Stability Aspects of Preformulation and Formulation of Solid Pharmaceuticals
TL;DR: The Stability Aspects of Preformulation and Formulation of Solid Pharmaceuticals: Vol. 10, No. 8-9, pp. 1373-1412 as mentioned in this paper.
Abstract: (1984). Stability Aspects of Preformulation and Formulation of Solid Pharmaceuticals. Drug Development and Industrial Pharmacy: Vol. 10, No. 8-9, pp. 1373-1412.
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TL;DR: The present review focuses on the techniques for compatibility screening of active pharmaceutical ingredient with their potential merits and demerits and highlights the applicability of these techniques using specific drug-excipient compatibility case studies.
173 citations
TL;DR: In this paper, a comparison of polyvinylpyrrolidone (PVP) and poly(ethylene glycol) (PEG) solid dispersions with Felodipine or Hesperetin having up to 20 wt% drug were prepared using solvent evaporation method.
145 citations
TL;DR: In this article, the current regulatory requirements for impurity identification and the chemical origins of various impurities, particularly those derived from degradation of drugs, are discussed followed by an overview of the critical steps and the roles of various analytical techniques, such as HPLC-DAD, LC-MS, LC•NMR, GC•MS, a...
Abstract: Identification of pharmaceutical impurities is a critical analytical activity in the drug development process whose goal is to fully elucidate the chemical structures of unknown pharmaceutical impurities present in either drug substances or drug products above a particular threshold. Knowledge of the chemical structure of an impurity is essential to assess its toxicological implications and to gain an understanding of its formation mechanism. Knowledge of the formation mechanism is critical for improving the synthetic chemical processes and optimizing the drug formulation to reduce or eliminate the impurity. This article reviews the current regulatory requirements for impurity identification and the chemical origins of various impurities, particularly those derived from degradation of drugs. Strategies for identification of pharmaceutical impurities are discussed followed by an overview of the critical steps and the roles of various analytical techniques, such as HPLC‐DAD, LC‐MS, LC‐NMR, GC‐MS, a...
111 citations
TL;DR: The chemical stability of repository compounds is affected by various environmental conditions during long-term storage, and results indicate no significant compound loss after 11 freeze/thaw cycles.
Abstract: The chemical stability of repository compounds is affected by various environmental conditions during long-term storage Studies were carried out to evaluate the effects of the following potential causes of instability of compounds in DMSO at a 10-mM concentration: water, oxygen, freeze/thaw cycles, and storage container material A set of compounds was selected for the study based on structural diversity and functional group representation Compound concentration was determined with liquid chromatography/ultraviolet spectroscopy/mass spectrometry (LC/UV/MS) analysis relative to an internal standard added to each sample An accelerated study was conducted, and results demonstrate that most compounds are stable for 15 weeks at 40 degrees C Water is more important in causing compound loss than oxygen The freeze/thaw cycle study was done with freezing at -15 degrees C and thawing under nitrogen atmosphere at 25 degrees C Two methods were used to redissolve compounds after thawing: agitation and repeated aspiration/dispense The results indicate no significant compound loss after 11 freeze/thaw cycles Compound recovery was also measured from glass and polypropylene containers for 5 months at room temperature, and no significant difference was found for these 2 types of containers
105 citations
Cites background from "Stability Aspects of Preformulation..."
...Studies on the stability of individual drugs in specific formulations at preclinical and clinical stages have been documented extensively, as required by the Food and Drug Administration (FDA) for drug approval.(16-18) These studies, although not applicable to repository compounds, nonetheless provide useful insights into some aspects of repository compound stability....
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TL;DR: In this article, a range of techniques (thermal methods, microscopy, X-ray diffraction, IR spectroscopy) were applied to characterize a drug (atenolol), several excipients (PVP=polyvinylpyrrolidone, MGST=magnesium stearate, Avicel©) and drug-excipients mixtures either as prepared, annealed, and exposed to moisture.
Abstract: We apply a range of techniques (thermal methods, microscopy, X-ray diffraction, IR spectroscopy) to characterize a drug (atenolol), several excipients (PVP=polyvinylpyrrolidone, MGST=magnesium stearate, Avicel©) and drug-excipients mixtures either as prepared, annealed, and exposed to moisture. We compare the data of the mixtures with those computed from a weighted average of similarly treated pure compounds to find evidence of drug properties modified by the interaction with the excipient. We find that thermal response is by far the most sensitive indicator of interaction while IR is the least sensitive one. Avicel© has essentially no interaction with atenolol, while MGST modifies significantly only the thermal response of the drug in the MGST-rich mixtures. PVP interacts strongly with atenolol, and this interaction appears to be mediated by the substantial amount of hydration water the excipient brings in its mixtures with a water-free drug.
63 citations
References
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01 Jan 1970
TL;DR: The theoty and practice of industrial pharmacacy as mentioned in this paper, Thetheory and Practice of Industrial Pharmacy, Thetheology and the Practice of industrial pharmacy, and Thethety and the practice of Industrial pharmacacy.
Abstract: The theoty and Practice of Industrial Pharmacy , The theoty and Practice of Industrial Pharmacy , کتابخانه دیجیتال جندی شاپور اهواز
2,889 citations
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TL;DR: There was a good correlation between calorimetric crystallinity and the (less precise) crystallinity derived from X-ray data, and provided amorphous and crystalline standards are appropriately chosen, the calorimal crystallinity correlates well with chemical stability.
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