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Formulation approaches to pediatric oral drug delivery: benefits and limitations of current platforms

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Komal Sudhakar Joshi, Raju Onkar Sonawane & Chandrakantsing Vijaysing Pardeshi. (2022) New κ-Carrageenan-montmorillonite Polyelectrolyte Complex used as a Polymer for the Extended Release Circular Pellets Containing Tapentadol Hydrochloride: Statistical optimization. Materials Technology 37:6, pages 367-380.
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Nicole Sheena Kaneria, Catherine Tuleu & Terry Ernest. (2022) Opportunities for enteral drug delivery for neonates, infants, and toddlers: a critical exploration. Expert Opinion on Drug Delivery 19:5, pages 475-519.
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Graciela Lizeth Pérez-González, Luis Jesús Villarreal-Gómez, Amelia Olivas-Sarabia, Ricardo Valdez & José Manuel Cornejo-Bravo. (2021) Development, characterization, and in vitro assessment of multilayer mucoadhesive system containing dexamethasone sodium phosphate. International Journal of Polymeric Materials and Polymeric Biomaterials 70:18, pages 1316-1328.
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Parmida Sadat Pezeshki, Aysan Moeinafshar, Faezeh Ghaemdoust, Sepideh Razi, Mahsa Keshavarz-Fathi & Nima Rezaei. (2021) Advances in pharmacotherapy for neuroblastoma. Expert Opinion on Pharmacotherapy 22:17, pages 2383-2404.
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Christina Karavasili, Angelos Gkaragkounis & Dimitrios G. Fatouros. (2021) Patent landscape of pediatric-friendly oral dosage forms and administration devices. Expert Opinion on Therapeutic Patents 31:7, pages 663-685.
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George Bebawy, Magda Sokar & Ossama Y. Abdallaha. (2021) Novel risperidone orally disintegrating minitablets for pediatric use: patient acceptance and dose adjustment. Drug Development and Industrial Pharmacy 47:4, pages 542-551.
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Harmanpreet Singh, Jasvinder Singh, Shashank K. Singh, Narpinder Singh, Surinder Paul, Harminder Singh Sohal, Umesh Gupta & Subheet Kumar Jain. (2020) Vitamin E TPGS based palatable, oxidatively and physically stable emulsion of microalgae DHA oil for infants, children and food fortification. Journal of Dispersion Science and Technology 41:11, pages 1674-1689.
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Muhammad Faisal, Willi Cawello, Bjoern B Burckhardt & Stephanie Laer. (2019) Model-dependent pharmacokinetic analysis of enalapril administered to healthy adult volunteers using orodispersible minitablets for use in pediatrics. Drug Design, Development and Therapy 13, pages 481-490.
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Tansel Comoglu & Emine Dilek Ozyilmaz. (2019) Orally disintegrating tablets and orally disintegrating mini tablets – novel dosage forms for pediatric use. Pharmaceutical Development and Technology 24:7, pages 902-914.
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Yasmin Thabet, Marta Slavkova & Jörg Breitkreutz. (2018) 10 years EU regulation of pediatric medicines – impact on cardiovascular drug formulations. Expert Opinion on Drug Delivery 15:3, pages 261-270.
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Tibor Casian, Sonia Iurian, Catalina Bogdan, Lucia Rus, Mirela Moldovan & Ioan Tomuta. (2017) QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization. Drug Development and Industrial Pharmacy 43:12, pages 1932-1944.
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Clemence Rauch, Luiz Lucio, Beatrice Bois De Fer & Michele Lheritier‐Barrand. (2023) Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride Oral Suspension. Clinical Pharmacology in Drug Development 12:12, pages 1194-1203.
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Emma A. Kean & Oluwatoyin A. Adeleke. (2023) A child-friendly anti-infective gummy formulation: Design, physicochemical, micromechanical, and taste sensory evaluation. Drug Delivery and Translational Research.
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Yingying Mu, Lijie Zhao & Lan Shen. (2023) Medication adherence and pharmaceutical design strategies for pediatric patients: An overview. Drug Discovery Today 28:11, pages 103766.
