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PubMed2002

The effect of spray drying solutions of polyethylene glycol (PEG) and lactose/PEG on their physicochemical properties.

The effect of spray drying polyethylene glycol (PEG) 4000 and lactose/PEG solutions was investigated. Micro-spherical PEG particles were successfully prepared from ethanol, which allowed lower outlet temperatures than water. The product was crystalline and consisted of rough spheres or rod like particles. In the case of lactose/PEG composites, spray dried from water, the crystallinity of both components was reduced on spray drying, the extent being dependent on the starting composition. Spray dried lactose/PEG with PEG present as 10% by weight was found to be the most amorphous of the systems prepared. Conversion to more crystalline products occurred over time, the rates of conversion being dependent on temperature and humidity. On storage at low humidity (31-34%) amorphous lactose in lactose/PEG spray dried systems converts to anhydrous crystalline lactose while at high humidity (75% RH) the monohydrate is formed. The rate of transformation of amorphous lactose to the crystalline monohydrate form, at high relative humidity, was quantified using the Avrami equation applied both to X-ray diffraction (XRD) peak intensity and heat of fusion data. Crystallisation of lactose appeared to be retarded at low PEG concentrations, where PEG was present predominantly in a non-crystalline state, but was accelerated at higher PEG contents.

Chemical Phenomena↗
PubMed2002

Study of release kinetics of small and high molecular weight substances dispersed into spray-dried ethylcellulose microspheres.

Spray-dried ethylcellulose microspheres were used as matrices for the encapsulation of a fungal lactase and/or small paramagnetic probes (Tempol or Tempo). Their dissolution in water was studied. Kinetics fitted with the model Q = kt(n) of Korsemeyer et al. [Int. J. Pharm. 15 (1983) 25] exhibited a non-Fickian diffusion. The calculated diffusional exponent (n) values were near 0.26 whatever the encapsulated probes. The release rates (k) were only slightly different for paramagnetic probes and lactase. This result indicated that the probes' release mechanisms are not diffusion controlled. Other factors such as matrix porosity and probe solubility in the matrix and in water could influence the probes' release rate.

Cellulose↗
PubMed2001

Stability of monoterpenes encapsulated in gum Arabic by spray-drying.

Microencapsulation using spray-drying was tested with gum arabic and monoterpenes as wall and core materials, respectively. Citral, linalool, beta-myrcene, limonene, and beta-pinene were used at concentrations of 10, 20, and 30% with respect to the wall material. The greatest percentages of retention occurred at a concentration of 10%. Linalool and citral presented the greatest losses with increase in concentration. The hydrocarbons used were the most retained. Of the hydrocarbons, beta-pinene was better retained in the capsules than limonene, and beta-myrcene was the least retained of all. The capsules presented similar external morphologies, with no apparent cracks or porosity and an average size varying between 15.7 and 23.2 microm. The stability of the capsules to temperature was monitored for 33 days. The degradation products of the monoterpenes were evaluated. The results indicated a greater stability of the capsules containing beta-pinene and citral than of those containing linalool and beta-myrcene presenting the lowest retentions.

Acyclic Monoterpenes↗
PubMed1998

Effect of storage time on solubility and color of spray-dried soymilk.

Soymilk was spray dried under various combinations of inlet air temperature and atomizer speed. The insolubility index and the tristimulus color parameters (L, a, b) of the fried soymilk were monitored over a 59-week storage time period. The soymilk insolubility exhibited erratic trends over time. Yellowness (b) and lightness (L) of the dried soymilk correlated well with dryer atomizer speed. yellowness data, however, showed no significant difference among treatments, even when variations over time where considered. Lightness data, on the other hand, was found to be a function of storage time and atomizer speed and could be predicted to within a +/- 1.0% error.

Animals↗
PubMed2001

Spray-dried diclofenac-loaded poly(epsilon-caprolactone) nanocapsules and nanospheres. Preparation and physicochemical characterization.

The aims of the present study were to prepare spray-dried polymeric nanocapsules (NC) and nanospheres (NS) from poly(epsilon-caprolactone) (P epsilon C) suspensions containing diclofenac (DIC) and to determine the physicochemical properties of the formulations. NC or NS suspensions were prepared by interfacial deposition of the polymer. DSC-thermograms of raw materials and NC or NS suspensions (evaporated or spray-dried) were obtained using a PL-DSC. Spray-dried powders were prepared by addition of 3% (w/v) Aerosil 200 into suspensions of NC or NS. These mixtures were fed into a spray-dryer. DIC was assayed by HPLC. NC and NS spray-dried powders were examined under SEM (Jeol Scanning Microscope, JSM-5800). NC and NS suspensions had acceptable diameter, 340 and 247 nm respectively. The yields of NC and NS spray-dried powders were 80% and 75% and the recovery of the DIC was 99% and 93%, respectively. The melting peak of P epsilon C in NC and NS was observed at a temperature about 10 degrees C lower than in the raw material. In the NC thermograms the maximum of the oil (Miglyol 810) melting peak (+1.6 degrees C) was lowered about 7 degrees C. For spray-dried NC formulations, the SEM analyses of powders showed spherical microparticles of silicon dioxide, covered by nanoparticles (300 nm), while for spray-dried NS formulations the microparticles presented a rugged surface at the same magnification.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

