Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology

Alshehri, Sultan; Park, Jun-Bom; Alsulays, Bader B.; Tiwari, Roshan V.; Almutairy, Bjad K.; Alshetaili, Abdullah; Morott, Joseph T.; Shah, Sejal; Kulkarni, Vijay; Majumdar, Soumyajit; Martin, S. T.; Mishra, Sanjay R.; Wang, Lijia; Repka, Michael A.

doi:10.1016/j.jddst.2015.03.003

Cited by 49 publications

(31 citation statements)

References 35 publications

(33 reference statements)

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“…For example, extrudates were produced by HME using water soluble cationic model drugs and various grades of anionic polymers (Eudragit L100 and Eudragit L100-55 (Acryl EZE)). It was found that the products not only had a significant taste masking effect, but also showed fast release for most drug substances (74)(75)(76).…”

Section: Formation Of Embedded Structures With Hot-melting Extrusion mentioning

confidence: 99%

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 Embedded Structures With Hot-melting Extrusion mentioning

confidence: 99%

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

et al. 2019

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“…The extrudates increased the API's solubility in media with acidic pH, when it was present in concentra-tion up to 25% in the mixture, due to the amorphous state of the drug. Extrudates containing 20% and 25% were milled and compressed into orodispersible tablets, which provided fast disintegration times, potential taste masking, improved API solubility and overall stability (Alshehri et al, 2015). Gryczke et al (2011) developed orodispersible tablets based on solid solutions of ibuprofen in pH sensitive metacrylic polymer (Eudragit® EPO).…”

Section: Taste Masking and Patient Friendly Dosage Formsmentioning

confidence: 99%

Hot-melt extrusion and prilling as contemporary and promising techniques in the solvent free production of solid oral dosage forms, based on solid dispersions

Aleksovski¹,

Vervaet²,

Dreu³

2016

Maced. Pharm. Bull.

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Hot melt extrusion and prilling are gaining importance as solvent free and continuous techniques in the production of solid oral dosage forms with added value, by incorporating active compound in a molten carrier which is further solidified to form solid dispersion. This article reviews these two techniques in terms of understanding process basics, equipment characteristics, required properties of processed materials and application of the processes for development of solid oral dosage forms. Studies revealed that both hot-melt extrusion and prilling are regarded as simple, robust and continuous methods for processing different types of materials and production of solid dosage forms based on solid matrices. However, understanding of their concepts and requirements together with careful material selection is crucial for stable material processing and obtaining stable products of high-quality. Hot-melt extrusion proved to be a suitable method for production of modified release dosage forms, taste masked dosage forms and dosage forms offering improved drug dissolution rate and solubility. Prilling till now has been successfully applied just in the production of multiple unit drug delivery systems for immediate and sustained drug delivery. Further studies on product development and process understanding are required for full implementation of prilling in the pharmaceutical field.

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“…Several researchers have suggested that owing to lower porosity and higher tortuosity, diffusion-controlled sustained-release dosage forms prepared using the HME technique have slower drug release rates than those prepared by traditional methods [12, 13]. Additionally, HME has been widely used to enhance the dissolution rate of actives via preparation of solid dispersions for immediate and sustained-release applications [11, 14, 15]. …”

Section: Introductionmentioning

confidence: 99%

Process analytical quality control of tailored drug release formulation prepared via hot-melt extrusion technology

Park

Lee

Kang

et al. 2017

Journal of Drug Delivery Science and Technology

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The objective of the present study was to compare the influence of Eudragit® RS PO and RL PO blends on the release of water-soluble and insoluble drugs from hot-melt extruded formulations. In addition, we aimed to evaluate drug content uniformity and distribution by Fourier transform-infrared (FT-IR) chemical imaging. Theophylline (TP) and carbamazepine (CBZ) were selected as the water-soluble and insoluble model drugs, respectively. Eudragit® RS PO and RL PO were selected as the polymeric matrices. FT-IR chemical imaging clearly demonstrated the content uniformity and distribution for both drugs in the extrudates, which was confirmed by HPLC. Increasing the ratio of Eudragit® RL PO led to an increase in the in vitro drug release, whereas an increase in the ratio of Eudragit® RS PO sustained the drug release for up to 12 h. The hot-melt extrusion of TP and CBZ with varying ratios of Eudragit® RS PO and RL PO can be employed to tailor the drug release profiles. In this study, we demonstrated, for the first time, the use of FT-IR chemical imaging as a process analytical technique to determine the drug content uniformity and distribution. Our data correlated well with the results of HPLC analysis in the study of tailored drug release from the prepared hot-melt extruded formulation.

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Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology

Cited by 49 publications

References 35 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

Hot-melt extrusion and prilling as contemporary and promising techniques in the solvent free production of solid oral dosage forms, based on solid dispersions

Process analytical quality control of tailored drug release formulation prepared via hot-melt extrusion technology

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