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Shristhi Sohan Rawat, Arya Rai, Deepika Raina & Inderbir Singh. 2023. Adhesives in Biomedical Applications. Adhesives in Biomedical Applications 121 149 .
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Varun Sundarkumar, Wanning Wang, Zoltan Nagy & Gintaras Reklaitis. (2023) Manufacturing pharmaceutical mini-tablets for pediatric patients using drop-on-demand printing. International Journal of Pharmaceutics 644, pages 123355.
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Marzia Cirri, Paola Mura, Simona Benedetti & Susanna Buratti. (2023) Development of a Hydroxypropyl-β-Cyclodextrin-Based Liquid Formulation for the Oral Administration of Propranolol in Pediatric Therapy. Pharmaceutics 15:9, pages 2217.
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SUSHMITA SANKESHWARI, GANGADHARAPPA H. V., ASHA SPANDANA K. M., ANU ELIYAS, SHAILESH THIRUMALESHWAR & PYDA VENKATA HARSHA VARDHAN. (2023) A REVIEW ON THE SOLID ORAL DOSAGE FORM FOR PEDIATRICS, REGULATORY ASPECTS, CHALLENGES INVOLVED DURING THE FORMULATION, AND TOXICITY OF THE EXCIPIENTS USED IN PEDIATRIC FORMULATION. International Journal of Applied Pharmaceutics, pages 12-27.
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Indeswati Diyatri, Wisnu Setyari Juliastuti, Rini Devijanti Ridwan, Ghinalya Chalbi Ananda, Fuad Adhi Waskita, Nita Vania Juliana, Shafa Putri Khansa, Reinaya Tifa Pratiwi & Cindy Ramadhan Putri. (2023) Antibacterial effect of a gingival patch containing nano-emulsion of red dragon fruit peel extract on Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, and Fusobacterium nucleatum assessed in vitro. Journal of Oral Biology and Craniofacial Research 13:3, pages 386-391.
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Carmen-Maria Jîtcă, George Jîtcă, Bianca-Eugenia Ősz, Amalia Pușcaș & Silvia Imre. (2023) Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review. Pharmaceutics 15:4, pages 1306.
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Klervi Golhen, Michael Buettcher, Jonas Kost, Jörg Huwyler & Marc Pfister. (2023) Meeting Challenges of Pediatric Drug Delivery: The Potential of Orally Fast Disintegrating Tablets for Infants and Children. Pharmaceutics 15:4, pages 1033.
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Kai-Wei Wu, Kai Zheng, Li Tian, Li Xia, Sung-Yong Hwang, Patrick E Nwakama, Wei-Jhe Sun, Myong-Jin Kim, Nilufer Tampal, Xiaoming Xu, Heather Boyce & Xin Feng. (2023) The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation. International Journal of Pharmaceutics 635, pages 122737.
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Emma A. Kean & Oluwatoyin A. Adeleke. (2023) Orally disintegrating drug carriers for paediatric pharmacotherapy. European Journal of Pharmaceutical Sciences 182, pages 106377.
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Shazia Bashir, Rawan Fitaihi & Hend E. Abdelhakim. (2023) Advances in formulation and manufacturing strategies for the delivery of therapeutic proteins and peptides in orally disintegrating dosage forms. European Journal of Pharmaceutical Sciences 182, pages 106374.
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Shuqin Hu, Xiaoxuan Liu, Shuangshuang Zhang & Danyi Quan. (2023) An Overview of Taste-Masking Technologies: Approaches, Application, and Assessment Methods. AAPS PharmSciTech 24:2.
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Khater AL-Japairai, Samah Hamed Almurisi, Abd Almonem Doolaanea, Syed Mahmood, Fawaz Alheibshy, Ahmed Alobaida, Nadiya Abdul-Halim & Bappaditya Chatterjee. (2023) A review on taste masked multiparticulate dosage forms for paediatric. International Journal of Pharmaceutics 632, pages 122571.
