Drug Formulation & Bioavailability Congress September 05-07, 2016 Beijing, China

Yuanchun Zeng has completed her Bachelor’s degree from Sichuan University of China. She was in Department of Molecular and Microbiology in Tufts Medical School for 4 years as Research Associate, working on Rho terminated RNA translation and transcription complex. She worked for couple of years in US Genomics on genomic DNA analysis. She has been working for seven years in Bio-analytical lab of Merck-Millipore on biological products related product quality analysis.

The presence of proteinaceous (aggregates) and non-proteinaceous particulates in biological drug manufacturing is of great concern due to potential effects on product safety, efficacy, and immunogenicity. Therefore, FDA requires that aggregates and particles be closely monitored. SEC-HPLC is the most commonly used method for aggregate detection and quantification; still there are limitations to SEC for analysis:SEC cannot detect insoluble aggregates as well as sub-visible and visible particles, the conditions required to perform SEC often dissociate reversible aggregates. Therefore, complementary analytical methods (such as DLS, fluidic imaging, fluorescent imaging) are essential to ensure that a broad range of aggregates/particles are detected. This poster will present multiple aggregates analysis tools that will present the complete profile of protein aggregates.

Aysegul Karatas has completed her PhD from Ankara University and Post-doctoral studies from the same University. She is an Associate Professor at the Department of Pharmaceutical Technology, School of Pharmacy. She has published more than 25 papers in reputed journals.

Etoposide (ETP) is an agent which is widely used in the therapy of various cancers. Its short half-life and toxicity to normal tissues are the major drawbacks in its clinical applications. Polymeric nanoparticulate drug delivery systems are rational carriers to deliver etoposide with higher efficiency and fewer side effects. In addition, tubular shaped drug carriers are found to show a great potential for drug delivery on the basis of promising results regarding particle shape and cellular uptake. Poly(methyl methacrylate) (PMMA) -based particulate carriers have a potential as a drug carrier via different routes of administration. In this study, etoposide loaded PMMA tubular nanocarriers have been developed by template wetting method using porous anodic aluminum oxide membranes as templates. The developed polymeric nanocarriers were evaluated for structural analysis, in vitro drug release studies and drug release kinetics. In this work, ETP was successfully loaded with polymeric tubular matrix. The developed RP-LC method was successfully utilized for the determination of ETP entrapped in PMMA nanocarriers. The morphological analysis and elemental analysis of ETP loaded polymeric tubular nanostructures was evaluated by SEM images EDX analysis. Examination of SEM images showed that PMMA nanostructures were obtained successfully in nano dimensions in diameter and with smooth surfaced tubular form. The in vitro release profile of ETP from PMMA tubular nanostructures followed a biphasic pattern, which established the sustained release manner subsequent to an initial burst release. The amount of total ETP released at the end of the 24 h was about 72.2%. Release kinetic of ETP was best fitted into the Korsmeyer-Peppas model whose r2 is 0.9964 and RMS is 0.0156.

Yildiz Ozsoy currently is a Professor of Pharmaceutical Technology at Faculty of Pharmacy, Istanbul University. She completed her PhD in 1989. She became a Lecturer at Istanbul University Faculty of Pharmacy in 1992. She has also worked Visiting Scientist at Aston University and School of Pharmacy in between 2005-2006; 2007-2008. She has published more than 50 papers in peer reviewed journals, and 10 book chapters in international books. She has given about 100 oral and poster presentations in international conferences. Her research focuses on the enhancement of nasal and transdermal permeation of drugs with micellar nanocarriers and the development of innovative controlled release systems, nasal and transdermal delivery carriers.

Self-micro/nanoemulsifying drug delivery systems (SNEEDs) consist of anisotropic mixture of oil, surfactant and co-surfactant. These systems are prepared at room temperature with gentle stirring process without using any other component or heating process and become micro-/nano-emulsion form upon gentle agitation in aqueous phase. Digestive motility helps in the formation of SNEEDs in gastrointestinal tract. SNEEDs improve oral bioavailability by increasing drug solubility and enhancing permeation through membranes. The aim of this study was to design SNEEDs formulation based on Quality by Design approach and comparison of new SNEEDs formulation with conventional tablet dosage form. Budesonide was selected as a model drug because of its low solubility and poor bioavailability. Labrafac Lipophile WL1349, Labrafac PG and Peceol were selected as oil phase; Labrasol, Labrafil M2125 were selected as surfactant and PlurolOleique and Transcutol were selected as co-surfactant. For each combination of SNEEDs ternary phase diagrams of surfactants, co-surfactants and oils were constructed to recognize the zone of nanoemulsion formation. Forty-eight samples were prepared and for each sample oil and surfactant:co-surfactant ratio was mixed in ratios ranging from %10:90 - %90:10. Each formulation was evaluated based on their physicochemical characteristic such as droplet size and polydispersity index values and formulations which contain Peceol as oil phase, Labrasol as surfactant and Transcutol as co-surfactant were chosen. To have an idea about the fate of the formulation in GIT in vitro release studies have been performed. Based on in vitro release data, the optimum SNEEDs formula of Budesonide was selected.

Ozgen Ozer is a Professor of Pharmaceutical Technology at Faculty of Pharmacy, Ege University. She completed her PhD in 1992. She was a Post-doctoral Researcher at Université Paris-Sud Centre D’Etudes Pharmaceutiques, Paris-France between 1996-1997 and 1999-2000. She has published more than 80 papers in peer reviewed journals, two chapters in international books. She has given about 85 oral and poster presentations in international conferences. Her research interest focuses on “Dermal/transdermal delivery of drugs and cosmetics with liposomes, nanoparticles emulsions and gels”.

Aim: 3D printers have been used in a wide area for different applications, including pharmaceutical applications. Thermoplastic filaments like PLA, ABS, PVC etc. are commonly used with 3D printers. In our study, we aimed to make flexible filaments that can be used with FDM printers for the formulation of drug delivery systems. For this purpose, we made filaments with hot melt extruder and the flexibility of the fabricated filaments was evaluated with texture profile analyzer. Preparation & Characterization: Filaments were prepared with a hot melt extruder (MiniLab II Micro Compounder, HAAKEâ„¢, Germany) with co-rotating twin screws. Different formulations were made and the characteristics of the filaments were investigated with texture profile analyzer and compared with commercially used PLA filaments. Texture analyzer was set in compression mode, and a probe was moved to the filaments at a speed of 1 mm/s. The angle was measured when the filaments were broken. Texture analyzers were made with Kollidon 12PF-PEO-PEG (6:1:1)(F1) and (6:2:2)(F2); PLA(F3) Kollidon VA64F-PEG (4:1)(F4) and; kollidon VA64F-PEG-aerosil (4:1:0.25)(F5) formulations. Results & Discussion: PLA filaments (F3) were made and compared with other formulations in terms of compatibility with 3D printers. Lutrol F68; PEG; Kollidon 12PF-PEO (9:1) and (6:1) blends were used with hot melt extruder and each of them resulted with brittle filaments which could be broken even with a small force application. Kollidon 12PF-PEO (3:1) and Kollidon 12PF-Lutrol F68-Gliserol (9:1:0.2) formulations resulted with very soft filaments. Since the FDM printing process is based on pushing/pulling the filament continuously, brittle or very soft filaments will cause problems. The closest results to F3 obtained with F2 and followed by F1, F5 and F4. The studies show that these filaments can be a good candidate for FDM 3D printers for different drug delivery systems.