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Developing oral drug delivery systems using formulation by design: vital precepts, retrospect and prospects

, M Pharm PhD DSt, , M Pharm, , M Pharm & , M Pharm PhD
Pages 1341-1360 | Published online: 27 Jul 2011

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Mohamad Taleuzzaman, Ali Sartaj, Dipak Kumar Gupta, Sadaf Jamal Gilani & Mohd. Aamir Mirza. (2023) Phytosomal gel of Manjistha extract (MJE) formulated and optimized with central composite design of Quality by Design (QbD). Journal of Dispersion Science and Technology 44:2, pages 236-244.
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Hibah M. Aldawsari, N. Raghavendra Naveen, Nabil A. Alhakamy, Prakash S. Goudanavar, GSN Koteswara Rao, Roja Rani Budha, Anroop B. Nair & Shaimaa M. Badr-Eldin. (2022) Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization. Drug Delivery 29:1, pages 2258-2268.
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Himanshu Gandhi, Charul Rathore, Kamal Dua, Samar Vihal, Murtaza M. Tambuwala & Poonam Negi. (2020) Efficacy of resveratrol encapsulated microsponges delivered by pectin based matrix tablets in rats with acetic acid-induced ulcerative colitis. Drug Development and Industrial Pharmacy 46:3, pages 365-375.
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C. Rathore, N. Upadhyay, R. Kaundal, R. P. Dwivedi, S. Rahatekar, A. John, K. Dua, Murtaza M. Tambuwala, S. Jain, D. Chaudari & P. Negi. (2020) Enhanced oral bioavailability and hepatoprotective activity of thymoquinone in the form of phospholipidic nano-constructs. Expert Opinion on Drug Delivery 17:2, pages 237-253.
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Chandra B. Tripathi, Poonam Parashar, Malti Arya, Mahendra Singh, Jovita Kanoujia, Gaurav Kaithwas & Shubhini A. Saraf. (2020) Biotin anchored nanostructured lipid carriers for targeted delivery of doxorubicin in management of mammary gland carcinoma through regulation of apoptotic modulator. Journal of Liposome Research 30:1, pages 21-36.
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Daniela Lopes-de-Campos, Rita M Pinto, Sofia A Costa Lima, Tiago Santos, Bruno Sarmento, Cláudia Nunes & Salette Reis. (2019) Delivering amoxicillin at the infection site – a rational design through lipid nanoparticles. International Journal of Nanomedicine 14, pages 2781-2795.
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Atul Jain, Sarwar Beg, Sumant Saini, Teenu Sharma, O. P. Katare & Bhupinder Singh. (2019) Application of chemometric approach for QbD-Enabled development and validation of an RP-HPLC method for estimation of methotrexate. Journal of Liquid Chromatography & Related Technologies 42:15-16, pages 502-512.
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Atul Jain, Teenu Sharma, Gajanand Sharma, Rajneet Kaur Khurana, Om Prakash Katare & Bhupinder Singh. (2019) QbD-Driven Analytical Method Development and Validation for Raloxifene Hydrochloride in Pure Drug and Solid Oral Dosage Form. Analytical Chemistry Letters 9:4, pages 463-477.
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Rajeev Sharma, Surabhi Dubey, Nishi Mody, Gajanand Sharma, Varun Kushwah, Sanyog Jain, Om Prakash Katare & Suresh P. Vyas. (2018) 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, pages 776-789.
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Babita Garg, Sarwar Beg, Ranjot Kaur, Rajendra Kumar, Om Prakash Katare & Bhupinder Singh. (2018) Long-chain triglycerides-based self-nanoemulsifying oily formulations (SNEOFs) of darunavir with improved lymphatic targeting potential. Journal of Drug Targeting 26:3, pages 252-266.
