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ISSN Druckformat: 0743-4863
ISSN Online: 2162-660X
Indexed in
Optimizing Drug Delivery Systems Using Systematic "Design of Experiments." Part II: Retrospect and Prospects
ABSTRAKT
The first study on application of Design of Experiments (DoE) in optimizing drug formulation appeared in 1967. Since then the number of literature reports on the use of DoE optimization in development of drug delivery technologies has been piling up steadily. Such systematic techniques find their use in every type of conventional dosage form and modern drug delivery system. The drug delivery devices investigated for optimization using response surface methodology include controlled release compressed matrices, microparticulates, macroparticulates, vesicular systems, floating systems, bioadhesive systems, semisolids, transdermals, and inhalations. The optimized processes mainly include extrusion-spheronization, pelletization, microencapsulation, coating, granulation, and tableting.
Part I of this article [Crit Rev Ther Drug Carrier Syst 2005; 22(1):27-106] dealt with the salient steps involved in the DoE optimization methodology using diverse experimental designs. Part II deals with various retrospective literature findings as well as the prospective application of such DoE procedures while optimizing varied drug delivery technologies. A vast account of various DoE reports on optimization of diverse drug delivery system and processes along with the critical graphical analysis of various designs, input, and response variables have been presented here in a categorical form. Such an explicit and updated review on drug delivery optimization has not been published anywhere else in the recent past.
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MANDAL Uttam, GOWDA Veeran, GHOSH Animesh, SELVAN Senthamil, SOLOMON Sam, PAL Tapan Kumar, Formulation and Optimization of Sustained Release Matrix Tablet of Metformin HCl 500 mg Using Response Surface Methodology, YAKUGAKU ZASSHI, 127, 8, 2007. Crossref
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Singh Bhupinder, Pahuja Sonia, Kapil Rishi, Ahuja Naveen, Formulation development of oral controlled release tablets of hydralazine: Optimization of drug release and bioadhesive characteristics, Acta Pharmaceutica, 59, 1, 2009. Crossref
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Singh Bhupinder, Khurana Lalit, Bandyopadhyay Shantanu, Kapil Rishi, Katare O.O.P., Development of optimized self-nano-emulsifying drug delivery systems (SNEDDS) of carvedilol with enhanced bioavailability potential, Drug Delivery, 18, 8, 2011. Crossref
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Cun Dongmei, Jensen Ditte Krohn, Maltesen Morten Jonas, Bunker Matthew, Whiteside Paul, Scurr David, Foged Camilla, Nielsen Hanne Mørck, High loading efficiency and sustained release of siRNA encapsulated in PLGA nanoparticles: Quality by design optimization and characterization, European Journal of Pharmaceutics and Biopharmaceutics, 77, 1, 2011. Crossref
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Singha Kaushik, Namgung Ran, Kim Won Jong, Polymers in Small-Interfering RNA Delivery, Oligonucleotides, 2011. Crossref
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Dhawan Sanju, Kapil Rishi, Singh Bhupinder, Formulation development and systematic optimization of solid lipid nanoparticles of quercetin for improved brain delivery, Journal of Pharmacy and Pharmacology, 63, 3, 2011. Crossref
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Singha Kaushik, Namgung Ran, Kim Won Jong, Polymers in Small-Interfering RNA Delivery, Nucleic Acid Therapeutics, 21, 3, 2011. Crossref
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Hooda Aashima, Nanda Arun, Jain Manish, Kumar Vikash, Rathee Permender, Optimization and evaluation of gastroretentive ranitidine HCl microspheres by using design expert software, International Journal of Biological Macromolecules, 51, 5, 2012. Crossref
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Kapoor Deepak N., Katare Om Prakash, Dhawan Sanju, In situ forming implant for controlled delivery of an anti-HIV fusion inhibitor, International Journal of Pharmaceutics, 426, 1-2, 2012. Crossref
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Yandrapu Sarath, Kompella Uday B., Development of Sustained-Release Microspheres for the Delivery of SAR 1118, an LFA-1 Antagonist Intended for the Treatment of Vascular Complications of the Eye, Journal of Ocular Pharmacology and Therapeutics, 29, 2, 2013. Crossref