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Vita D'Amico, Ilaria Arduino, Mirco Vacca, Rosa Maria Iacobazzi, Davide Altamura, Antonio Lopalco, Rosanna Rizzi, Annalisa Cutrignelli, Valentino Laquintana, Franco Massimo, Maria De Angelis, Nunzio Denora & Angela Assunta Lopedota. (2023) Colonic budesonide delivery by multistimuli alginate/Eudragit® FS 30D/inulin-based microspheres as a paediatric formulation. Carbohydrate Polymers 302, pages 120422.
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Penelope N. Rampedi, Modupe O. Ogunrombi, James Wesley-Smith & Oluwatoyin A. Adeleke. (2022) A Micro-Configured Multiparticulate Reconstitutable Suspension Powder of Fixed Dose Rifampicin and Pyrazinamide: Optimal Fabrication and In Vitro Quality Evaluation. Pharmaceutics 15:1, pages 64.
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Alice P. McCloskey, Peter E. Penson, Yincent Tse, Majadah A. Abdelhafiz, Shah N. Ahmed & Emma J. Lim. (2022) Identifying and addressing pill aversion in adults without physiological‐related dysphagia: A narrative review. British Journal of Clinical Pharmacology 88:12, pages 5128-5148.
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Nicolas Atrux-Tallau, Zulaikha Naimi & Eric-Olivier Jaudinot. (2022) Pharmacokinetics of Morphine Sulfate Orodispersible Tablets and Bioequivalence with Immediate-Release Oral Morphine Sulfate Formulations in Healthy Adult Subjects Under Fasting Conditions: Single-Dose Comparative Bioavailability Studies. Clinical Drug Investigation 42:12, pages 1101-1112.
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Smita Salunke, Fiona O'Brien, David Cheng Thiam Tan, David Harris, Marie-Christine Math, Tina Ariën, Sandra Klein & Carsten Timpe. (2022) Oral drug delivery strategies for development of poorly water soluble drugs in paediatric patient population. Advanced Drug Delivery Reviews 190, pages 114507.
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Nikhil Mehta & Rohan Pai. (2022) Amalgamation of Nanoparticles within Drug Carriers: A Synergistic Approach or a Futile Attempt?. Pharmaceutical Nanotechnology 10:5, pages 354-367.
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José Eduardo Juárez‐Hernández & Bruce C. Carleton. (2022) Paediatric oral formulations: Why don't our kids have the medicines they need?. British Journal of Clinical Pharmacology 88:10, pages 4337-4348.
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Catherine Litalien, Sophie Bérubé, Catherine Tuleu, Andrea Gilpin, Émilie Kate Landry, Marie Valentin, Robert Strickley & Mark A. Turner. (2022) From paediatric formulations development to access: Advances made and remaining challenges. British Journal of Clinical Pharmacology 88:10, pages 4349-4383.
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Samah Hamed Almurisi, Abd Almonem Doolaanea, Khater Ahmed Al-Japairai, Bappaditya Chatterjee & Md Zaidul Islam Sarker. (2022) Development and Validation of UV Spectrophotometric Method for Determination of Paracetamol in Chitosan Coated Alginate Beads and Dissolution Studies. Pharmaceutical Chemistry Journal 56:7, pages 1011-1016.
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Hamzeh Alkhatib, Abd Almonem Doolaanea, Elham Assadpour, Awis Sukarni Mohmad Sabere, Farahidah Mohamed & Seid Mahdi Jafari. (2022) Optimizing the encapsulation of black seed oil into alginate beads by ionic gelation. Journal of Food Engineering 328, pages 111065.
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Andreea Cornilă, Sonia Iurian, Ioan Tomuță & Alina Porfire. (2022) Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations. Pharmaceutics 14:8, pages 1621.
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Lehlogonolo N. F. Maphalle, Bozena B. Michniak-Kohn, Modupe O. Ogunrombi & Oluwatoyin A. Adeleke. (2022) Pediatric Tuberculosis Management: A Global Challenge or Breakthrough?. Children 9:8, pages 1120.
