scholarly journals Glass and Glass-Ceramic Scaffolds: Manufacturing Methods and the Impact of Crystallization on In-Vitro Dissolution

2017 ◽  
Author(s):  
Amy Nommeots-Nomm ◽  
Jonathan Massera
Keyword(s):  
Glass Ceramic ◽  
In Vitro Dissolution ◽  
Manufacturing Methods ◽  
The Impact

scholarly journals An In Vivo Predictive Dissolution Methodology (iPD Methodology) with a BCS Class IIb Drug Can Predict the In Vivo Bioequivalence Results: Etoricoxib Products

Pharmaceutics ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 507
Author(s):  
Isabel Gonzalez-Alvarez ◽  
Marival Bermejo ◽  
Yasuhiro Tsume ◽  
Alejandro Ruiz-Picazo ◽  
Marta Gonzalez-Alvarez ◽  
...  
Keyword(s):  
Plasma Concentrations ◽  
In Vitro Dissolution ◽  
Case Examples ◽  
Dissolution Studies ◽  
Weak Bases ◽  
Transit Times ◽  
Class Iib ◽  
The Impact

The purpose of this study was to predict in vivo performance of three oral products of Etoricoxib (Arcoxia® as reference and two generic formulations in development) by conducting in vivo predictive dissolution with GIS (Gastro Intestinal Simulator) and computational analysis. Those predictions were compared with the results from previous bioequivalence (BE) human studies. Product dissolution studies were performed using a computer-controlled multicompartmental dissolution device (GIS) equipped with three dissolution chambers, representing stomach, duodenum, and jejunum, with integrated transit times and secretion rates. The measured dissolved amounts were modelled in each compartment with a set of differential equations representing transit, dissolution, and precipitation processes. The observed drug concentration by in vitro dissolution studies were directly convoluted with permeability and disposition parameters from literature to generate the predicted plasma concentrations. The GIS was able to detect the dissolution differences among reference and generic formulations in the gastric chamber where the drug solubility is high (pH 2) while the USP 2 standard dissolution test at pH 2 did not show any difference. Therefore, the current study confirms the importance of multicompartmental dissolution testing for weak bases as observed for other case examples but also the impact of excipients on duodenal and jejunal in vivo behavior.

scholarly journals Porous Nanostructure, Lipid Composition, and Degree of Drug Supersaturation Modulate In Vitro Fenofibrate Solubilization in Silica-Lipid Hybrids

Pharmaceutics ◽  
2020 ◽  
Vol 12 (7) ◽  
pp. 687
Author(s):  
Ruba Almasri ◽  
Paul Joyce ◽  
Hayley B. Schultz ◽  
Nicky Thomas ◽  
Kristen E. Bremmell ◽  
...  
Keyword(s):  
Solid State ◽  
Oral Delivery ◽  
Drug Loading ◽  
Medium Chain Triglyceride ◽  
Water Soluble ◽  
In Vitro Dissolution ◽  
Valuable Insight ◽  
Drug Load ◽  
The Impact

The unique nanostructured matrix obtained by silica-lipid hybrids (SLHs) is well known to improve the dissolution, absorption, and bioavailability of poorly water-soluble drugs (PWSDs). The aim of this study was to investigate the impact of: (i) drug load: 3–22.7% w/w, (ii) lipid type: medium-chain triglyceride (Captex 300) and mono and diester of caprylic acid (Capmul PG8), and (iii) silica nanostructure: spray dried fumed silica (FS) and mesoporous silica (MPS), on the in vitro dissolution, solubilization, and solid-state stability of the model drug fenofibrate (FEN). Greater FEN crystallinity was detected at higher drug loads and within the MPS formulations. Furthermore, an increased rate and extent of dissolution was achieved by FS formulations when compared to crystalline FEN (5–10-fold), a commercial product; APO-fenofibrate (2.4–4-fold) and corresponding MPS formulations (2–4-fold). Precipitation of FEN during in vitro lipolysis restricted data interpretation, however a synergistic effect between MPS and Captex 300 in enhancing FEN aqueous solubilization was attained. It was concluded that a balance between in vitro performance and drug loading is key, and the optimum drug load was determined to be between 7–16% w/w, which corresponds to (200–400% equilibrium solubility in lipid Seq). This study provides valuable insight into the impact of key characteristics of SLHs, in constructing optimized solid-state lipid-based formulations for the oral delivery of PWSDs.

Performance and paroxetine stability in tablets manufactured by fused deposition modelling-based 3D printing

2021 ◽  
Author(s):  
Sara Figueiredo ◽  
Ana I Fernandes ◽  
Fátima G Carvalho ◽  
João F Pinto
Keyword(s):  
Process Parameters ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Fused Deposition Modelling ◽  
Dissolution Profile ◽  
Fused Deposition ◽  
The Impact ◽  
Hot Melt

Abstract Objectives The objective of this study was to develop a method for the preparation and characterization of paroxetine (PRX) tablets, obtained by coupling hot-melt extrusion and fused deposition modelling (FDM)-based three-dimensional printing (3DP) technology. The impact of the printing process parameters on the drug stability and on the tablets performance was assessed. Methods Tablets were obtained by FDM of hot-melt extruded PRX-loaded filaments. Physicochemical, thermal, spectroscopic, diffractometric analysis and in-vitro dissolution tests of the intermediate products and the finished dosage forms were performed. Key findings The characterization of printed tablets evidenced mass and dimensions uniformity, and consistency of drug content and dissolution profile. The formation of amorphous solid dispersions and interaction of formulation components throughout the manufacturing process were demonstrated. Layer thickness, printing temperature, printing and travelling speeds, and infill were the most impacting process parameters on both the physicochemical properties and the in-vitro performance of the 3D-printed tablets. Conclusions PRX tablets, meeting compendial limits, were manufactured by 3DP, envisaging their clinical use as individually designed dosage forms. The assessment of the impact of processing parameters on the printed tablets provided insights, which will ultimately allow streamlining of the 3D process set-up for quicker and easier production of patient-centric medicines.

The Impact of Formulation and Process Changes on In Vitro Dissolution and the Bioequivalence of Piroxicam Capsules

1998 ◽  
Vol 3 (4) ◽  
pp. 443-452 ◽  
Author(s):  
Deborah A. Piscitelli ◽  
Sian Bigora ◽  
Cecil Propst ◽  
Sanjay Goskonda ◽  
Paul Schwartz ◽  
...  
Keyword(s):  
In Vitro Dissolution ◽  
The Impact
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