Evaluation of coat uniformity and taste-masking efficiency of irregular-shaped drug particles coated in a modified tangential spray fluidized bed processor

Xu, Min; Heng, Paul Wan Sia; Liew, Celine Valeria

doi:10.1517/17425247.2015.1054278

Cited by 18 publications

(6 citation statements)

References 28 publications

(28 reference statements)

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“…It is an undeniable fact that polymers have a very excellent effect of taste masking; however, some of their properties are unsuitable, which directly affect their range of application. For example, Eudragit E PO is insoluble in neutral and basic pH but soluble in acidic pH (65). In a try to overcome this, citric acid was used as both pH-modifying agent and taste-masking agent with Eudragit E PO (66).…”

Section: Formation Of Core-shell Structures Via Coatingmentioning

confidence: 99%

“…In addition, it was also found that directly coating irregular-shaped drug particles with polymers was promising in achieving a wide size distribution for further application in ODT platforms. Moreover, when prepared by the fluidized bed process, the coated microgranules were much more effectively taste-masked than coated drug crystals (65,66). Finally, although coating with polymers might impair palatability, it can be improved by coating an outer layer containing flavors like mannitol (58).…”

Section: Formation Of Core-shell Structures Via Coatingmentioning

confidence: 99%

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Engineering Size and Structure of Particles in Novel Modified-Release Delivery Systems

et al. 2019

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Particle engineering has become a hot topic in the field of modified-release delivery systems during last decades. It has a wide range of pharmaceutical applications and is a bridge linking between drugs and drug delivery systems. Particles are an important part of many dosage forms and viewed as a carrier of drugs. Their size, shape, crystalline form, and structure directly affect the stability and releasing pattern of drugs. Engineering size or modifying particles by forming porous, core-shell, or skeleton structures can realize the development and utilization of functionally modified release systems (including fast-release systems, sustained-release systems, and targeted-release systems). However, there are certain problems in the practical application, such as bitter taste and coating damage. Combining with some polymer or lipid materials to form core-shell or embedded structures is considered as the key to taste masking. And, using cushioning agents is proven to be effective in preserving the integrity of the functional coating film of multiparticulates during tableting. To sum up, this review, from a particle engineering point, expounds the influence of different factors on the functionality of particles and offers some useful comments and suggestions for industry personnel.

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Section: Formation Of Core-shell Structures Via Coatingmentioning

confidence: 99%

Section: Formation Of Core-shell Structures Via Coatingmentioning

confidence: 99%

Engineering Size and Structure of Particles in Novel Modified-Release Delivery Systems

et al. 2019

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“…Fluidization of Geldart D particles is very important in many practical applications such as polymerization, refining, pharmaceutical granulation, combustion, gasification, catalytic cracking, calcinations, mineral chemistry, biomass, regeneration of exchangers, the treatment of industrial effluents, and the production of ethanol and medications. [1][2][3][4][5] These reactor systems offer a large exchange surface between gas and solid phases, a high intensity of heat and mass transfers between gas and particles, and between the fluidized bed and the reactor wall. The latter leads to an excellent homogeneity of the temperatures in the layer, and facilitates the control of this temperature by contribution or removal of the heat.…”

Section: Introductionmentioning

confidence: 99%

Three-dimensional computational fluid dynamics investigation of hydrodynamics behaviour of gas–solid flow in fluidized bed of Geldart D particles

Aiche

Belaadi

Lalaoua

et al. 2021

Proceedings of the Institution of Mechanical Engineers, Part E:

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Fluidized beds are widely used in many industrial processes as they ensure the desirable high-intensity heat and mass transfers between gas and particles and offer the possibility to perform operations in a continuous mode and powders recycling. Some of these industrial processes use Geldart D type of powders and operate in the slugging mode. This paper presents a 3 D numerical model of gas-solid flows in a fluidized bed based on the Two-Fluid Model (TFM). Turbulence modeling (k- ε) was used to predict flow behavior in fluidized bed of Geldart D particles. The solid phase consists of Geldart D powders and the gas flow is in a slug regime. The numerical results are validated against the experimental work of Azzi et al. Model predictions on flow patterns, bed expansion, volume fraction time series and pressure drop fluctuations are presented and discussed in details in order to demonstrate the cyclic process of slug formation (onset, growth, rising and bursting of slugs) and its effects on the overall performance of beds fluidizing Geldart D type of powders.

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“…The initial milled ritonavir ASD extrudate intermediate had a rather broad particle size distribution with a significant fraction of fine particles (<100 µm) and a particle shape that is not ideal for polymeric coating. Coating for conventional tablets, round pellets, or mini-tablets can be effective in reducing or eliminating API taste, resulting in “taste-neutral” formulations [15,16,17]. However, coating for irregularly shaped particulates/granules often results in an imperfect barrier film coat, exposing API in the oral cavity where it can be perceived.…”

Section: Introductionmentioning

confidence: 99%

Development and Palatability Assessment of Norvir® (Ritonavir) 100 mg Powder for Pediatric Population

Morris

Tisi

Tan

et al. 2019

IJMS

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: Norvir® (ritonavir) is a Biopharmaceutical Classification System Class IV compound with poor solubility in water (~5 µg/mL) and limited oral bioavailability. Early stage development efforts were focused on an oral solution (OS) which provided reasonable bioavailability but exhibited taste-masking challenges and required the use of solvents with potential pediatric toxicity. Norvir® oral powder, 100 mg (NOP) was developed to replace OS. The objective of this study is to provide an overview of the development of NOP and palatability assessment strategy. Palatability of NOP was assessed using the flavor profile method: (1) As an aqueous suspension dose/response and (2) evaluation with foods. The dose/response sensory analysis indicated that NOP has strong intensity bitterness and burnt aromatics (3 on the 0–3 flavor profile scale) at the clinical dose (100 mg/10 mL) and the recognition threshold was determined to be 0.3 mg/10 mL. To improve palatability, 100 mg/10 mL NOP aqueous suspension was evaluated with foods. Consuming foods high in fat and/or sugar content after NOP administration successfully reduced bitterness to a 1.5 intensity. In summary, NOP provides dose flexibility, enhanced stability, eliminated solvents, and maintains consistent bioavailability, with reduced bitterness and improved palatability via administration with common food products.

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Evaluation of coat uniformity and taste-masking efficiency of irregular-shaped drug particles coated in a modified tangential spray fluidized bed processor

Abstract: The FS processor shows promise for direct coating of irregular-shaped drug particles with wide size distribution. The coated particles with 15% coat were sufficiently taste masked and could be useful for further application in orally disintegrating tablet platforms.

Cited by 18 publications

References 28 publications

Engineering Size and Structure of Particles in Novel Modified-Release Delivery Systems

Engineering Size and Structure of Particles in Novel Modified-Release Delivery Systems

Three-dimensional computational fluid dynamics investigation of hydrodynamics behaviour of gas–solid flow in fluidized bed of Geldart D particles

Development and Palatability Assessment of Norvir® (Ritonavir) 100 mg Powder for Pediatric Population

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