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Richard H. ParrishIIII, Lisa D. Ashworth, Raimar Löbenberg, Sandra Benavides, Jeffrey J. Cies & Robert B. MacArthur. (2022) Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update. Pharmaceutics 14:5, pages 1032.
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Margarida Pereira, Filipa Cosme Silva, Sandra Simões, Helena Margarida Ribeiro, António José Almeida & Joana Marto. (2022) Innovative, Sugar-Free Oral Hydrogel as a Co-administrative Vehicle for Pediatrics: a Strategy to Enhance Patient Compliance. AAPS PharmSciTech 23:4.
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Harsh G. Shah, Vishal Rathod, Pratap Basim, Bhavin Gajera & Rutesh H. Dave. (2022) Understanding the Impact of Multi-factorial Composition on Efficient Loading of the Stable Ketoprofen Nanoparticles on Orodispersible Films Using Box-Behnken Design. Journal of Pharmaceutical Sciences 111:5, pages 1451-1462.
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Arkadiusz Hejduk & Janina Lulek. (2022) Dispensing of minitablets – Has the problem been resolved?. International Journal of Pharmaceutics 619, pages 121666.
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Sura Zuhair Mahmood, Nora Zawar Yousif & Zeina Dawood Salman. (2022) Types of Attractive Dosage Forms for Primary School Students and Associated Factors in Baghdad/ Iraq. Al Mustansiriyah Journal of Pharmaceutical Sciences 20:4, pages 13-22.
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Theresa Maier, Paula Peirce, Laura Baird, Sophie L. Whitehouse, Nigel K. H. Slater & Kathryn Beardsall. (2022) Drug delivery from a solid formulation during breastfeeding—A feasibility study with mothers and infants. PLOS ONE 17:3, pages e0264747.
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Dilawar Khan, Daniel Kirby, Simon Bryson, Maryam Shah & Afzal Rahman Mohammed. (2022) Paediatric specific dosage forms: Patient and formulation considerations. International Journal of Pharmaceutics 616, pages 121501.
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Maria Attebäck, Bengt Hedin & Sofia Mattsson. (2022) Formulation Optimization of Extemporaneous Oral Liquids Containing Naloxone and Propranolol for Pediatric Use. Scientia Pharmaceutica 90:1, pages 15.
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Surendra Agrawal, Joneth Fernandes, Fuzail Shaikh & Vishwa Patel. (2022) Quality aspects in the development of pelletized dosage forms. Heliyon 8:2, pages e08956.
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Guendalina Zuccari, Silvana Alfei, Danilo Marimpietri, Valentina Iurilli, Paola Barabino & Leonardo Marchitto. (2022) Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics. Pharmaceuticals 15:1, pages 108.
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Klaudia Bialek, Zaneta Wojnarowska, Marcin Skotnicki, Brendan Twamley, Marian Paluch & Lidia Tajber. (2021) Submerged Eutectic-Assisted, Solvent-Free Mechanochemical Formation of a Propranolol Salt and Its Other Multicomponent Solids. Pharmaceutics 13:12, pages 2125.
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Aashima Arora, M. Praveen Kumar, Aishwarya Anand, Lekha Saha, Pradip Kumar Saha, Ankit Kumar, Haresh Shendge & Amol N. Patil. (2021) Identification of At-risk Pregnant Population for Over-the-Counter Drug Usage in Low-Resource Settings. The Journal of Obstetrics and Gynecology of India 71:6, pages 600-608.
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Atabak Ghanizadeh Tabriz, Daniel Henri George Fullbrook, Lilian Vilain, Youri Derrar, Uttom Nandi, Clara Grau, Anaïs Morales, Gemma Hooper, Zoltan Hiezl & Dennis Douroumis. (2021) Personalised Tasted Masked Chewable 3D Printed Fruit-Chews for Paediatric Patients. Pharmaceutics 13:8, pages 1301.
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Sanika KOLE, Ashwin KUCHEKAR & Dnyanesh LİMAYE. (2021) Advancements in Formulation Approaches to Pediatric Oral Drug Delivery systems. Hacettepe University Journal of the Faculty of Pharmacy.