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Premjeet Singh Sandhu, Sarwar Beg, Rajendra Kumar, O. P. Katare & Bhupinder Singh. (2017) Analytical QbD-based systematic bioanalytical HPLC method development for estimation of quercetin dihydrate. Journal of Liquid Chromatography & Related Technologies 40:10, pages 506-516.
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Alexandre CC Vieira, Luíse L Chaves, Marina Pinheiro, Domingos Ferreira, Bruno Sarmento & Salette Reis. (2016) Design and statistical modeling of mannose-decorated dapsone-containing nanoparticles as a strategy of targeting intestinal M-cells. International Journal of Nanomedicine 11, pages 2601-2617.
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Chandra Bhushan Tripathi, Sarwar Beg, Ripandeep Kaur, Geeta Shukla, Shantanu Bandopadhyay & Bhupinder Singh. (2016) Systematic development of optimized SNEDDS of artemether with improved biopharmaceutical and antimalarial potential. Drug Delivery 23:9, pages 3209-3223.
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Poonam Negi, Bhupinder Singh, Gajanand Sharma, Sarwar Beg, Kaisar Raza & Om Prakash Katare. (2016) Phospholipid microemulsion-based hydrogel for enhanced topical delivery of lidocaine and prilocaine: QbD-based development and evaluation. Drug Delivery 23:3, pages 941-957.
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Sanjay Bansal, Sarwar Beg, Abhay Asthana, Babita Garg, Gyati Shilakari Asthana, Rishi Kapil & Bhupinder Singh. (2016) QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride. Drug Delivery 23:2, pages 437-451.
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Sarwar Beg, Premjeet Singh Sandhu, Rattandeep Singh Batra, Rajneet Kaur Khurana & Bhupinder Singh. (2015) QbD-based systematic development of novel optimized solid self-nanoemulsifying drug delivery systems (SNEDDS) of lovastatin with enhanced biopharmaceutical performance. Drug Delivery 22:6, pages 765-784.
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Poonam Negi, Bhupinder Singh, Gajanand Sharma, Sarwar Beg & Om Prakash Katare. (2015) Biocompatible lidocaine and prilocaine loaded-nanoemulsion system for enhanced percutaneous absorption: QbD-based optimisation, dermatokinetics and in vivo evaluation. Journal of Microencapsulation 32:5, pages 419-431.
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Naveen K. Bejugam, Shravan K. Mutyam & Gita N. Shankar. (2015) Tablet formulation of an active pharmaceutical ingredient with a sticking and filming problem: direct compression and dry granulation evaluations. Drug Development and Industrial Pharmacy 41:2, pages 333-341.
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Gurinder Singh & Roopa S Pai. (2014) Optimized PLGA nanoparticle platform for orally dosed trans-resveratrol with enhanced bioavailability potential. Expert Opinion on Drug Delivery 11:5, pages 647-659.
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Elcin Aktas, Hakan Eroglu, Umit Kockan & Levent Oner. (2013) Systematic development of pH-independent controlled release tablets of carvedilol using central composite design and artificial neural networks. Drug Development and Industrial Pharmacy 39:8, pages 1207-1216.
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Kaisar Raza, Om Prakash Katare, Arvind Setia, Amit Bhatia & Bhupinder Singh. (2013) Improved therapeutic performance of dithranol against psoriasis employing systematically optimized nanoemulsomes. Journal of Microencapsulation 30:3, pages 225-236.
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Rishi Kapil, Sanju Dhawan, Sarwar Beg & Bhupinder Singh. (2013) Buccoadhesive films for once-a-day administration of rivastigmine: systematic formulation development and pharmacokinetic evaluation. Drug Development and Industrial Pharmacy 39:3, pages 466-480.
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Nagarjun Rangaraj, Sravanthi Reddy Pailla, Saurabh Shah, Shubham Prajapati & Sunitha Sampathi. (2020) QbD aided development of ibrutinib-loaded nanostructured lipid carriers aimed for lymphatic targeting: evaluation using chylomicron flow blocking approach. Drug Delivery and Translational Research 10:5, pages 1476-1494.
