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Critical Reviews™ in Therapeutic Drug Carrier Systems

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Optimizing Drug Delivery Systems Using Systematic "Design of Experiments." Part I: Fundamental Aspects

Volume 22, Issue 1, 2005, pp. 27-105
DOI: 10.1615/CritRevTherDrugCarrierSyst.v22.i1.20
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Bhupinder Singh
Professor
Rajiv Kumar
Pharmaceutics Division, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India
Naveen Ahuja
Pharmaceutics Division, University Institute of Pharmaceutical Sciences, Panjab University, Chandigarh, India

ABSTRACT

Design of an impeccable drug delivery product normally encompasses multiple objectives. For decades, this task has been attempted through trial and error, supplemented with the previous experience, knowledge, and wisdom of the formulator. Optimization of a pharmaceutical formulation or process using this traditional approach involves changing one variable at a time. Using this methodology, the solution of a specific problematic formulation characteristic can certainly be achieved, but attainment of the true optimal composition is never guaranteed. And for improvement in one characteristic, one has to trade off for degeneration in another. This customary approach of developing a drug product or process has been proved to be not only uneconomical in terms of time, money, and effort, but also unfavorable to fix errors, unpredictable, and at times even unsuccessful.
On the other hand, the modern formulation optimization approaches, employing systematic Design of Experiments (DoE), are extensively practiced in the development of diverse kinds of drug delivery devices to improve such irregularities. Such systematic approaches are far more advantageous, because they require fewer experiments to achieve an optimum formulation, make problem tracing and rectification quite easier, reveal drug/polymer interactions, simulate the product performance, and comprehend the process to assist in better formulation development and subsequent scale-up. Optimization techniques using DoE represent effective and cost-effective analytical tools to yield the "best solution" to a particular "problem." Through quantification of drug delivery systems, these approaches provide a depth of understanding as well as an ability to explore and defend ranges for formulation factors, where experimentation is completed before optimization is attempted. The key elements of a DoE optimization methodology encompass planning the study objectives, screening of influential variables, experimental designs, postulation of mathematical models for various chosen response characteristics, fitting experimental data into these model(s), mapping and generating graphic outcomes, and design validation using model-based response surface methodology.
The broad topic of DoE optimization methodology is covered in two parts. Part I of the review attempts to provide thought-through and thorough information on diverse DoE aspects organized in a seven-step sequence. Besides dealing with basic DoE terminology for the novice, the article covers the niceties of several important experimental designs, mathematical models, and optimum search techniques using numeric and graphical methods, with special emphasis on computer-based approaches, artificial neural networks, and judicious selection of designs and models.

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  100. Patadia Riddhish, Vora Chintan, Mittal Karan, Mashru Rajashree C., Quality by Design Empowered Development and Optimisation of Time-Controlled Pulsatile Release Platform Formulation Employing Compression Coating Technology, AAPS PharmSciTech, 18, 4, 2017. Crossref

  101. Khan Anam, Imam Syed Sarim, Aqil Mohd, Sultana Yasmin, Ali Asgar, Khan Khalid, Design of experiment based validated stability indicating RP-HPLC method of temozolomide in bulk and pharmaceutical dosage forms, Beni-Suef University Journal of Basic and Applied Sciences, 5, 4, 2016. Crossref

  102. 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

  103. de Melo da Silva Lucas, Pereira Cavalcante Rodrigo, Fabbro Cunha Rebeca, Gozzi Fábio, Falcao Dantas Renato, de Oliveira Silvio Cesar, Machulek Amilcar, Tolfenamic acid degradation by direct photolysis and the UV-ABC/H2O2 process: factorial design, kinetics, identification of intermediates, and toxicity evaluation, Science of The Total Environment, 573, 2016. Crossref

  104. Sood Jatin, Sapra Bharti, Tiwary Ashok K., Microemulsion Transdermal Formulation for Simultaneous Delivery of Valsartan and Nifedipine: Formulation by Design, AAPS PharmSciTech, 18, 6, 2017. Crossref

