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Estimating the variability in fraction absorbed as a paradigm for informing formulation development in early clinical drug development.
Publication Type: Academic Journal
Source(s): European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences [Eur J Pharm Sci] 2016 Jun 30; Vol. 89, pp. 50-60. Date of Electronic Publication: 2016 Apr 09.
Abstract: Purpose: Inter-subject variability in oral drug absorption is usually reported using bioavailability, which has the components: fraction absorbed (fa), fraction passing the gut wall (fg) and fraction escaping hepatic metabolism (fh). In this study, we ...
Formulation pre-screening of inhalation powders using computational atom-atom systematic search method.
Publication Type: Academic Journal
Source(s): Molecular pharmaceutics [Mol Pharm] 2015 Jan 05; Vol. 12 (1), pp. 18-33. Date of Electronic Publication: 2014 Nov 24.
Abstract: The synthonic modeling approach provides a molecule-centered understanding of the surface properties of crystals. It has been applied extensively to understand crystallization processes. This study aimed to investigate the functional relevance of synth...
Robust method optimization strategy-a useful tool for method transfer: the case of SFC.
Publication Type: Academic Journal
Source(s): Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2014 Jan; Vol. 88, pp. 519-24. Date of Electronic Publication: 2013 Oct 12.
Abstract: The concept of Quality by Design (QbD) is now well established in pharmaceutical industry and should be applied to the development of any analytical methods. In this context, the key concept of Design Space (DS) was introduced in the field of analytica...
A Simplified Model Structure for Compression Characterization of Pharmaceutical Tablets.
Publication Type: Academic Journal
Source(s): Journal of pharmaceutical sciences [J Pharm Sci] 2022 Nov; Vol. 111 (11), pp. 3088-3095. Date of Electronic Publication: 2022 Jul 12.
Abstract: Despite, or maybe because of, many shortcomings, Heckel's equation is by far the most investigated compressibility model for decades. The somewhat overlooked Gurnham equation is proposed as a more stable and better fitting compressibility model. Combin...
Ascertain a minimum coating thickness for acid protection of enteric coatings by means of optical coherence tomography.
Publication Type: Academic Journal
Source(s): International journal of pharmaceutics [Int J Pharm] 2022 Apr 25; Vol. 618, pp. 121680. Date of Electronic Publication: 2022 Mar 18.
Abstract: Enteric coatings are designed to protect active pharmaceutical ingredients (APIs) against untimely release in the stomach. Acid protection of such coatings depends on the coating layer thickness and integrity, which must be determined in an accurate an...
Investigation into powder tribo-charging of pharmaceuticals. Part I: Process-induced charge via twin-screw feeding.
Publication Type: Academic Journal
Source(s): International journal of pharmaceutics [Int J Pharm] 2020 Dec 15; Vol. 591, pp. 120014. Date of Electronic Publication: 2020 Oct 26.
Abstract: Powder feeding is a crucial unit operation in continuous manufacturing (CM) of pharmaceutical products. Twin-screw feeders are typically employed to ensure the accurate mass flow of pharmaceutical materials throughout the production process. Here, cont...
Dissolution testing of modified release products with biorelevant media: An OrBiTo ring study using the USP apparatus III and IV.
Publication Type: Academic Journal
Source(s): European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V [Eur J Pharm Biopharm] 2020 Nov; Vol. 156, pp. 40-49. Date of Electronic Publication: 2020 Aug 31.
Abstract: During the OrBiTo project, our knowledge on the gastrointestinal environment has improved substantially and biorelevant media composition have been refined. The aim of this study was to propose optimized biorelevant testing conditions for modified rele...
Employing Multivariate Statistics and Latent Variable Models to Identify and Quantify Complex Relationships in Typical Compression Studies.
Publication Type: Academic Journal
Source(s): AAPS PharmSciTech [AAPS PharmSciTech] 2020 Jul 07; Vol. 21 (5), pp. 186. Date of Electronic Publication: 2020 Jul 07.
Abstract: The effect of storage condition (% RH) on flufenamic acid:nicotinamide (FFA:NIC) cocrystal compressibility, compactibility, and tabletability profiles was not observed after visual evaluation or linear regression analysis. However, multivariate statist...
Validated LC-MS/MS Method for Simultaneous Quantitation of SAFit-1 and SAFit-2 in Mice Plasma: Application to a Pharmacokinetic Study.
Publication Type: Academic Journal
Source(s): Drug research [Drug Res (Stuttg)] 2020 Jul; Vol. 70 (7), pp. 325-332. Date of Electronic Publication: 2020 May 13.
Abstract: SAFit-1 and SAFit-2 are selective FKBP51 (FK506-binding protein 51) ligands. In this paper, we present the development and validation data of an LC-MS/MS method for the simultaneous quantitation of SAFit-1 and SAFit-2 in mice plasma as per FDA regulato...
Quantitation of polymeric-microneedle-delivered HA15 in tissues using liquid chromatography-tandem mass spectrometry.
Publication Type: Academic Journal
Source(s): Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2020 Jun 05; Vol. 185, pp. 113230. Date of Electronic Publication: 2020 Mar 04.
Abstract: A rapid and sensitive liquid chromatography-tandem mass spectrometric method was developed and validated for the determination of HA15, an emerging anticancer compound targeting GSPA5/BIP delivered by dissolvable polymeric microneedles. The linear rang...