scholarly journals Comparison of a Novel Miniaturized Screening Device with Büchi B290 Mini Spray-Dryer for the Development of Spray-Dried Solid Dispersions (SDSDs)

Processes ◽  
2018 ◽  
Vol 6 (8) ◽  
pp. 129 ◽  
Author(s):  
Aymeric Ousset ◽  
Joke Meeus ◽  
Florent Robin ◽  
Martin Schubert ◽  
Pascal Somville ◽  
...  

Spray-drying is an increasingly popular technology for the production of amorphous solid dispersions (ASDs) in the pharmaceutical industry that is used in the early evaluation and industrial production of formulations. Efficient screening of ASD in the earliest phase of drug development is therefore critical. A novel miniaturized atomization equipment for screening spray-dried solid dispersions (SDSDs) in early formulation and process development was developed. An in-depth comparison between the equipment/process parameters and performance of our novel screening device and a laboratory Büchi B290 mini spray-dryer was performed. Equipment qualification was conducted by comparing the particle/powder attributes, i.e., miscibility/solid state, residual solvent, and morphological properties of binary SDSDs of itraconazole prepared at both screening and laboratory scales. The operating mode of the miniaturized device was able to reproduce similar process conditions/parameters (e.g., outlet temperature (Tout)) and to provide particles with similar drug–polymer miscibility and morphology as laboratory-scale SDSDs. These findings confirm that the design and operation of this novel screening equipment mimic the microscale evaporation mechanism of a larger spray-dryer. The miniaturized spray-dryer was therefore able to provide a rational prediction of adequate polymer and drug loading (DL) for SDSD development while reducing active pharmaceutical ingredient (API) consumption by a factor of 120 and cycle time by a factor of 4.

2013 ◽  
Vol 74 (2) ◽  
Author(s):  
Pik Han Chong ◽  
Mohammad Gulzarul Aziz ◽  
Yus Aniza Yusof ◽  
Naim Mohammad Nazli ◽  
Nyuk Ling Chin ◽  
...  

Amaranth betacyanin, responsible for a red or violet colour, is extracted from Amaranthus gangeticus by using the water extraction method and microencapsulated by spray drying. The physicochemical and morphological properties of microencapsulated betacyanins are assessed as inƀuenced by the inlet temperature and the maltodextrin concentration. The process was conducted using a mini spray dryer and maltodextrin is used as an encapsulating agent. Central composite design is applied and thirteen experiments are carried out. The responses are betacyanin retention, moisture content, water activity, particle densities, particle size, colour values and antioxidant activity. The quadratic effect of the inlet temperature is determined to be positive on betacyanin retention whereas the antioxidant is affected by the linear change of maltodextrin concentration. The moisture content and water activity of spray-dried betacyanin powders are insignißcantly affected by inlet temperature and maltodextrin concentration individually. Only the effect maltodextrin concentration is found to have a signißcant effect on colour value.Particle densities and sizes are slightly affected by the process conditions studied.


Author(s):  
A. Stunda-Zujeva ◽  
V. Stepanova ◽  
L. Bērziņa-Cimdiņa

<p class="R-AbstractKeywords"><span lang="X-NONE">Spray drying is an effective and common method for powder drying, e.g. clay. The morphology and properties of spray dried granules depend on properties of slurry and operational conditions of spray dryer. The aim of this study was to investigate the effect of spray dryer settings on the morphology of illite clay granules. </span></p><p class="R-AbstractKeywords"><span lang="X-NONE">Laboratory scale spray dryer was used. Operational conditions: inlet temperature 190-220˚C, outlet temperature 70-96˚C, spray dispersion is obtained using two-fluid nozzle where the slurry feed was varied from 4.5 to 15 ml/min and gas pressure 15-40 mm. Slurry was prepared from clay fraction under 2 µm without additives. Latvian illite clay from Iecava, Pavāri and Laža deposits was studied. Slurries with concentration 1, 8 and 15 mass% was used.The size and morphology was investigated by scanning electron microscopy, surface area and porosity by liquid nitrogen sorption.</span></p><p class="R-AbstractKeywords"><span lang="X-NONE">All obtained granules irrespective of </span><span lang="X-NONE">spray dryer settings</span><span lang="X-NONE"> were well-rounded and dense without large pores or holes, however the surface was rough. The mean diameter of granules was in range of 2.6-5.4 µm, depending on slurry feed rate. The surface area of produced granules mostly depended on clay composition and was in a range of 70-92 m2/g. Inlet temperature in a range of 190-220 °C was found to be appropriate to produce well dried clay granules (moisture content &lt;10 wt%).   </span></p>


2020 ◽  
Vol 37 (8) ◽  
Author(s):  
Kimberly B. Shepard ◽  
April M. Dower ◽  
Alyssa M. Ekdahl ◽  
Michael M. Morgen ◽  
John M. Baumann ◽  
...  