  105. Garg Neeraj K., Sharma Gajanand, Singh Bhupinder, Nirbhavane Pradip, Tyagi Rajeev K., Shukla Rahul, Katare O.P., 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, 2017. Crossref

  106. Khurana Rajneet Kaur, Bansal Arvind K., Beg Sarwar, Burrow Andrea Julie, Katare O.P., Singh Kamalinder K., Singh Bhupinder, Enhancing biopharmaceutical attributes of phospholipid complex-loaded nanostructured lipidic carriers of mangiferin: Systematic development, characterization and evaluation, International Journal of Pharmaceutics, 518, 1-2, 2017. Crossref

  107. Singh Bhupinder, Garg Babita, Bhatowa Rahul, Kapil Rishi, Saini Sumant, Beg Sarwar, Systematic development of a gastroretentive fixed dose combination of lamivudine and zidovudine for increased patient compliance, Journal of Drug Delivery Science and Technology, 37, 2017. Crossref

  108. Kaithwas Vikram, Dora Chander Parkash, Kushwah Varun, Jain Sanyog, Nanostructured lipid carriers of olmesartan medoxomil with enhanced oral bioavailability, Colloids and Surfaces B: Biointerfaces, 154, 2017. Crossref

  109. Sahu Prafulla Kumar, Ramisetti Nageswara Rao, Cecchi Teresa, Swain Suryakanta, Patro Chandra Sekhar, Panda Jagadeesh, An overview of experimental designs in HPLC method development and validation, Journal of Pharmaceutical and Biomedical Analysis, 147, 2018. Crossref

  110. Vohra Aamin M., Patel Chintankumar V., Kumar Praveen, Thakkar Hetal P., Development of dual drug loaded solid self microemulsifying drug delivery system: Exploring interfacial interactions using QbD coupled risk based approach, Journal of Molecular Liquids, 242, 2017. Crossref

  111. 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

  112. Khalid Ikrima, Ahmad Mahmood, Minhas Muhammad Usman, Sohail Muhammad, Formulation and in vitro evaluation of mucoadhesive controlled release matrix tablets of flurbiprofen using response surface methodology, Brazilian Journal of Pharmaceutical Sciences, 50, 3, 2014. Crossref

  113. Mohtashamian Shahab, Boddohi Soheil, Hosseinkhani Saman, Preparation and optimization of self-assembled chondroitin sulfate-nisin nanogel based on quality by design concept, International Journal of Biological Macromolecules, 107, 2018. Crossref

  114. 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

  115. Nagaraj K., Narendar D., Kishan V., Development of olmesartan medoxomil optimized nanosuspension using the Box–Behnken design to improve oral bioavailability, Drug Development and Industrial Pharmacy, 43, 7, 2017. Crossref

  116. Garg Babita, Beg Sarwar, Kaur Ranjot, Kumar Rajendra, Katare Om Prakash, Singh Bhupinder, Long-chain triglycerides-based self-nanoemulsifying oily formulations (SNEOFs) of darunavir with improved lymphatic targeting potential, Journal of Drug Targeting, 26, 3, 2018. Crossref

  117. 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

  118. Khurana Rajneet Kaur, Beg Sarwar, Burrow Andrea Julie, Vashishta Rakesh K., Katare O.P., Kaur Satvinder, Kesharwani Prashant, Singh Kamalinder K., Singh Bhupinder, Enhancing biopharmaceutical performance of an anticancer drug by long chain PUFA based self-nanoemulsifying lipidic nanomicellar systems, European Journal of Pharmaceutics and Biopharmaceutics, 121, 2017. Crossref

  119. Vardhan Harsh, Mittal Pooja, Adena Sandeep K. Reddy, Upadhyay Mansi, Mishra Brahmeshwar, Development of long-circulating docetaxel loaded poly (3-hydroxybutyrate-co-3-hydroxyvalerate) nanoparticles: Optimization, pharmacokinetic, cytotoxicity and in vivo assessments, International Journal of Biological Macromolecules, 103, 2017. Crossref

