Zobrazeno 1 - 10
of 23
pro vyhledávání: '"Kenneth Craig Waterman"'
Autor:
Teslin M Botoy, Alisa K Waterman, Kenneth Craig Waterman, Jane Li, Michael Hawley, Fenghe Qiu
Publikováno v:
Pharmaceutical Development and Technology. 26:1130-1135
An efficient protocol for assessing both the chemical and physical stability of cocrystalline forms of active pharmaceutical ingredients (APIs) is proposed. In this protocol, the cocrystalline material is used to prepare two standard formulations, mi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac424fbdf24b7ddaa9300f4f97d2f7dd
https://doi.org/10.1080/10837450.2021.2004607
https://doi.org/10.1080/10837450.2021.2004607
Publikováno v:
AAPS PharmSciTech. 18:1692-1698
The Accelerated Stability Assessment Program (ASAP) was applied for the first time to a peptide, the antibiotic active pharmaceutical ingredient bacitracin. Bacitracin and its complex with zinc were exposed to temperature and relative humidity condit
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fbbfeaacd49aa7dd56d6580df0dfad27
https://doi.org/10.1208/s12249-016-0635-7
https://doi.org/10.1208/s12249-016-0635-7
Autor:
Bruce C. MacDonald, Kenneth Craig Waterman, Garry Scrivens, Philip Waterman, Lili Chen, Andrew P. Monahan
Publikováno v:
Drug Development and Industrial Pharmacy. 42:1571-1578
A model is presented for determining the time when an active pharmaceutical ingredient in tablets/powders will remain within its specification limits during an in-use period; that is, when a heat-induction sealed bottle is opened for fixed time perio
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::566ec7a79bbd4f45a92db9b6e70fb1d5
https://doi.org/10.3109/03639045.2016.1153648
https://doi.org/10.3109/03639045.2016.1153648
Publikováno v:
Journal of Pharmaceutical Sciences. 103:3000-3006
Three competing mathematical fitting models (a point-by-point estimation method, a linear fit method, and an isoconversion method) of chemical stability (related substance growth) when using high temperature data to predict room temperature shelf-lif
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a77afff3cb583cd983ea134f4ff89bd8
https://doi.org/10.1002/jps.24075
https://doi.org/10.1002/jps.24075
Publikováno v:
Journal of Pharmaceutical Sciences. 101:4170-4177
A proposed generalized relationship for the impact of excipients on the solid-state chemical stability of drug products is presented and shown to be consistent across multiple degradation products with two example drugs. In this model, when the numbe
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c14b89f2e8b39dbd7b97793a0748283
https://doi.org/10.1002/jps.23268
https://doi.org/10.1002/jps.23268
Publikováno v:
Journal of Pharmaceutical Sciences. 101:610-615
The chemical reaction rate for solid-state product formation in a pharmaceutical case study was monitored by equilibration with either a 75%, 21.5%, 75% relative humidity (RH) cycle ("high-low-high", HLH) or a 21.5%, 75%, 21.5% RH cycle ("low-high-lo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1db28f71cd794e84448d5dc07dce6a78
https://doi.org/10.1002/jps.22789
https://doi.org/10.1002/jps.22789
Publikováno v:
Pharmaceutical Development and Technology. 14:548-555
An osmotic-controlled pulsatile delivery technology was developed for targeted drug delivery. This novel system consists of a tablet core surrounded by an osmotic coating that has been mechanically compromised in strategic locations to facilitate rel
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7c0f804cad5278151b0043ea56b9e3d9
https://doi.org/10.1080/10837450902838692
https://doi.org/10.1080/10837450902838692
Publikováno v:
Journal of Controlled Release. 134:201-206
A new controlled-release, extrudable core system (ECS) tablet has been developed which osmotically delivers high doses of low solubility active pharmaceutical ingredients (API's). The tablet has a single core formed in a modified oval shape with a se
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::455a2f1412a7c1ba05e2564c8b667a7a
https://doi.org/10.1016/j.jconrel.2008.11.017
https://doi.org/10.1016/j.jconrel.2008.11.017
Autor:
Barbara Alice Johnson, William B. Arikpo, Michael Bruce Fergione, Timothy W. Graul, Michael Christopher Roy, Bruce C. MacDonald, Kenneth Craig Waterman, Robert J. Timpano
Publikováno v:
Journal of Pharmaceutical Sciences. 97:1499-1507
Significant degradation of the amine-based smoking cessation drug varenicline tartrate in an early development phase osmotic, controlled-release (CR) formulation yields predominantly two products: N-methylvarenicline (NMV) and N-formylvarenicline (NF
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::318aeff24524cada1625015e31e7672c
https://doi.org/10.1002/jps.21119
https://doi.org/10.1002/jps.21119
Autor:
Bruce C. MacDonald, Patrick Lukulay, Anthony J. Carella, Michael Christopher Roy, Michael J. Gumkowski, Sheri L. Shamblin, Kenneth Craig Waterman
Publikováno v:
Pharmaceutical Research. 24:780-790
To propose and test a new accelerated aging protocol for solid-state, small molecule pharmaceuticals which provides faster predictions for drug substance and drug product shelf-life. The concept of an isoconversion paradigm, where times in different
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9d0370d331a1d64ffea37402460cb2ed
https://doi.org/10.1007/s11095-006-9201-4
https://doi.org/10.1007/s11095-006-9201-4