Crystal forms of anhydrous calcium stearate derivable from calcium stearate monohydrate

Vold, Marjorie J.; Hattiangdi, G. S.; Vold, Robert D.

doi:10.1016/0095-8522(49)90037-9

Cited by 18 publications

(7 citation statements)

References 3 publications

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“…The alkaline nature of the metallic stearates can be partially ascribed to the existence of basic impurities in the stearates. For instance, magnesium oxide is well documented as a basic impurity of MgSt, CaSt has calcium hydroxide as an impurity, while sodium hydroxide has been reported as an impurity in NaSt. ,− The slurry pH values of all three stearates are much higher than the pH max (2.8) of PIO-HCl salt indicating the potential for inducing salt disproportionation. Intuitively, based on the above observations, NaSt is expected to be the most problematic excipient in the formulation of hydrochloride salts due to its high specific surface area and strong alkalinity.…”

Section: Resultsmentioning

confidence: 98%

Impact of Metallic Stearates on Disproportionation of Hydrochloride Salts of Weak Bases in Solid-State Formulations

Nie

Xu²,

Ren

et al. 2016

Mol. Pharmaceutics

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Excipient-induced salt disproportionation (conversion from salt form to free form) in the solid state during storage or manufacturing is a severe formulation issue that can negatively influence product performance. However, the role of excipient properties on salt disproportionation and mechanisms of proton transfer between salt and excipients are still unclear. Moreover, knowledge about the formation of disproportionation products and the consequent impact of these reactions products on the disproportionation process is still inadequate. In the present study, three commonly used lubricants (sodium stearate, calcium stearate, and magnesium stearate) were mixed with a hydrochloride salt as binary mixtures to examine their different capabilities for inducing salt disproportionation at a stressed storage condition (40 °C/65% RH). The overall objective of this research is to explore factors influencing the kinetics and extent of disproportionation including surface area, alkalinity, hygroscopicity, formation of new species, etc. In addition, we also aim to clarify the reaction mechanism and proton transfer between the model salt and stearates to provide insight into the in situ formed reaction products. We found that the properties of stearates significantly affect the disproportionation process in the initial stage of storage, while properties of the reaction products negatively affect the hygroscopicity of the powder mixture promoting disproportionation during longer-term storage. In addition, lubrication difference among three stearates was evaluated by performing compaction studies. The findings of this study provide an improved understanding of the proton transfer mechanism between the ionized form of an active pharmaceutical ingredient and excipients in solid dosage forms. It also provides pragmatic information for formulation scientists to select appropriate lubricants and other excipients, and to design robust formulations.

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Section: Resultsmentioning

confidence: 98%

Impact of Metallic Stearates on Disproportionation of Hydrochloride Salts of Weak Bases in Solid-State Formulations

Nie

Xu²,

Ren

et al. 2016

Mol. Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…4) and the atmospheric moisture as well as prevent the crystal-to-crystal contact necessary for deliquescence lowering. Given its widespread use as a lubricant, calcium stearate would be expected to coat particles in a similar manner to that described for magnesium stearate (Vold et al, 1949). The different mechanisms by which anticaking agents function could influence the moisture sorption profiles of powder blends to which they are added.…”

Section: Effect Of Formulation On Deliquescence Behaviormentioning

confidence: 96%

Effects of anticaking agents and storage conditions on the moisture sorption, caking, and flowability of deliquescent ingredients

Lipasek

Ortiz

Taylor

et al. 2012

Food Research International

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“…The formation of a monolayer coating of calcium stearate on the CaCO 3 nanoparticles was through a reaction between stearic acid and the calcium carbonate. Hydrated calcium stearate is the common form of the product when the reaction is performed in an aqueous medium [36][37][38]. Since the nanoparticles were coated in a solution of water and ethanol, a hydrated calcium stearate coating is expected.…”

Section: Coating Characterizationmentioning

confidence: 99%

Nucleating effect of calcium stearate coated CaCO3 nanoparticles on polypropylene

Lin

Chen

Chan

et al. 2011

Journal of Colloid and Interface Science

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Crystal forms of anhydrous calcium stearate derivable from calcium stearate monohydrate

Cited by 18 publications

References 3 publications

Impact of Metallic Stearates on Disproportionation of Hydrochloride Salts of Weak Bases in Solid-State Formulations

Impact of Metallic Stearates on Disproportionation of Hydrochloride Salts of Weak Bases in Solid-State Formulations

Effects of anticaking agents and storage conditions on the moisture sorption, caking, and flowability of deliquescent ingredients

Nucleating effect of calcium stearate coated CaCO3 nanoparticles on polypropylene

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