  120. Sandhu Premjeet Singh, Beg Sarwar, Kumar Rajendra, Katare O. P., Singh Bhupinder, Analytical QbD-based systematic bioanalytical HPLC method development for estimation of quercetin dihydrate, Journal of Liquid Chromatography & Related Technologies, 40, 10, 2017. Crossref

  121. Hasnain M. Saquib, Ansari Shaukat Ali, Rao Shireen, Tabish Mohammad, Singh Mukul, Abdullah Mohammad Syafiq, Ansari Mohammed Tahir, QbD-Driven Development and Validation of Liquid Chromatography Tandem Mass Spectrometric Method for the Quantitation of Sildenafil in Human Plasma, Journal of Chromatographic Science, 55, 6, 2017. Crossref

  122. Singh Bhupinder, Saini Sumant, Lohan Shikha, Beg Sarwar, Systematic Development of Nanocarriers Employing Quality by Design Paradigms, in Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes, 2017. Crossref

  123. Mahajan Ashok, Surti Naazneen, Koladiya Pooja, Solid dispersion adsorbate technique for improved dissolution and flow properties of lurasidone hydrochloride: characterization using 32 factorial design, Drug Development and Industrial Pharmacy, 44, 3, 2018. Crossref

  124. Vijayavani S.Ch, Vidyavathi Maravajhala, Azadirachita indica gum based sildenafil citrate mucoadhesive microspheres – Design and optimization, Journal of Drug Delivery Science and Technology, 47, 2018. Crossref

  125. Beg Sarwar, Rahman Mahfoozur, Kohli Kanchan, Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products, Drug Discovery Today, 24, 3, 2019. Crossref

  126. de Melo da Silva Lucas, Gozzi Fábio, Sirés Ignasi, Brillas Enric, de Oliveira Silvio Cesar, Machulek Amilcar, Degradation of 4-aminoantipyrine by electro-oxidation with a boron-doped diamond anode: Optimization by central composite design, oxidation products and toxicity, Science of The Total Environment, 631-632, 2018. Crossref

  127. Fonseca Rafael F., Melo Caio C. B., Sanches Beatriz B. C. P., Bertucci-Neto Victor, Farinas Cristiane S., Kwong Wu H., Modelling of solid-state fermentation over wide operational range for application in process optimization, The Canadian Journal of Chemical Engineering, 96, 8, 2018. Crossref

  128. Parmar Chintan, Parikh Kinjal, Mundada Piyush, Bhavsar Dhaval, Sawant Krutika, Formulation and optimization of enteric coated bilayer tablets of mesalamine by RSM: In vitro – In vivo investigations and roentogenographic study, Journal of Drug Delivery Science and Technology, 44, 2018. Crossref

  129. Kedia Kishori, Wairkar Sarika, Improved micromeritics, packing properties and compressibility of high dose drug, Cycloserine, by spherical crystallization, Powder Technology, 344, 2019. Crossref

  130. Levin Alexandra, Sharma Vaibhav, Hook Lilian, García-Gareta Elena, The importance of factorial design in tissue engineering and biomaterials science: Optimisation of cell seeding efficiency on dermal scaffolds as a case study, Journal of Tissue Engineering, 9, 2018. Crossref

  131. Mittal Pooja, Vardhan Harsh, Ajmal Gufran, Bonde Gunjan Vasant, Kapoor Ramit, Mittal Ashu, Mishra Brahmeshwar, Formulation, optimization, hemocompatibility and pharmacokinetic evaluation of PLGA nanoparticles containing paclitaxel, Drug Development and Industrial Pharmacy, 45, 3, 2019. Crossref

  132. Hasnain Manzar, Imam Syed Sarim, Aqil Mohd., Ahad Abdul, Sultana Yasmin, Application of Lipid Blend-Based Nanoparticulate Scaffold for Oral Delivery of Antihypertensive Drug: Implication on Process Variables and In Vivo Absorption Assessment, Journal of Pharmaceutical Innovation, 13, 4, 2018. Crossref

