Organic Impurities in Drug Products: Origin, Control and Measurement

Elder, David

doi:10.1002/9780470988749.ch2

Cited by 2 publications

(2 citation statements)

References 79 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Conventionally, the studies have comprised mixing the API with one or more potential excipients and submitting these mixtures to accelerated storage conditions with the subsequent analysis by a chromatographic technique, primarily HPLC coupled to UV (Elder, 2007;Qiu, 2006;Wu et al, 2011). However, stability studies are time-consuming, and could be a hindrance for submission of the drug file to regulatory authorities.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of microwave oven heating for prediction of drug–excipient compatibilities and accelerated stability studies

Schou-Pedersen

Østergaard

Cornett

et al. 2015

International Journal of Pharmaceutics

View full text Add to dashboard Cite

Section: Introductionmentioning

confidence: 99%

Evaluation of microwave oven heating for prediction of drug–excipient compatibilities and accelerated stability studies

Schou-Pedersen

Østergaard

Cornett

et al. 2015

International Journal of Pharmaceutics

View full text Add to dashboard Cite

“…To accelerate the drug-excipient compatibility screening and formulation development, approaches using high throughput technology (8,11) and statistical experimental design (8,12,13) were reported. In this work, we are reporting the drug-excipient interaction between HPMC-AS and API, using compound A and dyphylline as model compounds, due to the esterification of the hydroxyl group(s) with succinic acid, which is generated from the hydrolysis of HPMC-AS.…”

Section: Introductionmentioning

confidence: 99%

Hydroxypropyl Methylcellulose Acetate Succinate: Potential Drug–Excipient Incompatibility

Dong

Choi

2008

AAPS PharmSciTech

View full text Add to dashboard Cite

Abstract. The stability of hydroxypropyl methylcellulose acetate succinate (HPMC-AS) and its potential incompatibility with active pharmaceutical ingredients (API) carrying hydroxyl group(s) were investigated in this research. HPMC-AS may undergo hydrolysis under harsh processing conditions with the generation of succinic acid and acetic acid, which can form ester bond(s) with the hydroxyl group(s) in API. In this case, the hot-melt extrusion (HME) product prepared from HPMC-AS and our model compound (compound A) was tested after heating at 140°C up to 5 h. The succinate esters of compound A and its epimer were found in the product, suggesting potential drug-excipient incompatibility during formulation development. In addition, dyphylline was also tested with HPMC-AS and the potential incompatibility was further confirmed.KEY WORDS: drug-excipient incompatibility; hot-melt extrusion; hydroxypropyl methylcellulose acetate succinate (HPMC-AS); solid dispersion; succinic acid.

show abstract

Organic Impurities in Drug Products: Origin, Control and Measurement

Cited by 2 publications

References 79 publications

Evaluation of microwave oven heating for prediction of drug–excipient compatibilities and accelerated stability studies

Evaluation of microwave oven heating for prediction of drug–excipient compatibilities and accelerated stability studies

Hydroxypropyl Methylcellulose Acetate Succinate: Potential Drug–Excipient Incompatibility

Contact Info

Product

Resources

About