A solid-state NMR study of molecular mobility and phase separation in co-spray-dried protein-sugar particles.

Molecular mobility and physical form of co-spray-dried sugar-lysozyme formulations were evaluated. Co-spray-dried trehalose:lysozyme and sucrose:lysozyme formulations in 1:9, 1:1 and 9:1 ratios (w:w) were stored at 0% RH and 75% RH for 5-6 days. Molecular mobility and physical form of the co-spray-dried formulations after storage were determined by using 13C and 1H solid-state NMR as well as X-ray powder diffractometry. The results showed that increasing sugar content in co-spray-dried formulations stored at 0% RH decreased molecular mobility of the amorphous formulations indicating a close association of the protein and sugar. Exposure of sugar-lysozyme 1:1 and 9:1 formulations to 75% RH led to separation of sugar and protein phases, where the sugar phase was crystalline. The intimate sugar-lysozyme interaction of the formulations stored at 0% RH and the phase separation of the sugar-rich formulations stored at 75% RH were also confirmed by using 13C solid-state NMR spin-lattice relaxation time-filter (T1-filter) measurements. The propensity of sucrose and trehalose to crystallise was similar; however, the results suggest that part of the sugar in the phase-separated formulations remained amorphous and in close association with lysozyme.

Carbohydrates↗
PubMed2006

Characterisation of salmon calcitonin in spray-dried powder for inhalation. Effect of chitosan.

Salmon calcitonin (sCT) powders suitable for inhalation, containing chitosan and mannitol as absorption enhancer and protection agent, respectively, were prepared using a spray-drying process. The effect of chitosan on physicochemical stability of sCT in the dry powder was investigated by different analytical techniques. High-performance liquid chromatography (HPLC) analysis indicated that sCT was chemically stable upon spray-drying. With the proportion of chitosan in spray-drying formulation being increased, dissolution of sCT from the dry powders was decreased both in phosphate buffer and acetate buffer. The thioflavine T fluorescence assay showed that no fibrils were present in the spray-dried powder. However, sCT partly fibrillated in the phosphate buffer, but not in acetate buffer. Fourier transform infrared (FTIR) spectra showed that the secondary structure of sCT was slightly changed in the dry powder, yet no aggregate signal was observed. Circular dichroism analysis indicated that the structure of sCT in an aqueous formulation was slightly altered by addition of chitosan. Nevertheless, recovery of sCT was not influenced by chitosan in the aqueous formulation as indicated by HPLC analysis. This study suggested that sCT, in absence of any additives, was stable during the spray-drying process under certain conditions. Addition of chitosan affects recovery of sCT from spray-dried powders, which may be due to formation of a partially irreversible complex between the protein and chitosan during the spray-drying process.

Administration, Inhalation↗
PubMed1998

Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody.

We have examined the stability and aerosol performance of the pharmaceutical protein recombinant humanized anti-IgE monoclonal antibody (rhuMAbE25) spray dried with mannitol. The aerosol performance was measured by the fine particle fraction (FPF), and stability was assessed by the formation of soluble aggregates. When mannitol was added to the spray-dried rhuMAbE25 formulation, its ability to stabilize the protein leveled off above about 20% (w/w, dry basis). The FPF of the spray-dried formulations was stable during storage for rhuMAbE25 containing 10% and 20% mannitol, but the 30% formulation exhibited a dramatic decrease upon storage at both 5 degreesC and 30 degreesC, due to mannitol crystallization. We tested the addition of sodium phosphate to a 60:40 rhuMAbE25:mannitol (w:w) mixture, which otherwise crystallized upon spray drying and yielded a nonrespirable powder. The presence of sodium phosphate was successful in inhibiting mannitol crystallization upon spray drying and dramatically lowering the rate of solid-state aggregation. However, over long-term storage some crystallization was observed even for the phosphate-containing samples, concomitantly with increased particle size and decreased suitability for aerosol delivery. Therefore, the physical state of mannitol (i.e., amorphous or crystalline) plays a role both in maintaining protein stability and providing suitable aerosol performance when used as an excipient for spray-dried powders. Agents which retard mannitol crystallization, e.g., sodium phosphate, may be useful in extending the utility of mannitol as an excipient in spray-dried protein formulations.