  133. 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

  134. Upadhyay Mansi, Adena Sandeep Kumar Reddy, Vardhan Harsh, Yadav Sarita K., Mishra Brahmeshwar, Development of biopolymers based interpenetrating polymeric network of capecitabine: A drug delivery vehicle to extend the release of the model drug, International Journal of Biological Macromolecules, 115, 2018. Crossref

  135. Praveen Arshiya, Aqil Mohd., Imam Syed Sarim, Ahad Abdul, Moolakkadath Thasleem, Ahmad Farhan J., Lamotrigine encapsulated intra-nasal nanoliposome formulation for epilepsy treatment: Formulation design, characterization and nasal toxicity study, Colloids and Surfaces B: Biointerfaces, 174, 2019. Crossref

  136. Fonseca Rafael Frederico, Oliveira Guilherme Henrique Duarte de, Zaiat Marcelo, Development of a mathematical model for the anaerobic digestion of antibiotic-contaminated wastewater, Chemical Engineering Research and Design, 134, 2018. Crossref

  137. 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

  138. Sharma Mandeep, Sharma Gajanand, Singh Bhupinder, Katare Om Prakash, Systematically Optimized Imiquimod-Loaded Novel Hybrid Vesicles by Employing Design of Experiment (DoE) Approach with Improved Biocompatibility, Stability, and Dermatokinetic Profile, AAPS PharmSciTech, 20, 4, 2019. Crossref

  139. Jain Atul, Beg Sarwar, Saini Sumant, Sharma Teenu, Katare O. P., Singh Bhupinder, 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, 2019. Crossref

  140. Arora Daisy, Nanda Sanju, 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, 2019. Crossref

  141. 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

  142. Gilani Sadaf Jamal, Rizwanullah Md., Imam Syed Sarim, Pandit Jayamanti, Aqil Mohd., Alam Meraj, Beg Sarwar, QbD Considerations for Topical and Transdermal Product Development, in Pharmaceutical Quality by Design, 2019. Crossref

  143. Kastner Elisabeth, Kaur Randip, Lowry Deborah, Moghaddam Behfar, Wilkinson Alexander, Perrie Yvonne, High-throughput manufacturing of size-tuned liposomes by a new microfluidics method using enhanced statistical tools for characterization, International Journal of Pharmaceutics, 477, 1-2, 2014. Crossref

  144. 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

  145. Rapalli Vamshi Krishna, Khosa Archana, Singhvi Gautam, Girdhar Vishal, Jain Rupesh, Dubey Sunil Kumar, Application of QbD Principles in Nanocarrier-Based Drug Delivery Systems, in Pharmaceutical Quality by Design, 2019. Crossref

  146. Beg Sarwar, Swain Suryakanta, Rahman Mahfoozur, Hasnain Md Saquib, Imam Syed Sarim, Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization, in Pharmaceutical Quality by Design, 2019. Crossref

  147. Kant Ravi, Bodla Ramesh Babu, Kapoor Garima, Bhutani Rubina, Optimization of a single HPLC-PDA method for quantifying Metformin, Gliclazide, Pioglitazone, Dapagliflozin, Empagliflozin, Saxagliptin, Linagliptin and Teneligliptin using central composite design, Bioorganic Chemistry, 91, 2019. Crossref

  148. da Silva Lucas M., Gozzi Fábio, Cavalcante Rodrigo P., de Oliveira Silvio C., Brillas Enric, Sirés Ignasi, Machulek Amilcar, Assessment of 4-Aminoantipyrine Degradation and Mineralization by Photoelectro-Fenton with a Boron-Doped Diamond Anode: Optimization, Treatment in Municipal Secondary Effluent, and Toxicity, ChemElectroChem, 6, 3, 2019. Crossref

  149. Li Wenji, Ng Ka-yun, Heng Paul Wan Sia, Development and Evaluation of Optimized Sucrose Ester Stabilized Oleanolic Acid Nanosuspensions Prepared by Wet Ball Milling with Design of Experiments, Biological and Pharmaceutical Bulletin, 37, 6, 2014. Crossref