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Ghosh Amitava, Chakraborty Prithviraj, Formulation and Mathematical Optimization of Controlled Release Calcium Alginate Micro Pellets of Frusemide, BioMed Research International, 2013, 2013. Crossref
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Dhingani Anjali, Patel Jaydeep, Garala Kevin, Raval Mihir, Dharamsi Abhay, Quality by Design Approach for Development of W/O Type Microemulsion-Based Transdermal Systems for Atenolol, Journal of Dispersion Science and Technology, 35, 5, 2014. Crossref
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Nayak Amit Kumar, Pal Dilipkumar, Santra Kousik, Plantago ovata F. Mucilage-Alginate Mucoadhesive Beads for Controlled Release of Glibenclamide: Development, Optimization, and In Vitro-In Vivo Evaluation, Journal of Pharmaceutics, 2013, 2013. Crossref
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Garala Kevin C., Patel Jaydeep M., Dhingani Anjali P., Dharamsi Abhay T., Preparation and evaluation of agglomerated crystals by crystallo-co-agglomeration: An integrated approach of principal component analysis and Box–Behnken experimental design, International Journal of Pharmaceutics, 452, 1-2, 2013. Crossref
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Yang Xiaoyan, Patel Sulabh, Sheng Ye, Pal Dhananjay, Mitra Ashim K., Statistical Design for Formulation Optimization of Hydrocortisone Butyrate-Loaded PLGA Nanoparticles, AAPS PharmSciTech, 15, 3, 2014. Crossref
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Good Clinical Practice, in Handbook of Bioequivalence Testing, 2014. Crossref
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Soema Peter C., Willems Geert-Jan, Jiskoot Wim, Amorij Jean-Pierre, Kersten Gideon F., Predicting the influence of liposomal lipid composition on liposome size, zeta potential and liposome-induced dendritic cell maturation using a design of experiments approach, European Journal of Pharmaceutics and Biopharmaceutics, 94, 2015. Crossref
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Tripathi Chandra Bhushan, Beg Sarwar, Kaur Ripandeep, Shukla Geeta, Bandopadhyay Shantanu, Singh Bhupinder, Systematic development of optimized SNEDDS of artemether with improved biopharmaceutical and antimalarial potential, Drug Delivery, 23, 9, 2016. Crossref
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Singh Sanjay Kumar, Dadhania Parth, Vuddanda Parameswara Rao, Jain Achint, Velaga Sitaram, Singh Sanjay, Intranasal delivery of asenapine loaded nanostructured lipid carriers: formulation, characterization, pharmacokinetic and behavioural assessment, RSC Advances, 6, 3, 2016. Crossref
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Pitta Shravan Kumar, Dudhipala Narendar, Narala Arjun, Veerabrahma Kishan, Development of zolmitriptan transfersomes by Box–Behnken design for nasal delivery: in vitro and in vivo evaluation, Drug Development and Industrial Pharmacy, 44, 3, 2018. Crossref
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N. Politis Stavros, Colombo Paolo, Colombo Gaia, M. Rekkas Dimitrios, Design of experiments (DoE) in pharmaceutical development, Drug Development and Industrial Pharmacy, 43, 6, 2017. Crossref
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Patro Chandra Sekhar, Sahu Prafulla Kumar, Combined Effect of Synthetic and Natural Polymers in Preparation of Cetirizine Hydrochloride Oral Disintegrating Tablets: Optimization by Central Composite Design, Journal of Pharmaceutics, 2017, 2017. Crossref
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Mahours Gamal M., Shaaban Diaa Edin Z., Shazly Gamal A., Auda Sayed H., The effect of binder concentration and dry mixing time on granules, tablet characteristics and content uniformity of low dose drug in high shear wet granulation, Journal of Drug Delivery Science and Technology, 39, 2017. Crossref
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Adena Sandeep Kumar Reddy, Upadhyay Mansi, Vardhan Harsh, Mishra Brahmeshwar, Development, optimization, and in vitro characterization of dasatinib-loaded PEG functionalized chitosan capped gold nanoparticles using Box–Behnken experimental design, Drug Development and Industrial Pharmacy, 44, 3, 2018. Crossref
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Kaur Inderpreet, Gaba Sonal, Kaur Sukhraj, Kumar Rajeev, Chawla Jyoti, Spectrophotometric determination of triclosan based on diazotization reaction: response surface optimization using Box–Behnken design, Water Science and Technology, 77, 9, 2018. Crossref