Antibodies, Anti-Idiotypic↗
PubMed2005

Changes in the amide I FT-IR bands of poly-L-lysine on spray-drying from alpha-helix, beta-sheet or random coil conformations.

Poly-L-lysine (PLS) was spray-dried in a laboratory-scale, mini spray-dryer at Tin/Tout =150/90-95 degrees C from three different liquid feeds composed mainly of alpha-helix, beta-sheet or random coil conformations of the homopolypeptide. FT-IR analysis of the liquid feeds, the spray-dried solids, and the re-dissolved solids was performed by considering the deconvoluted and second-derivative amide I spectra, as well as a Gaussian curve fitting procedure. All three initial conformations were transformed by spray-drying to anti-parallel beta-sheet with bands at 1623 and 1690 cm(-1). The beta-sheet liquid feed showed a band at 1616 cm(-1) indicating a denatured, extended chain structure that was also converted to anti-parallel beta-sheet on spray-drying. The shift to beta-sheet cannot therefore be a simple result of forming the conformation with the strongest H-bonds in the dried state. We suggest that steric effects arising from the close approach of the globular polypeptide molecules during drying make the anti-parallel beta-sheet structure energetically favorable in the solid state. This suggestion is supported by the effects of trehalose on the FT-IR amide I bands of the spray-dried PLS. No stabilizing effects were observed on either the initial alpha-helix or beta-sheet (extended chain) conformations. Random coil could be partially stabilized. Again, no direct relation to H-bond strength is evident. The efficacy of the trehalose could be related to the ability of newly-formed trehalose/PLS intermolecular H-bonds to stabilize the intramolecular H-bonds of the secondary structural elements.

Amides↗
PubMed2002

Integrity of crystalline lysozyme exceeds that of a spray-dried form.

The development of proteins as therapeutic agents is challenging partly due to their inherent instabilities. Consequently, crystallisation and spray drying techniques were assessed to determine their effects on protein integrity using lysozyme as a model protein. Unprocessed, crystallised and spray-dried lysozyme were characterised by: thermal analysis using hot stage microscopy (HSM), differential scanning calorimetry (DSC), high sensitivity differential scanning calorimetry (HSDSC) and thermogravimetry (TGA); and spectroscopic analysis employing Fourier transform Raman (FT-Raman). Moisture contents were determined by TGA and Karl Fisher titration (KFT). Enzymatic assay measured biological activity. HSM showed no changes in crystals until complete melting. TGA and KFT indicated that spray-dried lysozyme contained a lower moisture content than crystals, hence the higher apparent thermal stability was shown by DSC. HSDSC revealed that crystallisation and spray drying did not affect the denaturation temperature of lysozyme in solution when compared with unprocessed material. However, in the solid state, FT-Raman spectra showed perturbation of the conformational structure of spray-dried sample, whereas crystal conformation remained intact. Enzymatic assay revealed increased activity retention of crystals compared with spray-dried powder. Hence, crystals maintained the conformational integrity and activity of lysozyme in solution.

Crystallization↗
PubMed2004

Stability of crystallised and spray-dried lysozyme.

Moisture and temperature promote protein degradation. The stabilities of commercial, crystallised and spray-dried lysozyme, a model protein, were assessed under these stresses to explore whether a crystalline protein had better storage stability than a conventionally produced one. Samples were maintained at different relative humidities (RH) and temperatures for 20 weeks and stabilities estimated in solid and aqueous states. Differential scanning calorimetry (DSC) and thermogravimetry (TGA) characterised solid samples. Fourier transform Raman (FT-Raman) spectroscopy analysed solid material and aqueous solutions. High sensitivity differential scanning calorimetry (HSDSC) and enzymatic assays were used to monitor solutions. DSC and HSDSC data revealed that crystals maintained thermal stability at high RH; spray drying appreciably changed melting characteristics. These results correlated with enzymatic assays that demonstrated good activity retention for crystals but less so for spray-dried material (e.g. 95 and 87% relative to fresh samples after 20 weeks at 40 degrees C/75% RH). FT-Raman analysis showed that crystallised lysozyme better-maintained protein conformational integrity compared to spray-dried samples in accelerated stability studies. Based on TGA data, spray-dried protein absorbed water on storage under humid conditions, which induced instability. Thus, crystallisation enhanced storage stability of lysozyme with negligible loss of activity.