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Asia N Rashed, David Terry, Andy Fox, Nanna Christiansen & Stephen Tomlin. (2021) Feasibility of developing children’s Pill School within a UK hospital. Archives of Disease in Childhood 106:7, pages 705-708.
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Eman Zmaily Dahmash, Affiong Iyire & Hamad S. Alyami. (2021) Development of orally dissolving films for pediatric-centric administration of anti-epileptic drug topiramate – A design of experiments (DoE) study. Saudi Pharmaceutical Journal 29:7, pages 635-647.
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Tatsuaki Tagami, Chisa Morimura & Tetsuya Ozeki. (2021) Effective and simple prediction model of drug release from “ghost tablets” fabricated using a digital light projection-type 3D printer. International Journal of Pharmaceutics 604, pages 120721.
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Tilen Simšič, Boris Nolimal, Jasmina Minova, Ana Baumgartner & Odon Planinšek. (2021) A straw for paediatrics: How to administer highly dosed, bitter tasting paracetamol granules. International Journal of Pharmaceutics 602, pages 120615.
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Utkarsh Bhutani, Tithi Basu & Saptarshi Majumdar. (2021) Oral Drug Delivery: Conventional to Long Acting New-Age Designs. European Journal of Pharmaceutics and Biopharmaceutics 162, pages 23-42.
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Kwadwo Amanor Mfoafo, Masoud Omidian, Charise Dallazem Bertol, Yadollah Omidi & Hossein Omidian. (2021) Neonatal and pediatric oral drug delivery: Hopes and hurdles. International Journal of Pharmaceutics 597, pages 120296.
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Yanping Deng, Lian Shen, Yan Yang & Jie Shen. (2021) Development of nanoparticle-based orodispersible palatable pediatric formulations. International Journal of Pharmaceutics 596, pages 120206.
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Joseph Ali, Jong Bong Lee, Sally Gittings, Alessandro Iachelini, Joanne Bennett, Anne Cram, Martin Garnett, Clive J. Roberts & Pavel Gershkovich. (2021) Development and optimisation of simulated salivary fluid for biorelevant oral cavity dissolution. European Journal of Pharmaceutics and Biopharmaceutics 160, pages 125-133.
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John P. Gleeson, Katherine C. Fein, Namit Chaudhary, Rose Doerfler, Alexandra N. Newby & Kathryn A. Whitehead. (2021) The enhanced intestinal permeability of infant mice enables oral protein and macromolecular absorption without delivery technology. International Journal of Pharmaceutics 593, pages 120120.
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Danielle Andrews, Smita Salunke, Anne Cram, Joanne Bennett, Robert S. Ives, Abdul W. Basit & Catherine Tuleu. (2021) Bitter-blockers as a taste masking strategy: A systematic review towards their utility in pharmaceuticals. European Journal of Pharmaceutics and Biopharmaceutics 158, pages 35-51.
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Kuldeep Rajpoot, Rakesh Kumar Tekade, Bappaditya Chatterjee, Mukesh Chandra Sharma & Muktika Tekade. 2021. Biopharmaceutics and Pharmacokinetics Considerations. Biopharmaceutics and Pharmacokinetics Considerations 109 144 .
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Ra’fat Ali, Abdullah Shadeed, Hasan Fitian & Sa’ed H. Zyoud. (2020) The difficulties experienced during the preparation and administration of oral drugs by parents at home: a cross-sectional study from Palestine. BMC Pediatrics 20:1.
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Manjusha Annaji, Sindhu Ramesh, Ishwor Poudel, Manoj Govindarajulu, Robert D. Arnold, Muralikrishnan Dhanasekaran & R. Jayachandra Babu. (2020) Application of Extrusion-Based 3D Printed Dosage Forms in the Treatment of Chronic Diseases. Journal of Pharmaceutical Sciences 109:12, pages 3551-3568.
