Share This Author
Pharmaceutical Stress Testing : Predicting Drug Degradation
- S. Baertschi
- Materials Science, Biology
- 24 June 2005
This book discusses physical and chemical Stability Considerations in the Development and Stress Testing of Freeze-Dried Pharmaceuticals, and Comparative Stress Stability Studies for Rapid Evaluation of Manufacturing Changes of Materials from Multiple Sources.
Formation of thiol conjugates of 9-deoxy-delta 9,delta 12(E)-prostaglandin D2 and delta 12(E)-prostaglandin D2.
- J. Atsmon, B. Sweetman, S. Baertschi, T. Harris, L. Roberts
- Chemistry, BiologyBiochemistry
- 17 April 1990
Conjugation of both compounds with cysteine was found to occur more rapidly than with glutathione, and this effect was more pronounced with delta 12(E)-prostaglandin D2 in which 60% conjugated with Cysteine within 2 min.
A stress testing benchmarking study
A benchmarking survey was conducted to better understand current stress-testing practices in the pharmaceutical industry and addressed a range of issues such as stress testing study design, types of conditions, procedures, and the company organization used to conduct stress testing.
Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine.
The main conclusion is that drugs which are secondary amines (not just primary amines as sometimes reported) undergo the Maillard reaction with lactose under pharmaceutically relevant conditions.
Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products…
- S. Baertschi, D. Clapham, H. Tønnesen
- Political ScienceJournal of pharmaceutical sciences
- 1 November 2013
This commentary suggests a systematic approach, based on realistic "worst case" photoexposure scenarios and the existing ICH Option 1 and 2 light sources, to provide valuable data to pharmaceutical manufacturers and compounding pharmacists for the safe and effective use of photosensitive injection products.
Comparison of rates of enzymatic oxidation of aflatoxin B1, aflatoxin G1, and sterigmatocystin and activities of the epoxides in forming guanyl-N7 adducts and inducing different genetic responses.
- S. Baertschi, K. Raney, T. Shimada, T. Harris, F. Guengerich
- Chemistry, BiologyChemical research in toxicology
- 1 March 1989
Findings indicate that these structurally related guanyl-N7 DNA adducts have intrinsic differences which give rise to divergent biological responses.
Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate.
- P. Jansen, P. Oren, C. A. Kemp, S. Maple, S. Baertschi
- Chemistry, Materials ScienceJournal of pharmaceutical sciences
It is proposed that polymer-bound succinic and phthalic substituents can be cleaved from the polymer, resulting in the formation of either the free acids or the anhydrides, enabling the reaction to be enabled by migration of the free acid or anhydride through the formulation.
Preparation of the 8,9-epoxide of the mycotoxin aflatoxin B1: the ultimate carcinogenic species
Isolation and characterization of natural allene oxides: unstable intermediates in the metabolism of lipid hydroperoxides.
- A. Brash, S. Baertschi, C. D. Ingram, T. Harris
- ChemistryProceedings of the National Academy of Sciences…
- 1 May 1988
The isolation and structural elucidation of allene oxides prepared from the (13S)-hydroperoxides of linoleic and linolenic acids give direct proof of the structure of the allene oxide intermediates and should facilitate further investigation of the metabolism of this class of epoxide to prostaglandins, clavulones, and other stable end products.
Absolute configuration of cis-12-oxophytodienoic acid of flaxseed: implications for the mechanism of biosynthesis from the 13(S)-hydroperoxide of linolenic acid.
It is proposed that the biosynthesis of racemic cis-12-oxo-PDA proceeds by dehydration of the 13(S)-hydroperoxide to an allene oxide, the achiral precursor of the stable end product of pericyclic ring closure.