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Panigrahi Kahnu Charan, Jena Jayashree, Jena Goutam Kumar, Patra Ch. Niranjan, Rao M.E. Bhanoji, QBD-based systematic development of Bosentan SNEDDS: Formulation, characterization and pharmacokinetic assessment, Journal of Drug Delivery Science and Technology, 47, 2018. Crossref
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Sharma Rajeev, Dubey Surabhi, Mody Nishi, Sharma Gajanand, Kushwah Varun, Jain Sanyog, Katare Om Prakash, Vyas Suresh P., Release promoter-based systematically designed nanocomposite(s): a novel approach for site-specific delivery of tumor-associated antigen(s) (TAAs), Artificial Cells, Nanomedicine, and Biotechnology, 46, sup2, 2018. Crossref
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Sachin Jagdale, Aishwarya Panbude, Priya Navasare, Development, Characterization and Optimization of Mucoadhesive Tablet for Buccal Delivery of Domperidone, Drug Delivery Letters, 9, 1, 2019. Crossref
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Ali Asgar, Ali Salman, Aqil Mohd., Imam Syed Sarim, Ahad Abdul, Qadir Abdul, Thymoquinone loaded dermal lipid nano particles: Box Behnken design optimization to preclinical psoriasis assessment, Journal of Drug Delivery Science and Technology, 52, 2019. Crossref
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Kazmi Imran, Afzal Muhammad, Quazi Anwarulabedin Mohsin, Beg Sarwar, Emergence of Quality by Design in Extraction Technology for Bioactive Compounds, in Pharmaceutical Quality by Design, 2019. Crossref
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Rafiei Pedram, Haddadi Azita, A robust systematic design: Optimization and preparation of polymeric nanoparticles of PLGA for docetaxel intravenous delivery, Materials Science and Engineering: C, 104, 2019. Crossref
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Brito Raj S, Chandrasekhar Kothapalli Bonnoth, Reddy Kesavan Bhaskar, Formulation, in-vitro and in-vivo pharmacokinetic evaluation of simvastatin nanostructured lipid carrier loaded transdermal drug delivery system, Future Journal of Pharmaceutical Sciences, 5, 1, 2019. Crossref
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Jain Ankit, Hurkat Pooja, Jain Sanjay K., Development of liposomes using formulation by design: Basics to recent advances, Chemistry and Physics of Lipids, 224, 2019. Crossref
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Beg Sarwar, Dhiman Shashi, Sharma Teenu, Jain Ashish, Sharma Rakesh Kumar, Jain Atul, Singh Bhupinder, Stimuli Responsive In Situ Gelling Systems Loaded with PLGA Nanoparticles of Moxifloxacin Hydrochloride for Effective Treatment of Periodontitis, AAPS PharmSciTech, 21, 3, 2020. Crossref
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Sharma Teenu, Jain Atul, Kaur Ranjot, Saini Sumant, Katare O P, Singh Bhupinder, Supersaturated LFCS type III self-emulsifying delivery systems of sorafenib tosylate with improved biopharmaceutical performance: QbD-enabled development and evaluation, Drug Delivery and Translational Research, 10, 4, 2020. Crossref
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Pradhan Madhulika, Parihar Arun K., Singh Deependra, Singh Manju Rawat, Quality by design and formulation optimization using statistical tools for safe and efficient bioactive loading, in Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents, 2020. Crossref
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Miyamoto Kahori, Taga Hiroaki, Akita Tomomi, Yamashita Chikamasa, Simple Method to Measure the Aerodynamic Size Distribution of Porous Particles Generated on Lyophilizate for Dry Powder Inhalation, Pharmaceutics, 12, 10, 2020. Crossref
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Sinhorini Luiz F.C., Rodrigues Caio H.P., Leite Vitor B.P., Bruni Aline T., Synthetic fentanyls evaluation and characterization by infrared spectroscopy employing in silico methods, Computational and Theoretical Chemistry, 1204, 2021. Crossref
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Goswami Tarun, Audett Jay, Chemistry, manufacturing and controls in passive transdermal drug delivery systems, Therapeutic Delivery, 6, 9, 2015. Crossref
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Gilman James, Walls Laura, Bandiera Lucia, Menolascina Filippo, Statistical Design of Experiments for Synthetic Biology, ACS Synthetic Biology, 10, 1, 2021. Crossref
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Kumar Pramod, Sharma Gajanand, Kumar Rajendra, Malik Ruchi, Singh Bhupinder, Katare Om Prakash, Raza Kaisar, Stearic acid based, systematically designed oral lipid nanoparticles for enhanced brain delivery of dimethyl fumarate, Nanomedicine, 12, 23, 2017. Crossref
