Applying quality by design approach for the determination of potent paclitaxel loaded poly(lactic acid) based implants for localized tumor drug delivery

Abstract In the present study, poly(lactic acid) (PLA) and poly(ethylene succinate) (PESu) or poly(ethylene glycol) (PEG) under the framework of quality by design, were blended to produce effective sustained-release matrices for Paclitaxel delivery. A complete physicochemical characterization including weight variation, thickness, water uptake, moisture absorption, moisture loss, and hydrolytic degradation under physiological conditions, was performed. Quality by design approach was applied to study the critical parameters. In vitro cancer toxicity was studied in human cancer cell lines including lung and breast adenocarcinoma. The developed Paclitaxel-loaded films can act as a promising alternative topical matrix as an implant for breast and lung cancer treatment. Graphical Abstract

[1]  N. Mikhailova,et al.  Functional Polylactide Blend Films for Controlling Mesenchymal Stem Cell Behaviour , 2020, Polymers.

[2]  I. Amorim,et al.  Understanding Breast cancer: from conventional therapies to repurposed drugs. , 2020, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[3]  J. Ochocka,et al.  Real-time cell analysis system in cytotoxicity applications: Usefulness and comparison with tetrazolium salt assays , 2020, Toxicology reports.

[4]  E. Cevher,et al.  Product transfer from lab-scale to pilot-scale of quetiapine fumarate orodispersible films using quality by design approach , 2019 .

[5]  Liangyan Zhang,et al.  Hsa_circ_0002483 inhibited the progression and enhanced the Taxol sensitivity of non-small cell lung cancer by targeting miR-182-5p , 2019, Cell Death & Disease.

[6]  N. Okur,et al.  Design and characterization of nanocarriers loaded with Levofloxacin for enhanced antimicrobial activity; physicochemical properties, in vitro release and oral acute toxicity , 2019, Brazilian Journal of Pharmaceutical Sciences.

[7]  Jian Wang,et al.  Overcoming Taxol-resistance in A549 Cells: A Comprehensive Strategy of Targeting P-gp transporter, AKT/ERK Pathways, and Cytochrome P450 Enzyme CYP1B1 by 4-hydroxyemodin. , 2019, Biochemical pharmacology.

[8]  M. Gnant,et al.  Breast cancer , 2019, Nature Reviews Disease Primers.

[9]  Gülşah Erel-Akbaba,et al.  Development and characterization of nanobubbles containing paclitaxel and survivin inhibitor YM155 against lung cancer. , 2019, International journal of pharmaceutics.

[10]  R. Darie-Niță,et al.  Biocompatible Materials Based on Plasticized Poly(lactic acid), Chitosan and Rosemary Ethanolic Extract I. Effect of Chitosan on the Properties of Plasticized Poly(lactic acid) Materials , 2019, Polymers.

[11]  J. Sirc,et al.  Poly(d,l-lactide)/polyethylene glycol micro/nanofiber mats as paclitaxel-eluting carriers: preparation and characterization of fibers, in vitro drug release, antiangiogenic activity and tumor recurrence prevention. , 2019, Materials science & engineering. C, Materials for biological applications.

[12]  E. Cevher,et al.  An alternative approach to wound healing field; new composite films from natural polymers for mupirocin dermal delivery , 2019, Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society.

[13]  J. Krzak,et al.  Evaluation of the Release Kinetics of a Pharmacologically Active Substance from Model Intra-Articular Implants Replacing the Cruciate Ligaments of the Knee , 2019, Materials.

[14]  Alessandro Morais Saviano,et al.  Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) , 2018, Brazilian Journal of Pharmaceutical Sciences.

[15]  N. Okur,et al.  A novel approach for skin infections: Controlled release topical mats of poly(lactic acid)/poly(ethylene succinate) blends containing Voriconazole , 2018, Journal of Drug Delivery Science and Technology.

[16]  G. Sotgiu,et al.  Anticancer activity of paclitaxel-loaded keratin nanoparticles in two-dimensional and perfused three-dimensional breast cancer models , 2018, International journal of nanomedicine.

[17]  Naresh Pavurala,et al.  Quality by Design approach for studying the impact of formulation and process variables on product quality of oral disintegrating films. , 2017, International journal of pharmaceutics.

