title: Development of Oral Flexible Tablet (OFT) Formulation for Pediatric and Geriatric Patients: a Novel Age-Appropriate Formulation Platform.
abstract: Development of palatable formulations for pediatric and geriatric patients involves various challenges. However, an innovative development with beneficial characteristics of marketed formulations in a single formulation platform was attempted. The goal of this research was to develop solid oral flexible tablets (OFTs) as a platform for pediatrics and geriatrics as oral delivery is the most convenient and widely used mode of drug administration. For this purpose, a flexible tablet formulation using cetirizine hydrochloride as model stability labile class 1 and 3 drug as per the Biopharmaceutical Classification System was developed. Betadex, Eudragit E100, and polacrilex resin were evaluated as taste masking agents. Development work focused on excipient selection, formulation processing, characterization methods, stability, and palatability testing. Formulation with a cetirizine-to-polacrilex ratio of 1:2 to 1:3 showed robust physical strength with friability of 0.1% (w/w), rapid in vitro dispersion within 30 s in 2-6 ml of water, and 0.2% of total organic and elemental impurities. Polacrilex resin formulation shows immediate drug release within 30 min in gastric media, better taste masking, and acceptable stability. Hence, it is concluded that ion exchange resins can be appropriately used to develop taste-masked, rapidly dispersible, and stable tablet formulations with tailored drug release suitable for pediatrics and geriatrics. Flexible formulations can be consumed as swallowable, orally disintegrating, chewable, and as dispersible tablets. Flexibility in dose administration would improve compliance in pediatrics and geriatrics. This drug development approach using ion exchange resins can be a platform for formulating solid oral flexible drug products with low to medium doses.
authors.affiliation: Department of Pharmaceutical Technology, Centre for Excellence in Nanobio Translational Research, Bharathidasan Institute of Technology Campus, Anna University, Tiruchirappalli, TN, 620024, India.
authors.forename: Prabagaran
authors.initials: P
authors.lastname: Chandrasekaran
authors.affiliation: Department of Pharmaceutical Technology, Centre for Excellence in Nanobio Translational Research, Bharathidasan Institute of Technology Campus, Anna University, Tiruchirappalli, TN, 620024, India. hodpharma@gmail.com.|National Facility for Drug Development for Academia, Pharmaceutical and Allied Industries, Department of Pharmaceutical Technology, BIT Campus, Anna University, Tiruchirappalli, TN, 620024, India. hodpharma@gmail.com.
authors.forename: Ruckmani
authors.initials: R
authors.lastname: Kandasamy
mesh_terms: D000179:Acrylates / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism; D000284:Administration, Oral; D000328:Adult; D000367:Age Factors; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism; D017332:Cetirizine / Q000008:administration & dosage* / Q000737:chemistry* / Q000378:metabolism; D002648:Child; D004339:Drug Compounding / Q000379:methods*; D065546:Drug Liberation; D005079:Excipients; D006801:Humans; D007475:Ion Exchange Resins; D008297:Male; D011108:Polymers / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism; D012995:Solubility; D013607:Tablets; D013649:Taste / Q000187:drug effects* / Q000502:physiology
chemical_list: D000179:Acrylates; D018926:Anti-Allergic Agents; C477020:Eudragit E100; D005079:Excipients; D007475:Ion Exchange Resins; D011108:Polymers; D013607:Tablets; D017332:Cetirizine
keywords: age-appropriate formulations; flexible tablets; geriatrics; palatability; pediatrics