  150. 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

  151. Pandey Shitanshu, Kumar Sushil, Reactive extraction of gallic acid from aqueous solution with Tri-n-octylamine in oleyl alcohol: Equilibrium, Thermodynamics and optimization using RSM-rCCD, Separation and Purification Technology, 231, 2020. Crossref

  152. Jain Atul, Sharma Teenu, Sharma Gajanand, Khurana Rajneet Kaur, Katare Om Prakash, Singh Bhupinder, QbD-Driven Analytical Method Development and Validation for Raloxifene Hydrochloride in Pure Drug and Solid Oral Dosage Form, Analytical Chemistry Letters, 9, 4, 2019. Crossref

  153. Hildebrandt Claudia, Gopireddy Srikanth R., Scherließ Regina, Urbanetz Nora A., Assessment of material and process attributes' influence on tablet quality using a QbD and DEM combined approach, Powder Technology, 345, 2019. Crossref

  154. Martins Sarah Moherdaui, Müller Vinicius, Galan Vanderson, Souza Fabio Pinheiro de, Andreazza Itamar Francisco, Rosa Maurício Ferreira da, Development and evaluation of multiparticulate biphasic system for the treatment of circadian diseases, Brazilian Journal of Pharmaceutical Sciences, 54, 4, 2018. Crossref

  155. Bai Ge, Chen Zhijin, Raines Kimberly, Chen Hansong, Dave Kaushalkumar, Lin Ho-Pi, Zolnik Banu S., Assessment of Applications of Design of Experiments in Pharmaceutical Development for Oral Solid Dosage Forms, Journal of Pharmaceutical Innovation, 15, 4, 2020. Crossref

  156. Alavi Sonia, Akhlaghi Sarah, Dadashzadeh Simin, Haeri Azadeh, Green Formulation of Triglyceride/Phospholipid‐Based Nanocarriers as a Novel Vehicle for Oral Coenzyme Q10 Delivery, Journal of Food Science, 84, 9, 2019. Crossref

  157. Thatai Purva, Khan Arshad B., Management of nail psoriasis by topical drug delivery: a pharmaceutical perspective, International Journal of Dermatology, 59, 8, 2020. Crossref

  158. 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

  159. Siddiqui Lubna, Bag Janmejaya, Seetha , Mittal Disha, Leekha Ankita, Mishra Harshita, Mishra Monalisa, Verma Anita K., Mishra Pawan K., Ekielski Adam, Iqbal Zeenat, Talegaonkar Sushama, Assessing the potential of lignin nanoparticles as drug carrier: Synthesis, cytotoxicity and genotoxicity studies, International Journal of Biological Macromolecules, 152, 2020. Crossref

  160. Khurana Bharat, Arora Daisy, Narang Raj K., FbD Supported Development and In Vitro Evaluation of Carbomer based Resveratrol Loaded Topical Antipsoriatic Nanoemulgel for its Targeted Skin Delivery, Pharmaceutical Nanotechnology, 8, 2, 2020. Crossref

  161. Arun Jagdish Kumar, Vodeti Rajeshwar, Shrivastava Birendra, Bakshi Vasudha, Integrated Quality by Design Approach for Developing Nanolipidic Drug Delivery Systems of Olmesartan Medoxomil with Enhanced Antihypertensive Action, Advanced Pharmaceutical Bulletin, 10, 3, 2020. Crossref

  162. 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

  163. 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

  164. Sharma Mandeep, Sharma Gajanand, Singh Bhupinder, Dhiman Vandana, Bhadada Sanjay Kumar, Katare O.P., Holistic development of coal tar lotion by embedding design of experiments (DoE) technique: preclinical investigations, Expert Opinion on Drug Delivery, 17, 2, 2020. Crossref

  165. Kulpreechanan Narissara, Sorasitthiyanukarn Feuangthit N., Preparation and Optimization of Capsaicin-Loaded Chitosan Nanoparticles as Delivery Systems Using Box-Behnken Design, Materials Science Forum, 998, 2020. Crossref

