The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations

Filijović, Nataša Djordjević; Antonijević, Milan D.; Pavlović, Aleksandar; Vučković, Ivan; Nikolić, Katarina; Agbaba, Danica

doi:10.3109/03639045.2014.884114

Cited by 7 publications

(2 citation statements)

References 13 publications

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“…It is thus apparent that the DP resulting out of autoxidation may not always be stable and might undergo secondary reactions. Additionally for OLA, several reports have mentioned oxidative susceptibility in the solid , and solution , states. Moreover, studies conducted using AIBN in solution state may be expected to give rise to DPs by autoxidation.…”

Section: Resultsmentioning

confidence: 99%

Theoretical and Experimental Investigation of Autoxidation Propensity of Selected Drugs in Solution State

et al. 2023

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The C−H bond dissociation energy (BDE) of drug molecules is often used to estimate their relative propensities to undergo autoxidation. BDE calculations based on electronic structures provide a convenient means to estimate the risk for a given compound to degrade via autoxidation. This study aimed to verify the utility of calculated C−H BDEs of a range of drug molecules in predicting their autoxidation propensities, in the solution state. For the autoxidation study, 2,2′-azobis (2methylpropionitrile) was employed as the solution state stressor, and the experimental reaction rate constants were determined employing ultraperformance liquid chromatographic (UPLC) methods. Reaction rates in the solution state were compared to the calculated C−H BDE values of the respective compounds. The results indicated a poor correlation for compounds in the solution state, and their relative stabilities could not be explained with C−H BDE. On the other hand, a favorable relationship was observed between the relative extent of ionization and the autoxidation rates of the selected compounds. In the solution state, factors such as the type and extent of drug ionization, degree and type of solvation have been shown to contribute to differences in reactivity. By applying the computational method involving the effect of H-atom abstraction and potential ionization sites in the molecule, the calculated C−H BDE should relate better to the experimental autoxidation rates.

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Section: Resultsmentioning

confidence: 99%

Theoretical and Experimental Investigation of Autoxidation Propensity of Selected Drugs in Solution State

et al. 2023

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“…In the course of this study, it was discovered that the choice of tablet filler excipient plays an important role in the formulation of olanzapine film-coated tablets. Degradation of olanzapine film coated tablets was governed by temperature and moisture [54] [55].…”

Section: Ceronapril Degradation In Presence Of Mannitol and Dibasic Cmentioning

confidence: 99%

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Hotha¹,

Roychowdhury²,

Subramanian³

2016

AJAC

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The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms.

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Preformulation studies for atorvastatin calcium

Cristea

Baul

Ledeți

et al. 2019

J Therm Anal Calorim

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The stress stability of olanzapine: studies of interactions with excipients in solid state pharmaceutical formulations

Cited by 7 publications

References 13 publications

Theoretical and Experimental Investigation of Autoxidation Propensity of Selected Drugs in Solution State

Theoretical and Experimental Investigation of Autoxidation Propensity of Selected Drugs in Solution State

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

Preformulation studies for atorvastatin calcium

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