[18]  Wei He,et al.  The long noncoding RNA ANRIL acts as an oncogene and contributes to paclitaxel resistance of lung adenocarcinoma A549 cells , 2017, Oncotarget.

[19]  Dimitrios J. Giliopoulos,et al.  PLGA/SBA‐15 mesoporous silica composite microparticles loaded with paclitaxel for local chemotherapy , 2017, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[20]  Sandeep Karki,et al.  Thin films as an emerging platform for drug delivery , 2016 .

[21]  M. Li,et al.  Critical material attributes (CMAs) of strip films loaded with poorly water-soluble drug nanoparticles: I. Impact of plasticizer on film properties and dissolution. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[22]  D. Bikiaris,et al.  Novel electrospun nanofibrous matrices prepared from poly(lactic acid)/poly(butylene adipate) blends for controlled release formulations of an anti-rheumatoid agent. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[23]  Alper Okyar,et al.  Preparation and in-vivo evaluation of dimenhydrinate buccal mucoadhesive films with enhanced bioavailability , 2016, Drug development and industrial pharmacy.

[24]  J. Zak,et al.  Biomaterial-based regional chemotherapy: Local anticancer drug delivery to enhance chemotherapy and minimize its side-effects. , 2016, Materials science & engineering. C, Materials for biological applications.

[25]  K. Semba,et al.  ΔNp63α induces quiescence and downregulates the BRCA1 pathway in estrogen receptor‐positive luminal breast cancer cell line MCF7 but not in other breast cancer cell lines , 2016, Molecular oncology.

[26]  Buket Aksu,et al.  Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method. , 2016, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[27]  H. Yamane,et al.  The effect of poly(ethylene glycol) as plasticizer in blends of poly(lactic acid) and poly(butylene succinate) , 2016 .

[28]  B. Agianian,et al.  Synthesis of folate- pegylated polyester nanoparticles encapsulating ixabepilone for targeting folate receptor overexpressing breast cancer cells , 2015, Journal of Materials Science: Materials in Medicine.

[29]  M. Kostoglou,et al.  Controlled release formulations of risperidone antipsychotic drug in novel aliphatic polyester carriers: Data analysis and modelling. , 2015, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.

[30]  Özgen Özer,et al.  Novel nanostructured lipid carrier-based inserts for controlled ocular drug delivery: evaluation of corneal bioavailability and treatment efficacy in bacterial keratitis , 2015, Expert opinion on drug delivery.

[31]  Rushiraj H Jani,et al.  Hot melt extrusion: An industrially feasible approach for casting orodispersible film , 2015 .

[32]  Marius Raica,et al.  The Story of MCF-7 Breast Cancer Cell Line: 40 years of Experience in Research. , 2015, Anticancer research.

[33]  K. S. Rajan,et al.  Interaction and release kinetics study of hybrid polymer blend nanoparticles for pH independent controlled release of an anti-viral drug , 2015 .

[34]  Ji-Young Hwang,et al.  Production of CNT-taxol-embedded PCL microspheres using an ammonium-based room temperature ionic liquid: as a sustained drug delivery system. , 2015, Journal of colloid and interface science.

[35]  Yun Cai,et al.  Bioavailability Enhancement of Paclitaxel via a Novel Oral Drug Delivery System: Paclitaxel-Loaded Glycyrrhizic Acid Micelles , 2015, Molecules.

[36]  M. Rafiee-Tehrani,et al.  Design and development of intraocular polymeric implant systems for long-term controlled-release of clindamycin phosphate for toxoplasmic retinochoroiditis , 2015, Advanced biomedical research.

[37]  M. Misra,et al.  Analysis of Porous Electrospun Fibers from Poly(l-lactic acid)/Poly(3-hydroxybutyrate-co-3-hydroxyvalerate) Blends , 2014 .

[38]  Wan Md Zin Wan Yunus,et al.  Poly(lactic acid)/Poly(ethylene glycol) Polymer Nanocomposites: Effects of Graphene Nanoplatelets , 2013 .

[39]  P. Sajkiewicz,et al.  Investigations of polycaprolactone/gelatin blends in terms of their miscibility , 2013 .

[40]  M. Grinstaff,et al.  In vitro activity of Paclitaxel-loaded polymeric expansile nanoparticles in breast cancer cells. , 2013, Biomacromolecules.