  166. Mahajan Ashok Neelkanth, Surti Naazneen, Patel Priyal, Patel Ashwini, Shah Dimal, Patel Vandana, Melt Dispersion Adsorbed onto Porous Carriers: An Effective Method to Enhance the Dissolution and Flow Properties of Raloxifene Hydrochloride, ASSAY and Drug Development Technologies, 18, 6, 2020. Crossref

  167. Arora Udit, Thakkar Vaishali, Baldaniya Lalji, Gohel Mukesh C., Fabrication and evaluation of fast disintegrating pellets of cilostazol, Drug Development and Industrial Pharmacy, 46, 12, 2020. Crossref

  168. Aggarwal Rohan, Targhotra Monika, Sahoo P.K., Chauhan Meenakshi K., Efinaconazole nail lacquer for the transungual drug delivery: Formulation, optimization, characterization and in vitro evaluation, Journal of Drug Delivery Science and Technology, 60, 2020. Crossref

  169. Hosny Khaled M., Alhakamy Nabil A., Sindi Amal M., Khallaf Rasha A., Coconut Oil Nanoemulsion Loaded with a Statin Hypolipidemic Drug for Management of Burns: Formulation and In Vivo Evaluation, Pharmaceutics, 12, 11, 2020. Crossref

  170. Saini Sumant, Sharma Teenu, Patel Asha, Kaur Ranjot, Tripathi S.K., Katare O.P., Singh Bhupinder, QbD-steered development and validation of an RP-HPLC method for quantification of ferulic acid: Rational application of chemometric tools, Journal of Chromatography B, 1155, 2020. Crossref

  171. Tabora José E., Domagalski Nathan, Multivariate Analysis and Statistics in Pharmaceutical Process Research and Development, Annual Review of Chemical and Biomolecular Engineering, 8, 1, 2017. Crossref

  172. Gandhi Jeet, Suthar Disha, Patel Hetal, Shelat Pragna, Parejiya Punit, Development and characterization of microemulsion based topical gel of essential oil of clove (Syzygium aromaticum) for superficial fungal infections, Advances in Traditional Medicine, 21, 3, 2021. Crossref

  173. Hosny Khaled M, Asfour Hani Z, Rizg Waleed Y, Alhakamy Nabil A, Sindi Amal M, Alkhalidi Hala M, Abualsunun Walaa A, Bakhaidar Rana B, Almehmady Alshaimaa M, Akeel Sara K, Ali Sarah A, Alghaith Adel F, Alshehri Sultan, Khallaf Rasha A, Formulation, Optimization, and Evaluation of Oregano Oil Nanoemulsions for the Treatment of Infections Due to Oral Microbiota, International Journal of Nanomedicine, Volume 16, 2021. Crossref

  174. Bhattacharya Sankha, Central Composite Design for Response Surface Methodology and Its Application in Pharmacy, in Response Surface Methodology in Engineering Science, 2021. Crossref

  175. Mishra Mohini, Raza Kaisar, Design of Experiments for the Development of Transdermal Drug Products, in Design of Experiments for Pharmaceutical Product Development, 2021. Crossref

  176. Negi Poonam, Hemrajani Chetna, Agarwal Shweta, Design of Experiment for the Development of Vesicular Drug Products, in Design of Experiments for Pharmaceutical Product Development, 2021. Crossref

  177. Swain Suryakanta, Jena Bikash Ranjan, Beg Sarwar, Design of Experiments for the Development of Biotechnology Products, in Design of Experiments for Pharmaceutical Product Development, 2021. Crossref

  178. Kaur Ranjot, Saini Sumant, Patel Asha, Sharma Teenu, Kaur Ripandeep, Katare O. P, Singh Bhupinder, Developing a Validated HPLC Method for Quantification of Ceftazidime Employing Analytical Quality by Design and Monte Carlo Simulations, Journal of AOAC INTERNATIONAL, 104, 3, 2021. Crossref

  179. Thatai Purva, Sapra Bharti, Terbinafine hydrochloride nail lacquer for the management of onychomycosis: formulation, characterization and in vitro evaluation, Therapeutic Delivery, 9, 2, 2018. Crossref