Abstract Purpose The purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spray-drying process, API and excipients are co-dissolved in a volatile organic solvent, atomized into droplets through a nozzle, and introduced to a drying chamber containing heated nitrogen gas. The product dries rapidly to form a powder, but small amounts of residual solvent (typically, 1 to 10 wt%) remain in the product and must be removed in a secondary-drying process. For some spray-dried materials, secondary drying by traditional techniques can take days and requires balancing stability risks with process time. Methods Spray-dried polymers were secondary dried, comparing the results for three state-of-the-art methods that employed a jacketed, agitated-vessel dryer: (1) vacuum-only drying, (2) water-assisted drying, or (3) methanol-assisted drying. Samples of material were pulled at various time points and analyzed by gas chromatography (GC) and Karl Fischer (KF) titration to track the drying process. Results Model systems were chosen for which secondary drying is slow. For all cases studied, methanol-assisted drying outperformed the vacuum-only and water-assisted drying methods. Conclusions The observation that methanol-assisted drying is more effective than the other drying techniques is consistent with the free-volume theory of solvent diffusion in polymers.


Marine Drugs ◽  
2021 ◽  
Vol 19 (6) ◽  
pp. 329
Author(s):  
Nilia de la Paz ◽  
Mirna Fernández ◽  
Orestes López ◽  
Caridad Garcia ◽  
Antonio Nogueira ◽  
...  

We investigated a spray drying process for preparing water-soluble salts of high molecular weight chitosan (CH) intended for pharmaceutical excipient applications. CH was derived from chitin of marine lobster origin (Panulirus argus). The effects of organic acid (acetic or lactic acid) and the ratio (difference) of inlet/outlet air temperature (140/90 °C or 160/100 °C) on spray drying were studied. The yield of spray-dried CH salt powders ranged from 50% to 99% in laboratory and industrial-scale processes. The spray-dried dry powder of CH salts consisted of spherical agglomerated particles with an average diameter of 36.2 ± 7.0 µm (CH acetate) and 108.6 ± 11.5 µm (CH lactate). After dispersing the spray-dried CH salt powder samples in purified water, the mean particle sizes obtained for the CH acetate salts were 31.4 nm (batch A001), 33.0 nm (A002) and 44.2 nm (A003), and for the CH lactate salts 100.8 nm (batch L001), 103.2 nm (L002) and 121.8 nm (L003). The optimum process conditions for spray drying were found: an inlet air temperature of 160 ± 5 °C, an outlet temperature of 100 ± 5 °C and an atomizer disk rotational speed of 18,200 min−1. The X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC) results confirmed the amorphous state of the CH salts. The 1H nuclear magnetic resonance (NMR) and Fourier transform infrared (FT-IR) spectra of CH acetate and lactate salts verified that the spray drying process does not affect the polymer backbone. In conclusion, both laboratory and industrial-scale spray drying methods for preparing water-soluble acid salts of CH are reproducible, and the physicochemical properties of the corresponding CH acid salts are uniform.


Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 973
Author(s):  
Mónica C. García ◽  
Nabila Naitlho ◽  
José Manuel Calderón-Montaño ◽  
Estrella Drago ◽  
Manuela Rueda ◽  
...  

Stimulus-responsive liposomes (L) for triggering drug release to the target site are particularly useful in cancer therapy. This research was focused on the evaluation of the effects of cholesterol levels in the performance of gold nanoparticles (AuNPs)-functionalized L for controlled doxorubicin (D) delivery. Their interfacial and morphological properties, drug release behavior against temperature changes and cytotoxic activity against breast and ovarian cancer cells were studied. Langmuir isotherms were performed to identify the most stable combination of lipid components. Two mole fractions of cholesterol (3.35 mol% and 40 mol%, L1 and L2 series, respectively) were evaluated. Thin-film hydration and transmembrane pH-gradient methods were used for preparing the L and for D loading, respectively. The cationic surface of L allowed the anchoring of negatively charged AuNPs by electrostatic interactions, even inducing a shift in the zeta potential of the L2 series. L exhibited nanometric sizes and spherical shape. The higher the proportion of cholesterol, the higher the drug loading. D was released in a controlled manner by diffusion-controlled mechanisms, and the proportions of cholesterol and temperature of release media influenced its release profiles. D-encapsulated L preserved its antiproliferative activity against cancer cells. The developed liposomal formulations exhibit promising properties for cancer treatment and potential for hyperthermia therapy.


2009 ◽  
Vol 98 (12) ◽  
pp. 4724-4737 ◽  
Author(s):  
Hisham Al-Obaidi ◽  
Steve Brocchini ◽  
Graham Buckton

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