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Sara Cunha, Cláudia Pina Costa, João Nuno Moreira, José Manuel Sousa Lobo & Ana Catarina Silva. (2020) Using the quality by design (QbD) approach to optimize formulations of lipid nanoparticles and nanoemulsions: A review. Nanomedicine: Nanotechnology, Biology and Medicine 28, pages 102206.
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Sarwar Beg, Shashi Dhiman, Teenu Sharma, Ashish Jain, Rakesh Kumar Sharma, Atul Jain & Bhupinder Singh. (2020) Stimuli Responsive In Situ Gelling Systems Loaded with PLGA Nanoparticles of Moxifloxacin Hydrochloride for Effective Treatment of Periodontitis. AAPS PharmSciTech 21:3.
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Kanika Thakur, Akanksha Mahajan, Gajanand Sharma, Bhupinder Singh, Kaisar Raza, Sanjay Chhibber & Om Prakash Katare. (2020) 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, pages 118977.
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Jyothsna Manikkath, Gautham G. Shenoy, Sureshwar Pandey & Srinivas Mutalik. (2019) Response Surface Methodology for Optimization of Ultrasound-Assisted Transdermal Delivery and Skin Retention of Asenapine Maleate. Journal of Pharmaceutical Innovation 14:4, pages 391-399.
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Ankit Jain, Pooja Hurkat & Sanjay K. Jain. (2019) Development of liposomes using formulation by design: Basics to recent advances. Chemistry and Physics of Lipids 224, pages 104764.
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Babita Garg, Sarwar Beg, Rajendra Kumar, O.P. Katare & Bhupinder Singh. (2019) Nanostructured lipidic carriers of lopinavir for effective management of HIV-associated neurocognitive disorder. Journal of Drug Delivery Science and Technology 53, pages 101220.
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Vidyalaxmi, Garima Kaushik & Kaisar Raza. (2019) Potential of novel Dunaliella salina from sambhar salt lake, India, for bioremediation of hexavalent chromium from aqueous effluents: An optimized green approach. Ecotoxicology and Environmental Safety 180, pages 430-438.
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Teresa Musumeci, Angela Bonaccorso, Claudia Carbone, Giulia Russo, Francesco Pappalardo & Giovanni Puglisi. (2019) Design and optimization of PEGylated nanoparticles intended for Berberine Chloride delivery. Journal of Drug Delivery Science and Technology 52, pages 521-530.
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Daisy Arora & Sanju Nanda. (2019) Quality by design driven development of resveratrol loaded ethosomal hydrogel for improved dermatological benefits via enhanced skin permeation and retention. International Journal of Pharmaceutics 567, pages 118448.
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Rajeev Sharma, Nishi Mody, Varun Kushwah, Sanyog Jain & S.P. Vyas. (2019) Development, characterization and ex vivo assessment of lipid-polymer based nanocomposite(s) as a potential carrier for site-specific delivery of immunogenic molecules. Journal of Drug Delivery Science and Technology 51, pages 310-319.
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Rajan Jog & Diane J. Burgess. (2019) Comprehensive quality by design approach for stable nanocrystalline drug products. International Journal of Pharmaceutics 564, pages 426-460.
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Sarwar Beg, Ravinder Kaur, Rajneet Kaur Khurana, Vikas Rana, Teenu Sharma & Bhupinder Singh. (2019) QbD-Based Development of Cationic Self-nanoemulsifying Drug Delivery Systems of Paclitaxel with Improved Biopharmaceutical Attributes. AAPS PharmSciTech 20:3.
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Julia Jacyna, Marta Kordalewska & Michał J. Markuszewski. (2019) Design of Experiments in metabolomics-related studies: An overview. Journal of Pharmaceutical and Biomedical Analysis 164, pages 598-606.