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Esteban Patricia P., Patel Hamza, Veraitch Farlan, Khalife Rana, Optimization of the nutritional environment for differentiation of human‐induced pluripotent stem cells using design of experiments—A proof of concept, Biotechnology Progress, 2021. Crossref
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Thakur Kanika, Mahajan Akanksha, Sharma Gajanand, Singh Bhupinder, Raza Kaisar, Chhibber Sanjay, Katare Om Prakash, Implementation of Quality by Design (QbD) approach in development of silver sulphadiazine loaded egg oil organogel: An improved dermatokinetic profile and therapeutic efficacy in burn wounds, International Journal of Pharmaceutics, 576, 2020. Crossref
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Vasavi Ayanam, Mrunalini Miriyala, Vasanthi Ayanam, Babu G. Raveendra, M. Sowjanya, Formulation and Evaluation of Sustained Release Stavudine Microspheres by Ionotropic Gelation Method, Asian Journal of Pharmacy and Technology, 2022. Crossref
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Jain Atul, Sharma Teenu, Kumar Rajendra, Katare O. P., Singh Bhupinder, Raloxifene-loaded SLNs with enhanced biopharmaceutical potential: QbD-steered development, in vitro evaluation, in vivo pharmacokinetics, and IVIVC, Drug Delivery and Translational Research, 12, 5, 2022. Crossref
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Khan Karishma, Aqil Mohd, Imam Syed Sarim, Ahad Abdul, Moolakkadath Thasleem, Sultana Yasmin, Mujeeb Mohd, Ursolic acid loaded intra nasal nano lipid vesicles for brain tumour: Formulation, optimization, in-vivo brain/plasma distribution study and histopathological assessment, Biomedicine & Pharmacotherapy, 106, 2018. Crossref
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Gorantla Srividya, Saha Ranendra N., Singhvi Gautam, Exploring the affluent potential of glyceryl mono oleate – myristol liquid crystal nanoparticles mediated localized topical delivery of Tofacitinib: Study of systematic QbD, skin deposition and dermal pharmacokinetics assessment, Journal of Molecular Liquids, 346, 2022. Crossref
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Cunha Sara, Costa Cláudia Pina, Moreira João Nuno, Sousa Lobo José Manuel, Silva Ana Catarina, Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: A review, Nanomedicine: Nanotechnology, Biology and Medicine, 28, 2020. Crossref
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Singh Bhupinder, Sharma Teenu, Kaur Ranjot, Saini Sumant, Kaur Ripandeep, Beg Sarwar, QbD-Steered Systematic Development of Drug Delivery Nanoconstructs: Vital Precepts, Retrospect and Prospects, in Biomedical Translational Research, 2022. Crossref
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Simões Marta F., Silva Gabriel, Pinto Ana C., Fonseca Marlene, Silva Nuno E., Pinto Rui M.A., Simões Sérgio, Artificial neural networks applied to quality-by-design: From formulation development to clinical outcome, European Journal of Pharmaceutics and Biopharmaceutics, 152, 2020. Crossref
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Kaur Ripandeep, Gorki Varun, Singh Guneet, Kaur Ranjot, Katare O.P., Nirmalan Niroshini, Singh Bhupinder, Intranasal delivery of polymer-anchored lipid nanoconstructs of artemether-lumefantrine in Plasmodium berghei ANKA murine model, Journal of Drug Delivery Science and Technology, 61, 2021. Crossref
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Bhardwaj Ankur, Mehta Shuchi, Yadav Shailendra, Singh Sudheer K., Grobler Anne, Goyal Amit Kumar, Mehta Abhinav, Pulmonary delivery of antitubercular drugs using spray-dried lipid–polymer hybrid nanoparticles, Artificial Cells, Nanomedicine, and Biotechnology, 44, 6, 2016. Crossref
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Mali Sandip, Oza Nishant, Formulation and optimization of Paliperidone palmitate biodegradable injectable microspheres using Box-Behnken design, Journal of Drug Delivery Science and Technology, 74, 2022. Crossref
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Gijo E.V., Application of tools and techniques of quality by design in pharmaceutical process, International Journal of Productivity and Performance Management, 71, 7, 2022. Crossref
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Garg Sarita, Singla Rajeev K., Rahman Md. Mominur, Sharma Rohit, Mittal Vineet, Yang Shuli, Evaluation of Ulcer Protective Activity of Morus alba L. Extract-Loaded Chitosan Microspheres in Ethanol-Induced Ulcer in Rat Model, Evidence-Based Complementary and Alternative Medicine, 2022, 2022. Crossref