  180. Ansari Farzaneh, Khodaiyan Faramarz, Rezaei Karamatollah, Rahmani Anosheh, Modelling of aflatoxin G1 reduction by kefir grain using response surface methodology, Journal of Environmental Health Science and Engineering, 13, 1, 2015. Crossref

  181. Berkani Farida, Dahmoune Farid, Achat Sabiha, Dairi Sofiane, Kadri Nabil, Zeghichi-Hamri Sabrina, Abbou Amina, Benzitoune Imane, Adel Khadidja, Remini Hocine, Belbahi Amine, Madani Khodir, Response Surface Methodology Optimization of Microwave-Assisted Polysaccharide Extraction from Algerian Jujube (Zizyphus lotus L.) Pulp and Peel, Journal of Pharmaceutical Innovation, 16, 4, 2021. Crossref

  182. Rothstein Sam N., Kay Jennifer E., Schopfer Francisco J., Freeman Bruce A., Little Steven R., A Retrospective Mathematical Analysis of Controlled Release Design and Experimentation, Molecular Pharmaceutics, 9, 11, 2012. Crossref

  183. Kathpalia H, Jogi K., DESIGN AND OPTIMIZATION OF IMMEDIATE RELEASE TABLETS OF HYDROCHLOROTHIAZIDE USING THE DESIGN OF EXPERIMENTS APPROACH, INDIAN DRUGS, 53, 09, 2016. Crossref

  184. Dong Yachao, Georgakis Christos, Mustakis Jason, Hawkins Joel M., Han Lu, Wang Ke, McMullen Jonathan P., Grosser Shane T., Stone Kevin, Constrained Version of the Dynamic Response Surface Methodology for Modeling Pharmaceutical Reactions, Industrial & Engineering Chemistry Research, 58, 30, 2019. Crossref

  185. Beg Sarwar, Rahman Mahfoozur, Design of experiments application for analytical method development, in Handbook of Analytical Quality by Design, 2021. Crossref

  186. Taleuzzaman Mohamad, Sartaj Ali, Kumar Gupta Dipak, Gilani Sadaf Jamal, Mirza Mohd. Aamir, Phytosomal gel of Manjistha extract (MJE) formulated and optimized with central composite design of Quality by Design (QbD), Journal of Dispersion Science and Technology, 2021. Crossref

  187. Altekar Maneesha, Homon Carol A., Kashem Mohammed A., Mason Steven W., Nelson Richard M., Patnaude Lori A., Yingling Jeffrey, Taylor Paul B., Assay Optimization: A Statistical Design of Experiments Approach, JALA: Journal of the Association for Laboratory Automation, 11, 1, 2006. Crossref

  188. Beg Sarwar, Swain Suryakanta, Introduction to the Experimental Designs: Basic Fundamentals, in Design of Experiments for Pharmaceutical Product Development, 2021. Crossref

  189. Shirzadian Touraj, Nourbakhsh Mohammad Sadegh, Fattahi Ali, Bahrami Gholamreza, Mohammadi Ghobad, Characterization and optimization of de‐esterified Tragacanth‐chitosan nanocomposite as a potential carrier for oral delivery of insulin: In vitro and ex vivo studies, Journal of Biomedical Materials Research Part A, 109, 11, 2021. Crossref

  190. Basso João, Ramos Maria Luísa, Pais Alberto, Vitorino Rui, Fortuna Ana, Vitorino Carla, Expediting Disulfiram Assays through a Systematic Analytical Quality by Design Approach, Chemosensors, 9, 7, 2021. Crossref

  191. Sivadasan Durgaramani, Sultan Muhammad Hadi, Madkhali Osama, Almoshari Yosif, Thangavel Neelaveni, Polymeric Lipid Hybrid Nanoparticles (PLNs) as Emerging Drug Delivery Platform—A Comprehensive Review of Their Properties, Preparation Methods, and Therapeutic Applications, Pharmaceutics, 13, 8, 2021. Crossref

  192. Long James, Hutcheon Gillian A., Cooper Andrew I., Combinatorial Discovery of Reusable Noncovalent Supports for Enzyme Immobilization and Nonaqueous Catalysis, Journal of Combinatorial Chemistry, 9, 3, 2007. Crossref