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Imran Kazmi, Muhammad Afzal, Anwarulabedin Mohsin Quazi & Sarwar Beg. 2019. Pharmaceutical Quality by Design. Pharmaceutical Quality by Design 379 397 .
Sabya Sachi Das, Avi Singh, Sweta Kar, Riya Ghosh, Moumita Pal, Meher Fatima, Neeru Singh & Sandeep Kumar Singh. 2019. Pharmaceutical Quality by Design. Pharmaceutical Quality by Design 297 350 .
Sadaf Jamal Gilani, Md. Rizwanullah, Syed Sarim Imam, Jayamanti Pandit, Mohd. Aqil, Meraj Alam & Sarwar Beg. 2019. Pharmaceutical Quality by Design. Pharmaceutical Quality by Design 131 150 .
Kinjal J. Parikh & Krutika K. Sawant. (2018) Comparative Study for Optimization of Pharmaceutical Self-Emulsifying Pre-concentrate by Design of Experiment and Artificial Neural Network. AAPS PharmSciTech 19:7, pages 3311-3321.
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Kahnu Charan Panigrahi, Jayashree Jena, Goutam Kumar Jena, Ch. Niranjan Patra & M.E. Bhanoji Rao. (2018) QBD-based systematic development of Bosentan SNEDDS: Formulation, characterization and pharmacokinetic assessment. Journal of Drug Delivery Science and Technology 47, pages 31-42.
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Chandra Bhushan Tripathi, Poonam Parashar, Malti Arya, Mahendra Singh, Jovita Kanoujia, Gaurav Kaithwas & Shubhini A. Saraf. (2018) QbD-based development of α-linolenic acid potentiated nanoemulsion for targeted delivery of doxorubicin in DMBA-induced mammary gland carcinoma: in vitro and in vivo evaluation. Drug Delivery and Translational Research 8:5, pages 1313-1334.
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Rajneet Kaur Khurana, Balan Louis Gaspar, Gail Welsby, O. P. Katare, Kamalinder K. Singh & Bhupinder Singh. (2018) Improving the biopharmaceutical attributes of mangiferin using vitamin E-TPGS co-loaded self-assembled phosholipidic nano-mixed micellar systems. Drug Delivery and Translational Research 8:3, pages 617-632.
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Chandra Bhushan Tripathi, Neha Gupta, Pranesh Kumar, Ashok Kumar Singh, Vinit Raj, Poonam Parashar, Mahendra Singh, Jovita Kanoujia, Malti Arya, Shubhini A Saraf & Sudipta Saha. (2017) ω-3 Fatty Acid Synergized Novel Nanoemulsifying System for Rosuvastatin Delivery: In Vitro and In Vivo Evaluation. AAPS PharmSciTech 19:3, pages 1205-1218.
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David Julian McClements. (2017) Delivery by Design (DbD): A Standardized Approach to the Development of Efficacious Nanoparticle‐ and Microparticle‐Based Delivery Systems. Comprehensive Reviews in Food Science and Food Safety 17:1, pages 200-219.
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Rajneet Kaur Khurana, Sarwar Beg, Andrea Julie Burrow, Rakesh K. Vashishta, O.P. Katare, Satvinder Kaur, Prashant Kesharwani, Kamalinder K. Singh & Bhupinder Singh. (2017) Enhancing biopharmaceutical performance of an anticancer drug by long chain PUFA based self-nanoemulsifying lipidic nanomicellar systems. European Journal of Pharmaceutics and Biopharmaceutics 121, pages 42-60.
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Amanpreet Kaur, Bhupinder Singh Bhoop, Sanjay Chhibber, Gajanand Sharma, Vijay Singh Gondil & Om Prakash Katare. (2017) Supramolecular nano-engineered lipidic carriers based on diflunisal-phospholipid complex for transdermal delivery: QbD based optimization, characterization and preclinical investigations for management of rheumatoid arthritis. International Journal of Pharmaceutics 533:1, pages 206-224.
