Application of spray granulation for conversion of a nanosuspension into a dry powder form

Bose, Sonali; Schenck, Daniel; Ghosh, Indrajit; Hollywood, Al; Maulit, Ester; Ruegger, Colleen

doi:10.1016/j.ejps.2012.04.020

Cited by 61 publications

(21 citation statements)

References 29 publications

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“…Although the corresponding processes normally yield products with superior properties towards subsequent processing, e.g., into tablets [28], the number of publications regarding their applicability for conversion of API nanosuspensions into solid products is rather low. Available literature describes bead-coating/layering with API nanosuspensions [29][30][31] or the application of the corresponding suspensions as granulation liquids in fluidized granulation processes [32][33][34][35][36]. Most of these studies focus on the general feasibility of applying API nanosuspensions in the corresponding processes by showing enhanced dissolution profiles for nanoparticle-loaded products compared to the coarse API particles [29][30][31][32][33][34][35][36].…”

Section: Introductionmentioning

confidence: 99%

“…Available literature describes bead-coating/layering with API nanosuspensions [29][30][31] or the application of the corresponding suspensions as granulation liquids in fluidized granulation processes [32][33][34][35][36]. Most of these studies focus on the general feasibility of applying API nanosuspensions in the corresponding processes by showing enhanced dissolution profiles for nanoparticle-loaded products compared to the coarse API particles [29][30][31][32][33][34][35][36]. However, the degree of nanoparticle agglomeration during drying, typically assessed by redispersibility studies of the dry product, was investigated only in a few studies, although it has been shown to be an important criterion to assess the overall performance of the dried nanosuspension, directly influencing the dissolution rate and/or bioavailability [32][33][34].…”

Section: Introductionmentioning

confidence: 99%

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Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

et al. 2020

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The particle size reduction of active pharmaceutical ingredients is an efficient method to overcome challenges associated with a poor aqueous solubility. With respect to stability and patient’s convenience, the corresponding nanosuspensions are often further processed to solid dosage forms. In this regard, the influence of several formulation parameters (i.e., type of carrier material, type and amount of additional polymeric drying excipient in the nanosuspension) on the redispersibility of naproxen nanoparticle-loaded granules produced in a fluidized bed process was investigated. The dissolution rate of the carrier material (i.e., sucrose, mannitol, or lactose) was identified as a relevant material property, with higher dissolution rates (sucrose > mannitol > lactose) resulting in better redispersibility of the products. Additionally, the redispersibility of the product granules was observed to improve with increasing amounts of polymeric drying excipient in the nanosuspension. The redispersibility was observed to qualitatively correlate with the degree of nanoparticle embedding on the surface of the corresponding granules. This embedding was assumed to be either caused by a partial dissolution and subsequent resolidification of the carrier surface dependent on the dissolution rate of the carrier material or by resolidification of the dissolved polymeric drying excipient upon drying. As the correlation between the redispersibility and the morphology of the corresponding granules was observed for all investigated formulation parameters, it may be assumed that the redispersibility of the nanoparticles is determined by their distance in the dried state.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

et al. 2020

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“…Techniques of electrostatic adsorption [13], spray drying [14], covalent graft [12] and layer-by-layer assembly [15] have been developed to introduce PEI on surface of inorganic or organic solid sphere. Spray drying often is used as an encapsulation technique by the food [16] and pharmaceutical industry [17]. Murakami et al made use of the technique to produce PEI-coated hydroxyapatite with various fractions of PEI [14].…”

Section: Introductionmentioning

confidence: 99%

Characterization of a Polyamine Microsphere and Its Adsorption for Protein

Wang

Liu

Nie

et al. 2012

IJMS

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A novel polyamine microsphere, prepared from the water-in-oil emulsion of polyethylenimine, was characterized. The investigation of scanning electron microscopy showed that the polyamine microsphere is a regular ball with a smooth surface. The diameter distribution of the microsphere is 0.37–4.29 μm. The isoelectric point of the microsphere is 10.6. The microsphere can adsorb proteins through the co-effect of electrostatic and hydrophobic interactions. Among the proteins tested, the highest value of adsorption of microsphere, 127.8 mg·g−1 microsphere, was obtained with lipase. In comparison with other proteins, the hydrophobic force is more important in promoting the adsorption of lipase. The microsphere can preferentially adsorb lipase from an even mixture of proteins. The optimum temperature and pH for the selective adsorption of lipase by the microsphere was 35 °C and pH 7.0.

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“…Novartis compound A and itraconazole nanosuspension dried as powders and subsequently filled in capsules was found to enhance bioavailability after oral administration in beagle dogs [6] and rats [39], respectively. In vitro dissolution test and in vivo studies in rats demonstrated a marked improvement in bioavailability of glimepiride nanocrystal-loaded capsules compared to the marketed formulation [15].…”

Section: Capsulesmentioning

confidence: 99%

Emerging role of nanosuspensions in drug delivery systems

2020

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Rapid advancement in drug discovery process is leading to a number of potential new drug candidates having excellent drug efficacy but limited aqueous solubility. By virtue of the submicron particle size and distinct physicochemical properties, nanosuspension has the potential ability to tackle many formulation and drug delivery issues typically associated with poorly water and lipid soluble drugs. Conventional size reduction equipment such as media mill and high-pressure homogenizers and formulation approaches such as precipitation, emulsion-solvent evaporation, solvent diffusion and microemulsion techniques can be successfully implemented to prepare and scale-up nanosuspensions. Maintaining the stability in solution as well as in solid state, resuspendability without aggregation are the key factors to be considered for the successful production and scale-up of nanosuspensions. Due to the considerable enhancement of bioavailability, adaptability for surface modification and mucoadhesion for drug targeting have significantly expanded the scope of this novel formulation strategy. The application of nanosuspensions in different drug delivery systems such as oral, ocular, brain, topical, buccal, nasal and transdermal routes are currently undergoing extensive research. Oral drug delivery of nanosuspension with receptor mediated endocytosis has the promising ability to resolve most permeability limited absorption and hepatic first-pass metabolism related issues adversely affecting bioavailability. Advancement of enabling technologies such as nanosuspension can solve many formulation challenges currently faced among protein and peptide-based pharmaceuticals.

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Application of spray granulation for conversion of a nanosuspension into a dry powder form

Cited by 61 publications

References 29 publications

Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process

Characterization of a Polyamine Microsphere and Its Adsorption for Protein

Emerging role of nanosuspensions in drug delivery systems

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