Crystallization↗
PubMed1998

Physicochemical stability of crystalline sugars and their spray-dried forms: dependence upon relative humidity and suitability for use in powder inhalers.

Lactose, trehalose, sucrose, and mannitol were purchased in crystalline form and fractionated by sieving. Coarse (125-212 microns) and fine (44-74 microns) free-flowing fractions were selected as typical of drug carriers in dry-powder inhalers. In addition, one batch of each sugar was spray-dried to form a respirable powder (> 50% [w/w], < 5 microns). Both fractions and the spray-dried powders were characterized before and after storage for 30 days at < 23%, 23%, 52%, 75% and 93% relative humidity (RH) at 25 degrees C. Moisture uptake was determined by thermogravimetric analysis (TGA) validated by Karl Fischer titration. Sieve fractions (before storage at different RHs) and spray-dried materials (before and after storage) were further characterized by differential scanning calorimetry (DSC) and x-ray powder diffraction (XRPD). All crystalline sieve fractions (except sucrose at 93% RH) were stable at 25 degrees C and showed insignificant moisture uptake when exposed to each relative humidity for 30 days. Sucrose dissolved in sorbed moisture at 93% RH. Spray-dried lactose, sucrose, and trehalose, which were collected in the amorphous form, showed moisture uptake, without recrystallization, when held for 30 days at 23% RH. These sugars recrystallized as sintered masses and became undispersible at > or = 52% RH. Spray-dried mannitol was apparently 100% crystalline when collected directly from the spray-dryer; it did not show humidity-induced changes. The physicochemical behavior of each sugar form is discussed as it relates to the sugar's suitability as a powder-inhaler excipient, with both conventional and protein drugs.

Calorimetry, Differential Scanning↗
PubMed2005

Preparation and release of salbutamol from chitosan and chitosan co-spray dried compacts and multiparticulates.

Chitosan microparticulates were prepared by spray drying from aqueous media containing hydrochloric acid or acetic acid. The medium affected the morphology and degree of acetylation of chitosan, the presence of acetic acid resulting in increased acetylation of the polymer during processing. Co-spray drying salbutamol sulphate/chitosan systems with the crosslinking agent formaldehyde had no detectable effect on particle morphology. However, with increasing salbutamol loading particles became less spherical, taking on a collapsed appearance. Spray dried chitosan-salbutamol sulphate microparticulates were X-ray amorphous. Chitosan-salbutamol sulphate composites were compressed into discs to quantify drug release and showed delayed release of salbutamol sulphate. The general power law equation fitted the data better than the t0.5, mono- or bi-exponential models and gave n indices greater than 0.5, i.e. in the range 0.53-0.71. Crosslinking did not dramatically alter the drug release behaviour. Both crosslinked and non-crosslinked composites swelled during release, the former to the greater extent. The release data for crosslinked composites gave slightly higher n values than the corresponding non-crosslinked composites, consistent with the increased swelling of these systems. Release studies were also conducted on the microparticulates. Because of the small particle size and large surface area present, the release of the highly soluble drug salt was extremely rapid (> 90% release in 5 min). Twin impinger analysis indicated good in vitro deposition of the microparticulates and potential for pulmonary delivery.

Adrenergic beta-Agonists↗
PubMed1998

Solid state characterization of spray-dried powders of recombinant human deoxyribonuclease (rhDNase).

rhDNase is a recombinant human protein approved as an aqueous solution for human use by inhalation. To study the feasibility of preparation of dry powders for inhalation, spray-dried powders of pure rhDNase and co-spray-dried mixtures of rhDNase with an excipient approved for inhalation products, lactose, were prepared. Both types of powders were initially amorphous. The lactose, however, was found to crystallize after exposure to a humid environment. The crystals in the powder were identified as the alpha-monohydrate polymorph of lactose by hot-stage optical and scanning electron microscopy, differential scanning calorimetry and thermogravimetry, FTIR spectroscopy, and X-ray powder diffraction. Moisture sorption isotherms indicated that crystallization occurred at high relative humidities (70-85%), depending on the temperature of the environment (5-40 degreesC). The practical implications for the manufacturing and storage of protein powders for inhalation are discussed.

Administration, Inhalation↗
PubMed1998

Spray-drying of air-liquid interface sensitive recombinant human growth hormone.

