobacterium pseudocatenulatum G4 following spray-drying and freeze-drying in skim milk was evaluated. After spray-drying, the strain experienced over 99% loss in viability regardless of the air outlet temperature (75 and 85 °C) and the heat-adaptation temperature (45 and 65 °C, 30 min). The use of heat-adaptation treatment to improve the thermotolerance of this strain was ineffective. On the other hand, the strain showed a superior survival at 71.65%–82.07% after freeze-drying. Viable populations of 9.319–9.487 log10 cfu/g were obtained when different combinations of skim milk and sugar were used as cryoprotectant. However, the addition of sugars did not result in increased survival during the freeze-drying process. Hence, 10% (w/v) skim milk alone is recommended as a suitable protectant and drying medium for this strain. The residual moisture content obtained was 4.41% ± 0.44%.

Moisture adsorption capacity and surface area as deduced from vapour pressure isotherms in relation to hygroscopic water of soils

Six calcareous and alluvial soil profiles differing in their texture, CaCO3 and salinity were chosen from west and middle Nile Delta for the present study. The 1st and 2nd profiles from Borg El-Arab area were sandy loam in texture and > 30% CaCO3, while the 3rd and 4th profiles (from Nubaria area) were sandy clay loam and < 30% CaCO3. The 2nd and 4th profiles were taken from cultivated area with maize. The 5th profile from Epshan area was non-saline clay alluvial soil and the 6th from El-Khamsen was saline clay alluvial soil. The relation between soil moisture content (W%) and water vapour pressure (P/Po) was established for the mentioned soils. Data showed that the specific surface area (S) values were 34–53 and 44–60 m2/g for calcareous soils of Borg El-Arab and Nubaria areas, 206–219 and 206–249 m2/g for non-saline and saline clay alluvial soils of Epshan and El-Khamsen areas, respectively. The corresponding values of the external specific surface area (Se) were 16–21, 14–22, 72–86 and 92–112 m2/g. Submitting Wm+Wme as an adsorption boundary of moisture films (Wc) (where Wm is mono-adsorbed layer of water vapour on soil particles and Wme is the external mono-adsorbed layer), the maximum water adsorption capacity (Wa) was found to be Wc + Wme or Wm + 2Wme. It was ranged from 1.88 to 2.70%, 1.97 to 2.95%, 9.70–10.70% and 10.80 to 13.12% while the maximum hygroscopic water (MH) values were 2.43–3.78%, 2.91–4.65%, 16–17% and 18.30–21.9% for the studied soil profiles respectively. The residual moisture content (θr) at pF 7 and P/Po = 0 was ranged from 0.0005–0.0010%, 0.0007–0.0019% and 0.0043–0.0048% in Borg El-Arab, Nubaria and Epshan soil profiles, respectively.

Hydraulic properties of fen peat soils in Poland

The hydraulic properties of fen peat soils from the Biebrza River Valley in the north-east of Poland were investigated. 87 soil samples were collected from nine typical peat-moorsh soil profiles representing three types of peat: moss with fibrous structure, herbaceous and wooden peat characterised by amorphous structure with high humus content. The multi-step outflow method was used to determine the parameters of the Mualem-van Genuchten model (MVG) that describes soil moisture retention characteristics and the unsaturated hydraulic conductivity function of each soil sample. The agglomerative hierarchical cluster analysis of the parameters of MVG model was applied in order to obtain typical hydraulic functions for the three types of peat considered. As a result of the analysis, the hydraulic properties of the fen peat soils were agglomerated into five clusters. The MVG model parameters as well as hydraulic functions were analysed for distinguished clusters. The parameters of the moss peats with low degree of decomposition and fibric structure were different from those of the herbaceous and wooden decomposed peats with high humus content. The largest values of the hydraulically active pore space (difference between saturated and residual moisture content) were observed for moss peat samples, while the lowest values were observed for wooden peat samples. The empirical parameters describing the shape of the unsaturated hydraulic conductivity function were depended on the type of the peat and therefore the degree of decomposition. The L parameter values of the herbaceous and wooden peats were generally greater than 0, whereas for the moss peat samples they were ranging from − 5 to 5. The unsaturated hydraulic conductivity of the herbaceous and wooden peat soils was close to that of very fine-textured mineral soils.

Physico-chemical characterisation of PLGA nanoparticles after freeze-drying and storage

Nanoparticles represent promising carriers for controlled drug delivery. Particle size and size distribution of the particles are important parameters for the in vivo behaviour after intravenous injection and have to be characterised precisely. In the present study, the influence of lyophilisation on the storage stability of poly( d, l lactic-co-glycolic acid) (PLGA) nanoparticles, formulated with several cryoprotective agents, was evaluated. Nanoparticles were prepared by a high pressure solvent evaporation method and freeze-dried in the presence of 1%, 2%, and 3% (m/v) sucrose, trehalose, and mannitol, respectively. Additionally, to all samples containing 3% of the excipients, l-arginine hydrochloride was added in concentrations of 2.1% or 8.4% (m/V). Dynamic light scattering (DLS), analytical ultracentrifugation and transmission electron microscopy (TEM) were used for particle characterisation before and after freeze-drying and subsequent reconstitution. In addition, glass transition temperatures were determined by differential scanning calorimetry (DSC), and the residual moisture of the lyophilisates was analysed by Karl Fischer titration. It was demonstrated that 1% sucrose or 2% trehalose were suitable to maintain particle integrity after reconstitution of lyophilised PLGA nanoparticles. The storage stability study over 3 months showed notable changes in mean particle size, size distribution, and residual moisture content, depending on the composition of the formulation.