2022
DOI: 10.1016/j.xphs.2022.08.011
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The Role of Titanium Dioxide (E171) and the Requirements for Replacement Materials in Oral Solid Dosage Forms: An IQ Consortium Working Group Review

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Cited by 17 publications
(8 citation statements)
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“…More treatment time was used for microsized TiO 2– x compared with the nanosized one possibly due to different surface area ratios. TiO 2 is one of the most commonly used pharmaceutical excipients and is used very often in solid oral dosage forms and in semisolid oral dosage forms as a white pigment or opacifier. , We believe that usage of microsized TiO 2– x instead of nano-TiO 2– x is beneficial for clinical transformation by avoiding the uncertain toxicity and biosafety concerns of nanomaterials. Although the negative nano-TiO 2 effects on human health have not been fully demonstrated yet, in vitro and in vivo small animal tests have reported that TiO 2 nanoparticles are more dangerous than microsized ones. , As a kind of nondegradable metal oxide nanomaterial, nano-TiO 2 would build up in tissues or organs through the hematologic system or digestive system .…”
Section: Discussionmentioning
confidence: 99%
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“…More treatment time was used for microsized TiO 2– x compared with the nanosized one possibly due to different surface area ratios. TiO 2 is one of the most commonly used pharmaceutical excipients and is used very often in solid oral dosage forms and in semisolid oral dosage forms as a white pigment or opacifier. , We believe that usage of microsized TiO 2– x instead of nano-TiO 2– x is beneficial for clinical transformation by avoiding the uncertain toxicity and biosafety concerns of nanomaterials. Although the negative nano-TiO 2 effects on human health have not been fully demonstrated yet, in vitro and in vivo small animal tests have reported that TiO 2 nanoparticles are more dangerous than microsized ones. , As a kind of nondegradable metal oxide nanomaterial, nano-TiO 2 would build up in tissues or organs through the hematologic system or digestive system .…”
Section: Discussionmentioning
confidence: 99%
“…TiO 2 is one of the most commonly used pharmaceutical excipients and is used very often in solid oral dosage forms and in semisolid oral dosage forms as a white pigment or opacifier. 30,39 We believe that usage of microsized TiO 2−x instead of nano-TiO 2−x is beneficial for clinical transformation by avoiding the uncertain toxicity and biosafety concerns of nanomaterials. Although the negative nano-TiO 2 effects on human health have not been fully demonstrated yet, in vitro and in vivo small animal tests have reported that TiO 2 nanoparticles are more dangerous than microsized ones.…”
Section: Discussionmentioning
confidence: 99%
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“…PAR hard capsules formulations contain typical excipients, including gelatin for the capsule shell formation, titanium dioxide as a white pigment and opacifier, and magnesium stearate, primarily used as a lubricant in capsule and tablet manufacturing (25). Titanium dioxide has been recognized as a potentially genotoxic excipient and great efforts are being made to find a suitable alternative regarding tablet and/or capsule opacifiers (28). In addition, sodium lauryl sulphate, used as solubilizing agent and lubricant in tablets and capsules formulations (29), was identified in many formulations.…”
Section: Solid Dosage Formsmentioning
confidence: 99%