Spray-drying is an attractive method for preparing fine recombinant human growth hormone (rhGH) powders if the detrimental effect of protein degradation at the air-liquid interface on the protein can be minimized. In this study, we demonstrated that rhGH degradation (insoluble and soluble aggregate formation), as the consequence of air-liquid interfacial degradation, could be prevented using the appropriate formulation. Adding polysorbate-20 surfactant into the liquid feed (with no presence of sugar protectant) significantly reduced the formation of insoluble protein aggregates, while adding the divalent metal zinc ion effectively suppressed the formation of soluble protein aggregates. The combination of the two yielded a spray-dried rhGH powder having insignificant protein degradation. Our data suggest that the two components might protect the protein through different mechanisms. Polysorbate molecules occupy the air-liquid interface of spray droplets, thereby reducing the chance for rhGH to form insoluble aggregates by surface denaturation. Two zinc ions associate with two rhGH molecules to form a dimer complex that can resist the formation of soluble protein aggregates. Characterization of spray-dried powders by scanning electron microscopy suggests that both formulation and drying conditions have a strong influence on particle morphology and shape. Overall, spherical rhGH powders of smooth surface and good biochemical quality can be prepared by spray-drying using this formulation with no addition of sugar protectant.

Calorimetry, Differential Scanning↗
PubMed2000

An Aqueous Polymer Two-Phase System as Carrier in the Spray-Drying of Biological Material.

This investigation describes a novel concept in the formulation of carrier systems for the spray-drying of biological materials. As carrier material a system composed of poly(vinyl pyrrolidone) (PVP) and dextran was used. This system yields an aqueous two-phase system in which each phase is enriched in one of the polymers. By varying the composition of the system, the effective structure of a "stirred" system can be varied, covering the entire range from dextran continuous to PVP continuous. This facilitates encapsulation of either of these polymers in a spray-drying operation. In an attempt to investigate the spray-drying from such a system, the surface composition of the spray-dried powder obtained from various compositions of the two-phase system was analyzed by electron spectroscopy for chemical analysis (ESCA), providing information on the distribution of the polymers in the powder and thus also in the spray droplets. The two-phase system was applied for the spray-drying of live bacteria. The survival rate of the bacteria depended on the composition of the two-phase system. The storage stability of the bacteria in these formulations was investigated after storage at room temperature under dry conditions for 4 weeks, and it was found that the survival rate was 10-45%. The results therefore show that this type of formulation holds promise for future applications for micro-organisms as well as other sensitive biological materials such as proteins. Copyright 2000 Academic Press.

Journal Article↗
PubMed1999

Physicochemical properties of amorphous clarithromycin obtained by grinding and spray drying.

In order to characterize the amorphous clarithromycin (CAM) obtained by grinding and spray drying, physicochemical properties (crystallinity, thermal behavior, stability and solubility parameters) were evaluated. From powder X-ray diffraction, it was estimated that the crystalline state of CAM was changed into an amorphous state by grinding and spray drying. In differential scanning calorimetry measurements, both broad and sharp peaks for crystallization were observed in ground samples, whereas spray dried samples showed one broad peak due to crystallization. As to the stability test under high humidity, structural difference was confirmed between ground CAMs and spray dried CAM. The heat of dissolution of ground CAMs was greater than that of intact CAM. In the solubility parameter measurement, the increase of the special term, deltas, indicated that the energy change was due to the polarity of the surface energy of the powder particles by grinding.

Anti-Bacterial Agents↗
PubMed2004

The effect of vehicle on physical properties and aerosolisation behaviour of disodium cromoglycate microparticles spray dried alone or with L-leucine.

The aim of this study was to improve the aerosolisation behaviour of disodium cromogycate (DSCG), using spray drying technique. The effect of vehicle on the drug particle properties was investigated. L-leucine was selected as a natural antiadherent amino acid to improve the deagglomeration of DSCG particles. Spray dried samples of DSCG alone or with L-leucine were prepared from water and ethanol under the same conditions. The powder properties of the samples were examined by laser diffraction, helium densitometer, X-ray diffraction, differential scanning calorimetry and thermogravimetric analysis. The in vitro deposition was determined, using an Andersen cascade impactor with a Spinhaler at a flow rate of 60 l/min. An amorphous form of the drug was obtained when water was used. However, crystal transformation of original DSCG in the presence of ethanol during spray drying resulted in production of elongated particles. These particles exhibited improved aerodynamic properties, compared to the amorphous and commercial materials. Significant differences in fine particle fraction were observed using the two vehicles. Co-spray drying of DSCG and L-leucine improved the deposition profiles of the drug. These results indicated that the change in crystal structure of DSCG during spray drying process was susceptible to the nature of the vehicle. A crystalline form of DSCG with good aerodynamic properties was achieved during spray drying process. In addition, the processing of DSCG with L-leucine in a single step using ethanol resulted in an improvement in dispersion properties of the drug particles.

Aerosols↗