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Sarwar Beg, O.P. Katare & Bhupinder Singh. (2017) Formulation by design approach for development of ultrafine self-nanoemulsifying systems of rosuvastatin calcium containing long-chain lipophiles for hyperlipidemia management. Colloids and Surfaces B: Biointerfaces 159, pages 869-879.
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Mohd Qumbar, Ameeduzzafar, Syed Sarim Imam, Javed Ali, Javed Ahmad & Asgar Ali. (2017) Formulation and optimization of lacidipine loaded niosomal gel for transdermal delivery: In-vitro characterization and in-vivo activity. Biomedicine & Pharmacotherapy 93, pages 255-266.
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N. K. Yadav, Sanju Nanda, Gajanand Sharma & O. P. Katare. (2016) Systematically Optimized Ketoprofen-Loaded Novel Proniosomal Formulation for Periodontitis: In Vitro Characterization and In Vivo Pharmacodynamic Evaluation. AAPS PharmSciTech 18:5, pages 1863-1880.
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Premjeet Singh Sandhu, Rajendra Kumar, OP Katare & Bhupinder Singh. (2017) Surface-tailored nanomixed micelles containing quercetin–salicylic acid physical complex for enhanced cellular and in vivo activities: a quality by design perspective . Nanomedicine 12:11, pages 1281-1303.
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G.K. Güler, H. Eroğlu & L. Öner. (2017) Development and formulation of floating tablet formulation containing rosiglitazone maleate using Artificial Neural Network. Journal of Drug Delivery Science and Technology 39, pages 385-397.
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Riddhish Patadia, Chintan Vora, Karan Mittal & Rajashree C. Mashru. (2016) Quality by Design Empowered Development and Optimisation of Time-Controlled Pulsatile Release Platform Formulation Employing Compression Coating Technology. AAPS PharmSciTech 18:4, pages 1213-1227.
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Neeraj K. Garg, Gajanand Sharma, Bhupinder Singh, Pradip Nirbhavane, Rajeev K. Tyagi, Rahul Shukla & O.P. Katare. (2017) Quality by Design (QbD)-enabled development of aceclofenac loaded-nano structured lipid carriers (NLCs): An improved dermatokinetic profile for inflammatory disorder(s). International Journal of Pharmaceutics 517:1-2, pages 413-431.
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Shalaka Dhat, Swati Pund, Chandrakant Kokare, Pankaj Sharma & Birendra Shrivastava. (2017) Risk management and statistical multivariate analysis approach for design and optimization of satranidazole nanoparticles. European Journal of Pharmaceutical Sciences 96, pages 273-283.
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Bhupinder Singh, Sumant Saini, Shikha Lohan & Sarwar Beg. 2017. Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes. Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes 110 148 .
Sanjay Bansal, Sarwar Beg, Babita Garg, Abhay Asthana, Gyati S. Asthana & Bhupinder Singh. (2015) QbD-Oriented Development and Characterization of Effervescent Floating-Bioadhesive Tablets of Cefuroxime Axetil. AAPS PharmSciTech 17:5, pages 1086-1099.
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Mohammad Saquib Hasnain, Salman Siddiqui, Shireen Rao, Priyadarsan Mohanty, Tahseen Jahan Ara & Sarwar Beg. (2016) QbD-Driven Development and Validation of a Bioanalytical LC–MS Method for Quantification of Fluoxetine in Human Plasma. Journal of Chromatographic Science 54:5, pages 736-743.
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Babita Garg, O.P. Katare, Sarwar Beg, Shikha Lohan & Bhupinder Singh. (2016) Systematic development of solid self-nanoemulsifying oily formulations (S-SNEOFs) for enhancing the oral bioavailability and intestinal lymphatic uptake of lopinavir. Colloids and Surfaces B: Biointerfaces 141, pages 611-622.
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