[41]  Gustaaf Van Tendeloo,et al.  Novel core-shell magnetic nanoparticles for Taxol encapsulation in biodegradable and biocompatible block copolymers: preparation, characterization and release properties. , 2013, International journal of pharmaceutics.

[42]  N. Garud,et al.  Development and Evaluation of Transdermal Patches of Quetiapine fumerate for the treatment of psychosis , 2013 .

[43]  M. Attimarad,et al.  In vitro techniques to evaluate buccal films. , 2013, Journal of controlled release : official journal of the Controlled Release Society.

[44]  Yuanyuan Shen,et al.  PCL films incorporated with paclitaxel/5-fluorouracil: Effects of formulation and spacial architecture on drug release. , 2012, International journal of pharmaceutics.

[45]  S. Buratti,et al.  Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system , 2011, Drug development and industrial pharmacy.

[46]  Wei-Ting Chen,et al.  Immiscibility-miscibility phase transformation in blends of poly(ethylene succinate) with poly(L-lactic acid)s of different molecular weights , 2010 .

[47]  Prasanta Chowdhury,et al.  Kinetic modeling on drug release from controlled drug delivery systems. , 2010, Acta poloniae pharmaceutica.

[48]  W. Kao,et al.  Drug release kinetics and transport mechanisms of non-degradable and degradable polymeric delivery systems , 2010, Expert opinion on drug delivery.

[49]  A. Nussinovitch,et al.  Plasticizers in the manufacture of novel skin-bioadhesive patches. , 2009, International journal of pharmaceutics.

[50]  L. Lim,et al.  Preparation and properties of pullulan-alginate-carboxymethylcellulose blend films , 2008 .

[51]  E. Perez,et al.  Weekly paclitaxel in the adjuvant treatment of breast cancer. , 2008, The New England journal of medicine.

[52]  Wantai Yang,et al.  Fully biodegradable poly(3-hydroxybutyrate-co-hydroxyvalerate)/poly(ethylene succinate) blends: Phase behavior, crystallization and mechanical properties , 2008 .

[53]  Wantai Yang,et al.  Fully biodegradable blends of poly(l-lactide) and poly(ethylene succinate): Miscibility, crystallization, and mechanical properties , 2007 .

[54]  D. Bikiaris,et al.  Adjusting drug release by using miscible polymer blends as effective drug carries , 2006 .

[55]  Randall V. Sparer,et al.  Adjusting drug diffusivity using miscible polymer blends. , 2005, Journal of controlled release : official journal of the Controlled Release Society.

[56]  Mustafizur Rahman,et al.  The plasticizer market: an assessment of traditional plasticizers and research trends to meet new challenges , 2004 .

[57]  R. Panchagnula,et al.  Development and characterization of biodegradable chitosan films for local delivery of paclitaxel , 2004, The AAPS Journal.

[58]  T. Nishi,et al.  DSC and TMDSC study of melting behaviour of poly(butylene succinate) and poly(ethylene succinate) , 2003 .

[59]  S. Feng,et al.  A novel controlled release formulation for the anticancer drug paclitaxel (Taxol): PLGA nanoparticles containing vitamin E TPGS. , 2003, Journal of controlled release : official journal of the Controlled Release Society.

[60]  Shen‐guo Wang,et al.  In vitro study on the drug release behavior from Polylactide‐based blend matrices , 2002 .

[61]  P. Costa,et al.  Modeling and comparison of dissolution profiles. , 2001, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.

[62]  S. Feng,et al.  Effects of emulsifiers on the controlled release of paclitaxel (Taxol) from nanospheres of biodegradable polymers. , 2001, Journal of controlled release : official journal of the Controlled Release Society.

[63]  J. G. Hiremath,et al.  Paclitaxel loaded carrier based biodegradable polymeric implants: Preparation and in vitro characterization. , 2013, Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society.

[64]  B. Aksu,et al.  Development and comparative evaluation of extended release indomethacin capsules , 2013 .

[65]  F. Atyabi,et al.  Preparation of a Reservoir Type Levonorgestrel Delivery System using High Molecular Weight Poly L-Lactide , 2009 .

[66]  C. Osborne,et al.  Biological differences among MCF-7 human breast cancer cell lines from different laboratories , 2005, Breast Cancer Research and Treatment.