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Patricija Januskaite, Xiaoyan Xu, Sejal R. Ranmal, Simon Gaisford, Abdul W. Basit, Catherine Tuleu & Alvaro Goyanes. (2020) I Spy with My Little Eye: A Paediatric Visual Preferences Survey of 3D Printed Tablets. Pharmaceutics 12:11, pages 1100.
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Pattaraporn Panraksa, Suruk Udomsom, Pornchai Rachtanapun, Chuda Chittasupho, Warintorn Ruksiriwanich & Pensak Jantrawut. (2020) Hydroxypropyl Methylcellulose E15: A Hydrophilic Polymer for Fabrication of Orodispersible Film Using Syringe Extrusion 3D Printer. Polymers 12:11, pages 2666.
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Miguel Moreira & Mafalda Sarraguça. (2020) How can oral paediatric formulations be improved? A challenge for the XXI century. International Journal of Pharmaceutics 590, pages 119905.
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Mohsen Khodadadi Yazdi, Ali Taghizadeh, Mohsen Taghizadeh, Florian J. Stadler, Mehdi Farokhi, Fatemeh Mottaghitalab, Payam Zarrintaj, Joshua D. Ramsey, Farzad Seidi, Mohammad Reza Saeb & Masoud Mozafari. (2020) Agarose-based biomaterials for advanced drug delivery. Journal of Controlled Release 326, pages 523-543.
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Zainab H. Mahdi. (2020) Oral Jellies for Improving Oral Drug Delivery in Dysphagia. Al Mustansiriyah Journal of Pharmaceutical Sciences 20:3, pages 94-104.
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Justyna Katarzyna Hofmanová, Joanne Bennett, Alastair Coupe, Jeremy A. Bartlett, Andrew Monahan & Hannah Katharine Batchelor. (2020) A Novel Oral Syringe for Dosing and Administration of Multiparticulate Formulations: Acceptability Study in Preschool and School Children. Pharmaceutics 12:9, pages 806.
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Nyaradzo Matawo, Oluwatoyin A. Adeleke & James Wesley-Smith. (2020) Optimal Design, Characterization and Preliminary Safety Evaluation of an Edible Orodispersible Formulation for Pediatric Tuberculosis Pharmacotherapy. International Journal of Molecular Sciences 21:16, pages 5714.
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Claudia A. Ortega, Laura S. Favier, Valeria A. Cianchino & Diego A. Cifuente. (2020) New Orodispersible Mini Tablets of Enalapril Maleate by Direct Compression for Pediatric Patients. Current Drug Delivery 17:6, pages 505-510.
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Neel Desai, Andrew Redfearn, Graeme MacLeod, Catherine Tuleu, Ben Hanson & Mine Orlu. (2020) How Do Orodispersible Tablets Behave in an In Vitro Oral Cavity Model: A Pilot Study. Pharmaceutics 12:7, pages 651.
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Preeya Raja, Mark Duffett, Maryann Mazer-Amirshahi, Ashaka Patel, Andrea Gilpin, Catherine Litalien, Anthony K. Chan, John van den Anker, Thierry Lacaze-Masmonteil & Samira Samiee-Zafarghandy. (2020) Pediatric drug data in Canadian drug monographs: a descriptive analysis. CMAJ Open 8:3, pages E522-E529.
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Hend E. Abdelhakim, Gareth R. Williams, Duncan Q.M. Craig, Mine Orlu & Catherine Tuleu. (2020) Human mouthfeel panel investigating the acceptability of electrospun and solvent cast orodispersible films. International Journal of Pharmaceutics 585, pages 119532.
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Clarinda Costa, Zehua Liu, João P. Martins, Alexandra Correia, Patrícia Figueiredo, Antti Rahikkala, Wei Li, Jani Seitsonen, Janne Ruokolainen, Sami-Pekka Hirvonen, Ana Aguiar-Ricardo, M. Luísa Corvo & Hélder A. Santos. (2020) All-in-one microfluidic assembly of insulin-loaded pH-responsive nano-in-microparticles for oral insulin delivery. Biomaterials Science 8:12, pages 3270-3277.
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