  193. 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

  194. Kulkarni Shailesh, Londhe Vaishali, Oral jelly of metformin hydrochloride – Formulation development using Design of Experiments and characterization, Journal of Drug Delivery Science and Technology, 63, 2021. Crossref

  195. Kumar Sushil, Pandey Shitanshu, Wasewar Kailas L., Ak Namık, Uslu Hasan, Reactive Extraction as an Intensifying Approach for the Recovery of Organic Acids from Aqueous Solution: A Comprehensive Review on Experimental and Theoretical Studies, Journal of Chemical & Engineering Data, 66, 4, 2021. Crossref

  196. Kaur Ranjot, Dennison Sarah R., Burrow Andrea J., Rudramurthy Shivaprakash M., Swami Rajan, Gorki Varun, Katare O. P., Kaushik Anupama, Singh Bhupinder, Singh Kamalinder K., Nebulised surface-active hybrid nanoparticles of voriconazole for pulmonary Aspergillosis demonstrate clathrin-mediated cellular uptake, improved antifungal efficacy and lung retention, Journal of Nanobiotechnology, 19, 1, 2021. Crossref

  197. Kulkarni Shailesh, Londhe Vaishali Y., Development and evaluation of extended release metformin pellets suspended in teneligliptin jelly for the treatment of diabetes mellitus, Journal of Drug Delivery Science and Technology, 70, 2022. Crossref

  198. Jahangir Mohammed Asadullah, Khan Ruqaiyah, Sarim Imam Syed, Formulation of sitagliptin-loaded oral polymeric nano scaffold: process parameters evaluation and enhanced anti-diabetic performance, Artificial Cells, Nanomedicine, and Biotechnology, 46, sup1, 2018. Crossref

  199. Qumbar Mohd, Ameeduzzafar , Imam Syed Sarim, Ali Javed, Ahmad Javed, Ali Asgar, Formulation and optimization of lacidipine loaded niosomal gel for transdermal delivery: In-vitro characterization and in-vivo activity, Biomedicine & Pharmacotherapy, 93, 2017. Crossref

  200. 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

  201. Butreddy Arun, Bandari Suresh, Repka Michael A., Quality-by-design in hot melt extrusion based amorphous solid dispersions: An industrial perspective on product development, European Journal of Pharmaceutical Sciences, 158, 2021. Crossref

  202. Bimbrawh Senha, Chopra Shruti, Ansari Mohammad Javed, Alrobaian Majed, Almalki Waleed H, Alharbi Khalid S, Alenezi Sattam K, Kaur Ripandeep, Beg Sarwar, Bhatia Amit, Biocompatible phospholipid‐based nanovesicular drug delivery system of ketoprofen: Systematic development, optimization, and preclinical evaluation, Biotechnology and Applied Biochemistry, 2022. Crossref

  203. Jena Bikash Ranjan, Panda Siva Prasad, Umasankar Kulandaivelu, Swain Suryakanta, Koteswara Rao Gudhanti Siva Naga, Damayanthi Dalu, Ghose Debashish, Pradhan Debi Prasad, Applications of QbD-based Software’s in Analytical Research and Development, Current Pharmaceutical Analysis, 17, 4, 2021. Crossref

  204. 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

  205. Li Tingting, Wan Bo, Jog Rajan, Costa Antonio, Burgess Diane J., Pectin microparticles for peptide delivery: Optimization of spray drying processing, International Journal of Pharmaceutics, 613, 2022. Crossref

  206. Latrous Latifa, Optimization and Validation in Liquid Chromatography Using Design of Experiments, Chemistry Africa, 5, 3, 2022. Crossref

  207. Pathak Kamla, Sharma Vijay, Sharma Meenu, Optimization, in vitro cytotoxicity and penetration capability of deformable nanovesicles of paclitaxel for dermal chemotherapy in Kaposi sarcoma, Artificial Cells, Nanomedicine, and Biotechnology, 44, 7, 2016. Crossref

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